Medical imaging plays a prominent role in clinical trials as it can help in providing answers to the critical challenges that occur in drug development process. It takes about 15 years for a drug to move from a laboratory set-up to FDA approval.
The chances of a compound getting regulatory approval are minimal as out of 6 to 11,000 compounds that are evaluated in the pre-clinical stage, only 5 are able to make it to the clinical trials and only one of them gets regulatory approval. Medical imaging can help play a crucial role in the product development process as it can reduce the late-stage attrition by gathering more information in the pre-clinical trials of safety, efficacy, and mechanism of action.
Medical imaging applications for pharmaceutical clinical trials include identifying disease predisposition, diagnosing and evaluating lesions and their severity, determining the responder patients, and monitoring therapy effects and their follow-ups. Nuclear imaging techniques such as positron emission tomography (PET) are used to observe drug pharmacokinetics and distribution along with studying the specific molecular endpoints.
For drug efficacy studies, use of imaging surrogate endpoints and imaging biomarkers can provide quick results with good statistical power as they help in facilitating small group sizes. In addition, imaging has a huge potential in drug safety assessment during clinical trials in the absence of suitable biomarker. With its widespread applications, medical imaging is witnessing a rapid growth in its use for clinical trials. In fact, medical imaging is used as an endpoint for about half of all clinical trials.
Factors that are driving the growth of the global clinical trial imaging market are increase in the biotechnology and pharmaceutical industries, rise in the number of contract manufacturing/contract research organizations, and an overall increase in research and development spending. Furthermore, the increasing prevalence of chronic diseases, portability and miniaturization of equipment, and rise in geriatric population are fueling the growth of the market. On the other hand, high cost of installation of these systems and enormous cost of clinical trials are projected to impede the growth of the market. However, the rise in demand for multimodal imaging systems and the growth potential offered by the emerging markets are projected to further boost the growth of the market during the forecast period.