Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 7 | 4 |
List of Tables | 10 | 1 |
List of Figures | 10 | 1 |
Generic Growth Strategies - Introduction | 11 | 1 |
Generic Growth Strategies - Market Overview | 12 | 11 |
Overview of the Generics Market | 12 | 1 |
Leading Generics Companies | 12 | 2 |
Generics Market Share | 14 | 1 |
Drivers and Restraints | 15 | 1 |
Drivers | 16 | 1 |
Patent Expiries | 16 | 2 |
ANDA Applications and Approvals are on the Rise | 18 | 2 |
Generic Drug Opportunities in the European Market | 20 | 1 |
Restraints | 21 | 1 |
Delayed Launch of Generic Equivalents | 21 | 1 |
Less Profit Margin | 21 | 1 |
Tender Systems Affect Generic Pricing | 21 | 1 |
Lack of Regulations | 21 | 1 |
Biosimilar Approvals Fall in the European Market | 22 | 1 |
Generic Growth Strategies - Regulatory Landscape | 23 | 12 |
The US | 23 | 1 |
Hatch-Waxman Act and ANDA | 23 | 2 |
Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics | 25 | 1 |
Pay-For-Delay Ban to be Detrimental to Innovators as Well as Generics | 25 | 1 |
Cost-sharing of Generic Drugs | 25 | 1 |
Impact of Supplemental Examination Provision of Patent Reform Act on Generics | 26 | 1 |
Biologics Price Competition and Innovation Act Falls Short | 26 | 1 |
Biosimilarity Compared to Interchangeability | 27 | 1 |
Biosimilar Approval Pathway | 27 | 1 |
Patent Resolution | 28 | 1 |
Europe | 28 | 1 |
Generic Penetration | 28 | 1 |
Generic Substitution | 29 | 1 |
Pricing and Reimbursement | 29 | 1 |
Marketing Authorization for Generics | 29 | 1 |
Generic Landscape in Leading European Markets | 29 | 1 |
Germany | 29 | 1 |
France | 30 | 1 |
The UK | 30 | 1 |
Italy | 30 | 1 |
Spain | 30 | 1 |
Russia | 31 | 1 |
Common European Union Patent System | 31 | 1 |
Tendering | 32 | 1 |
Regulatory Landscape for Biosimilars | 32 | 1 |
The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork | 32 | 1 |
Japan | 33 | 1 |
Generics | 33 | 1 |
Transformation of the Generic Pharmaceutical Market | 33 | 1 |
Registration and Pricing of Generic Drugs | 33 | 1 |
Measures for Generic Growth | 33 | 1 |
Biosimilar | 34 | 1 |
Generic Growth Strategies - Major Strategies | 35 | 12 |
Authorized Generics | 35 | 2 |
Case Study | 37 | 1 |
Mergers and Acquisitions | 37 | 2 |
Vertical Integration | 39 | 1 |
Therapeutic Expansion - Biosimilars | 39 | 1 |
Outsourcing | 40 | 1 |
Outsourcing Opportunities in Biosimilars | 40 | 1 |
Outsourcing is Also a Source of Income for Generics Companies | 40 | 1 |
Marketing Partnership | 41 | 1 |
Case Studies | 41 | 1 |
Marketing Partner DRL Increases Generic Fondaparinux s Sales in the US | 41 | 1 |
Pfizer-Mylan Partnership Brings Generics into Japan | 41 | 1 |
Prompt Launch of Lipitor Generic due to Collaboration Efforts Between Wockhardt and Ind-Swift | 41 | 1 |
Paragraph IV Certifications | 42 | 1 |
Case Studies | 42 | 1 |
Example of a Paragraph IV Challenge That Did Not Work Out for a Generic | 42 | 1 |
R&D Strategies Employed by Key Players in the Generics Market | 43 | 1 |
Super Generics | 43 | 1 |
Case Study | 43 | 1 |
Biosimilars | 44 | 1 |
Patent Protection around Biologic Drugs | 44 | 1 |
The EU and the US Regulatory Pathways | 44 | 1 |
Early Approvals - Limited to First Generation Products | 45 | 1 |
Cost and Marketing of Biogenerics | 45 | 1 |
Absence of Automatic Substitution is a Threat | 45 | 1 |
Higher Development and Manufacturing Costs as Compared to Generics | 46 | 1 |
Increasing Awareness and Acceptance | 46 | 1 |
Generic Growth Strategies - Competitive Landscape | 47 | 26 |
Teva Pharmaceutical Industries Limited | 47 | 1 |
Overview | 47 | 1 |
Revenue Analysis | 47 | 1 |
Generics | 47 | 1 |
Biosimilars | 47 | 1 |
R&D | 47 | 1 |
Therapeutic Focus | 48 | 1 |
Geographic Focus | 48 | 1 |
Generic Growth Strategies | 48 | 1 |
Generic Approvals | 48 | 1 |
Strong Pipeline | 48 | 1 |
Geographic Expansion | 48 | 1 |
Strategic Consolidations | 49 | 1 |
New Product Launch | 49 | 1 |
Infrastructure | 50 | 1 |
SWOT | 51 | 1 |
Sandoz | 52 | 1 |
Overview | 52 | 1 |
Revenue Analysis | 52 | 1 |
Therapeutic Focus | 52 | 1 |
Geographic Focus | 52 | 1 |
Generic Growth Strategies | 53 | 1 |
Strategic Consolidations | 53 | 1 |
Pipeline Products | 53 | 1 |
Launch Strategy | 53 | 1 |
Biosimilar Development | 53 | 1 |
SWOT | 54 | 1 |
Mylan | 55 | 1 |
Overview | 55 | 1 |
Revenue Analysis | 55 | 1 |
Therapeutic Focus | 55 | 1 |
Geographic Focus | 55 | 1 |
North America | 56 | 1 |
EMEA | 56 | 1 |
Japan | 56 | 1 |
Generic Growth Strategies | 57 | 1 |
Generic Drug Pipeline | 57 | 1 |
Strategic Consolidations | 57 | 1 |
New Product Launch | 57 | 1 |
SWOT | 58 | 1 |
Watson | 59 | 1 |
Overview | 59 | 1 |
Revenue Analysis | 59 | 1 |
Therapeutic Focus | 59 | 1 |
Geographic Focus | 59 | 1 |
Generic Growth Strategies | 60 | 1 |
Generic Drug Pipeline | 60 | 1 |
New Product Launch | 60 | 1 |
Infrastructure | 60 | 1 |
Strategic Consolidations | 60 | 1 |
SWOT | 61 | 1 |
Actavis | 62 | 1 |
Overview | 62 | 1 |
Revenue Analysis | 62 | 1 |
Therapeutic Focus | 62 | 1 |
Geographic Focus | 62 | 1 |
Generic Growth Strategies | 62 | 1 |
Strategic Consolidations | 62 | 1 |
New Product Launch | 62 | 1 |
Infrastructure | 63 | 1 |
SWOT | 63 | 1 |
Hospira | 64 | 1 |
Overview | 64 | 1 |
Revenue Analysis | 64 | 1 |
Therapeutic Focus | 64 | 1 |
Geographic Focus | 64 | 1 |
Generic Growth Strategies | 65 | 1 |
Challenging Intellectual Property | 65 | 1 |
Generic Drug Pipeline | 65 | 1 |
New Product Launch | 65 | 1 |
Generic Product Development | 65 | 1 |
Strategic Consolidations | 65 | 1 |
Biosimilar Product Development | 65 | 1 |
SWOT | 66 | 1 |
Sanofi | 67 | 1 |
Overview | 67 | 1 |
Revenue Analysis | 67 | 1 |
Geographic Focus | 67 | 1 |
Generic Growth Strategies | 67 | 1 |
Strategic Consolidations | 67 | 1 |
New Product Launch | 67 | 1 |
SWOT | 68 | 1 |
Daiichi Sankyo | 68 | 1 |
Overview | 68 | 1 |
Revenue Analysis | 68 | 1 |
Geographic Focus | 68 | 1 |
Generic Growth Strategies | 68 | 1 |
SWOT | 69 | 1 |
Aspen | 69 | 1 |
Overview | 69 | 1 |
Revenue Analysis | 69 | 1 |
Geographic Focus | 69 | 1 |
Generic Growth Strategies | 70 | 1 |
Strategic Consolidations | 70 | 1 |
New Product Launch | 70 | 1 |
SWOT | 70 | 1 |
STADA | 71 | 1 |
Overview | 71 | 1 |
Revenue Analysis | 71 | 1 |
Therapeutic Focus | 71 | 1 |
Geographic Focus | 71 | 1 |
Generic Growth Strategies | 72 | 1 |
SWOT | 72 | 1 |
Generic Growth Strategies - Conclusion | 73 | 1 |
Generic Growth Strategies - Appendix | 74 | 5 |
Market Definitions | 74 | 1 |
Abbreviations | 74 | 1 |
Bibliography | 75 | 2 |
Research Methodology | 77 | 2 |
Coverage | 77 | 1 |
Secondary Research | 77 | 1 |
Primary Research | 78 | 1 |
Expert Panel Validation | 78 | 1 |
Contact Us | 78 | 1 |
Disclaimer | 78 | 1 |