The rapidly growing clinical pipeline and challenges associated with the conduct of clinical trials in a cost and time effective manner, has presented lucrative opportunities for service providers with expertise in clinical trial site management


The Site Management Organizations Market report features an extensive study of the current market landscape and future potential of the site management organizations market. 


Roots Analysis has announced the addition of “Site Management Organizations (SMO) Market, 2021 – 2035” report to its list of offerings


In recent years, drug / device developers have demonstrated a preference to continue relying on SMOs for conducting clinical trials in order to significantly optimize trial cost and research timelines. Driven by the steady growth in clinical research activity and inherent benefits offered by SMOs, the market opportunity for such players is projected to grow at a significant pace in the foreseen future.


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Key Market Insights


Around 250 companies across the world claim to offer clinical trial site management services

Majority (43%) of the industry stakeholders are headquartered in North America, followed by those based in Asia-Pacific (32%) and Europe (19%). In addition, 25% of the companies engaged in this domain offer site management services across the globe, followed by those providing services in Asia-Pacific (23%).


200+ partnerships were established in this domain, during the period 2016-2021

Service alliances (26%) and clinical trial agreements (23%) emerged as the most common types of partnership models adopted by stakeholders engaged in this domain. Nearly 65% of the deals in this domain were established after 2018, with the maximum activity being reported in 2021 (56).


~USD 1 billion invested in various domain focused initiatives, since 2015

Maximum number of funding instances (21%) were reported in 2021, amounting to USD 614 million in capital investments. A significant number of funding instances (43%) were venture capital rounds, followed by instances of other equity (29%) and grants (7%).


Till 2035, annual demand for clinical trial study participants is expected grow at a CAGR of 8.2%

Currently, North America and Asia-Pacific hold the majority share of the overall demand for clinical trial study participants (60%). By 2035, the demand for patients in clinical trial studies is projected to reach 25 million. Further, currently, the highest demand is generated via phase III trials (43%), followed by phase IV studies (38%).


North America and Europe are anticipated to capture close to 65% of the market share, by 2035

In addition, the market in Asia-Pacific is likely to grow at a relatively faster pace (9%) in the long term. Further, in 2035, the majority share (~45%) of clinical trial site management revenues is likely to be generated from trials focused on phase III evaluation of clinical studies.


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Key Questions Answered

  • Who are the leading players engaged in the clinical trial site management domain?
  • What is the relative competitiveness of different site management organizations?
  • What type of partnership models are commonly adopted by stakeholders in this industry?
  • What is the capital investments trend in the site management organizations domain?
  • Which are the most active clinical trial centers?
  • What are the major market trends and driving factors that are likely to impact the growth of site management organizations market?
  • How is the current and future market opportunity likely to be distributed across key market segments?


The financial opportunity within the SMOs market has been analyzed across the following segments:


  • Therapeutic Areas
  • Oncological Disorders
  • CNS Disorders
  • Infectious Diseases
  • Respiratory Disorders
  • Cardiovascular Diseases
  • Endocrine Disorders
  • Gastrointestinal Disorders
  • Musculoskeletal Diseases
  • Immunological Disorders
  • Others


  • Trial Phases
  • Phase I
  • Phase II
  • Phase III
  • Phase IV


  • Clinical Trial Components
  • Site Management
  • Onsite Monitoring
  • Project Management
  • Data Management
  • Regulatory Affairs
  • Logistics
  • Quality Control
  • Others


  • Types of Interventions
  • Therapeutics
  • Devices
  • Surgical Procedure


  • Key Geographical Regions 
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • MENA
  • Rest of the World 


The report also features inputs from eminent industry stakeholders, according to whom, complexities associated with clinical trial processes and increasing clinical pipeline will drive the growth of the third-party service providers, such as SMOs, engaged in this domain, in the coming future. The report includes detailed transcripts of discussions held with the following experts:


The research includes profiles of key players (listed below); each profile features a brief overview of the company, details related to its site management service portfolio, recent developments and an informed future outlook.

  • FOMAT Medical Research
  • Parexel
  • Pharm-Olam
  • Veristat
  • WCCT Global
  • Worldwide Clinical Trials
  • Fidelis Research
  • Scandinavian CRO
  • TFS HealthScience
  • Trialbee
  • CMIC
  • George Clinical
  • Tigermed
  • Veeda Clinical Research


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