Global Decentralized Clinical Trials(DCTs) Market Analysis

The Global Decentralized Clinical Trials (DCTs) Market size stood at around xx Bn in 2023 and is projected to reach US $xx Bn by 2033, exhibiting a CAGR of xx% during the forecast period.

The Global Decentralized Clinical Trials (DCTs) Market Analysis Executive Summary

Decentralized clinical trials (DCTs) utilize digital technologies to shift trial operations from centralized sites, like academic medical centres, to more accessible locations such as patients' homes, local pharmacies, and community clinics. This model enhances patient participation and convenience by allowing remote involvement through telemedicine, mobile health apps, and remote monitoring devices. DCTs can be fully virtual, where all interactions occur online, or hybrid, combining traditional site-based activities with decentralized methods. By prioritizing the patient experience and reducing the need for travel, DCTs aim to improve enrolment and retention rates while maintaining the integrity of clinical research.

The decentralized clinical trials (DCT) market is rapidly expanding due to advancements in technology, a focus on patient-centric approaches, and the potential for cost savings. DCTs leverage digital health tools, wearables, and telemedicine to enhance trial efficiency and participant convenience, allowing for broader geographic reach and more diverse patient samples. However, challenges such as regulatory complexities, data security concerns, and technology adoption barriers persist. The market is also seeing trends like AI integration and increased use of patient engagement tools, which are expected to drive further growth and innovation in the field.    

Global Decentralized Clinical Trials (DCTs) Market Dynamics

Market Growth Drivers

The rise of RWE is expanding usage of DCTs since it permits collecting information from real-world settings for beyond clinical trial observations. Good regulations, backed up by most global agencies, are aiding in the actualization of DCTs, expanding the patients’ chance and effectiveness of the trial. Evolvements in the use of technology in health delivery, increasing tie-ups observed between the pharma industry and information technology providers, and the fact that DCT is patient-centric are opening doors to this change further. COVID-19 has increased the use of DCTs, proving that they are feasible, and the changes that have taken place are now permanent. Besides, the availability of the clinical trials to new markets offers new opportunities. 

Opportunity

AI, machine learning, smart wearable devices, and blockchain advances patient enrolments, data protection, and timely vigilance, emphasizing innovation in trial orchestration. Opportunities for further utilization of DCTs include extending its applicability not only for oncology but also for chronic diseases and mental health, implementing mixed-reference models of trials, and navigating multi-stakeholder collaborations. Also, regulatory convergence and a shift of focus toward patients further assist in the development of DCTs, culminating in improved efficient, accessible, and patient-oriented clinical trials. 

Market Restraints

Some of the challenges that surround the implementation and use of decentralized clinical trials include; complicated and diverse regulatory environment, data privacy and protection, and technology barriers that may lock out some patients. This lack of standardization applies to protocols and guidelines for applying the trial design as well as data comparison across trials. However, patient collaboration and provider push back remain challenges, not to mention defining proper reimbursement for DCT-related activities. This analysis suggests that these challenges need to be surmounted if DCTs are to deliver on the promise of revolutionising clinical research. 

Competitive Landscape for Decentralized Clinical Trials (DCTs) Market in Global

Key Players

• LEO Innovation Lab
• ICON Plc
• Medrio
• IQVIA
• Medable
• Covance
• Science 37
• Clinical Ink

Recent Developments

June 2024, Lokavant has announced the launch of an artificial intelligence (AI) clinical trial feasibility software solution, Spectrum. According to Lokavant, the solution is the first of its kind. Spectrum will allow study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction.

Mergers and Acquisitions

August 2024, Walgreens, BARDA Team in $100M Partnership to Boost Decentralized Clinical Trials.

June 2024, IQVIA Launches “One Home” Clinical Trial Technology Platform - Solves Challenges and Reduces Overload at Sites.

February 2024, Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division.

July 2021, ICON closes $12bn acquisition of PRA Health Sciences. The merged company will operate as ICON from 150 locations across 47 countries.

September 2021, Syneos Health Acquires StudyKIK. Acquisition Offers Sites and Sponsors Access to Technology-Enabled, Insight-Powered Solutions, Accelerating Clinical Trial Recruitment, Retention and Diversity

Healthcare Policies and Regulatory Landscape for Decentralized Clinical Trials (DCTs) Market in Global

Policy changes and Reimbursement scenario

There has been an increase in guidance documents for decentralized clinical trials (DCTs) from regulatory authorities such as the FDA and the EMA with a focus on patient safety and data quality as well as encouraging trials that incorporate both centralised and decentralised approaches. This is because the success of DCTs is also influenced by reimbursement policies that differ from one region to another and can considerably affect the implementation of the technology. This external context requires partnerships between pharmaceutical companies, technology providers, CROs, and regulators to establish acceptable guidelines and practices that support the expansion and longevity of DCTs and, in turn, contribute to clinical trials’ efficiency, accessibility, and patient focus.