For large companies with significant manufacturing capacity such as Amgen or Genentech, access to biomanufacturing capacity is less critical than for small and medium size companies which rely on CMOs to reduce the financial risk
Paris, France (PRWEB) September 15, 2008
Biologics are products derived from living organisms or their products. The manufacturing of such biologics involves the culture or manufacturing of living organisms and is named biomanufacturing. According to CBDM.T, biologic drugs (including vaccines), corresponding to less than 12% of global sales in 2001, are expected to contribute 30% of the global drug sales in 2012. Growing pharmaceutical market categories such as vaccines, HIV, neurodegeneration, anti-inflammation, cancer and diabetes reflect continued penetration of biologics. By being derived from living organisms, biologics are complex molecules that are difficult to manufacture. Compared to small molecules, this is a tremendous "advantage" making the development of generic version extremely difficult.
Manufacturing of biologics or biomanufacturing is a multi-step process with a current 60:40 split between mammalian cell culture and microbial fermentation. Today about 60% of all recombinant protein pharmaceuticals are produced in mammalian cells (Avastin, Advate, Erbitux, Rebif, Herceptin, Advate, Fabrazyme…) and 40% are produced in microbial cells (E.coli: Infergen, Ontak, Enbrel and yeast: Novolog, Twinrix Pediarix…). Microbial fermentation is used when smaller and less complex molecules with no post-translational modifications are required (peptides, small proteins, enzymes and antibody fragment). Mammalian cell culture is definitely dominating the manufacturing of complex proteins (glycosylated) and monoclonal antibodies. Transgenics, plant systems or microalgae are still at development stage and could be in the long term not really alternatives but more complimentary production systems (safety, productivity, cost and efficiency).
The first biologic product was recombinant human insulin, which was approved by the FDA back in 1982. Today, human insulin from Novo Nordisk is still the 9th in the top 10 biotech drugs sold in the US. The top 5 leading biotech drugs sold in the USA are Enbrel (Amgen, Wyeth), Aranesp (Amgen), Rituxan (Biogen Idec, Genentech, Roche), Remicade (Johnson & Johnson, Schering-Plough) and Procrit (Johnson and Johnson).
According to CBDMT®, contract biomanufacturing is a significant market estimated at €2.3 billion this year with an annual growth of about 10 to 15%. Pharmaceutical biomanufacturing could account for more than 20% of the global contract manufacturing market in 2012. If we analyze the segregation of production capacity between CMOs (Contract Manufacturing Organisations) and product development companies, the "build versus buy" decision is still significantly to the advantage of in-house manufacturing. For both mammalian cell culture and microbial fermentation capacities, product development companies currently control 70 to 80% of the industry capacity. But we know that the outsourcing of biomanufacturing will increase in the next five years. "For large companies with significant manufacturing capacity such as Amgen or Genentech, access to biomanufacturing capacity is less critical than for small and medium size companies which rely on CMOs to reduce the financial risk" comments Philippe Tramoy, managing partner.
Key players: Amgen, Wyeth, GSK, Genentech, Novo Nordisk, Intermune, Ligand, Baxter, Genzyme, Biogen, DSM, Diosynth, Lonza Biologics, Merck Serono, Boehringer Ingelheim, Celltrion, Cora Biomanufacturing, Xcellerex, Avecia, Mera Pharmaceuticals, GTC Biotherapeutics, Pharming, Eden Biodesign, Genopole Biomanufacturing Center, Algenics…
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