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.
Table of Contents
Table of Contents
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
Regulatory Framework for Biosimilars in Major Markets
European Union Ahead in the Biosimilars Race
Europe Sets Guidelines for Biosimilar Monoclonal Antibodies
Select Biosimilars Availability in Regional Markets
The US Passes Act to Create Biosimilars Pathway, Finally
Biosimilar Deals: Surging Ahead
2. MARKET OUTLOOK
Myriad Factors Foretell Lower Market Penetration of Biosimilar Products
Issues Put Aside, Biosimilars Offer Great Promise
Opportunity Abound for Biosimilars
Table 1: Top Biologic Drugs Losing Patent Protection through 2011-2015 (includes corresponding Graph/Chart)
3. MARKET TRENDS
Biosimilars to Gain Prominence in the US
Biosimilars Find More Growth in Emerging Markets
Future Opportunities for Biosimilars
Major Biotechnology Products Having Lost Patent Protection over the Recent Years
Table 2: Number of Biological Drugs Going Off-Patent through to 2015 (includes corresponding Graph/Chart)
Table 3: List of Select Biologic Drugs Losing Patent Protection: 2012-2015 (includes corresponding Graph/Chart)
Small and New Biosimilar-Focused Companies to Gain Foothold
Indian Companies to Emerge Strong in the Western Markets
Chinese Manaufacturers, Not a Major Threat Globally, Atleast in the Near Term
Companies Eye Human Insulin Biosimilars
Insulin Manufacturers Planning to Enter European and US Biosimilars Markets
Biosimilar Entry Barriers - Diverse Across Regions
Comparison of Entry Barriers for Biogenerics in Select Global Markets
Impediments to Market Acceptance
Strategies to Aid Survival of Companies in Biosimilars
Bio-betters Provide an Alternative Entry into Biosimilars Market
5. MARKET DRIVERS AND RESTRAINTS
Market Drivers
Patent Expiries
Patent Expiries of Biopharmaceuticals in Developed Regions - Europe and United States
Cost Containment Measures
Growing Aging Population
Presence of Major Players
Growth Restraints
Uncertain Regulations
High Lead-time
High Manufacturing Costs
Delivery and Commercialization
Automatic Substitution
Others
6. COMPETITIVE SCENARIO
Biosimilars Market to Remain Competitive
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)
Market Players with Approved and Pipeline Biosimilar Drugs
Increasing Competition Between Pharma Giants and Generic Manufacturers
Defensive Strategies for Branded Drug Manufacturers
7. GLOBAL BIOLOGICS MARKET
Global Biopharmaceutical Drug Market - A Primer
Table 5: Global Biopharmaceuticals Market: Annual Sales for the Years 2007 through 2009 (includes corresponding Graph/Chart)
North America - the Largest Biologics Market Worldwide
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)
Increasing Proportion of Biologics to Drive Biosimilars Market
Number of Biotech Drugs Amongst Top 10 Pharma List: 2008
Biologics to Strengthen Presence in the Global Pharmaceutical Market: 2015
Table 7: Leading Biopharmaceutical Drugs Worldwide By Revenues: 2009 (includes corresponding Graph/Chart)
Cost Effective Methods of Pure Biologics Production
8. 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
9. PRODUCT APPROVALS/INTRODUCTIONS
DRL Launches Cresp® in India
Hospira Receives EC Approval for Nivestim™
Reliance Life Sciences to Introduce Erythropoietin in Europe
Sandoz Introduces Zarzio® Filgrastim Preparation
Shasun Chemicals & Drugs Introduces Streptokinase
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
Wockhardt Launches Glaritus Insulin In India
10. PRODUCT APPROVALS/INTRODUCTIONS - A HISTORIC PERSPECTIVE BUILDER
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
11. CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE
Sandoz Commences Phase II Clinical Trial for Biosimilar Version of Rituximab
Cipla to Acquire Minority Stake in Bio Mabs and Mab Pharm
Biocon Signs Agreement with Pfizer
Actavis Group to Purchase Majority Stake in Biopartners from Bioton
Sandoz and Momenta Receive FDA Approval for Biosimilar Enoxaparin Sodium
Hospira Initiates Phase I Clinical Trial for EPO in the US
Watson Pharmaceuticals and Itero Biopharmaceuticals Sign Agreement
Cephalon Acquires Mepha
Hikma Pharmaceuticals Inks Agreement with Celltrion Healthcare and Celltrion
Ranbaxy Laboratories Signs Agreement with Pfenex
Ranbaxy Laboratories Acquires Biovel Life Sciences
Sanofi-Aventis Acquires Controlling Stake in Shantha Biotechnics
GlaxoSmithKline and JCR Pharmaceuticals Ink License Agreement
Hospira Enters into Agreement with Celltrion
Cipla Terminates Marketing Agreement with Avesthagen
Mylan Collaborates with Biocon
F. Hoffmann-La Roche Acquires Genentech
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
12. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER
BioGeneriX Commences GlycoPEG-GCSF Phase II Clinical Trial
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
13. 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)
Shantha Biotechnics Ltd., A Part of Sanofi Group (India)
Teva Pharmaceutical Industries Ltd. (Israel)
Wockhardt Ltd. (India)
14. GLOBAL MARKET ANALYTICS
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)
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)
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)
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)
III. MARKET
1. THE UNITED STATES
A. Market Analysis
Market Overview
US Establishes Drug Approval Pathway for Biosimilars
Overview of Various Sections of the Act
Progress of US in the Biosimilars Space
US Share to Increase in the Global Market
Biopharma Patent Expiries to Drive Biosimilars Growth
Patent Expiries of Select Biological Products in the US
Which Biosimilars Would Make a Mark in the US ?
Biosimilar Initiatives in the US
B. Market Analytics
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)
2. JAPAN
Market Analysis
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)
3. EUROPE
A. Market Analysis
Market Overview
Biosimilar Approvals and Filings in Europe
A List of the Few of Withdrawn and Rejected Biosimilar Applications 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
B. Market Analytics
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)
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)
4. REST OF WORLD
A. Market Analysis
India - A Biosimilars Hotspot
Indian Biopharmaceutical Industry Makes Rapid Progress
Table 16: Indian Market for Biosimilars by Drug Class (2009): Revenues for Insulin, EPO, Interferon, Streptokinase and G-CSF (includes corresponding Graph/Chart)
Growth Drivers in the Indian Biosimilars Market
Biosimilar Cancer Drugs Yet to Make a Mark
Bottlenecks to Limit Biosimilar Penetration
Competitive Scenario
Competition Intensifies in the Indian Biosimilar Industry
Indian Players' Presence in the Biosimilars Market
Rising Prominence of Indian Biosimilar Industry Worldwide
Overcoming Current Limitations Remains the Key
Biosimilars Interlace Opportunities and Snags for Indian Companies
Indian Pharmaceutical Companies Ogle Cancer Market
Indian Pharma Majors Gear Up for Biosimilars Fray
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
B. Market Analytics
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)
IV. COMPETITIVE LANDSCAPE
Biosimilars published by Global Industry Analysts, Inc. in April 1, 2012. This report consists of Pages: 348 and the price starts from US $ 4500.
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