Reports

Ideas That Generate Results

1. Analyst View

2. Research Methodology

3. Market Drivers
     3.1 Inclining Healthcare Expenditure
     3.2 Rising Disposable Incomes
     3.3 Increasing Ageing Population
     3.4 Patent Expiry of Blockbuster Drugs
     3.5 Mergers & Acquisitions

4. Market Challenges
     4.1 Surging Generic Drug Prices
     4.2 Long Product Approval Process
     4.3 Legal Controversies

5. Overview of Generics Sector
     5.1 US Pharmaceutical Market
     5.2 Share of Branded vs. Generics
     5.3 Generics Drugs Market

6. Market Potential for Generic Drugs in Key Therapies Segments
     6.1 Oncology
     6.2 Obesity & Cholesterol
     6.3 Mental Health (Antipsychotics & Anti-Depressants)
     6.4 Hypertension (Angiotensin II Receptor)
     6.5 Diabetes
     6.6 Anti-Ulcerants (Proton Pump Inhibitors)
     6.7 Thyroid
     6.8 Respiratory

7. Market Trends & Developments
     7.1 New Product Launch
     7.2 Launch of Biosimilars (BioGenerics)
     7.3 Progress in User Fees for Generic Manufacturers (GDUFA)
     7.4 Revision of Pay-for-delay Agreement Policies

8. Regulatory Environment
     8.1 Drug Efficacy Study Implementation (DESI) Program
     8.2 Hatch-Waxman Act
     8.3 Patent Infringement Litigations
     8.4 Para IV & the 180-day Marketing Exclusivity
     8.5 FDA Requirements
     8.6 Generic Initiative for Value & Efficiency (GIVE)
     8.7 Healthcare Bill 2013
     8.8 Ban on “Pay for delay” Settlements
     8.9 Patient Protection and Affordable Care Act

9. Competitive Landscape
     9.1 Market Share of Leading Players
     9.2 Market Share of Leading Generic Drugs
     9.3 Profiles
            9.3.1 Teva Pharmaceuticals USA
            9.3.2 Actavis Plc
            9.3.3 Mylan Inc.
            9.3.4 Pfizer Inc.
            9.3.5 Sandoz Inc. (Novartis)
            9.3.6 Endo International Plc.
            9.3.7 Lupin Limited
            9.3.8 Dr. Reddy’s Laboratories Ltd.
            9.3.9 Zydus Pharmaceuticals Inc.
            9.3.10 Amneal Pharmaceuticals