HEALTHCARE
TRANSPLANT DIAGNOSTICS MARKET FORECAST TO 2021
REPORT CODE MD 3686
TRANSPLANT DIAGNOSTICS MARKET - FORECAST TO 2021 By Technology (SSO-PCR, SSP-PCR, NGS, Sanger’s Sequencing), Products & Services (Instruments, Reagents, Software), Application (Diagnostics, Research), End User (Hospitals, Academia, Diagnostic Center)
REPORT OVERVIEW 1.1
OBJECTIVES OF THE STUDY •
To define, describe, and forecast the global transplant diagnostics market on the basis of technologies, products & services, applications, and end users
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To provide detailed information regarding major factors influencing growth of the market (drivers, restraints, growth opportunities, and challenges)
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To strategically analyze micromarkets with respect to individual growth trends, future prospects, and contributions to the overall market
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To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
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To forecast the size of the market segments with respect to four main regions, namely, North America (U.S. and Canada), Europe (Germany, U.K., France, and Rest of Europe), Asia-Pacific (Japan, China. India, and Rest of APAC), and the Rest of the World
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To strategically profile the key players and comprehensively analyze their market shares and core competencies
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To track and analyze competitive developments such as joint ventures; mergers and acquisitions; new product developments; and partnerships, agreements, and collaborations in the transplant diagnostics market
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INTRODUCTION
1.2
MARKET DEFINITION
•
Assessment of tissue compatibility between donor-recipient is of utmost importance to avoid the risk of immunorejection in a patient during or after an organ transplantation procedure. Transplant diagnostics is a well-established diagnostic procedure used to determine donor-recipient compatibility before or after an organ transplantation procedure. Traditionally, serological assay procedures were used to determine donor-recipient tissue compatibility, based on antigen-antibody reaction. However, technological advancements during the last three decades have led to the use of advanced genomic techniques (such as PCR and NGS) to assess donorrecipient compatibility before or after an organ transplantation procedure.
•
In the current research study, the transplant diagnostics market refers to HLA typing techniques that are utilized in the field of human healthcare to determine donor-recipient compatibility before or after a transplantation procedure (such as solid organ, soft tissue, and stem cell transplantation). This market study is based on several aspects of transplant diagnostics technologies, including their applications (such as diagnostics and research), end-user activities, and study of various products (including instruments, reagents, consumables, and software) and services available in the market.
1.3
MARKET SCOPE
1.3.1 MARKETS COVERED •
TRANSPLANT DIAGNOSTICS MARKET
BY PRODUCTS & SERVICES •
Instruments
•
Reagents and Consumables
•
BY APPLICATION
BY TECHNOLOGY •
Software and Services •
Non-molecular Assaybased
Serological Assays
Mixed Lymphocyte Culture (MLC) Assays
Molecular Assay-based
PCR-based
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Diagnostics
•
Research
BY END USER •
Hospitals and Transplant Centers
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Research Laboratories and Academic Institutes
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Commercial Service Providers
o Sequence-specific Primer (SSP) o Sequence-specific Oligonucleotide (SSO)
Sequencing-based o Sanger Sequencing o Next-generation Sequencing
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INTRODUCTION
1.3.2 GEOGRAPHIC SCOPE •
EUROPE • • • •
Germany France U.K. Rest of Europe
NORTH AMERICA • •
U.S. Canada
ASIA-PACIFIC • • • •
Japan China India Rest of Asia-Pacific
REST OF THE WORLD • • •
Latin America Middle East Africa
•
1.3.3 YEARS CONSIDERED FOR THE STUDY
2016-e–2021-p
•
2016-e 2015 2014
HISTORICAL YEAR
BASE YEAR
ESTIMATED YEAR
FORECAST PERIOD
•
1.4 CURRENCY •
The currency used in the report is United States Dollar (USD), with market size indicated in USD million. •
For companies reporting their revenues in USD, their revenues were picked from their annual reports, SEC Filings, and other revenue filings
•
For companies reporting their revenues in currencies other than USD, the average annual currency conversion rate was used for the particular year to convert the value to USD
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INTRODUCTION
1.5 LIMITATIONS •
The transplant diagnostics market for veterinary applications is not covered in this report since it is not related to the human healthcare business
•
The report does not cover quantitative information on the volume market for North America, Europe, AsiaPacific, and the RoW. However, the report provides regional-level and country-level quantitative data as well as qualitative information for the value market
•
Limited number of industry experts participated in the primary research from APAC and Latin American regions due to specific language barriers. In such cases, the geographic market size is derived on the basis of weightages assigned to these markets based on the qualitative insights from global industry experts, analyzing demographic parameters and adoption trends for typical healthcare technology observed in these markets
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Financial information for privately held companies is not available in the public domain. Hence, their financial details are not provided in the company profiles section
1.6 STAKEHOLDERS •
Transplant Diagnostic Product Manufacturing Companies
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Healthcare Service Providers (Including Hospitals and Transplant Centers)
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Research and Development (R&D) Companies
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Commercial Service Providers
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Diagnostic Laboratories
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Clinical Research Organizations (CROs)
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Research Laboratories and Academic Institutes
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Market Research and Consulting Firms
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RESEARCH METHODOLOGY
2.1
RESEARCH DATA
•
This research study involves the extensive usage of secondary sources, directories, and databases (such as Hoovers, Bloomberg Business, Factiva, and Avention) to identify and collect information useful for this technical, market-oriented, and commercial study of the transplant diagnostics market. In-depth interviews were conducted with various primary respondents, which include key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among other experts, to obtain and verify critical qualitative and quantitative information as well as to assess future market prospects. The following figure shows the market research methodology applied in making this report. • FIGURE 1
•
RESEARCH DESIGN
HISTORICAL DATA FOR THE TRANSPLANT DIAGNOSTICS MARKET
INFLUENCING FACTORS (Market Trends and Dynamics)
MARKET SHARE ANALYSIS
COMPETITIVE LANDSCAPE
GEOGRAPHIC ANALYSIS
REGIONAL USAGE PATTERN
MARKET DRIVERS: • Rising number of solid organ soft tissue, and stem cell transplantations • Technological advancements in field of HLA typing • Increased funding, research grants, and public-private investments
MARKET OPPORTUNITIES:
MARKET RESTRAINTS: • High device costs associated with NGS and PCR-based devices • Limited medical reimbursements for organ donation and transplantation procedure
MARKET CHALLENGES:
• Technological shift from serological assay to gene-based HLA profiling • Improving healthcare infrastructure across developing countries
•
Significant gap between the number of organs donated and required annually
• NEW PRODUCT LAUNCHES: About 25 new product launches over the last three years • AGREEMENTS & COLLABORATIONS: About 30 major agreements & collaborations over the last three years
FORECAST PERIOD (2016–2021)
HISTORICAL DATA OF THE MARKET
IMPACT ANALYSIS OF MARKET TRENDS
TRANSPLANT DIAGNOSTICS MARKET: • • • •
By Technology By Products & Services By Application By End User
ARRIVE AT THE MARKET SIZE, SHARE, AND CAGR FOR THE TRANSPLANT DIAGNOSTICS MARKET
•
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2.1.1 SECONDARY DATA •
The secondary sources referred to for this research study include government sources {such as the U.S. Census Bureau, World Health Organization (WHO), Organisation for Economic Cooperation and Development (OECD), The World Bank, and GLOBOCAN 2012}; corporate filings (annual reports, SEC filings, investor presentations, and financial statements); and trade, business, and professional associations, among others. Secondary data was collected and analyzed to arrive at the overall market size of the transplant diagnostics market, which was validated by primary research.
2.1.1.1 KEY DATA FROM SECONDARY SOURCES SOURCES
PARAMETERS
•
MARKET SIZE
• • • • • •
Company Financials Magazines Journals Press Releases Paid Databases MarketsandMarkets Data Repository
REVENUE OF COMPANIES
• • • •
Annual Reports Company Websites Public Databases MarketsandMarkets Data Repository
QUALITATIVE INFORMATION (MARKET DYNAMICS AND TRENDS)
• • • •
Company Websites Annual Reports Press Releases MarketsandMarkets Data Repository
QUANTITATIVE INFORMATION (MARKET DYNAMICS AND TRENDS)
• • • • •
Company Websites Annual Reports Press Releases Databases (Globocan, WHO, and OECD) MarketsandMarkets Data Repository
•
2.1.2 PRIMARY DATA •
Extensive primary research was conducted after acquiring basic knowledge on the transplant diagnostics market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand (research laboratories, clinical research organizations, pharmaceutical & biotechnology companies, and transplant centers & hospitals) and supply sides (instruments, reagents, consumables, and software developers; commercial service providers; and product distributors) across four major geographies— North America, Europe, Asia-Pacific, and the Rest of the World (Latin America, the Middle East, and Africa). Approximately 20% and 80% primary interviews were conducted involving demand and supply-side participants, respectively. This primary data was collected through questionnaires, mails, and telephonic interviews.
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2.1.2.1 KEY DATA FROM PRIMARY SOURCES TYPE
•
PARAMETERS
DATA Transplant diagnostics market, by region North America (U.S. and Canada)
Overall market and subsegments in 2015
Europe (Germany, France, U.K., and the Rest of Europe)
REGIONAL SPLIT CAGR of each region in the forecast period (2016–2021)
Asia-Pacific (Japan, China, India, and the Rest of Asia-Pacific) Rest of the World
GLOBAL MARKET SIZE
The global market size for 2015
Global transplant diagnostics market
CAGR for the forecast period (2016–2021)
Transplant diagnostics market, by segment
Non-molecular assay (serological assay and MLC assays) and molecular assay [PCR-based (SSO and SSP) and sequencing-based (Sanger sequencing and next-generation sequencing)]
Transplant diagnostics market, by technology Transplant diagnostics market, by products and services
Instruments, reagents & consumables, and software & services
MARKET SPLIT
Transplant diagnostics market, by application
Diagnostic and research applications
Transplant diagnostics market, by end user
Hospitals & transplant centers, research laboratories & academic institutes, and commercial service providers
•
Source: Industry Experts and MarketsandMarkets Analysis
2.1.2.2 BREAKDOWN OF PRIMARIES •
10%
45%
34%
•
8%
14%
21%
Tier 1
BY REGION
BY DESIGNATION
BY COMPANY
20%
76%
Tier 2
Tier 3
D Level
40%
32%
C Level
Others*
North America Asia-Pacific
Europe RoW
Note 1: Companies are grouped based on their annual revenue into Tier 1 (> USD 500 million), Tier 2 (USD 100–USD 500 million), and Tier 3 (< USD 100 million) companies, respectively Note 2: *Others include sales managers, product managers, technical consultants, and product specialists
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2.2
OPPORTUNITY INDICATORS
2.2.1 INTRODUCTION •
The description and analysis of the global transplant diagnostics market defines the structure and restrictions of the potential market analysis through the supply- and demand-side factors. This helps in judging individual market players to ascertain growth opportunities offered at individual region- and country-level. In this background, it is vital to discuss and define these factors to comprehend the mechanism of inference-obtaining processes, which include the analysis of demand-side drivers and factors influencing the supply side of the target market. The analysis of the studied market and the estimations of market sizes and their growth patterns depend on factors such as the political environment and the overall economic and market conditions which include (but are not limited to historical trends) seasonal effects and business cycles. For this report, we have used statistical/ quantitative techniques to estimate the impact of demand- and supply-side variables to arrive at the market size numbers of the forecast period. Statistical techniques were used to understand the correlation of the demand and supply variables with the studied market, and to assign weightages to these variables for developing a model to forecast market numbers. Wherever such analyses was not feasible due to unavailability of data and other statistical/quantitative constraints, the inferences were made using judgmental forecasting techniques.
2.2.2 DEMAND-SIDE ANALYSIS •
Revenue-specific macroeconomic indicators and exogenous variables (variables that do not influence the concerned market directly) are considered for the demand-side analysis. Common demand-side variables that drive the market at the aggregate level are the economic growth (GDP) of a country/region, seasonal trends in the foreign exchange market, nature of the corresponding economic sector, parent/industry market growth, and demographic/political factors, among others.
•
The demand-side variables considered in the study of the transplant diagnostics market include:
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•
Healthcare expenditure patterns
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Rapid growth in geriatric population
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Rising incidence and prevalence of cancer
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Growing burden of cardiovascular diseases (CVDs)
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Increasing number of organ donations and transplantations
The estimations, however, assume that the regions studied will remain stable in terms of economic conditions and do not factor in any significant aberrance from the projected economic growth of the studied regions/countries.
2.2.2.1 HEALTHCARE EXPENDITURE PATTERNS •
The healthcare expenditure of a country includes spending by both public and private sources on medical goods and services, public health and prevention programs, and administration (Source: OECD). Growth in healthcare expenditure is a direct indicator of a country’s growth in the healthcare market. In addition, it also reflects the improvements in diverse financing and organizational structures of the healthcare system in a particular country.
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•
Globally, healthcare needs are changing owing to the lower fertility rates, longer life expectancies, and the growing burden of chronic diseases (such as cardiovascular diseases and cancer). These demographic and epidemiological transitions would present health challenges for most of the countries at every income level. In high-income countries, the growth in aging population, rapidly increasing healthcare costs, and limited availability of resources to meet the increasing healthcare needs would further increase the pressure on publicly financed healthcare systems. Middle and low-income countries, which are facing several difficulties to provide basic healthcare services, require additional funds from external financing sources for developing their healthcare infrastructure and catering to the growing healthcare needs.
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Accommodating the changes in the size and structure of the population, several countries across the globe are continuously progressing through an epidemiological transition (which is an important indication for the life expectancy and burden of diseases as well as healthcare expenditure).
•
Changes in the size and age structure of the population are expected to have major effects on the current as well as future health financing needs. In high-income countries, even if the population ages rapidly, the consequences on healthcare expenditure would not be critical. However, low- and middle-income countries will spend more on healthcare (in terms of modernization of healthcare facilities, development of new hospitals/diagnostic centers, or improvement in the reimbursement for medical procedures) due to the growing elderly population and burden of chronic diseases. Owing to this, low- and middle-income countries are considered as the new revenue pockets for the growth of the transplant diagnostics market in the coming years.
2.2.2.2 RAPID GROWTH IN GERIATRIC POPULATION •
The geriatric population is defined as the number of inhabitants aged 65 years and above, in a given study group. Changes in the size and age structure of any population primarily depends on the dynamics of birth and death rates characterizing their demographic transition. With an increase in the geriatric population, the chances of healthcare crisis, epidemiologic spurts in the patient population, and financial crunch also increase.
•
The global geriatric population increased from 6.2% in 1990 to 7.9% in 2013, and is expected to reach 16.5% by 2050 (Source: World Bank). Currently, approximately two-thirds of the overall geriatric population is concentrated in less-developed countries. As the older population is growing faster in less-developed countries, the concentration of this population will be higher in these countries in the future. It is estimated that 8 in every 10 elderly individuals globally would live in less-developed countries by 2050 (Source: United Nations Department of Economic and Social Affairs).
•
As the older population (65 years and above) is more susceptible to chronic diseases such as cardiovascular disease and various cancers (that require organ or tissue transplantation in the critical stage), the demand for transplant diagnostics tests is expected to rise continuously. Thus, growth in geriatric population and patient population base for target diseases (which include chronic diseases and cancer) is encouraging the development and commercialization of better transplant diagnostics procedures for donor-recipient incompatibility testing.
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2.2.2.3 RISING INCIDENCE AND PREVALENCE OF CANCER •
The incidence of various cancers and their mortality rates increase with age. Considering that the population of people aged 65 years and above is expected to double by 2030; a 67% rise in the global cancer incidence is expected in this population group. Prostate, breast, lung, and colorectal cancer are the four most frequently occurring cancers in population aged 50 and above. Owing to the rapidly increasing burden of cancer (that require organ or tissue transplantation in critical stage), the demand for transplant diagnostics procedures is steadily increasing, which is forcing government organizations as well as healthcare providers and institutions to provide facilities for effective diagnosis and testing. This is further stimulating the development of effective transplant diagnostic assay methods for specific cancer patients.
•
In the developed countries, cancer is the second-leading cause of death after cardiovascular disease. According to epidemiological evidences, this trend is emerging in the less-developed countries (particularly in middleincome countries such as Brazil, Colombia, India, China, and Russia).
•
As molecular diagnostic technologies are used for the early diagnosis of donor-recipient incompatibility during organ, tissue, or stem cell transplantation in cancer patients, the increasing prevalence of various types of cancers (such as kidney, lung, and liver) is expected to augment the demand for transplant diagnostic products during the forecast period.
2.2.2.4 GROWING BURDEN OF CARDIOVASCULAR DISEASES (CVDS) •
Cardiovascular diseases refers to diseases of the heart and blood vessels and include conditions such as coronary heart disease, cerebrovascular disease (stroke), heart failure, rheumatic heart disease, and hypertension (high blood pressure). Cardiovascular diseases often result in the need for tissue transplantation (such as of heart valves or blood vessels) or heart transplantation in terminally ill patients.
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CVD is responsible for approximately one-third of deaths globally, and this figure is expected to rise in both developed as well as developing countries due to the growing incidences of hypertension, obesity, and diabetes as well as poor diets and increasing tobacco consumption, which are all key risk factors for the disease (Source: WHO). In 2010, low- and middle-income countries accounted for over 80% of CVD deaths (Source: WHO, 2010). In addition, stroke-related deaths in low- and middle-income countries were five times more in high-income countries in 2010 (Source: Lancet). In developed countries, lower socioeconomic groups have a higher prevalence of risk factors, higher incidence of CVDs, and higher mortality rates. As the CVD epidemic matures in developing countries, the greater disease burden is expected to shift towards the lower socioeconomic groups. Furthermore, the impact of CVDs is greatest in developing countries due to scarcity of both financial resources and healthcare professionals with expertise for the prevention and management of CVDs.
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The burden of cardiovascular diseases is growing across the globe and is resulting in higher death rates, increased disabilities, and added economic costs. Governments across the globe are taking various initiatives (such as improving healthcare facilities, holding public awareness programs, and providing grants for research activities) to lower the socioeconomic burden caused by CVDs. Cardiovascular diseases often result in need for tissue transplantation (such as of heart valves or blood vessels) or heart transplantation in terminally ill patients. Therefore, in future, with the growing incidence and prevalence of CVDs, the demand for transplant diagnostic procedures is also expected to increase.
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2.2.2.5 INCREASING NUMBER OF ORGAN DONATIONS AND TRANSPLANTATIONS •
Transplant diagnostic procedures are utilized globally to ensure clinical success of organ, tissue, or stem cell transplantation. This includes pre- and post-transplantation analysis for the diagnosis and treatment of donorrecipient incompatibility and risk of possible organ rejection or immune response in recipients.
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Globally, the number of organ, tissue, and stem cell transplantations is increasing across major markets such as the U.S., Canada, Germany, the U.K., France, Japan, China, India, and Brazil. The trend of growing number of transplantations is further augmented by the rising number of chronic diseases that require tissue or organ transplantation in terminal patients (coupled with growing geriatric population that are at higher risk of contracting chronic diseases than adults) as well as by growing number of deceased & living organ donations (coupled with increased public awareness related to organ and stem cell donations).
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Increase in the number of organ, tissue, and stem cell transplantation will directly boost the number of transplant diagnostic procedures performed across the globe, which translates into higher market growth for transplant diagnostic products in the coming years. Furthermore, with the increased shift from serology-based analysis to gene-based donor-recipient screening before transplantation procedure; market demand for PCR and sequencing-based transplant diagnostic products is poised to witness a significant growth across major markets.
2.2.3 SUPPLY-SIDE ANALYSIS •
In most cases, industry-specific microeconomic indicators and endogenous variables (factors determined by the states of other variables in the model) are considered. Common factors driving the market on a local level are raw material prices (fluctuations), prices of competitive/substitute products, sales strategies, economies of scale, specialization advantages, and business law & regulations, among others.
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The supply-side indicators considered in the study of the transplant diagnostics market include the following:
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•
The number of new products launched: transplant diagnostics vs. competitive technologies
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Parent market analysis: Immunoassay market
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Growth and market size of transplant diagnostic products vs. competitive products
The estimations, however, assume that the regions studied will remain stable in terms of economic conditions and do not factor in any significant aberrance from the projected economic growth of the studied regions/countries.
2.2.3.1 NUMBER OF NEW PRODUCT LAUNCHES: TRANSPLANT DIAGNOSTICS VS. COMPETITIVE TECHNOLOGIES •
Human leucocyte antigen (HLA) profiling is a widely adopted methodology for donor screening prior to organ and tissue transplantation as well as during pre- and post- transplantation diagnosis in recipients. Molecular assaybased transplant diagnostic techniques (PCR, NGS, and Sanger sequencers) are increasingly being preferred over the serological assay method owing to their benefits, such as gene-based diagnosis, better accuracy in predicting donor-recipient incompatibility, and less analysis time. Apart from HLA profiling techniques, several other immunoassay techniques are also being utilized for donor-recipient screening prior to a transplantation procedure, which include rapid tests, western blotting, and enzyme-linked immunosorbent assay (ELISA).
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•
Key players in the transplant diagnostics industry are continuously focusing on developing technologically advanced and affordable molecular diagnostic products that could be used for donor-recipient screening. This is evident from the launch of innovative PCR and NGS-based transplant diagnostic products in the last three years, such as the 3500 DX Sanger Sequencer by Life Technologies, Inc. (U.S.) in May 2013, Ion Torrent PGM system by One Lambda, Inc. (U.S.) in December 2014, MiSeq Sequencing system from Illumina, Inc. (U.S.) in September 2015, Assign SBT software by Olerup Ssp Ab (Sweden) in June 2013, TruSight HLA Sequencing panel by Illumina, Inc. (U.S.) in March 2015, and Holotype HLA analysis software by Illumina, Inc. (U.S.) in April 2016. These new products are equipped with advanced features such as high image resolution, intuitive user interface, real-time data access, easy data analysis, flexible design, high-throughput workflow, increased accuracy, and capability of efficient data generation with low-volume consumption of regents and consumables. Moreover, the development of affordable transplant diagnostic devices and reagents has increased their adoption in developing countries, such as China, India, and Brazil. Automation and integration of robotics in laboratory workflow has further boosted the adoption of molecular assay-based transplant diagnostic techniques.
2.2.3.2 PARENT MARKET ANALYSIS: IMMUNOASSAY MARKET •
Immunoassay techniques are utilized by healthcare professionals and researchers during routine immunoanalysis in patients (suffering from chronic or infectious diseases), biomarker screening studies, and cancer patients, among others. They are highly specific in vitro biochemical tests that have a wide range of applications in various disease categories such as oncology, infectious diseases, endocrinology, bone and mineral, cardiology, hematology, autoimmunity, toxicology, transplant diagnostics, and neonatal screening.
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The overall market for transplant diagnostic technology has witnessed steady demand growth due to the increasing accuracy and precision of innovative techniques (particularly, molecular assay-based analysis which includes PCR, NGS, and Sanger sequencing devices) coupled with technological shift from serology-based to molecular assay-based HLA typing. Furthermore, specific technology segments of the transplant diagnostics market, such as PCR and NGS, are witnessing higher market growth owing to their benefits such as real-time process monitoring, low reagent consumption, automation of workflow, and greater reproducibility and precision.
2.3 •
MARKET SIZE ESTIMATION The top-down approach was followed to estimate and validate the size of the global transplant diagnostics market and other dependent submarkets. The key players in the market were identified through secondary research, and their market shares in the respective geographies were determined through primary and secondary research. This entire research methodology includes the study of the annual and quarterly financial reports of the top market players as well as interviews with industry experts (such as CEOs, VPs, directors, and marketing executives) for key insights (both quantitative and qualitative) on the transplant diagnostics market. All percentage shares, splits, and breakdowns were determined by using secondary sources, and verified through primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. This data was consolidated and added with detailed inputs and analysis from MarketsandMarkets, and presented in this report. The following figure shows the overall market size estimation process employed for the purpose of this study.
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2.3.1 BOTTOM-UP APPROACH •
The bottom-up approach was employed to arrive at the overall size of the transplant diagnostics market from the revenues of key players and their shares in the market. Calculations based on the revenues of key players identified in the market led to the overall market size.
•
For the calculation of the global market size, individual segmental revenue was calculated based on the number of units sold and their average selling price in respective regions; this was used to implement the bottom-up approach. The bottom-up approach was also implemented for data extracted from secondary research to validate the market segment revenues obtained. • FIGURE 15
BOTTOM-UP APPROACH: TRANSPLANT DIAGNOSTICS INSTRUMENTS MARKET
• Global Market Value
Total Market Size (USD Million) = North America (Total Units of Transplant Diagnostics Instruments Sold Annually x ASP) + Europe (Total Units of Transplant Diagnostics Instruments Sold Annually x ASP) +………………………..
Summation of A x B of All Regions PRIMARY SOURCES: Demand- and Supply-side Experts
Average selling price (ASP) per region for specific transplant diagnostics instrument types (B)
SECONDARY SOURCES: Annual Reports, Presentations, Press Releases, Journals, Paid Databases, and MarketsandMarkets Repository
Regional split of the transplant diagnostics instruments sold annually (A)
Number of transplant diagnostics instruments sold annually, globally
•
Source: MarketsandMarkets Analysis
• FIGURE 16
BOTTOM-UP APPROACH: TRANSPLANT DIAGNOSTIC REAGENTS AND CONSUMABLES MARKET
• Global Market Value
Total Market Size (USD Million) = North America (Total Units of Transplant Diagnostics Reagents Consumed Annually x ASP) + Europe (Total Units of Transplant Diagnostics Reagents Consumed Annually x ASP) +………………………..
Summation of A x B of All Regions
Average selling price (ASP) per region for specific transplant diagnostics reagents (B)
Regional split of the transplant diagnostics reagents consumed annually (A)
PRIMARY SOURCES: Demand- and Supply-side Experts
SECONDARY SOURCES: Annual Reports, Presentations, Press Releases, Journals, Paid Databases, and MarketsandMarkets Repository
Volume of transplant diagnostics reagents consumed annually, globally
•
•
Source: MarketsandMarkets Analysis
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2.3.2 TOP-DOWN APPROACH •
In the top-down approach, the overall transplant diagnostics market size was used to estimate the size of individual markets (mentioned in the market segmentation) through percentage splits from secondary and primary research.
•
For the calculation of specific market segments, the most appropriate immediate parent market size was used to implement the top-down approach. The bottom-up approach was also implemented for data extracted from secondary research to validate the market segment revenues obtained.
•
Market shares were then estimated for each company to verify the revenue shares used earlier in the bottom-up approach for data validation. With the data triangulation procedure and validation of data through primaries, the overall parent market size and each individual market size were determined and confirmed in this study. The data triangulation procedure used for this study is explained in the next section. • FIGURE 17
TOP-DOWN APPROACH
• Global transplant diagnostics market size, by product (USD Million)
The Global Market Size is Validated Through Primaries (Demand- and Supply-side Experts)
Percentage split for the specific product type in the transplant diagnostics market
Geographical split to the individual transplant diagnostics product categories Regional Market for Each Product Categories
•
PRIMARY SOURCES: Demand- and Supply-side Experts
SECONDARY SOURCES: Annual Reports, Presentations, Press Releases, Journals, Paid Databases, and MarketsandMarkets Repository
Source: MarketsandMarkets Analysis
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2.4
MARKET BREAKDOWN AND DATA TRIANGULATION
•
After arriving at the overall market size from the market size estimation process explained above, the total transplant diagnostics market was split into several segments and subsegments. In order to complete the overall market engineering process and arrive at the exact statistics for all the segments and subsegments, the data triangulation and market breakdown procedure was employed wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides. Along with this, the overall transplant diagnostics market was validated using the top-down approach. • FIGURE 18
•
DATA TRIANGULATION PRIMARY SOURCES
SECONDARY SOURCES
DEMAND SIDE
INTERVIEWS WITH: • Transplant Diagnostics Product Manufacturers • Transplant Diagnostics Software Developers • Research Institutes and Laboratory Technicians • Surgeons, Physicians, Oncologists, and Other Healthcare Professionals • Chief Information Officers • Purchase Managers in Healthcare Provider Organizations
SUPPLY SIDE
INTERVIEWS WITH: • Presidents, CEOs, Vice Presidents, Directors, General Managers, Heads of the Transplant Diagnostics Product Segment, and Senior Managers • Product/Sales/Marketing/ Business Development/Client Portfolio Managers or Specialists • Distributors/Suppliers/Channel Partners and Business Intelligence Consultants
Annual Reports, Presentations, Websites, and Press Releases of Top Players; News Articles; Journals; and Paid Databases
MnM KNOW*
DATA PRIMARY TRIANGULATION SOURCES SECONDARY SOURCES
•
The World Bank
•
World Health Organization (WHO)
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Organisation for Economic Cooperation and Development (OECD)
•
The U.S. Census Bureau
•
National Human Genome Research Institute (U.S.)
•
American Society of Transplantation (U.S.)
INFORMATION SOURCED
Key Players
Competitive Landscape
Opportunities and Challenges
Drivers and Restraints
Market Size (2016)
Porter’s Five Force Analysis
Market Share (2015)
Geographical Analysis
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Source: MarketsandMarkets Analysis
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RESEARCH METHODOLOGY
2.5
RESEARCH ASSUMPTIONS
2.5.1 ASSUMPTIONS •
The following assumptions were taken into consideration to complete the overall market engineering of the transplant diagnostics market: • FIGURE 19
•
ASSUMPTIONS OF THE RESEARCH STUDY
PARAMETERS
•
ASSUMPTIONS
IMPACTS
ECONOMY
A positive economic climate will continue in the Asia-Pacific countries till the end of 2021
A positive economic climate in the Asia-Pacific nations will result in a positive spending on R&D activities
GOVERNMENT R&D SPENDING PATTERNS
The current R&D spending patterns were assumed to be consistent in major countries across the four regions during the forecast period
This will lead to increasing growth opportunities for transplant diagnostics market players in the emerging Asia-Pacific and Latin American countries
EXCHANGE RATES
It has been assumed that USD fluctuations will not affect the market forecast to a significant extent
The stability in exchange rates will stabilize the prices of transplant diagnostics devices during imports and exports
COMPANY FINANCIALS
The revenues of private companies acquired from paid databases were assumed to be in line with the actual company financials
The revenue of companies are of high importance for estimating the size of the parent market and its subsegments
Note1: Region-wise inflation/deflation of prices of transplant diagnostics products in the next five years have been considered while forecasting the market size. Note 2: The market values have been rounded off till the second decimal. Due to this, there may be a slight difference in the actual total and the total mentioned in the market tables.
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TABLE OF CONTENTS
1 INTRODUCTION.........................................................................................................................16 •
1.1
OBJECTIVES OF THE STUDY...........................................................................................................................................16
•
1.2
MARKET DEFINITION.......................................................................................................................................................16
•
1.3
MARKET SCOPE...............................................................................................................................................................17
•
1.3.1
MARKETS COVERED......................................................................................................................................17
•
1.3.2
GEOGRAPHIC SCOPE....................................................................................................................................17
•
1.3.3
YEARS CONSIDERED FOR THE STUDY.........................................................................................................18
•
1.4 CURRENCY......................................................................................................................................................................18
•
1.5 LIMITATIONS....................................................................................................................................................................18
•
1.6 STAKEHOLDERS...............................................................................................................................................................19
2
RESEARCH METHODOLOGY.....................................................................................................20 •
2.1 •
RESEARCH DATA..............................................................................................................................................................20 2.1.1
• •
•
SECONDARY DATA........................................................................................................................................21 2.1.1.1
2.1.2
KEY DATA FROM SECONDARY SOURCES................................................................................21
PRIMARY DATA..............................................................................................................................................22
•
2.1.2.1
KEY DATA FROM PRIMARY SOURCES.....................................................................................22
•
2.1.2.2
BREAKDOWN OF PRIMARIES...................................................................................................23
2.2
OPPORTUNITY INDICATORS............................................................................................................................................23
•
2.2.1 INTRODUCTION.............................................................................................................................................23
•
2.2.2
DEMAND-SIDE ANALYSIS.............................................................................................................................24
•
2.2.2.1
HEALTHCARE EXPENDITURE PATTERNS.................................................................................24
•
2.2.2.2
RAPID GROWTH IN GERIATRIC POPULATION..........................................................................27
•
2.2.2.3
RISING INCIDENCE AND PREVALENCE OF CANCER...............................................................29
•
2.2.2.4
GROWING BURDEN OF CARDIOVASCULAR DISEASES (CVDS)..............................................31
•
2.2.2.5
INCREASING NUMBER OF ORGAN DONATIONS AND TRANSPLANTATIONS..........................33
•
2.2.3
SUPPLY-SIDE ANALYSIS...............................................................................................................................34
•
2.2.3.1
NUMBER OF NEW PRODUCT LAUNCHES: TRANSPLANT DIAGNOSTICS VS. COMPETITIVE TECHNOLOGIES.................................................................34
•
2.2.3.2
PARENT MARKET ANALYSIS: IMMUNOASSAY MARKET.........................................................35
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TABLE OF CONTENTS
•
2.3
MARKET SIZE ESTIMATION.............................................................................................................................................36
•
2.3.1
BOTTOM-UP APPROACH..............................................................................................................................36
•
2.3.2
TOP-DOWN APPROACH................................................................................................................................38
•
2.4
MARKET BREAKDOWN AND DATA TRIANGULATION......................................................................................................39
•
2.5
RESEARCH ASSUMPTIONS.............................................................................................................................................40
•
2.5.1 ASSUMPTIONS..............................................................................................................................................40
3
EXECUTIVE SUMMARY..............................................................................................................41 •
3.1 INTRODUCTION...............................................................................................................................................................41
•
3.2
CURRENT SCENARIO.......................................................................................................................................................41
•
3.3
FUTURE OUTLOOK...........................................................................................................................................................42
•
3.4 CONCLUSION..................................................................................................................................................................47
4
PREMIUM INSIGHTS.................................................................................................................48 •
4.1
GLOBAL TRANSPLANT DIAGNOSTICS MARKET OVERVIEW...........................................................................................48
•
4.2
GLOBAL TRANSPLANT DIAGNOSTICS TECHNOLOGY MARKET, BY REGION (2016).....................................................49
•
4.3
GLOBAL TRANSPLANT DIAGNOSTICS PRODUCT AND SERVICES MARKET, BY REGION (2016-2021).........................50
•
4.4
GLOBAL TRANSPLANT DIAGNOSTICS APPLICATIONS MARKET, BY REGION (2016-2021)...........................................51
•
4.5
GLOBAL TRANSPLANT DIAGNOSTICS MARKET, BY END USER (2016–2021)...............................................................51
•
4.6
GLOBAL TRANSPLANT DIAGNOSTICS MARKET, BY COUNTRY (2016–2021)................................................................52
5
MARKET OVERVIEW..................................................................................................................53 •
5.1 INTRODUCTION...............................................................................................................................................................54
•
5.2
MARKET SEGMENTATION................................................................................................................................................54
•
5.3
MARKET DYNAMICS........................................................................................................................................................55
•
5.3.1
KEY MARKET DRIVERS..................................................................................................................................56
•
5.3.1.1
GROWING NUMBER OF SOLID ORGAN, SOFT-TISSUE, AND STEM CELL TRANSPLANTATION PROCEDURES.............................................................56
•
5.3.1.2
TECHNOLOGICAL ADVANCEMENTS IN THE FIELD OF HLA TYPING.......................................57
•
5.3.1.3
INCREASED FUNDING, RESEARCH GRANTS, AND PUBLIC-PRIVATE INVESTMENTS............58
•
5.3.2
KEY MARKET RESTRAINTS............................................................................................................................59
•
5.3.2.1
HIGH COST OF NGS AND PCR-BASED DEVICES.....................................................................59
•
5.3.2.2
LIMITED MEDICAL REIMBURSEMENTS FOR ORGAN DONATION AND TRANSPLANTATION PROCEDURES.................................................................................60
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TABLE OF CONTENTS
•
5.3.3
•
5.3.3.1
TECHNOLOGICAL SHIFT FROM SEROLOGICAL ASSAYS TO GENE-BASED HLA PROFILING.................................................................................................60
•
5.3.3.2
IMPROVING HEALTHCARE INFRASTRUCTURE ACROSS DEVELOPING COUNTRIES..............61
•
5.3.4
•
6
KEY MARKET OPPORTUNITIES.....................................................................................................................60
KEY MARKET CHALLENGES..........................................................................................................................62 5.3.4.1
SIGNIFICANT GAP BETWEEN NUMBER OF ORGANS DONATED AND ORGANS REQUIRED ANNUALLY......................................................................................62
INDUSTRY INSIGHTS................................................................................................................63 •
6.1 INTRODUCTION...............................................................................................................................................................63
•
6.2
VALUE CHAIN ANALYSIS.................................................................................................................................................63
•
6.3
INDUSTRY TRENDS.........................................................................................................................................................65
• •
7
6.4
6.3.1
INTEGRATION OF ADVANCED TECHNOLOGIES WITH MOLECULAR ASSAY PROCEDURE..........................65
PORTER’S FIVE FORCES ANALYSIS.................................................................................................................................66
•
6.4.1
THREAT OF NEW ENTRANTS.........................................................................................................................67
•
6.4.2
THREAT OF SUBSTITUTES.............................................................................................................................67
•
6.4.3
BARGAINING POWER OF SUPPLIERS...........................................................................................................67
•
6.4.4
BARGAINING POWER OF BUYERS.................................................................................................................68
•
6.4.5
INTENSITY OF COMPETITIVE RIVALRY.........................................................................................................68
TRANSPLANT DIAGNOSTICS MARKET, BY TECHNOLOGY........................................................69 •
7.1 INTRODUCTION...............................................................................................................................................................70
•
7.2 •
7.2.1
PCR-BASED MOLECULAR ASSAYS...............................................................................................................72
•
7.2.1.1
SEQUENCE-SPECIFIC PRIMER (SSP)-PCR..............................................................................73
•
7.2.1.2
SEQUENCE-SPECIFIC OLIGONUCLEOTIDE (SSO)-PCR..........................................................74
•
•
MOLECULAR ASSAYS......................................................................................................................................................71
7.2.2
SEQUENCING-BASED MOLECULAR ASSAYS...............................................................................................75
•
7.2.2.1
SANGER SEQUENCING.............................................................................................................77
•
7.2.2.2
NEXT-GENERATION SEQUENCING (NGS)................................................................................78
7.3
NON-MOLECULAR ASSAYS.............................................................................................................................................79
•
7.3.1
SEROLOGICAL ASSAYS.................................................................................................................................80
•
7.3.2
MIXED LYMPHOCYTE CULTURE (MLC) ASSAYS..........................................................................................81
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TABLE OF CONTENTS
8
TRANSPLANT DIAGNOSTICS MARKET, BY PRODUCTS & SERVICES.......................................82 •
8.1 INTRODUCTION...............................................................................................................................................................83
•
8.2
•
8.3 INSTRUMENTS.................................................................................................................................................................85
•
8.4
9
REAGENTS AND CONSUMABLES....................................................................................................................................84
SOFTWARE AND SERVICES.............................................................................................................................................86
TRANSPLANT DIAGNOSTICS MARKET, BY APPLICATION........................................................87 •
9.1 INTRODUCTION...............................................................................................................................................................88
•
9.2
DIAGNOSTIC APPLICATIONS...........................................................................................................................................89
•
9.3
RESEARCH APPLICATIONS..............................................................................................................................................90
10
TRANSPLANT DIAGNOSTICS MARKET, BY END USER.............................................................92
•
10.1 INTRODUCTION...............................................................................................................................................................93
•
10.2
HOSPITALS AND TRANSPLANT CENTERS......................................................................................................................95
•
10.3
COMMERCIAL SERVICE PROVIDERS..............................................................................................................................96
•
10.4
RESEARCH LABORATORIES AND ACADEMIC INSTITUTES.............................................................................................97
11
TRANSPLANT DIAGNOSTICS MARKET, BY REGION.................................................................98
•
11.1 INTRODUCTION...............................................................................................................................................................99
•
11.2
NORTH AMERICA...........................................................................................................................................................100
•
11.2.1 U.S...............................................................................................................................................................102
•
11.2.2 CANADA.......................................................................................................................................................104
•
•
•
11.3 EUROPE..........................................................................................................................................................................106 •
11.3.1 GERMANY....................................................................................................................................................108
•
11.3.2 U.K...............................................................................................................................................................109
•
11.3.3 FRANCE.......................................................................................................................................................111
•
11.3.4
REST OF EUROPE (ROE)..............................................................................................................................113
11.4 ASIA-PACIFIC................................................................................................................................................................115 •
11.4.1 JAPAN..........................................................................................................................................................117
•
11.4.2 CHINA..........................................................................................................................................................118
•
11.4.3 INDIA............................................................................................................................................................120
•
11.4.4
11.5
REST OF ASIA-PACIFIC (ROAPAC)..............................................................................................................122
REST OF THE WORLD (ROW).........................................................................................................................................124
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TABLE OF CONTENTS
12
COMPETITIVE LANDSCAPE.....................................................................................................128
•
12.1 OVERVIEW......................................................................................................................................................................128
•
12.2
MARKET SHARE ANALYSIS...........................................................................................................................................129
•
12.3
COMPETITIVE SCENARIO..............................................................................................................................................131
•
12.4
RECENT DEVELOPMENTS.............................................................................................................................................132
13
•
12.4.1
AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS..........................................................................132
•
12.4.2
NEW PRODUCT LAUNCHES, APPROVALS, AND PRODUCT ENHANCEMENTS..........................................133
•
12.4.3
STRATEGIC ACQUISITIONS.........................................................................................................................134
•
12.4.4
GEOGRAPHIC EXPANSIONS........................................................................................................................135
COMPANY PROFILES...............................................................................................................136 •
•
(Business Overview, Products & Services, Developments, MnM View)*
13.1 INTRODUCTION.............................................................................................................................................................136 •
13.1.1
GEOGRAPHIC BENCHMARKING..................................................................................................................136
•
13.1.2
STRATEGIC BENCHMARKING......................................................................................................................137
•
13.1.2.1
CAPACITY BUILDING AND CAPABILITY ENHANCEMENT......................................................137
•
13.2
THERMO FISHER SCIENTIFIC, INC................................................................................................................................138
•
13.3
IMMUCOR, INC..............................................................................................................................................................143
•
13.4
OLERUP SSP AB............................................................................................................................................................147
•
13.5
QIAGEN N.V....................................................................................................................................................................149
•
13.6
BIO-RAD LABORATORIES, INC.......................................................................................................................................154
•
13.7
ILLUMINA, INC...............................................................................................................................................................159
•
13.8
AFFYMETRIX, INC..........................................................................................................................................................163
•
13.9
F. HOFFMANN-LA-ROCHE LIMITED..............................................................................................................................166
•
13.10 LUMINEX CORPORATION..............................................................................................................................................168
•
13.11 ABBOTT LABORATORIES, INC........................................................................................................................................171
•
*Details on MarketsandMarkets view, Introduction, Product & Services, New Developments might not be captured in case of unlisted companies.
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TABLE OF CONTENTS
14 APPENDIX................................................................................................................................174 •
14.1
INSIGHTS OF INDUSTRY EXPERTS...............................................................................................................................174
•
14.2
DISCUSSION GUIDE......................................................................................................................................................175
•
14.3
KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL...................................................................179
•
14.4
INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE..............................................................................................181
•
14.5
AVAILABLE CUSTOMIZATIONS......................................................................................................................................182
•
14.6
RELATED REPORTS........................................................................................................................................................183
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LIST OF TABLES
• TABLE 1
TOTAL COST OF TRANSPLANT PROCEDURES IN THE U.S.: BY ORGAN TRANSPLANTATION STAGES (INCLUDING TRANSPLANT DIAGNOSIS AND MONITORING)...........................................................................59
• TABLE 2
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION)...........70
• TABLE 3
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE FOR MOLECULAR ASSAYS, BY TYPE, 2014-2021 (USD MILLION)...............................................................................................................71
• TABLE 4
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................72
• TABLE 5
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE FOR PCR-BASED MOLECULAR ASSAYS, BY TYPE, 2014-2021 (USD MILLION)...............................................................................................................72
• TABLE 6
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR PCR-BASED MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................73
• TABLE 7
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SSP-PCR-BASED MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................74
• TABLE 8
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SSO-PCR-BASED MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................75
• TABLE 9
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SEQUENCING-BASED MOLECULAR ASSAYS, BY TYPE, 2014-2021 (USD MILLION)...............................................................................................................76
• TABLE 10
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SEQUENCING-BASED MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................76
• TABLE 11
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SANGER SEQUENCING, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................77
• TABLE 12
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR NGS, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................78
• TABLE 13
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR NON-MOLECULAR ASSAYS, BY TYPE, 2014-2021 (USD MILLION)...............................................................................................................79
• TABLE 14
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR NON-MOLECULAR ASSAYS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................80
• TABLE 15
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SEROLOGICAL ASSAYS, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................80
• TABLE 16
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR MLC ASSAYS, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................81
• TABLE 17
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION)...............................................................................................................................83
• TABLE 18
TRANSPLANT DIAGNOSTIC REAGENTS AND CONSUMABLES MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................84
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LIST OF TABLES
• TABLE 19
TRANSPLANT DIAGNOSTIC INSTRUMENTS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)...............................................................................................................................85
• TABLE 20
TRANSPLANT DIAGNOSTIC SOFTWARE AND SERVICES MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................86
• TABLE 21
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION)...............................................................................................................................88
• TABLE 22
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR DIAGNOSTIC APPLICATIONS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................89
• TABLE 23
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR RESEARCH APPLICATIONS, BY REGION, 2014-2021 (USD MILLION)...........................................................................................................91
• TABLE 24
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014–2021 (USD MILLION)...............................................................................................................................93
• TABLE 25
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR HOSPITALS AND TRANSPLANT CENTERS, BY REGION, 2014–2021 (USD MILLION)..........................................................................................................95
• TABLE 26
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR COMMERCIAL SERVICE PROVIDERS, BY REGION, 2014–2021 (USD MILLION)..........................................................................................................96
• TABLE 27
TRANSPLANT DIAGNOSTICS MARKET SIZE FOR RESEARCH LABORATORIES AND ACADEMIC INSTITUTES, BY REGION, 2014–2021 (USD MILLION).........................................................97
• TABLE 28
TRANSPLANT DIAGNOSTICS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)...................................99
• TABLE 29
NORTH AMERICA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021..........................100
• TABLE 30
U.S.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION)...............102
• TABLE 31
U.S.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................103
• TABLE 32
U.S.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION)...............103
• TABLE 33
U.S.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)....................103
• TABLE 34
CANADA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................104
• TABLE 35
CANADA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................104
• TABLE 36
CANADA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................105
• TABLE 37
CANADA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................105
• TABLE 38
EUROPE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021 (USD MILLION).............................................................................................................................106
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LIST OF TABLES
• TABLE 39
GERMANY: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................108
• TABLE 40
GERMANY: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................108
• TABLE 41
GERMANY: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................109
• TABLE 42
GERMANY: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021....................................109
• TABLE 43
U.K.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................110
• TABLE 44
U.K.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................110
• TABLE 45
U.K.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................110
• TABLE 46
U.K.: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................111
• TABLE 47
FRANCE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................111
• TABLE 48
FRANCE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................112
• TABLE 49
FRANCE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................112
• TABLE 50
FRANCE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................112
• TABLE 51
ROE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................113
• TABLE 52
ROE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................113
• TABLE 53
ROE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................114
• TABLE 54
ROE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................114
• TABLE 55
ASIA-PACIFIC: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021 (USD MILLION).............................................................................................................................115
• TABLE 56
JAPAN: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................117
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LIST OF TABLES
• TABLE 57
JAPAN: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................117
• TABLE 58
JAPAN: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................118
• TABLE 59
JAPAN: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................118
• TABLE 60
CHINA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................119
• TABLE 61
CHINA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................119
• TABLE 62
CHINA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................119
• TABLE 63
CHINA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................120
• TABLE 64
INDIA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................121
• TABLE 65
INDIA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................121
• TABLE 66
INDIA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................121
• TABLE 67
INDIA: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................122
• TABLE 68
ROAPAC: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................122
• TABLE 69
ROAPAC: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................123
• TABLE 70
ROAPAC: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................123
• TABLE 71
ROAPAC: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................123
• TABLE 72
ROW: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION).............................................................................................................................126
• TABLE 73
ROW: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY PRODUCTS & SERVICES, 2014-2021 (USD MILLION).............................................................................................................................126
• TABLE 74
ROW: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION).............................................................................................................................126
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LIST OF TABLES
• TABLE 75
ROW: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................127
• TABLE 76
TOP AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS, 2012–2016..................................................132
• TABLE 77
TOP NEW PRODUCT LAUNCHES, APPROVALS, AND PRODUCT ENHANCEMENTS, 2012–2016..................133
• TABLE 78
TOP STRATEGIC ACQUISITIONS, 2012–2016.................................................................................................134
• TABLE 79
TOP GEOGRAPHICAL EXPANSIONS, 2012–2016............................................................................................135
•
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LIST OF FIGURES
• FIGURE 1
RESEARCH DESIGN...........................................................................................................................................20
• FIGURE 2
HEALTHCARE EXPENDITURE ACROSS MAJOR COUNTRIES: 2000–2013........................................................24
• FIGURE 3
HEALTHCARE EXPENDITURE ACROSS MAJOR REGIONS: 2000–2013............................................................25
• FIGURE 4
HEALTHCARE SPENDING MATRIX: KEY MARKETS (2013)...............................................................................26
• FIGURE 5
INCREASE IN GERIATRIC POPULATION, BY COUNTRY (2011–2030)...............................................................27
• FIGURE 6
INCREASE IN THE PROPORTION OF THE ELDERLY IN THE OVERALL POPULATION, BY COUNTRY (2011–2030)...............................................................................................................................28
• FIGURE 7
PERCENTAGE INCREASE IN GERIATRIC POPULATION, BY REGION (1980–2010 VS. 2010–2040)..................28
• FIGURE 8
GLOBAL BURDEN OF CANCER, BY REGION (2005–2030)................................................................................29
• FIGURE 9
NUMBER OF NEW CANCER CASES, BY COUNTRY (2012–2020).....................................................................30
• FIGURE 10
INCREASING INCIDENCE OF VARIOUS CANCERS, 2008–2020........................................................................31
• FIGURE 11
GLOBAL BURDEN OF CARDIOVASCULAR DISEASES, BY REGION (2005–2030).............................................32
• FIGURE 12
NUMBER OF LIVING AND DECEASED ORGAN DONATIONS, BY COUNTRY (2010–2014)................................33
• FIGURE 13
NUMBER OF NEW PRODUCT LAUNCHES: TRANSPLANT DIAGNOSTIC ASSAY VS. COMPETITIVE MODALITIES, 2012–2015........................................................................................35
• FIGURE 14
MOLECULAR ASSAY-BASED TRANSPLANT DIAGNOSTIC TECHNOLOGY IS EXPECTED TO BE THE FASTEST-GROWING IMMUNOASSAY TECHNOLOGY BY 2021.................................................................36
• FIGURE 15
BOTTOM-UP APPROACH: TRANSPLANT DIAGNOSTICS INSTRUMENTS MARKET.........................................37
• FIGURE 16
BOTTOM-UP APPROACH: TRANSPLANT DIAGNOSTIC REAGENTS AND CONSUMABLES MARKET...............37
• FIGURE 17
TOP-DOWN APPROACH....................................................................................................................................38
• FIGURE 18
DATA TRIANGULATION......................................................................................................................................39
• FIGURE 19
ASSUMPTIONS OF THE RESEARCH STUDY.....................................................................................................40
• FIGURE 20
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2016 VS. 2021...............................42
• FIGURE 21
GEOGRAPHIC ANALYSIS: TRANSPLANT DIAGNOSTICS MARKET, BY PRODUCTS & SERVICES, 2016...................................................................................................................43
• FIGURE 22
GEOGRAPHIC ANALYSIS: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2016 VS. 2021......................................................................................................................44
• FIGURE 23
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY END USER, 2016 VS. 2021.....................................45
• FIGURE 24
TRANSPLANT DIAGNOSTICS MARKET SHARE, BY REGION, 2016...................................................................46
• FIGURE 25
GROWING NUMBER OF TRANSPLANTATION PROCEDURES TO DRIVE THE MARKET GROWTH FOR TRANSPLANT DIAGNOSTICS..............................................................................48
• FIGURE 26
NORTH AMERICA IS EXPECTED TO DOMINATE THE TRANSPLANT DIAGNOSTICS MARKET, BY TECHNOLOGY, IN 2016................................................................................................................................49
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LIST OF FIGURES
• FIGURE 27
REAGENTS AND CONSUMABLES TO DOMINATE THE TRANSPLANT DIAGNOSTICS PRODUCTS MARKET DURING THE FORECAST PERIOD...........................................................50
• FIGURE 28
NORTH AMERICA IS EXPECTED TO COMMAND THE LARGEST SHARE OF TRANSPLANT DIAGNOSTICS APPLICATIONS MARKET IN 2016......................................................................51
• FIGURE 29
HOSPITALS AND TRANSPLANT CENTERS TO DOMINATE THE TRANSPLANT DIAGNOSTICS MARKET DURING THE FORECAST PERIOD...............................................................................51
• FIGURE 30
U.S. AND GERMANY ARE EXPECTED TO DOMINATE THE GLOBAL TRANSPLANT DIAGNOSTICS MARKET TILL 2021....................................................................................................................52
• FIGURE 31
TRANSPLANT DIAGNOSTICS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES............................................................................................................................................55
• FIGURE 32
NUMBER OF ORGAN TRANSPLANT PROCEDURES, 2010–2013......................................................................57
• FIGURE 33
PERCENTAGE CHANGE IN ANNUAL HEALTHCARE EXPENDITURE— DEVELOPED VS. DEVELOPING COUNTRIES (2010–2013)................................................................................61
• FIGURE 34
VALUE CHAIN ANALYSIS: MAJOR VALUE IS ADDED TO THE OVERALL PRODUCT PRICING DURING R&D PHASE..........................................................................................................................64
• FIGURE 35
PORTER’S FIVE FORCES ANALYSIS: TRANSPLANT DIAGNOSTICS MARKET (2015)........................................66
• FIGURE 36
GROWING ADOPTION OF PCR- AND NGS-BASED PRODUCTS IS PROPELLING REVENUE GROWTH FOR MOLECULAR ASSAYS MARKET.................................................................................................70
• FIGURE 37
NGS-BASED DEVICES ARE EXPECTED TO FORM THE FASTEST-GROWING MOLECULAR ASSAY TECHNOLOGY SEGMENT TILL 2021...............................................................................71
• FIGURE 38
SEROLOGICAL ASSAY TECHNIQUE IS EXPECTED TO WITNESS POSITIVE MARKET GROWTH DURING 2016-2021...........................................................................................................................79
• FIGURE 39
REAGENTS AND CONSUMABLES SEGMENT TO DOMINATE THE TRANSPLANT DIAGNOSTICS MARKET DURING THE FORECAST PERIOD (2016–2021).........................................................83
• FIGURE 40
DIAGNOSTIC APPLICATIONS SEGMENT TO DOMINATE THE MARKET DURING THE FORECAST PERIOD....................................................................................................................................88
• FIGURE 41
THE HOSPITALS & TRANSPLANT CENTERS END-USER SEGMENT IS EXPECTED TO DOMINATE THE TRANSPLANT DIAGNOSTICS MARKET IN 2016........................................................................................94
• FIGURE 42
U.S. AND GERMANY TO GROW AT THE HIGHEST RATES IN THE TRANSPLANT DIAGNOSTICS MARKET......................................................................................................99
• FIGURE 43
NORTH AMERICAN TRANSPLANT DIAGNOSTICS MARKET SNAPSHOT: 2016-2021.....................................101
• FIGURE 44
EUROPEAN TRANSPLANT DIAGNOSTICS MARKET SNAPSHOT: 2016-2021.................................................107
• FIGURE 45
ASIA-PACIFIC TRANSPLANT DIAGNOSTICS MARKET SNAPSHOT: 2016-2021.............................................116
• FIGURE 46
ROW TRANSPLANT DIAGNOSTICS MARKET SNAPSHOT: 2016-2021............................................................125
• FIGURE 47
AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS: KEY GROWTH STRATEGY ADOPTED BY A MAJORITY OF MARKET PLAYERS FROM 2012 TO 2016.............................................................................128
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LIST OF FIGURES
• FIGURE 48
GLOBAL TRANSPLANT DIAGNOSTICS MARKET SHARE, KEY PLAYER, 2015................................................129
• FIGURE 49
GROWING NUMBER OF AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS IS STIMULATING MARKET COMPETITION AMONG KEY PRODUCTS MANUFACTURERS..........................................................131
• FIGURE 50
GEOGRAPHIC REVENUE MIX OF THE TOP 5 MARKET PLAYERS* (2015).......................................................136
• FIGURE 51
CAPACITY BUILDING AND CAPABILITY ENHANCEMENT: A KEY GROWTH STRATEGY ADOPTED BY MAJOR MARKET PLAYERS..........................................................137
• FIGURE 52
THERMO FISHER SCIENTIFIC, INC.: COMPANY SNAPSHOT..........................................................................138
• FIGURE 53
IMMUCOR, INC.: COMPANY SNAPSHOT........................................................................................................143
• FIGURE 54
QIAGEN N.V.: COMPANY SNAPSHOT..............................................................................................................149
• FIGURE 55
BIO-RAD LABORATORIES, INC.: COMPANY SNAPSHOT................................................................................154
• FIGURE 56
ILLUMINA, INC.: COMPANY SNAPSHOT........................................................................................................159
• FIGURE 57
AFFYMETRIX, INC.: COMPANY SNAPSHOT....................................................................................................163
• FIGURE 58
F. HOFFMANN-LA-ROCHE LTD: COMPANY SNAPSHOT.................................................................................166
• FIGURE 59
LUMINEX CORPORATION: COMPANY SNAPSHOT.........................................................................................168
• FIGURE 60
ABBOTT LABORATORIES, INC.: COMPANY SNAPSHOT.................................................................................171
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SAMPLE TABLES
TABLE 1 TRANSPLANT DIAGNOSTICS MARKET SIZE FOR SANGER SEQUENCING, BY REGION, 2014-2021 (USD MILLION) 2014
2015
2016-e
2021-p
CAGR (2016–2021)
North America
xx.x
xx.x
xx.x
xx.x
xx.x%
Europe
xx.x
xx.x
xx.x
xx.x
xx.x%
Asia-Pacific
xx.x
xx.x
xx.x
xx.x
xx.x%
RoW
xx.x
xx.x
xx.x
xx.x
xx.x%
TOTAL
xx.x
xx.x
xx.x
xx.x
xx.x%
REGION
Source: WHO, OECD, CIHR, FIPR, NLDAC, OPTN, IRODaT, GODT, GLOBOCAN, World Bank, Eurostat, ClinicalTrials.Gov, U.S. Census Bureau, U.S. Department of Health & Human Services, American Society of Nephrology, Canadian Society of Nephrology, European Journal of Cancer, Office of National Statistics (U.K.), MHLW (Japan), Ministry of Health (China), Annual Reports, SEC Filings, Press Releases, Investor’s Presentations, Journals, Expert Interviews, and MarketsandMarkets Analysis
TABLE 2 GLOBAL TRANSPLANT DIAGNOSTICS MARKET SIZE, BY APPLICATION, 2014-2021 (USD MILLION) 2014
2015
2016-e
2021-p
CAGR (2016–2021)
Diagnostic Applications
xx.x
xx.x
xx.x
xx.x
xx.x%
Research Applications
xx.x
xx.x
xx.x
xx.x
xx.x%
TOTAL
xx.x
xx.x
xx.x
xx.x
xx.x%
APPLICATION
Source: WHO, OECD, CIHR, FIPR, NLDAC, OPTN, IRODaT, GODT, GLOBOCAN, World Bank, Eurostat, ClinicalTrials.Gov, U.S. Census Bureau, U.S. Department of Health & Human Services, American Society of Nephrology, Canadian Society of Nephrology, European Journal of Cancer, Office of National Statistics (U.K.), MHLW (Japan), Ministry of Health (China), Annual Reports, SEC Filings, Press Releases, Investor’s Presentations, Journals, Expert Interviews, and MarketsandMarkets Analysis
TABLE 3 FRANCE: TRANSPLANT DIAGNOSTICS MARKET SIZE, BY TECHNOLOGY, 2014-2021 (USD MILLION) 2014
2015
2016-e
2021-p
CAGR (2016–2021)
Molecular Assays
xx.x
xx.x
xx.x
xx.x
xx.x%
Non-molecular Assays
xx.x
xx.x
xx.x
xx.x
xx.x%
TOTAL
xx.x
xx.x
xx.x
xx.x
xx.x%
TECHNOLOGY
Source: WHO, OECD, OPTN, IRODaT, GODT, GLOBOCAN, World Bank, Eurostat, ClinicalTrials.Gov, European Journal of Cancer, Annual Reports, SEC Filings, Press Releases, Investor Presentations, Journals, Expert Interviews, and MarketsandMarkets Analysis
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APPENDIX
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RELATED REPORTS
RELATED REPORTS REPORT TITLE
PUBLISHED DATE
1
MOLECULAR DIAGNOSTICS MARKET By Application (Infectious Disease (HIV, HPV, TB), Oncology, Genetics, Microbiology), Technology (PCR, Microarray, DNA Sequencing), End User (Hospital, Laboratories), Product (Instruments, Reagent, Software) - Forecast to 2020
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Fore Market –
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Transplant Diagno stics
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OPE
SC MARKET
CO VER ED
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NT
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BY TECHNOLO
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TS & SERV
•
Instruments nts and • Reage s Consumable es and Servic • Software
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d lar Assay-base Non-molecu s gical Assay Serolo e Lymphocyt s Mixed Assay Culture (MLC) d Assay-base ular • Molec ased PCR-b
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2015
plant and Trans Hospitals Centers s Laboratorie Research tes mic Institu and Acade Service Commercial Providers
2014
Diag no
BASE YEAR
stics M
RESEA
2.1
arket –
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st to
2021
RCH METH ODO
RES This EAR ESTIMATED YEAR re CH D as Ho search FOREC AST stu PERIOD A ov
LOGY
TA
dy inv ers, tech Bloo olves nic mbe th were al, mar ket-o rg Busin e ex tens cond rie es ex pe ive ucte us rts (S d wi nted, an s, Facti th va va, an age of obta d co M seco in an Es), Cmm rious ndar ercia d Aven level pros d ve prim tion) y so ex The currency used pects ary re l study rif urce . The y critic ecutives in the report is of th to id en spon s, dir al qu United States of ke tif follo e de ecto Dollar (USD), with FIGU wing alita y mar nts, wh transpla y and co ries, tive figur marke and ich inc REt size nt ket lle For compa and 1 indicated in USD e sh pla data lude diagnos ct inform nies reporting ow base million RESE tics s the . quantit yers, an their revenues ation s (su mar d ind key ind ative reports, SEC Filings ARCH in USD, their revenu mar us ket. ch ustry ustry ket re infor , and other revenu HIST es were picked DESI In -de eful for pa co m sear e filings from GN pth this their annual ch m ation as nsultan rticipan DATA ORICAL For compa ts, su intervie ts, am etho nies reporting TRAN FOR THE ws bject dolog well as ong their revenues SPLA -mat othe y currency conver to ap in DI curren NT te plied as AGNO r cies sion rate was other in m sess fu ex perts, r STIC than USD, the averag used for the particu S MA ak ing ture to e lar year to conver annua l m this tRK ET value to the repo arket USDMARKET rt.
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NORTH AME
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WORLD
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