By Kate Hammeke, research manager, Nice Insight
Heightened interest in developing cancer treatments, combined with R&D efforts during the past decade, contribute to the type of positive news that was aired at the American Society of Clinical Oncology’s annual meeting in June, where the emergence of a class of “smart bomb” therapies was reported as one of the most hopeful developments in the field. These drugs use antibodies, which bond to specific cancer cells to deliver a very toxic ingredient directly to the cancerous cell while leaving healthy tissue alone. The second major development reported to have demonstrated some success uses the body’s own immune system to fight cancer — an idea that has been around for a century. But training the immune system to recognize cancer cells as an “enemy” and attack them had previously met with limited success. These potential new types of therapies, combined with progress in diagnostic tests that will help to more accurately predict which medicines will work for which patients, are important tools in reducing cancer deaths — and consequently carry huge potential for developers that can bring them to market. What does this momentum mean for the outsourcing market?
Between January and the end of April 2012, the FDA approved 6 oncology drugs — a faster pace than 2011, when 12 oncology medicines were approved, comprising 1/3 of new drug approvals for the year. The large number of oncology therapies being investigated and developed should come as no surprise, considering cancer is a leading cause of death in the United States, second only to cardiovascular diseases. The vast market for cancer treatments has promoted this disease to a major therapeutic area of focus in the drug development pipelines of 1/3 of all pharmaceutical and biotechnology businesses.
FILLING PIPELINES WITH ONCOLOGY TREATMENTS
Looking at the different sponsor segments, Nice Insight research data show that 45% of Big Pharma companies have oncology drugs in their development pipeline, consistent with the 46% who indicated so in the Q1 survey. Biotech sponsors follow Big Pharma, where 40% include oncology medicines in their drug development pipeline — an 8% increase from 32% in Q1. Specialty pharma showed a slight drop from 29% to 26%, as did emerging biotech, down from 31% to 29%. However, emerging pharma sponsors demonstrated an increased interest in oncology as a therapeutic area of focus, rising 5% between Q1 and Q2 to 18%.
The results from the Nice Insight pharmaceutical and biotechnology outsourcing survey show that sponsors typically have two to three different therapeutic areas of focus in their drug development pipelines (2.2 in Q1 and 2.31 in Q2). Among the businesses whose pipeline includes oncology medicines, 82% are engaged in the development of biologics-based therapeutics. These respondents are heavy outsourcers, averaging 6.9 different services in 2012, as compared to the overall average of 5.3 different services outsourced this year.
This heavy outsourcing is accompanied by substantial outsourcing expenditure. Forty-one percent of businesses whose therapeutic area of focus includes oncology diseases indicated they will spend more than $50M this year, compared to 26% of the overall respondent group. Thirty-six percent will spend between $10M and $50M, versus 41% of the overall, and 22% had an outsourcing expenditure under $10M, significantly lower than the overall at 33%.
As such, sponsors with a therapeutic focus in oncology have considerable influence over the market size of the services they outsource. Looking at spending across each service included in the quarterly survey, data showed that for 12 of the 25 services, projects related to oncology therapeutics accounted for the greatest percentage of the service’s market size. The next tier of expenditure can be attributed to services outsourced for the development of cardiovascular therapeutics.
Despite extensive focus, the American Society of Clinical Oncology states that the cancer community is still experiencing severe and worsening shortages of many critical therapies for a myriad of reasons. So demand and advocacy appear set to continue to promote opportunities and interest in the development of new therapies to counter the scourge of cancer.