Outsourced Clinical Trials and Formulation

Global Outsourced Clinical Trials and Formulation Market to Reach US$22.2 Billion by 2030

The global market for Outsourced Clinical Trials and Formulation estimated at US$15.6 Billion in the year 2024, is expected to reach US$22.2 Billion by 2030, growing at a CAGR of 6.1% over the analysis period 2024-2030. Oral Dosage Form, one of the segments analyzed in the report, is expected to record a 6.7% CAGR and reach US$14.5 Billion by the end of the analysis period. Growth in the Injectable Dosage Form segment is estimated at 5.2% CAGR over the analysis period.

The U.S. Market is Estimated at US$4.2 Billion While China is Forecast to Grow at 9.7% CAGR

The Outsourced Clinical Trials and Formulation market in the U.S. is estimated at US$4.2 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$4.6 Billion by the year 2030 trailing a CAGR of 9.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 3.0% and 6.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.0% CAGR.

Global Outsourced Clinical Trials and Formulation Market - Key Trends & Drivers Summarized

Why Is Outsourcing Clinical Trials and Formulation Becoming the Norm in Drug Development?

Pharmaceutical and biotechnology companies are increasingly outsourcing clinical trials and drug formulation activities to specialized contract research and manufacturing organizations. This shift is driven by factors such as the need to reduce operational complexity, accelerate time-to-market, and access global patient pools for clinical testing. Outsourcing allows sponsors to focus internal resources on innovation and regulatory strategy while leveraging external expertise in protocol design, regulatory submissions, patient recruitment, and data management.

Formulation development, which includes optimizing dosage form, bioavailability, and stability, is also being outsourced to tap into advanced technologies and manufacturing platforms. These services are particularly valuable in early-stage development, where formulation outcomes affect downstream clinical success and regulatory approval. As pipelines become more diverse, especially with biologics, orphan drugs, and personalized medicine, specialized service providers offer flexible solutions tailored to molecular complexity and therapeutic requirements.

How Are CRO and CDMO Capabilities Evolving to Support Complexity and Globalization?

Contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) are expanding service portfolios to offer integrated solutions across phases I to IV of clinical trials, as well as formulation, analytical development, and scale-up services. Providers are investing in decentralized trial technologies, wearable monitoring devices, and real-world data platforms to enhance patient-centric trial designs and improve recruitment efficiency.

Formulation providers are expanding capabilities in oral solid dosage forms, injectables, lipid nanoparticles, and sustained-release systems. They are also supporting drug-device combinations, nasal and transdermal systems, and pediatric-friendly formats. Facilities are being upgraded to handle high-potency APIs and aseptic processing, while adherence to global quality standards ensures regulatory readiness across multiple jurisdictions. Digital tools and AI-based analytics are being adopted for adaptive trial designs, risk-based monitoring, and real-time data analysis.

Where Is Demand Increasing and What Therapeutic Areas Are Fueling Outsourcing?

North America and Europe remain the leading hubs for outsourced clinical and formulation services due to robust regulatory systems and established CRO/CDMO infrastructure. Asia-Pacific, particularly India, China, and South Korea, is gaining momentum owing to lower trial costs, large treatment-naive populations, and improving regulatory clarity. Emerging markets in Latin America and Eastern Europe are also being tapped for patient recruitment diversity and accelerated enrollment.

Therapeutic areas such as oncology, central nervous system disorders, autoimmune diseases, and rare conditions are driving demand for outsourced services. These domains often require complex trial designs, biomarker analysis, and niche formulation strategies. Biopharmaceutical and advanced therapy medicinal product (ATMP) developers are also partnering with specialized providers to support novel delivery routes, stability studies, and combination product registration.

Growth in the Outsourced Clinical Trials and Formulation market is driven by several factors…

Growth in the outsourced clinical trials and formulation market is driven by factors such as increasing R&D expenditure, rising complexity of drug molecules, and the need for accelerated development timelines. Expanding demand for specialized expertise in complex biologics, sterile formulations, and patient-centric dosage forms is strengthening outsourcing partnerships.

Regulatory pressure to improve trial transparency and data integrity, coupled with the globalization of clinical research, is supporting growth across multiple regions. Technological integration, rising adoption of decentralized trials, and scalability advantages offered by CROs and CDMOs are also contributing to market expansion. Moreover, a growing pipeline of niche therapeutics and orphan drugs continues to increase reliance on external service providers with disease-specific capabilities and global regulatory alignment.

SCOPE OF STUDY:

The report analyzes the Outsourced Clinical Trials and Formulation market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Form (Oral Dosage Form, Injectable Dosage Form, Other Forms); Application (API Manufacturing Application, Fill-Finish Product Manufacturing Application, Drug Product Development Application, Packaging / Labeling Application, Other Applications); End-Use (Pharma & Biotech Companies End-Use, Emerging / Virtual Pharma Companies End-Use, Nutraceuticals Companies End-Use)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 32 Featured) -

• Charles River Laboratories
• Covance (Labcorp Drug Development)
• Evotec SE
• Eurofins Scientific
• ICON plc
• IQVIA
• KCR S.A.
• Medpace Holdings, Inc.
• Parexel International Corporation
• Piramal Pharma Solutions
• PPD (Thermo Fisher Scientific)
• PRA Health Sciences
• Premier Research
• Recipharm AB
• SGS Life Sciences
• Syneos Health
• Thermo Fisher Scientific Inc.
• Veeda Clinical Research
• Viatris (Mylan + Upjohn)
• WuXi AppTec

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