Clinical trial imaging is a research study conducted with people who volunteer to take part. Clinical trials include the discovery, preclinical and clinical testing, regulatory filing, and life cycle management of a drug product. The clinical phase is subdivided into 3 phases phase I, phase II, and phase III, which form the basis of progressing a drug candidate through development towards regulatory submission. Before the start of clinical trials, a preclinical trial takes place in which the primary objective is to establish the safety profile of the drug candidate and establish the pharmacokinetic and pharmacodynamic properties of the compound. Phase 1 clinical trial is the first opportunity to evaluate the drug candidate’s clinical evaluation of safety and tolerability through dose range. In phase 1 clinical trials in which subjects typically have refractory advanced solid tumors, imaging is routinely applied to either acquire any evidence of anti-tumor activity via lesion shrinkage on CT or interrogate pharmacodynamics that may relate to the drug action. Once an acceptable safety profile has been established and the drug dose and schedule defined, a phase II trial can be planned. This trial aims to evaluate drug efficacy and safety within a targeted patient population. It established the first opportunity for a robust efficacy evaluation for an intended indication. In phase II clinical imaging is typically used and assessed using standard response criteria such as RECIST. Phase III trials aim to provide substantive evidence regarding the safety and efficacy of a drug within a large population for which drug administration is indicated. Most phase III trials in solid tumors utilize established RECIST criteria based on established and routine imaging methods.
Imaging is utilized on a day-to-day basis for evaluating disease response, the context in which imaging is used in clinical trials differs to some degree from how this is utilized in clinical trials. Functional imaging techniques such as PET/CT, CT perfusion imaging, DCE-MRI, DW-MRI, and MRS have been utilized to form drug effects in clinical trials and have also sometimes provided unique prognostic information.
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Global Clinical Trial Imaging Market – Competitive Landscape
On November 27, 2023, Aidoc Unveils USD30 million investment in a revolutionary foundation model for imaging AI at RSNA 2023. On November 27, 2023, Cleveland Clinic and Canon Inc. entered a partnership to advance global innovation medical imaging solutions. On October 10, 2023, Japanese firm Mitsui invested USD 8 million in US-based clinical intelligence startup Lokavant. On July 13, 2023, NVIDIA invested USD 50 million in AI-enabled drug discovery. On March 8, 2023, Lilly provided an update on the A4 study of Solanezumab for preclinical Alzheimer’s Disease. On December 23, 2022, CapVest’s GLO Healthcare completes the acquisition of Calyx, a global leader in the delivery of improved outcomes from clinical trials.
Some of the Key Players in the Global Clinical Trial Imaging Market Include –
- Icon PLC
- Wirb-Copernicus Group
- Ixico PLC
- Navitas Clinical Research, Inc
- Bio Telemetry Inc.
- Biomedical System Corporation
- Medpace
- WCG Clinical
Global Clinical Trial Imaging Market – Growth Drivers
The rising prevalence of chronic diseases, including cancer and cardiovascular disorders, drives the demand for clinical trials utilizing advanced imaging technologies. Imaging plays a crucial role in disease diagnosis, monitoring, and treatment evaluation. According to World Health Organization non-communicable diseases such as chronic disease kills USD 41 million people each year, equivalent to 74% of all death globally. Continuous innovation in imaging modalities such as MRI, CT Scan, and PET Scan contributes to the growth of the clinical trial imaging market. Enhanced precision, resolution, and speed of imaging techniques attract pharmaceutical companies and researchers. The growing emphasis on precision medicine, tailoring treatments based on individual characteristics, boosts the demand for imaging studies. Imaging biomarkers and personalized diagnostic approaches play a key role in developing targeted therapies. The globalization of clinical trials, with an increasing number conducted in diverse geographic regions, fuels the demand for standardized and advanced imaging services. This trend opens new opportunities for market expansion and collaboration with international stakeholders. The widespread involvement of contract research organizations in clinical trials leads to increased demand for imaging, driving efficiency and supporting pharmaceutical companies in their research endeavors.
Global Clinical Trial Imaging Market – Restraints
Adopting advanced imaging technologies in clinical trials involves substantial upfront costs for equipment, software, and staff training. This financial barrier poses a restraint, particularly for smaller pharmaceutical companies and research organizations with limited budgets. According to ASPE GOV highest clinical research burden across all phases is the respiratory system USD 115.3 million followed by pain and anesthesia USD 105.4 million and oncology USD 78.6 million. The complex and varied regulatory landscape for clinical trial imaging across different regions poses a challenge. Adhering to diverse regulatory standards requires meticulous planning and execution, potentially slowing down the initiation and progress of global clinical trials. The increasing reliance on digital imaging and the collection of sensitive patient data raise concerns about data security and privacy. Stricter regulations and the need for secure data management solutions add complexities and potential hurdles to the clinical trial imaging market. The lack of standardized imaging protocols across different therapeutic areas and regions hampers the comparability and consistency of imaging data. This elimination complicates multi-center trials and may affect the reliability of results. The operations and analysis of advanced imaging technologies require specialized skills. A shortage of skilled personnel in the field of clinical trial imaging poses a restraint, leading to potential delays and increased competition for qualified professionals.
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Global Clinical Trial Imaging Market – Opportunities
The integration of artificial intelligence and machine learning enhances the precision and efficiency of image analysis, contributing to more robust and reliable clinical trial results. The shift towards decentralized and remote clinical trials creates opportunities for imaging services. Remote patient monitoring and imaging data collection offer cost-effective and patient-centric alternatives, especially in post COVID-19 landscape. The growing importance of data analytics and integration in clinical trials presents opportunities for imaging market players. Efficient data management, analysis, and integration of imaging data with other trial endpoints contribute to more comprehensive and insightful outcomes.
Global Clinical Trial Imaging Market – Geographical Insight
The market for global clinical trial imaging is segmented into regions such as North America, Latin America, Europe, Asia-Pacific, the Middle East & Africa. Asia-Pacific is a rapidly growing market for clinical trial imaging due to a rapid increase in clinical trial activities, driven by factors such as a large and diverse patient population, lower operational costs, and supportive regulatory frameworks in countries like China and India. European countries collaborate through imaging networks, fostering knowledge exchange and standardization. This collaboration enhances the efficiency and reliability of clinical trial imaging data across borders. North America, particularly the United States, holds a leading position in global clinical research. The region’s well-established research infrastructure and regulatory framework make it a hub for clinical trials including those utilizing advanced imaging technologies.
Global Clinical Trial Imaging Market – Key Development
- On October 10, 2023, UTA created a USD 6.2 million clinical imaging research center.
- On October 5, 2023, Imperial partners in the UK launched the first total-body PET platform for drug discovery.
- On July 24, 2023, PathAI launched AIM-HER2 breast cancer, an artificial intelligence-powered HER2 scoring algorithm for Biopharma Research and Clinical Labs.
- On June 9, 2023, Serac Imaging launched clinical testing of a portable gamma camera in the US.
- On March 13, 2023, Clario launched a Cloud-based image viewer for clinical trials USA.