Biosimilars: Market Research Report
This report analyzes the worldwide markets for Biosimilars in US$ Million.
The report provides separate comprehensive analytics for US, Europe, and Japan.
Annual estimates and forecasts are provided for each region for the period 2008 through 2015.
The report profiles 56 companies including many key and niche players such as Biocon Ltd, Biopartners GMBH, Cipla Ltd., Dr. Reddy's Laboratories Ltd., Hospira, Inc., Intas Biopharmaceuticals Ltd., Sandoz International GmbH, Ratiopharm GmbH, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., and Wockhardt Ltd.
Market data and analytics are derived from primary and secondary research.
Company profiles are mostly extracted from URL research and reported select online sources.
The report provides separate comprehensive analytics for US, Europe, and Japan.
Annual estimates and forecasts are provided for each region for the period 2008 through 2015.
The report profiles 56 companies including many key and niche players such as Biocon Ltd, Biopartners GMBH, Cipla Ltd., Dr. Reddy's Laboratories Ltd., Hospira, Inc., Intas Biopharmaceuticals Ltd., Sandoz International GmbH, Ratiopharm GmbH, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., and Wockhardt Ltd.
Market data and analytics are derived from primary and secondary research.
Company profiles are mostly extracted from URL research and reported select online sources.
I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.MARKET OVERVIEW
Biosimilars – The New Pharma Industry’s Dynamite
European Union Ahead of the US
Regulatory Framework Approval for Biosimilars in Major Markets
Biosimilars Availability in Regional Markets
Myriad Factors Foretell Lower Market Penetration of Biosimilar Products
Issues Put Aside, Biosimilars Offer Great Promise
Growth Drivers
Patent Expiries
Patent Expiries of Select Biopharmaceuticals in Europe and United States
Patent Expiries of Major Biotechnology Products before 2007
Cost Containment Measures
An Aging Population
Presence of Major Players
Growth Restraints
Uncertain Regulations
High Lead-time
High Manufacturing Costs
Delivery and Commercialization
Automatic Substitution
Others
2.MARKET PARTICIPANTS
Market Players with Approved and Pipeline Biosimilar Drugs
3.GLOBAL MARKET OVERVIEW
Pharmaceutical Companies Eye Biosimilars Opportunities
Small and New Biosimilar-Focused Companies to Gain Foothold
Indian Companies to Emerge Strong
Impact of Chinese Companies
Entry Barriers for Biogenerics
Comparison of Entry Barriers for Biogenerics in Select Global Markets
Alternative Method of Entry
Biosimilars Market to Remain Competitive
Increasing Competition Between Pharma Giants and Generic Manufacturers
Defensive Strategies for Branded Drug Manufacturers
Companies Eye Human Insulin Biosimilars
Insulin Manufacturers Planning to Enter European and US Biosimilars Markets
Impediments to Market Acceptance
Strategies to Aid Survival of Companies in Biosimilars Market
4.CURRENT MARKET SCENARIO AND PROSPECTS
Outlook
Opportunities Abound for Biosimilars
5.GLOBAL BIOLOGICS MARKET
Increasing Proportion of Biologics to Drive Biosimilars Market
Biologics’ Foothold in the Top 10 Pharmaceutical Drugs Worldwide: 2008
Biologics to Strengthen Presence in the Global Pharmaceutical Market: 2015
Cost Effective Methods of Pure Biologics Production
6.PRODUCT OVERVIEW
Introduction
Characteristics of Biosimilars
Biological Drugs
Biological Drugs Manufacturing Process
Development Cycle of Biosimilars
Industry Participants
Classification of Pharmaceutical Companies Based on their Existing Capabilities in Global Biosimilars Market
7.PRODUCT APPROVALS
Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid Cartridge
Sandoz Launches Somatropin in Japan
Sandoz Obtains European Approval for Third Biosimilar, Filgrastim
Ratiopharm Introduces Neupogen Biosimilar in French Market
Biocon Launches Basalog in India
Reliance Life Sciences to Launch Three More Biosimilars in 2010
Teva Pharmaceutical Obtains Marketing Authorization from EU for TevaGrastim®
Ratiopharm Obtains Approval from EMEA for Biosimilar Ratiograstim
Hospira Introduces Retacrit in UK
Retacrit® Demonstrates Safety and Efficacy in Chemotherapy Induced Anaemia
Sandoz Collaborates with Gambro for Binocrit
ABRPL to Launch Eight Biosimilars in India
Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar
Sandoz Bags EC Marketing Approval for Omnitrope
Biopartners Bags EU Marketing Approval for Valtropin
Omnitrope Receives US FDA Approval
8.CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE
Innogene Kalbiotech Signs Deal with CIMAB
Hospira Acquires Global Rights to Filgrastim
Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin Alfa
Cipla Joint Ventures with Chinese Firm to form Biomab
Merck & Co. Signs Deal with Insmed to Acquire Biosimilars Portfolio
Mylan Signs Partnership Deal with Biocon
Elona Biotechnologies Sets Up Two Subsidiaries
Lonza and Teva's Joint Venture Receives Approval by European Commission
GTC Biotherapeutics Signs Collaboration with AgResearch for Biosimilars
Apotex Signs Agreement with IBPL
Cipla Terminates Marketing Agreement with Avesthagen
Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I Clinical Trial of Neukine®
Q Chip to Develop Biosimilars Based on Bioencapsulation Technology
Hospira Signs Agreement with Celltrion to Develop Biosimilars
Teva to Seek Approval of US Authorities
Nomad Bioscience Signs Agreement with Bayer Innovation and Icon Genetics
Biocon Signs Agreement with AxiCorp
Merck Forms New Biotechnology Division, BioVentures
Teva Pharmaceuticals Acquires CoGenesys
Biocon and Abraxis BioScience Ink Licensing Agreement
9.FOCUS ON SELECT MARKET PLAYERS
Biocon Ltd. (India)
Biopartners GMBH (Switzerland)
Cipla Ltd. (India)
Dr. Reddy's Laboratories Ltd. (India)
Hospira, Inc. (US)
Intas Biopharmaceuticals Ltd. (India)
Sandoz International GmbH (Germany)
Ratiopharm GmbH (Germany)
Shantha Biotechnics Ltd. (India)
Teva Pharmaceutical Industries Ltd. (Israel)
Wockhardt Ltd. (India)
10.MARKET ANALYTICS
III. MARKET
1.THE UNITED STATES
A. MARKET ANALYSIS
Current & Future Analysis
Market Overview
Biosimilars Regulatory Pathway
Overview of Two Competing Bills Presently with the US Senate/Congress
Generics and Biologics Regulatory Pathway
US Share to Increase in the Global Biosimilars Market
Biopharma Patent Expiries to Drive Biosimilars Growth
Patent Expiries of Select Biological Products in the US
Product Approvals
B. MARKET ANALYTICS
2.JAPAN
A. MARKET ANALYSIS
Current & Future Analysis
Product Approval
B. MARKET ANALYTICS
3.EUROPE
A. MARKET ANALYSIS
Current & Future Analysis
Market Overview
Biosimilar Approvals and Filings in Europe
Biosimilars Regulatory Framework
Biosimilar Regulatory Timeline from Legislation to Approval in the EU
Growth Drivers
Payers Eye Biosimilars to Curtail Costs
Challenges Ahead
Heavy Investment and Regulations
Complex Production Process
Biocapacity
Regional Issues
Select Product Approvals
B. MARKET ANALYTICS
3A.FRANCE
Market Analysis
3B.GERMANY
Market Analysis
3C.THE UNITED KINGDOM
Market Analysis
3D.SPAIN
Market Analysis
3E.REST OF EUROPE
Market Analysis
4.INDIA
Indian Biopharmaceutical Industry Makes Rapid Progress
Indian Pharma Companies Explore Biosimilars Potential
Select Major Indian Companies’ Marketed and Pipeline Biosimilars
Indian Firms Eyeing European Market
Select Leading Indian Companies Planning to Enter European Market
Indian Biogeneric Drugs to Enter the US Market
Product Approvals
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 56 (including Divisions/Subsidiaries - 62)
Region/CountryPlayers
The United States12
Canada
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)
Latin America
Africa
Middle-East
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.MARKET OVERVIEW
Biosimilars – The New Pharma Industry’s Dynamite
European Union Ahead of the US
Regulatory Framework Approval for Biosimilars in Major Markets
Biosimilars Availability in Regional Markets
Myriad Factors Foretell Lower Market Penetration of Biosimilar Products
Issues Put Aside, Biosimilars Offer Great Promise
Growth Drivers
Patent Expiries
Patent Expiries of Select Biopharmaceuticals in Europe and United States
Patent Expiries of Major Biotechnology Products before 2007
Cost Containment Measures
An Aging Population
Presence of Major Players
Growth Restraints
Uncertain Regulations
High Lead-time
High Manufacturing Costs
Delivery and Commercialization
Automatic Substitution
Others
2.MARKET PARTICIPANTS
Market Players with Approved and Pipeline Biosimilar Drugs
3.GLOBAL MARKET OVERVIEW
Pharmaceutical Companies Eye Biosimilars Opportunities
Small and New Biosimilar-Focused Companies to Gain Foothold
Indian Companies to Emerge Strong
Impact of Chinese Companies
Entry Barriers for Biogenerics
Comparison of Entry Barriers for Biogenerics in Select Global Markets
Alternative Method of Entry
Biosimilars Market to Remain Competitive
Increasing Competition Between Pharma Giants and Generic Manufacturers
Defensive Strategies for Branded Drug Manufacturers
Companies Eye Human Insulin Biosimilars
Insulin Manufacturers Planning to Enter European and US Biosimilars Markets
Impediments to Market Acceptance
Strategies to Aid Survival of Companies in Biosimilars Market
4.CURRENT MARKET SCENARIO AND PROSPECTS
Outlook
Opportunities Abound for Biosimilars
5.GLOBAL BIOLOGICS MARKET
Table 1. Global Biologics Market by Region: Percentage Share Breakdown for North America, Europe, Japan, Asia-Pacific and Latin America for 2003 and 2007 (includes corresponding Graph/Chart)
Increasing Proportion of Biologics to Drive Biosimilars Market
Biologics’ Foothold in the Top 10 Pharmaceutical Drugs Worldwide: 2008
Biologics to Strengthen Presence in the Global Pharmaceutical Market: 2015
Table 2. Leading Players in the Global Biologics Market: 2007 (includes corresponding Graph/Chart)
Cost Effective Methods of Pure Biologics Production
6.PRODUCT OVERVIEW
Introduction
Characteristics of Biosimilars
Biological Drugs
Biological Drugs Manufacturing Process
Development Cycle of Biosimilars
Industry Participants
Classification of Pharmaceutical Companies Based on their Existing Capabilities in Global Biosimilars Market
7.PRODUCT APPROVALS
Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid Cartridge
Sandoz Launches Somatropin in Japan
Sandoz Obtains European Approval for Third Biosimilar, Filgrastim
Ratiopharm Introduces Neupogen Biosimilar in French Market
Biocon Launches Basalog in India
Reliance Life Sciences to Launch Three More Biosimilars in 2010
Teva Pharmaceutical Obtains Marketing Authorization from EU for TevaGrastim®
Ratiopharm Obtains Approval from EMEA for Biosimilar Ratiograstim
Hospira Introduces Retacrit in UK
Retacrit® Demonstrates Safety and Efficacy in Chemotherapy Induced Anaemia
Sandoz Collaborates with Gambro for Binocrit
ABRPL to Launch Eight Biosimilars in India
Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar
Sandoz Bags EC Marketing Approval for Omnitrope
Biopartners Bags EU Marketing Approval for Valtropin
Omnitrope Receives US FDA Approval
8.CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE
Innogene Kalbiotech Signs Deal with CIMAB
Hospira Acquires Global Rights to Filgrastim
Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin Alfa
Cipla Joint Ventures with Chinese Firm to form Biomab
Merck & Co. Signs Deal with Insmed to Acquire Biosimilars Portfolio
Mylan Signs Partnership Deal with Biocon
Elona Biotechnologies Sets Up Two Subsidiaries
Lonza and Teva's Joint Venture Receives Approval by European Commission
GTC Biotherapeutics Signs Collaboration with AgResearch for Biosimilars
Apotex Signs Agreement with IBPL
Cipla Terminates Marketing Agreement with Avesthagen
Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I Clinical Trial of Neukine®
Q Chip to Develop Biosimilars Based on Bioencapsulation Technology
Hospira Signs Agreement with Celltrion to Develop Biosimilars
Teva to Seek Approval of US Authorities
Nomad Bioscience Signs Agreement with Bayer Innovation and Icon Genetics
Biocon Signs Agreement with AxiCorp
Merck Forms New Biotechnology Division, BioVentures
Teva Pharmaceuticals Acquires CoGenesys
Biocon and Abraxis BioScience Ink Licensing Agreement
9.FOCUS ON SELECT MARKET PLAYERS
Biocon Ltd. (India)
Biopartners GMBH (Switzerland)
Cipla Ltd. (India)
Dr. Reddy's Laboratories Ltd. (India)
Hospira, Inc. (US)
Intas Biopharmaceuticals Ltd. (India)
Sandoz International GmbH (Germany)
Ratiopharm GmbH (Germany)
Shantha Biotechnics Ltd. (India)
Teva Pharmaceutical Industries Ltd. (Israel)
Wockhardt Ltd. (India)
10.MARKET ANALYTICS
Table 3. US, Europe, and Japan Recent Past, Current, and Future Analysis for Biosimilars Market by Region: Annual Sales in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
Table 4. US, Europe, and Japan Recent Past, Current, and Future Analysis for Biosimilars Market by Drug Class: Annual Sales in US$ Million for Years 2008 through 2015 for Epoetin Alpha, Granulocyte-CSF, Human Growth Hormone, Interferon, and Insulin (includes corresponding Graph/Chart)
Table 5. US, Europe, and Japan Biosimilars Market by Drug Class: Percentage Share Breakdown for Years 2009, 2012, and 2015 for Epoetin Alpha, Granulocyte-CSF, Human Growth Hormone, Interferon, and Insulin (includes corresponding Graph/Chart)
III. MARKET
1.THE UNITED STATES
A. MARKET ANALYSIS
Current & Future Analysis
Market Overview
Biosimilars Regulatory Pathway
Overview of Two Competing Bills Presently with the US Senate/Congress
Generics and Biologics Regulatory Pathway
US Share to Increase in the Global Biosimilars Market
Biopharma Patent Expiries to Drive Biosimilars Growth
Patent Expiries of Select Biological Products in the US
Product Approvals
B. MARKET ANALYTICS
Table 6. US Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
2.JAPAN
A. MARKET ANALYSIS
Current & Future Analysis
Product Approval
B. MARKET ANALYTICS
Table 7. Japanese Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
3.EUROPE
A. MARKET ANALYSIS
Current & Future Analysis
Market Overview
Biosimilar Approvals and Filings in Europe
Biosimilars Regulatory Framework
Biosimilar Regulatory Timeline from Legislation to Approval in the EU
Growth Drivers
Payers Eye Biosimilars to Curtail Costs
Challenges Ahead
Heavy Investment and Regulations
Complex Production Process
Biocapacity
Regional Issues
Select Product Approvals
B. MARKET ANALYTICS
Table 8. European Recent Past, Current & Future Analysis for Biosimilars by Geographic Region – France, Germany, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
Table 9. European 8-Year Perspective for Biosimilars by Geographic Region –Percentage Breakdown of Dollar Sales for France, Germany, UK, Spain and Rest of Europe Markets for 2009, 2012 & 2015 (includes corresponding Graph/Chart)
3A.FRANCE
Market Analysis
Table 10. French Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
3B.GERMANY
Market Analysis
Table 11. German Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
3C.THE UNITED KINGDOM
Market Analysis
Table 12. UK Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
3D.SPAIN
Market Analysis
Table 13. Spanish Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
3E.REST OF EUROPE
Market Analysis
Table 14. Rest of Europe Recent Past, Current & Future Analysis for Biosimilars – Annual Sales Figures in US$ Million for Years 2008 through 2015 (includes corresponding Graph/Chart)
4.INDIA
Indian Biopharmaceutical Industry Makes Rapid Progress
Indian Pharma Companies Explore Biosimilars Potential
Select Major Indian Companies’ Marketed and Pipeline Biosimilars
Indian Firms Eyeing European Market
Select Leading Indian Companies Planning to Enter European Market
Indian Biogeneric Drugs to Enter the US Market
Product Approvals
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 56 (including Divisions/Subsidiaries - 62)
Region/CountryPlayers
The United States12
Canada
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)
Latin America
Africa
Middle-East
