NEW YORK, Aug. 14, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
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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 the period 2008 through 2017. The report profiles 55 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, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., and Wockhardt Ltd. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
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
Regulatory Framework for Biosimilars in Major Markets II-1
European Union Ahead in the Biosimilars Race II-1
Europe Sets Guidelines for Biosimilar Monoclonal Antibodies II-2
Select Biosimilars Availability in Regional Markets II-2
The US Passes Act to Create Biosimilars Pathway, Finally II-3
Biosimilar Deals: Surging Ahead II-3
2. MARKET OUTLOOK II-4
Myriad Factors Foretell Lower Market Penetration of Biosimilar
Products II-4
Issues Put Aside, Biosimilars Offer Great Promise II-5
Opportunity Abound for Biosimilars II-5
Table 1: Top Biologic Drugs Losing Patent Protection through
2011-2015 (includes corresponding Graph/Chart) II-5
3. MARKET TRENDS II-7
Biosimilars to Gain Prominence in the US II-7
Biosimilars Find More Growth in Emerging Markets II-7
Future Opportunities for Biosimilars II-7
Major Biotechnology Products Having Lost Patent Protection
over the Recent Years II-8
Table 2: Number of Biological Drugs Going Off-Patent through
to 2015 (includes corresponding Graph/Chart) II-8
Table 3: List of Select Biologic Drugs Losing Patent
Protection: 2012-2015 (includes corresponding Graph/Chart) II-9
Market Challenges and Outlook II-9
4. MARKET DYNAMICS II-10
Pharmaceutical Companies Eye Biosimilars Opportunities II-10
Small and New Biosimilar-Focused Companies to Gain Foothold II-10
Indian Companies to Emerge Strong in the Western Markets II-10
Chinese Manaufacturers, Not a Major Threat Globally, Atleast
in the Near Term II-10
Companies Eye Human Insulin Biosimilars II-11
Insulin Manufacturers Planning to Enter European and US
Biosimilars Markets II-11
Biosimilar Entry Barriers - Diverse Across Regions II-11
Comparison of Entry Barriers for Biogenerics in Select Global
Markets II-12
Impediments to Market Acceptance II-12
Strategies to Aid Survival of Companies in Biosimilars II-12
Bio-betters Provide an Alternative Entry into Biosimilars Market II-13
5. MARKET DRIVERS AND RESTRAINTS II-14
Market Drivers II-14
Patent Expiries II-14
Patent Expiries of Biopharmaceuticals in Developed Regions -
Europe and United States II-14
Cost Containment Measures II-15
Growing Aging Population II-15
Presence of Major Players II-15
Growth Restraints II-15
Uncertain Regulations II-15
High Lead-time II-15
High Manufacturing Costs II-16
Delivery and Commercialization II-16
Automatic Substitution II-16
Others II-16
6. COMPETITIVE SCENARIO II-18
Biosimilars Market to Remain Competitive II-18
Table 4: Leading Players in the Global Biosimilars Market
(2010): Percentage Breakdown of Revenues for Sandoz, Bioton,
Pliva/Teva/Barr, LG LifeSciences, Wockhardt and Others
(includes corresponding Graph/Chart) II-18
Market Players with Approved and Pipeline Biosimilar Drugs II-18
Increasing Competition Between Pharma Giants and Generic
Manufacturers II-20
Defensive Strategies for Branded Drug Manufacturers II-20
7. GLOBAL BIOLOGICS MARKET II-21
Global Biopharmaceutical Drug Market - A Primer II-21
Table 5: Global Biopharmaceuticals Market: Annual Sales for
the Years 2007 through 2009 (includes corresponding
Graph/Chart) II-21
North America - the Largest Biologics Market Worldwide II-21
Table 6: 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-22
Increasing Proportion of Biologics to Drive Biosimilars Market II-22
Number of Biotech Drugs Amongst Top 10 Pharma List: 2008 II-22
Biologics to Strengthen Presence in the Global Pharmaceutical
Market: 2015 II-23
Table 7: Leading Biopharmaceutical Drugs Worldwide By
Revenues: 2009 (includes corresponding Graph/Chart) II-23
Cost Effective Methods of Pure Biologics Production II-24
8. PRODUCT OVERVIEW II-25
Introduction II-25
Characteristics of Biosimilars II-25
Biological Drugs II-26
Biological Drugs Manufacturing Process II-26
Development Cycle of Biosimilars II-27
Industry Participants II-27
Classification of Pharmaceutical Companies Based on their
Existing Capabilities in Global Biosimilars Market II-28
9. PRODUCT APPROVALS/INTRODUCTIONS II-29
DRL Launches Cresp® in India II-29
Hospira Receives EC Approval for Nivestim™ II-29
Reliance Life Sciences to Introduce Erythropoietin in Europe II-29
Sandoz Introduces Zarzio® Filgrastim Preparation II-29
Shasun Chemicals & Drugs Introduces Streptokinase II-30
Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid
Cartridge II-30
Sandoz Launches Somatropin in Japan II-30
Sandoz Obtains European Approval for Third Biosimilar, Filgrastim II-31
Ratiopharm Introduces Neupogen Biosimilar in French Market II-31
Biocon Launches Basalog in India II-31
Reliance Life Sciences to Launch Three More Biosimilars in 2010 II-31
Wockhardt Launches Glaritus Insulin In India II-32
10. PRODUCT APPROVALS/INTRODUCTIONS - A HISTORIC PERSPECTIVE BUILDER II-33
Teva Pharmaceutical Obtains Marketing Authorization from EU
for TevaGrastim® II-33
Ratiopharm Obtains Approval from EMEA for Biosimilar Ratiograstim II-33
Hospira Introduces Retacrit in UK II-33
Retacrit® Demonstrates Safety and Efficacy in Chemotherapy
Induced Anaemia II-33
Sandoz Collaborates with Gambro for Binocrit II-34
ABRPL to Launch Eight Biosimilars in India II-34
Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar II-34
Sandoz Bags EC Marketing Approval for Omnitrope II-34
Biopartners Bags EU Marketing Approval for Valtropin II-35
Omnitrope Receives US FDA Approval II-35
11. CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE II-36
Sandoz Commences Phase II Clinical Trial for Biosimilar
Version of Rituximab II-36
Cipla to Acquire Minority Stake in Bio Mabs and Mab Pharm II-36
Biocon Signs Agreement with Pfizer II-36
Actavis Group to Purchase Majority Stake in Biopartners from
Bioton II-37
Sandoz and Momenta Receive FDA Approval for Biosimilar
Enoxaparin Sodium II-37
Teva Pharmaceutical Industries Acquires Ratiopharm II-37
Hospira Initiates Phase I Clinical Trial for EPO in the US II-38
Watson Pharmaceuticals and Itero Biopharmaceuticals Sign
Agreement II-38
Cephalon Acquires Mepha II-38
Hikma Pharmaceuticals Inks Agreement with Celltrion Healthcare
and Celltrion II-39
Ranbaxy Laboratories Signs Agreement with Pfenex II-39
Ranbaxy Laboratories Acquires Biovel Life Sciences II-39
Sanofi-Aventis Acquires Controlling Stake in Shantha Biotechnics II-39
GlaxoSmithKline and JCR Pharmaceuticals Ink License Agreement II-40
Hospira Enters into Agreement with Celltrion II-40
Cipla Terminates Marketing Agreement with Avesthagen II-40
Mylan Collaborates with Biocon II-40
F. Hoffmann-La Roche Acquires Genentech II-41
Innogene Kalbiotech Signs Deal with CIMAB II-41
Hospira Acquires Global Rights to Filgrastim II-41
Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin
Alfa II-41
Cipla Joint Ventures with Chinese Firm to form Biomab II-42
Merck & Co. Signs Deal with Insmed to Acquire Biosimilars
Portfolio II-42
Mylan Signs Partnership Deal with Biocon II-42
Elona Biotechnologies Sets Up Two Subsidiaries II-43
Lonza and Teva's Joint Venture Receives Approval by European
Commission II-43
GTC Biotherapeutics Signs Collaboration with AgResearch for
Biosimilars II-43
Apotex Signs Agreement with IBPL II-43
Cipla Terminates Marketing Agreement with Avesthagen II-44
Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I
Clinical Trial of Neukine® II-44
Q Chip to Develop Biosimilars Based on Bioencapsulation
Technology II-44
Hospira Signs Agreement with Celltrion to Develop Biosimilars II-45
Teva to Seek Approval of US Authorities II-45
12. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-46
BioGeneriX Commences GlycoPEG-GCSF Phase II Clinical Trial II-46
Nomad Bioscience Signs Agreement with Bayer Innovation and
Icon Genetics II-46
Biocon Signs Agreement with AxiCorp II-46
Merck Forms New Biotechnology Division, BioVentures II-46
Teva Pharmaceuticals Acquires CoGenesys II-47
Biocon and Abraxis BioScience Ink Licensing Agreement II-47
13. FOCUS ON SELECT MARKET PLAYERS II-48
Biocon Ltd. (India) II-48
Biopartners GmbH (Switzerland) II-48
Cipla Ltd. (India) II-48
Dr. Reddy's Laboratories Ltd. (India) II-48
Hospira, Inc. (US) II-49
Intas Biopharmaceuticals Ltd. (India) II-49
Sandoz International GmbH (Germany) II-49
Shantha Biotechnics Ltd., A Part of Sanofi Group (India) II-50
Teva Pharmaceutical Industries Ltd. (Israel) II-50
Wockhardt Ltd. (India) II-51
14. GLOBAL MARKET ANALYTICS II-52
Table 8: World Recent Past, Current, and Future Analysis for
Biosimilars by Geographic Region - US, Japan, Europe and Rest
of World Markets Analyzed Independently with Annual Sales
Figures in US$ Million for Years 2008 through 2017 (includes
corresponding Graph/Chart) II-52
Table 9: World 10-Year Perspective for Biosimilars by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Japan, Europe and Rest of World Markets for Years 2008,
2011 & 2017 (includes corresponding Graph/Chart) II-53
Table 10: World Recent Past, Current, and Future Analysis for
Biosimilars by Drug Class: Epoetin Alpha, Granulocyte-CSF,
Granulocyte Macrophage-CSF, Human Growth Hormone, Interferons,
and Insulin Analyzed with Annual Sales Figures in US$ Million
for Years 2008 through 2017 (includes corresponding
Graph/Chart) II-54
Table 11: World 10-Year Perspective for Biosimilars by Drug
Class: Percentage Share Breakdown of Dollar Sales for Epoetin
Alpha, Granulocyte-CSF, Granulocyte Macrophage-CSF, Human
Growth Hormone, Interferons, and Insulin Markets for Years
2008, 2011, and 2017 (includes corresponding Graph/Chart) II-55
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
Market Overview III-1
US Establishes Drug Approval Pathway for Biosimilars III-1
Overview of Various Sections of the Act III-1
Progress of US in the Biosimilars Space III-3
US Share to Increase in the Global Market III-4
Biopharma Patent Expiries to Drive Biosimilars Growth III-4
Patent Expiries of Select Biological Products in the US III-4
Which Biosimilars Would Make a Mark in the US ? III-5
Biosimilar Initiatives in the US III-5
B.Market Analytics III-6
Table 12: US Recent Past, Current & Future Analysis for
Biosimilars - Annual Sales Figures in US$ Million for Years
2008 through 2017 (includes corresponding Graph/Chart) III-6
2. JAPAN III-7
Market Analysis III-7
Table 13: Japanese Recent Past, Current & Future Analysis
for Biosimilars - Annual Sales Figures in US$ Million for
Years 2008 through 2017 (includes corresponding Graph/Chart) III-7
3. EUROPE III-8
A.Market Analysis III-8
Market Overview III-8
Biosimilar Approvals and Filings in Europe III-8
A List of the Few of Withdrawn and Rejected Biosimilar
Applications in Europe III-9
Biosimilars Regulatory Framework III-9
Biosimilar Regulatory Timeline from Legislation to Approval
in the EU III-10
Growth Drivers III-10
Payers Eye Biosimilars to Curtail Costs III-10
Challenges Ahead III-10
Heavy Investment and Regulations III-10
Complex Production Process III-11
Biocapacity III-11
Regional Issues III-11
B.Market Analytics III-12
Table 14: 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
2017 (includes corresponding Graph/Chart) III-12
Table 15: European 10-Year Perspective for Biosimilars by
Geographic Region - Percentage Breakdown of Dollar Sales for
France, Germany, UK, Spain and Rest of Europe Markets for
2008, 2011 & 2017 (includes corresponding Graph/Chart) III-13
4. REST OF WORLD III-14
A.Market Analysis III-14
India - A Biosimilars Hotspot III-14
Indian Biopharmaceutical Industry Makes Rapid Progress III-14
Table 16: Indian Market for Biosimilars by Drug Class
(2009): Revenues for Insulin, EPO, Interferon,
Streptokinase and G-CSF (includes corresponding
Graph/Chart) III-14
Growth Drivers in the Indian Biosimilars Market III-14
Biosimilar Cancer Drugs Yet to Make a Mark III-15
Bottlenecks to Limit Biosimilar Penetration III-15
Competitive Scenario III-15
Competition Intensifies in the Indian Biosimilar Industry III-15
Indian Players' Presence in the Biosimilars Market III-16
Rising Prominence of Indian Biosimilar Industry Worldwide III-16
Overcoming Current Limitations Remains the Key III-16
Biosimilars Interlace Opportunities and Snags for Indian
Companies III-17
Indian Pharmaceutical Companies Ogle Cancer Market III-17
Indian Pharma Majors Gear Up for Biosimilars Fray III-17
Select Major Indian Companies' Marketed and Pipeline
Biosimilars III-18
Indian Firms Eyeing European Market III-19
Select Leading Indian Companies Planning to Enter
European Market III-19
Indian Biogeneric Drugs to Enter the US Market III-19
B.Market Analytics III-20
Table 17: Rest of World Recent Past, Current & Future
Analysis for Biosimilars - Annual Sales Figures in US$
Million for Years 2008 through 2017 (includes corresponding
Graph/Chart) III-20
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 55 (including Divisions/Subsidiaries - 60)
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Region/Country Players
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The United States 11
Canada 2
Europe 17
France 1
Germany 9
The United Kingdom 2
Rest of Europe 5
Asia-Pacific (Excluding Japan) 26
Latin America 1
Africa 1
Middle-East 2
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