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Promising Outlook for Biotech APIs
Biotechnology-based active pharmaceutical ingredients (APIs) account for a smaller portion of the global market for APIs compared with chemically synthesized APIs, but their growth prospects are much stronger. Double-digit growth is projected for the global market for biotech APIs, including APIs from innovator companies. And growth for biogeneric APIs or biosimilars is even more robust, particularly for Asia-Pacific markets.
Crunching the numbers
The global market for biotech APIs was $9.15 billion in 2007 and is expected to reach $16.07 billion by 2011, according to a recent analysis by the Chemical Pharmaceutical Generic Association (CPA, Milan, Italy) (1). These projections represent average annual growth for biotech APIs of 15.1%, nearly triple the projected average annual growth rate of 5–6% for chemically synthesized APIs.
Recombinant proteins account for the largest share of the global biotech API market at $6.18 billion, or 68% of the global market, followed by monoclonal antibodies at nearly $2.04 billion or 22% of the market, and vaccines at $935 million, or 10.2%, according to CPA (1). The leading recombinant proteins are erythropoietin, which accounts for $1.3 billion, or 14.2% of the global market for biotech APIs, recombinant human insulin at $900 million, or 9.8% of the market, and granulocyte colony-stimulating factors at $550 million, or 6% of the market.
Strong growth is projected for both therapeutic proteins and monoclonal antibodies, with projected average annual growth of 15.9% for therapeutic proteins and 14.6% for monoclonal antibodies (1). This double-digit growth is compatible with recent growth in the global market for biotech APIs, which had average annual growth of 18.8% through 1999–2007. Similar growth is projected through 2011 as the market is expected to increase at an average annual rate of 15.1% through 2011 and reach $16.07 billion, according to CPA (1).
Approximately 84% of the global market for biotechnology-based APIs is based in the developed economies in North America, Western Europe, and Japan. The United States accounts for $5.14 billion, or 56.2% of the global market, Western Europe $1.42 billion, or 15.5%, and Japan $780 million, or 8.5%. Among Western European countries, the United Kingdom is the largest producer of biotechnology-based APIs, accounting for roughly 35% of total biotech output in Western Europe.
Growth in these geographic markets will be robust through 2011. Average annual growth of biotech APIs from 2007 through 2011 is projected at 14.0% in North America, 10.6% in Western Europe, and 21.7% in Asia Pacific, which is led by growth of 33.2% in China and 30.1% in India, according to CPA (1).
Increased attention to post-translational modification (PTM), or the chemical modification of a protein, is an important trend in biotech-based API production, according to CPA. Typical PTMs may involve the following:
• Acylation, or the addition of an acyl group to the protein
• Pegylation, or the attachment of polyethylene glycol polymer chains to the protein
• Glycosylation, or the addition of polysaccharides to proteins. Glycosylation is the most prevalent PTM used, accounting for more than one-third of all approved biotech-based APIs (1).