Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs - GBI Research Reports

Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs

Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs - GBI Research Reports
Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs
Published Dec 14, 2012
78 pages — Published Dec 14, 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 research, Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs. The report provides a comprehensive overview of the generic drugs market in the US, the top five countries in the European Union (EU, covering the UK, France, Germany, Spain and Italy) and Japan. The report focuses on the detailed analysis of major strategies implemented by the top 10 generic companies in the generic drugs market along with company portfolios and strategic analysis. The report gives detail on the current landscape and changes that have structured the generic drugs market. The report also contains an impact analysis of the regulatory landscape in the major geographies pertaining to the generic drugs market. The report also provides in-depth analysis of the unmet needs, drivers and barriers that affect the global generics market.

The 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 generics market generated revenues of approximately $162 billion with a growth of 9.3% in 2011, representing about 19% of generic market share in the international pharmaceutical market. The generic pharmaceutical industry is significantly fragmented; the top 10 pharmaceutical companies accounted for 26% of global generics sales by value in 2011. The US has very high levels of generic utilization, with nearly 80% of prescriptions dispensed being generics.

The pharmaceutical industry will experience major patent expiries during 20132020, of which 2014 to 2017 are expected to be peak years, with the loss of patents for drugs whose sales were worth more than $76 billion during 2011. By 2015, branded products with sales of up to $135 billion will go off-patent, giving generic pharmaceutical companies immense opportunities to capitalize on the market. Along with generic drugs, pharmaceutical companies will also have the opportunity to develop biosimilars, as biologics with 2011 sales of approximately $64 billion will go off-patent over the next five years.

Scope

- Detailed study of generic growth strategies with special emphasis on strategies which help in combating intensive competition.
- Analysis of the major strategies adopted by companies looking to expand geographical reach.
- Analysis of the generic pharmaceutical market in the leading geographies of the world, which includes the US, the UK, Germany, France, Italy, Spain, and Japan.
- Key drivers and barriers that have a significant impact on the market.
- Competitive benchmarking of leading companies. Key companies studied in this report are Teva, Sandoz, Mylan, Watson, Actavis, Hospira, Sanofi, Daiichi Sankyo, Aspen and STADA.

Reasons to buy

- Build understanding of the key generic growth strategies in place and the trends in the market.
- Align your product portfolio to the markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the potential region and therapeutics market segments poised for strong growth.
- Create a more tailored country strategy through the understanding of key drivers and barriers in the global generics market.
- Optimize your R&D pipeline through the identification and understanding of the key strategy for your drug.
- Identify the key players best positioned to capitalize on their products through the effective management of their patented products.
- Develop effective business strategies related to generic drugs through the analytical insight gained fro

  
Source:
Document ID
GBIHC263MR
Industry
Format:
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Sections

TitleStarting PageNumber of Pages
Table of Contents74
  List of Tables101
  List of Figures101
Generic Growth Strategies - Introduction111
Generic Growth Strategies - Market Overview1211
  Overview of the Generics Market121
    Leading Generics Companies122
    Generics Market Share141
  Drivers and Restraints151
    Drivers161
      Patent Expiries162
      ANDA Applications and Approvals are on the Rise182
      Generic Drug Opportunities in the European Market201
    Restraints211
      Delayed Launch of Generic Equivalents211
      Less Profit Margin211
      Tender Systems Affect Generic Pricing211
      Lack of Regulations211
      Biosimilar Approvals Fall in the European Market221
Generic Growth Strategies - Regulatory Landscape2312
  The US231
    Hatch-Waxman Act and ANDA232
    Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics251
     Pay-For-Delay Ban to be Detrimental to Innovators as Well as Generics251
    Cost-sharing of Generic Drugs251
    Impact of Supplemental Examination Provision of Patent Reform Act on Generics261
    Biologics Price Competition and Innovation Act Falls Short261
      Biosimilarity Compared to Interchangeability271
      Biosimilar Approval Pathway271
      Patent Resolution281
  Europe281
    Generic Penetration281
    Generic Substitution291
    Pricing and Reimbursement291
    Marketing Authorization for Generics291
    Generic Landscape in Leading European Markets291
      Germany291
      France301
      The UK301
      Italy301
      Spain301
      Russia311
    Common European Union Patent System311
    Tendering321
    Regulatory Landscape for Biosimilars321
    The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork321
  Japan331
    Generics331
      Transformation of the Generic Pharmaceutical Market331
      Registration and Pricing of Generic Drugs331
      Measures for Generic Growth331
    Biosimilar341
Generic Growth Strategies - Major Strategies3512
  Authorized Generics352
    Case Study371
  Mergers and Acquisitions372
    Vertical Integration391
    Therapeutic Expansion - Biosimilars391
  Outsourcing401
    Outsourcing Opportunities in Biosimilars401
    Outsourcing is Also a Source of Income for Generics Companies401
  Marketing Partnership411
    Case Studies411
      Marketing Partner DRL Increases Generic Fondaparinux s Sales in the US411
      Pfizer-Mylan Partnership Brings Generics into Japan411
      Prompt Launch of Lipitor Generic due to Collaboration Efforts Between Wockhardt and Ind-Swift411
  Paragraph IV Certifications421
    Case Studies421
    Example of a Paragraph IV Challenge That Did Not Work Out for a Generic421
  R&D Strategies Employed by Key Players in the Generics Market431
    Super Generics431
      Case Study431
    Biosimilars441
      Patent Protection around Biologic Drugs441
      The EU and the US Regulatory Pathways441
      Early Approvals - Limited to First Generation Products451
      Cost and Marketing of Biogenerics451
      Absence of Automatic Substitution is a Threat451
      Higher Development and Manufacturing Costs as Compared to Generics461
  Increasing Awareness and Acceptance461
Generic Growth Strategies - Competitive Landscape4726
  Teva Pharmaceutical Industries Limited471
    Overview471
    Revenue Analysis471
      Generics471
      Biosimilars471
      R&D471
    Therapeutic Focus481
    Geographic Focus481
    Generic Growth Strategies481
      Generic Approvals481
      Strong Pipeline481
      Geographic Expansion481
      Strategic Consolidations491
      New Product Launch491
      Infrastructure501
    SWOT511
  Sandoz521
    Overview521
    Revenue Analysis521
    Therapeutic Focus521
    Geographic Focus521
    Generic Growth Strategies531
      Strategic Consolidations531
      Pipeline Products531
      Launch Strategy531
      Biosimilar Development531
    SWOT541
  Mylan551
    Overview551
    Revenue Analysis551
    Therapeutic Focus551
    Geographic Focus551
      North America561
      EMEA561
      Japan561
    Generic Growth Strategies571
      Generic Drug Pipeline571
      Strategic Consolidations571
      New Product Launch571
    SWOT581
  Watson591
    Overview591
    Revenue Analysis591
    Therapeutic Focus591
    Geographic Focus591
    Generic Growth Strategies601
      Generic Drug Pipeline601
      New Product Launch601
      Infrastructure601
      Strategic Consolidations601
    SWOT611
  Actavis621
    Overview621
    Revenue Analysis621
    Therapeutic Focus621
    Geographic Focus621
    Generic Growth Strategies621
      Strategic Consolidations621
      New Product Launch621
      Infrastructure631
    SWOT631
  Hospira641
    Overview641
    Revenue Analysis641
    Therapeutic Focus641
    Geographic Focus641
    Generic Growth Strategies651
      Challenging Intellectual Property651
      Generic Drug Pipeline651
      New Product Launch651
      Generic Product Development651
      Strategic Consolidations651
      Biosimilar Product Development651
    SWOT661
  Sanofi671
    Overview671
    Revenue Analysis671
    Geographic Focus671
    Generic Growth Strategies671
      Strategic Consolidations671
      New Product Launch671
    SWOT681
  Daiichi Sankyo681
    Overview681
    Revenue Analysis681
    Geographic Focus681
    Generic Growth Strategies681
    SWOT691
  Aspen691
    Overview691
    Revenue Analysis691
    Geographic Focus691
    Generic Growth Strategies701
      Strategic Consolidations701
      New Product Launch701
    SWOT701
  STADA711
    Overview711
    Revenue Analysis711
    Therapeutic Focus711
    Geographic Focus711
    Generic Growth Strategies721
    SWOT721
Generic Growth Strategies - Conclusion731
Generic Growth Strategies - Appendix745
  Market Definitions741
  Abbreviations741
  Bibliography752
  Research Methodology772
    Coverage771
    Secondary Research771
    Primary Research781
    Expert Panel Validation781
  Contact Us781
  Disclaimer781

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Cite this Report

  
MLA:
GBI Research Reports. "Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs" Dec 14, 2012. Alacra Store. May 04, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Generic-Growth-Strategies-Market-Driven-by-Impending-Patent-Cliff-Declining-R-D-Productivity-and-Government-Initiatives-to-Reduce-Healthcare-Costs-2115-544>
  
APA:
GBI Research Reports. (2012). Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs Dec 14, 2012. New York, NY: Alacra Store. Retrieved May 04, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Generic-Growth-Strategies-Market-Driven-by-Impending-Patent-Cliff-Declining-R-D-Productivity-and-Government-Initiatives-to-Reduce-Healthcare-Costs-2115-544>
  
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