SPI Infoamtion

Table of Contents

1. Executive Summary
1.1 Crucial Aspects of this Report
1.1.1 Accurate Data: Quantitative and Qualitative Aspects
1.1.2 Accounting for Healthcare Developments
1.1.3 Two of Visiongain's Most Market-Relevant Predictions
1.2 Aims, Scope and Format of this Report
1.2.1 Contents Breakdown: Types of Forecasts
1.2.2 Chapter Breakdown
1.3 Research Methods

2. Overview of Market and Regulatory Conditions
2.1 The Food and Drug Administration (FDA)
2.1.1 Office of Regulatory Affairs (ORA)
2.1.2 Center for Drug Evaluation and Research (CDER)
2.1.3 Dietary Supplements: Regulated as Food under the FDA
2.2 The US Patent and Trademark Office: Guarding Intellectual Property Rights
2.3 National Institutes of Health (NIH)
2.3.1 The NIH and Disease Definitions: Diabetes
2.3.2 The NIH and Disease Definitions: Cardiovascular “At-Risk” Status
2.4 The Pharmaceutical Research and Manufacturers of America (PhRMA)
2.5 US Pricing Policies
2.5.1 Insurance Conglomerates and Price Negotiation
2.5.2 Medicare and Medicaid
2.5.2.1 Medicare
2.5.2.2 Medicaid
2.5.2.3 State Children's Health Insurance Program (SCHIP)
2.5.3 Reimbursement Calculation
2.5.4 Market Pressures Mean Cheap Generics
2.6 Direct to Consumer (DTC) Advertising
2.6.1 Market Value of DTC Spending
2.6.2 FDA Relaxed DTC Rules for Broadcasting in 1997
2.6.3 Web DTC Advertising: Curtailed in March 2009, but Regulations Likely to Change
2.6.4 Will Sponsored Web Advertisements Return?
2.7 Blockbuster Branded Pharmaceuticals: Is the Business Model Crumbling?
2.8 Limited Growth in the US Pharmaceutical Market: Fewer FDA Approvals
2.9 Obtaining FDA Approval: NDAs and ANDAs
2.10 The Hatch-Waxman Act of 1984: Speeding Generics, Changing Pharma
2.10.1 The Hatch-Waxman Act Title 1: Promoting Generics
2.10.2 The Hatch-Waxman Act Title 2: Incentives for the Branded Industry
2.11 Insurance Prevalence: A Crucial Market-Determining Factor
2.11.1 Pharmaceutical Companies in Favour of Increased Insurance Coverage in the US
2.11.2 Partnership for Prescription Assistance (PPA)

3. Total Market Forecasts: Top Drug Categories and Forecasts, 2009-2024
3.1 Full Market Forecast
3.1.1 Patent Expiries: Shrinking the Market in 2011/2012
3.1.2 Losing Worldwide Market Share?
3.2 Category Breakdown Tables and Figures
3.2.1 Changing Market Shares
3.2.2 Comparative CAGRs and Growth Rates over 2009 Value
3.3 Mental Health Treatments: Antipsychotics, Antidepressants, Mood Stabilisers and Psychostimulants
3.3.1 Mental Health Treatments Forecast Discussion, Tables and Figures
3.3.2 Seroquel and Abilify: Patent Expiries Looming
3.4 Cardiovascular Treatments: Cholesterol and Triglyceride Regulators and Platelet Aggregation Inhibitors
3.4.1 Cardiovascular Treatments Forecast Discussion, Tables and Figures
3.4.2 Lipitor and Plavix: Patents Expiring in 2011
3.4.3 Statins going OTC?
3.5 Antiulcerants
3.5.1 Antiulcerants Forecast Discussion, Tables and Figures
3.5.2 Takepron Expired in 2009
3.6 Cancer Treatments: Other Antineoplastics
3.6.1 Cancer Treatments Forecast Discussion, Tables and Figures
3.6.2 Niche Treatments: A Major Growth Driver
3.7 Anti-Epileptics
3.7.1 Anti-epileptics Forecast Discussions, Tables and Figures
3.8 Narcotic Anaesthetics
3.8.1 Narcotics Forecast Discussion, Tables and Figures
3.8.2 Cancer Pain: A Major Growth Driver
3.8.3 Addiction and Abuse: Growth Restraints Soon to be Overcome
3.8.3.1 Alza Corporation's Lonsys
3.8.3.2 Durect's SABER Technology
3.9 HIV Antivirals
3.9.1 HIV-Antivirals Forecast Discussion, Tables and Figures
3.9.2 The Fastest-Growing Market
3.10 Human Insulin and Analogues
3.10.1 Human Insulin and Analogues Forecast Discussion, Tables and Figures
3.10.2 Accounting for Biosimilars
3.10.3 Growth Driver: The Relevance of Metabolic Syndrome / Pre-Diabetes / Insulin Resistance
3.10.4 Alternative Delivery Methods
3.11 Others (including Respiratory Treatments and Oral Antidiabetics)
3.11.1 Others Forecast Discussion, Tables and Figures
3.11.2 Seretide: Expiring in 2010
3.11.3 Singulair: Expiring in 2012
3.11.4 Actos for Diabetes: Expiring in 2011

4. Generics
4.1 What Are Generics?
4.2 Authorised, Branded and True Generics
4.3 Generics Market Forecasts, 2009-2024
4.4 Increasing Market Penetration
4.5 Major Drugs Losing Patent Protection Through to 2012
4.6 Generics Approval Process
4.7 The 1984 Hatch-Waxman Act Title 1: Facilitating Generics Approvals
4.7.1 The Bolar Provision
4.7.2 Incentives for Patent Challenges
4.7.3 Consequences of the Hatch-Waxman Act
4.8 Patent Expiry and Immediate Presence of Generics
4.9 Big Pharma Enters the Generics Market
4.10 Growing Consumer Acceptance of Generic Medicines
4.11 Pro-Generics Political Climate
4.11.1 Healthcare on a Budget
4.11.2 Biogenerics / “Biosimilars” Approvals
4.11.3 Generics and Increased Healthcare Coverage
4.12 Slowing the Generics Market: The ANDA Backlog
4.13 Thinning Pipelines: A Problem for Generics Too?
4.14 Is Market Penetration Reaching a Saturation Point?
4.14.1 Market Saturation and Pricing Pressures
4.14.2 Possible Price Controls?
4.15 Declining Worldwide Market Share
4.16 Comments from Mr Charlie Mayr, GPhA
4.16.1 The Value of the Generics Market
4.16.2 Generics Savings and Challenges
4.16.3 On Authorized Generic Products

5. Over the Counter (OTC) Market
5.1 What are OTC Drugs?
5.1.1 Benefits of OTC Drugs
5.2 US OTC Market Forecasts, 2009-2024
5.3 Crucial OTC Market Growth Driver: OTC Switching
5.3.1 Statins Going OTC: Visiongain's Prediction
5.3.2 Oral Contraceptives: Current Sales Values
5.3.3 Proton Pump Inhibitors: Current Sales Values
5.4 OTC Market Growth Restraint: Increasing Competition
5.4.1 Private-Label Pharmaceuticals
5.5 OTC-Switching Regulation in the US
5.6 OTC Switching: Marketing and Revenues
5.6.1 OTC Switching and Marketing Exclusivity
5.6.2 Drug Manufacturers Can Apply to Switch
5.6.3 Retaining Revenues via OTC Switching
5.7 OTC Medicines: Reducing Costs and Increasing Care Prevalence
5.8 The OTC Market Chain
5.8.1 Wholesalers
5.8.2 Retailers
5.8.3 Online OTC Products
5.9 Top 8 OTC Brands (Worldwide)

6. Interviews
6.1 Interview with Dr May Mak
6.1.1 On the Impact of a Revised US Healthcare System on R&D
6.1.2 On OTC Statins
6.1.3 On the Prescription-to-OTC Trend
6.1.4 On the Potential Adverse Effects of OTC Statins
6.1.5 On the Worldwide Relevance of the US Pharma Market
6.2 Interview with Dr Donald W. Light
6.2.1 On Return on Investment in the US versus Europe
6.2.2 On Drug Development Inefficiencies and Clinical Trials
6.2.3 On Direct-to-Consumer Advertising
6.2.4 On Doctors and Sales Representatives
6.2.5 On Phase IV Clinical Trials as Part of R&D
6.2.6 Is R&D of Declining Relevance in the US?
6.2.7 What Will Happen in the US Pharmaceutical Market in the Future?

7. Recent Cultural and Regulatory Developments
7.1 Drug Costs Climate: Expensive Brands, Cheap Generics
7.1.1 The Debate about Drug Costs
7.1.2 Long- versus Short-Term Drug Costs
7.2 Healthcare Reform: Changes to Take Effect in 2013
7.2.1 The PhRMA's Perspective on Reform
7.2.2 Pharma Companies: Offered to Cut Profits to Facilitate Reform
7.3 Legislation Against “Evergreening”
7.4 Legislation on “Biosimilars”: Upcoming Changes?
7.4.1 Background on Biosimilars / Biogenerics
7.4.2 Bills in Congress in Mid-2009
7.5 Importing Prescription Drugs: New Laws on the Horizon
7.5.1 The Impact of Legal Pharmaceutical Imports
7.5.2 Concerns about Safety Standards
7.5.3 Re-importation: Not a Viable Option
7.6 New Marijuana Policy Memo: October 2009
7.6.1 Opening the Door for Cannabinoid Pharmaceuticals?
7.7 Changes to Medicaid: Recent and Recurring
7.7.1 October 2009 Cuts on Procedure Reimbursement
7.7.2 Primary Care versus Specialist Care
7.8 Institute of Medicine Reviewing FDA Medical Devices Approval Policies
7.8.1 With What Result? Visiongain's Analysis
7.9 Paying Fees to the FDA: Prescription Drug User Fee Act (PDUFA)

8. The Future: SWOT
8.1 Medicare Part D: Addressing the “Doughnut Hole”
8.1.1 Drug Companies: Offered to Assist Change by Surrendering $80bn
8.1.2 The House of Representatives Bill on Medicare Part D: Price Negotiation, not $80bn Agreement
8.2 Healthcare Changes: Inevitable, but Unpredictable
8.2.1 House Bill Ratified: 7 November 2009
8.2.2 Changes in Both Extant Healthcare Bills
8.2.3 Fraught Variables: the Public Option and Individual Mandate
8.2.4 How New Legislation Becomes Law
8.2.5 The Next Congressional Hiatus: 26 November 2009
8.3 Strengths and Weaknesses of the Current Market
8.3.1 History of Importance: a Major Strength
8.3.2 Strong R&D Culture: Another Market Strength
8.3.3 Generics Competition: A Significant Weakness
8.3.4 Low Number of FDA Approvals and Risk-Averse Behaviours: Related and Ongoing Problems
8.4 Opportunities in and Threats to the Future Market
8.4.1 Primary Care and Diabetes: Future Opportunities
8.4.2 Niche Cancer Care: The Future Market Driver
8.4.3 Genotyping: Appearing in 10 Years?
8.4.4 Biosimilars / Biogenerics: Opportunity or Threat?
8.4.5 The Threat of Relative Efficacy: Will the FDA Change its Approval Requirements?
8.4.6 OTC Statins: Will They Happen?
8.4.7 Mergers and Acquisitions Mean More R&D Money is Going Abroad
8.5 The Weakening Dollar Could Have an Impact in the Future

9. Conclusions
9.1 The US Market Will Exceed $300bn by 2014
9.2 Some Summary Numbers from This Report
9.2.1 Highest Growth Categories
9.2.2 Negative Growth Categories
9.2.3 OTC and Generics Summary Data
9.3 Summary Figures: Category Market Shares for 2009, 2014, 2019 and 2024
9.4 Cancer: A Major Market Driver
9.5 The US Market Will Continue to Grow, but Will Lose Worldwide Market Share

List of Tables
Table 2.1 Institutes of the NIH
Table 2.2 Insurance Prevalence Data Comparing 2007 to 2008 (in % and Millions of Persons)
Table 3.1 Total Market Forecasts, 2009-2014
Table 3.2 Total Market Forecasts, 2014-2024
Table 3.3 Total Market Forecast, by Category, 2009-2014 ($bn)
Table 3.4 Total Market Forecast, by Category, 2014-2024 ($bn)
Table 3.5 Total Market Share Percentage Changes, 2009-2024 (%)
Table 3.6 Categories' 15-Year Growth and CAGR Percentages 2009-2024 (Highest to Lowest by % Growth over 2009 Value)
Table 3.7 Mental Health Treatments Forecast, 2009-2014 ($bn)
Table 3.8 Mental Health Treatments Forecast, 2014-2024 ($bn)
Table 3.9 Cardiovascular Treatments Forecasts, 2009-2014 ($bn)
Table 3.10 Cardiovascular Treatments Forecasts, 2014-2024 ($bn)
Table 3.11 Antiulcerants Forecasts, 2009-2014 ($bn)
Table 3.12 Antiulcerants Forecasts, 2014-2024 ($bn)
Table 3.13 Cancer Treatments Forecasts, 2009-2014 ($bn)
Table 3.14 Cancer Treatments Forecasts, 2014-2024 ($bn)
Table 3.15 Number of Cancer Deaths by Type, 2007
Table 3.16 Drug Types Used as Anti-Epileptics
Table 3.17 Anti-Epileptics Forecasts, 2009-2014 ($bn)
Table 3.18 Anti-Epileptics Forecasts, 2014-2024 ($bn)
Table 3.19 Narcotic Anaesthetics Forecasts, 2009-2014 ($bn)
Table 3.20 Narcotic Anaesthetics Forecasts, 2014-2024 ($bn)
Table 3.21 HIV Antivirals Forecasts, 2009-2014 ($bn)
Table 3.22 HIV Antivirals Forecasts, 2014-2024 ($bn)
Table 3.23 Human Insulin and Analogues Forecasts, 2009-2014 ($bn)
Table 3.24 Human Insulin and Analogues Forecasts, 2014-2024 ($bn)
Table 3.25 Pipeline of Alternative Methods of Insulin Delivery, by Method and Development Stage
Table 3.26 Others Forecasts, 2009-2014 ($bn)
Table 3.27 Others Forecasts, 2014-2024 ($bn)
Table 4.1 Generics Market Forecast, 2009-2014 ($bn)
Table 4.2 Generics Market Forecast, 2014-2024 ($bn)
Table 4.3 Generics and Branded Drugs: Values and Market Shares Forecasts, 2009-2014 ($bn and %)
Table 4.4 Generics and Branded Drugs: Values and Market Shares Forecasts, 2014-2024 ($bn and %)
Table 4.5 Drugs in Top-Selling Categories Losing Patent Protection in the US, 2009-2012
Table 5.1 US OTC Market Forecast, 2009-2014 ($bn)
Table 5.2 US OTC Market Forecast, 2014-2024 ($bn)
Table 5.3 Major US Retailers
Table 5.4 Top Eight OTC Brands (Worldwide, based on 2008 Sales)
Table 5.5 Top Ten OTC Pharmaceutical Manufacturers (Worldwide, based on 2008 Sales)
Table 8.1 Strengths and Weaknesses in the Current and Short-term Market, 2009-2014
Table 8.2 Opportunities and Threats of the Future Market, 2014-2024
Table 9.1 Growth Percentages of High-Growing Countries, 12 months through Q2 2009 ($bn)

List of Figures
Figure 2.1 Number of New Drugs Approved by the FDA for Four Years
Figure 2.2 Insurance Coverage Percentages, 2007-2008 (%)
Figure 2.3 Insurance Coverage Numbers, 2007-2008 (millions of persons)
Figure 3.1 Total Market Forecasts, 2009-2024 ($bn)
Figure 3.2 Top 4 Categories Forecasts, 2009-2024 ($bn)
Figure 3.3 Bottom 4 Categories Forecasts, 2009-2024 ($bn)
Figure 3.4 Market Share Percentage Changes, 2009-2024 (%)
Figure 3.5 Mental Health Treatments Forecasts, 2009-2024 ($bn)
Figure 3.6 Cardiovascular Treatments Forecasts, 2009-2024 ($bn)
Figure 3.7 Antiulcerants Forecasts, 2009-2024 ($bn)
Figure 3.8 Cancer Treatments Forecasts, 2009-2024 ($bn)
Figure 3.9 Anti-Epileptics Forecasts, 2009-2024 ($bn)
Figure 3.10 Narcotics Forecasts, 2009-2024 ($bn)
Figure 3.11 HIV Antivirals Forecasts, 2009-2024 ($bn)
Figure 3.12 Human Insulin and Analogues Forecasts, 2009-2024 ($bn)
Figure 3.13 Others Forecasts, 2009-2024 ($bn)
Figure 4.1 Generics Market Forecast, 2009-2024 ($bn)
Figure 4.2 Generics and Branded Drugs: Value Market Share Forecasts, 2009-2024 (%)
Figure 4.3 Generics and Branded Drugs: Market Value Forecasts, 2009-2024 ($bn)
Figure 5.1 OTC Market Forecast, 2009-2024
Figure 5.2 The OTC Pharmaceutical Supply Chain
Figure 7.1 Sample Drug Costs, 5-40 Years Post-Launch (US versus Price-Controlled Markets)
Figure 9.1 Generics Market versus the OTC Market, 2009-2024 ($bn)
Figure 9.2 Treatment Categories Market Relevance (minus Others) in 2009 ($bn)
Figure 9.3 Treatment Categories Market Relevance (minus Others) in 2014 ($bn)
Figure 9.4 Treatment Categories Market Relevance (minus Others) in 2019 ($bn)
Figure 9.5 Treatment Categories Market Relevance (minus Others) in 2024 ($bn)