The global clinical trials outsourcing market size was estimated at USD 42.84 billion in 2021 and it is expected to reach around USD 76.57 billion by 2030, registering growth at a CAGR of 6.67% during the forecast period 2022 to 2030.
Clinical trial outsourcing refers to the delegation of several duties involved in conducting clinical trials and related activities by the medical or pharmaceutical companies to indicate what works for the patient and what does not by testing them in a professional setup. The market growth can be attributed to the rising need for new and advanced drugs and therapeutics to be tested and approved to address the rising prevalence of several life-threatening diseases. Moreover, the increasing investments in healthcare research and drug development activities are also adding to the market growth. Outsourcing clinical trials offers several advantages to pharmaceutical and biotech companies such as cost efficiency, minimum timeline, timely result delivery, etc. As a result, pharmaceutical industries are increasingly opting for clinical trial outsourcing services to avail significant advantages in terms of cost as well as efficient drugs or vaccines.
Pharmaceutical companies are looking for ways to reduce overall expenses, for which they need to save costs in the research and development infrastructure and downsize their research staff. Therefore, pharma companies are outsourcing research and development work to a third party in order to increase the success rate, accelerate drug approvals and increase profits. Moreover, growing investments by both private players and government authorities for the development of novel drugs and therapies are providing a boost to the global clinical trial outsourcing market.
In addition, the development of precision medicines is gaining wide traction in the healthcare sector. Precision medicine is a customized healthcare model that has tailored treatments and practices according to a patient’s molecular profiling and genetics. Most of the clinical research outsourcing (CROs) providers are extensively working on developing precision medicine to reduce the overall cost of failure of a drug and develop effective therapy in less time. CROs provide guidance and support through all the stages of precision medicine trials. As a result, several biotech and pharma companies are highly relying on such service providers for drug trials and approvals, which in turn, is adding to the growth of the global clinical trial outsourcing market.
Increasing Number of Communicable and Non-Communicable Diseases Are Driving the Industry
The increasing prevalence of different diseases around the world and the rising demand for new medications to treat them are promoting market expansion. The major cause of death worldwide is non-communicable diseases (NCDs), which include mostly cardiovascular illnesses, diabetes, malignancies, and chronic respiratory diseases. They cause the death of seven out of ten, or 74% of all fatalities, majorly in low- and middle-income countries. The industry is also progressing due to the increasing government regulation, research, and innovation; improving primary healthcare; surging production of new drugs; and rising technical assistance.
Additionally, communicable diseases, including neglected tropical diseases (NTDs), such as HIV/AIDS, tuberculosis (TB), malaria, and viral hepatitis, are among the common causes of death and disability in low-income countries and marginalized groups. As a result, the market is being driven by the increased prevalence of these diseases and the rising drug demand. Also, the global COVID-19 pandemic and the expanding need for effective treatments are increasing the demand for clinical trials outsourcing services.
Outsourcing of Phase 3 Clinical Trials Is Increasing
In 2021, phase 3 clinical trials accounted for the largest revenue share, of more than 36%, in the market. Due to a huge number of clinical trials in the phase 3 stage and the high chance of failure in clearing this phase, pharmaceutical companies look forward to partnering with outsourcing partners, which, in turn, contributes to the clinical trials outsourcing market expansion.
Furthermore, the phase 3 category is likely to grow significantly in the coming years because it provides information on potential drug interactions as well as drug safety and efficacy. Phase 3 clinical research enables medical professionals and researchers to gain a deeper understanding of drugs and their side effects. With this knowledge, they can find new and improved methods for disease detection, diagnosis, treatment, and prevention, all of which benefit disease sufferers.
Demand for AI-Based Clinical Trial Solutions To Rise Significantly in Future
One of the main trends in the industry is the substantial investments that pharmaceutical companies are making to use AI to replenish their different pipelines. The market is also being driven by the increasing number of public and private initiatives to encourage the implementation of AI-powered solutions in new medication efficacy trials, in order to hasten drug discovery. Due to the rising use of AI-based tools and supportive government initiatives for their adoption in various healthcare domains, the demand for AI-based clinical trial solutions is projected to grow significantly in the coming years.
Moreover, to increase the use of AI-based clinical trial solutions for the development of drugs, healthcare players have collaborated with technology companies. For instance, Bristol-Myers Squibb announced in March 2019 that it had reached a strategic agreement with Concerto HealthAI, to use Concerto's AI-based solution for drug research.
Small & Mid-Sized Companies To Show Faster Growth
The small & mid-sized companies category is expected to witness faster growth during the forecast period. Contract outsourcing transfers the execution of drug safety functions and processes to a third party. A lot of companies outsource to reduce high initial investments and fixed overhead costs, improve resource flexibility, and secure additional capacity. For small and medium-sized businesses, outsourcing is a cost-effective option. Outsourcing can make it possible for small & mid-sized players to conduct clinical trials in the therapeutic area where they may not have the expertise and/or resources to independently develop drugs.
Cancer Application Dominates Market
In 2021, the cancer category accounted for the highest revenue share, of around 34%, in the market. Because of their side effects, cancer medications must be evaluated for safety. The rise in cancer prevalence has hastened the demand for such medications. Thus, this factor increases the number of clinical trials and contributes to the market expansion in this category.
Whereas, the nervous system disorder category is projected to grow at the highest CAGR during the forecast period, owing to the increasing prevalence of nervous system disorders, including tension-type headaches, migraine, dementias, and traumatic brain injury. Moreover, the absence of essential drugs is driving the demand for drug developments, which, in turn, propels the market.
North America Captured Majority of Revenue Share
Geographically, North America generated the highest revenue in 2021 in the market. This is due to the presence of developed healthcare infrastructure, high healthcare expenditure, the rise in the number of advanced drug research studies, high investment in clinical trials, and the presence of key players in the region.
In addition, Europe holds the second position in the market, due to the lower cost of clinical trials and well-established infrastructure for clinical trials. Furthermore, a dense network of healthcare facilities, clinical research universities, and high R&D expenditure of pharmaceutical companies will propel the demand for clinical trials outsourcing services in the coming years. Moreover, the rapidly increasing percentage of the aging population, which is being caused by a low fertility rate, emigration of young people, and rising life expectancy in Central and Eastern European countries, is leading to the rising healthcare investment. Thus, the increasing expenditure on the healthcare sector drives the regional market growth.
On the other hand, the APAC market is expected to witness the fastest growth, advancing at a CAGR of over 7.5%, during the forecast period. This can be mainly ascribed to the improving healthcare infrastructure, increasing drug research activities, and rising prevalence of diseases in the region. Additionally, low costs of clinical trials, a high patient population, and the rise in the number of CROs in APAC are also boosting the regional market growth.
Company Profile
ICON plc. (PRA Health Sciences), PAREXEL International Corp., Thermo Fischer Scientific, Inc. (Pharmaceutical Product Development, LLC.), Sygnature Discovery Limited, WuXi AppTec Co., Ltd., Laboratory Corporation of America Holdings, Jubilant Biosys Limited, Charles River Laboratories International, Inc., Albany Molecular Research, Inc., and Syneos Health Inc are the leading market players of the global clinical trial outsourcing market.
Key Players in the Clinical Trials Outsourcing Market Are:
Market Segmentation
Based on Phase
Based on End User
Based on Application
Geographical Analysis
1. Product Overview
2. Research Methodology
3. Executive Summary
4. Impact of COVID-19
5. Voice of Customer
5.1. Reasons for Clinical Trial Outsourcing
5.2. Clinical Trial Outsourcing, by Region
5.3. Clinical Trial Outsourcing, by Clinical Trial Phase
5.4. Clinical Trial Outsourcing, by Therapeutic Area
5.5. Brand Awareness
6. Global Clinical Trial Outsourcing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Clinical Trial Phase (Phase 0, Phase 1, Phase 2, Phase 3, Phase 4)
6.2.2. By Therapeutic Area (Oncology, Hematology, Central Nervous System, Cardiovascular/Metabolic, Respiratory, Infectious Diseases, Immunology, Rare Diseases, Medical Devices, Others)
6.2.3. By End-user (Biotechnology & Pharmaceutical Companies, Medical Device Companies, Academic & Research Institutions)
6.2.4. By Company (2021)
6.2.5. By Region
6.3. Product Market Map
7. North America Clinical Trial Outsourcing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Clinical Trial Phase
7.2.2. By Therapeutic Area
7.2.3. By End-user
7.2.4. By Country
7.3. North America: Country Analysis
7.3.1. United States Clinical Trial Outsourcing Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Clinical Trial Phase
7.3.1.2.2. By Therapeutic Area
7.3.1.2.3. By End-user
7.3.2. Mexico Clinical Trial Outsourcing Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Clinical Trial Phase
7.3.2.2.2. By Therapeutic Area
7.3.2.2.3. By End-user
7.3.3. Canada Clinical Trial Outsourcing Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Clinical Trial Phase
7.3.3.2.2. By Therapeutic Area
7.3.3.2.3. By End-user
8. Europe Clinical Trial Outsourcing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Clinical Trial Phase
8.2.2. By Therapeutic Area
8.2.3. By End-user
8.2.4. By Country
8.3. Europe: Country Analysis
8.3.1. France Clinical Trial Outsourcing Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Clinical Trial Phase
8.3.1.2.2. By Therapeutic Area
8.3.1.2.3. By End-user
8.3.2. Germany Clinical Trial Outsourcing Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Clinical Trial Phase
8.3.2.2.2. By Therapeutic Area
8.3.2.2.3. By End-user
8.3.3. United Kingdom Clinical Trial Outsourcing Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Clinical Trial Phase
8.3.3.2.2. By Therapeutic Area
8.3.3.2.3. By End-user
8.3.4. Italy Clinical Trial Outsourcing Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Clinical Trial Phase
8.3.4.2.2. By Therapeutic Area
8.3.4.2.3. By End-user
8.3.5. Spain Clinical Trial Outsourcing Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Clinical Trial Phase
8.3.5.2.2. By Therapeutic Area
8.3.5.2.3. By End-user
9. Asia-Pacific Clinical Trial Outsourcing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Clinical Trial Phase
9.2.2. By Therapeutic Area
9.2.3. By End-user
9.2.4. By Country
9.3. Asia-Pacific: Country Analysis
9.3.1. China Clinical Trial Outsourcing Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Clinical Trial Phase
9.3.1.2.2. By Therapeutic Area
9.3.1.2.3. By End-user
9.3.2. India Clinical Trial Outsourcing Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Clinical Trial Phase
9.3.2.2.2. By Therapeutic Area
9.3.2.2.3. By End-user
9.3.3. South Korea Clinical Trial Outsourcing Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Clinical Trial Phase
9.3.3.2.2. By Therapeutic Area
9.3.3.2.3. By End-user
9.3.4. Japan Clinical Trial Outsourcing Market Outlook
9.3.4.1. Market Size & Forecast
9.3.4.1.1. By Value
9.3.4.2. Market Share & Forecast
9.3.4.2.1. By Clinical Trial Phase
9.3.4.2.2. By Therapeutic Area
9.3.4.2.3. By End-user
9.3.5. Australia Clinical Trial Outsourcing Market Outlook
9.3.5.1. Market Size & Forecast
9.3.5.1.1. By Value
9.3.5.2. Market Share & Forecast
9.3.5.2.1. By Clinical Trial Phase
9.3.5.2.2. By Therapeutic Area
9.3.5.2.3. By End-user
10. South America Clinical Trial Outsourcing Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Clinical Trial Phase
10.2.2. By Therapeutic Area
10.2.3. By End-user
10.2.4. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Clinical Trial Outsourcing Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Clinical Trial Phase
10.3.1.2.2. By Therapeutic Area
10.3.1.2.3. By End-user
10.3.2. Argentina Clinical Trial Outsourcing Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Clinical Trial Phase
10.3.2.2.2. By Therapeutic Area
10.3.2.2.3. By End-user
10.3.3. Colombia Clinical Trial Outsourcing Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Clinical Trial Phase
10.3.3.2.2. By Therapeutic Area
10.3.3.2.3. By End-user
11. Middle East and Africa Clinical Trial Outsourcing Market Outlook
11.1. Market Size & Forecast
11.1.1. By Value
11.2. Market Share & Forecast
11.2.1. By Clinical Trial Phase
11.2.2. By Therapeutic Area
11.2.3. By End-user
11.2.4. By Country
11.3. MEA: Country Analysis
11.3.1. South Africa Clinical Trial Outsourcing Market Outlook
11.3.1.1. Market Size & Forecast
11.3.1.1.1. By Value
11.3.1.2. Market Share & Forecast
11.3.1.2.1. By Clinical Trial Phase
11.3.1.2.2. By Therapeutic Area
11.3.1.2.3. By End-user
11.3.2. Saudi Arabia Clinical Trial Outsourcing Market Outlook
11.3.2.1. Market Size & Forecast
11.3.2.1.1. By Value
11.3.2.2. Market Share & Forecast
11.3.2.2.1. By Clinical Trial Phase
11.3.2.2.2. By Therapeutic Area
11.3.2.2.3. By End-user
11.3.3. UAE Clinical Trial Outsourcing Market Outlook
11.3.3.1. Market Size & Forecast
11.3.3.1.1. By Value
11.3.3.2. Market Share & Forecast
11.3.3.2.1. By Clinical Trial Phase
11.3.3.2.2. By Therapeutic Area
11.3.3.2.3. By End-user
12. Market Dynamics
12.1. Drivers
12.2. Challenges
13. Market Trends & Developments
14. Competitive Landscape
14.1. ICON plc. (PRA Health Sciences)
14.2. PAREXEL International Corp.
14.3. Thermo Fischer Scientific, Inc. (Pharmaceutical Product Development, LLC.)
14.4. Sygnature Discovery Limited
14.5. WuXi AppTec Co., Ltd.
14.6. Laboratory Corporation of America Holdings
14.7. Jubilant Biosys Limited
14.8. Charles River Laboratories International, Inc.
14.9. Albany Molecular Research, Inc.
14.10. Syneos Health Inc
15. Strategic Recommendations