Pharmaceuticals, biologics and biopharmaceuticals - Pharmaceutical Biotechnology: Concepts and Aapplications - page 10

1.5 Biopharmaceuticals: current status and future prospects

Approximately one in every four new drugs now coming on the market is a biopharmaceuti-
cal. By mid 2006, some 160 biopharmaceutical products had gained marketing approval in the
USA and/or EU. Collectively, these represent a global biopharmaceutical market in the region of
US$35 billion (Table 1.5), and the market value is estimated to surpass US$50 billion by 2010.
The products include a range of hormones, blood factors and thrombolytic agents, as well as vac-
cines and monoclonal antibodies (Table 1.6). All but two are protein-based therapeutic agents.
The exceptions are two nucleic-acid-based products: 'Vitravene', an antisense oligonucleotide, and
'Macugen', an aptamer (Chapter 14). Many additional nucleic-acid-based products for use in gene
therapy or antisense technology are in clinical trials, although the range of technical diffi culties
that still beset this class of therapeutics will ensure that protein-based products will overwhelm-
ingly predominate for the foreseeable future (Chapter 14).
Many of the initial biopharmaceuticals approved were simple replacement proteins (e.g. blood
factors and human insulin). The ability to alter the amino acid sequence of a protein logically
coupled to an increased understanding of the relationship between protein structure and function
(Chapters 2 and 3) has facilitated the more recent introduction of several engineered therapeutic
proteins (Table 1.3). Thus far, the vast majority of approved recombinant proteins have been pro-
duced in the bacterium E. coli , the yeast S. cerevisiae or in animal cell lines (most notably Chinese
hamster ovary (CHO) cells or baby hamster kidney (BHK) cells. These production systems are
discussed in Chapter 5.
Although most biopharmaceuticals approved to date are intended for human use, a number of
products destined for veterinary application have also come on the market. One early such exam-
ple is that of recombinant bovine GH (Somatotrophin), which was approved in the USA in the
early 1990s and used to increase milk yields from dairy cattle. Additional examples of approved
veterinary biopharmaceuticals include a range of recombinant vaccines and an interferon-based
product (Table 1.7).

Table 1.5 Approximate annual market values of some leading approved biopharmaceutical products. Data
gathered from various sources, including company home pages, annual reports and industry reports

Product (Company) Product description (use) Annual sales value (US$, billions)

Procrit (Amgen/Johnson &
Johnson)

EPO (treatment of anaemia) 4.0

Epogen & Aranesp combined
(Amgen)

EPO (treatment of anaemia) 4.0

Intron A (Schering Plough) IFN- α (treatment of leukaemia) 0.3

Remicade (Johnson & Johnson) Monoclonal antibody based

(treatment of Crohn's disease)

1.7

Avonex (Biogen) Interferon-β (IFN-β; treatment of

multiple sclerosis)

1.2

Embrel (Wyeth) Monoclonal antibody based

(treatment of rheumatoid
arthritis)

1.3

Rituxan (Genentech) Monoclonal antibody based (non-

Hodgkin's lymphoma)

1.5

Humulin (Eli Lilly) Insulin (diabetes) 1.0