BIOLOGICS MARKET SIZE Scope of the Study This report on Biologics gives a market insight into product types including Monoclonal Antibodies, Blood & Blood Products, Vaccines, Insulin and Other, for both human and animal consumption. Market projections and estimates are illustrated by region and by type. The report serves as a guide to Biologics market, covering more than 250 companies that are engaged in Biologics products and services. Major Contract Research Organizations, Research Institutes and Universities serving the Animal Biologics industry are also covered in the corporate directory section of this report. Information related to recent product releases, product developments, partnerships, collaborations, and mergers and acquisitions is covered in the report. Compilation of Worldwide Patents related to Biologic products is also provided. A global perspective is presented along with regional analysis covering the regions of North America, Europe, Asia-Pacific, and Rest of World with 116 exclusive graphically represented exhibits. Biologics’ report is an ideal research tool providing strategic business intelligence to the corporate sector. This report may help strategists, investors, laboratories, pharmaceutical companies, contract research organizations, biotechnology companies and drug approval authorities in-
Gauging Competitive Intelligence
Identifying Key Growth Areas and Opportunities
Understanding Geographic Relevance to Product
Knowing Regional Market Sizes and Growth Opportunities and Restraints
Keeping Tab on Emerging Technologies
Equity Analysis
Tapping New Markets
Analytics and data presented in this report pertain to several parameters such as –
Global and Regional Market Sizes, Market Shares, Market Trends
Product (Global and Regional) Market Sizes, Market Shares, Market Trends
Technology Trends
Corporate Intelligence
Key Companies by Sales, Brands, Products
Consumer Behavioral Patterns
Other Strategic Business Affecting Data
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Research Methodology RI Technologies publishes business intelligence reports by going through a cycle of diligent research and analysis activity. Research is done using both online and offline resources. The study outline of this report is sketched on the following lines – global market analysis, regional market analysis, product segmentation, global and regional market analysis by product segment, market trends, M&A, R&D, competitive landscape, technology trends, and other key drivers. Current data helps in analyzing the future of the industry and is also helpful for doing market evaluations, and estimating the market size for the future.
This report is uniquely researched and the methodology includes:
Need and Scope of Study
Product Definitions
Segmental Analysis
Regional Analysis
Exclusive Data Analytics
Corporate Intelligence
Feedback
Right from concept to final compilation of this report, both primary and secondary research methods are applied. We have provided exclusive feedback forms/pre-release questionnaires for this report to use the information for authentication of our own findings. Secondary research includes government publications, investment research reports, web based surveys, website information of both companies and markets, and other offline resources such as print publications and CDs. Our compilation of easy to navigate PDF reports are essential value addition resources for leading and growing companies.
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CHAPTER II - REPORT SYNOPSIS Biologics Biologics is a preparation like a drug, a vaccine or an antitoxin which is produced from living organisms or products obtained from them. These are used as diagnostic, preventive or an agent for treatment. The official definition of biologics or biological products according to FDA is “any virus, toxin, antitoxin, therapeutic serum or analogous product that can be used to prevent, treat or cure diseases or injuries of man”. Biopharmaceuticals: This is a pharmaceutical that has been obtained from biological sources particularly those manufactured by using biotechnology. Biosimilars: Biosimilars are also called as follow -on biologics. These are biologic medical products wherein the active drug substance is synthesized by a living organism or derived from a living organism by using either recombinant DNA or controlled gene expression procedure. Monoclonal Antibodies: Monoclonal Antibodies (mAb or moAb) are essentially monospecific antibodies. These are the same as they are made by exactly same immune cells that are clones of a unique parent cell. As opposed to this, polyclonal antibodies are made from several different immune cells. Monoclonal antibodies have monovalent affinity as these bind to the same epitope.
Segmentation of Biologics Market Exhibit 1. Segmentation of Global Biologics Market by Type and Species Type
Species
Monoclonal Antibodies
Human
Blood & Blood Products
Animal
Vaccines Insulin Other * Growth Hormones/Factors © RIT, 2013
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Global Market Analysis Global Biologics market is projected to reach about US$ XX.XX billion by 2020 from an estimated US$ XX.XX billion in 2012, growing at a very high compounded annual growth rate (CAGR) of XX.XX % during the analysis period 2005-2020. Exhibit 2. Biologics – Global Value Market Estimations and Predictions (2005-2020) in US$ Million Year
Value
2005
XX.XX
2006
XX.XX
2007
XX.XX
2008
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© RIT Figures, 2013
US$ Million
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
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Exhibit 3. List of Major Global Biologics Companies S. No
Company
Country
Website
1
Abbott Laboratories
USA
www.abbott.com
2
Novartis Animal Health
Switzerland
www.ah.novartis.com
3
Sanofi SA
France
www.sanofi.com
4
Zoetis Animal Health
USA
www.zoetis.com
More… © RIT, 2013
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III. MARKET DYNAMICS North American Biologics Market United States is estimated as the largest market for Biologics in North America, with an estimated share of XX.XX % in 2012. In terms of value, United States is projected to reach US$ XX.XX billion by 2020, from an estimated US$ XX.XX billion in 2012. Canada is projected to represent the fastest growing market for Biologics in North American region during 2005-2020 with a CAGR of XX.XX %. Exhibit 4. Biologics - North American Value Market Estimations and Predictions (2005-2020) by Countries for United States and Canada in US$ Billion Year/Country
United States
Canada
Total
2005
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2007
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2019
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2020
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CAGR%
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© RIT Figures, 2013
US$ Billion
2005
2006
2007
2008
2009
2010
United States
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
Canada
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Exhibit 5. Biologics - North American Value Market Shares (2010, 2015 & 2020) by Country for United States and Canada Year/Country
United States
Canada
Total
2010
XX.XX
XX.XX
XX.XX
2015
XX.XX
XX.XX
XX.XX
2020
XX.XX
XX.XX
XX.XX
CAGR%
XX.XX
XX.XX
XX.XX
© RIT Figures, 2013
US Biologics Market United States Biologics market is projected to grow at a CAGR of XX.XX % during 2005-2020, to almost reach US$ XX.XX billion by 2020, from an estimated market value of US$ XX.XX billion in 2012.
Canadian Biologics Market Canadian Biologics market is projected to grow at a CAGR of XX.XX % during 2005-2020 to reach US$ XX.XX billion by 2020, from an estimated market value of US$ XX.XX billion in 2012.
RITMIR039: Biologics – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com
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Biologics - Analysis by Type Global market for Blood & Blood Products is estimated as the largest Biologics segment, valued at US$ XX.XX billion in 2012, accounting for more than half of the market. Blood & Blood Products market is expected to reach about US$ XX.XX billion by 2020, and fastest CAGR of XX.XX %, followed by Monoclonal Antibodies with a CAGR of XX.XX % during the above analysis period 2005-2020. Exhibit 6. Biologics – Global Value Market Estimations and Predictions (2005-2020) by Type for Monoclonal Antibodies, Blood & Blood Products, Vaccines, Insulin and Other in US$ Billion Year/Region
Monoclonal Antibodies
Blood & Blood Products
Vaccines
Insulin
Other
Total
2005
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2006
XX.XX
XX.XX
XX.XX
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2008
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2011
XX.XX
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2012
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2013
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2014
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2015
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2016
XX.XX
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2017
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XX.XX
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2018
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CAGR%
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© RIT Figures, 2013
US$ Billion
2005
2006
2007
2008
2009
Monoclonal Antibodies
2010
2011
2012
2013
Blood & Blood Products
2014
2015
2016
Vaccines
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2017 Insulin
2018
2019
2020
Other
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Exhibit 7. Biologics– Global Value Market Shares (2010, 2015 &2020) by Type for Monoclonal Antibodies, Blood & Blood Products, Vaccines, Insulin and Other Year/Region Monoclonal Antibodies Blood & Blood Products
Vaccines
Insulin
Other
Total
2010
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2015
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
2020
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
CAGR%
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
© RIT Figures, 2013
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IV. PRODUCT/TECHNOLOGY RESEARCH Biologics – Introduction There have been a lot of developments in biotechnology and medicines and this has led to entry and increase of biologics. Chemical drugs are simple, small molecule compounds. These have been developed by chemists and produced in the form of pills. Examples include aspirin, Ibuprofen etc. Biologics are large, complex molecules developed by bioengineered bacteria and other living organisms. These have a great potential for the therapy of cancer, autoimmune diseases and other critical diseases. Drug producers have been promised patent protection and are tempted by the strong market rates so they have ventured into this area. They are working to develop new biologics to be used in several therapeutic areas. Biologics development has not reached its full potential as it is expensive and the second important factor is the safety issue. Therapy with biologics is costly and the total costs may go up to hundreds of thousands of dollars annually. The second important concern is safety. This is due to the fact that biologics are larger and more complex than small-molecule drugs. Hence, the manufacture, quality control and quality assurance is a big problem. Minute changes in a biologic’s production can alter its chemical properties and the way it affects individuals. Competition from generic versions of brand name biologics termed as “follow-on biologics”, would take care of the expenses by providing inexpensive alternatives and also offer growth for generic biologic producers to continue research and development. As such there is no legislative framework to look after approval of generic biologics. As per the Public Health Safety Act (“PHSA”) generic biologics too have to be approved similar to the reference biologics. A biologic medicine is a big molecule which is obtained from living cells and used for therapy, diagnosis or prevention of disease. The biologic medicines are therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins. Biologic medicines are about 200 to 1000 times larger than small molecule drugs and are structurally complex as well. These are very sensitive, so it is difficult to manufacture and categorize these. Due to the properties of size and sensitivity, the biologic medicines are mostly injected into the body of the patient. Exhibit 8. List of Best Selling Biologics Biologic
Company
Description
Patent Expiry
Sales (2011)
Enbrel
Amgen
TNF inhibitor
2028
US$ 7.4 billion
Novolog
Novo Nordisk
Insulin Analog
2014
US$ 2.4 billion
Lantus
Sanofi SA
Insulin Analog
2015
US$ 5.4 billion
Neulasta
Amgen
G-CSF
2015
US$ 5.2 billion
Humira
Abbott
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Rituxan
Genentech
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More…. © RIT, 2013
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About RI Technologies RI Technologies is a premier source of market research on the Biotechnology & Healthcare sector. We emphasize on factual insights and forecasts with maximum global coverage. RI Technologies is constantly monitoring the biotechnology & Healthcare industry, tracking market trends, and forecasting industry based on specialized analysis. The life sciences sector is an ever growing marketplace with emerging technologies in areas of discovery, design and development.
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Identifying Key Growth Areas and Opportunities
Understanding Geographic Relevance to Product
Knowing Regional Market Sizes and Growth Opportunities and Restraints
Keeping Tab on Emerging Technologies
Equity Analysis
Tapping New Markets
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