Outsourcing accounted for around a third of the total spent on drug development by the pharmaceutical industry in 2005, according to a new report from Kalorama Information,
The Kalorama report – which covers the global contract drug development market and specifically preclinical and clinical testing – notes that the market was valued at $19 billion in 2005, and is expected to grow at an annual rate of 17% to reach $42 billion by 2010.
Anscomb said that preclinical and Phase I testing will grow at a rate of 15% between 2003 and 2008, while Phase IIIb/IV will advance at 16% a year, outpacing Phase II/III trials.
“As discovery technologies more quickly determine greater numbers of targets, increasing numbers of compounds are reaching the Phase I clinical trial phase of development. Phase I spending is also fueled by drug developers’ emphasis on eliminating drug candidates at an earlier stage before they enter the more expensive Phase II-III trials,” noted Anscomb.
She told PharmaTimes that Phase IIIb/IV studies will also enjoy brisk growth, resulting from the need to recruit larger numbers of patients because of “a myriad of scientific, regulatory, and commercial objectives.”
These include a move towards more long-term safety studies, driven by regulators stung by criticism of their performance in monitoring drug safety after a series of high-profile product withdrawals, as well as a shift towards and disease prevention studies by the pharmaceutical industry.
But a major bottleneck for developers continues to be delays in patient recruitment for clinical trials which can result in millions of dollars of lost sales, with estimates that each day a trial is delayed costs the sponsor $35,000 in protocol-related costs, while the overall cost has been estimated at $1.3 million a day by CenterWatch, an information source for the clinical trials industry.
According to CenterWatch data, 80% of total trials are delayed at least one month because of unfulfilled enrollment. In 2003, 22% of studies were completed with a one-month delay, while 72% of studies saw a delay of over one month.
Outsourcing has become a widely-used solution for shortening recruitment time and increasing patient retention, according to Anscomb.
Each company involved in the clinical trial industry has developed strategies to reduce drug development costs, improve time to market, and use human resources more efficiently.
For example, one way Quintiles Transnational has gone about patient recruiting has been to develop a solution based on informatics. As a result of its relationships with hospitals and pharmacies, Quintiles has been able to mine prescription and claims data to facilitate the process of pinpointing an investigative site and patients to participate in the trial.
Meanwhile, Kendle International’s approach is based on accurate investigator/patient databases that the company has compiled over years of diligent recording keeping. Kendle has compiled databases of physicians who have good access to patients, have been proficient in recruiting certain kinds of patients with certain kinds of illnesses, has the necessary infrastructure to conduct clinical trials, and the commitment to ensure that patients complete the trial.
“Outsourcing will only continue to expand as pharma and biotech companies come to rely on these services to cover gaps in their own capacity, increase their skills base, and bring drugs to market more efficiently,” according to Anscomb.
More information about the report, entitled Outsourcing in Drug Development (2nd edition) is available here.