CMR International, a Thomson Reuters business, has released the 2011 CMR International Asia Pacific R&D Pharmaceutical Factbook, according to which multinational pharmaceutical companies are likely to face increased competition for new molecular entities from India-based generics companies.
According to the research contained in the fact book, India's generic drug companies are making significant investments in innovative R&D. These companies have reportedly generated the largest new drug pipelines among generics companies worldwide in the years between 2006 and 2010.
India-based generics companies are now leading the rest of the world's generics companies in discovering and developing new biopharmaceutical entities that have not been previously available for therapeutic use in man. Although India is reported to have nearly 90 innovative products in the pipeline, almost half of them are already in the preclinical phase, the fact book says.
The Asia Pacific Factbook also reports that by continuing to shift their operating model towards participating in high risk, high-reward drug patent challenges (known as Paragraph IV challenges), India-based generic companies are adopting an increasingly aggressive approach to securing market share. The change in approach is highlighted by the 72 percent increase in the number of Paragraph IV patent challenges raised by Indian companies between 2009 and 2010.
According to the fact book, Asia Pacific continues to be a key area of focus for the global pharmaceutical industry. The region's large prospective patient population offers an attractive market for approved drugs and makes it highly suitable for patient recruitment and clinical development. In 2009, the Asia Pacific region contributed 10 percent of the total patients recruited globally – twice as much as in 2003. This is a considerable shift away from US-focused clinical development strategies.
Despite the increasing trend of Asia's involvement in global clinical trials, countries in the region still face significant challenges, the fact book points out.
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