Industry Statistics The Pharma and Biotech Industries

The worldwide pharmaceutical marketplace is composed of four geographic areas; the United States, Europe (European Union), Asia (Japan, China, Australia), and the rest of the world (ROW). In addition, pharmaceutical companies are generally divided into five categories; pharmaceuticals (brand drugs, also known as "ethical" drugs), biotechnology products, generic drugs, over-the-counter (OTC) drugs (non-prescription), and devices. Support companies for the industry exist in many categories as well. Seven categories are suggested as follows; research or discovery technology (e.g., high-throughput screening, genomics, antisense, monoclonal antibodies), venture capital companies (financing support especially for small companies), clinical research organizations (generally operations and management for clinical research), specialty services companies for conduct of clinical trials to supplement company staffing (e.g., statistics, patient recruitment, medical writers, regulatory), medical education and/or communication companies (symposia and educational materials developed and implemented), advertising and/or promotion agencies, market research and marketing data companies, and law offices (patent and regulatory work).

The medical university setting serves as a source of several critical functions and expert individuals, such as basic science laboratories for disease and drug research, medical experts for disease and drug advice, clinical investigators to conduct the studies, health economists to assess a product's humanistic and financial utility, health care systems to understand the product's full impact and use of the product, and access to patients in the hospitals and clinics, all of which need to be used by pharmaceutical and biotechnology companies. The measurement of success of a company involves several sets of statistics that we will review in this chapter, including sales of products, New Drug Applications and approvals, research pipeline, alliances and collaborations, and reputation. Several other factors, especially many financial statistics, are important metrics, but are outside the scope of this book, such as profitability, market capitalization, profits to earnings ratio, which will only be mentioned in context.

Product sales are reported to the investment community and general public on a quarterly basis by companies. Sales figures that are reported usually include total sales of all products and services for the company, sales data for each product, regional/global sales, growth over time (quarter to quarter and year over year), market share within a therapeutic or pharma-cologic category, gross margin (sales less all expenses), and profit. For a single product, the term "blockbuster" product usually refers to a sales level of $1 billion per year. Generic drugs are copies of the original patented product that have proven equivalence primarily of ingredients and pharmacoki-netic parameters, especially bioavailability.

Sales data for all pharmaceuticals are reviewed for the years of 2001 to 2004, depending on availability of the data (Fig. 1.8). Prescription drug sales were $550 billion (B) worldwide (WW) in 2004, a 7% growth over 2003 ($492

k $ 248 U.S. (9% of Health spend in 2000 & 2003)

r Market WW % 2004: US 48%, EU 30%, Jap 11%, Asia/Pac 8%, ROW 4%

Top 200 products (2004): CV $56B-1st , CNS $59-2nd, Onc $27B-3rd, ID $22-4rd, GI $18B-4th, Resp $17B-5th, MSK $22B-6th r Generics 50% of all Rxs; 2/3rd market share in 12 mo.s after originator patent loss r Company growth target: Increases of > 10% /year

Fig. 1.8. Industry Statistics in Sales Source: © 2005 Thomson Center Watch

Fig. 1.9. Blockbuster Products (04-94 BBs = S1S6 Billion)

Lipitor

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