세계의 임상시험 지원기관 시장 : 치료영역별, 시험단계별, 임상시험 구성요소별, 개입유형별, 주요 지역별 업계 동향과 예측

SITE MANAGEMENT ORGANIZATION MARKET: OVERVIEW

As per Roots Analysis, the site management organization market is estimated to grow from USD 12.4 billion in the current year to USD 31. 6 billion by 2035, at a CAGR of 9.8% during the forecast period, till 2035.

SITE MANAGEMENT ORGANIZATIONS MARKET: GROWTH AND TRENDS

Clinical trials are a crucial step of the entire drug development process, allowing for the essential assessment of a drug candidate's safety and effectiveness. Research indicates that approximately 40% of the overall investment allocated for the advancement of drug candidates is spent on clinical trials, amounting to an annual cost of USD 78 billion. Nonetheless, conducting such trials frequently presents significant difficulties, including scientific and operational intricacies, challenges with recruitment and retention of appropriate patients, challenges associated with data management, and rigorous regulatory standards.

Additionally, due to the intrinsic complexity of the entire process and the participation of multiple stakeholders, these trials are susceptible to delays. Over 80% of clinical trials experience delays ranging from one to six months, whereas merely 10% of the studies finish on schedule. Consequently, innovators within the pharmaceutical sector are consistently working on enhancing methods for executing clinical trials and managing them effectively. Among other options, delegating different trial operations to a dedicated service provider, such as site management organizations (SMOs), has become a prominent choice for many developers. As the complexity increases and the number of registered clinical trials rises, the need for SMOs is expected to see consistent market growth throughout the forecast period.

Market Growth Drivers:

The site management organization (SMO) market is driven by increasing clinical trial volume and complexity, as registered studies require specialized site assistance for Phase II / III and precision medicine. Moreover, the increasing prevalence of chronic and rare diseases drives the need for SMOs' expertise in patient recruitment and retention via EHRs and community networks. The transition to decentralized and hybrid trials boosts SMO implementation for overseeing remote monitoring, digital resources, and data accuracy. Further, trends in outsourcing, growth of emerging markets in Asia-Pacific and LATAM, along with technology integration such as AI and eConsent propel further expansion. It is worth highlighting that the need for real-world evidence and post-marketing research is transforming SMOs into scalable, high-value networks.

Market Restraints:

The Site Management Organization (SMO) market faces considerable limitations due to high operational expenses, such as employee training, adherence to regulations, and technology integration which present competitive pricing challenges. Severe rivalry from internal site networks, major CROs with incorporated SMOs, and rising integrated research organizations (IROs) hampers market share and compels smaller SMOs to focus on niche sectors. Recruitment and retention of patients continue to pose challenges, leading to considerable trial delays from insufficient enrollment, even with SMO initiatives. Ultimately, reliance on CRO-sponsor agreements and economic fluctuations in emerging markets subject SMOs to revenue unpredictability, thus hindering their market expansion.

SITE MANAGEMENT ORGANIZATIONS MARKET: KEY INSIGHTS

The report delves into the current state of the site management organizations market and identifies potential growth opportunities within industry. Some key findings from the report include:

1. Presently, around 250 players across the globe claim to offer clinical trial site management services to trial sponsors, for both therapeutic products and medical devices.

2. The market is fragmented, featuring the presence of both established players and new entrants based in different geographies that claim to be capable of offering site management services, for wide range of therapeutic areas.

3. Companies involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and comply to evolving industry benchmarks.

4. Over 200 deals have been inked in the past five years; majority of the reported collaborations were focused on forming service alliances and clinical trial agreements to offer clinical research services to sponsors.

5. Foreseeing a lucrative future, a large number of investors have invested capital worth USD 1 billion, across 29 instances, in companies offering clinical trial site management services.

6. In 2020, around 10,000 trials were registered to evaluate various types of potential interventions and develop evidence-based medicine and health care solutions, worldwide.

7. There has been a surge in the demand for study participants owing to the continuous growth in number of clinical trials; this has prompted drug developers to leverage services to third party service providers.

8. With more than 60% of the clinical trial operations currently being outsourced, we expect the market to grow at a steady pace over the next decade.

9. The anticipated opportunity is expected to be segregated across a variety of therapeutic areas; it is also likely to be well-distributed across key geographical regions.

Site Management Organization Market

The market sizing and opportunity analysis has been segmented across the following parameters:

Therapeutic Areas

• Oncological Disorders
• CNS Disorders
• Infectious Diseases
• Cardiovascular Diseases
• Others

Trial Phases

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

Clinical Trial Components

• Site Management
• Onsite monitoring
• Project Management
• Others

Type of Interventions

• Therapeutics
• Devices
• Surgical Procedures

Key Geographies

• North America
• Europe
• Rest of the World

SITE MANAGEMENT ORGANIZATIONS MARKET: KEY SEGMENTS

SMOs Market is Likely to be Dominated by Trial Studies Intended for the Treatment / Management of Oncological Indications

In terms of therapeutic area, the market is segmented across oncological disorders, CNS disorders, infectious diseases, respiratory disorders, cardiovascular diseases, endocrine disorders, gastrointestinal disorders, musculoskeletal diseases, immunological disorders, dermatological disorders and others. The SMOs market is likely to be dominated by trial studies intended for the treatment / management of oncological indications, capturing 38% of the market share by 2035. This is owing to an increase in number of trials currently being / anticipated to be conducted to investigate the potential of drugs targeting oncological indications, worldwide.

SMOs market for Phase II Trial Studies is Likely to Dominate during the Forecast Period

In terms of the trial phase, the overall market is segmented across Phase I, Phase II, Phase III and Phase IV. The SMOs market for phase II trial studies is likely to capture nearly 40% of the market share in the current year, growing at a CAGR of 12.1%, during the given time period

Site Management Activities is Anticipated to Lead the Site Management Organization Market during the Forecast Period

In terms of clinical trial operations, the overall market is segmented across site management, data management, quality control, onsite manufacturing, regulatory affairs, project management, logistics and others. The SMOs market for site management activities (including site identification and selection, site contracting and payments, site initiation and activation and site close-out) is likely to capture around 30% of the market share in the current year, growing at a CAGR of 9.8%, during the given forecast period.

Market For Therapeutics (Drugs and Biologics) is Likely to Grow at a CAGR of 9.8%, During the Given Time Period

In terms of therapeutics, the overall market is segmented across surgical procedures, devices and therapeutics. the SMOs market for therapeutics (drugs and biologics) is likely to be worth USD 22 billion in 2035, growing at a CAGR of 9.8%, during the given time period.

North America is Likely to Propel the Growth of the Site Management Organization Market

In terms of geographical regions, the overall market is segmented across North America, Europe, Asia-Pacific, Latin America, MENA and RoW.

In the current year, North America captures the majority share of the overall clinical trial site management market and this trend is unlikely to change in the foreseen future. However, Asia-Pacific is likely to grow at a faster growth rate, with a CAGR of 13.7% during the forecast period.

Recent Developments in Site Management Organization Market:

Several recent developments have taken place in the field of site management organization. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• Psyence Biomed entered into a strategic agreement with Australian Clinical Trial Network (ACTioN) for its Phase IIb clinical trial.
• Flourish Research received strategic investment from Genstar Capital to further expand its clinical research services.
• Neutra Corporation acquired Mercury Clinical Research, a US based site management organization. Blackstone, an asset management company, also announced its plans to acquire Tokyo based SMO I'rom Group.

Primary Research Overview

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following individuals:

• Country Head - Clinical Operations, Mid-sized Company, India
• Medical Director and Operations Manager, Small Company, Argentina
• Project Manager, Small Company, India

Example Players in Site Management Organizations Market

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

SITE MANAGEMENT ORGANIZATIONS MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the site management organizations market, focusing on key market segments, including [A] therapeutic area, [B] trial phases, [C] clinical trial components, [D] type of interventions, and [E] key geographical regions.
• Market Landscape: A detailed assessment of overall competitive landscape companies offering clinical trial management services to various organizations, including CROs, and pharmaceutical, biotechnology and medical devices companies based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of service offered, and [E] therapeutic expertise of service providers.
• Company Competitiveness Analysis: A comprehensive competitive analysis of service providers segregated into three peer groups based on location of their headquarters (North America, Europe, and Asia-Pacific and RoW), examining factors, such as [A] supplier strength [B] product strength and [C] application areas.
• Company Profiles: In-depth profiles of prominent players that offer various SMO services focusing on [A] year of establishment, [B] location of headquarters, [C] product portfolio, [D] recent developments and [E] an informed future outlook.
• Partnerships and Collaborations: An analysis of the partnerships that have been inked by stakeholders engaged in site management organization market, based on various parameters, such as [A] year of partnership, [B] type of partnership, [C] focus area and [D] most active players.
• Funding and Investment Analysis: A detailed analysis of various investments received by players engaged in site management organization market based on several relevant parameters, such as [A] year of investment, [B] number of funding instances, [C] amount invested, [D] type of funding (grant, seed, venture capital, secondary offering, other equity, debt and others) and [E] type of investor, [F] most active players, [G] most active investors and [H] geographical distribution (in terms of number of funding instances and amount invested).
• Clinical Trial Analysis: An in-depth analysis of completed, ongoing and planned clinical studies based on several relevant parameters, such as [A] trial registration year, [B] number of enrolled patients, [C] trial status, [D] trial phase, [E] type of sponsor and [F] geographical distribution of number of trials and enrolled patient population.
• Demand Analysis: An analysis of the annual demand for clinical study participants, taking into account the target patient population in ongoing and planned clinical trials, sponsored by both industry and non-industry players.

KEY QUESTIONS ANSWERED IN THIS REPORT

• What is a site-specific management organization and how does it operate?
• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• Which region dominates the site management organizations market?
• What are the key trends observed in the site management organizations market?
• What factors are likely to influence the evolution of this market?
• What are the primary challenges faced by site management organizations?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

• 1.1. Scope of the Report
• 1.2. Research Methodology
• 1.3. Key Questions Answered
• 1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1. Chapter Overview
• 3.2. Site Management Organizations
• 3.3. Role of Site Management Organizations in Clinical Trials
• 3.4. Services Offered by Site Management Organizations
• 3.5. Advantages of One-Stop-Shops
• 3.6. Concluding Remarks

4. COMPETITIVE LANDSCAPE

• 4.1. Chapter Overview
• 4.2. Site Management Organizations: Overall Market Landscape
  • 4.2.1. Analysis by Year of Establishment
  • 4.2.2. Analysis by Company Size
  • 4.2.3. Analysis by Location of Headquarters
  • 4.2.4. Analysis by Service(s) Offered
  • 4.2.5. Analysis by Therapeutic Expertise
  • 4.2.6. Analysis by Geographical Reach

5. COMPANY COMPETITIVENESS ANALYSIS

• 5.1. Chapter Overview
• 5.2. Assumptions and Key Parameters
• 5.3. Methodology
• 5.4. Site Management Organizations: Company Competitiveness Analysis
  • 5.4.1. Competitiveness Analysis: Site Management Organizations in North America
    • 5.4.1.1. Competitiveness Analysis: Small Companies in North America
    • 5.4.1.2. Competitiveness Analysis: Mid-sized Companies in North America
    • 5.4.1.3. Competitiveness Analysis: Large Companies in North America
  • 5.4.2. Competitiveness Analysis: Site Management Organizations in Europe
    • 5.4.2.1. Competitiveness Analysis: Small Companies in Europe
    • 5.4.2.2. Competitiveness Analysis: Mid-sized Companies in Europe
    • 5.4.2.3. Competitiveness Analysis: Large Companies in Europe
  • 5.4.3. Competitiveness Analysis: Site Management Organizations in Asia-Pacific and Rest of the World
    • 5.4.3.1. Competitiveness Analysis: Small Companies in Asia-Pacific and Rest of the World
    • 5.4.3.2. Competitiveness Analysis: Mid-sized Companies in Asia-Pacific and Rest of the World
    • 5.4.3.3. Competitiveness Analysis: Large Companies in Asia-Pacific and Rest of the World

6. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN NORTH AMERICA

• 6.1. Chapter Overview
• 6.2. FOMAT Medical Research
  • 6.2.1. Company Overview
  • 6.2.2. Clinical Trial Site Management Services
  • 6.2.3. Recent Developments and Future Outlook
• 6.3. Parexel
  • 6.3.1. Company Overview
  • 6.3.2. Clinical Trial Site Management Services
  • 6.3.3. Recent Developments and Future Outlook
• 6.4. Pharm-Olam
  • 6.4.1. Company Overview
  • 6.4.2. Clinical Trial Site Management Services
  • 6.4.3. Recent Developments and Future Outlook
• 6.5. Veristat
  • 6.5.1. Company Overview
  • 6.5.2. Clinical Trial Site Management Services
  • 6.5.3. Recent Developments and Future Outlook
• 6.6. WCCT Global
  • 6.6.1. Company Overview
  • 6.6.2. Clinical Trial Site Management Services
  • 6.6.3. Recent Developments and Future Outlook
• 6.7. Worldwide Clinical Trials
  • 6.7.1. Company Overview
  • 6.7.2. Clinical Trial Site Management Services
  • 6.7.3. Recent Developments and Future Outlook

7. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN EUROPE

• 7.1. Chapter Overview
• 7.2. CROMSOURCE
  • 7.2.1. Company Overview
  • 7.2.2. Clinical Trial Site Management Services
  • 7.2.3. Recent Developments and Future Outlook
• 7.3. Fidelis Research
  • 7.3.1. Company Overview
  • 7.3.2. Clinical Trial Site Management Services
  • 7.3.3. Recent Developments and Future Outlook
• 7.4. Scandinavian CRO
  • 7.4.1. Company Overview
  • 7.4.2. Clinical Trial Site Management Services
  • 7.4.3. Recent Developments and Future Outlook
• 7.5. TFS HealthScience
  • 7.5.1. Company Overview
  • 7.5.2. Clinical Trial Site Management Services
  • 7.5.3. Recent Developments and Future Outlook
• 7.6. Trialbee
  • 7.6.1. Company Overview
  • 7.6.2. Clinical Trial Site Management Services
  • 7.6.3. Recent Developments and Future Outlook

8. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN ASIA-PACIFIC

• 8.1. Chapter Overview
• 8.2. CMIC Group
  • 8.2.1. Company Overview
  • 8.2.2. Clinical Trial Site Management Services
  • 8.2.3. Recent Developments and Future Outlook
• 8.3. George Clinical
  • 8.3.1. Company Overview
  • 8.3.2. Clinical Trial Site Management Service
  • 8.3.3. Recent Developments and Future Outlook
• 8.4. Tigermed
  • 8.4.1. Company Overview
  • 8.4.2. Clinical Trial Site Management Services
  • 8.4.3. Recent Developments and Future Outlook
• 8.5. Veeda Clinical Research
  • 8.5.1. Company Overview
  • 8.5.2. Clinical Trial Site Management Services
  • 8.5.3. Recent Developments and Future Outlook

9. PARTNERSHIPS AND COLLABORATIONS

• 9.1. Chapter Overview
• 9.2. Partnership Models
• 9.3. Site Management Organizations: Partnerships and Collaborations
  • 9.3.1. Analysis by Year of Partnership
  • 9.3.2. Analysis by Type of Partnership
  • 9.3.3. Analysis by Year and Type of Partnership
  • 9.3.4. Analysis by Focus Area
  • 9.3.5. Most Active Players: Analysis by Number of Partnerships
  • 9.3.6. Geographical Analysis
    • 9.3.6.1. Region-wise Distribution
    • 9.3.6.2. Country-wise Distribution

10. FUNDING AND INVESTMENT ANALYSIS

• 10.1. Chapter Overview
• 10.2. Types of Funding
• 10.3. Site Management Organizations: Funding and Investment Analysis
  • 10.3.1. Analysis by Year of Investment
  • 10.3.2. Analysis by Amount Invested
  • 10.3.3. Analysis by Type of Funding
  • 10.3.4. Year-wise Analysis by Type of Funding and Amount Invested
  • 10.3.5. Most Active Players: Analysis by Number of Funding Instances
  • 10.3.6. Most Active Investors: Analysis by Number of Funding Instances
  • 10.3.7. Analysis by Type of Investor
  • 10.3.8. Analysis by Geography

11. KEY INSIGHTS FROM CLINICAL TRIAL ANALYSIS

• 11.1. Chapter Overview
• 11.2. Scope and Methodology
• 11.3. Site Management Organizations: Clinical Trial Key Insights
  • 11.3.1. Analysis by Trial Registration Year
  • 11.3.2. Analysis by Trial Registration Year and Enrolled Patient Population
  • 11.3.3. Analysis by Trial Status
  • 11.3.4. Analysis by Trial Registration Year and Trial Status
  • 11.3.5. Analysis by Trial Phase
  • 11.3.6. Analysis by Trial Phase and Enrolled Patient Population
  • 11.3.7. Analysis by Trial Registration Year and Trial Phase (in terms of Number of Clinical Trials)
  • 11.3.8. Analysis by Trial Registration Year and Trial Phase (in terms of Number of Enrolled Patient Population)
  • 11.3.9. Analysis by Type of Sponsor / Collaborator
  • 11.3.10. Geographical Analysis by Number of Clinical Trials
  • 11.3.11. Geographical Analysis by Enrolled Patient Population

12. ANALYSIS OF DEMAND FOR CLINICAL TRIAL PARTICIPANTS

• 12.1. Chapter Overview
• 12.2. Methodology and Key Assumptions
• 12.3. Global Demand for Clinical Trial Participants: Analysis by Enrolled Patient Population
  • 12.3.1. Analysis of Demand by Trial Phase
  • 12.3.2. Analysis of Demand by Therapeutic Area
  • 12.3.3. Geographical Demand by Enrolled Patient Population

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 13.1. Chapter Overview
• 13.2. Forecast Methodology and Key Assumptions
• 13.3. Global Site Management Organizations Market, Till 2035
• 13.4. Site Management Organizations Market, 2021 and 2035: Distribution by Therapeutic Area
• 13.5. Site Management Organizations Market, Till 2035: Distribution by Trial Phase
• 13.6. Site Management Organizations Market, Till 2035: Distribution by Clinical Trial Components
• 13.7. Site Management Organizations Market, Till 2035: Distribution by Type of Intervention
• 13.8. Site Management Organizations Market, 2021 and 2035: Distribution by Region
  • 13.8.1. Site Management Organizations Market, 2021 and 2035: Distribution by Country
  • 13.8.2. Site Management Organizations Market in North America, Till 2035
    • 13.8.2.1. Site Management Organizations Market in the US, Till 2035
    • 13.8.2.2. Site Management Organizations Market in Canada, Till 2035
    • 13.8.2.3. Site Management Organizations Market in Rest of North America, Till 2035
  • 13.8.3. Site Management Organizations Market in Europe, Till 2035
    • 13.8.3.1. Site Management Organizations Market in the UK, Till 2035
    • 13.8.3.2. Site Management Organizations Market in France, Till 2035
    • 13.8.3.3. Site Management Organizations Market in Germany, Till 2035
    • 13.8.3.4. Site Management Organizations Market in Spain, Till 2035
    • 13.8.3.5. Site Management Organizations Market in Italy, Till 2035
    • 13.8.3.6. Site Management Organizations Market in Rest of Europe, Till 2035
  • 13.8.4. Site Management Organizations Market in Asia-Pacific, Till 2035
    • 13.8.4.1. Site Management Organizations Market in China, Till 2035
    • 13.8.4.2. Site Management Organizations Market in Korea, Till 2035
    • 13.8.4.3. Site Management Organizations Market in India, Till 2035
    • 13.8.4.4. Site Management Organizations Market in Australia, Till 2035
    • 13.8.4.5. Site Management Organizations Market in Japan, Till 2035
    • 13.8.4.6. Site Management Organizations Market in Israel, Till 2035
    • 13.8.4.7. Site Management Organizations Market in Rest of Asia-Pacific, Till 2035
  • 13.8.5. Site Management Organizations Market in Latin America, Till 2035
  • 13.8.6. Site Management Organizations Market in MENA, Till 2035
  • 13.8.7. Site Management Organizations Market in Rest of the World, Till 2035

14. CONCLUDING REMARKS

15. EXECUTIVE INSIGHTS

• 15.1. Chapter Overview
• 15.2. Company A
  • 15.2.1. Company Snapshot
  • 15.2.2. Interview Transcript: Country Head-Clinical Operations
• 15.3. Company B
  • 15.3.1. Company Snapshot
  • 15.3.2. Interview Transcript: Medical Director and Operations Manager
• 15.4. Company C
  • 15.4.1. Company Snapshot
  • 15.4.2. Interview Transcript: Project Manager

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS