Europe Clinical Trials Market Boosted by AI and Regulations 2025

Europe Clinical Trials Market Size, Key Players with Shares and Trends

The Europe clinical trials market size is calculated at US$ 13.6 billion in 2024, grew to US$ 14.25 billion in 2025, and is projected to reach around US$ 21.73 billion by 2034. The market is expanding at a CAGR of 4.80% between 2025 and 2034.

Due to a growing geriatric population and increasing incidences of various diseases, the clinical trials in Europe are increasing. Additionally, the growth in awareness is driving the demand for accurate and fast diagnostic devices as well as for targeted and personalized treatment options. Additionally, the presence of strong regulatory standards ensures the product quality, safety, and effectiveness, where AI is also being used in these trials due to its various applications. Moreover, the companies are participating in clinical trials supported by the investments, where their results are also being presented in various European events, promoting the market growth.

Key Takeaways

• Europe clinical trials sector pushed the market to USD 13.6 billion by 2024.
• Long-term projections show USD 21.73 billion valuation by 2034.
• Growth is expected at a steady CAGR of 4.80% in between 2025 to 2034.
• The global clinical trials market, valued at USD 54.39 billion in 2024, is projected to reach USD 94.68 billion by 2034, growing at a CAGR of 5.7%.
• By phase type, the phase 3 segment dominated the Europe clinical trials market in 2024.
• By phase type, the phase 2 segment is expected to be the fastest growing during the forecast period.
• By study design type, the interventional study segment dominated the market in 2024 and is expected to be the fastest growing during the forecast period.
• By indication type, the pain management segment dominated the market in 2024 and is expected to be the fastest growing during the forecast period.

Quick Facts Table

What are the Europe Clinical Trials?

The Europe clinical trials market is driven by growing adoption of new technologies and streamlined regulations to maintain its position as a global leader in clinical research. The Europe clinical trials refer to the clinical trials of the products conducted within the European regions under the regulatory framework of the European Medicines Agency (EMA) and other government and national authorities, to ensure the safety, efficacy, and quality of the products developed. The area of interest for these clinical trials includes the development of lung cancer vaccines, personalized vaccines, HIV prevention solutions, and other treatment options.

Europe Clinical Trials Market Outlook

• Industry Growth Overview: Despite strong competition from the Asia Pacific region, the clinical trials market in Europe is expected to show steady growth. The increasing demand for personalized medicines, rising R&D investments, and new EU regulations are the major factors driving this growth.
• Sustainability Trends: The growing shift towards decentralized clinical trials to minimize the travel emissions for patients and staff is the major sustainability trend in the Europe clinical trials market. Moreover, the industry-wide corporate social responsibility efforts and new regulations, such as the Green Deal of the EU to minimize the environmental impact from the pharmaceutical sector, are also supporting this digital transformation.
• Startup Ecosystem: The startup ecosystem in the market is focusing on utilizing technologies to improve the efficiency, patient centricity, and minimize the cost of the trials. Furthermore, the growing telemedicine, remote patient monitoring, direct-to-patient services, etc, are other key areas driving the implementation of the EU Clinical Trials Regulation (CTR) and increasing the use of hybrid or decentralized models.

What are the AI Technological Shifts in the Europe Clinical Trials Market?

The use of AI in Europe is transforming the drug development process, which in turn is driving its use in clinical trials and to develop smarter, faster, and patient-centric trials. They are also being used to develop decentralized trials and help in the detection of critical operational risks. Moreover, the growing awareness and investment are encouraging the use of AI to improve site readiness and boost trial efficiency.

For instance,

• In October 2025, the data of EVX-01, which is a personalized skin cancer vaccine, will be presented by Evaxion at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, which was developed with the use of the AI-Immunology™ platform of Evaxion.

What are the New Government Initiatives in the Europe Clinical Trials Market?

Growing initiatives: To simplify and harmonize the complex regulatory submission process of clinical trials, new initiatives are being introduced by the government and other regulatory bodies. These initiatives are encouraging innovations across Europe. Additionally, they are also attracting investments, accelerating the clinical trials.

For instance,

• In September 2025, to improve efficiency and transparency of clinical studies across European member states, a new clinical trial framework was announced by the European Medicines Agency (EMA). The framework aims at the development of a centralized online platform to enhance access to essential trial data and seamless documentation to the researchers and regulatory bodies, new guidelines to streamline application submission processes, transparency measures, and multinational clinical trials.
• In September 2025, to make the European Union (EU) a more attractive destination for clinical research and to enhance access to innovative medicines for patients, two new targets for clinical trials were developed by the collaboration between the EMA, the European Commission (EC), and the Heads of Medicines Agencies (HMA).

Table: Recent Clinical Trials Data Revealed by the Companies in Europe

Segmental Insights

Which Phase Type Segment Held the Dominating Share of the Europe Clinical Trials Market in 2024?

By phase type, the phase 3 segment held the dominating share of the market in 2024, due to a growth in drug development. At the same time, the presence of a wide range of patients enhanced the phase 3 trials. Additionally, the growth in the collaboration with other countries also encouraged these trials.

By phase type, the phase 2 segment is expected to show the highest growth during the predicted time. The increasing number of startups is focusing on the development of novel treatment options for various diseases, which is promoting the phase 2 trials. Similarly, the growing demand for targeted therapies to tackle the growing genetic diseases is also contributing to the same.

What Made the Interventional Study the Dominant Segment in the Europe Clinical Trials Market in 2024?

By study design type, the interventional study segment led the market in 2024 and is expected to show the fastest growth rate during the upcoming years, driven by stringent regulations that require evidence-based data. Moreover, the growth in drug development, along with new diagnostic devices, has enhanced the use of these study designs. Additionally, as they provide reliable and reproducible results, their use in phase 2 and 3 trials has increased.

Why Did the Pain Management Segment Dominate in the Europe Clinical Trials Market in 2024?

By indication type, the pain management segment led the market in 2024 and is expected to sustain its position during the predicted time, due to growth in the geriatric population. Similarly, the growing cases of arthritis, back pain, or neuropathy are also driving the clinical trial of pain management treatment. Moreover, the growing demand for opioid alternatives is also contributing to the same.

In the pain management segment, the oncology subsegment held the largest share of the market and is expected to show the highest growth during the upcoming years, as there is a rise in cancer cases. This, in turn, is increasing the demand for targeted and personalized treatment options. Additionally, the growing R&D investment is driving oncology innovation, promoting their clinical trials.

A 2025 publication from the Annals of Oncology estimated a decrease in the European Union from 2020 to 2025, with favorable trends for most cancers except pancreatic, lung, and bladder cancers. In 2022, the World Health Organization (WHO) reported over 3.7 million new cases and 1.9 million deaths from cancer annually in Europe, making it the second leading cause of death. 

Regional Insights

Unified Regulatory Framework Drives Europe

The Europe clinical trials market is expected to show significant growth during the forecast period, as it consists of a unified regulatory framework, such as the EU Clinical Trials Regulation, which streamlines the approval process, attracting sponsors from different countries. The growth in research and development supported by the government funding is also driving the clinical trials. Additionally, the growing diseases, awareness, and demand for targeted treatment options are also increasing innovation, promoting their clinical trials. All these factors, along with the growing utilization of advanced technologies, are enhancing the market growth.

Country-level analysis

In April 2025, to develop a new Health Data Research Service, which will provide a single, secure access point to national datasets, a total of £600m ($764m) funding was announced by the UK Government. Moreover, to enhance the development of novel therapies and the fast-tracking of clinical trials will be supported by these funds.

Global Clinical Trials Market Growth

The global clinical trials market is valued at USD 54.39 billion in 2024 and is projected to reach USD 94.68 billion by 2034, growing at a compound annual growth rate (CAGR) of 5.7% over the forecast period from 2024 to 2034.

Europe Clinical Trials Market Value Chain Analysis

R&D

With the use of technological advancements and regulatory harmonization, the R&D of Europe clinical trials are focusing on increasing the research efficiency and patient centricity.

Key Players: Novartis, AstraZeneca, F. Hoffmann-La Roche, Novo Nordisk, Bayer, Sanofi.

Clinical Trials and Regulatory Approvals

The implementation and optimization of the clinical trials regulation (CTR) to increase transparency, harmonize, and streamline the entire process through a single online platform is the primary focus in Europe clinical trials and regulatory approvals.

Key Players: Novartis, AstraZeneca, F. Hoffmann-La Roche, Novo Nordisk, Bayer, Sanofi, GlaxoSmithKline (GSK), Pfizer.

Formulation and Final Dosage Preparation

The formulation and final dosage preparation in the Europe clinical trials are expected to comply with the GMP standards outlined in Annex 13 of the EU GMP Guide, where the product must ensure its safety, quality, and consistency.

Key Players: Thermo Fisher Scientific, Catalent, Lonza, Almac Group, and Recipharm.

Packaging and Serialization

The packaging and serialization in the Europe clinical trials are expected to comply with Annex 13 of the EU GMP Guide and Falsified Medicines Directive (FMD), and must ensure patient safety and convenience during the complexity of decentralized trials.

Key Players: Thermo Fisher Scientific, Catalent, Lonza, Almac Group, Recipharm, Aenova Group.

Distribution to Hospitals, Pharmacies

The distribution of investigational medicinal products to hospitals and pharmacies is expected to adhere to EU Good Distribution Practices (GDP) and Annex 13 of the EU GMP Guide, where they must ensure products' integrity, traceability, and security, along with a temperature-controlled and transparent transportation process.

Key Players: Movianto, DHL Supply Chain, World Courier.

Patient Support and Services

To enhance the patient experience and adherence, Europe clinical trials focus on enhancing their education, providing financial assistance, and decentralized trial elements such as home healthcare.

Key Players: ICON plc, IQVIA, Syneos Health, Parexel, Thermo Fisher Scientific

Top vendors and Their Offerings in the Europe Clinical Trials Market

• IQVIA: The company focuses on accelerating innovation, aiming for a healthier world. They utilize AI technologies to accelerate clinical trials and improve patient outcomes.
• Thermo Fisher Scientific: It is a life sciences and clinical research company, well known for its global supply of analytical instruments, clinical development solutions, specialty diagnostics, etc.
• ICON plc.: It is one of the leading contract research organisations (CRO), backed by Healthcare Intelligence. The company also provides specialized planning, execution, analysis, and management for phase 2-3 clinical trials.
• Labcorp (Fortrea): The company focuses on developing solutions for emerging viruses to life-threatening conditions, and very rare diseases. Moreover, they use advanced technologies to identify, diagnose, manage, and solve critical health challenges.
• Parexel: The company provides faster and better trials with an unwavering commitment to the patients. The company focuses on developing organized trials with the right treatment, on time, every time, and safely for the patients.

Top Companies in the Europe Clinical Trials Market

• Novo Nordisk
• Syneos Health
• AstraZeneca
• Novartis
• F. Hoffmann-La Roche
• Bayer
• Sanofi
• Charles River Laboratories
• Johnson & Johnson
• PSI
• Medpace Holdings
• TFS HealthScience
• Ergomed
• Almac Group
• WuXi AppTec

What are the Recent Developments in the Europe Clinical Trials Market?

• In October 2025, three posters of Phase II and Phase III clinical trials of evenamide for the treatment of schizophrenia will be presented by Newron Pharmaceuticals S.p.A. at the upcoming 38th Congress of the European College of Neuropsychopharmacology, which will be held on October 11 to 14, 2025, in Amsterdam.
• In September 2025, to evaluate the effectiveness of vaccines for severe acute respiratory infections, 3 new studies were launched in Manchester, making it the first trials delivered by the Greater Manchester Commercial Research Delivery Centre (GM CRDC), supported by the National Institute for Health and Care Research.

Segments Covered in the Report

By Phase

• Phase 1
• Phase 2
• Phase 3
• Phase 4

By Study Design

• Observational Study
• Interventional Study
• Expanded Access Study

By Indication

• Autoimmune/Inflammation
  • Rheumatoid arthritis
  • Multiple Sclerosis
  • Osteoarthritis
  • Irritable Bowel Syndrome (IBS)
  • Others
• Pain Management
  • Chronic Pain
  • Acute Pain
  • Oncology
  • Blood Cancer
  • Solid Tumors
  • Other
• CNS Condition
  • Epilepsy
  • Parkinson's Disease (PD)
  • Huntington's Disease
  • Stroke
  • Traumatic Brain Injury (TBI)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Muscle Regeneration
  • Others
• Diabetes
  • Obesity
  • Cardiovascular
  • Others