Clinical Trials Site Management Organizations Market Size, Share & Trends Analysis Report By Clinical Trail Services/Components, By Phase, By Therapeutic Areas (Oncology, Cardiology, CNS), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global clinical trials site management organizations market size was valued at USD 5,572.0 million in 2021 and is anticipated to expand at a CAGR of 6.1% from 2022 to 2030. The market has noticed critical growth on account of the rising R&D investments by pharmaceutical companies owing to the high burden of chronic and infectious diseases. Apart from this, the COVID-19 pandemic has contributed significantly to the demand for clinical trials; as of 12^th April 2022, over 4,645 studies for COVID-19 were in the active stage. Such factors are promoting the market growth.

In recent years the number of clinical trials has increased tremendously. According to Clinical trials.gov, the total number of clinical trials accounted for 325,773 in 2020, whereas, as of April 2022, the number of clinical trials accounted for 410,903. The growth in clinical trial activities has profited the market for clinical trial site management organizations (SMOs). Complexities associated with clinical trials have improved the demand for CROs. A significant number of CROs offering clinical trial site management organizations solutions have further promoted market growth.

During the advent of the pandemic, clinical trials were halted to reduce the spread of the virus. However, owing to the urgent need for vaccines, diagnostics, and therapeutics, the clinical trials were resumed by following social distancing measures. Public organizations globally had made a high investment in R&D to support the clinical trials of COVID-19 vaccines and therapeutics. For instance, as of February 2022, the U.K., government has invested USD 119.1 million to support the development of the Oxford/AstraZeneca COVID-19 vaccine. This is expected to have a positive impact on the market for clinical trial site management organizations.

Clinical research sites have historically been a highly fragmented sector, consisting largely of part-time physician practices and small stand-alone companies. Consolidation has been occurring at an unprecedented rate, with sites coming together under common ownership or administration to operate as a single network. There are two business models in the clinical research industry for clinical trial sites - Free-standing research sites or dedicated research centers, and physician-affiliated clinical trial sites.

Private equity and other institutional investors are more involved in clinical trial sites. The investment thesis for private equity companies is the opportunity to consolidate operations in a highly fragmented industry, resulting in a predictable cash-flow business with economies of scale. Many companies are actively pursuing freestanding sites as part of a roll-up strategy. They prefer to acquire sites with a minimum revenue size, a track record of predictable positive EBITDA, and a diverse PI base, or, at the very least, an active PI who agrees to stay on for an extended period of time. Other institutionally funded companies are pursuing a physician-only model. These companies are exploring relationships with a large number of medical practices in order to scale. Large health systems are particularly appealing partners due to their size and reach, both in terms of PIs and patients.

Clinical Trial Service/Components Insights

The project management segment dominated the market for clinical trial site management organizations and accounted for the largest revenue share of 27.6% in 2021. A clinical trial is considered a large and complex project. Project management involves many complex components and moving parts. These include components such as study design, recruiting, labs, an investigational product, data, materials, and site management. Various project tools and templates can be utilized prior to starting a clinical trial to successfully design and execute a clinical trial. The tools include Microsoft Access, Excel, Outlook, SharePoint, and Visio, as well as Web-based applications. The clinical trial project management life cycle includes study start-up, team management, recruiting, clinical evaluation, and intervention.

The onsite monitoring segment is expected to witness the fastest CAGR of 6.6% during the forecast period. The site monitoring service records the progress of clinical trials and ensures that the monitoring is conducted, and reported in accordance with the SOPs of clinical studies. The clinical trial sites are required to be monitored as per the requirements of the GCP. The growing number of clinical trials has improved the demand for onsite monitoring services in the market for clinical trial site management organizations.

Therapeutic Areas Insights

The CNS segment dominated the market for clinical trial site management organizations and accounted for a revenue share of 16.3% in 2021. The high prevalence of CNS-related issues is contributing to the demand for clinical trials, thereby driving the segment. For instance, the WHO, in 2021, reported that over 55.0 million people have dementia worldwide. The growing geriatric population is one of the key reasons for the high prevalence of dementia. The funding for CNS-related clinical studies from various public organizations is expected to improve the demand for site management and is likely to support the segmental market.

The oncology segment is expected to witness the fastest CAGR of 6.6% in the market for clinical trial site management organizations during the forecast period. Cancer is one of the major causes of death worldwide. As per the estimates of Cancer Tomorrow, 30.2 million people are likely to have cancer by 2040. The high prevalence of the disease is contributing to its demand in research; this is the prime reason for the segment growth. A sedentary lifestyle is further contributing to an increase in cancer incidence, thus promoting the research demand for cancer trials.

Phase Insights

The phase III segment dominated the clinical trials Site Management Organizations (SMOs) market and accounted for the maximum revenue share of 54.0% in 2021. The segment is likely to remain dominant even during the forecast years. Clinical studies in phase III are more complicated than those in earlier stages; this phase also includes a greater number of patients than other phases, which increases the demand for site management in this phase of clinical trials. The failure rate is also highest in this phase as the sample size and research design need precise dosing at an optimal level. Such complications further promote the demand for site management in phase III trials.

The phase I segment is expected to witness the fastest CAGR of 6.6% in the market for clinical trial site management organizations during the forecast period. The surge in R&D spending and increase in the demand for innovative treatments is contributing to the demand for phase I trials, thereby promoting the need for site management services. The high burden of diseases globally, contributing to the demand for new research, is likely to have a positive impact on segment growth.

Regional Insights

In Asia Pacific, the market for clinical trial site management organizations is projected to witness a CAGR of 6.8% during the forecast period. The region has become a hotspot for conducting clinical trials on account of the ease of regulatory compliance, cheap study costs, a growing patient population, and the existence of a few elite clinical institutions functioning as sites. These factors are supporting the demand for site management services, thus promoting the market for clinical trial site management organizations.

Site management organizations operating as independent Contract Research Organization (CRO) divisions offer some significant advantages in the changing Asian market for clinical trials, where fast recruitment of large patient numbers is essential. They are typically used when district physicians or hospital physicians serve as investigators. The majority of study visits are overseen by the patient's personal doctor, who is assisted by research/practice nurses. Such SMOs would be in charge of site training and assistance and would be part of a regional coordination framework. Patients are recruited through database searches and doctor visits, making the model suited for enrolling a large number of people.

Key Companies and Market Share Insights

Mergers, acquisitions, and partnerships among others are the key strategies adopted by notable players to maintain their market share. For instance, in April 2022, ClinChoice partnered with clinical research and development solution provider Cloudbyz. As per the partnership, Cloudbyz provided its clinical research management technology platform for helping ClinChoice in clinical studies, with services such as site identification, site feasibility, and clinical monitoring. Similarly, in September 2021, Elligo Health acquired ClinEdge for USD 135 million to expand its clinical trials service offerings. Some of the prominent players in the clinical trials site management organizations market include:

• Clinedge

• WCG

• ClinChoice

• Access Clinical Research

• FOMAT Medical Research INC.

• SGS

• KV Clinical

• SMO-Pharmina

• Xylem Clinical Research

• Aurum Clinical Research

 Clinical Trials Site Management Organizations Market Report Scope

Segments Covered in the Report 

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global clinical trials site management organizations market report on the basis of clinical trial services/components, phase, therapeutic areas, and region:

• Clinical Trial Services/ Components Outlook (Revenue, USD Million, 2018 - 2030)

  • Site Management

  • Project Management

  • Regulatory

  • Onsite Monitoring

  • Others

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Therapeutic Areas Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Cardiology

  • CNS

  • Pain Management

  • Endocrine

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE