The story of the pharmaceutical industry in the 21st century can be told in two graphs: one showing the number of yearly approvals by the U.S. Food & Drug Administration (FDA), which has fluctuated between 17 and 45, the other showing the explosion in the number of clinical trials in each successive year, from 5,633 in 2000 to 207,088 in 2015.1
The growth in clinical trials has been driven by multiple trends in the industry and market, which are all driven ultimately by a growing, richer and longer-living world population vulnerable to chronic diseases that need improved treatments.
Market analysts diverge markedly on the size of the global clinical trials market. Mordor Intelligence and Market Data Forecast put the market at $14.2 billion and $14.7 billion, respectively, in 2016, reaching $22 billion and $21.4 billion in 2021; Research & Markets has it at $38.4 billion in 2015 and $64 billion in 2020. All three foresee strong compound annual growth rates of 7.5%, 7.7% and 9.0%, respectively.1,2,3
The U.S. is still overwhelmingly the prime location for clinical trials. As of January 2017, according to ClinicalTrials.gov, over 235,000 trials were taking place worldwide. North America accounted for 109,420 (46.5%), of which the U.S. was 98,840 (42.0%). Other prominent regions, predictably, were Europe (66,416, 28.2%) and East Asia (23,822, 10.1%), not including Japan.4
Clinical trials have become more complex and difficult to manage, as well as more numerous. Drug developers, who are already under pressure to develop better drugs and keep costs down, have turned to CROs.
This response has led to the growth of outsourcing, particularly the new model of ‘virtually integrated drug development’ with preferred service providers. Over 70% of all clinical trial services could be outsourced by 2020.3
That said, the direction of travel is clear. Outsourcing is growing at 4%-6% per year, even in conservative analysis. Changing priorities mean that CROs will expand their services starting from the early phases in order to remain competitive in the later ones.5 According to the 2017 Nice Insight Preclinical and Clinical Contract Research Survey, the top reason for partnering with a CRO is access to specialized technology, which even beats out quality. Indeed, CROs are implored to innovate.
As well as the sheer amount of clinical research and innovation in drug development — directly correlated to biologics — the market is being driven by technology changes, and vice-versa.
One key trend that many observers note is the use of wearable monitors, sensors and other medical and diagnostic devices. As well as standard consumer devices, clinical- and research-grade wearables and sensors are gaining FDA clearance. This, thanks to advances like electronic data capture (EDC) and ever-expanding Wi-Fi connectivity, has made patients themselves sources of massive volumes of data.
Wearables enable companies conducting trials to capture a mass of data that was inaccessible or difficult to measure objectively before, for instance on exactly how much pain a patient was suffering. Now devices make it possible to measure by multiple indicators and to collect and analyze the data in real-time.6
Similarly, eConsent — an automated means to engage patients and secure informed consent — and remote monitoring make it possible to control costs and adapt to new ways of communicating, although some human interaction will
remain necessary.7
Such technology developments are both cause and effect of patient-centricity in clinical trials. The FDA has its own Patient-Focused Drug Development Program that, during the 2016-17 financial year, held meetings on nine areas of therapy.8
Patient-centricity, in turn, feeds back into how data is used. Pfizer, for instance, has recently launched its Blue Button pilot, an initiative to enable patients from clinical trials to download their individual data. This came in response to calls for openness about data in general, but is also seen as an opportunity for the pharma industry.
“We’re helping to develop the model of the patient as an aggregator of his or her own data,” said Craig Lipset, Head of Clinical Innovation at Pfizer. “We are interested in understanding how patients might use those data. For instance, how they can use the data from their participation in a research study to help improve their overall health and wellness, to share those data with other providers on their care team, or to use [the data] to enable other types of decision support.”9
Feeding data back is also seen as a way of building trust. Patients who have access to — and control over — their health data are more willing to share it to support research. This also ties in with the need to improve compliance in clinical trials when using marketed drugs, even if only by improving the user experience and making them more ready to do as directed.
Traditionally, the clinical trials sector has not been innovation-driven but has responded to its clients’ needs and timelines. It has also tended to operate in silos, with clinical research, lab research, data management and other key elements managed largely in separation from each other. Ongoing technology development will change that; companies will need to adapt their models accordingly in order to survive.10
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