In the last 5 years, big pharma has continued its move toward large molecules and biologics for drug development. Two recent studies from Withers & Rogers (a UK law firm specializing in IP) and KMR Group (a pharma consultancy) report on some of the trends among major pharmaceutical corporations during that time period.
Highlights of the W&R report include the fact that 60% of all patent filings from big pharma (top 10 companies) by 2009 covered biologics—a dramatic reshaping of a pharma IP landscape that was dominated by small molecules for as long as anyone can remember. Even though total patent filings from those companies dropped by over 30% between 2007 and 2009, biologics fillings increased by nearly 15% during the same period. Abbott is leading the way in terms of biologics IP, with large molecules accounting for 80% of its overall portfolio of recent patent filings.
The KMR report, released less than a month earlier, illustrated biologics’ higher success rates advancing to market in comparison to small molecules. The period of the KMR study was between 2006 and 2010, when 25% of large molecules in Phase II studies ultimately reached market—compared to only 10% of small molecules at the same stage. Furthermore, KMR reported that while only 2% of small molecules advance from preclinical to clinical studies, 12% of large molecules successfully clear that critical hurdle.
The differences could be due to the fact that big pharma has been focused on small molecules for decades, and the rate of innovation in that field—particularly discoveries with blockbuster potential—has slowed dramatically. What’s left in the pipeline is “all the low-hanging fruit…found in the last 10 to 15 years”, according to Scott Martin, a KMR consultant.
The differences—particularly in the clinic—may also be due to the generally more targeted nature of large molecule therapeutics toward disease areas where safety issues are less prevalent and it is easier to track therapeutic success (e.g., immunology, replacement therapies). But as more and more biologics enter the research pipeline, and new applications and indications are pursued, this may change drastically in the years to come.
For more thoughts on the subject: ThePharmaLetter… GenEngNews… PharmaField
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