Virtual Clinical Trials Market

Virtual Clinical Trials Market Overview

The global virtual clinical trials market size is estimated to be $13.92 billion in 2023 and is anticipated to grow at a compounded annual growth rate (CAGR) of around 10% over the forecast period 2023-2035.

The development of a new molecular entity, for pharmacological use, is complex as well as cost intensive process. It requires close to 10 years and over USD 2.5 billion capital investment for a prescription therapeutic to traverse from bench to market. It is worth noting that a significant proportion of the overall R&D budget is dedicated to clinical research for evaluating the safety and efficacy of novel therapeutic interventions in human subjects. In the US, clinical research costs account for 40% of the overall pharmaceutical R&D expenditure. Even with substantial expenditure, several challenges such as patient recruitment-related concerns, inadequacies in handling (generation, logging and processing) clinical data still persist. There’s also the risk of failure, mostly owing to safety concerns and side effects of the drug / therapy being evaluated, and unforeseen delays leading to deterrence from predetermined completion timelines. In fact, retrospective studies have demonstrated that, in over 90% of the cases, clinical trials are delayed due to the inability to either recruit or retain the required number of patients. As indicated earlier, another notable challenge in this space is clinical data handling, which can be primarily attributed to inconsistencies and inefficiencies related to the recording and maintenance of electronic health records. Further, the onset of COVID pandemic in 2020 impacted clinical research activities, when almost all available medical resources were directed towards treating the novel coronavirus infection and curtail its spread, and a number of clinical studies were halted for considerable durations. Even though sponsors have gradually resumed the clinical trials post COVID, there are a number of restrictions and considerations that need to be taken into account, in order to ensure compliance with the new normal way of operating. 

In order to mitigate the unforeseen and other prevailing challenges, the concept of virtual clinical trials, also known as site less clinical trials or decentralized clinical trials, is one among the many developments in the modern pharmaceutical industry. A number of drug developers have been collaborating with the virtual clinical trial companies / decentralized clinical trials companies for utilizing their services and platforms supporting decentralized clinical trials (DCT). The virtual clinical trial companies enable therapy developers / trials sponsors to address some of the exigent concerns related to clinical trial conduct and offer the means to resume clinical research activities even during the pandemics. Presently, there are several virtual CROs offering a wide range of services and solutions for conducting and managing various aspects of clinical trials. Further, by allowing sponsors / trial affiliates to become more patient centric, improving the reach of trials to wider pool of patients and reducing the workload of trial investigators, allows various players involved in offering services related to the decentralized clinical trials to witness growth beyond pandemics. The fundamental requirements of decentralized clinical trials / virtual clinical trials include (but not limited to) dedicated software applications, remote patient monitoring equipment and web-based social engagement platforms. Using such solutions, experts believe that sponsors can save up to 25% of the total capital investment in a trial. Further, the initiatives focused on conducting decentralized clinical trials / virtual clinical trials and developing affiliated solutions have garnered the attention of several private and public investors who have invested more than USD 9 billions in this domain, since 2021. Owing to the ongoing pace of innovation, the rising interest of the investors and the increased number of decentralized clinical trials post-2018, the decentralized clinical trials / virtual clinical trials market is likely to experience significant market growth over the forecasted period.

Key Market Insights

The Decentralized Clinical Trials Market / Virtual Clinical Trials Market (2nd Edition): Distribution by Mode of Clinical Trial (Hybrid Clinical Trial and Fully Virtual Clinical Trial), Type of Therapeutic Area (Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Neurological Disorders, Oncological Disorders, Respiratory Disorders and Other Disorders), Clinical Trial Phase (Phase I, Phase II, Phase III and Phase IV), Company Size (Small, Mid-sized and Large), End Users (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes , Medical Device Industries and Other End Users) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with the decentralized clinical trials / virtual clinical trials market, during the given forecast period. The market report highlights the efforts of virtual / decentralized clinical trials companies engaged in this growing segment of the pharmaceutical industry. Key takeaways of the virtual clinical trials market report are briefly discussed below.

The Basics of Decentralized Clinical Trials / Virtual Clinical Trials

According to the FDA, the decentralized clinical trials / virtual clinical trials are those trials that are executed through telemedicine and local / mobile healthcare providers, using procedures and technologies that differ from the conventional clinical trial model. Decentralized clinical trials are typically conducted remotely rather than at a site facility, with patients staying at home during most of the trial period. The users interact with websites through connected devices, phone applications and software. In addition to offering technology-enabled face-to-face connections with investigators, these solutions feed sites and sponsors’ critical trial data. Such trials have shown to improve patients’ experience with clinical trials.

Current Market Landscape of the Decentralized Clinical Trials Companies / Virtual Clinical Trial Companies

Presently, around 140 virtual CRO are focused on providing decentralized clinical trials / virtual clinical trials services for drug development. The landscape of decentralized clinical trials companies / virtual clinical trial companies features a mix of large, mid-sized and small companies. Further, it is worth mentioning that these players offer services across a wide range of therapeutic areas, such as cardiovascular disorders, dermatological disorders, endocrinological disorders, gastroenterological disorders, genetic disorders, gynecological disorders, hematological disorders, hepatological disorders, immunological disorders, infectious diseases, metabolic disorders, nephrological disorders, neurological disorders, oncological disorders, ophthalmic disorders, pediatric disorders, rare disorders, respiratory disorders and other disorders.

Market Trends: Virtual Clinical Trial Companies Partnering to Expand their Service Portfolios

In recent years, several partnerships and collaborations have been established by stakeholders engaged in offering services related to decentralized clinical trials / virtual clinical trials. Such deals are forged to allow companies to expand their respective product / service portfolios and gain additional capabilities related to emerging technologies for various therapeutic areas. For instance, recently Allucent has partnered with THREAD (May 2023) to launch its new platform, Allucent Patient Direct Trials for small and mid-sized biotechnology companies. Further, the partnerships signed in this industry have primarily focused on electronic data collection and analysis, followed by those signed for remote patient monitoring, conducting trials, patient recruitment and patient retention. In addition to this, there have been a significant number of mergers and acquisitions, including the acquisition of the US-based DSG by Signant Health (July 2023) and PRA Health Sciences by ICON (February 2021). The acquisition of DSG helped Signant Health expand its capabilities in electronic data capture (EDC) and direct data capture (DDC) technology for improving its traditional and decentralized clinical trials. We expect the virtual CRO to continue to partner with or acquire digital tool providers, expanding their service portfolio to meet the customer demand and drive the virtual clinical trials market growth during the forecast period. 

Funding Analysis:  Virtual Clinical Trials have Experienced Rapid Investment Growth in the Past Years

Over the years, monetary assistance from angel investors, venture capitalists, and funding schemes of various public and private organizations / funds, along with assistance from regulatory authorities, have allowed start-ups / small companies to progress their R&D efforts related to the development of decentralized clinical trials / virtual clinical trial platforms / solutions. It is worth noting that most of the funding instances reported within this industry were venture capital rounds. For instance, SubjectWell, a patient recruiting platform has raised USD 35 million in Venture Series B (October 2022) and Curavit Clinical Research has raised USD 5 million Venture Series A (November 2022). ,  

Virtual Clinical Trials Market Size: North America to Hold the Largest Market Share, While Asia-Pacific to Witness Highest Market Growth

The decentralized clinical trials / virtual clinical trials market is estimated to be USD 4.02 billion in 2023, with North America holding the largest market share of around 45%. This is essentially owing to the adoption of decentralized clinical trials model by the big pharmaceutical companies based in the US. Additionally, of the virtual service providers / CRO identified in the report, more than 95% are based in the US. It is worth noting that in terms of market growth, the decentralized clinical trials / virtual clinical trials market in Asia-Pacific is likely to grow at a relatively faster pace in the long term. As the developed markets are facing financial downturns post-COVID, the Asian economies continue to grow. There has been increased research and clinical trial activity in Asia Pacific, with the companies investing in digitization. Such factors will support the adoption of virtual clinical trials in the Asia Pacific market in long-term, driving the overall market growth. For instance, in November 2022, Oracle and ObvioHealth collaborated to expand their services related to decentralized clinical trials / virtual clinical trials in Asia-Pacific region.  

Market Analysis: Neurological and Metabolic Disorders to Continue to Dominate the Market; Phase III Clinical Trials Hold Huge Potential

Among various therapeutic areas, CROs involved in conducting decentralized clinical trials / virtual clinical trials related to neurological disorders (~30%) and metabolic disorders (~20%) are anticipated to capture the largest market share. The plausible reason could be the use of decentralized services in collecting real-time data for neurological disorders, analyzing the disease progression and growing severity over time, particularly in patients who have only recently been diagnosed. 

Further, in terms of phase of clinical trial, the maximum revenue generation potential is likely to be related to the conduct of phase III decentralized clinical trials / virtual clinical trials. 

Market Drivers: Issuance of Guidance from the FDA and EMA Recognizes Decentralized Clinical Trials as an Important Part of Digitization of the Pharmaceutical Industry

In May 2023, FDA published an updated draft for guidance on decentralized clinical trials, covering information on the design of such trials, use of digital health technologies, conducting DCTs and more aspects. These guidelines came six months after EMA published its recommendation paper on decentralized elements in clinical trials in December 2022. The guidance from the drug authorities show their belief in the advantages of virtual clinical trials and their intent to fasten the drug development due to increased participant diversity in trials as well as improved patient outcomes.

Additionally, growing adoption of wearable devices and their use for remote patient monitoring will play an important role in driving the market growth for virtual clinical trials, globally.

Key Players Offering Decentralized Clinical Trials / Virtual Clinical Trials

Examples of the key companies engaged in the decentralized clinical trials / virtual clinical trials domain (the complete list of players is available in the full report) include (in alphabetic order) Cambridge Cognition, Fortrea, IQVIA, KORE Wireless, Labcorp, Medidata Solutions, Medpace, PanAmerican Clinical Research, Parexel, PPD (a Thermo Fisher Company), Science 37, Signant Health, Syneos Health and Veeva. This market report also includes an easily searchable excel database of all the decentralized clinical trials / virtual clinical trials service providers for clinical trials worldwide.

Recent Developments in the Decentralized Clinical Trials / Virtual Clinical Trials Market

Several recent developments have taken place in the field of decentralized clinical trials, over the past few years, essentially since 2019. Some of these recent initiatives have been mentioned below. These developments, even though took place post the release of our market report, substantiate the overall market trends that we have outlined in our analyses. For instance, in June 2023, Medable launched a tool kit in collaboration with MRCT Center for the decentralized trials. The aim of the comprehensive tool kit is to offer common framework and best practices for the ethical conduct of DCT. 

Scope of the Report

The market report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in providing decentralized clinical trials / virtual clinical trials solutions. The different industry segments are defined in the below table:

Key Report Attributes	Details
Base Year	2022
Forecast Period	2023 – 2035
Historical Trends	2018-2022
Market Size 2023	$ 13.92 Billion
CAGR	10%
Mode of Clinical Trial	Hybrid Clinical Trial Fully Virtual Clinical Trial
Type of Therapeutic Area	Cardiovascular Disorders Infectious Diseases Metabolic Disorders Neurological Disorders Oncological Disorders Respiratory Disorders Other Disorders
Clinical Trial Phase	Phase I Phase II Phase III Phase IV
Company Size	Small Mid-sized Large
End-user	Pharmaceutical and Biotechnology Companies Research and Diagnostic Laboratories Medical Device Industries Other End-Users
Key Geographical Regions	North America Europe Asia-Pacific Middle East and North Africa Latin America
Key Companies Profiled	Aardex Cambridge Cognition CareShare Clariness Cliniv Clinscience CMIC DynamiQ Health Emovis Ergomed Flatworld Solutions  Fortrea  Gsap Guild Hexaware Technologies Huma ICON IQVIA Kayentis KORE Wireless Labcorp Medidata Solutions Medpace PanAmerican Clinical Research Parexel PPD (a Thermo Fisher Company) Science 37 Signant Health Syneos Health Tata Consultancy Services Veeva Viedoc WeGuide  Wren Healthcare (Full list of ~140 companies captured in the market landscape analysis of the report)
Customization Scope	15% Free Customization Option (equivalent to 5 analysts working days)
PowerPoint Presentation (Complimentary)	Available
Excel Data Packs (Complimentary)	Market Landscape Analysis Company Competitiveness Analysis Clinical Trial Analysis Partnerships and Collaborations  Funding and Investments Analysis Cost Saving Analysis Market Forecast and Opportunity Analysis

Amongst other elements, the market report includes: 

• A preface providing an introduction to the full report, Decentralized Clinical Trials / Virtual Clinical Trials Market (2nd Edition), 2018-2035.
• An outline of the systematic research methodology adopted to conduct the study on decentralized clinical trials / virtual clinical trials market, providing insights on the various assumptions, methodologies and quality control measures employed to ensure accuracy and reliability of our findings.
• An overview of economic factors that impact the overall decentralized clinical trials / virtual clinical trials market, including historical trends, currency fluctuation, foreign exchange impact, recession and inflation measurement.
• An executive summary of the insights captured during our research. It offers a high-level view on the current state of decentralized clinical trials market / virtual clinical trials market and its likely evolution, in the mid to long term.
• A general overview of the decentralized clinical trials / virtual clinical trials, along with its comparison with traditional clinical trials and the need for decentralized clinical trials. Additionally, it features modes of decentralized clinical trials along its various applications. Further, the chapter consists of a detailed outline of the various upcoming trends that are anticipated to play a crucial role in shaping the future of decentralized clinical trials, along with the challenges associated with it.
• An overview of the current market landscape of virtual clinical trials / decentralized clinical trials companies, featuring information on year of establishment, company size, location of headquarters, key offering (platforms, services and devices), compliance, mode of decentralized clinical trial (hybrid clinical trials and fully virtual clinical trials),  type of capability (electronic patient recruitment / retention, patient engagement, pre-screening, study start-up, electronic data capture, at-home patient care and nursing, trial notification / scheduling reminder, telemedicine / virtual visits, eConsent, direct-to-patient shipment, connected devices, digital communication, remote patient monitoring, mobile / local laboratories and risk-based monitoring), therapeutic area (immunological disorders, cardiovascular disorders, dermatological disorders, endocrinological disorders, gastroenterological disorders, gynecological disorders, hematological disorders,  infectious diseases, metabolic disorders, nephrological disorders, neurological disorders, oncological disorders, ophthalmic disorders, pediatric disorders, rare disorders, respiratory disorders and others) and phase of clinical trial (phase I, phase II, phase III and phase IV).
• Elaborate profiles of companies offering services for decentralized clinical trials / virtual clinical trials, featuring information on their year of establishment, location of headquarters, company size (in terms of number of employees), key executives, financial information (if available), decentralized clinical trial offerings, recent developments and an informed future outlook.
• A detailed competitiveness analysis of decentralized clinical trials / virtual clinical trials service providers based on several relevant parameters, such as company strength (in terms of number of years since it was established and company size), service strength (in terms of number of key offerings, mode of decentralized clinical trials and capabilities) and service diversity (in terms of number of therapeutic areas).
• An insightful clinical trial analysis of completed / ongoing decentralized clinical trials / virtual clinical trials, based on various relevant parameters, such as trial registration year, number of patients enrolled, clinical trial phase, trial status, target patient population, patient gender, therapeutic area, type of sponsor, emerging focus areas, study design, patient allocation model used, trial masking adopted, type of intervention, trial purpose, most active players (in terms of number of clinical trials sponsored) and geography.
• An analysis of the partnerships and collaborations inked in the decentralized clinical trials / virtual clinical trials market, during the period 2018-2023, based on several parameters, such as year of partnership, type of partnership, type of partners, type of capability, most active players (in terms of number of partnerships) and geographical analysis. 
• An analysis of the funding and investments made in the decentralized clinical trials / virtual clinical trials market, during the period 2018-2023, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are engaged in this field, based on several parameters, such as year-wise trend of funding instances, amount invested, type of funding, geographical analysis, leading players (in terms of number of funding instances and amount raised) and investors (in terms of number of funding instances).
• A case study on the initiatives of big pharmaceutical companies related to decentralized clinical trials / virtual clinical trials, offering insights on such clinical studies that have been conducted / planned by the aforementioned players, along with details on associated constraints and the future plans of players engaged in this industry.
• A detailed study highlighting the key differences between traditional and decentralized contract research organization / virtual contract research organization and an elaborate road map presenting the requirements for a traditional contract research organization to transit to a decentralized contract research organization / virtual contract research organization business model. 
• A brief case study highlighting the impact of COVID pandemic on the companies engaged in the decentralized clinical trials / virtual clinical trials market.
• A detailed cost saving analysis, highlighting the overall cost saving potential of decentralized clinical trials / virtual clinical trials till 2035. We have highlighted the cost saving potential of decentralized clinical trials / virtual clinical trials for different clinical trial phases (phase I, phase II and phase III) amongst various geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America).
• An in-depth analysis of the factors that can impact the growth of decentralized clinical trials / virtual clinical trials market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities and existing challenges.

One of the key objectives of the market report was to evaluate the primary growth drivers and estimate the future market growth potential associated with the decentralized clinical trials market / virtual clinical trials market, along with the decentralized clinical trials market / virtual clinical trials services market, over the forecast period. Based on parameters, such as number of pre- or post-approval studies conducted annually, capital investments made in these studies, and the likely cost and time saving opportunities, we have provided an informed estimate of the likely evolution of the decentralized clinical trials market / virtual clinical trials market, for the forecast period 2023-2035. The market report also features the likely distribution of the current and forecasted opportunity across mode of decentralized clinical trial (hybrid clinical trial and fully virtual clinical trial), type of therapeutic area (cardiovascular disorders, infectious diseases, metabolic disorders, neurological disorders, oncological disorders, respiratory disorders and other disorders), clinical trial phase (phase I, phase II, phase III and phase IV), company size (small, mid-sized and large), end users (pharmaceutical and biotechnology companies, academic and research institutes , medical device industries and other end-users) and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America). 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.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in the virtual clinical trials market. In addition, the research report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):

• Chief Executive Officer and Founder, Small Company, Belgium
• Chief Executive Officer, Very Large Company, USA
• Chief Innovation Officer and President, Mid-sized Company, USA
• Chief Commercial Officer, Chief Technology Officer, Chief Delivery Officer, Head of Marketing, Large Company, USA
• Chief Strategy Officer, Small Company, USA
• Executive Director, Small Company, USA
• Senior Business Development Director, Small Company, Singapore
• Director Business Development, Mid-sized Company, Germany
• Head of Operations, Small Company, UK
• Senior Manager Business Development, Mid-sized Company, UK
• Chief Executive Officer, Small Company, Australia
• Business Development Manager, Mid-sized Company, UK
• Ex-Chief Executive Officer and Co-founder, Ex-Chief Solutions Officer and Co-founder, Very Small Company, Singapore
• Co-founder and Advisor, Small Company, USA

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.

Frequently Asked Questions

Question 1: What is decentralized clinical trial? What is a virtual clinical trial?

Answer: Decentralized clinical trials / virtual clinical trials are the clinical trials in which a part of or all of the clinical trial's activities take place in a location other than a conventional clinical trial site, utilizing digital health technologies. These alternative locations may include the participant's residence, a nearby health care facility or laboratory.

Question 2: What are the advantages of decentralized clinical trials / virtual clinical trials?

Answer: Decentralized clinical trials have allowed the sponsors to reach a wider range of participants beyond those living in the vicinity of traditional study sites, leading to higher recruitment and retention rates. Further, decentralized clinical trial reduces the need for investigational study sites and the associated overhead costs.

Question 3: How many companies are providing decentralized clinical trials / virtual clinical trial services?

Answer: Presently, around 140 companies offer various decentralized clinical trials / virtual clinical trial related services, including study start-up, remote patient monitoring, patient retention, drug logistics and patient engagement. Such services help in enhancing patient related outcomes.

Question 4: How many decentralized clinical trials / virtual clinical trials have been conducted?

Answer: Till 2022, more than 1,550 decentralized clinical trials / virtual clinical trials have been conducted.

Question 5: How big is the virtual clinical trials market?

Answer: The global virtual clinical trials market is estimated to be USD 13.92 billion in 2023.

Question 6: What is anticipated decentralized clinical trials / virtual clinical trials market growth?

Answer: The decentralized clinical trials / virtual clinical trials market is estimated to grow at a CAGR of around 10% during the forecast period 2023-2035.

Question 7: What is the largest market segment (by mode of operation) in the decentralized clinical trials / virtual clinical trials market?

Answer: The hybrid mode holds the largest market share in the decentralized clinical trials / virtual clinical trials market.

Question 8: Which phase of the clinical trial occupies the largest market share of the decentralized clinical trials / virtual clinical trials market?

Answer: Phase III and Phase IV occupies the largest market share (>70%) of the decentralized clinical trials / virtual clinical trials market.

Question 9: In which therapeutic areas are decentralized clinical trials / virtual clinical trials primarily being implemented?

Answer: The most common therapeutic areas of interest to virtual clinical trials market include neurological disorders, metabolic disorders and cardiovascular disorders.

Question 10: Who is the major end user of decentralized clinical trials / virtual clinical trials?

Answer: Pharmaceutical and biotechnology companies are the major end users of decentralized clinical trials / virtual clinical trials

Question 11: Which region is expected to witness the highest growth rate in decentralized clinical trials market / virtual clinical trials market?

Answer: The decentralized clinical trials market / virtual clinical trials market in Asia-Pacific is likely to grow at the highest CAGR, during the forecast period 2023-2035.

Question 12: What type of partnerships are most common in the field of decentralized clinical trials / virtual clinical trials?

Answer: Currently, platform integration agreement is the most preferred type of partnership model adopted by the stakeholders in this industry. This is followed by product / technology integration and clinical trial collaborations.