Site Management Organizations Market, 2021-2035

Site Management Organizations Market, 2021-2035

INTRODUCTION

Clinical trials form an integral part of the overall drug development process, enabling the necessary evaluation of the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of drug candidate is dedicated to clinical trials; this is equivalent to an expenditure of USD 78 billion annually. However, the conduct of such trials is often fraught with challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. Further, owing to the inherent complexity of the overall process and involvement of several different stakeholders, these trials are prone to delays. In fact, over 80% of the clinical trials are delayed by at least one to six months, while only 10% of the studies are completed on time. Therefore, innovators in the pharmaceutical industry are constantly developing ways to improve the process of conducting clinical trials and managing research sites. Amidst other alternatives, outsourcing various trial operations to a specialized service provider, such as site management organizations (SMOs), has emerged as a viable option for various developers. The advantages of engaging such specialized service providers are numerous and enable sponsors to meet their clinical research timelines. In addition, SMOs can facilitate rapid patient recruitment, reduce study timelines, and manage the entire clinical trial processes and administrative work for their clients. Moreover, drug / medical device developers, and even the contract research organizations (CROs), can employ the therapeutic and operational expertise, global site networks and well-established processes and tools offered by SMOs in order to carry out their clinical research and site management activities in a cost and time efficient manner.

Currently, around 250 companies claim to be actively providing clinical site management services to drug and medical device developers across the world. Recently, there has been a lot of activity within the site management market, primarily focused on consolidation of affiliated capabilities, service portfolio expansions and collaborations to extend geographical reach. The aforementioned developments may be attributed to the growing preference for one-stop-shops among sponsor companies, and the gradual acceptance of outsourcing as a viable and beneficial operating model for conducting clinical trials and managing research sites. With the growing complexity, as well as rise in the number of clinical trials being registered, the demand for SMOs is anticipated to grow at a steady pace in the coming years.

SCOPE OF THE REPORT

The ‘Site Management Organizations Market – Distribution by Therapeutic Areas (Oncological Disorders, CNS Disorders, Infectious Diseases, Cardiovascular Diseases and Others), Trial Phases (Phase I, Phase II, Phase III and Phase IV), Clinical Trial Components (Site Management, Onsite Monitoring, Project Management and Others), Type of Interventions (Therapeutics, Devices and Surgical Procedure) and Key Geographies (North America, Europe, Asia-Pacific, Latin America, MENA, and RoW): Industry Trends and Global Forecasts, 2021-2035’ report features an extensive study of the current market landscape and future potential of the site management organizations market. The study features an in-depth analysis, highlighting the capabilities of clinical trial site management service providers engaged in this domain. Amongst other elements, the report features:

A detailed review of the overall landscape of companies offering clinical trial site management services to various organizations, including CROs, and pharmaceutical, biotechnology and medical devices companies, along with information on their year of establishment, company size (in terms of employee count), location of headquarters and geographical reach of the companies. The chapter also covers details related to type of service(s) offered (site identification and selection, study feasibility, study protocol development, patient recruitment, patient retention, project management, regulatory support, clinical monitoring, site management, clinical trial data management, patient follow-up, real-time enquiry / information support, study contract, budget and expense management / contract negotiation, hiring / training study investigator, logistics management, quality control and quality assurance and others) and therapeutic expertise of service providers.

An insightful 2×2 representation of the competitiveness analysis of various service providers segregated into three peer groups based on location of their headquarters (North America, Europe, and Asia-Pacific and RoW). The companies were further distributed across the geographies, based on their employee count, into three categories, namely small (1-200 employees), mid-sized (201-500 employees) and large (>500 employees), highlighting the top players in this domain, based on their respective capabilities.

An analysis of the partnerships that have been inked by stakeholders engaged in this domain, during the period 2016-2021 (till August). The various types of partnerships captured in our study include (in alphabetical order) acquisitions, clinical trial agreements, clinical trial site agreements, joint ventures, mergers, product / technology integration agreements, research agreements, service alliances, technology licensing agreements, technology utilization agreements and other related agreements. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership, focus area and most active players (in terms of number of partnerships). It also highlights the regional distribution of the collaborations.

A detailed analysis of various investments received by players engaged in this domain during the period 2015-2021 (till August), based on several relevant parameters, such as year of investment, number of funding instances, amount invested, type of funding (grant, seed, venture capital, secondary offering, other equity, debt and others) and type of investor, along with information on the most active players (in terms of number of funding instances and amount raised), most active investors (in terms of number of funding instances) and geographical distribution (in terms of number of funding instances and amount invested).

An in-depth analysis of completed, ongoing and planned clinical studies during the period 2016-2021 (till August), to present clinical trial key insights, based on several relevant parameters, such as trial registration year, number of enrolled patients, trial status, trial phase, type of sponsor and geographical distribution of number of trials and enrolled patient population.

An informed estimate 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.

Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) that offer various clinical trial site management services, across North America, Europe and Asia-Pacific. Each profile provides an overview of the company, featuring information on the year of establishment, number of employees, location of their headquarters, details related to its site management service portfolio, recent developments, and an informed future outlook.

One of the key objectives of the report was to evaluate the current opportunity and the future potential of the site management organizations market over the coming decades. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2021-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] therapeutic areas (oncological disorders, CNS disorders, infectious diseases, respiratory disorders, cardiovascular diseases, endocrine disorders, gastrointestinal disorders, musculoskeletal diseases, immunological disorders and others), [B] clinical trial phases (phase I, phase II, phase III and phase IV), [C] clinical trial components (site management, onsite monitoring, project management, data management, regulatory affairs, logistics, quality control and others), [D] types of interventions (therapeutics, devices and surgical procedure) and [E] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and RoW). To account for future uncertainties in the market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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

Vinod Gyanchandani (Country Head - Clinical Operations, GDD Experts)

Marisa Vico (Medical Director and Operations Manager, SMO – Dra. Marisa Vico)

Eugene Winifred (Project Manager, Syncretic Clinical Research Services)

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED

Who are the leading players 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 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?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the likely evolution of the site management organizations market in the short to mid-term, and long term.

Chapter 3 provides a general introduction to SMOs, featuring information on their working model and major differences between a SMO and CRO. Further, it provides details related to the various services offered by SMOs. Additionally, it highlights the advantages offered by SMOs acting as one-stop-shops. The chapter concludes with a discussion on the anticipated opportunity areas for SMOs and inputs on their projected growth in the coming years.

Chapter 4 features a detailed review of the current market landscape of around 250 companies offering clinical trial site management services. Additionally, it features an in-depth analysis of service providers, based on a number of relevant parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters. The chapter also covers details about type of site management service(s) offered (site identification and selection, study feasibility, study protocol development, patient recruitment, patient retention, project management, regulatory support, clinical monitoring, site management, clinical trial data management, patient follow-up, real-time enquiry / information support, study contract, budget and expense management / contract negotiation, hiring / training study investigator, logistics management, quality control and quality assurance and others), therapeutic expertise of service providers (oncological disorders, CNS disorders, infectious diseases, respiratory disorders, cardiovascular diseases, endocrine disorders, gastrointestinal disorders, musculoskeletal diseases, immunological disorders, dermatological disorders and others) and geographical reach of the companies.

Chapter 5 presents an insightful competitiveness analysis of the site management organizations, located in North America, Europe and Asia-Pacific. The companies are further segmented based on their employee count, into three categories, namely small (1-200 employees), mid-sized (201-500 employees) and large (>500 employees) across these geographies. The analysis compares the service providers on the basis of various parameters, such as site management services offered, therapeutic expertise, geographical reach and year of establishment. In the chapter, stakeholder entities have been plotted on a 2×2 matrices, having a company’s experience (based on its year of establishment) (abscissa) and company competitiveness (ordinate) as the two axes.

Chapter 6 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in offering clinical trial site management services in North America. Each profile provides an overview of the company, information related to its site management service portfolio, and details on recent developments, as well as an informed future outlook.

Chapter 7 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in offering clinical trial site management services in Europe. Each profile provides an overview of the company, information related to its site management service portfolio, and details on recent developments, as well as an informed future outlook.

Chapter 8 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in offering clinical trial site management services in Asia-Pacific. Each profile provides an overview of the company, information related to its site management service portfolio, and details on recent developments, as well as an informed future outlook.

Chapter 9 features an analysis of the various collaborations and partnerships that have been inked by stakeholders engaged in this domain, during the period 2016-2021 (till August). It includes a brief description of the partnership models (including service alliances, clinical trial agreements, acquisitions, product / technology integration agreements, technology utilization agreements, R&D agreements, mergers, joint ventures, clinical trial site agreements, technology licensing agreements and others) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of agreement, type of agreement, focus area and most active player(s) (in terms of number of partnerships inked). Further, the chapter includes a world map representation of all the deals inked in this field in the period 2016-2021, highlighting both intercontinental and intracontinental partnership activity.

Chapter 10 presents details on various investments received by various players engaged in clinical trial site management domain. It also includes an analysis of the funding instances that have taken place in the market, during the period 2015-2021 (till August), highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 11 provides a detailed analysis of completed, ongoing, and planned clinical studies during the period 2016-2021 (till August), to present clinical trial key insights, highlighting prevalent trends across various relevant parameters, such as trial registration year, number of enrolled patients, trial status, trial phase, type of sponsor and geographical distribution of number of trials and enrolled patient population.

Chapter 12 provides an informed estimate 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.

Chapter 13 presents an insightful market forecast analysis, highlighting the likely growth of the site management organizations market till the year 2035. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] therapeutic areas (oncological disorders, CNS disorders, infectious diseases, respiratory disorders, cardiovascular diseases, endocrine disorders, gastrointestinal disorders, musculoskeletal diseases, immunological disorders and others), [B] clinical trial phases (phase I, phase II, phase III and phase IV), [C] clinical trial components (site management, onsite monitoring, project management, data management, regulatory affairs, logistics, quality control and others), [D] types of interventions (therapeutics, devices and surgical procedure) and [E] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and RoW).

Chapter 14 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 15 provides the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the site management domain. In this chapter, we have presented the details of our conversation with Vinod Gyanchandani (Country Head - Clinical Operations, GDD Experts), Marisa Vico (Medical Director and Operations Manager, SMO – Dra. Marisa Vico) and Eugene Winifred (Project Manager, Syncretic Clinical Research Services).

Chapter 16 is an appendix, that provides tabulated data and numbers for all the figures included in the report.

Chapter 17 is an appendix that provides the list of companies and organizations that have been mentioned in the report.