Lowest Price Guaranteed From USD 4,799
Companies Covered
421
Pages
480
View Count
15731
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.
![]() |
![]() |
![]() |
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.
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.
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.
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.
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). ,
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.
![]() |
![]() |
![]() |
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.
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.
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.
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.
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 |
|
|
Type of Therapeutic Area |
|
|
Clinical Trial Phase |
|
|
Company Size |
|
|
End-user |
|
|
Key Geographical Regions |
|
|
Key Companies Profiled |
|
|
Customization Scope |
|
|
PowerPoint Presentation (Complimentary) |
|
|
Excel Data Packs (Complimentary) |
|
Amongst other elements, the market report includes:
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):
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.