TABLE 2-3 Biotechnology Drugs Currently in Development

 

1989

1990

1991

1993

Approved medicines

9

11

14

19

Medicines or vaccines in development

 

 

 

 

Phase I

26

38

48

41

Phase I/II

12

13

16

22

Phase II

23

32

46

53

Phase II/III

8

6

7

6

Phase III

11

15

18

33

Phase not specified

5

3

2

4

Application at FDA for review

10

19

21

11

TOTAL medicines or vaccines in development

95

126

158

170

NOTE: Total medicines or vaccines in development reflects medicines in development for more than one indication.

SOURCE: PMA, Biotechnology Medicines in Development, 1993.

Research and Development Investments by the Medical Devices Industry

In contrast to pharmaceuticals and biotechnology, medical devices encompass a more diverse group of products, ranging from disposable needles to sophisticated and expensive modalities such as magnetic resonance imaging (MRI). At present, the Food and Drug Administration (FDA) identifies about 1,700 different types of medical devices, which are developed and manufactured by as many as 11,000 device companies (including foreign companies; Gelijns et al., forthcoming). According to the U.S. Department of Commerce, surgical and medical instruments, surgical appliances and supplies, electromedical equipment, and X-ray equipment were projected to be among the fastest growing sectors of U.S. industry in 1993 (U.S. Department of Commerce, 1993).

In 1993, the medical device industry invested less than 7 percent of sales in R&D, compared to 17 percent in pharmaceuticals (Business Week, 1994). Large variations in R&D spending exist among device categories, however, reflecting the complexity of the type of product involved—developing MRI, of course, is considerably more complicated than developing a new set of surgical instruments. R&D spending also varies depending on company size, mirroring the division of labor between large pharmaceutical companies and biotechnology companies. According to an analysis by the Health Care Technology Institute, device companies with less than $5 million in sales spent 77.5 percent of their sales in 1991 on R&D, or almost the identical figure for biotechnology (although the absolute level of spending is almost certainly less). This spending for R&D compares to 17.2 percent for companies with between $5 and $20 million in



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement