Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth - GBI Research Reports

Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth - GBI Research Reports
Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth
Published Jul 10, 2012
141 pages — Published Jul 10, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

Summary

GBI Research, the leading business intelligence provider, has released its latest report, Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth that provides key data, information and analysis of the major trends and issues affecting the biosimilar market in developed countries covering the US, the top five European markets and Japan. The report provides a comprehensive insight into the biosimilar market, and offers market forecasts by geography as well as biosimilar categories. It also provides the drivers and restraints affecting the biosimilars market, as well as the business environment and the key success factors in the global biosimilar industry. In addition, the report describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. Finally, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that have taken place.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Researchs team of industry experts.

The global biosimilars industry has grown significantly over the past few years and has a great scope for future growth due to the expiry of patents for major biological drugs, pressure on the governments of developed nations to cut healthcare costs and the savings in treatment costs offered by biosimilars. The global biosimilar industry was valued at $450m in 2011 and is expected to increase to $7.5billion in 2018 at a compound annual growth rate (CAGR) of 49.6%. Access to the US market after the issuance of draft guidelines by the US Food and Drug Administration (FDA) will offer a major boost to the growth of the global biosimilar market. The establishment of guidelines for the approval of biosimilar interferons in the European Union will also drive global biosimilar market growth.

Currently, the global biosimilar market is at nascent stage. Major pharmaceutical companies including Teva Pharmaceuticals, Sandoz and Hospira have made a strong position for themselves in the European biosimilar market. However, the markets in the US and Japan have not been explored fully. Companies such as Pfizer, Mylan and Merck have shown interest in the opportunities offered by the global biosimilar market and have taken initiatives enter into it. Players such as Biocon and Celltrion from the emerging economies are collaborating with these global pharmaceutical companies to develop and market biosimilars. The market is expected to witness a large amount of strategic consolidation between these players in near future.

Scope

- Data and analysis on the biosimilar market in the leading geographies of the world the US, the UK, Germany, France, Italy, Spain, and Japan.
- Market forecast for global biosimilar market from 2011 to 2018, by geography as well as product category.
- Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
- The regulatory environment for biosimilars in the US, the EU and in Japan.
- Analysis of competitive environment in the industry and profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddys, Biocon, Intas, Celltrion and 3S Bio.
- Key M&A activities and Licensing Agreements that took place between 2009 up until February 2012 in the global biosimilar market.

Reasons to buy

- Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.
- Iden

  
Source:
Document ID
GBIHC211MR
Industry
Format:
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Sections

TitleStarting PageNumber of Pages
Table of Contents58
  List of Tables82
  List of Figures103
Introduction131
Biosimilars in Developed Countries- Market Overview148
  Introduction141
  Biologics and Small Molecules151
    Structural Differences between Biologics and Small Molecules151
  Market Size and Patent Expiries of Branded Biologics161
    Market Size of Branded Biologics &Sales by Major Drug Classes in 2010161
    Top Ten Biologics in 2010171
    Patent Expiry of Leading Biologics, 2011 2018181
  Approved Biosimilars in Europe until December 2011191
  Biopharmaceutical and Biosimilars Manufacturing and Development Process201
    Manufacturing Process201
    Setting up a new biosimilar manufacturing facility211
    Development Process &Cost211
Biosimilars in Developed Countries- Geographic Landscape2248
  Introduction221
  Global Biosimilar Market231
    Market Size and Forecast232
    Drivers and Barriers251
  US Biosimilar Market261
    Market Size and Forecast262
    Regulatory Landscape281
    Objectives of Biosimilar Legislation and Regulatory Frameworks291
      Comparison of the biosimilar with reference biologic291
      Level of clinical trial data and duration of the study adequate for the biosimilar approval291
      Prerequisites for post-marketing safety evaluation studies291
      Standards and criteria for the interchangeability of the biosimilar291
      Incentives to innovator company R&D through Intellectual Property protection and market exclusivity.291
    Regulatory Framework for Biopharmaceutical Industry303
    Evolution of Regulatory Pathways for Biosimilars333
    BPCI Act and the Pathway for Approval of Biosimilar Products361
      Biosimilarity vs. Interchangeability361
      FDA Guidance Documents361
      Contents of the Biosimilar Application - Clinical Studies371
      Differences between Biosimilar and Interchangeable Biosimilar Products371
      Market and Data Exclusivity381
      Patent Dispute Procedure382
      Notice of Commercial Marketing401
      Other Provisions401
      Substitution is a Decision Taken at Local Level411
    Drivers and Barriers421
  Top Five European Markets- Biosimilar Market Size and Forecast431
    Introduction431
    Market Size and Forecast432
    Regulatory Framework for Biopharmaceutical Industry451
    Evolution of Regulatory Pathways for Biosimilars461
    Current Position on Biosimilars471
      Overarching Guidelines471
      Quality Guidelines471
      Non-Clinical and Clinical Guidelines481
      Annexes Product Specific Guidelines481
      Post-Authorization Requirements481
      Data Exclusivity Period491
      What does this mean for the biosimilar industry?491
    The Bolar Type Provision501
    The Comparability Exercise502
    Biosimilars Approvals and Applications522
    EMA Guidelines for Biosimilar mAb541
    European Biosimilars Industry- Issues541
      Naming551
      Labeling551
      Substitution/Interchangeability551
      Pharmacovigilance551
    Drivers and Barriers561
    Country Analysis The UK571
      Structure of the Healthcare System571
      Pricing and Reimbursement Mechanisms571
      Drivers and Barriers for Biosimilars581
    Country Analysis Germany581
      Structure of the Healthcare System581
      Pricing and Reimbursement Mechanisms591
      Drivers and Barriers for Biosimilars591
    Country Analysis France601
      Structure of the Healthcare System601
      Pricing and Reimbursement Mechanisms601
      Drivers and Barriers for Biosimilars611
    Country Analysis Spain621
      Structure of the Healthcare System621
      Pricing and Reimbursement Mechanisms621
      Drivers and Barriers for Biosimilars631
    Country Analysis Italy641
      Structure of the Healthcare System641
      Pricing and Reimbursement Mechanisms641
      Drivers and Barriers for Biosimilars641
  Japan Biosimilars Market Size and Forecasts651
    Market Size and Forecast651
  Regulatory Landscape in Japan661
    Regulatory Framework for Biopharmaceutical Industry661
    Evolution of Regulatory Pathways for Biosimilars671
    Current Position on Biosimilars681
      Approved Biosimilars681
    Drivers and Barriers691
Biosimilars in Developed Countries Market Characterization7028
  Human Growth Hormone Biosimilars Market701
    Pipeline molecules711
    Drivers and barriers721
  Erythropoietin (EPO) Biosimilars Market732
    Pipeline molecules751
    Drivers and barriers761
  Granulocyte-Colony Stimulating Factor (G-CSF) Biosimilars Market772
    Pipeline molecules791
    Drivers and barriers801
  Interferon alpha Biosimilars Market811
    Pipeline molecules821
  Interferon beta Biosimilars Market821
    Pipeline molecules831
    Interferon alpha and Interferon beta Drivers and Barriers841
  Insulin and Insulin Analogs Biosimilars Market852
    Pipeline molecules871
    Drivers and barriers881
  TNF-alpha Inhibitor Biosimilars Market892
    Pipeline molecules911
    Drivers and barriers921
  Biosimilars Market for Monoclonal Antibodies against Cancer932
    Pipeline molecules952
    Drivers and barriers971
Biosimilars in Developed Countries- Case Study9811
  Market Share of Biosimilars in Top Five European Markets981
    Market Share Filgrastim981
    Market Share- Somatropin981
    Market Share- EPO991
  Pricing of Biosimilars in Top Five European Markets1002
  Strategies Adopted By Branded Biologic Companies to Beat Generic Competition1021
    Introduction1021
    Second Generation Biologics1021
    New Formulation1031
    Combination Products1031
    New Approved Indications1041
    Caps1041
  Industry Dynamics- Strategies to Be Adopted by Companies to Enter the Biosimilar Market1051
    Product1061
      Regulatory and Clinical Expertise1061
      Capital Investment1061
      Manufacturing Capability1061
    Price1061
      Discount to originator1061
      Reimbursement1061
      Competitors Pricing1071
    Place1071
      Market Segment to Target1071
      Prescribing trends1071
      Sustainability of originator1071
    Promotion1071
      Customized Sales and Marketing1071
      Differentiation1081
    People1081
      Decision Makers- Prescribers1081
      Decision Makers- Payers1081
Biosimilars in Developed Countries-Competitive Landscape1099
  Celltrion1091
    Company Profile1091
    SWOT Analysis1091
  Dr Reddy s Laboratories1101
    Company Profile1101
    SWOT Analysis1101
  Hospira1111
    Company Profile1111
    SWOT Analysis1111
  Biocon1121
    Company Profile1121
    SWOT Analysis1121
  Teva Pharmaceuticals Ltd1131
    Company Profile1131
    SWOT Analysis1131
  Sandoz1141
    Company Profile1141
    SWOT Analysis1141
  3SBio1151
    Company Profile1151
    SWOT Analysis1151
  Intas Pharma1161
    Company Profile1161
    SWOT Analysis1161
  Samsung Biologics1171
    Company Profile1171
    SWOT Analysis1171
Biosimilars in Developed Countries- Strategic Consolidations11816
  Deals by Type1181
  Mergers &Acquisitions (M&A)1191
    M&A Deals by Year1191
    M&A Deals by Value1201
    M&A Deals by Geography1211
    M&A Deals in 20111221
      SemBioSys Genetics Completes Private Placement of Bonds for $4.01m1221
      Therapeutic Proteins Secures $2.5m in the Second Tranche of Venture Financing Round1221
      Teva Completes Acquisition of Cephalon1221
  Licensing Agreements in the Biosimilars Market1231
    Licensing Agreements By Year1231
    Licensing Agreements By Value1241
    Licensing Agreements By Geography1251
    Licensing Agreement Deals1261
      Richter Gedeon Enters Into Licensing Agreement With STADA Arzneimittel For Rituximab1261
      Richter Gedeon Enters Into Licensing Agreement With STADA Arzneimittel For Trastuzumab1261
      Hanwha Chemical Enters Into Licensing Agreement With Merck For HD2031271
      Compass Biotechnologies Enters Into Licensing Agreement With Arecor1271
      Viropro Enters Into Licensing Agreement With Spectrum Pharmaceuticals For Rituximab1271
  Co- Development Deals1281
    Co-Development Deals By Year1281
    Co-Development Deals By Value1291
    Co-Development Deals By Geography1301
    Co-Development Deals1311
      Amgen Enters Into Co-Development Agreement With Watson For Generic Cancer Drugs1321
      Samsung Forms Joint Venture With Biogen Idec For Biosimilars1321
      Samsung and Quintiles Team Up for Co-Development of Biosimilar1321
      Baxter International Enters Into Co-Development Agreement with Momenta Pharmaceuticals for Biologics1331
Biosimilars in Developed Countries- Appendix1348
  Market Definitions1341
  Abbreviations1352
  Bibliography1372
  Research Methodology1393
    Market Overview1401
      Methodology1401
      Sources of Coverage1401
    Geographic Landscape1401
      Methodology1401
      Sources of Coverage1401
    Market Characterization1401
      Methodology1401
      Sources of Coverage1401
    Case Study1411
      Methodology1411
      Sources of Coverage1411
    Competitive Landscape1411
      Methodology1411
      Sources of Coverage1411
    Strategic Consolidations1411
      Methodology1411
      Sources of Coverage1411
  Contact Us1411
  Disclaimer1411

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Cite this Report

  
MLA:
GBI Research Reports. "Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth" Jul 10, 2012. Alacra Store. May 05, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Biosimilars-in-Developed-Countries-Launch-of-Biosimilar-mAbs-in-Europe-and-New-Regulatory-Pathways-in-the-US-to-Spur-Market-Growth-2115-455>
  
APA:
GBI Research Reports. (2012). Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth Jul 10, 2012. New York, NY: Alacra Store. Retrieved May 05, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Biosimilars-in-Developed-Countries-Launch-of-Biosimilar-mAbs-in-Europe-and-New-Regulatory-Pathways-in-the-US-to-Spur-Market-Growth-2115-455>
  
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