Drug repurposing or re-profiling has been the hallmark to bring strong business growth and the trend is being followed by majority of the pharmaceutical and biopharmaceutical companies. Among all biologics approved in the U.S. during 2007–2009, 30–40% of them were the drugs repurposed or repositioned. National Institute of Health (NIH), U.S. Department of Health defines drug repurposing as discovering new uses for approved drugs to provide the quickest possible transition from bench to bedside. Drug repurposing opens up various opportunities to answer current unmet medical needs to come up with cost-effective solutions to expensive drug development process.
Repurposing or re-profiling of drugs which are suspended due to lack of efficacy or specificity can be a good start over for further development for new indication. Finding new indications for already studied drugs can benefit patients by getting quick access to new treatment choices and also to developer by saving time and money while maintaining its original IP protection. For many expensive indications such as cancer, scrutinizing for anti-cancer activity among dozens of off-patent drugs that have already established their safety is a powerful method opted by majority of the big pharma companies. However, repurposing is not a new strategy and there are bunch of drugs which are repositioned or repurposed, some of them are Raloxifene (approved for treatment of osteoporosis in 2007, originally indicated for breast cancer treatment), Thalidomide (repositioned for use in treatment of leprosy and multiple myeloma in 2006), Rapamycin (repurposed in 1999 for prevention of organ transplant rejection), Sildenafil (originally approved for erectile dysfunction and recently got approved for treatment of angina) and many others.
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Requirement of low investment of time and money in the drug development is the prime advantage of drug repurposing and majority of the drugs in pipeline of major pharmaceutical companies are thus adopt this method. Some of the factors accelerating the drug repurposing activities include sunk research cost, ready availably of bioavailability, pharmacology, toxicity profile & pharmacokinetics data, well established manufacturing protocol etc.; which are expected to drive the global drug repurposing market. There are thousands of failed molecules shelved into the drug libraries, which hold vast potential to reposition. Whereas, limited access chemical structure data of drug molecules, lack of funding etc. are some of the factors limiting the growth of global drug repurposing market.
Patent-cliff and drug attrition rate are the major challenge for pharmaceutical and healthcare industry, putting huge pressure on pipeline. Today’s industry also faces considerable competition from generic versions of off-patent drugs. Repurposing thus gives a major hope for the pipeline growth and future of healthcare industry. This also provides legacy of out-licensing clinical candidates that have been proven save but could not met the end point.
The global market for drug repurposing is segmented on basis of disease indication and geography:
Oncology holds the highest growth potential in the global drug repurposing market as there is significant unmet need for cancer treatment and divergent nature of a disease. On the basis of regional presence, global drug repurposing market is segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America is expected to lead the global market due to strong funding sources for drug repurposing such as NIH’s National Center for Advancing Translational Sciences.
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Companies operating in pharmaceutical market are exploiting drug repurposing strategy to protect the market exclusivity of their blockbuster molecules. Several big pharmaceutical companies like Sanofi are forming venture with medium to small scale companies for use of their repurposing platform to find alternative use for clinical-stage molecules.
Some of the other players operating in global drug repurposing market are:
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