Patient Recruitment and Retention Services Market (3rd Edition), 2022-2035

Patient Recruitment and Retention Services Market (3rd Edition), 2022-2035

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. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. Studies suggest that around 40% of the total investment made for the development of a drug candidate is dedicated to clinical trials. 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. It is worth mentioning that around 80% of the clinical trials are delayed due to insufficient patient recruitment. Further, retaining patients is also a major concern in pharmaceutical research and development; 15% to 40% of the enrolled patients drop out before the studies are completed, significantly impacting product approvals / launch timelines. Therefore, patient outreach, recruitment and retention strategies have evolved significantly, especially with the availability of a variety of digital data generation, management and marketing solutions. In fact, a number of modern technology-enabled offerings are now available to support various aspects of clinical research and patient recruitment.

Q1. What is the current market landscape of the patient recruitment and retention services market?

Amongst several known challenges, patient recruitment is considered to be one of the rate limiting steps when it comes to getting drugs to the market. Presently, more than 155 companies have the required capabilities to offer patient recruitment and retention services across different geographical locations. Such service providers employ a variety of outreach methods and, over time, have attained a vital role in the successful conduct of clinical research. Further, several contract service providers are entering into strategic alliances in order to enhance their respective capabilities and offer an expanded portfolio of services to their clients.

Q2. How has outsourcing evolved in the patient recruitment and retention domain?

Several small and mid-sized players do not have dedicated patient enrolment teams and lack the necessary capabilities / expertise to successfully recruit desired number of patients in clinical trials. In some cases, the clinical studies are too large or geographically broad to be managed by internal staff. Further, the stringent ethical and regulatory guidelines associated with patient enrollment in trials impose a significant burden on drug developers. As a result, outsourcing has become a popular operating model with regards to patient recruitment and retention; several specialty service providers, with expertise and experience in this domain, are driving the growth of this upcoming segment of the healthcare market. The advantages of engaging contract service providers are numerous and enable sponsors to meet their clinical research timelines and thereby, launch respective offerings as planned.

Q3. What are the recent developments and expected trends in the patient recruitment and retention domain?

Over the past decade, the patient recruitment and retention industry has witnessed tremendous increase in the use of social media platforms, including Facebook, Instagram, Pinterest, LinkedIn and Twitter, and mobile applications for engaging and recruiting patients in clinical studies; these approaches are cost-effective and can be used to connect with diverse and hard-to-reach patient populations. In pursuit of capability and competence improvements, several service providers have also begun adopting and implementing modern technical strategies, such as Electronic Health Records (EHRs) and Real-World Evidence (RWE) for patient enrolment; these novel methods tend to be more efficient and yield a narrow pool of potentially eligible participants for targeted mailings.

Q4. What are the key challenges faced by patient recruitment and retention service providers?

The primary challenge faced by patient recruitment and retention service providers is the lack of awareness amongst individuals regarding the clinical studies and the benefits offered to study participants. Further, pharmaceutical companies do not allocate adequate budget for carrying out the patient enrolment process. Specifically for clinical trials evaluating orphan drugs and personalized therapies, finding the specialized pool of eligible patients is a burdensome and costly task. Other challenges in this domain include fear of individuals about the adverse events associated with clinical trials, lack of communication between study participants and researchers due to language barrier, and large geographical distance between the patient’s residence and study site, which affect the participation and retention of patients in research studies.

Q5. What are the key value drivers in the patient recruitment and retention service market?

Owing to rise in the number of clinical trials that seek to enroll millions of patients, and complexities associated with patient accrual, drug developers are likely to outsource the patient recruitment and retention process to service providers. Moreover, we believe that increase in clinical development activity in emerging markets, availability of one-stop patient recruitment service providers, and stringent regulations related to patient enrollment are likely to provide further impetus to the patient recruitment services market.

Q6. What is the current market scenario and likely growth associated with patient recruitment services domain?

The patient recruitment services market is anticipated to grow at a steady pace in the coming years. Owing to the need for large and diverse patient populations, phase III trials are anticipated to be responsible for the maximum share of revenues within this domain. Currently, in terms of therapeutic area, the market is captured by patient recruitment projects for trials evaluating drugs intended for the treatment of cardiovascular disorders. However, this trend is likely to change in the foreseen future with the rising clinical trials focusing on therapeutics targeting oncological disorders. Specifically, in terms of geography, the patient recruitment services market in Asia Pacific is likely to grow at a relatively faster pace in the long term.

SCOPE OF THE REPORT

The “Patient Recruitment and Retention Services Market (3rd Edition), 2022-2035: Distribution by Patient Recruitment Step (Pre-screening and Screening), Trial Phase (Phase I, Phase II, Phase III and Phase IV) Therapeutic Area (Cardiovascular Diseases, Oncological Disorders, Infectious Diseases, CNS Disorders, Respiratory Disorders, Hematological Disorders, Dermatological Disorders, Ophthalmic Disorders and Others) and Key Geographies (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa and Rest of the World)” report features an extensive study of the current market landscape and future potential of the patient recruitment and retention services market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report includes:

A general overview of the clinical trials, featuring information on the different phases of clinical trials and their importance. The chapter also lays emphasis on patient recruitment process, its associated challenges and the different strategies used to enhance patient enrolment in clinical research studies. It also presents information on the affiliated ethical considerations and outsourcing activity in this domain. Further, it features an elaborate discussion on the various patient recruitment associated services offered by contract service providers as well as the patient retention strategies employed to prevent drop-out of enrolled individuals from clinical trials.

A brief information on the various types of patient outreach methods used by contract service providers in this domain, to identify and enroll patients in clinical trials. Further, the chapter highlights the various advantages and limitations of these outreach methods.

A detailed assessment of the overall landscape of companies offering patient recruitment and retention services, along with the information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, patient recruitment and retention services offered, patient outreach methods (social media outreach, traditional media outreach, directly approaching individual patients, leveraging proprietary patient databases, exploiting patient communities and advocacy groups, engaging local enrolment specialists, using digital advertising solutions, organizing large scale events / campaigns and exploiting real world data sources), number of patient outreach methods (less than 3 methods, 3 to 6 methods and more than 6 methods), patient recruitment associated service(s) offered (pre-screening potential study participants, study feasibility / protocol development, site identification and selection, project management, site management, IRB/EC submission, core CRO services, clinical monitoring, web development solutions, clinical trial data management, real-time enquiry / information support and investigator grant management), number of patient recruitment associated service(s) offered (less than 3 associated services, 3 to 6 associated services and more than 6 associated services), patient retention method(s) used (dedicated patient engagement solutions, offering study-branded amenities / education materials and offering transportation (to site) support), number of patient retention method(s) used (less than 2 methods, 2 to 5 methods and more than 5 methods), geographical reach (North America, Europe, Asia-Pacific and Rest of the World), therapeutic expertise (respiratory disorders, gastrointestinal disorders, healthy volunteers, cardiovascular disorders, central nervous system and mental health disorders, metabolic disorders, dermatological disorders, oncological disorders, musculoskeletal disorders, infectious diseases, autoimmune disorders, ophthalmic disorders, medical devices, rare diseases / personalized therapies and others). The chapter also covers details on the payment model, patient recruitment platforms / technologies used and the various certifications / accreditations awarded by regulatory bodies.

A detailed competitiveness analysis of patient recruitment and retention service providers, taking into consideration supplier strength (based on their experience in this field) and service strength (based on number of patient outreach methods, number of patient recruitment associated service(s) offered, number of patient retention method(s) used, geographical reach and therapeutic expertise).

Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) offering patient recruitment and retention services, across North America, Europe, and Asia-Pacific and Rest of the World. Each profile features a brief overview of the company, along with details related to its patient recruitment and retention service portfolio, recent developments and an informed future outlook.

An insightful analysis of the recent collaborations within the patient recruitment and retention industry, based on several relevant parameters, such as year of partnership, type of partnership (acquisitions, joint ventures, mergers, patient recruitment agreements, service alliances, technology development agreements, technology licensing agreements and others), focus area (clinical trial management, patient recruitment and patient retention), therapeutic area (autoimmune disorders, cardiovascular disorders, CNS disorders, dermatological disorders, metabolic disorders, oncological disorders, pain, rare diseases, respiratory disorders, and others), most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2013-2022.

A review of the emerging trends in the patient recruitment industry, including the use of social media, mobile technologies, electronic health records (EHR), real-world evidence (RWE) and artificial intelligence, to overcome the challenges associated with patient enrolment and retention.

A detailed discussion on the key growth opportunities (such as rise in the number of clinical trials, development of personalized medicines / orphan drugs, growing opportunities in emerging markets, increasing preference for one-stop solutions, stringent regulations related to patient enrollment and technological advancements in clinical trial conduct) in the field of patient recruitment and retention that are likely to impact the evolution of the market over the coming years.

A case study on regulatory landscape of patient recruitment, highlighting the regulatory process involved in patient enrollment, along with the information on regulatory guidelines, regulatory framework for patient recruitment, ethics committees in different countries and documents reviewed by the ethics committees.

A brief overview of patient recruitment in clinical trials focused on personalized medicines and rare diseases, highlighting the key challenges in patient enrollment, specialized patient outreach methods being used to recruit and the key players engaged in this field.

A detailed analysis of the annual demand for study participants, taking into account the target patient population in ongoing and planned clinical trials, sponsored by both industry and non-industry players.

A detailed assessment on the impact of the COVID-19 pandemic on the patient recruitment and retention services market. In addition, it features various strategies that different companies adopted in order to mitigate the challenges associated with patient recruitment faced during the global crisis.

One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the patient recruitment and retention services market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters, such as [A] patient recruitment steps (pre-screening and screening), [B] trial phase (phase I, phase II, phase III and phase IV), [C] therapeutic area (cardiovascular disorders, oncological disorders, infectious diseases, CNS disorders, respiratory disorders, haematological disorders, metabolic disorders, dermatological disorders, ophthalmic disorders and others) and [D] key geographies (North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America and Rest of the World).

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

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.

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:

Susan Fitzpatrick-Napier (Founder and Director, TrialWire)

Kate Shaw (Chief Executive Officer and Founder) and Marco Lassandro (Marketing and Communications Manager, Innovative Trials)

Simon Klaasen (Co-founder and Managing Director, Link2Trials)

Stefan Mayer-Eggersmann (Chief Commercial Officer, Clariness)

Ken Shore (Chief Commercial Officer, Continuum Clinical)

Hagit Nof (Chief Operation Officer and Business Development Officer, nRollmed)

Paul Ivsin (Ex-Managing Director, Seeker Health)

Kasturi Lakhe (Inside Sales Specialist, EVERSANA)

MARKET SEGMENTATIONS

Patient Recruitment and Retention Services: Market Segmentations

Market Segments Details

Forecast Period 2022 - 2035

Patient Recruitment Step Pre-screening

Screening

Trial Phase Phase I

Phase II

Phase III

Phase IV

Therapeutic Area Cardiovascular Diseases

Oncological Disorders

Infectious Diseases

CNS Disorders

Respiratory Disorders

Hematological Disorders

Dermatological Disorders

Ophthalmic Disorders

Others

Key Geographical Regions North America

Europe

Asia-Pacific

Latin America

Middle East and North Africa

Rest of the World

Source: Roots Analysis

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

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

Chapter 2 is an executive summary of the insights captured in our report. It offers a high-level view of the current state of the patient recruitment and retention services market and its likely evolution in the short term, mid-term and long term.

Chapter 3 provides a general overview of the clinical trials, featuring information on the different phases of clinical trials and their importance. The chapter also lays emphasis on patient recruitment process, its associated challenges and the different strategies used to enhance patient enrolment in clinical research studies. It also presents information on the affiliated ethical considerations and outsourcing activity in this domain. Further, it features an elaborate discussion on the various patient recruitment associated services offered by contract service providers as well as the patient retention strategies employed to prevent drop-out of enrolled individuals from clinical trials.

Chapter 4 provides a brief information on the various types of patient outreach methods used by contract service providers in this domain, to identify and enroll patients in clinical trials. Further, the chapter highlights the various advantages and limitations of these outreach methods.

Chapter 5 features a detailed review of the overall market landscape of patient recruitment and retention services providers, along with the information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, patient recruitment and retention services offered, patient outreach methods (social media outreach, traditional media outreach, directly approaching individual patients, leveraging proprietary patient databases, exploiting patient communities and advocacy groups, engaging local enrolment specialists, using digital advertising solutions, organizing large scale events / campaigns and exploiting real world data sources), number of patient outreach methods (less than 3 methods, 3 to 6 methods and more than 6 methods), patient recruitment associated service(s) offered (pre-screening potential study participants, study feasibility / protocol development, site identification and selection, project management, site management, IRB/EC submission, core CRO services, clinical monitoring, web development solutions, clinical trial data management, real-time enquiry / information support and investigator grant management), number of patient recruitment associated service(s) offered (less than 3 associated services, 3 to 6 associated services and more than 6 associated services), patient retention method(s) used (dedicated patient engagement solutions, offering study-branded amenities / education materials and offering transportation (to site) support), number of patient retention method(s) used (less than 2 methods, 2 to 5 methods and more than 5 methods), geographical reach (North America, Europe, Asia-Pacific and Rest of the World), therapeutic expertise (respiratory disorders, gastrointestinal disorders, healthy volunteers, cardiovascular disorders, central nervous system and mental health disorders, metabolic disorders, dermatological disorders, oncological disorders, musculoskeletal disorders, infectious diseases, autoimmune disorders, ophthalmic disorders, medical devices, rare diseases / personalized therapies and others). The chapter also covers details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded by regulatory bodies.

Chapter 6 presents insightful company competitiveness analysis of patient recruitment and retention service providers. The companies are further segmented based on their company size, into three categories, namely small companies, mid-sized companies, and large and very large companies. The analysis compares the contract service providers on the basis of various parameters, such as number of patient outreach methods, number of patient recruitment associated service(s) offered, number of patient retention service(s) used, geographical reach and therapeutic expertise.

Chapter 7 features detailed profiles of the prominent companies that offer patient recruitment and retention services in North America. Each company profile features a brief overview of the company (including information on their headquarters, year of establishment, number of employees and key executives), details related to patient recruitment and retention service portfolio, recent developments and an informed future outlook.

Chapter 8 features detailed profiles of the prominent companies that offer patient recruitment and retention services in Europe. Each company profile features a brief overview of the company (including information on their headquarters, year of establishment, number of employees and key executives), details related to patient recruitment and retention service portfolio, recent developments and an informed future outlook.

Chapter 9 features detailed profiles of the prominent companies that offer patient recruitment and retention services in Asia-Pacific and Rest of the World. Each company profile features a brief overview of the company (including information on their headquarters, year of establishment, number of employees and key executives), details related to patient recruitment and retention service portfolio, recent developments and an informed future outlook.

Chapter 10 features an elaborate analysis of the several recent collaborations within the patient recruitment and retention domain, in the period 2013 - 2022. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership (acquisitions, joint ventures, mergers, patient recruitment agreements, service alliances, technology development agreements, technology licensing agreements and others), focus area (clinical trial management, patient recruitment and patient retention), therapeutic area (autoimmune disorders, cardiovascular disorders, CNS disorders, dermatological disorders, metabolic disorders, oncological disorders, pain, rare diseases, respiratory disorders, and others), most active player(s) (in terms of number of deals inked) and regional distribution of partnership activity.

Chapter 11 provides a detailed review of emerging trends in the industry, including the use of social media, mobile technologies, EHR, RWE and artificial intelligence, to overcome the challenges associated with patient enrolment and retention.

Chapter 12 features a detailed discussion on the key growth opportunities and upcoming trends (such as rise in the number of clinical trials, development of personalized medicine / orphan drugs, growing opportunities in emerging markets, increasing preference for one-stop solutions, stringent regulations related to patient enrollment and technological advancements in clinical trial conduct) in the field of patient recruitment and retention that are likely to impact the evolution of the market over the coming years.

Chapter 13 present a case study on regulatory landscape of patient recruitment, highlighting the regulatory process involved in patient enrollment, along with the information on regulatory guidelines, regulatory framework for patient recruitment, ethics committees in different countries and documents reviewed by the ethics committees.

Chapter 14 features a brief overview of patient recruitment in clinical trials focused on personalized medicines and rare diseases, highlighting the key challenges in patient enrollment, specialized patient outreach methods being utilized to recruit and the key players engaged in this field.

Chapter 15 provides a detailed analysis of the annual demand for study participants, taking into account the target patient population in ongoing and planned clinical trials, sponsored by both industry and non-industry players.

Chapter 16 features a comprehensive market forecast analysis, highlighting the likely growth of the patient recruitment and retention services market, till 2035. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] patient recruitment steps (pre-screening and screening), [B] trial phase (phase I, phase II, phase III and phase IV), [C] therapeutic area (cardiovascular disorders, oncological disorders, infectious diseases, CNS disorders, respiratory disorders, haematological disorders, metabolic disorders, dermatological disorders, ophthalmic disorders and others) and [D] key geographies (North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America and Rest of the World). It is worth mentioning that we adopted a mixture of top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 17 provides a detailed assessment on the impact of the COVID-19 pandemic on the patient recruitment and retention services market. In addition, it features various strategies that different companies have adopted in order to mitigate the challenges associated with patient recruitment faced during the global crisis.

Chapter 18 summarizes the overall report. The chapter provides the key takeaways from the report and expresses our independent opinion of the patient recruitment and retention services market, based on the research and analysis described in the previous chapters.

Chapter 19 is a collection of interview transcripts of the discussions held with key stakeholders in this domain. In this chapter, we have presented the details of interview held with Susan Fitzpatrick-Napier (Founder and Director, TrialWire), Kate Shaw and Marco Lassandro (Chief Executive Officer and Founder, and Marketing and Communications Manager, Innovative Trials), Simon Klaasen (Co-founder and Managing Director, Link2Trials), Stefan Mayer-Eggersmann (Chief Commercial Officer, Clariness), Ken Shore (Chief Commercial Officer, Continuum Clinical), Hagit Nof (Chief Operation Officer and Business Development Officer, nRollmed), Paul Ivsin (Ex-Managing Director, Seeker Health) and Kasturi Lakhe (Inside Sales Specialist, EVERSANA).

Chapter 20 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 21 is an appendix, which contains the list of companies and organizations mentioned in the report.