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Market Overview

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The global clinical trials outsourcing market is projected to experience a compound annual growth rate (CAGR) of 6.71% from 2022 to 2027, reaching $56.30 billion by 2027, compared to $38.14 billion in 2021. Pharma and biotech companies often engage other companies to conduct clinical trials due to a lack of expertise, time, or infrastructure. Outsourcing clinical trials offers advantages such as cost efficiency, quicker timelines, and optimal results. Contract research organizations and third-party vendors are commonly outsourced for conducting clinical trials, as they provide professional setups to test the efficacy of treatments on humans. These factors contribute to the growing demand in the global clinical trials outsourcing market.

One significant advantage of outsourcing clinical trials is cost reduction. Clinical drug development trials require substantial investment in infrastructure and expertise. The complexity of clinical trial processes puts pressure on sponsors from regulatory authorities, insurers, and medical communities to minimize costs while improving various aspects, including development size, pipeline expansion, drug quality, safety, and regulatory compliance.

Biopharmaceutical companies allocate a significant portion of their expenditure towards research and development activities and clinical trials. However, the low success rates of these trials can greatly impact a company’s growth. Outsourcing clinical trials effectively addresses this complexity. Remote trials, for example, can reduce trial costs by approximately 25 to 30% by eliminating expenses associated with patient travel and reducing the number of staff needed for on-site monitoring. This contributes to the growth of the global clinical trials outsourcing market.

One of the major challenges faced by developed countries is the increasing patient population, which leads to higher healthcare expenditures. Consequently, there is a demand for advanced treatments that offer value-based solutions for patients. Biopharmaceutical companies are constantly searching for new drugs and conducting clinical trial activities. Research and development in the pharmaceutical and biopharmaceutical industry play a crucial role, providing significant potential for the clinical trial outsourcing market and related activities.

The COVID-19 pandemic has caused a significant shift in the clinical trial industry, leading to increased reliance on outsourcing. The complexity of clinical trials is a major driver for outsourcing, and robust pipelines and stringent regulations further support the need for clinical development services.

Virtual clinical trials are a rapidly growing trend in the biopharmaceutical industry. This underutilized method offers a cost-effective, time-saving, and participant-friendly approach to conducting clinical trials and research. By utilizing virtual collaboration strategies and clinical trial software, businesses can work more efficiently, eliminate the need for sharing documents across multiple office locations, and reduce administrative burdens, thereby contributing to the growth of the clinical trial outsourcing market.

To manage costs and reduce expenditure, many biopharmaceutical companies have downscaled their operations, leading to an increase in clinical trial outsourcing. The globalization, digitalization, and personalized medicine trends have also had a significant impact on the clinical trial industry, contributing to the growth of the global clinical trial outsourcing market in recent years.

India’s biotech industry alone accounts for 2,700 start-ups, and this number is expected to increase to 10,000 by 2024. Globally, there are over 2,093,000 pharmaceutical start-ups, and the rise of smaller companies will further boost the clinical trials outsourcing market.

Synthetic data is improving clinical development by reducing or replacing the control arm of clinical trials, thereby reducing the need for patient recruitment, saving time and money, and eliminating ethical issues related to placebos.

The implementation of artificial intelligence (AI) in clinical trials is a revolutionary technology, primarily adopted by large contract research organizations (CROs). During the COVID-19 pandemic, AI applications were rapidly explored to accelerate clinical trials for faster pandemic cure. AI enhances efficiency in various stages of clinical trials, including design, patient recruitment and retention, and outsourcing services provided by CROs. It also enables companies to manage extensive data accurately and make informed decisions, contributing to the growth of the global clinical trials outsourcing market.

Rare diseases present a significant opportunity for the global clinical trials outsourcing market due to the limited patient population and increasing prevalence worldwide. Outsourcing leaders find it easier to recruit and retain patients in low- and middle-income countries where rare diseases are more prevalent. These CROs often have partnerships with government bodies and large healthcare providers to facilitate patient recruitment. Moreover, the increasing demand for large molecules and personalized medicines, such as cell and gene therapies, further drives the outsourcing market for clinical trials.

The growing number of small biopharmaceutical companies represents another significant opportunity for the global clinical trials outsourcing market. These companies conduct a substantial number of clinical trials but face challenges due to limited capital, lack of infrastructure, and expertise. As a result, they turn to outsourcing clinical trials.

Pharmaceutical and biotech companies heavily rely on research and development activities to develop new drugs. The increasing expenditure on clinical research and development presents lucrative opportunities for the clinical trials outsourcing market.

In the pharma and biopharma industries, research and development activities through outsourcing are continuously increasing, leading to strategic partnerships and collaborations. Most of these associations are based on outcome-based models, ensuring alignment between the sponsors and contract research organizations in terms of expected deliverables. Outsourcing is the preferred choice for drug development, allowing companies to leverage the expertise of contract research organizations, which has significantly contributed to the growth of the global clinical trials outsourcing market. Numerous drugs have been developed through outsourcing services outside of pharmaceutical companies and laboratories.

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Market Segmentation

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The market is segmented based on various factors, including clinical trial phase, end-users, application, and geography.

Segmentation by Application
Cancer
CVDs
Infectious Diseases
Infectious Diseases
Musculoskeletal Diseases
Nervous System Disorders
Other Diseases

Segmentation by Clinical Trial Phase
Phase I
Phase II
Phase III
Phase IV

Segmentation by End-Users
Small & Mid-Size Companies
Large Size Companies

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico
Middle East & Africa -Saudi Arabia, UAE

The global clinical trials outsourcing market is segmented by phase, including Phase I, Phase II, Phase III, and Phase IV. Phase III holds the largest market share in the global clinical trial outsourcing market. As there is a lower likelihood of new drugs successfully advancing from Phase II to Phase III, clinical trials outsourcing services primarily focus on comprehensive analysis of Phase II clinical trials. During Phase III, outsourcing services assess the side effects, efficacy rate, and specific mechanisms of new drugs compared to existing standard drugs.

Cancer is a leading and highly impactful disease worldwide, causing a significant number of deaths. The increasing prevalence of cancer has led to a rise in demand for medications. In 2021, the cancer segment accounted for 33.64% of the market share in the global clinical trial outsourcing market. The clinical trial outsourcing market is further segmented by application, including cancer, cardiovascular disease, nervous system disease, infectious disease, gastroenterology diseases, musculoskeletal disease, nervous system disorders, and other disease applications.

The end-users of the clinical trials outsourcing market are divided into two categories: small and mid-size companies, and large companies. Small and mid-size companies occupy a higher market share and dominate the other segments. Large companies generate annual revenue of over USD 10 billion, while small companies have less than USD 1 billion in revenue.

Due to the extensive research and development activities conducted by pharmaceutical and biotech companies, the later stages of clinical trials are often outsourced, with only the initial discovery phase being performed in-house. The increasing number of small and mid-size biopharmaceutical companies, along with the demand for clinical trial activities from larger biotech and pharma companies, has led to consistent growth in the global clinical trial outsourcing market.

North America holds the dominant position in the global clinical trials outsourcing market, with a market share of 34.33%. The region’s growth is driven by the presence of numerous vendors for clinical trials, significant investments in clinical trials, and high expenditure on drug development activities. The United States and Canada are the major countries conducting a large number of clinical trials in North America. The region’s favorable environment for drug discovery and expertise, coupled with the presence of big pharma and biotech companies, contributes to the high adoption of clinical trial outsourcing services. Additionally, the entry of small and mid-size biopharma CRO companies, new startups, and increased investments further boost the market.

Europe ranks second in the global clinical trial outsourcing market, with a market share of 31.14% globally. This region embraces advanced technologies and aims to reduce expenditure on the process, leading large biotechnology and pharma companies to rely on clinical trial outsourcing.

The Asia-Pacific (APAC) region is experiencing rapid growth in the clinical trial outsourcing market due to its low costs, large patient population, and lenient regulations on clinical trials. The APAC clinical research market’s rapid expansion has created a substantial demand for clinical trial outsourcing. Countries such as China and India provide favorable conditions for conducting clinical trials, attracting Western vendors to these regions. Moreover, there is a growing number of CROs emerging in Asia-Pacific countries.

In recent years, clinical trial outsourcing has shifted towards emerging markets, particularly low-middle-income countries with high patient populations and limited access to affordable treatments. Emerging geographies like the BRICS nations (Brazil, Russia, India, China, and South Africa) present significant opportunities for the clinical trial outsourcing market due to their potential for outsourcing trials. The abundance of patients in these countries is a key factor driving outsourcing activities.

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Competitive Landscape

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The global clinical trial outsourcing market is characterized by intense competition. Numerous international, national, regional, and local market participants vie for supremacy by offering advanced and comprehensive outsourcing services. The increasing competition within the pharmaceutical industry directly influences the competitiveness of the clinical trial outsourcing market. Furthermore, due to the relatively low success rate of clinical trials, outsourcing service providers place significant emphasis on ensuring successful delivery and optimal outcomes, aiming to capture a larger share of the international market.

Key players in the global clinical trial outsourcing market, including IQVIA, Labcorp, Charles River Laboratory, Wuxi AppTec, Syneos Health, PPD (Thermo Fisher Scientific), and Icon Plc, contribute significantly to the market’s substantial size through the provision of high-quality outsourcing services to biopharmaceutical companies, government entities, and academic institutes. These major market players adopt strategic measures such as partnerships and collaborations with both key and prominent industry stakeholders, resulting in heightened competition within the market. Through these strategic approaches and increased participation in clinical research studies, these key market players have been able to secure a considerable market share.

Key companies profiled in this report include Charles River Laboratories, IQVIA, ICON plc, Labcorp Drug Development, Syneos Health, Thermo Fischer Scientific, Wuxi AppTec, Paraxel, Advanced Clinical, Bioanalytix, Curia Global, CMED, Cromos Pharma, Criterium, KCR SA., Medpace, Medelis, Oct Group, Protrials Research, Prometrika, Quality Data Services, QPS, Sofpromed, Veristat, Worldwide Clinical Trials.

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Key Questions Answered

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What is the projected growth of the global clinical trials outsourcing market?

The global clinical trials outsourcing market is predicted to experience a compound annual growth rate (CAGR) of 6.71% and reach a value of USD 56.30 billion by 2027, after being valued at USD 38.14 billion in 2021.

Who are the key players in the clinical trials outsourcing market?

Prominent participants in the clinical trials outsourcing market include Charles River Laboratories, IQVIA, ICON plc, Labcorp Drug Development, Syneos Health, Thermo Fischer Scientific, Wuxi AppTec, and Paraxel.

What is the growth rate of the clinical trials outsourcing market?

The clinical trials outsourcing market is anticipated to grow at a rate of 6.71% during the period between 2021 and 2027.

How has COVID-19 impacted the market growth and market share of clinical trials outsourcing?

The COVID-19 pandemic has caused a significant shift in the clinical trial industry, compelling them to explore outsourcing as a viable option.

What are the factors that contribute to the growth of the clinical trials outsourcing market?

Several factors fuel the growth of the clinical trials outsourcing market, including the increasing demand for drug discovery, rising expenditure in research and development activities, the growing need for large-molecule development, and the emergence of rare disease and personalized medicine.