Current and future prospects for the global biotechnology industry
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Keywords: biotechnology, pharmaceutical, R&D, drug development, clinical trials, contract research organisations, regulatory review, USA, Europe, Japan
Current and future prospects for the global biotechnology industry Faiz Kermani and Pietro Bonacossa Date received (in revised form): 23rd September, 2003
Abstract The number of biotechnology compounds has been increasing steadily over the past 20 years, reflecting the key contribution that biotechnology is now making to healthcare. Recombinant DNA technology has been used to develop a number of therapeutic proteins, including antibodies, cytokines, hormones and vaccines for use in tackling and diagnosing a range of disorders. Worldwide there are more than 4,000 specialised biotechnology companies. The most well-known companies are located in the USA and Europe, but there are significant companies emerging in Canada, Australia, New Zealand and throughout Asia – particularly in Japan. Most of these companies are small in size and limited when it comes to finances and this has had an impact on the output of the industry in terms of new drugs.
DECLINING NEW DRUG OUTPUT In 2002, only 28 new molecular entities (NMEs) were launched onto the global market, which represented the lowest number of new medicines launched in over 20 years.1 The declining new drug
output represents a puzzling trend, given that many companies have been increasing their R&D spend on a regular basis over the past 10 years (Figure 1). Some industry observers believe that there is an ‘innovation deficit’ in new drug development, and that many of the
Dr Faiz Kermani Budgets, Proposals and Marketing Executive, Business Development, Chiltern International Limited, Wellington House, 20 Queensmere, Slough SL1 1DB, UK Tel: +44 (0) 1753 216678 Fax: +44 (0) 1753 511116 E-mail: [email protected]
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Figure 1: Number of innovative new drugs launched globally (1992–2002) Source: CMR International1,3
& HENRY STEWART PUBLICATIONS 1478-565X. J O U R N A L O F C O M M E R C I A L B I O T E C H N O L O G Y . VOL 10. NO 2. 154–161. DECEMBER 2003
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Current and future prospects for the global biotechnology industry
Many in the industry have looked to biotechnology to provide continuing innovation in R&D
Worldwide, there are now more than 350 biotech drug products and vaccines in clinical trials
major companies involved lack new ideas and methodologies.2 Critics within the general public believe that the industry is producing too many new drugs that are similar to each other and that offer little clinical advantage over those already on the global market. As a result, many in the industry have looked to biotechnology to provide continuing innovation in R&D, which will lead to a new generation of medical treatments. Although the major pharmaceutical companies are involved in biotechnology research, most public attention has been focused on small biotechnology companies that have spe
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