NEW YORK, April 18, 2019 /PRNewswire/ -- INTRODUCTION
Clinical trials represent an arduous step in the drug development process and are crucial to understanding the safety and efficacy profiles of novel therapeutic interventions. As these trials are prone to delays, and can even fail altogether, they impose an immense financial pressure on sponsors. 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. It is estimated that 80% of clinical trials do not meet their designated patient enrolment deadlines. In fact, around 37% of research sites fail to meet their subject accrual goals, while more than 10% don't even enroll a single patient. In addition, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. Delays in product launch, due to inability of the sponsors to recruit / retain patients, are highly common and are estimated to result in an average loss of USD 8 million per day in opportunity costs, for a blockbuster drug.
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The abovementioned challenges have led several players in the pharmaceutical industry to outsource their patient recruitment-related needs to capable, specialty service providers. Employing contract service providers has been shown to expedite the patient recruitment process. Such service providers employ a variety of outreach methods, such as social media, mobile technologies, electronic health records (EHRs) and real-world evidence (RWE), and, over time, have attained a vital role in the successful conduct of clinical research. Although some big pharma players carry out patient recruitment in-house, the growing complexity of clinical trials and demand for niche patient populations for studies evaluating orphan drugs / personalized medicines is likely to prompt more developer companies to outsource various aspects of their clinical research-related operations in the foreseen future. In fact, the market has recently witnessed the establishment of several partnerships, which include agreements between study sponsors and patient recruitment firms (outsourcing deals) and partnerships between stakeholders aimed to combine their respective services portfolios related to patient recruitment and retention (service alliances). This niche services industry has also witnessed some consolidation as multiple smaller players have been acquired by more established entities, in an effort to expand geographical reach.
SCOPE OF THE REPORT
The 'Patient Recruitment and Retention Services, 2019-2030' report offers a comprehensive study of the current scenario and future potential of the players providing patient enrollment and retention services. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders in this domain. In addition to other elements, the study includes:
A detailed assessment of the current market landscape of companies offering patient recruitment and retention services, including information on over 10 types of patient outreach methods employed, types of services offered ([A] patient recruitment (including pre-screening and Institutional Review Board (IRB) / Ethics Committee (EC) submission), [B] patient retention (considering various strategies, such as the use of study-branded gifts, study-branded reminders, providing education and support materials, reimbursement programs, transportation programs, patient engagement web site, patient reconnect programs, mobile applications to track patient engagement and others) and [C] other associated services (including site identification and selection, study feasibility / protocol development, project management, clinical trial monitoring and other services), year of establishment, geographical location, and size of company. The chapter also covers an analysis of the geographical reach and therapeutic expertise of service providers, along with details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded by regulatory bodies.
An analysis of the most active regions (in terms of patient recruitment activity), based on the locations of headquarters of companies engaged in this domain, featuring schematic world map representations that highlight key hubs across the globe.
An insightful 2X2 representation of the results of a competitiveness analysis of various service providers (segregated into three peer groups based on their employee count (small-sized (1-50 employees), mid-sized (50-200 employees) and large (>200 employees)), highlighting capable players in this domain, based on their respective capabilities.
Comprehensive profiles of patient recruitment and retention service providers, featuring information on the location of their headquarters, year of establishment, patient recruitment services / platforms portfolio, recent developments and a comprehensive future outlook.
An analysis of the partnerships that have been established in the recent past, covering outsourcing agreements, service alliances, acquisitions, joint ventures, mergers, technology licensing and development agreements, and other forms of partnerships.
A review of emerging trends in the industry, including the use of social media, mobile technologies, EHRs and RWE, to overcome the challenges associated with patient recruitment and retention.
One of the key objectives of the report was to estimate the existing market size and review the potential growth opportunities for patient recruitment service providers over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2019-2030. In addition, we have segmented the future opportunity across [A] therapeutic area (oncology, infectious diseases, cardiovascular diseases, CNS disorders, respiratory disorders, metabolic disorders, and others), [B] steps in patient recruitment process (pre-screening and screening), [C] phases of development (phase I, phase II, phase III and phase IV), and [D] different global regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):
Simon Klaasen (Co-founder and Managing Director, Link2Trials)
Hagit Nof (Chief Operation Officer and Business Development, nRollmed)
Paul Ivsin (Managing Director, Seeker Health)
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 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 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 segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
News releases from company websites
Government policy documents
Industry analysts' views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various 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.
1.1. CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the current state of the patient recruitment and retention services market and describes the upcoming opportunity in short to mid-term and long term.
Chapter 3 provides a general introduction to the patient recruitment and retention process in clinical trials. It includes a detailed discussion on the different phases of clinical trials, patient recruitment and its associated challenges, various strategies used to enhance patient accrual, affiliated ethical considerations and outsourcing activity in this domain. Further, it includes a detailed discussion on the various patient recruitment services offered by different contract service providers. Additionally, the chapter features a discussion on diverse patient retention strategies that are presently being employed to prevent enrolled participants from dropping out of clinical research studies.
Chapter 4 provides a comprehensive overview of the various types of patient outreach methods used by contract service providers in this domain, to identify and enroll patients in clinical trials. The chapter also highlights the various advantages and limitations of these outreach methods.
Chapter 5 provides a comprehensive view of the current market landscape of companies that offer patient recruitment and retention services. It presents detailed analyses on the basis of their year of establishment, geographical location, size of company, type of services offered, type of patient outreach methods, geographical reach, and the therapeutic expertise of service providers. In addition, it includes details on the payment model, patient recruitment platforms / technologies used, and the various certifications / accreditations awarded to companies, by regulatory bodies from across the world.
Chapter 6 features a competitiveness analysis of the companies providing patient recruitment and retention services based on various parameters, such as patient outreach methods, number of patient recruitment and retention services offered, therapeutic expertise, geographical reach and year of establishment. In the chapter, stakeholder entities have been plotted on a 2X2 matrix, having a company's Experience (based on its year of establishment) (abscissa) and Company Competitiveness (ordinate) as the two axes.
Chapter 7 features detailed profiles of key stakeholders in this industry; each profile provides information on their headquarters, year of establishment, patient recruitment services / platforms portfolio, recent developments and a comprehensive future outlook.
Chapter 8 features an elaborate discussion and analysis of the various partnerships / collaborations that have been inked amongst players in this market. It includes a brief description on the various types of partnership models (outsourcing agreements, service alliances, acquisitions, joint ventures, mergers, technology licensing agreements, development agreements, and others) adopted by industry stakeholders, highlighting the most common forms of deals / agreements that have been established in the period between 2013-2018.
Chapter 9 provides a detailed overview of the prevalent trends in the patient recruitment and retention services domain, including the use of social media, mobile technologies, EHRs and RWE, to overcome the challenges associated with patient recruitment and retention in clinical research.
Chapter 10 features a detailed discussion on the upcoming opportunities (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 and others) in the field of patient recruitment and retention that are likely to impact the evolution of the market over the coming years.
Chapter 11 features a comprehensive market forecast analysis, highlighting the future potential of patient recruitment services market till the year 2030. We have segmented the projected opportunity on the basis of [A] therapeutic area (oncology, infectious diseases, cardiovascular diseases, CNS disorders, respiratory disorders, metabolic disorders, and others), [B] steps in patient recruitment process (pre-screening and screening), [C] phases of development (phase I, phase II, phase III and phase IV), and [D] different global regions (North America, Europe, Asia-Pacific and rest of the world).
Chapter 12 summarizes the entire report. It presents a list of key takeaways from the report, and offers our independent opinion on the current market scenario.
Chapter 13 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Simon Klaasen (Co-founder and Managing Director, Link2Trials), Hagit Nof (Chief Operation Officer and Business Development, nRollmed) and Paul Ivsin (Managing Director, Seeker Health).
Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. More than 135 players currently offer patient recruitment and retention services to pharmaceutical and medical device industry. The market landscape is fragmented, featuring a mix of small-sized (less than 50 employees, 69%), mid-sized (51-200 employees, 14%), and large-sized (more than 200 employees, 17%) companies. Examples of large-sized players engaged in this domain include (in alphabetical order, no selection criteria) Accelovance, Acurian, Bioclinica, BMC Group, CROee, IQVIA, Klick Health, Synexus, Syneos Health and WCCT Global. On the other hand, examples of players that have recently (since 2015) entered the market include (in alphabetical order, no selection criteria) Access Clinical Research (2017), Clinically Media (2017), Orphanos (2017), Splash Clinical (2016), CarthagoPharma (2016), Clinspire Research (2016), Akcelis (2015) and PatientEvolution (2015).
2. Majority of the aforementioned service providers (80%) are based in North America and Europe. However, a growing proportion of such companies are presently emerging in the Asia-Pacific and other developing regions of the world. Examples of companies based in the latter regions include (in alphabetical order, no selection criteria) Clinical Trial Connect (CTC), Clinical Trial Group, nRollmed, S4 Research, SitePartner, TrialWire and RemediumOne. Specifically, around 35 companies provide their services globally. Examples of some of these players include (in alphabetical order, no selection criteria) Acurian, Antidote, BBK Worldwide, Bioclinica, Clariness, ClinicalConnection, PAREXEL, ThreeWire, and WCCT Global.
3. Close to 80% of the services providers claim to offer patient recruitment specific services, such as project management (48), assistance in institutional review board (IRB) / ethics committee (EC) submissions (37), core CRO services (33), site management (26), clinical trial monitoring (24), trial master file management (8), conducting meetings for staff / patients (3), and investigator grant management (2). Further, over 75 companies claim to provide patient retention services.
4. More than 60% of the players claim to use social media platforms to enroll patients for clinical studies. Further, traditional broadcasting platforms, including TV, radio and newspaper, constitute the second most popular medium for patient outreach campaigns, and is utilized by 41% of stakeholders in this domain. Other popular outreach methods include print advertisement (32%), patient advocacy groups (32%), physician referrals (30%), cold call / call center (28%), patient networks (27%), proprietary patient databases (27%), direct mail / e-mail (24%), and EMRs / pharmacy / health care data (14%).
5. Over 70 firms mention that cardiovascular, CNS and mental health disorders are their primary focus areas. Other therapeutic areas for which patient recruitment services are presently offered include (in decreasing order of number of associated service providers) oncological disorders, gastrointestinal disorders, respiratory disorders, autoimmune disorders, infectious diseases, musculoskeletal disorders, metabolic disorders, eye disorders, and rare diseases. On the other hand, 30 companies claim to provide services for recruiting patients in trials evaluating medical devices.
6. A number of strategic partnerships dwere inked between stakeholders in this domain, during the period 2013-2018. Most of the aforementioned deals were service alliances (34%), signed between companies to combine their respective capabilities to offer an expanded portfolio of services to their clients. Outsourcing agreements were the second most popular type, representing 30% of the total number of deals. Recent examples of outsourcing agreements include partnerships between Synexus and University of Exeter (2018), CROee and Pfizer (2018), and Foundation Medicine and European Organization for Research and Treatment of Cancer (2018). These were followed by acquisitions (20%), mergers (6%), technology development / licensing agreements (4%), joint ventures (3%), and other agreements (2%).
7. Driven by the steady growth in the volume of clinical trials, we expect the patient recruitment services market to grow at an annualized rate of nearly ~4% between 2019 and 2030. Based on our estimates, clinical trials evaluating drugs for cancer indications are expected to contribute to 23% of the revenues generated within the market by 2030; this is likely to be followed by trials evaluating therapies for infectious diseases (15%), cardiovascular diseases (15%), CNS disorders (10%), respiratory disorders (7%), metabolic disorders (6%), and other indications (24%).
8. North America (primarily the US) and Europe currently hold the larger share (in terms of revenues, over 80%) within the overall patient recruitment services market. This is followed by the Asia-Pacific region and rest of the world. Within Asia-Pacific, markets in India and China are expected to grow at a relatively faster rate (~11%) in the coming decade. We are led to believe that the abovementioned trend is not likely to change significantly in the foreseen future.
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