Clinical Research Organization Market Outlook
The global Clinical Research Organization (CRO) market was estimated at USD 80.6 Billion in 2022 and is anticipated to reach USD 220.3 Billion by 2031, expanding at a CAGR of 12.2% during the forecast period.
A clinical research organization (CRO) provides support to the pharmaceuticals, biotechnology, and medical devices industries in the form of research services outsourced on a contract basis. Clinical research organizations (CROs) play a crucial role in the development of pharmaceuticals, medical devices, and therapies. A sponsor (a business, organization, or institution) who wishes to run a clinical trial hires CROs to plan, coordinate, execute, and manage the lifecycle of the clinical trial, safely and efficiently.
CROs have the knowledge, capabilities, processes, and procedures that are needed to develop and run a successful clinical trial while ensuring trial quality and compliance with national and international standards. A CRO serves as the main contact between the sponsor and other stakeholders throughout the trial and communicates with ethics and compliance committees, regulatory personnel, vendors, physicians, and research coordinators.
Macro-economic Factors
Increasing Healthcare Expenditure
Healthcare expenditure refers to the amount of money spent on healthcare goods and services, such as medical treatments, hospitalizations, medical equipment, and other healthcare-related expenses. It includes both public and private spending on healthcare, such as expenditure by governments, insurance companies, and individuals.
Global spending on health more than doubled in real terms over the past two decades, reaching around US$ 8.5 trillion in 2019, or 9.8% of global GDP. Increasing healthcare spending raises the amount of funds for clinical research and development. This results in a large number of clinical trials and high demand for the services of CROs. High-income countries accounted for nearly 80% of global spending on health, with the US accounting for more than 40% alone.
Regulatory Environment
The regulatory environment has a significant impact on the clinical research organization (CRO) market. Regulatory requirements for conducting clinical trials vary by country and region and considerably affect the demand for the services of CROs, the cost of conducting clinical trials, and the profitability of CROs.
Government policies, such as regulations on quality standards, impact the market significantly. For instance, the Drugs and Cosmetics Act (1940) regulates the import, manufacture, and distribution of drugs and ensures that drugs and cosmetics sold are safe, effective, and conform to essential quality standards.
Clinical Research Organization Market Dynamics
Market Drivers
- Rise in the Number of Drug Development Activities
Rising Drug development activities are one of the positive factors for the clinical research organizations (CROs) market. The demand for CRO services increases drastically, as pharmaceuticals and biotechnology companies continue to invest in research and development to bring new drugs to market.
Drug development is a complex and expensive process that involves various steps, that includes drug discovery, preclinical studies, clinical trials, regulatory approval, and others. CROs offer significant cost savings to a large number of pharmaceutical companies by providing economies of scale. Drug development activities are increasing worldwide, which is a primary driving force of clinical research organizations.
The demand for clinical trials to test the safety and efficacy of new drugs and medical devices is increasing, as the pharmaceutical industry continues to expand. For instance, in 2022, Labcorp Drug Development helped to develop 100% of oncology drugs approved by the FDA (The United States Food and Drug Administration).
- Technology Advancement and Outsourcing of Clinical Trials
Outsourcing of clinical trials has become a common practice in the pharmaceutical and biotechnology industries. Clinical trials are complex and require significant resources, including specialized equipment, facilities, and personnel.
Many pharmaceuticals and biotech companies are outsourcing their clinical trial activities to clinical research organizations (CROs) to reduce costs, streamline operations, and improve efficiency. The demand for CROs increases, as more pharmaceutical companies outsource their clinical trials. This is boosting the market for these organizations.
Market Restraint
Regulatory Compliance
Regulatory compliance is an essential aspect of conducting clinical trials, and it is considered to be a significant restraint for the market. CROs are required to comply with strict regulations and guidelines set by regulatory authorities such as the FDA, EMA (The European Medicines Agency), and other national regulatory agencies.
Protecting the rights, safety, and welfare of people who participate in clinical trials is a critical aspect of the regulations set by the FDA. The organization oversees clinical trials to ensure they are designed, conducted, analyzed, and reported according to federal law and good clinical practice (GCP) regulations. Compliance with these regulations is challenging and time-consuming, which makes it difficult for CROs to compete in the market.
Scope of Clinical Research Organization Market Report
The report on the global Clinical Research Organization (CRO) market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes
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Details
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Report Title
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Clinical Research Organization (CRO) Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016-2021
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Forecast Period
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2023–2031
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Segmentation
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Service (Clinical Research Services, Early Phase Development Services, Laboratory Services, Consulting Services, and Others); Molecule Type (Small molecules and Biologics); End User (Pharmaceutical & Biotechnology Company, Research & Academic Institute, and Others)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, Middle East, and Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
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Key Players Covered
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IQVIA Inc, LabCorp, Thermo Fisher Scientific Inc. ICON plc, Syneos Health
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Clinical Research Organization Market Segmental Outlook
On the basis of Service, the global clinical research organization (CRO) market is segmented into clinical research services, early-phase development services, laboratory services, consulting services, and others.
The clinical research services segment is expected to expand at a CAGR of 12.4% from 2023 to 2031. The clinical research services are further categorized into Phase I, Phase II, Phase III, and Phase IV. The growth of the segment is attributed to the increasing prevalence of chronic diseases and the increasing demand for effective medications & diagnostics products across the globe.
Furthermore, various contract research organizations offer a wide range of clinical trial research services and support different areas of medical device & drug development. In 2020, Parexel and Synairgen plc formed a strategic collaboration for conducting a Phase III study of an Interferon-beta (IFN-beta) treatment for COVID-19 patients. Such strategic initiatives by CROs are expected to minimize the hindrance and boost the segment.
In terms of molecule type, the global clinical research organization (CRO) market is segmented into small molecules and biologics.
The small molecules segment is expected to hold 38.5% share of the market during the forecast period, owing to the increasing number of chronic diseases. According to the British Heart Foundation's statistics in August 2022, around 7.6 billion people in the UK suffered from some form of heart or cardiovascular disease in 2021. Such an increase in the number of chronic diseases is expected to increase the demand for treatments, and ultimately the demand for small molecules.
In terms of end-user, the global clinical research organization (CRO) market is segmented into pharmaceutical & biotechnology companies, research & academic institute, and others. The pharmaceutical & biotechnology company is expected to hold 46.3% share of the market in 2022.
The market is growing at a CAGR of 12.5%, owing to the growing population and rising prevalence of chronic diseases. The increasing prevalence of chronic diseases requires more drugs, which in turn, drives the segment.
Regional Outlook
On the basis of region, the global clinical research organization (CRO) market is divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for 40.0% share of the market in 2022. This is attributed to the presence of major pharmaceutical companies in the region and their widespread drug development activity and excellent healthcare infrastructure.
Additionally, several key pharmaceutical companies in the region are outsourcing R&D and clinical trials, due to the changes in competition and reimbursement from generic drugs. This is boosting the Clinical Research Organization (CRO) market in North America.
Key Benefits for Industry Participants & Stakeholders
- In-depth Analysis of the Global Clinical Research Organization (CRO) Market
- Historical, Current, and Projected Market Size in Terms of Value
- Potential & Niche Segments and Regions Exhibiting Promising Growth Covered
- Industry Drivers, Restraints, and Opportunities Covered in the Study
- Recent Industry Trends and Developments
- Competitive Landscape & Strategies of Key Players
- Neutral Perspective on Global Clinical Research Organization (CRO) Market Performance
Segments
By Service
- Clinical Research Services
- Early Phase Development Services
- Laboratory Services
- Consulting Services
- Others
By Molecule Type
- Small molecules
- Biologics
By End-user
- Pharmaceutical & Biotechnology Company
- Research & Academic Institute
- Others
Regions
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
Key Market Players Profiled in the Report
- Asymchem Laboratories (Tianjin) Co., Ltd
- Charles River Laboratories.
- Dalton Pharma Services
- Domainex
- Eurofins Scientific
- Evotec
- Frontage Holdings Corporation
- Genscript
- Hangzhou Tigermed Consulting Co., Ltd.
- ICON plc
- Inotiv
- IQVIA Inc
- Jubilant Pharmova Limited
- LabCorp
- Medpace, Inc.
- Parexel International Corporation
- Pharmaron Beijing Co., Ltd.
- Piramal Enterprises Ltd.
- REPROCELL Inc.
- SGS
- Sun Pharmaceutical Industries Ltd.
- Syneos Health
- Thermo Fisher Scientific Inc.
- WuXi AppTec
Competitive Landscape
- Manufacturers operating in the global Clinical Research Organization (CRO) market include Asymchem Laboratories (Tianjin) Co., Ltd, Charles River Laboratories., Dalton Pharma Services, Domainex, Eurofins Scientific, Evotec, Frontage Holdings Corporation, Genscript, Hangzhou Tigermed Consulting Co., Ltd., ICON plc, Inotiv, IQVIA Inc, Jubilant Pharmova Limited, LabCorp, Medpace, Inc., Parexel International Corporation, Pharmaron Beijing Co., Ltd., Piramal Enterprises Ltd, REPROCELL Inc., SGS, Sun Pharmaceutical Industries Ltd., Syneos Health, Thermo Fisher Scientific Inc., WuXi AppTec.
- Market players are pursuing key strategies such as acquisitions, collaborations, and geographic expansion to increase their market share.