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Worldwide Generic Prescription Drug Industry Abstract This report analyzes the worldwide generic drug industry and provides market analysis and forecasts for 1996, 1997, 1998 and 2003. Therapeutic categories discussed in this report include antiarthritic/analgesic agents, anticancer agents, antifungal agents, anti-infective agents, cardiovascular agents, central nervous system agents, dermatological agents, gastrointestinal agents, respiratory agents, biotechnology, hormones, and other generic drugs. Profiles of leading generic only companies and generic divisions of branded pharmaceutical companies and strategies employed by them to meet the challenges of this highly competitive market are discussed. The regulatory environment affecting the generic industry is analyzed country by country, as is the impact of the General Agreement on Tariffs and Trade (GATT). Table of Contents Introduction
Summary Overview
Government Regulation In The U.S.
Patent Analysis
The U.S. Market For Generic Drugs
The International Generic Drug Industry
Generic Drug Market Strategies
Company Profiles
Appendix: Company Names And Addresses List Of Tables
1 Geographic Shares Of Generic Drugs, 1998 And Projected For 2003 2 Worldwide Generic Market Share By Volume And By Value Of All Prescription Pharmaceuticals For Selected Countries, 1998 And Projected To 2003 3 Percent Of Selected International Prescription Pharmaceutical Markets Held By Generics, By Value, 1996 And Projected To 2003 4 Generic Drug Company Revenues: Worldwide, 1997 5 Selected Brand Name Pharmaceutical Firms And Their Generic Subsidiaries, 1998 6 Generic Drug Market By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003 7 Growth In Prescription Unit Market Share Of Generic Drugs*, 1984 To 1997 8 U.S. Unit Market Share And Number Of Generic Drugs Manufactured, By Company, 1997 9 U.S. Andas Pending And Estimated Generic Product Launches, By Company In 1998 10 Manufacturing Capabilities Of Selected Generic Companies 11 Sales Representatives Marketing Generic And Branded Products, By Company, 1997 And Projected For 1998 12 Prescription Shares Of Leading Suppliers Of Generically Available Agents, U.S., 1997 13 U.S. Anda Approvals In 1997 And Projected Anda Filings And Generic Product Launches For 1998, By Company 14 Average Prescription Price Comparison Of Generic And Innovator Drugs, By Number Of Manufacturers, 1994 15 Average Retail Price And Market Share, By Type Of Drug, 1994 16 Average Percentage Change In Drug Prices Of All Pharmaceuticals, Branded Products, And Generic Products From 1996 To 1997 17 U.S. Market Share Percentage Of Prescriptions Held By Generics, 1986-1997 18 Percentage Of Pharmacists Who Are Reluctant To Substitute Generic Drugs, By Therapeutic Category, 1997 19 Percentage Of Pharmacists Who Prefer Originator's Brand, By Product, 1997 20 Decision-Making Among Pharmacists Regarding Dispensing Generic For Specific Drugs 21 Most Commonly Cited Problems With Generic Products 22 Percent Of Sales By Venue For Top-Selling Generic Versus Branded Products, By Chemical Entity, 1997 23 Average Duration Of Hatch-Waxman Extensions For Drugs Approved Between 1992 And 1995 24 FDA Orange Book Therapeutic Equivalence Rating Codes 25 U.S. Patent/Exclusivity Expiration Dates Of Major Pharmaceuticals And Estimated Sales, 1996-2003 26 1997 Sales And Projected Sales Of Branded Pharmaceuticals Losing U.S. Patent Protection, 1998-2003 27 Injectable Agents Losing U.S. Patent Protection From 1998-2002 And U.S. Sales In 1997 28 U.S. Sales Of Complex Drugs Available For Generic Competition, 1997 29 Generic Drug Market, By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003 30 Generic Products With U.S. Retail Sales In Excess Of $100 Million, 1997 31 Generic Drugs Approved For The First Time In 1997 32 Estimated Worldwide Sales And Patent Expirations Of Leading Antiarthritic And Analgesic Agents 33 Market For Generic Antiarthritic And Analgesic Agents: U.S., 1996, 1997, 1998 And 2003 34 Forecast Of The Generic Market Share Of Antiarthritic And Analgesic Agents: U.S., 1998 And 2003 35 Estimated Worldwide Sales And Patent Expirations Of Leading Anticancer Agents 36 Market For Generic Anticancer Agents: U.S., 1996, 1997, 1998 And 2003 37 Forecast Of The Generic Market Share Of Anticancer Agents: U.S., 1998 And 2003 38 Market For Generic Anti-Infective Agents: U.S., 1996, 1997, 1998 And 2003 39 Estimates Of Generic Market Share Of Anti-Infective Drugs, By Category: U.S., 1996, 1997, 1998 And 2003 40 Estimated Worldwide Sales And Patent Expirations Of Leading Antibacterial Agents 41 Estimated Worldwide Sales And Patent Expirations Of Leading Antifungal Agents 42 Estimated Worldwide Sales And Patent Expirations Of Leading Antiviral Agents 43 Estimated Worldwide Sales And Patent Expirations Of Leading Biotechnology Drugs 44 Market For Generic Biotechnology Drugs: U.S., 1996, 1997, 1998 And 2003 45 Estimates Of Generic Market Share Of Biotechnology Drugs: U.S., 1998 And 2003 46 Market For Generic Cardiovascular Agents: U.S., 1996, 1997, 1998 And 2003 47 Estimates Of Generic Market Shares Of Cardiovascular Drugs, By Category: U.S., 1998 And 2003 48 Leading Cardiovascular Drugs, 1996 Sales, And Year Of U.S. Patent Expiration 49 Estimated Worldwide Sales And Patent Expirations Of Leading Adrenergic Inhibitors 50 Estimated Worldwide Sales And Patent Expirations Of Leading Ace Inhibitors 51 Estimated Worldwide Sales And Patent Expirations Of Leading Anticoagulant, Antiplatelet And Thrombolytic Agents 52 Estimated Worldwide Sales And Patent Expirations Of Leading Beta Blockers 53 Estimated Worldwide Sales And Patent Expirations Of Leading Calcium Channel Blockers 54 Estimated Worldwide Sales And Patent Expirations Of Leading Cholesterol-Reducing Agents 55 Estimated Worldwide Sales And Patent Expirations Of Leading Vasodilators 56 Estimated Worldwide Sales And Patent Expiration Of Leading Central Nervous System Agents 57 Market For Generic Central Nervous System Agents: U.S., 1996, 1997, 1998 And 2003 58 Forecast Of The Generic Market Share Of Central Nervous System Agents: U.S., 1998 And 2003 59 Estimated Worldwide Sales And Patent Expirations Of Leading Gastrointestinal Drugs 60 Market For Generic Gastrointestinal Agents: U.S., 1996, 1997, 1998 And 2003 61 Forecast Of The Generic Market Share Of Gastrointestinal Agents: U.S., 1998 And 2003 62 Estimated Worldwide Sales And Patent Expirations Of Leading Hormone Drugs 63 Market For Generic Hormones: U.S., 1996, 1997, 1998 And 2003 64 Forecast Of The Generic Market Share Of Hormones: U.S., 1998 And 2003 65 Estimated Worldwide Sales And Patent Expirations Of Leading Respiratory Drugs 66 Market For Generic Respiratory Agents: U.S., 1996, 1997, 1998 And 2003 67 Forecast Of The Generic Market Share Of Respiratory Agents: U.S., 1998 And 2003 68 Estimated Worldwide Sales And Patent Expirations Of Leading Drugs In Other Therapeutic Categories 69 Market For Other Generic Therapeutic Agents: U.S., 1996, 1997, 1998 And 2003 70 Forecast Of The Generic Market Share Of Other Therapeutic Agents: U.S., 1998 And 2003 71 Market For Generic Drugs: France, 1996, 1997, 1998 And 2003 72 Market For Generic Drugs: Germany, 1996, 1997, 1998 And 2003 73 Market For Generic Drugs: Italy, 1996, 1997, 1998 And 2003 74 Projected Share (By Value And Volume) Of Generics Within Total Molecular Entity Sales For Selected Agents Projected For 2001: Italy 75 Market For Generic Drugs: U.K., 1996, 1997, 1998 And 2003 76 Market For Generic Drugs: Canada, 1996, 1997, 1998 And 2003 77 Market For Generic Drugs: Japan, 1996, 1997, 1998 And 2003 78 Market For Generic Drugs: Russia, 1996, 1997, 1998 And 2003 79 The Top 10 Generics Companies By Advertising Expenditures, 1997 80 The Top 10 Generics Companies By Advertising Expenditures, 1996 81 Selected Generic And Branded Drug Firm Alliances 82 Generics Subsidiaries Of Brand-Name Pharmaceutical Companies 83 Products Manufactured And/Or Marketed By Duramed 84 Mylan Laboratories Revenue Forecast, 1997 Through 2000 85 Mylan's Product Pipeline 86 Schein's Percentage Of Net Revenues By Business Sector, 1995, 1996 And 1997 List Of Figures
1 Percent Of Selected International Prescription Pharmaceutical Markets Held By Generics, By Value, 1996 And Projected To 2003 2 Generic Drug Market By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003 3 Growth In Prescription Unit Market Share Of Generic Drugs, 1984 To 1997 4 U.S. Unit Market Share And Number Of Generic Drugs Manufactured, By Company, 1997 More Details INTRODUCTION STUDY GOALS AND OBJECTIVES This report provides a range of information–from detailed market analyses through industry trends–to quantify and qualify the market for prescription generic drugs. Forecasts of product categories and industry trends are provided for the U.S. market and, when available, for international markets. Forecasts and trends are gleaned from interviews with industry sources as well as from considered assessment of available and emerging technologies. The report develops forecasts for the generic drug market for major therapeutic categories through 2003 and also examines strategies employed by generics-only companies and generics divisions of branded pharmaceuticals firms to meet the challenges of this highly competitive market. The regulatory environment affecting the generics industry is analyzed country-by-country, as is the impact of the General Agreement on Tariffs and Trade (GATT). REASONS FOR DOING THE STUDY Issues driving the international generic drug industry include patent expirations of many of the best-selling drugs within the next decade, the increasing presence of managed care and other cost-containment efforts in the U.S. and international markets, and increasing numbers of prescriptions filled with less expensive generic alternatives. By 2000 it is projected that, in the U.S., generics will surpass branded products in the number of new prescriptions written. Generics represent a smaller percentage of prescriptions written in most other countries but are gaining share almost universally. In 1998, generics represented approximately 9% of the inter-national pharmaceutical market and 12% of the U.S. drug market in dollars. The generics drug market is projected to enjoy double-digit growth throughout the forecast period, compared to 5% to 6% growth projected for branded products. CONTRIBUTIONS OF THE STUDY AND FOR WHOM This report provides a thorough analysis of the prescription generic drug market, offering information needed to understand the current market and to approach the emerging one. It is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investor consultants, and anyone interested in the prescription generic pharmaceuticals market, its products, its industry participants, and its future. SCOPE AND FORMAT The scope of this study is worldwide, although the focus is the U.S. market. All major therapeutic categories for prescription generic drugs are forecasted and discussed. Markets addressed include Canada, France, Germany, Italy, Japan, Mexico, Spain and the U.K., with a special section on emerging markets such as Russia and South America. The major emphasis of the report is the U.S. generic drug industry because of its maturity, current size, potential for market growth, and leadership in generic and therapeutic drug substitution. The overview section presents the market trends affecting generic drug industry growth and prescribing, a comprehensive market size and growth analysis for the U.S. prescription generic drug industry over the period 1996 to 2003, and describes industry and regulatory activities that will shape the future of the industry. The government regulation section provides an assessment of the U.S. Food and Drug Administration (FDA) relationship with the generic drug industry, generic drug development and regulatory approval requirements, and the performance and productivity of the FDA in approving prescription generic drugs. The patent analysis section presents the leading generic drug opportunities by U.S. dollar volume between 1996 and 2003, as well as an assessment of the current and evolving impact of various international regulatory and trade protocols and practices–including the 1995 GATT treaty–on U.S. patent extensions and other factors affecting the international generic drug market. The market analysis section comprises the focus of the report. It presents sales data and market size estimates for each major therapeutic category, including biotechnology products, products within each category open to generic competition, the degree of historic and future generic penetration, and forecasts of market size. Lastly, it estimates growth rates for each major therapeutic category over the period 1996 through 2003. Therapeutic categories discussed in this report include:
Market figures are based on revenues at the manufacturers’ level and are projected at 1998 dollar value— that is, inflation is not computed into the projection figures. The international generic drug industry section provides an assessment of selected major international generic drug markets. It describes drug pricing policies, cost containment efforts, and political and economic trends affecting the growth of each major generic drug market; and projects, for selected countries, the current and future market size estimates and growth rates. The section on generic drug market strategies provides an assessment of the key factors for success as viewed by senior management of generic drug companies as well as the strategies employed by research-based pharmaceutical companies to successfully compete in the generic drug industry. Profiles of leading generics-only companies and generic divisions of research-based pharmaceutical companies are provided. METHODOLOGY Information to prepare this study was derived from interviews with marketing strategists, industry executives and others at leading companies in the generic drug industry. Discussions were also held with government agencies and regulatory bodies that monitor and/or regulate generic drugs. Physicians and pharmacists were surveyed to assess prescribing practices and opinions on products. Searches of secondary material such as company annual reports and 10Ks, journal articles, prospectus assessments, government resources, and data from health care institutions were also conducted. INFORMATION SOURCES Information to prepare this report was obtained from primary interviews with companies, industry analysts, healthcare personnel, trade associations such as the Generic Pharmaceutical Industry Association and National Association of Pharmaceutical Manufacturers, government agencies such as the Office of Generic Drugs of the U.S. FDA, literature searches, annual reports, 10Ks, and product literature. |