Patent applications for biologics by leading pharmaceutical companies are surging further ahead of applications for small-molecule drugs, according to a new report.
Another report notes that the next few years will offer major opportunities for pharma companies to develop biosimilars.
Both of these findings reflect the increasing importance of biotechnology in drug development.
Research by patent law specialist Withers & Rogers shows that while the number of patent applications for biologics has exceeded that for small-molecule drugs for 15 years, the gap has widened rapidly since 2007.
The legal firm’s analysis of the top 10 global pharma companies reveals that the gap between the numbers of patents filed for biologics and for small molecules grew by 14.5% between 2007 and 2009.
By 2009, 60% of the drug patents filed by these companies were for biologics.
Novartis made the greatest number of patent applications for biologics in 2009, followed by Johnson & Johnson and Merck & Co.
Nicholas Jones, patent attorney at Withers & Rogers, said that despite the impact of “economic uncertainty and cost pressures facing big pharma as blockbuster drugs hit the patent cliff, R&D interest in biologics has remained strong.”
He noted although “it is considerably easier to develop and manufacture small-molecule drugs”, major drug companies may be “increasingly willing to compete with major generics producers for a share of the follow-on biologics market”.
Growth partnership company Frost & Sullivan (F&S) reached the same conclusion in a report on the growing opportunity for biosimilars in the European drug market, where numerous blockbuster biologics are nearing the patent cliff.
However, the report noted, the cost of developing and manufacturing biosimilars makes them financially a more high-risk option than conventional generics.
Srinivas Sashidhar, Research Analyst at F&S, said: “$100 billion worth biologics are expected to go off patent by 2020, as a result of which the market is likely to hold significant potential.”
Before this potential can be exploited, he commented, “Improvements concerning the manufacturing and the clinical development processes of biosimilars have to take place.”
The report predicted the European biosimilars market will grow from $172m in 2010 to $3,987 in 2017, at a CAGR of 56.7%.
To overcome the challenges in the way of access to the growing biosimilars market, Sashidhar said, “Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market.”
F&S expects the growing biosimilars market to drive growth in such therapy areas as diabetes and oncology, where biologics are having the greatest impact.