NEW YORK, June 16 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue:
http://www.reportlinker.com/p0197181/Global-Biosimilars--industry.html
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.
BIOSIMILARS MCP-6201
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
II. EXECUTIVE SUMMARY
1. MARKET OVERVIEW II-1
Biosimilars - The New Pharma Industry's Dynamite II-1
European Union Ahead of the US II-1
Regulatory Framework Approval for Biosimilars in Major Markets II-1
Biosimilars Availability in Regional Markets II-2
Myriad Factors Foretell Lower Market Penetration of Biosimilar
Products II-2
Issues Put Aside, Biosimilars Offer Great Promise II-3
Growth Drivers II-3
Patent Expiries II-3
Patent Expiries of Select Biopharmaceuticals in Europe and
United States II-4
Patent Expiries of Major Biotechnology Products before 2007 II-4
Cost Containment Measures II-4
An Aging Population II-5
Presence of Major Players II-5
Growth Restraints II-5
Uncertain Regulations II-5
High Lead-time II-5
High Manufacturing Costs II-5
Delivery and Commercialization II-6
Automatic Substitution II-6
Others II-6
2. MARKET PARTICIPANTS II-7
Market Players with Approved and Pipeline Biosimilar Drugs II-7
3. GLOBAL MARKET OVERVIEW II-8
Pharmaceutical Companies Eye Biosimilars Opportunities II-8
Small and New Biosimilar-Focused Companies to Gain Foothold II-8
Indian Companies to Emerge Strong II-8
Impact of Chinese Companies II-9
Entry Barriers for Biogenerics II-9
Comparison of Entry Barriers for Biogenerics in Select Global
Markets II-9
Alternative Method of Entry II-9
Biosimilars Market to Remain Competitive II-9
Increasing Competition Between Pharma Giants and Generic
Manufacturers II-10
Defensive Strategies for Branded Drug Manufacturers II-10
Companies Eye Human Insulin Biosimilars II-10
Insulin Manufacturers Planning to Enter European and US
Biosimilars Markets II-11
Impediments to Market Acceptance II-11
Strategies to Aid Survival of Companies in Biosimilars Market II-11
4. CURRENT MARKET SCENARIO AND PROSPECTS II-12
Outlook II-12
Opportunities Abound for Biosimilars II-12
5. GLOBAL BIOLOGICS MARKET II-13
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) II-13
Increasing Proportion of Biologics to Drive Biosimilars Market II-13
Biologics' Foothold in the Top 10 Pharmaceutical Drugs
Worldwide: 2008 II-14
Biologics to Strengthen Presence in the Global Pharmaceutical
Market: 2015 II-14
Table 2: Leading Players in the Global Biologics Market:
2007 (includes corresponding Graph/Chart) II-15
Cost Effective Methods of Pure Biologics Production II-15
6. PRODUCT OVERVIEW II-16
Introduction II-16
Characteristics of Biosimilars II-16
Biological Drugs II-17
Biological Drugs Manufacturing Process II-17
Development Cycle of Biosimilars II-18
Industry Participants II-18
Classification of Pharmaceutical Companies Based on their
Existing Capabilities in Global Biosimilars Market II-19
7. PRODUCT APPROVALS II-20
Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid
Cartridge II-20
Sandoz Launches Somatropin in Japan II-20
Sandoz Obtains European Approval for Third Biosimilar,
Filgrastim II-20
Ratiopharm Introduces Neupogen Biosimilar in French Market II-21
Biocon Launches Basalog in India II-21
Reliance Life Sciences to Launch Three More Biosimilars in 2010 II-21
Teva Pharmaceutical Obtains Marketing Authorization from EU
for TevaGrastim® II-21
Ratiopharm Obtains Approval from EMEA for Biosimilar
Ratiograstim II-22
Hospira Introduces Retacrit in UK II-22
Retacrit® Demonstrates Safety and Efficacy in Chemotherapy
Induced Anaemia II-22
Sandoz Collaborates with Gambro for Binocrit II-22
ABRPL to Launch Eight Biosimilars in India II-22
Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar II-23
Sandoz Bags EC Marketing Approval for Omnitrope II-23
Biopartners Bags EU Marketing Approval for Valtropin II-23
Omnitrope Receives US FDA Approval II-23
8. CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE II-24
Innogene Kalbiotech Signs Deal with CIMAB II-24
Hospira Acquires Global Rights to Filgrastim II-24
Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin
Alfa II-24
Cipla Joint Ventures with Chinese Firm to form Biomab II-25
Merck & Co. Signs Deal with Insmed to Acquire Biosimilars
Portfolio II-25
Mylan Signs Partnership Deal with Biocon II-25
Elona Biotechnologies Sets Up Two Subsidiaries II-25
Lonza and Teva's Joint Venture Receives Approval by European
Commission II-26
GTC Biotherapeutics Signs Collaboration with AgResearch for
Biosimilars II-26
Apotex Signs Agreement with IBPL II-26
Cipla Terminates Marketing Agreement with Avesthagen II-27
Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I
Clinical Trial of Neukine® II-27
Q Chip to Develop Biosimilars Based on Bioencapsulation
Technology II-27
Hospira Signs Agreement with Celltrion to Develop Biosimilars II-28
Teva to Seek Approval of US Authorities II-28
Nomad Bioscience Signs Agreement with Bayer Innovation and
Icon Genetics II-28
Biocon Signs Agreement with AxiCorp II-28
Merck Forms New Biotechnology Division, BioVentures II-29
Teva Pharmaceuticals Acquires CoGenesys II-29
Biocon and Abraxis BioScience Ink Licensing Agreement II-29
9. FOCUS ON SELECT MARKET PLAYERS II-30
Biocon Ltd. (India) II-30
Biopartners GMBH (Switzerland) II-30
Cipla Ltd. (India) II-30
Dr. Reddy's Laboratories Ltd. (India) II-30
Hospira, Inc. (US) II-31
Intas Biopharmaceuticals Ltd. (India) II-31
Sandoz International GmbH (Germany) II-31
Ratiopharm GmbH (Germany) II-32
Shantha Biotechnics Ltd. (India) II-32
Teva Pharmaceutical Industries Ltd. (Israel) II-32
Wockhardt Ltd. (India) II-33
10. MARKET ANALYTICS II-34
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) II-34
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) II-35
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) II-36
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
Current & Future Analysis III-1
Market Overview III-1
Biosimilars Regulatory Pathway III-1
Overview of Two Competing Bills Presently with the US
Senate/Congress III-2
Generics and Biologics Regulatory Pathway III-2
US Share to Increase in the Global Biosimilars Market III-2
Biopharma Patent Expiries to Drive Biosimilars Growth III-2
Patent Expiries of Select Biological Products in the US III-3
Product Approvals III-4
B.Market Analytics III-4
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) III-4
2. JAPAN III-5
A.Market Analysis III-5
Current & Future Analysis III-5
Product Approval III-5
B.Market Analytics III-6
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) III-6
3. EUROPE III-7
A.Market Analysis III-7
Current & Future Analysis III-7
Market Overview III-7
Biosimilar Approvals and Filings in Europe III-8
Biosimilars Regulatory Framework III-8
Biosimilar Regulatory Timeline from Legislation to Approval
in the EU III-9
Growth Drivers III-9
Payers Eye Biosimilars to Curtail Costs III-9
Challenges Ahead III-9
Heavy Investment and Regulations III-9
Complex Production Process III-10
Biocapacity III-10
Regional Issues III-10
Select Product Approvals III-10
B.Market Analytics III-13
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) III-13
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) III-14
3a. FRANCE III-15
Market Analysis III-15
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) III-15
3b. GERMANY III-16
Market Analysis III-16
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) III-16
3c. THE UNITED KINGDOM III-17
Market Analysis III-17
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) III-17
3d. SPAIN III-18
Market Analysis III-18
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) III-18
3e. REST OF EUROPE III-19
Market Analysis III-19
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) III-19
4. INDIA III-20
Indian Biopharmaceutical Industry Makes Rapid Progress III-20
Indian Pharma Companies Explore Biosimilars Potential III-20
Select Major Indian Companies' Marketed and Pipeline Biosimilars III-21
Indian Firms Eyeing European Market III-21
Select Leading Indian Companies Planning to Enter European
Market III-22
Indian Biogeneric Drugs to Enter the US Market III-22
Product Approvals III-22
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 56 (including Divisions/Subsidiaries - 62)
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Region/Country Players
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The United States 12
Canada 2
Europe 18
France 1
Germany 10
The United Kingdom 2
Rest of Europe 5
Asia-Pacific (Excluding Japan) 25
Latin America 1
Africa 1
Middle-East 3
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To order this report:
Biopharmaceutical Industry: Global Biosimilars industry
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Nicolas Bombourg |
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