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Biogenerics - Global Strategic Business Report

Price:
USD $3,450.00
ISBN/SKU #:
GIA-MCP1537
Research Group:
Global Industry Analysts
Date of Publication:
July 2006
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Summary

This report analyzes the worldwide markets for Biogenerics in US$ Million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2007 through 2013. The report profiles 42 companies including many key and niche players worldwide such as Biocon Limited, BioPartners, BioGeneriX AG, Cangene Corporation, Cipla Ltd., Dr. Reddy's Laboratories, GeneMedix, LG Life Sciences, Pliva d.d., Ranbaxy Laboratories Limited, Sandoz International GmbH, Stada Arzneimittel, Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, and Wockhardt Limited. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

BIOGENERICS									MCP-1537
A GLOBAL STRATEGIC BUSINESS REPORT


                                            CONTENTS


  I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS


 II. EXECUTIVE SUMMARY

  1. Market Overview                                                    II-1
      Biogenerics Spell Opportunities                                   II-1
      Patent Expiration of Biotech Medicines Paves Way for  New
       Generation Biogenerics                                           II-1
       Patent Expiration of Major Biotechnology Products  before 2007   II-2
      Market Structure                                                  II-2
       Potential Key Competitors in the Biogenerics Space               II-2
      Entry Barriers for Biogenerics                                    II-3
       Comparison of Entry Barriers for Biogenerics in  Select
        Global Markets                                                  II-3
      Is Commercialization of Biogenerics Possible?                     II-3
      Will Biopharmaceutical Market Witness Intense  Competition
       from Generic Firms?                                              II-3
      Branded Vs Generics Drugs - The Debate Continues                  II-3
      Growth Impediments                                                II-4
       Heavy Investment                                                 II-4
       Shortage of Manufacturing Capacity                               II-4
       Lack of Clear Regulatory Mechanism                               II-4
      Overview of Select Markets                                        II-5
       United States                                                    II-5
        Biogenerics to Exhibit Slow Start                               II-5
       Europe                                                           II-5
       Australia                                                        II-6
       India - Emerging Player in the Biogeneric Market                 II-6

  2. Trends and Issues                                                  II-8
      US FDA Under Pressure                                             II-8
      Entry Barriers Limit Competition in Biogenerics Market            II-8
      Bend the Rule or Not - Authorities in Dilemma                     II-8
      Biogenerics Market Gains Support from Other Institutions          II-8
      Generic Drug Producers Adopt "Evergreening" Concept               II-8
      Biogenerics Need to Conform to the Production Norms of
       Original Products                                                II-9

  3. Drug Approval Process in US and Europe                             II-10
      Bioequivalence Tests - Mandatory Requirement  for Generics        II-10
      Approval Process in the US                                        II-10
       Hatch Waxman Act and FDA Approval Process                        II-10
       ANDA Review Process                                              II-11
       Generic Exclusivity                                              II-13
       30-Month Stay Period                                             II-13
       180-Days Exclusivity Period7                                     II-13
       Time Period for Generic Approval                                 II-13
      Approval Process in Europe                                        II-13
       Generic Companies Face Strict Regulations  for Approval          II-13
       Data Exclusivity                                                 II-13

  4. Product Overview                                                   II-15
      What are Biogenerics?                                             II-15
      Biogenerics - Generic Version of Biopharmaceuticals               II-15
      Biopharmaceuticals                                                II-16
      Biogenerics Versus Conventional Generics                          II-17
      Manufacturing Process of Biogenerics -  A Debatable Issue         II-17

  5. Recent Industry Activity                                           II-18
      Teva Acquires IVAX Corporation                                    II-18
      Biopartners Bags EU Marketing Approval for Valtropin              II-18
      Sandoz Bags EC Marketing Approval for Omnitrope                   II-18
      Omnitrope Receives US FDA Approval                                II-18
      Biocon Limited Partners with Vaccinex Inc                         II-18
      Novartis Pockets Hexal AG                                         II-18
      Mayne's Pharma Division Collaborates with Pliva                   II-19
      Clinigene Initiates Clinical Trials on Biocon's EGFR
       Monoclonal Antibody                                              II-19
      Barr Laboratories Signs Agreement with Pliva for  Developing
       G-CSF                                                            II-19
      Pliva Croatia Bags Approval for Biogeneric EPO                    II-20
      Teva Pharmaceutical Industries Acquires SICOR                     II-20
      Biocon Launches Bio-Insulin                                       II-20
      Cipla in Strategic Alliance with Dongbao Pharmaceutical
       Company Ltd                                                      II-20
      Crucell N.V. Signs a Licensing Agreement with Gene  Medicine
       Japan Inc                                                        II-20

  6. Focus on Select Players                                            II-21
      Biocon Limited (India)                                            II-21
      BioPartners (Switzerland)                                         II-21
      BioGeneriX AG (Germany)                                           II-21
      Cangene Corporation (Canada)                                      II-21
      Cipla Ltd. (India)                                                II-21
      Dr. Reddy's Laboratories (India)                                  II-22
      GeneMedix (UK)                                                    II-22
      LG Life Sciences (Korea)                                          II-22
      Pliva d.d. (Croatia)                                              II-23
      Ranbaxy Laboratories Limited (India)                              II-23
      Sandoz International GmbH (Germany),  a Unit of Novartis          II-24
      Stada Arzneimittel (Germany)                                      II-24
      Teva Pharmaceutical Industries Ltd. (Israel)                      II-25
       Teva Pharmaceuticals USA (USA)                                   II-25
      Wockhardt Limited (India)                                         II-26

  7. Global Market Perspective                                          II-27
      Table 1: Worldwide Market for Biogenerics - Market Projections
      for US, Europe and Rest of World with Annual Sales Figures  in
      US$ Million for Years 2007 through 2013 (includes
      corresponding Graph/Chart)                                        II-27

      Table 2: Worldwide 6-Year Perspective for Biogenerics -
      Percentage Breakdown of Dollar Sales for US, Europe and  Rest
      of World for Years 2007, 2010 & 2013 (includes corresponding
      Graph/Chart)                                                      II-27


III. COMPETITIVE LANDSCAPE

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