Biopharmaceuticals Market

The value of therapeutic mAbs marketed in 2004 was above US 13 billion. At the same time, the market value for the many presentation forms of erythropoietin exceeded US 8 billion, and the global biopharmaceutical market surpassed US 50 billion. 

The biopharmaceutical global market grew from 2000 to 2004 at an annual rate of 19%, and was evaluated at US 48 billion in 2005. This represents a much higher growth rate than that experienced by the pharmaceutical industry as a whole. The forecast is that the biopharmaceutical market will reach US 100 billion by 2010 (Research and Markets, 2005a). 

At the time of writing, there is no simple pathway by which biogenerics can be approved in the United States. This is of escalating importance. The biopharmaceutical market had reached 56 billion by 2006 and is expected to reach 100 billion by 2010. ... 

Innovators will seek to shape the emerging foUow-on biopharmaceuticals market. The narrow product focus of a number of biopharmaceutical innovator companies that are strong in biopharmaceuticals puts a lot of value at stake in defense of single products. As a result, biopharmaceutical innovators will have to learn quickly from experience in small molecules and even nonhealthcare industries to muster a defense. Fortunately for iimovators, although less fortunately for foUow-on players, the probable lack of direct therapeutic inter-changeabihty for foUow-on biopharmaceuticals will create many more degrees of freedom for iimovator defense strategies than are typically seen in small molecules. 

It was demonstrated that glycoengineered proteins can be produced in the pilot scale [153] however, they have not reached the biopharmaceutical market to date. New strategies and perspectives oiP. pastoris glycoengineering have been reviewed recently [126]. 

The three main sources of competitive advantage in the manufacture of high value protein products are first to market, high product quaUty, and low cost (3). The first company to market a new protein biopharmaceutical, and the first to gain patent protection, enjoys a substantial advantage. The second company to enter the market may find itself enjoying only one-tenth of the sales. In the absence of patent protection, product differentiation becomes very important. Differentiation reflects a product that is purer, more active, or has a greater lot-to-lot consistency. 

As the twentieth century came to a close, the job market for computational chemists had recovered from the 1992-1994 debacle. In fact, demand for computational chemists leaped to new highs each year in the second half of the 1990s [135]. Most of the new jobs were in industry, and most of these industrial jobs were at pharmaceutical or biopharmaceutical companies. As we noted at the beginning of this chapter, in 1960 there were essentially no computational chemists in industry. But 40 years later, perhaps well over half of all computational chemists were working in pharmaceutical laboratories. The outlook for computational chemistry is therefore very much linked to the health of the pharmaceutical industry itself. Forces that adversely affect pharmaceutical companies will have a negative effect on the scientists who work there as well as at auxiliary companies such as software vendors that develop programs and databases for use in drug discovery and development. 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

Table 1.3 Selected engineered biopharmaceutical types/products that have now gained marketing approval. These and additional such products will be discussed in detail in subseguent chapters...

Table 1.4 Pharmaceutical companies who manufacture and/or market biopharmaceutical products approved for general medical use in the USA and EU...

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 example 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...

The expression of recombinant proteins in cells in which they do not naturally occur is termed heterologous protein production (Chapter 3). The first biopharmaceutical produced by genetic engineering to gain marketing approval (in 1982) was recombinant human insulin (tradename Humulin ), produced in E. coli. An example of a more recently approved biopharmaceutical that is produced in E. coli is that of Kepivance, a recombinant keratinocyte growth factor used to treat oral mucositis (Chapter 10). Many additional examples are provided in subsequent chapters. 

Table 5.2 Some biopharmaceuticals currently on the market which are produced by genetic engineering in either E. coli or animal cells...

In contrast to vitamin and mineral products, which are chemically well-defined, the biopharmaceutical quality and behavior of botanical dosage forms marketed as dietary supplements are often not well documented. In most cases,... 

---