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Global Biosimilars Market and Forecast (By Product Type, Applications, Country Wise and Companies) to 2021 and Biosimilars Approved and Pipeline Analysis

Global Biosimilars Market and Forecast (By Product Type, Applications, Country Wise and Companies) to 2021 and Biosimilars Approved and Pipeline Analysis

The biosimilars are poised to capture an unprecedented position in the biopharmaceutical industry driven by an increased extent of adoption and growing investment and deal making activity globally. The global biosimilars market is predicted to cross US$ 25 Billion mark by 2020. With the continuous increasing demand for biologics, manufacturers are looking for novel strategies that will help them attain maximum returns on investment. Biosimilars are seen as the key weapon to curbing soaring healthcare costs globally. The major factor that is driving the market for biosimilars industry is the fact that major biologics are nearing the patent cliff. Further, the lower cost of these drugs as compared to the patented biologics, the increasing encumbrance to curb healthcare costs globally, increasing nationwide government initiatives, and the strong pipeline for the biosimilar drugs is expected to fuel the biosimilars industry. On the other hand, high manufacturing complexities and costs, stringent regulatory requirements in countries and operational challenges are restricting the growth of the biosimilars market.

Key Highlights of the Report

Biosimilars Market - By Product Type

  • The erythropoietin (EPO) captures maximum share of the global biosmilars market.
  • The Granulocyte- Colony Stimulating Factor (G-CSF) market is expected to cross US$ 6 Billion mark by 2021.
  • The Human Growth Hormone (HGH) biosimilars market is expected to grow with a double digit CAGR during the period 2016 - 2021.
  • The monoclonal antibody is expected to show the highest growth rate during the period 2016 - 2021.
  • The insulin and interferon product segment each accounted for single digit share of the global biosimilars market respectively in 2015.
Biosimilars Market - By Applications
  • Among various application segments of biosimilar market, blood disorders and oncology together accounted for over 55% share of the global biosimilars market in 2015.
  • Growth hormone deficiencies application is expected to show double digit CAGR during the period 2016 - 2021.
  • The chronic and autoimmune disorders captured XX% share of the biosmilars market in 2015.
Biosimilars Market - By Country Wise
  • The market for biosimilars in the U.S. has gained momentum after the launch of Novartis’ Zarxio in September 2015.
  • In the European countries, Germany is at the forefront with around XX% share of the biosimilars market in 2015 followed by France with XX% share in the same year.
  • China accounted for XX% share of the global biosimilar market in 2015.
  • India is seen as a key player in the biosimilar space with an exceptionally high number of approvals granted in the last decade compared to the global average.
  • South Korea captured XX% of the global biosimilar market in 2015 being closely followed by Brazil with XX% share in the same year.
iGATE RESEARCH report titled “Global Biosimilars Market and Forecast (By Product Type, Applications, Country Wise & Companies) to 2021 and Biosimilars Approved & Pipeline Analysis” provides a comprehensive assessment of the fast-evolving, high-growth Global Biosimilars market.

This 177 Page report with 74 Figures and 27 Tables is analyzed from 6 viewpoints:

1. Global Biosimilars Market and Forecast - By Product Type
2. Global Biosimilars Market and Forecast - By Applications
3. Global Biosimilars Market and Forecast - By Country Wise
4. Global Biosimilars Company - Profile, Revenue, Approved and Pipeline Biosimilars Analysis
5. Country with Biosimilar Guideline and Published Year
6. Global Biosimilars Market - Driving Factors and Challenges

Global Biosimilars Market and Forecast - 7 Product Types Covered

1. Erythropoietin (EPO)
2. Human Growth Hormone (HGH)
3. Granulocyte- Colony Stimulating Factor (G-CSF)
4. Monoclonal Antibody (mAb)
5. Insulin
6. Interferon (IFN)
7. Others

Global Biosimilars Market and Forecast - 5 Applications Covered

1. Oncology
2. Blood Disorders
3. Growth Hormone Deficiencies
4. Chronic and Autoimmune Disorders
5. Other Applications

Global Biosimilars Market and Forecast - 16 Countries Covered

1. United States
2. Canada
3. Argentina
4. Germany
5. France
6. Italy
7. Spain
8. United Kingdom
9. China
10. Japan
11. India
12. South Korea
13. Australia
14. Brazil
15. Mexico
16. Rest of the World

Global Biosimilars Company Analysis - 13 Companies Covered

1. Biocad
2. Celltrion Inc.
3. Dong-A Socio Group
4. Pfizer Inc.
5. Intas Pharmaceuticals Ltd.
6. Sandoz International GmbH - A Novartis Company
7. Stada Arzneimittel AG
8. Teva Pharmaceutical Industries Ltd
9. Amgen Inc.
10. Biocon
11. Dr. Reddy’s Laboratories
12. Mylan
13. Merck KGaA

Source of Information

iGATE RESEARCH employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. This report is built by using data and information sourced from Proprietary Information Database, Primary and Secondary Research Methodologies, and In house analysis by iGATE Research dedicated team of qualified professionals with deep industry experience and expertise.

Research Methodologies

Primary Research Methodologies:


Questionnaires, Surveys, Interviews with Individuals, Small Groups, Telephonic Interview, etc.

Secondary Research Methodologies:

Printable and Non-printable sources, Newspaper, Magazine and Journal Content, Government And NGO Statistics, white Papers, Information on the Web, Information from Agencies Such as Industry Bodies, Companies Annual Report, Government Agencies, Libraries And Local Councils and a large number of Paid Databases.


1. Executive Summary
2. Global Biosimilars Market and Forecast to 2021
3. Global Biosimilars Market Share and Forecast to 2021
3.1 Global Biosimilars Market Share and Forecast - By Product Type
3.2 Global Biosimilars Market Share and Forecast - By Applications
3.3 Global Biosimilars Market Share and Forecast - By Country Wise
4. Global Biosimilars Market and Forecast - By Product Type
4.1 Erythropoietin (EPO) Biosimilars Market and Forecast
4.2 Human Growth Hormone (HGH) Biosimilars Market and Forecast
4.3 Granulocyte - Colony Stimulating Factor (G-CSF) Biosimilars Market and Forecast
4.4 Monoclonal Antibody (mAb) Biosimilars Market and Forecast
4.5 Insulin Biosimilars Market and Forecast
4.6 Interferon (IFN) Biosimilars Market and Forecast
4.7 Others Biosimilars Market and Forecast
5. Global Biosimilars Market and Forecast - By Applications
5.1 Oncology Biosimilars Market and Forecast
5.2 Blood Disorders Biosimilars Market and Forecast
5.3 Growth Hormone Deficiencies Biosimilars Market and Forecast
5.4 Chronic and Autoimmune Disorders Biosimilars Market and Forecast
5.5 Other Applications Biosimilars Market and Forecast
6. Global Biosimilars Market and Forecast - By Country Wise
6.1 United States Biosimilars Market and Forecast
6.2 Canada Biosimilars Market and Forecast
6.3 Argentina Biosimilars Market and Forecast
6.4 Germany Biosimilars Market and Forecast
6.4.1 Reimbursement of Biosimilars in Germany
6.5 France Biosimilars Market and Forecast
6.5.1 Reimbursement of Biosimilars in France
6.6 Italy Biosimilars Market and Forecast
6.6.1 Pricing and Reimbursement of Biosimilars in Italy
6.7 Spain Biosimilars Market and Forecast
6.8 United Kingdom Biosimilars Market and Forecast
6.8.1 Reimbursement of Biosimilars in United Kingdom
6.9 China Biosimilars Market and Forecast
6.10 Japan Biosimilars Market and Forecast
6.11 India Biosimilars Market and Forecast
6.12 South Korea Biosimilars Market and Forecast
6.13 Australia Biosimilars Market and Forecast
6.14 Brazil Biosimilars Market and Forecast
6.15 Mexico Biosimilars Market and Forecast
6.16 Rest of the World Biosimilars Market and Forecast
7. Global Biosimilars Company - Profile, Revenue, Approved and Pipeline Biosimilars Analysis
7.1 Biocad
7.1.1 Company Profile
7.1.2 Biocad - Major Biosimilars Approved for Marketing
7.1.3 Biocad - Major Biosimilars in Pipeline
7.2 Celltrion Inc.
7.2.1 Company Profile
7.2.2 Celltrion Inc. - Annual Revenue (2013 - 2015)
7.2.3 Celltrion Inc. - Major Biosimilars Approved for Marketing
7.2.4 Celltrion Inc.- Major Biosimilars in Pipeline
7.3 Dong-A Socio Group
7.3.1 Company Profile
7.3.2 Dong-A Socio Group - Annual Revenue (2014 - 2015)
7.3.3 Dong-A Socio Group - Major Biosimilars in Pipeline
7.4 Pfizer Inc.
7.4.1 Company Profile
7.4.2 Pfizer Inc. - Annual Revenue (2011 - 2015)
7.4.3 Pfizer Inc. - Major Biosimilars Approved for Marketing
7.4.4 Pfizer Inc.- Major Biosimilars in Pipeline
7.5 Intas Pharmaceuticals Ltd.
7.5.1 Company Profile
7.5.2 Intas Pharmaceuticals Ltd. - Annual Revenue (2011 - 2015)
7.5.3 Intas Pharmaceuticals Ltd. - Major Biosimilars Approved for Marketing
7.5.4 Intas Pharmaceuticals Ltd. - Major Biosimilars in Pipeline
7.6 Sandoz International GmbH - A Novartis Company
7.6.1 Company Profile
7.6.2 Sandoz International GmbH - Annual Revenue (2012 - 2015)
7.6.3 Sandoz International GmbH - Major Biosimilars Approved for Marketing
7.6.4 Sandoz International GmbH - Major Biosimilars in Pipeline
7.7 Stada Arzneimittel AG
7.7.1 Company Profile
7.7.2 Stada Arzneimittel AG - Annual Revenue (2011 - 2015)
7.7.3 Stada Arzneimittel AG - Major Biosimilars Approved for Marketing
7.7.4 Stada Arzneimittel AG - Major Biosimilars in Pipeline
7.8 Teva Pharmaceutical Industries Ltd.
7.8.1 Company Profile
7.8.2 Teva Pharmaceutical Industries Ltd. - Annual Revenue (2011 - 2015)
7.8.3 Teva Pharmaceutical Industries Ltd. - Major Biosimilars Approved for Marketing
7.9 Amgen Inc.
7.9.1 Company Profile
7.9.2 Amgen Inc. - Annual Revenue (2011 - 2015)
7.9.3 Amgen Inc. - Major Biosimilars in Pipeline
7.10 Biocon
7.10.1 Company Profile
7.10.2 Biocon - Annual Revenue (2011 - 2015)
7.10.3 Biocon - Major Biosimilars Approved for Marketing
7.10.4 Biocon - Major Biosimilars in Pipeline
7.11 Dr. Reddy’s Laboratories
7.11.1 Company Profile
7.11.2 Dr. Reddy’s Laboratories - Major Biosimilars Approved for Marketing
7.11.3 Dr. Reddy’s Laboratories - Major Biosimilars in Pipeline
7.12 Mylan
7.12.1 Company Profile
7.12.2 Mylan - Annual Revenue (2011 - 2015)
7.12.3 Mylan - Major Biosimilars in Pipeline
7.13 Merck KGaA
7.13.1 Company Profile
7.13.2 Merck KGaA - Annual Revenue (2013 - 2014)
7.13.3 Merck KGaA - Major Biosimilars in Pipeline
8. Biosimilars Approved in Europe
9. Country with Biosimilar Guideline and Published Year
10. Global Biosimilars Market - Driving Factors
10.1 Several Blockbuster Biologics Losing Patent Protection Over the Next Decade
10.2 Growing Geriatric Population and Rising Incidences of Chronic Diseases
10.3 Entry of Biosimilars in the US Market
10.4 Ability to Curb Healthcare Cost
10.5 Clash of Global Titans Brewing in Europe and Emerging Markets
10.6 Drug Delivery Device Companies Hit the Sweet Spot
10.7 Government Initiatives
10.7.1 Initiatives Taken by Government in Various Countries
11. Global Biosimilars Market - Challenges
11.1 Regulatory Issues
11.2 Operational Challenges for Biosimilars
11.3 Biosimilars Manufacturing Challenges
List of Figures:
Figure 2-1: Global - Biosimilars Market (Million US$), 2008 - 2015
Figure 2-2: Global - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 3-1: By Applications - Global Biosimilars Market Share (Percent), 2014 - 2015
Figure 3-2: By Applications - Forecast for Global Biosimilars Market Share (Percent), 2016 - 2021
Figure 4-1: Global - Erythropoietin (EPO) Biosimilars Market (Million US$), 2008 - 2015
Figure 4-2: Global - Forecast for Erythropoietin (EPO) Biosimilars Market (Million US$), 2016 - 2021
Figure 4-3: Global - Human Growth Hormone (HGH) Biosimilars Market (Million US$), 2008 - 2015
Figure 4-4: Global - Forecast for Human Growth Hormone (HGH) Biosimilars Market (Million US$), 2016 - 2021
Figure 4-5: Global - Granulocyte - Colony Stimulating Factor (G-CSF) Biosimilars Market (Million US$), 2009 - 2015
Figure 4-6: Global - Forecast for Granulocyte - Colony Stimulating Factor (G-CSF) Biosimilars Market (Million US$), 2016 - 2021
Figure 4-7: Global - Monoclonal Antibody (mAb) Biosimilars Market (Million US$), 2013 - 2015
Figure 4-8: Global - Forecast for Monoclonal Antibody (mAb) Biosimilars Market (Million US$), 2016 - 2021
Figure 4-9: Global - Insulin Biosimilars Market (Million US$), 2013 - 2015
Figure 4-10: Global - Forecast for Insulin Biosimilars Market (Million US$), 2016 - 2021
Figure 4-11: Global - Interferon (IFN) Biosimilars Market (Million US$), 2014 - 2015
Figure 4-12: Global - Forecast for Interferon (IFN) Biosimilars Market (Million US$), 2016 - 2021
Figure 4-13: Global - Others Biosimilars Market (Million US$), 2013 - 2015
Figure 4-14: Global - Forecast for Others Biosimilars Market (Million US$), 2016 - 2021
Figure 5-1: Global - Oncology Biosimilars Market (Million US$), 2014 - 2015
Figure 5-2: Global - Forecast for Oncology Biosimilars Market (Million US$), 2016 - 2021
Figure 5-3: Global - Blood Disorders Biosimilars Market (Million US$), 2014 - 2015
Figure 5-4: Global - Forecast for Blood Disorders Biosimilars Market (Million US$), 2016 - 2021
Figure 5-5: Global - Growth Hormone Deficiencies Biosimilars Market (Million US$), 2014 - 2015
Figure 5-6: Global - Forecast for Growth Hormone Deficiencies Biosimilars Market (Million US$), 2016 - 2021
Figure 5-7: Global - Chronic and Autoimmune Disorders Biosimilars Market (Million US$), 2014 - 2015
Figure 5-8: Global - Forecast for Chronic and Autoimmune Disorders Biosimilars Market (Million US$), 2016 - 2021
Figure 5-9: Global - Other Applications Biosimilars Market (Million US$), 2014 - 2015
Figure 5-10: Global - Forecast for Other Applications Biosimilars Market (Million US$), 2016 - 2021
Figure 6-1: United States - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-2: United States - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-3: Canada - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-4: Canada - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-5: Argentina - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-6: Argentina - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-7: Germany - Biosimilars Market (Million US$), 2012 - 2015
Figure 6-8: Germany - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-9: France - Biosimilars Market (Million US$), 2012 - 2015
Figure 6-10: France - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-11: Italy - Biosimilars Market (Million US$), 2012 - 2015
Figure 6-12: Italy - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-13: Spain - Biosimilars Market (Million US$), 2012 - 2015
Figure 6-14: Spain - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-15: United Kingdom - Biosimilars Market (Million US$), 2012 - 2015
Figure 6-16: United Kingdom - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-17: China - Biosimilars Market (Million US$), 2013 - 2015
Figure 6-18: China - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-19: Japan - Biosimilars Market (Million US$), 2013 - 2015
Figure 6-20: Japan - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-21: India - Biosimilars Market (Million US$), 2013 - 2015
Figure 6-22: India - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-23: South Korea - Biosimilars Market (Million US$), 2010 - 2015
Figure 6-24: South Korea - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-25: Australia - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-26: Australia - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-27: Brazil - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-28: Brazil - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-29: Mexico - Biosimilars Market (Million US$), 2014 - 2015
Figure 6-30: Mexico - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 6-31: Rest of the World - Biosimilars Market (Million US$), 2013 - 2015
Figure 6-32: Rest of the World - Forecast for Biosimilars Market (Million US$), 2016 - 2021
Figure 7-1: Celltrion Inc. - Annual Revenue (Million US$), 2013 - 2015
Figure 7-2: Dong-A Socio Group - Annual Revenue (Million US$), 2014 - 2015
Figure 7-3: Pfizer Inc. - Annual Revenue (Million US$), 2011 - 2015
Figure 7-4: Intas Pharmaceuticals Ltd. - Annual Revenue (Million US$), 2011 - 2015
Figure 7-5: Intas Pharmaceuticals Ltd. - Major Biosimilars in Pipeline
Figure 7-6: Sandoz International GmbH - Annual Revenue (Million US$), 2012 - 2015
Figure 7-7: Stada Arzneimittel AG - Annual Revenue (Million US$), 2011 - 2015
Figure 7-8: Teva Pharmaceutical Industries Ltd. - Annual Revenue (Million US$), 2011 - 2015
Figure 7-9: Amgen Inc. - Annual Revenue (Million US$), 2011 - 2015
Figure 7-10: Biocon - Annual Revenue (Million US$), 2011 - 2015
Figure 7-11: Mylan - Annual Revenue (Million US$), 2011 - 2015
Figure 7-12: Merck KGaA - Annual Revenue (Million US$), 2013 - 2014
Figure 10-1: Global - Ageing Population & Forecast (Million), 2010 - 2050
Figure 11-1: The EMA Development and Approval Pathway for Biosimilars
List of Tables:
Table 3-1: By Product Type - Global Biosimilars Market Share (Percent), 2013 - 2015
Table 3-2: By Product Type - Forecast for Global Biosimilars Market Share (Percent), 2016 - 2021
Table 3-3: Country Wise - Biosimilars Market Share (Percent), 2014 - 2015
Table 3-4: Country Wise - Forecast for Biosimilars Market Share (Percent), 2016 - 2021
Table 6-1: Australia: Biosimilar Medicines Approved and Listed on the Pharmaceutical Benefits Scheme
Table 7-1: Biocad - Major Biosimilars Approved for Marketing
Table 7-2: Biocad - Major Biosimilars in Pipeline
Table 7-3: Celltrion Inc. - Major Biosimilars Approved for Marketing
Table 7-4: Celltrion Inc.- Major Biosimilars in Pipeline
Table 7-5: Dong-A Socio Group - Major Biosimilars in Pipeline
Table 7-6: Pfizer Inc. - Major Biosimilars Approved for Marketing
Table 7-7: Pfizer Inc.- Major Biosimilars in Pipeline
Table 7-8: Intas Pharmaceuticals Ltd. - Major Biosimilars Approved for Marketing
Table 7-9: Sandoz International GmbH - Major Biosimilars Approved for Marketing
Table 7-10: Sandoz International GmbH - Major Biosimilars in Pipeline
Table 7-11: Stada Arzneimittel AG - Major Biosimilars Approved for Marketing
Table 7-12: Stada Arzneimittel AG - Major Biosimilars in Pipeline
Table 7-13: Teva Pharmaceutical Industries Ltd. - Major Biosimilars Approved for Marketing
Table 7-14: Amgen Inc. - Major Biosimilars in Pipeline (Pivotal Trials Phase 3)
Table 7-15: Amgen Inc. - Major Biosimilars in Pipeline
Table 7-16: Biocon - Major Biosimilars Approved for Marketing
Table 7-17: Biocon - Major Biosimilars in Pipeline
Table 7-18: Dr. Reddy’s Laboratories - Major Biosimilars Approved for Marketing
Table 7-19: Merck KGaA - Major Biosimilars in Pipeline
Table 8-1: List of EMA Approved Biosimilars - Till May 2016
Table 9-1: List of Countries with Biosimilar Guideline and Published Year
Table 10-1: Europe and US: Major biological Patent Expiries, 2010 - 2020

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