With some estimates showing that contract research organizations will run three-quarters of clinical trials within the next couple of years, a new survey shows what the pharmaceutical and biotechnology companies hiring them are looking for.
Morrisville, North Carolina-based CRO Worldwide Clinical Trials released results of its third annual survey of pharmaceutical and biotech executives from 169 companies, in charge of clinical operations, outsourcing, regulatory affairs and drug safety, who provided more than 350 responses.
CROs are firms to which life sciences companies outsource clinical trial operations, including site selection and data management, sometimes even hiring them to run an entire clinical trial. There are also preclinical CROs that specialize in operations like animal studies. The Worldwide survey cited a 2015 article in PharmaVoice indicating that 75 percent of all clinical trials will be run by CROs.
The survey found a growing urgency for CRO expertise in early-phase clinical research, meaning first-in-human studies through proof of concept.
The percentage of respondents saying they were likely or very likely to engage CROs in early-stage development saw the most growth, from 55 percent in 2016 to 63 percent last year, likely reflecting the growing volume of early-stage compounds and drugmakers’ limited resources and operational expertise. Meanwhile, overall demand for CROs also grew, with 68 percent of respondents said they were much more likely to hire a vendor than they were five years ago, and compared with the 65 percent who said so in 2016. The report attributed the overall growth to the value the firms create by allowing drugmakers to focus on development rather than clinical trial operations.
The percentage of respondents for whom data quality was the most important CRO evaluation criterion fell slightly, from 96 percent in 2016 to 92 percent in 2017. Thirty-six percent ranked overall trial management as the area that can make the greatest impact for a sponsor-CRO relationship, and 74 percent said costs are significant or very significant to new drug development.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A report in April by market research firm Grand View Research stated that the global healthcare CRO market is expected to reach $51.3 billion by 2024, driven by the increasing cost of drug development, which itself is driven by pressure on sponsors due to patent expiration and generics. In addition, increasing incidence of diseases like cancers, Alzheimer’s and others has driven government funding, thereby driving increased research and development activities, and even government organizations are outsourcing some activities to CROs. North America accounted for 40 percent of the global market, with Europe coming in second and Asia Pacific seeing rapid growth.
Major players in the industry listed in the report include Quintiles, Covance, PPD, Parexel, Charles River Laboratories, ICON, inVentiv Health, Medidata Solutions and Theorem Clinical Research. Quintiles merged with IMS Health in October 2016, and the combined company is now known as IQVIA. inVentiv Health and INC Research merged in January, and the company is now called Syneos Health.
Another report by the same company, published in November 2017, found that the preclinical CRO market would reach $6.6 billion by 2025.
Photo: Martin Barraud, Getty Images
