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The US Pharmaceutical Market 2009-2024
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The United States has by far the world's largest pharmaceutical market. In the twelve months to Q2 2009, the US accounted for 41% of world pharmaceutical sales. Its vast economy, high standard of livi.....
The United States has by far the world's largest pharmaceutical market. In the twelve months to Q2 2009, the US accounted for 41% of world pharmaceutical sales. Its vast economy, high standard of living, minimal pricing controls and strong intellectual property rights help make it the world's most dominant pharma market. The US also has one of the most stringent regulatory environments in the world. This brand new report - US Pharmaceutical Market 2009-2024 - will provide you with extensive information about the US pharma market and industry to benefit your work. This report presents the information you really need to know, to assess this market in light of impending changes. US Pharmaceutical Market 2009-2024 gives you current information and analyses you need to understand the following aspects of the US pharmaceuticals market, in particular: • The regulatory environment • The healthcare distribution system • The prevalence and relevance of the insurance industry • The pricing system for pharmaceuticals • Government-run Medicare and Medicaid systems • Direct-to-consumer advertising • The legal and regulatory status of generics. The US has been the world's most prominent pharma market for a long time, but what will happen next? Can the market sustain growth and, if so, by how much? What will happen when Lipitor's patent expires? Will the US market for cardiovascular treatments grow or shrink? What about the US market for cancer treatments? This report also includes interviews with three experts - Dr May Mak, Dr Donald Light and Mr Charlie Mayr - to provide additional insight into current market factors, looking ahead. US healthcare reforms – impact on the market The US is on the verge of reforming its healthcare system. Under most schemes, the reforms will not take full effect until 2013. However, the prospect of reform could have a psychological impact even before then. This market study discusses important US healthcare issues, and takes potential reforms into account in its forecasts. How would wider insurance coverage affect prescription drug sales? Will governmental price negotiations be approved? If governmental negotiation is approved, how would that affect sales revenues? This report addresses these and other relevant healthcare questions, and gives you a tool to help predict the impact of expected changes in US healthcare policy. We believe that significant US healthcare reform will happen from 2010. This report tells you what the changes could mean for pharma companies serving the US, both domestic and foreign. Comprehensive analysis of the United States' pharma sector In particular, US Pharmaceutical Market 2009-2024 contains detailed sales forecasts and supporting information. The sections, data tables and figures include: • Forecasts and other analyses for the total US pharma market • Forecasts and other analyses for individual treatment categories, including mental health treatments, cardiovascular treatments, antiulcerants, cancer treatments, anti-epileptics, narcotics, HIV antivirals, human insulins and analogues • Forecasts and other analyses for the over-the-counter (OTC) market • Forecasts and other analyses for the generics market (which visiongain believes will eventually include biosimilars) • SWOT tables outlining the strengths, weaknesses, opportunities and threats in the current and future US pharmaceutical market. This new report examines that sector critically, through a comprehensive review of information sources, both primary and secondary. There are over 65 tables and figures included, as well as three detailed interviews with relevant authorities. The result is a comprehensive market- and industry-centred study, with analyses and informed opinion to benefit your work. Crucial questions answered by this report – the main benefits of US Pharmaceutical Market 2009-2024 This new report provides a range of vital information, and answers a variety of questions. You will benefit from answers to crucial questions such as the following: • Will the US market grow more quickly from 2009 to 2014, or from 2014 to 2019? • Which treatment categories will grow in value? Which will shrink? • What impact will patent expiries have on the cardiovascular market? On the mental health treatments market? • Why will insulin sales increase significantly? • What regulatory conditions make the US an attractive location for R&D? • Will sales of generic drugs increase by value through to 2024? How much will they increase by volume? • What are the major points of the healthcare reform bills? How will healthcare reform change insurance coverage? • What are the restraints on the US OTC market? What are its drivers? • What is Medicaid Part D? What will happen to pharma revenues if legislation for Part D changes? • What will be THE major growth area for pharmaceuticals in the US from 2010 onwards? Medical spending in the US is the highest per capita in the world. The US is the world-leader in sales and consumption of new drugs, but will this trend continue? How much more growth can the US market achieve? Which aspects of its market will prosper the most from 2009 to 2024? Companies Listed 23andMe Abbott Actavis Albertson's Inc. Altea Therapeutics Alza Corporation American Consumer Products AmerisourceBergen Aspen AstraZeneca Aurobindo Baxter International Bayer Blue Cross Blue Shield Association Boehringer Ingelheim Bristol-Myers Squibb Cardinal Health Center for Drug Evaluation and Research (CDER) Centers for Disease Control and Prevention (CDC) Centers for Medicare and Medicaid Services comScore Congressional Budget Office CPEX / Bentley CVS Corporation Daiichi-Sankyo decodeME Department of Health and Human Services Diabetology Division of Drug Marketing, Advertising and Communication (DDMAC) Dr. Reddy's Laboratories Duane Reade Durect Emisphere European Medicines Agency (EMEA) Federal Trade Commission (FTC) Food and Drug Administration (FDA) Galenix Generex Biotechnology Generic Pharmaceuticals Association (GPhA) GlaxoSmithKline Greenstone Health Mart Hoechst (sanofi-aventis) Institute of Medicine Johnson & Johnson Kaiser Family Foundation Leiner Health Products Long's Drugs (recently acquired by CVS) Lundbeck MannKind McKesson Medley Merck & Co. Mylan National Association of Pharmaceutical Sales Representatives (NAPRx) National Institutes of Health (NIH) Novartis NutraMax Products Inc. Office of Generic Drugs (OGD) Office of Oncology Drug Products Office of Regulatory Affairs Oramed Perrigo Pfizer Pharmaceutical Research and Manufacturers of America (PhRMA) Phosphagenics Proctor & Gamble Qdose Ranbaxy Ratiopharm Reckitt Benckiser Rite Aid Safeway Stores Sandoz (Novartis) Sanofi-aventis Takeda Teva UCB US Census Bureau Walgreens Co. Walmart/Wal-Mart Wyeth Zentiva [Studien Infos ausblenden] |
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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 $300bn by 2014 9.2 Some Summary Numbers from This Report 9.2.1 Highest Growth Categories 9.2.2 Negative Growth Categories 9.2.3 OTC and Generics Summary Data 9.3 Summary Figures: Category Market Shares for 2009, 2014, 2019 and 2024 9.4 Cancer: A Major Market Driver 9.5 The US Market Will Continue to Grow, but Will Lose Worldwide Market Share [Inhaltsverzeichnis ausblenden] |
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Table 2.1 Institutes of the NIH Table 2.2 Insurance Prevalence Data Comparing 2007 to 2008 (in % and Millions of Persons) Table 3.1 Total Market Forecasts, 2009-2014 Table 3.2 Total Market Forecasts, 2014-2024 Table 3.3 Total Market Forecast, by Category, 2009-2014 ($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) 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) [Tabellenverzeichnis ausblenden] |
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