세계 임상시험 시장 예측(-2030년) : 페이즈별, 서비스 유형별, 치료 영역별, 시험 디자인별, 스폰서별, 용도별, 지역별 분석

According to Stratistics MRC, the Global Clinical Trials Market is accounted for $53.68 billion in 2023 and is expected to reach $90.81 billion by 2030 growing at a CAGR of 7.8% during the forecast period. Clinical trials are basically research studies performed by researchers on people that are aimed at finding out a new treatment, like a new drug, diet, or medical device. It is also used to find out whether it is safe and effective for people. These trials aim to advance medical knowledge, improve healthcare, and provide evidence-based information for informed decision-making by healthcare professionals, regulators, and patients. Clinical trials apply to drug development, vaccine testing, medical device evaluation, behavioural interventions, cancer research, and genetic studies.

According to a report published by the World Heart Federation, Cardiovascular illnesses continue to impact more than half a billion people worldwide and were responsible for 20.5 million deaths in 2021, or close to a third of all deaths worldwide, and a rise from the anticipated 121 million CVD fatalities.

Market Dynamics:

Driver:

Globalization of clinical trials

Emerging economies, such as India, China, Brazil, and Eastern European nations, provide attractive environments for clinical trials due to their large and varied patient populations, skilled medical professionals, and cost-effective trial conduct. Sponsors and contract research organisations (CROs) are drawn to these regions because of the potential for quicker participant recruitment, reduced trial costs, and accelerated trial timelines. Additionally, globalisation helps address global health challenges by ensuring a broader representation of ethnicities and demographics, leading to a better understanding of treatment efficacy and safety across diverse populations. This will contribute to a robust and dynamic clinical trials market, fostering innovation and advancements in healthcare and pharmaceuticals. Therefore, there is an increasing demand for market growth.

Restraint:

High cost

The high costs associated with conducting clinical trials present a significant restraint in the clinical trials market. Research and development expenses, participant recruitment, trial management, data collection, and regulatory compliance contribute to the substantial financial burden. Additionally, the expense of addressing evolving regulatory requirements further amplifies the financial strain. The cost of bringing a new drug or treatment to market is consistently escalating, making it challenging for smaller organisations and academic institutions to fund trials. Thus, this factor is hampering market demand.

Opportunity:

Increased R&D activities in the biotech and pharmaceutical industries

The rise in research and development (R&D) activities within the biotechnology and pharmaceutical industries represents a significant opportunity in the clinical trials market. Both sectors are investing extensively in the discovery and development of innovative drugs, biologics, medical devices, and therapies to address a wide array of diseases and health conditions. The advancement in understanding the molecular basis of diseases, coupled with the availability of sophisticated technologies, has propelled R&D efforts. Biotechnology, with its focus on utilising living organisms and biological systems to develop products and technologies, has opened new avenues for drug development. The pharmaceutical industry, on the other hand, is actively researching and creating traditional drugs as well as novel compounds through computational modelling, high-throughput screening, and other advanced methodologies. Thus, there is a lucrative growth for clinical trials market.

Threat:

Shortage of skilled professionals in clinical trials

The shortage of skilled professionals in clinical trials poses a significant threat to the clinical trials market. Conducting trials requires a multidisciplinary team of experts, including clinical researchers, trial coordinators, data managers, regulatory specialists, and biostatisticians. The demand for these professionals is rapidly increasing due to the growing number and complexity of clinical trials. However, there is a shortage of adequately trained and experienced personnel to meet this demand. This scarcity can lead to delays in trial execution, compromised data quality, and increased operational costs. Therefore, it is a significant barrier to market expansion.

COVID-19 Impact

The impact of COVID-19 pandemic resulted in the slow growth of the market during the pandemic. Many clinical studies were put on hold after the sudden outbreak of COVID-19 due to lockdown restrictions and the low presence of resources. However, many pharmaceutical and biotechnological companies increased their focus on the development of drugs, test kits, and vaccines against the SARS-CoV-2 virus. These companies increased their focus on collaboration and partnership with CRO service providers for R&D and clinical studies. There has been an increased interest in virtual/decentralized trials in the clinical trial space, and those have been featured on conference agendas and in articles for a long time.

The Phase 3 segment is expected to be the largest during the forecast period

The Phase 3 segment is estimated to hold the largest share. The Phase 3 segment of the clinical trials market represents a crucial stage in the development and evaluation of medical interventions, such as drugs, treatments, or therapies. Phase III clinical trials are considered complex clinical trials that require both robust technologies and reliable clinical resources to recruit patients efficiently, initiate sites quickly, and provide cost-effective study management. Furthermore, during Phase 3 trials, researchers carefully gather data to confirm and extend the findings from earlier phases. They aim to demonstrate statistically significant results and compare the intervention against standard treatments, placebos, or other relevant comparators.

The Clinical Trial Data Management Services segment is expected to have the highest CAGR during the forecast period

The Clinical Trial Data Management Services segment is anticipated to have lucrative growth during the forecast period, owing to the increase in demand for comprehensive and effective data management services as the pharmaceutical and biotechnology sectors continue to grow. It involves the systematic collection, integration, and management of data generated during clinical trials. These services ensure that the data collected is accurate, reliable, and in compliance with regulatory requirements. Clinical Trial Data Management Services encompass a range of activities, including database design, data entry, data validation, coding, quality control, and database lock. Also, it helps in identifying potential safety concerns, evaluating the efficacy of the tested interventions, and ultimately influencing medical decision-making.

Region with largest share:

North America commanded the largest market share during the extrapolated period. The market is expanding in North America due to a number of factors, including the rising incidence of infectious and chronic diseases, the demand for personalised treatment, and the existence of a thriving pharmaceutical sector. The regulatory climate in the area is also supportive, with the FDA playing a key role in the approval and supervision of clinical trials. With an increase in vaccine and therapy studies, the COVID-19 pandemic has also fuelled growth in the North American clinical trials market. As a result, the region's robust healthcare infrastructure, favourable government policies, and other factors are projected to fuel the growth of the North American clinical trials market.

Region with highest CAGR:

Asia-Pacific region is expected to witness profitable growth over the projection period, due to the growing patient base and affordable treatments. The clinical trials market has excellent development potential in Asia and the Pacific. This can be attributed to the region's affordable clinical trials, expanding manufacturing facilities, enacting supportive government regulations, and expanding pharmaceutical business. Cost savings, a large treatment population, participant retention in clinical trials, and ongoing regulatory procedural improvements are mostly responsible for the rise of clinical trial activities in the area. Most pharmaceutical, biopharmaceutical, and medical device companies now outsource their clinical trial work to CROs in this sector due to these advantages.

Key players in the market

Some of the key players in the Clinical Trials Market include: Parexel, IQVIA, Pharmaceutical Product Development, LLC, Wuxi AppTec Inc, Charles River Laboratory ICON Plc, Syneos Health, SGS SA, Chiltern International Ltd, Novo Nordisk A/S, Clinipace, Pfizer, Omnicare, Laboratory Corporation of America Holdings, Medpace Holdings, Inc. and Lilly.

Key Developments:

In March 2023, Syneos Health entered into a multiyear agreement with Microsoft to create a platform that uses machine learning to elevate biopharma companies' commercial performance and speed up clinical trial analysis, planning, and operation.

In March 2023, LEO Pharma and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution in a patient-centric and cost-effective way. The partnership would also support LEO Pharma's overall ambition of building one of the most effective and efficient clinical portfolio execution organizations in the industry.

In February 2023, Syneos Health partnered with Haystack Health, a Roivant Health portfolio company engaged in developing advanced artificial intelligence (AI) and natural language processing (NLP) solutions to improve the identification and enrollment of patients for clinical trials.

In February 2023, Parexel launched a new expert series, New Medicines, Novel Insights. The series features fresh insights from the company's global, cross-functional experts analyzing drug development trends and offering evidence-based guidance to the biopharmaceutical industry.

In January 2023, Rznomics announced a partnership with Charles River Laboratories International, Inc., a viral vector contract development and manufacturing organization (CDMO). Rznomics would leverage Charles River's viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

Phases Covered:

• Phase I
• Phase II
• Phase III
• Phase IV

Service Types Covered:

• Laboratory Services
• Decentralized Clinical Trial Services
• Bioanalytical Testing Services
• Patient Recruitment
• Analytical Testing Services
• Protocol Designing
• Medical Device Testing Services
• Site Identification
• Clinical Trial Supply & Logistic Services
• Clinical Trial Data Management Services
• Other Service Types

Therapeutic Areas Covered:

• Oncology
• Neurology
• Immunology
• Genetic Diseases
• Infectious Diseases
• Metabolic Disorders
• Cardiology
• Other Therapeutic Areas

Study Designs Covered:

• Observational
• Expanded Access
• Interventional

Sponsors Covered:

• Industry
• Non-Government Organizations
• Government Organizations
• Associations
• Other Sponsors

Applications Covered:

• Small Molecules
• Vaccine
• Monoclonal Antibodies
• Cell & Gene Therapy
• Other Applications

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 Emerging Markets
• 3.8 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Clinical Trials Market, By Phase

• 5.1 Introduction
• 5.2 Phase I
• 5.3 Phase II
• 5.4 Phase III
• 5.5 Phase IV

6 Global Clinical Trials Market, By Service Type

• 6.1 Introduction
• 6.2 Laboratory Services
• 6.3 Decentralized Clinical Trial Services
• 6.4 Bioanalytical Testing Services
• 6.5 Patient Recruitment
• 6.6 Analytical Testing Services
• 6.7 Protocol Designing
• 6.8 Medical Device Testing Services
• 6.9 Site Identification
• 6.10 Clinical Trial Supply & Logistic Services
• 6.11 Clinical Trial Data Management Services
• 6.12 Other Service Types

7 Global Clinical Trials Market, By Therapeutic Area

• 7.1 Introduction
• 7.2 Oncology
• 7.3 Neurology
• 7.4 Immunology
• 7.5 Genetic Diseases
• 7.6 Infectious Diseases
• 7.7 Metabolic Disorders
• 7.8 Cardiology
• 7.9 Other Therapeutic Areas

8 Global Clinical Trials Market, By Study Design

• 8.1 Introduction
• 8.2 Observational
• 8.3 Expanded Access
• 8.4 Interventional

9 Global Clinical Trials Market, By Sponsor

• 9.1 Introduction
• 9.2 Industry
• 9.3 Non-Government Organizations
• 9.4 Government Organizations
• 9.5 Associations
• 9.6 Other Sponsors

10 Global Clinical Trials Market, By Application

• 10.1 Introduction
• 10.2 Small Molecules
• 10.3 Vaccine
• 10.4 Monoclonal Antibodies
• 10.5 Cell & Gene Therapy
• 10.6 Other Applications

11 Global Clinical Trials Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 Parexel
• 13.2 IQVIA
• 13.3 Pharmaceutical Product Development, LLC
• 13.4 Wuxi AppTec Inc
• 13.5 Charles River Laboratory
• 13.6 ICON Plc
• 13.7 Syneos Health
• 13.8 SGS SA
• 13.9 Chiltern International Ltd
• 13.10 Novo Nordisk A/S
• 13.11 Clinipace
• 13.12 Pfizer
• 13.13 Omnicare
• 13.14 Laboratory Corporation of America Holdings
• 13.15 Medpace Holdings, Inc.
• 13.16 Lilly