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Biosimilars

Abstract

Description

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

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)
  • Market Challenges and Outlook

4. MARKET DYNAMICS

  • Pharmaceutical Companies Eye Biosimilars Opportunities
  • 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
  • Teva Pharmaceutical Industries Acquires Ratiopharm
  • 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

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