Moving to the Next Level in Biomanufacturing - Pharmaceutical Technology

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Moving to the Next Level in Biomanufacturing
Growth in the market for monoclonal antibodies, recombinant proteins, and vaccines creates new opportunities for drug companies and suppliers.


Pharmaceutical Technology
Volume 34, Issue 4, pp. 64-70


Patricia Van Arnum
Biologics are playing a more prominent role in drug development. Although biologic-based drugs account for only roughly 10% of commercial drugs, they are an increasingly important strategic part of drug companies' pipelines, thereby creating opportunities for developing improved production methods.

Crunching the numbers

Biopharmaceuticals accounted for approximately 10% of the global prescription drug market based on a 2007 global prescription drug market of $712 billion, according to data from IMS Health. The research firm PharmaVision offers comparable data, which showed that in 2009, biotherapeutics represented 7.5% of all drugs on the market and accounted for approximately 10% of the total expenditures for marketed drugs. The firm projects that the biologics market is growing at an annual rate of approximately 15%, and that biologics constitute more than 30% of all pipeline research programs (1).


IMAGE: DON BISHOP, BRAND X PICTURES, GETTY IMAGES
The importance of biologics in the drug portfolios of Big Pharma is intensifying as well. The compound annual growth rate of prescription drug sales from Big Pharma is expected to be only 1.8% through 2013, increasing from $366.6 billion in 2007 to a projected $407 billion in 2013, according to an analysis in 2009 by the research firm Life Science Analytics. Biologics are expected to account for 20% of Big Pharma's prescription drug sales by 2013. At the same time, sales from its core products, largely small molecules, are expected to fall by nearly 50% to $47 billion by 2013 (2).

The market research firm Evaluate Pharma projects that biologics will account for 50% of the top 100 drugs in 2014, compared with 28% in 2008, and 11% in 2000. Only one biologic, epoetin alfa, marketed as Epogen by Amgen (Thousand Oaks, CA) and as Procrit by Johnson & Johnson (New Brunswick, NJ), was among the 10 top-selling drugs in the global market in 2000. In 2008, five biotech products made Evaluate Pharma's top 10 list: Avastin (bevacizumab), Enbrel (etanercept), Epogen/Procrit, Remicade (infliximab), and Rituxan (rituximab). The firm projects that by 2014 the six top-selling products will be biologics: Avastin, Enbrel, Humira (adalimumab), Rituxan, Lantus (insulin glargine), and Herceptin (trastuzumab). Remicade is projected to occupy the ninth spot, meaning that 7 out of the 10 top-selling drugs will be biologics (3).

New biologics

The rise of biologics is further evident in recent drug approvals. In 2009, the US Food and Drug Administration's Center for Drug Evaluation and Research approved 19 new molecular entities and 6 new biologic license applications (BLAs). The BLAs approved in 2009 were: Simponi (golimumab) and Stelara (ustekinumab) from Centocor Ortho Biotech, a subsidiary of Johnson & Johnson (New Brunswick, NJ); Dysport (abobotulinumtoxinA) by Ispen Biopharma (Paris); Ilaris (canakinumab) by Novartis (Basel, Switzerland); Arzerra (ofatumumab) by GlaxoSmithKline (London); and Kalbitor (ecallantide) by Dyax (Cambridge, MA).

Four BLAs approved in 2009 were monoclonal antibodies (mAbs). Simponi is an mAb that targets and neutralizes excess tumor necrosis factor-alpha, a protein that when overproduced in the body, due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage, and tissue. Stelara is an mAb that selectively targets the cytokines interleukin-12 and interleukin-23, naturally occurring proteins that are believed to play a role in the development of psoriasis. Ilaris is an mAb that blocks action of the inflammatory protein interleukin-1 beta (IL-1 beta) and was approved to treat cryopyrin-associated periodic syndrome, a rare auto-inflammatory disease. Arzerra is an mAb that causes the body's immune response to fight against normal and cancerous B-cells by attaching to portions of a surface molecule called CD20. The other two BLAs approved in 2009 were Kalbitor, a plasma kallikrein inhibitor to treat acute attacks of hereditary angioedema, and Dysport, an acetylcholine release inhibitor and neuromuscular blocking agent to treat cervical dystonia.


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