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The worldwide prescription generic drug market has evolved into a formidable and important participant in the complex world of healthcare. Generic drug manufacturers are poised for strong growth in the future as patent protection for a host of major pharmaceuticals are due to expire and new legislative reforms in the generic drug approval process may facilitate bringing products to market. Although the generic industry has stagnated since the late 1990s, that could change directly and the outlook for generic promotion is favorable in the next five years.

The landscape of generic companies is changing. Traditionally, generic companies developed a broad range of products that were easily manufactured, low-cost, and undifferentiated in the marketplace. However, a new breed of generic company is emerging, which will likely bring a greater threat to brand manufacturers than ever before. Many generic companies are using increased revenue generated from generic versions of a growing number of top-selling branded drugs to explore new drug targets, including specialty generics, generics with a distinction, generic biologicals, and proprietary molecules. Generic manufacturers have also been able to cross over into the brand name domain by establishing a foothold in specialty therapeutic areas.

This study is designed to provide a comprehensive look at the various strategies being used by generic companies in the marketplace, the issues and trends that are shaping the marketplace, and an individual look at the various markets within the prescription generic industry. This is the fourth time since 1995 that Kalorama Information has investigated the prescription generic market.

Scope and Methodology

For the purposes of this study, the prescription generic drug market was examined at the level of manufacturers’ revenues in each of the following product categories:

• Allergy and respiratory drugs
• Analgesic, NSAIDs, and anti-rheumatic drugs
• Anesthesia
• Anti-infectives
• Cancer drugs
• Cardiovascular drugs
• CNS drugs
• Gastrointestinal drugs
• Hormones
• Ophthalmic drugs

The information and analysis presented in this report are based on an extensive survey of senior management in the prescription generic drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals. Key information from published literature was used to conduct interviews with over 55 industry executives and product managers to validate and obtain expert opinion on current and future trends in the psychotherapeutic industry. Interviews were also used to confirm and/or adjust market size and market share estimates, as well as in formulating market projections.

Data are expressed in current U.S. dollars. The base year for data was 2001. Historical data are provided for each of the years 1996 through 2000, and forecast data are provided for each of the years 2002 through 2006. Historical, base year, and forecast data are provided for each market segment. Market shares are provided for each market segment for the 2001 base year. Geographically, revenues are reported for the world and then breakdown is given for U.S. and non-U.S. revenue.

Author
Mary Anne Crandall has been publishing market research in the life sciences for more than 10 years. She is a registered nurse and is the founder and CEO of Mountaintop Medical, LLC, a consulting firm in Oregon. She has been teaching at Southern Oregon University for over 12 years, and before joining Kalorama’s analytical team, she published with Frost & Sullivan, Theta Reports, FIND/SVP, MDI, FeedBack Research Services, Prognosis and Hall Enterprises. Ms. Crandall specializes in prescription pharmaceutical markets, with a particular focus on generic drug markets.

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