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Tuesday, March 13, 2012 1:08:39 AM
Consultant Pharmaceutical Biotechnology R&D & Advisor
Geneva, Switzerland & New York, USA
Global Market Analysis & Blockbuster mabs
"Despite economic downturn, the growth in the mAbs showed no sign of slowing down. The global monoclonal antibody market (mAbs) for therapeutic use was $48 billion as compared to $ 40 billion in 2009 and $ 37 billion in 2008. The combined sales of top 10 mab were 45 billion dollar. If $10 billion sales of mAbs for diagnosis and as reagents in research are included, then the total mAbs market was worth $ 55 billion. As in previous years, Remicade was the top selling mAbs brand followed by Avastin, Rituxan, Humira and Herceptin. The top 4 mabs had sales gain of over 1 billion last year over the sales of 2009. Cancer and Arthritis mAbs accounted for over 75% of the total mAbs market. The top 5 brands had sales of over $ 5 billion each. Introduction of newer monoclonal antibodies and uses in chronic conditions like Asthma, Osteoporosis will greatly expand the market. All the pharma majors now have mAbs projects in their R&D portfolio. Once again M&A and mAbs deals in R&D and marketing increased in 2010. Two new mab, Actemra and Prolia were approved by the FDA and EMA each in 2010. FDA had approved 4 new mAbs and EMA had approved 7 new mAbs in 2009, a new record. Sales of new mabs Actemra, Simponi, Cimzia, Stelara totaled 1 billion dollars in 2010. Belimumab the first mab to pass Phase III end points in Lupus was recommended for approval by the FDA expert panel. Ipilimumab, a new magical cure for metastatic melanoma waiting for the FDA approval in 1Q2011. The FDA ODAC recommended withdrawal of Avastin indication for use in breast cancer. Motavizumab a new mab for RSV infections in premature babies was rejected by the FDA. The mAbs driven M&A activity continued in 2010 with the mab tie up of Regeneron with Sanofi Aventis and the hostile takeover by Abbott of Facit for $450 million. There were at least 6 new mAbs under regulatory review, 25 mAbs and 5 mab fusion proteins (32 in 2008, 26 in 2009) in phase III and over 100 in Phase II clinical trials. Out of 457 Phase III mab trials, 185 were active and open for new patients. Majority of these studies were new indications for marketed mab brands. This is the first and earliest report providing 2010 monoclonal antibody market, sales and ranking and beat out the commercial reports by several months."
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