The global virtual clinical trials market is expected to reach USD 5.10 billion by 2027 from USD 1.93 billion in 2021, growing with a CAGR of 17.59% from 2022-2027. The virtual clinical trials market is one of the innovative approaches for traditional clinical trials, through remote monitoring and more patient-centric approaches. These virtual clinical trials adoption was high during the COVID-19 pandemic period and the usage of decentralized clinical trials components application rate. Most clinical trial conductors started to move towards the decentralized or hybrid clinical trial model.
Virtual clinical trials are also known as de-centralized clinical trials. Although the vendors adopted virtual clinical trials for many years, however, it was very slow adoption before the pandemic. The virtual clinical trials market includes the application of digital tools and technological processes that take trials from healthcare settings to patients’ homes or places of work. The reduction in site visits, associated time, and economic cost cuttings eliminate the burden placed on patients and solve the challenges for trial participation. The virtual clinical trials market brought significant advantages and reduced major challenges like patient retention, recruitment, and more. These are the factors that fuel market growth.
Virtual clinical trials are an alternative method to traditional clinical trial methods. The new connected devices power clinical trial activities with better clinical data collection, analysis, and interpretations play a significant role. Clinical trial monitoring devices, clinical trial software, eCOA & ePRO, and eConsent are some digital tools that strengthen clinical trial activities and give a new shift in the clinical trial industry. On another side, the bring-your-own-devices strategy, a newly adopted trend, is widely accepted among CROs and sponsors. This new strategy allows the trial participants to deliver required data with their own internet-enabled solutions. Technological advances and confidence in improved study outcomes can bring new solutions.
The latest retrospective approach, adopting the synthetic clinical trial approach, delivers significant clinical development. Many biopharma and medical device companies face challenges in finding participants for clinical trials; this synthetic arm process is one of the easy methods, using the innovative approach for collecting and comparing data called the synthetic control arm. This is one of the fully new approaches in the virtual clinical trials market and is expected to drive significant growth. In addition, the involvement of Artificial Intelligence (AI) in clinical trials significantly changes the trial procedure as AI can expedite target validation, clinical trial design, and patient identification for participation in virtual clinical trials.
The COVID-19 pandemic is the significant factor that shifted the traditional clinical trials approach to the virtual clinical trials market. The rapid surge of COVID-19 infections poses substantial challenges in the clinical trial space, where the virtual clinical trial model significantly pushed the biopharmaceutical and medical device industry towards decentralization (DCT). During the COVID-19 pandemic period, approximately 87% of clinical trial sponsors and contract research organizations decentralized the clinical trial activities compared with 28% only pre-covid period.
The market players and the companies pioneer in clinical trials activities understand that decentralization in clinical trials is the future of the clinical trials space. Over the last few years, decentralization has rapidly grown in the clinical trials industry. Decentralization of clinical trials has significant potential since the virtual clinical trials are independent of regional/geographical locations and are implemented through digital health platforms as well as mobile and local healthcare segments; this makes the providers eliminate the constraints associated with the traditional model.
Regulatory changes in favor of DCT: The pandemic period (COVID-19 Crisis) has supercharged the changes for virtual clinical trials from regulatory agencies worldwide. Including Food Drugs Administration (FDA), UK’s Medicine and Healthcare Product Regulatory Agency (MHRA), European Medicine Agency (EMA), China’s Center for Drug Evaluation (CDE), and Singapore Health Science Authority (HSA) have made revolutionary regulations towards the virtual clinical trials market.
On another side, the challenges associated with the virtual clinical trials model, such as the high expenditure required for the initial implementation, data reliability and integrity, and varied state law and regulations, are some factors that hamper the market growth. In addition, the increasing digital tools and growing risk of cyber-attacks are challenging aspects of the virtual clinical trials market growth.
INSIGHTS BY STUDY TYPE
The global virtual clinical trials market by study type is segmented into interventional and others. The interventional study type segment accounts for an 80.15% higher market share and dominates other segments. The increasing R&D activities in the medical industry led to increased clinical trials. In interventional study type, the growing application of a digital tool for clinical trial data collection and analysis gives high demand for virtual clinical trials platform that increases the segmental growth. Also, with the increasing infection rate of SARS-COV-2, a higher number of clinical trials for vaccine development registered in the period 2020 to 2022, which has increased the adoption of virtual tools in clinical trials.
INSIGHTS BY STAGE OF DEVELOPMENT
The early and late phases are two primary segments under the stage of development in the global virtual clinical trials market. The early phase segment accounted for 41.55% market share, and the late phase segment accounted for 58.45% market share in 2021. The high number of clinical trials are currently accounted for the phase III & phase IV, which is increasing the adoption of DCT platforms for data accuracy and better outcomes. As well as increasing adoption of DCT platforms and tools in phase, I & phase II trial procedures for patient participation will drive the market growth of the early phase segment in 2021.
INSIGHTS BY THERAPY AREA
The global virtual clinical trials market is segmented into cancer, CVD, infectious diseases, gastroenterology disorders, musculoskeletal diseases, nervous system, and other indications by therapy area. The oncology segment accounted for 44.85% higher market share in the virtual clinical trials market in 2021 and dominated all other segments. The de-centralized clinical trials are majorly accounted for oncology therapeutic areas. More home-based clinical trials are adopted in the diseases segment. This is more patient-centric and helps them provide better clinical outcomes to the clinical trial sponsors. Most of the major market players also show the major de-centralized clinical trials are associated with cancer indications. In 2020, the oncology therapeutic area showed more than 22% for adopting de-centralized clinical trials.
The rare and genetic diseases segment is second, accounting for 15.54% of the market share. Increasing prevalence and constantly addressing rare new diseases and genetic diseases drive the high demand for clinical research. Rare and genetic disorders are one of the major challenging segments in traditional clinical trials segment. This is easily overcome using virtual clinical trials, especially in patient recruitment, retention, and more. Globally more than 6,000 rare diseases the time addressed. It might be increasing in the upcoming time, which will drive the demand for clinical research activities; the increasing prevalence of genetic diseases and rare diseases are the factors that drive the demand for de-centralized clinical trial adoption.
North America is the leading region in the global virtual clinical trials market, accounting for 53.54% market share. The increasing clinical trial activities, well-established and advanced clinical trial infrastructure, and adoption of decentralization in clinical trials over the last decades have driven the high market growth in the North American region. Behind North America, Europe is one of the leading regions for virtual clinical trials. The increased acceptance of digital and more connected technologies, the high patient population, and increasing awareness among clinical trial investigators, sponsors, and contract research organizations about virtual clinical trials drive the market growth in the region. In addition, larger geographical landmass and limited healthcare settings make virtual clinical trials an ideal solution for Europe.
APAC is still in the infant stage of adopting virtual clinical trials, but it has vast opportunities to deliver to the virtual clinical trials market. In recent years, clinical trial activities in APAC countries significantly increased. Currently, APAC is well known for its clinical trial industry hub. Large patient populations, diverse ethnicities & geographies, treatment demanding populations, similar diseases pattern, increasing technology adoption in clinical trials, and rapidly growing biopharma industries are some key elements that accelerate virtual clinical trials market growth.
Medable, Science 37, THREAD, Dassault Systèmes (Medidata), IQVIA, Clinical ink, Castor, ObvioHealth, Labcorp Drug Development, ERT, Signant Health, Covance, Jeeva, Accenture, and Delve Health are some of the significant players in the global virtual clinical trials market. Further, factors such as increasing drug development focused by various big pharma and biotech companies, continuously increasing their expenditure on research and development activities, clinical trials, and development of advanced solutions triggered high competency in the biopharmaceutical industry. Increasing competition in the pharma industry directly impacts the competitiveness in the virtual clinical trial market.
THREAD offers a unique, innovative, and highly advanced decentralized clinical trial platform in the virtual clinical trials market. THREAD is a fully configurable and singular DCT platform with services that deliver global scalability and rapid flexibility from DCT study design. In 2022, the company acquired inVibe to ingrate the voice of the trial participants and broaden the trial design and research capabilities.