Clinical Trials Outsourcing Market

Market Overview

The Total Addressable Market (TAM) for clinical trials outsourcing was valued at USD 40.77 billion in 2022. It is estimated to reach USD 74.38 billion by 2031, growing at a CAGR of 6.91% during the forecast period (2023–2031).

Most pharmaceutical and biotechnology firms need more expertise, time, and infrastructure to conduct extensive clinical trials. Therefore, most clinical trials are outsourced to contract research organizations (CROs) and third-party vendors with well-established processes, vast operational and therapeutic area expertise, and geographic reach. CROs specialize in providing research services outsourced on a contractual basis to the pharmaceutical, biotechnology, and medical device industries. These services include biopharmaceutical development, commercialization, clinical development, pharmacovigilance, and clinical trial management. Clinical trial outsourcing by small- and medium-sized companies enables them to conserve their limited resources, enhance efficiency, reduce R&D costs, shorten timelines, and ensure the delivery of the best results.

Market Dynamics

Global Clinical Trials Outsourcing Market Drivers

• Rising Initiatives to Improve Efficiency in Clinical Trials

Biopharmaceutical companies spend considerable resources on conducting clinical trials due to poor patient recruitment and retention and incomplete or failed studies, which is a significant financial burden. However, the surge in the presence of CROs that conduct clinical trials and offer research support services has eliminated these problems. Remote clinical trials, adaptive clinical trials, AI to lower costs, and supply chain activities done by outsourcing services help reduce the costs of clinical trials.

Remote trials can reduce clinical trial costs by around 25%–30%, minimize patient travel costs, and require staff on the clinical trials site. Adaptive clinical trials lead to cost savings due to the flexibility of such clinical studies allowing researchers and scientists to adopt standard protocols to complete the trial requirements based on the collected information. Additionally, AI is instrumental in making every clinical trial stage more efficient with practical design, patient recruitment, and retention in outsourcing services by contract research organizations. These factors have contributed to a surge in clinical trial outsourcing activities in recent years.

• High Demand for Large Molecule Products and Personalized Medicines 

Small-molecule medications have become a significant pillar of the pharmaceutical business over the past few decades. Currently, small-molecule drugs account for 90% of global pharmaceutical sales. However, large molecules, such as biologics, have emerged as popular options recently and achieved high importance across the pharmaceutical and biopharmaceutical industries. Large molecules have highly impactful therapeutic effects that drive drug discovery. These are majorly carried out through clinical research outsourcing companies. Due to the complex structure of large molecules and the complexity of trials, these drugs have complex processes requiring more than 1,000 steps. The rise in demand for extensive molecule drug discovery is expected to propel the demand for clinical trial outsourcing services and offer lucrative growth opportunities to vendors in the market.

Several rare diseases are highly prevalent worldwide, and more than 6,000–8,000 require various treatments, which has resulted in a surge in drug discovery. The rise in the development of drugs for rare diseases will drive the demand for research and expertise in the field. The stringent regulatory environment, investment in initiatives by small biotechnology companies to develop orphan drugs, and lack of manufacturing capabilities are expected to accelerate the demand for outsourcing services in clinical trials.

Global Clinical Trials Outsourcing Market Restraint

• Geographical Locations and Crucial Regulatory Aspects for Clinical Trials

The burden of high expenditure and a smaller number of successful clinical trials and approvals are significant growth barriers to outsourcing clinical trials. Most companies engaged in drug development must adhere to increasingly stringent regulations. In clinical trial procedures, cooperation between outsourcing services providers and research sponsors, such as biopharmaceutical companies, academic organizations, and government organizations, is essential. Furthermore, selecting the optimal geographical locations to conduct clinical trials is one of the significant challenges in conducting CT. The primary factor is that there is a difference in regulations with other sites for outsourcing clinical trials, which hampers the outsourcing activities.

Global Clinical Trials Outsourcing Market Opportunities

• Entry of Start-Ups Specializing in Drug Discovery

The surge in the prevalence of various communicable and non-communicable diseases has propelled the demand for new therapies and drugs. Consequently, several pharmaceutical companies are conducting clinical trials for multiple indications. Most small and mid-sized biotechnology and pharmaceutical companies need the development infrastructure and in-house expertise to conduct clinical trials. Therefore, these companies primarily rely on clinical research outsourcing to CROs. Compared to large biopharmaceutical companies, small companies are working toward the launch of new drugs in the market. In 2020, around 40% of the new drugs launched in the US market were from emerging pharmaceutical companies, a significant increase from the last five years.

Although small pharmaceutical start-ups are highly focused on drug discovery, the lack of development infrastructure and capital has compelled small biopharmaceutical companies to rely on clinical research associates. In recent years, the rise in expenditure on R&D initiatives by start-ups and small biopharmaceutical companies has propelled the demand for clinical trial outsourcing services.

Segmental Analysis

The global clinical trials outsourcing market is segmented by phase, application, and end-user.

By phase, the global clinical trials outsourcing market is divided into phase I, phase II, phase III, and phase IV.

The phase III segment is the highest contributor to the market and is anticipated to grow at a CAGR of 7.37% over the forecast period. In phase III, around 300 to 3,000 volunteers are required to participate in the study. The duration of phase III clinical trials is about 1–4 years, which is relatively higher than all the other phases. The long-term requirements for a large patient population make this phase more expensive. Furthermore, the phase involves checking the efficacy of drugs and monitoring adverse reactions. Thus, the adverse reactions associated with most drugs limit their chances of moving to the next phase to 25%–30%. In this phase, the effectiveness of a new drug is compared with current standard treatments. As per the WHO, around 68,999 drugs entered phase III by 2022.

In phase II researcher administer the new drug to a larger group of volunteers (around 100 to 1000) with the disease for which the drug is developed to assess its effectiveness and safety for the next stage. For a drug developer company, navigating the complexities for phase 2 of clinical trials is highly challenging due to a high number of volunteers, so with outsourcing service providers make it simple. Availability of specific volunteer data by outsourcing reduced the recruitment time; every step will be on track quickly and save time and budget for the sponsor company. As per the WHO, around 88,530 compounds were in phase II clinical trials till 2022.

By application, the global clinical trials outsourcing market is segmented into cancer, cardiovascular diseases, nervous system diseases, infectious diseases, musculoskeletal diseases, gastroenterology diseases, and others.

The cancer segment owns the market and is expected to grow at a CAGR of 6.69% over the forecast period. Oncology is one of the most dominant therapeutic areas in clinical trials. In both industry and non-industry-sponsored clinical trial methods, the oncology segment dominates the market with accounts for the higher number of clinical trial activities. Due to the rising prevalence of cancer conditions, there is a massive demand for clinical trials. Due to the changing paradigm of cancer testing in the world, there is a constant increase in the number of patients affected by the disease pressuring companies to invest in clinical trials for better results.

The rapid increase in the prevalence of cardiovascular diseases (CVDs) worldwide is expected to drive the demand for appropriate treatments. CVDs have emerged as one of the leading causes of mortality worldwide over the years. For instance, in 2019, more than 17.9 million individuals succumbed to CVD, almost 32% of global deaths. Around 85% of this population is prone to death caused by heart attacks and strokes. In low- and middle-income countries, CVD prevalence has rapidly increased in recent years. Cardiovascular diseases are becoming more common and harder to deal with, which will drive the need for clinical trials on CVD. There is a high demand for participant enrollment and recruitment procedures conducted for clinical trials in the market, which is also one of the challenges for pharmaceutical and medical device companies. Thus, these companies actively outsource their clinical trial requirements to CROs.

By end-user, the global clinical trials outsourcing market is segmented into small and mid-size enterprises and large enterprises.

The small and mid-size enterprises segment is the highest contributor to the market and is anticipated to grow at a CAGR of 7.09% for the forecast period. In recent years, the global pharmaceutical and biotechnology sectors have witnessed rapid growth in terms of volume and revenue. The global prevalence of various diseases has propelled the demand for new drugs and therapies. Additionally, conducting clinical trials is one significant activity in the biopharmaceutical industry for testing the safety level of drugs and the effectiveness of newly developed solutions. Currently, small and mid-size biopharmaceutical companies are highly relying on outsourcing for drug development activities of new drugs.

Large pharmaceutical companies such as Roche, Johnson & Johnson, Pfizer, and Merck & Co., witnessed significant growth in R&D expenditure in 2021. These enterprises are known to spend billions of dollars on R&D initiatives. Most large pharmaceutical and biotechnology companies have been conducting clinical trials internally. However, the trend has changed over the past decade as many large companies outsource their clinical trials to focus on other products and marketing trends, work on multiple pipeline products simultaneously, and more.

Regional Analysis

By region, the global clinical trials outsourcing market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global clinical trials outsourcing market shareholder and is anticipated to grow at a CAGR of 6.67% during the forecast period. The US and Canada are the two leading countries in North America conducting most clinical investigations. The presence of an increased number of big biopharmaceutical companies and high development in clinical trials propel the market growth in the country; due to stringent regulations and high costs required for the clinical trials in the region, most of the clinical trials are outsourced in the North American region. Stringent regulations for drug approvals in the market and rising demand for biosimilars and biologics is driving the adoption of clinical trials outsourcing in this region. In addition, factors like cost optimization, patient recruitment, and government regulations significantly contribute to the transition of clinical trial outsourcing from the US to other countries.

Europe is estimated to grow at a CAGR of 7.26% over the forecast period. One of the primary reasons for the increasing demand for clinical trial outsourcing in Europe is the lower cost of clinical trials compared to the US. Most of the more prominent pharmaceutical companies are looking for outsourcing services in the region from regional to foreign markets. The two major factors that drive outsourcing of clinical trials in the region are time and money. In the 20th century, Western Europe witnessed a decline in clinical trials, which paved the way for Eastern Europe to leverage the opportunity. In addition, several Eastern European nations have developed infrastructure for clinical trials. The extensive, centralized healthcare system is the critical fact that triggered the fast enrolment in clinical trial outsourcing in various regions. On the other side, based on patient population, many populations were available for the vendors to conduct the clinical trials.

The rapid growth in the Asia-Pacific clinical research market has created a massive market for clinical trial outsourcing. The region is ahead in conducting decentralized clinical trials in the market. Countries like China and India are mainly influencing clinical trial outsourcing globally. China is working to improve the regulatory process to reduce start-up times. The cost of conducting clinical trials in this region is  25 to 30% lower than in the US and some European countries. The number of clinical trials in Asian counties is increasing, which is not reducing. Some developing countries like Vietnam, Indonesia, Philippines have seen rising standards of living, mainly contributing to the clinical trials in Asian countries.

Latin America is one of the emerging regions for clinical trial outsourcing and includes the six most dominant countries: Brazil, Mexico, Argentina, Chile, Peru, and Colombia. These countries account for two-thirds of regional populations and 60%–70% of clinical trials. Mexico, Brazil, and Argentina dominate the region. Various changes in the regulatory environment are expected to have an impact on the regional market. The Middle East and Africa region is popularly known for conducting clinical trials in the infectious disease segment, as this region as it is prone to several epidemics and outbreaks. In addition, the most extensively performed clinical trials in the region are in the therapeutic area of oncology, followed by gastroenterology, respiratory, and more.

Recent Developments

• December 2022- Labcorp announced that it had begun operations at a new, more extensive anatomic pathology and histology (APH) laboratory in Los Angeles, expanding its global central laboratory capabilities. The new laboratory is a dedicated Center of Excellence focused on APH laboratory testing solutions.
• October 2022- Labcorp announced the fulfillment of transactions establishing a long-term laboratory agreement with Ascension, one of the nation's leading non-profit and Catholic health systems. Labcorp purchased select assets of Ascension’s outreach laboratory business and will manage the health system’s hospital-based laboratories in Alabama, Florida, Kansas, Maryland, Michigan, New York, Oklahoma, Tennessee, Texas, and Wisconsin.

Clinical Trials Outsourcing Market Segmentation

By Phase

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

By Applications

• Cancer
• Cardiovascular Diseases
• Nervous System Diseases
• Infectious Diseases
• Musculoskeletal Disease
• Gastroenterology Diseases
• Others

By End-User

• Small and Mid-Size Enterprises
• Large Enterprises

By Regions

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa