Tufts Study Says Biotech Advances Have Boosted R&D Success Rates

03/08/2005

Advances in biotechnology R&D, which are driving new product development and improving success rates, will result in nearly 50 new biotech medicines receiving market approval from the U.S. Food and Drug Administration (FDA), according to a study released today by the Tufts Center for the Study of Drug Development.

Based on its analysis of approval success rates for new biopharmaceuticals, the Tufts Center estimates that of approximately 250 protein-based therapeutic products currently in development worldwide, 33 recombinant protein (rDNA) and 16 monoclonal antibody (mAb) therapeutics are likely to receive market approval from the FDA.

"Biotechnology advances made during the late 1980s and the 1990s allowed researchers to design novel products, which have led to an expansion in the number and variety of recombinant products in clinical study and an increase in success rates," noted Tufts Center Director Kenneth I. Kaitin. "Development of mAb therapeutics, particularly those based on human genes, has also progressed significantly, with much higher success rates than murine, or mouse-based, products."

He said the bulk of new biotech product development will focus on treating oncologic, immunological, and cardiovascular/hemostasic diseases.

The Tufts Center's analysis, summarized in its March/April Tufts CSDD Impact Report, also found that:

• rDNA therapeutics entering clinical study during 1990-97 had success rates of 35%, a 35% increase over success rates for those entering study during 1980-89.
  
  
• Immunological chimeric mAbs and humanized mAbs for oncology indications had success rates greater than 30%.
  
  
• Safety, efficacy, and commercial issues are the primary reasons for termination of protein therapeutics during the clinical phase of development.
  
  
• Maintaining or improving future success rates of new biotech products will depend on novel molecular engineering, intellectual property protection, and efficient manufacturing.

To access the complete study, click here.