India Generics Companies Lead Pharmaceutical Innovation In Asia Pacific, According To Thomson Reuters
Thomson Reuters Asia Pacific R&D Factbook details significant increases in innovation investment and development of novel drug pipelines
Singapore — Multi-national pharmaceutical companies are likely to face increased competition for new molecular entities from India-based generics companies, according to the 2011 CMR International Asia Pacific R&D Pharmaceutical Factbook released today by CMR International, a Thomson Reuters business.
According to the research contained in the Factbook, India’s generic drug companies are making significant investments in innovative R&D and have 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.
Phil Miller, product director at Thomson Reuters, said: “Between 2006 and 2010, the majority of the innovative drug pipeline developed by India-based generic companies was in the pre-clinical stage but over time, we expect these candidates to transition to latter stages of the R&D pipeline as a normal evolution of pipeline development. We believe this developing pipeline will be both a source of new competition for the established multi-national pharmaceutical companies, as well as an opportunity for them to invest in, or collaborate with, emerging players.”
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.
“If a generic company is the first to file its Abbreviated New Drug Application1 (ANDA) with a Paragraph IV certification and prevails in the subsequent lawsuit, it would be granted a period of market exclusivity of 180 days,” said Miller. “This exclusivity can be a significant advantage for a generic company as it would have the only generic version available in the market.”
According to the Factbook, 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, including:
- By stage of regulatory filing, in 2008, Japan was more than two years behind the first ever submission. This means that new medicines are not being filed in Japan until more than two years after they were filed in the first market (typically the regulated markets such as the U.S. or EU).
- Between 60 percent and 90 percent of companies perceive Chinese regulatory requirements to be higher than “normal”.
- Singapore has the highest occurrence of low performing clinical trial sites in the region.
The information published in the Factbook is based on primary sources covering major pharmaceutical companies which account for approximately 80 percent of the industry’s global R&D expenditure.
CMR International, a Thomson Reuters business, is the world leader in global pharmaceutical R&D performance measurement. For almost 15 years, CMR International has worked with the leading global pharmaceutical companies to assess R&D productivity and provide insights into industry trends in order to strengthen planning and effectiveness of R&D. Since 2003, CMR International has published the pharmaceutical R&D Factbook, an annual report for the pharmaceutical R&D sector providing a reliable source of key reference metrics. For further information, please go to: http://cmr.thomsonreuters.com/services/factbook.
1An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
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