임상시험 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The clinical trials market is estimated to generate USD 90.1 billion in 2025 and is set to widen to USD 123.5 billion in 2030, translating to a 6.51% CAGR between 2025 and 2030.

Commercial sponsors are pivoting toward decentralized or hybrid execution models to contain site-related expenses, shorten enrollment timelines and support real-time oversight enabled by connected devices. Final adoption of the ICH E6(R3) Good Clinical Practice guideline in January 2025 is accelerating this shift by formally endorsing risk-based quality management, pragmatic data collection and remote-first monitoring. Oncology retains the largest share of global protocol starts, yet neurology, rare diseases and cell-and-gene therapies are expanding faster because they benefit from adaptive designs and biomarker-guided cohort enrichment. Contract research organizations (CROs) defend margins through technology investment, while emerging mid-tier specialists chip away at large-cap incumbents by offering therapeutic depth and region-specific regulatory expertise. Persistent shortages of experienced site personnel and rising biomarker-assay complexity temper growth, keeping cost inflation above historical norms.

Global Clinical Trials Market Trends and Insights

Accelerated Adoption of Decentralized & Hybrid Trial Platforms

Decentralized approaches allow participants to complete visits through tele-health, local labs and at-home devices, reducing travel burden and increasing retention. The global DCT revenue pool is forecast to reach USD 13.3 billion by 2030, equal to a 6.6% CAGR. Ninety-percent of patients consider DCT participation acceptable, underscoring strong demand for remote-first engagement. The US FDA's final guidance on decentralized clinical trials, issued in September 2024, confirms that regulatory expectations for data integrity, informed consent and safety oversight remain identical to those for site-based studies. Sponsors therefore face new operational requirements around technology qualification, risk-based monitoring and cybersecurity, which are already shaping vendor selection criteria and driving CRO investment in digital platforms.

Surge in Rare-Disease and Orphan-Drug Pipelines Globally

Genomics and next-generation sequencing have illuminated molecular causes for thousands of previously idiopathic disorders, triggering a wave of targeted therapy programs. Although roughly 30 million US residents live with rare diseases, only 500 conditions currently have approved treatments. Tax incentives, user-fee waivers and seven-year exclusivity under the US Orphan Drug Act continue to attract venture and large-pharma capital. FDA's Therapeutics for Rare and Neglected Diseases grant program further de-risks early human studies, leading to high growth in natural-history cohort collection and molecularly stratified proof-of-concept trials. Recruitment remains difficult because patient populations are geographically dispersed and diagnostic latency averages five to seven years, pushing sponsors toward global, multi-site or fully virtual enrollment strategies.

Persistent Shortages of Experienced Clinical Research Coordinators in Emerging Markets

Rapid protocol growth in Asia-Pacific, Latin America and Eastern Europe has outstripped the supply of site staff proficient in ICH-GCP, remote-data collection and complex regulatory dossiers. Developing a fully competent coordinator takes two to three years of mentored exposure, outpacing the graduation rate of new clinical-research programs such as the CAAHEP-accredited Master of Clinical Research offered by The Ohio State University. Inexperienced teams elevate protocol-deviation risk, prolong monitoring visits and strain quality-assurance budgets, eroding some of the cost advantages that originally motivated offshoring. Sponsors respond by bundling staff-training modules into vendor contracts, deploying mobile monitoring units and increasing central-statistical surveillance, but skills gaps remain an acute short-term bottleneck.

Other drivers and restraints analyzed in the detailed report include:

1. Growing Inclusion of Asia-Pacific Sites to Optimize Recruitment Timelines
2. AI-Enabled Patient Recruitment Solutions Improving Enrollment Efficiency
3. Rising Complexity & Cost of Biomarker-Driven Adaptive Designs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Phase III studies captured 55.0% of the clinical trials market in 2024 because they involve large multicenter cohorts and regulatory-grade endpoints that command premium CRO budgets. A single Phase III oncology protocol can top USD 40,000 per patient, with biomarker screening costs fueling expenditure growth. Nevertheless, Phase II trials will expand faster at 6.8% CAGR as adaptive designs compress proof-of-concept timelines and combine dose-ranging with early efficacy. The Asia-Pacific region now hosts 58% of global Phase I starts thanks to China's expedited IND review pathway, bolstering early access to genetically diverse populations.

Sponsors deploy seamless Phase I/II frameworks to accelerate go/no-go milestones and gate Phase III investment, an approach that spreads risk and optimizes asset prioritization. Venture-backed biotech companies frequently outsource these studies to mid-tier CROs with laboratory genomics integration, while large pharma maintains internal Phase I units for flagship modalities. Regulatory agencies support innovation through guidance that balances statistical rigor with flexibility, incentivizing novel endpoints and digital biomarker inclusion. Together these trends reinforce a pipeline where exploratory phases become more data-rich even as late-stage trials keep absorbing the majority of spend in the clinical trials market.

Interventional randomized controlled trials remain the regulatory gold standard, absorbing 72.3% revenue in 2024 and anchoring risk calculations for most therapeutics. The ICH E6(R3) guidance explicitly endorses proportionate oversight, encouraging sponsors to embed interim analyses and pre-specified stopping rules, thereby fueling 8.2% CAGR for adaptive frameworks. Oncology is at the forefront: umbrella, basket and platform structures test multiple biomarker-defined cohorts in parallel, leveraging shared control arms to cut enrollment burden.

The clinical trials market increasingly integrates platform trials for infectious diseases, neurologic disorders and autoimmune conditions where heterogeneity complicates treatment evaluation. Simulated-operating-characteristic packages accompany regulatory submissions to demonstrate error-rate control, and central-statistical monitoring flags data anomalies faster than traditional on-site verification. Continued acceptance of master-protocol constructs widens the use of adaptive enrichment, reinforcing the perception that flexible design is no longer experimental but an essential feature of modern evidence generation within the clinical trials market.

The Clinical Trials Market Report is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Study Design (Diagnostic Radiology, and More), Service Type (Protocol Design & Feasibility, and More), Therapeutic Area (Oncology, and More), Sponsor Type (Pharmaceutical & Biopharmaceutical Companies, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America generated 49.2% of global revenue in 2024, supported by a mature regulatory ecosystem, advanced investigator networks and abundant scientific capital. State-level economic multipliers highlight the local value of trial spending: Florida captured USD 8.3 billion, Texas USD 7.7 billion and California USD 7.1 billion in 2024 activity. Regional authorities increasingly prioritize methodological innovation over sheer volume, evidenced by agency guidance on decentralized trials, adaptive designs and real-world-evidence integration. The clinical trials market here faces cost pressure, driving sponsors to hybrid models that retain strategic US hubs while offshoring lower-intensity procedures.

Asia-Pacific is forecast to grow at 7.9% CAGR, reshaping the global clinical trials market through regulatory liberalization, accelerated review timelines and large treatment-naive populations. China and India together represent nearly 40% of total active protocols. South Korea's centralized IRB framework, Japan's conditional approval pathway for regenerative medicine, and Taiwan's data-integrity sandbox for blockchain-based e-source verification collectively establish differentiated niches. The region's cost structure-30-40% cheaper per patient-and recruitment speed-two to three times faster than Western benchmarks-create a compelling proposition. However, variation in data-privacy statutes and English-language proficiency poses cross-border master-protocol challenges, prompting CRO alliances that blend regional know-how with global process standardization.

Europe retains considerable scientific expertise and specialized infrastructure, yet its relative share of the clinical trials market has edged downward amid protracted startup timelines and cost inflation. The Clinical Trials Regulation (CTR) aims to streamline multi-member-state permissions through a centralized portal, while the European Medicines Agency emphasizes patient-focused outcome measurement. Brexit introduces an extra layer of complexity: UK sponsors must navigate dual compliance tracks, although the new Windsor Framework facilitates data flow for Northern Ireland. Future growth will likely concentrate on rare diseases, advanced therapy medicinal products and complex statistical methods where Europe's academic networks retain competitive strength.

1. IQVIA
2. LabCorp
3. ICON
4. Syneos Health
5. Parexel International Corp.
6. Thermo Fisher Scientific Inc. (PPD)
7. Lilly (Lilly Clinical Innovation)
8. Pfizer
9. MedPace
10. Charles River
11. Caidya
12. ACM Global Laboratories
13. Wuxi AppTec Co. Ltd.
14. ClinChoice
15. KCR S.A.
16. Pharmaron Inc.
17. Novotech
18. Aragen Life Sciences Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Accelerated Adoption of Decentralized & Hybrid Trial Platforms
  • 4.2.2 Surge in Rare-Disease and Orphan-Drug Pipelines Globally
  • 4.2.3 Growing Inclusion of Asia-Pacific Sites to Optimize Recruitment Timelines
  • 4.2.4 AI-Enabled Patient Recruitment Solutions Improving Enrollment Efficiency
  • 4.2.5 Government Incentives for Oncology Trials Globally
  • 4.2.6 Rising Use-case of Real-World Evidence (RWE) Post-Approval Studies
• 4.3 Market Restraints
  • 4.3.1 Persistent Shortages of Experienced Clinical Research Coordinators in Emerging Markets
  • 4.3.2 Rising Complexity & Cost of Biomarker-Driven Adaptive Designs
  • 4.3.3 Increased Scrutiny Around Data-Privacy Laws (GDPR, CCPA) Hindering e-Consent Roll-outs
  • 4.3.4 Inflation-driven Escalation of Investigator and Site Management Fees in Western Europe
• 4.4 Regulatory Outlook
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Phase
  • 5.1.1 Phase I
  • 5.1.2 Phase II
  • 5.1.3 Phase III
  • 5.1.4 Phase IV
• 5.2 By Study Design
  • 5.2.1 Interventional / Treatment Studies
  • 5.2.2 Observational Studies
  • 5.2.3 Expanded Access Studies
• 5.3 By Service Type
  • 5.3.1 Protocol Design & Feasibility
  • 5.3.2 Site Identification & Start-up
  • 5.3.3 Regulatory Submission & Approval
  • 5.3.4 Clinical Trial Monitoring
  • 5.3.5 Data Management & Biostatistics
  • 5.3.6 Medical Writing
  • 5.3.7 Other Service Types
• 5.4 By Therapeutic Area
  • 5.4.1 Oncology
  • 5.4.2 Cardiovascular
  • 5.4.3 Neurology
  • 5.4.4 Infectious Diseases
  • 5.4.5 Metabolic Disorders (Diabetes, Obesity)
  • 5.4.6 Immunology / Autoimmune
  • 5.4.7 Other Therapeutic Areas
• 5.5 By Sponsor Type
  • 5.5.1 Pharmaceutical & Biopharmaceutical Companies
  • 5.5.2 Medical Device Companies
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Government & Non-profit Organizations
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle-East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Strategic Moves (M&A, Partnerships, Funding)
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.4.1 IQVIA Holdings Inc.
  • 6.4.2 Laboratory Corporation of America Holdings (Labcorp)
  • 6.4.3 ICON plc
  • 6.4.4 Syneos Health
  • 6.4.5 Parexel International Corp.
  • 6.4.6 Thermo Fisher Scientific Inc. (PPD)
  • 6.4.7 Lilly (Lilly Clinical Innovation)
  • 6.4.8 Pfizer Inc.
  • 6.4.9 Medpace Holdings Inc.
  • 6.4.10 Charles River Laboratories International Inc.
  • 6.4.11 Caidya
  • 6.4.12 ACM Global Laboratories
  • 6.4.13 Wuxi AppTec Co. Ltd.
  • 6.4.14 ClinChoice
  • 6.4.15 KCR S.A.
  • 6.4.16 Pharmaron Inc.
  • 6.4.17 Novotech
  • 6.4.18 Aragen Life Sciences Ltd.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment