(MENAFN- Market Press Release) October 28, 2025 9:26 am - Clinical Trials Market Outlook 2035: Decentralization, Digital Integration, and Patient-Centric Evolution Driving Industry Expansion

The global clinical trials market, valued at US$ 64.7 billion in 2024, is projected to grow at a CAGR of 5.2% from 2025 to 2035, crossing US$ 112.9 billion by the end of 2035. This steady expansion underscores the sector's critical role in advancing medical innovation and translating scientific discovery into patient care.

With the healthcare ecosystem witnessing accelerated transformation - from digital enablement and AI-driven patient recruitment to decentralized and hybrid models - clinical trials have become the backbone of modern therapeutic development. Rising chronic disease prevalence, increasing focus on novel modalities such as cell and gene therapies, and the adoption of patient-centric and technology-enabled study models are shaping the industry's growth trajectory.

Rising Demand Fueled by Chronic Disease Burden

The increasing prevalence of chronic and lifestyle-related diseases is a major driver for the clinical trials market. Conditions such as diabetes, cancer, cardiovascular disorders, and respiratory diseases continue to burden healthcare systems worldwide, driving the need for innovative therapies and clinical validation.

According to the World Health Organization (WHO), over 14% of adults aged 18 and above had diabetes in 2022, almost double the prevalence in 1990. Simultaneously, the Global Cancer Observatory reported over 19.9 million new cancer cases globally in 2022. These trends highlight the growing need for continuous therapeutic innovation.

Clinical trials provide the essential framework for assessing the safety, efficacy, and dosing of new interventions. Pharmaceutical and biotechnology companies are investing heavily in trial launches across diverse therapeutic classes, particularly in oncology and metabolic disorders. For instance, as of September 2025, more than 4,350 clinical trials are being conducted specifically for breast cancer treatment evaluation.

Focus on Novel and Advanced Therapies

The next decade will see an upsurge in clinical studies focused on cell-based, gene, and RNA-based therapies. As of September 2025, there are over 740 ongoing clinical trials for gene therapy and around 5,500 trials for cell therapy worldwide.

These advanced modalities require customized trial designs, tailored endpoints, and new regulatory frameworks. The success of mRNA-based vaccines during the COVID-19 pandemic has further accelerated confidence and investment in RNA-based therapeutics, paving the way for a surge in mRNA-focused clinical programs targeting infectious diseases, oncology, and rare genetic conditions.

As sponsors pivot toward precision medicine and personalized therapy models, biomarker-driven trials are gaining traction. This trend has led to the rapid expansion of bioanalytical testing, biomarker testing, and PK/PD services, now integral components of modern clinical operations.

Decentralization and Hybrid Models Reshape the Trial Landscape

A transformative trend reshaping the global clinical trials market is the shift toward decentralized and hybrid trial models. The integration of telemedicine, remote monitoring, and home healthcare services has redefined how studies are conducted, improving patient accessibility and reducing operational complexity.

Decentralized Clinical Trials (DCTs) enable patients to participate from their homes or community health centers through digital platforms, minimizing the need for travel and frequent site visits. These models leverage eConsent, electronic source data capture (eSource), and remote data verification to maintain data integrity and regulatory compliance.

Leading organizations are embracing master protocol designs - such as platform, basket, and umbrella trials - to evaluate multiple interventions simultaneously under a unified framework. This approach shortens study timelines, improves flexibility, and facilitates adaptive modifications without halting trial progression.

AI and Data Integration: Transforming Patient Recruitment and Trial Efficiency

The use of artificial intelligence (AI) and machine learning (ML) is transforming every aspect of clinical research - from site selection and feasibility studies to patient matching and real-time data monitoring. Sponsors are transitioning AI tools from pilot phases to large-scale operational use, enabling data-driven decision-making and faster patient enrollment.

Digitally facilitated recruitment, eConsent, and direct-from-device data capture reduce administrative burden while ensuring participant engagement and compliance. Integration with electronic health records (EHRs) and interoperable data standards enhances efficiency, minimizes manual errors, and accelerates regulatory submissions.

AI-based predictive modeling also supports risk-based monitoring (RBM), which prioritizes critical data points and optimizes quality oversight. This shift improves safety monitoring while cutting costs associated with traditional manual verification processes.

Outsourcing and Strategic Alliances Bolster Market Growth

The clinical trials landscape is witnessing a fundamental transition toward outsourced and partnership-based operating models. Sponsors increasingly engage Contract Research Organizations (CROs) for end-to-end services - from study design and patient recruitment to pharmacovigilance and regulatory compliance.

This outsourcing trend is driven by the need for operational efficiency, access to global expertise, and faster turnaround times. CROs are expanding service portfolios to include data management, real-world evidence (RWE) generation, risk-adjusted quality management, and cybersecurity solutions.

Many leading players are pursuing strategic acquisitions of niche service providers such as home nursing agencies, imaging core labs, and data analytics firms to enhance their service ecosystem. Moreover, partnerships with hospital networks and academic medical centers ensure access to diverse patient populations and trial-ready infrastructure.

Regulatory Support and Government Initiatives

Regulatory bodies and governments worldwide are streamlining approval processes and offering incentives to boost clinical trial activity. Harmonized models and risk-based monitoring (RBM) systems are reducing redundancies, while tax incentives, funding programs, and expedited approval pathways are promoting faster study initiation.

Agencies such as the U.S. FDA, EMA, and regional counterparts in Japan, China, and India have adopted adaptive regulatory frameworks to accommodate hybrid and decentralized trial models. These initiatives have significantly reduced delays, encouraging sponsors to initiate multiple concurrent protocols across therapeutic areas.

Phase III Trials Continue to Dominate

Among all phases, Phase III trials continue to account for the largest market share. These studies are critical for demonstrating efficacy and safety in large patient populations and serve as the final step before regulatory approval and commercialization.

Given the scale, complexity, and investment involved, Phase III trials generate substantial data and often determine the commercial success of novel therapies. The segment's prominence will persist as companies seek to bring next-generation biologics, immunotherapies, and targeted drugs to market.

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