EUROPE GENETIC TESTING MARKET
2014 - 2020 Growth Trends & Forecasts
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1. INTRODUCTION 1.1 REPORT DESCRIPTION
A Genetic or Genomic test involves an analysis of human chromosomes, DNA, RNA, genes, and/or gene products (e.g., enzymes and other types of proteins). These tests are predominately used to detect heritable or somatic mutations, genotypes, or phenotypes related to disease and health.
The purpose of genetic tests includes predicting risk of disease, screening newborns, directing clinical management, identifying carriers, and establishing prenatal or clinical diagnoses or prognoses in individuals or families, and populations.
Genetic testing represents the most rapidly expanding segment of the molecular diagnostics market. Growing incidences of genetic diseases have unraveled new opportunities for genetic testing. The transformation of genetic testing from being a service-driven market to a product-driven market is expected to provide an impetus to the diagnostic companies for the expansion of their operations.
European Genetic testing market sales are expected to reach $6.7 billion annually in 2014 with a compound annual growth rate (CAGR) of 15.9% in the forecasted period of time. The genetic testing market’s growth is driven by increasing adoption of oncology applications, growing public awareness and demand for personalized medicine. It advances with an aging population and the subsequent rise in the number of chronic diseases. These and the increasing incidences of cancer cases are the other factors propelling growth in the genetic testing market.
This research report provides the Genetic Testing Market evolution in Europe, strategic assessment of Indications market impact analysis, country level variation and current, future market trends. The report also provides company profiles with pipeline products and financials.
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1.2 RESEARCH METHODOLOGY
1) Secondary Research: Information was collected from a number of public and paid data sources. Public sources involved Government websites, publications from the genetic testing programs of different countries, company annual reports, white papers and research publications by recognized industry experts. Paid data sources include authentic industry databases.
2) Primary Research: After collecting data from secondary sources, primary interviews were conducted with stakeholders at different points of the feed value chain like manufacturers, distributors, ingredient suppliers, companies producing enzymes and key opinion leaders of the industry. Primary research is used both to validate the data points obtained from secondary research and to fill any gaps in data.
3) Market Analysis: The market analysis phase involves analyzing the collected data, market breakdowns and forecasting. Macroeconomic indicators and bottom-up and top-down approaches are used to arrive at a complete set of data points that give way to valuable qualitative and quantitative insights. Each data point is verified by the process of data triangulation to validate the numbers and arrive at a close estimate.
4) Expert Validation: The market analysis data is verified and validated by a number of experts, both in-house and external.
5) Report Writing: After the data is curated through the process, our analysts begin to write the report. Garnering insights from data and forecasts, insights are drawn to visualize the entire business ecosystem in a single report.
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2. EUROPE GENETIC TESTING MARKET
The European market for genetic testing is projected to reach US$16.3 billion by 2020, from an estimated US$6.7 billion in 2014, by recording a CAGR of 15.9% in 2014-2020.
While Germany accounts for the largest share of the genetic testing market in Europe, estimated at 26.7% in 2014, the demand for these tests is likely to be the fastest growing in the United Kingdom, with a forecast CAGR of 16.6% during 2014-2020.
In terms of segment, demand for newborn screening in Europe is the largest, as well as the fastest growing and is expected to post a CAGR of 16.8% over 2014-2020, to reach a projected US$6.7 billion by 2020.
Genetic testing has become quite prevalent in Europe over the last few years, with recent developments in molecular medicine expected to provide further impetus to this critical area. The integration of these technologies into the healthcare system necessitates that their application is implemented within a responsible framework of accompanying measures and activities.
As a consequence of this, genetic testing has been subjected to policy debates at various institutional and international levels. The European Commission has recognized certain salient topics involving genetic testing that need further clarity, which include regional distribution of genetic services, suggestions for the rationalization of services, methods for improving national accreditation of genetic laboratories, long-term organization of external quality assessment, validation of next generation sequencing platforms and applications, perspectives on direct-to-consumer genetic testing.
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Table 1: European Genetic Testing Market for 2010-2020 by Country (In US$ Million)
Region
2010
2011
2012
2013
2014
2020
% CAGR (2014-2020)
France
1,017.45
1,104.60
1,211.16
1,341.23
1,497.53
3,525.32
15.34
Germany
1,200.51
1,308.14
1,439.47
1,600.06
1,796.55
4,421.46
16.2
Italy
607.04
656.47
716.78
790.24
879.6
2,039.40
15.05
Spain
455.62
495.1
543.18
601.73
672.95
1,600.77
15.54
United Kingdom
888.18
973.86
1,078.08
1,205.06
1,359.69
3,415.04
16.59
Rest of Europe
351.19
381.99
419.52
465.34
521.26
1,258.32
15.82
Total
4,519.99
4,920.16
5,408.19
6,003.66
6,727.58
16,260.31
15.85
Source: Mordor Intelligence Analysis
Europe Genetic Testing Market by Country (2010- 2020) 18.00 16.00 14.00
Rest Of Europe
$ Billion
12.00
U.K
10.00
Spain
8.00
Italy
6.00
Germany
4.00
France
2.00 0.00 2010
2011
2012
2013
2014
Source: Mordor Intelligence Analysis
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Table 2: European Genetic Testing Market for 2010-2020 by Segment (In US$ Million) Segment
2010
2011
2012
Carrier Testing
807.36
869.64
945.77
Diagnostic Testing
318.29
339.48
365.65
Newborn Screening Predictive & Presymptomatic Testing Prenatal Testing Total
2013
2014
1,038.78 1,149.83
2020
% CAGR (20142020)
2,577.80
14.4
936.65
13.55
6,675.87
16.79
2,088.45
15.24
3,981.54
16.19
4,519.99 4,920.16 5,408.19 6,003.66 6,727.58 16,260.31
15.85
397.79
437.07
1,708.86 1,875.92 2,079.43 2,327.67 2,630.57 611.73
662.51
724.4
799.94
891.84
1,073.75 1,172.61 1,292.94 1,439.49 1,618.26
Source: Mordor Intelligence Analysis
Europe Genetic Testing Market by Category (2010-2020)
18 16
Prenatal Testing
$ Billion
14 Predicstive Testing
12 10
Newborn testing
8 6
Diagnostic testing
4 Carrier Testing
2 0 2010
2011
2012
2013
2014
Source: Mordor Intelligence Analysis European Genetic Testing Market | Sample
2020
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2.1 MARKET DRIVERS
The European genetic testing market is driven by certain key factors that are inseparable from the market expansion of genetic testing in Europe 2.1.1
EARLY CONFIRMATION OF GENETIC DISORDERS
The prevalence of cancer is expected to increase as the population ages. Approximately 75-80% of all cancers are diagnosed in people aged 55 or older and this pattern is expected to increase by 2020. According to the United Nations Department of Economic and Social Affairs, the number of senior citizens (aged 60 years or over) is 841 million people in 2013 and is expected to more than 2 billion by 2050. 396.2 people per 100,000 of the population were diagnosed with cancer in the UK in 2011 (European age-standardized incidence rate).Cancers of the breast, lung, prostate and bowel account for over half (54%) of all new cancer cases in the UK alone in 2011. These statistics indicate oncology testing is to be the fastest growing segment in genetic testing.
2.1.2
MINIMAL PROCEDURE RISK
Genetic Testing is done on a sample of blood, cheek cells, urine, amniotic fluid or other body tissues. For cancer, several tubes of blood are collected through a thin needle put into a vein (usually in the arm) to get the blood sample. Genetic tests help directly examine the specific genes or it may involve linkage analysis or indirect testing which analyses the ‘markers’ or stretches of DNA located near the target gene. A DNA sample is obtained from a blood sample although it can be acquired from several other tissues. Genetic testing makes use of molecular probes to detect a specific sequence along the length of a person's DNA molecule that is responsible for a genetic disorder. European Genetic Testing Market | Sample
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Several other clinical tests, biopsy and oncology devices are used for cancer treatment and diagnosis. Among all others, genetic testing provides a minimal risk. Many of the risks associated with genetic testing involve the emotional, social and financial consequences of the test results.
2.1.3
GUIDE STRATEGIES FOR MAINTAINING HEALTH
Genetic testing guide strategy is mainly aimed at preventing genetic disorders. Genetic testing helps to identify several types of genes, which can cause inherited susceptibility to cancer; if inherited in a faulty state. The integration of genetic testing into clinical practice provides multiple beneďŹ ts to individuals in families with history of genetic disorders. The benefits include earlier detection of genetic disorders and prevention of these disorders, providing greater choice of surgical and other intervention options and provision of information for planning family and career decisions. In hereditary disorders, genetic testing has been shown to be cost-effective.
2.1.4
GUIDE TREATMENT CHOICES FOR A VARIETY OF DISEASE CONDITIONS
Genetic testing refers to the analysis of DNA to identify changes in gene sequence or expression levels. It can also refer to biochemical tests for gene products (proteins) and for microscopic analysis of stained chromosomes. Still in its early stages, both patients and experienced physicians may need guidance when it comes to navigating this new and complex territory. Genetic counselors are health professionals with specialized graduate degrees and experience in the areas of medical genetics and counseling. They guide patients with their treatment choices for a variety of disease conditions. Generally genetic testing is used clinically in:
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•
Diagnostic medicine, which helps in identifying whether an individual has a certain genetic disease. This type of test commonly detects a specific gene alteration but is often not able to determine disease severity or age of onset.
•
Predictive medicine, which helps in identifying whether an individual has an increased risk for a particular disease. Results from this type of test are usually expressed in terms of probability and are therefore less definitive since disease susceptibility may also be influenced by other genetic and non genetic (e.g. environmental, lifestyle) factors.
•
Pharmacogenomic testing helps in classifying subtle variations in an individual's genetic makeup, thus determining whether a drug is suitable for a particular patient. Also provides details of the safest and most effective dose for the patient.
2.2 MARKET RESTRAINTS 2.2.1
FALSE-POSITIVE AND FALSE-NEGATIVE RESULTS
Genetic tests are not completely reliable and are not available for every possible inherited disorder. Genetic testing cannot always provide definitive answers and it is possible for test results to show false negatives, positives or return as variants of unknown significance. Another thing to think about is the possibility that the test results are wrong. A false positive result occurs when a genetic test has wrongly detected a certain allele or faulty chromosome. It means that the test looking for inherited disorder has produced DNA differences in the results. It does not mean a 100% certainty of inherited disorder, but only means that in a large group of people, the ones with the same type of DNA are more likely to get inherited disorder. A false negative result happens when a genetic test has failed to detect a certain allele or faulty chromosome. It means test has not produced DNA differences in the results looking for inherited disorder. It does not mean there won’t be chance of developing inherited disorder, but it only means that another version of the gene is present for this inherited disorder. European Genetic Testing Market | Sample
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2.2.2
POTENTIALLY ADVERSE PERSONAL OR SOCIETAL CONSEQUENCES
Personal Genome Testing is susceptible to misunderstanding and misinterpretation due to complexity of genetic information together with the limited predictive ability of the tests themselves. Psychological risks, health risks and societal risks are different types of risks expected from personal genome testing; as a result of its limited clinical validity. Adverse psychological risks are well known from clinical genetic testing, such as emotional distress, depression or survivor guilt as a result of test outcomes; and are not to be expected from genetic profiling to the same extent. As test outcomes for multifactorial diseases lack clinical validity, they are much more likely to lead to epistemic uncertainty than to the major psychological impact known from clinical genetics. Health risks are frequently argued for multifactorial diseases. Because of false reassurance on the basis of testing of limited clinical validity, lead patients or consumers have adopted to unhealthier lifestyles, neglect standard preventive measures and neglect regular screening; thus harming their health. Indirect economic risks and loss of public confidence are two perceived societal risks involved in low clinical validity of personal genome testing. On the basis of personal genome test results, consumers may turn to their physicians for advice and follow-up research or medication. Due to uncertain results from the clinical validity, most of the follow-up will be unnecessary while it does drive up the costs of public health care.
2.2.3
NON-INCLUSION OF REIMBURSEMENT POLICY
In most countries, a specific regulation for the reimbursement of comprehensive exploration of an individual’s genome is not in place. A few laboratories in Europe have already been accredited for NGS
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applications, including exome sequencing (for targeted analysis), even if no clear guidelines or consensus criteria exist. Also the lack of reimbursement for genetic testing , when done in a country other than the country of residence or social security subscription of the patient, based on geography hampers equal availability of good genetic testing services to all citizens within the EU. In some countries certain genetic tests when done are fully reimbursed as a part of the national health services for the regional population. In others the tests may or may not be included, with also the enforcement of a symbolic contribution to the payment by the patients themselves. Coverage by private insurers is also not systemized as some ill cover tests done y both public and private establishments whereas most will not cover these tests at all.
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3. COUNTRY WISE SEGMENTATION 3.1 GERMANY Germany forms the largest European market for genetic testing, accounting for an estimated share of 26.7% equating to US$1.8 billion, which is further projected to reach US$4.4 billion by 2020 at a robust CAGR of 16.2% during 2014-2020. The demand for newborn screening is the largest in Germany, and also the fastest growing, projected to reach US$1.9 billion by 2020, by compounding annually at 17.2% over 2014-2020.
The German Parliament, in April 2009, granted approval to the Human Genetic Examination Act that prohibited all forms of direct-to-consumer (DTC) genetic testing. This law stipulated that genetic tests can only be carried out by a doctor, with full consent of all concerned parties. Therefore, it becomes illegal to conduct anonymous paternity tests, with the fine for violation of the same being up to €5,000. The law has further limited the use of genetic testing on fetuses only for medical purposes, implying that parents cannot use these tests for determining the sex of their unborn children.
An April 2013 publication by the German Ethics Council putting forth its opinion on a paper titled “The Future of Genetic Diagnostics – From Research to Clinical Application” has presented a set of recommendations that are applicable to local laws and regulations, in addition to ethical perspectives. These recommendations have been explicit in stating the lack of adequacy in safeguarding the rights of consumers pertaining to genetic testing in Germany and Europe as a whole.
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German Genetic Testing Market for 2010-2020 by Segment (In US$ Million) Segment
2010
2011
2012
2013
2014
2020
% CAGR (20142020)
Carrier Testing
203.49
219.14
238.25
261.74
290.5
662.94
14.74
Diagnostic Testing
79.47
84.19
90.09
97.36
106.3
228.91
13.64
Newborn Screening
474.92
522.41
580.3
650.92
737.49
1,910.90
17.2
Predictive & Presymptomatic Testing
166.39
180.5
197.68
218.78
244.37
579.87
15.49
Prenatal Testing
276.24
301.9
333.15
371.26
417.89
1,038.84
16.39
Total
1,200.51
1,308.14
1,439.47
1,600.06
1,796.55
4,421.46
16.2
Source: Mordor Intelligence Analysis
Genetic Testing Market Distribution 2013
Diagnostic Testing Prenatal Testing
Source: Mordor Intelligence Analysis
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