Virtual Clinical Trials Market Research Report: Information by Study Type (Interventional, Observational), by Phase (Phase 1, Phase 2, Phase 3, Phase 4), by Indication (Oncology, Cardiovascular, Immunology, Gastrointestinal, Respiratory, Endocrinology, Ophthalmology), and by Region (North America, Europe, Asia-Pacific, and Rest of the World) - Forecast till 2027

Virtual Clinical Trials Market Forecast

The global virtual clinical trials market is expected to cross ~USD 11,239.0 million by 2027 at a CAGR of ~5.89%.

Market Overview:

Virtual clinical trials incorporate patient-facing technologies, such as tablets, smartphone apps, or wearable sensors. The virtual clinical trials are anticipated to use more of mobile technology, web-based patient diaries, wearable technologies and other digital approaches. Often, they are described as virtual trials, decentralized trials, remote trials, direct-to-patient trials, and hybrid trials. The market is driven by various factors such as increase in shift towards virtual clinical trials due to COVID-19 pandemic, rise in integration of mobile-based health platform and the increasing demand for flexibility of investigational site. However, the lack of regulations and need for data integration arising from large influx of data may hamper the growth of the market.

COVID-19 Analysis

The present COVID-19 pandemic has impacted people all over the world and forced the closure of operational facilities across the world. During the lockdown, the healthcare business faced extraordinary challenges such as supply chain disruptions, resulting in an increase in warehouse inventories of manufactured goods. However, the market for virtual clinical trials did not hamper to a great extent.

The COVID-19 pandemic also created growth opportunities for the companies involved in the virtual clinical trials industry. This is due to the increased R&D efforts to produce drugs for COVID-19, testing vaccines on clinical stage and benefits provided by virtual clinical trials to reduce contact between investigators and volunteers. Manufacturers of medical devices, pharmaceutical drugs, biologics and innovative therapies were engaged in continuing their ongoing clinical trials by shifting to hybrid model. Contract research organizations were focused on collaborating with technology providers to adopt to changing scenario for clinical trials during COVID-19 pandemic.

Market Dynamics

• Convenience provided as compared to traditional method
  
  
  
  • Clinical drug development process takes up to 10 to 15 years. Approximately 85% of experimental therapies fail through early phases while 50% of phase 3 trials are approved. The virtual clinical trials with respect to certain ailments like dermatological disease requiring telehealth follow-up can be easily completed without the volunteers requiring travel to investigational site. Most of the clinical trials are delayed due to patient recruitment process. The virtual clinical trials employ digital technologies thereby maintaining patient records, using big data to find probable volunteers, reporting adverse effects on real-time basis and digitization provides other benefits as compared to traditional method.
  
  
  • Moreover, the geographic proximity is always a concern which can be eliminated by virtual trials. For example, an observational study focused on recording behavior of subjects after administration of an anti-viral drug can be completed by recruiting volunteers from different continents. For the process of informed consent, the volunteers can provide digital signature which reduces expenses for investigators. In case if laboratory diagnosis is required, digital methods save time by scheduling appointments. Moreover, communication with patients does not stop and vital signs of participants are monitored continuously. Additionally, the findings of study are in electronic mode and paperless which reduces time for analyzing data and reporting.
  
  
  
  


• Integration of mobile-based health platform


• COVID-19 as a catalysis for virtual trials

• Increasing need for virtual clinical trials
  
  
  
  • Large number of experimental therapies, investigational drugs and medical devices are expected to be approved during the forecast period. In 2018, almost half of approved drugs were attributed to smaller biopharmaceuticals, and in recent years large pharma companies have reduced in-house research and development activities and greatly increased inlicensing or acquisition of products to fill their pipelines, according to a report by HBM Partners AG (Switzerland). An increasing number of spin out, seed-stage funding, licensing agreements and similar strategies are observed among startups in the recent years.
  
  
  • Contract research organizations are attracting more of outsourcing projects order from clinical-stage companies in the form of clinical trials. The availability of research funding has increased to a greater extent in the pharmaceutical industry. According to the Congressional Budget Office’s Research and Development in the Pharmaceutical Industry Report, April 2021, between 2010 and 2019, the number of new drugs approved for sale increased by 60 percent compared with the previous decade. 59 new drugs approved in 2018. In 2019, the pharmaceutical industry spent USD 83 billion on R&D and the amount was 10 times per year as compared to 1980s. An increasing amount spent on R&D and large number of startups in need of virtual clinical trial services is expected to increase the lucrativeness of virtual clinical trials market.
  
  
  
  

• Lack of data security
  
  
  
  • Virtual modalities can help reach more patients, digitalizing important steps of the process but it also poses ethical dilemmas that are better handled face to face. Moreover, certain surgical procedures under review cannot be completed virtually. With increasing adoption of eConsent, the investigators are required to encrypt data. The eConsent requirements vary from country to country. Non-adherence to norms set by regulatory bodies can delay study progression and result in delay.
  
  
  
  


• Value Chain Analysis
  
  
  
  • The global virtual clinical trials market is projected to exhibit significant growth over the forecast period, which can be attributed to factors such as an increase in healthcare R&D expenditure, higher adoption of virtual clinical trials, a rise in the number of startups, and the increasing demand for services for data management. The value chain analysis for the virtual clinical trials industry comprises four major components, which start with research & development, followed by the manufacturing of the products, distribution & sales, and ends with post marketing surveillance.
  
  
  
  

• Interventional


• An interventional study tests an intervention such as a potential drug in pipeline, medical device like vibration vest, activity such as exercise, or procedure in target population. New potential drugs need to pass through three phases of interventional testing to show that they are safe and effective.


• Observational


• Observational studies do not test potential treatments. Instead, researchers observe participants on their current treatment plan and track health outcomes. For example, after a new drug is approved, the FDA often requires that the pharmaceutical company continue to monitor the effectiveness and safety of the drug in what is known as a Phase 4 study.


• Others


• The other studies that are observed are the one related to expanded access based on compassionate use. Patients with life-threatening conditions or serious diseases need immediate treatment. Certain drugs, biologics and medical devices can be approved on compassionate basis so that patients are treated speedily.

• Phase 1


• Investigators need to prove there is a chance that the new treatment will work better than the one available. Phase 1 clinical trial assess whether a new drug, treatment, or medical device is safe for people. Investigators collect information on the dose or treatment, frequency of dosage, adverse effects and complications associated with procedure.


• Phase 2


• A phase 2 clinical trial helps investigators understand the safety of treatment and how well it works with diverse groups. Diagnostic tests are employed to check whether new treatment works to reduce symptoms and help alleviate pain. An investigator might measure the tumor size using radiological examination or analyze blood samples to assess the availability of biomarkers. Patient health records consisting of treatment regime and effectiveness of therapy are maintained.


• Phase 3


• Treatments that worked well for volunteers in phase 2 clinical trial are tested in phase 3 clinical trials. Investigators use phase 3 trial to compare the new treatment with the available standard treatment. The toxicity, safety and efficacy of treatments are studied to compare with available treatments. This phase can take many years. The interpretations of clinical trials are documented and reported to regulatory bodies. The medications, medical devices and procedures are reviewed by regulatory agencies for approval if end points meet criteria set forth.


• Phase 4


• Phase 4 clinical trials are initiated to monitor the safety of approved products or procedures. It is also known as post-marketing surveillance study. The pharmacovigilance of drugs and medical devices is necessary to understand safety. However, if certain adverse effects or complications arise; regulatory agencies might ask sponsors to initiate recall process. During the ongoing phase 4 study, sponsors may assess the efficacy of medication or combination therapy to obtain regulatory nod for other indications.

• Oncology


• From 2017 to 2019, the US FDA approved 146 supplemental indications for 107 therapeutics on the basis of 181 pivotal efficacy trials. 53% of the supplemental indication approvals were for the treatment of cancer. The clinical trials related oncology has increased as compared to the past decade. Moreover, in 2020, an estimated 1,806,590 new cases of cancer were diagnosed in the United States. The burden of disease is higher as compared to other indications.


• Cardiovascular


• The clinical trials related to cardiology are expected to increase with increasing prevalence of cardiovascular diseases. Increasing number of procedures associated with percutaneous coronary intervention techniques and intravascular ultrasound-guided procedures are expected to take place during the forecast period. The approval of next generation stents and transcatheter aortic valve implantation in low-risk patients need monitoring over a longer duration of time. These factors are expected to increase demand for virtual clinical trial services related to cardiovascular diseases.


• Immunology


• Autoimmune diseases are increasing globally, from an estimated prevalence of 3.2% around 1995 to 19.1% reported in 2018. Immunological rheumatic diseases are a diverse group of conditions that primarily affect the joints, bones, muscle, and connective tissue, with rheumatoid arthritis being the most common. According to the National Institutes of Health, up to 23.5 million Americans suffered from an autoimmune disease in 2018.


• Gastrointestinal


• Gastrointestinal diseases comprise various indications such as celiac disease, Irritable Bowel Syndrome (IBS), lactose intolerance, chronic diarrhea, constipation, Gastroesophageal Reflux Disease (GERD), peptic ulcer disease and Crohn's disease. According to the data available from National Institute of Diabetes and Digestive and Kidney Diseases, about 68% of the world’s population has lactose malabsorption. In the United States, about 36% of people have lactose malabsorption.


• Respiratory


• The pandemic of COVID-19 has increased the number of clinical trials related to respiratory diseases. A whooping large number of clinical trials were registered on clinicaltrials.gov after March 2020. According to the WHO's International Clinical Trials Registry Platform, 5,706 clinical trials were registered as of 29th November, 2021. Moreover, the coronavirus family including COVID-19, SARS virus and MERS need clinical trials to be monitored virtually to minimize the probability of infection and transmission.


• Endocrinology


• Diabetes, growth disorder, infertility, osteoporosis, polycystic ovary syndrome and thyroid disorders are some of the common endocrine disorders. As many as 1 in 3 the U.S. adults could have diabetes by 2050 if current trends continue, according to a new analysis from the Centers for Disease Control and Prevention.


• Ophthalmology


• An increasing number of clinical trials related to age-related farsightedness, uveitis, astigmatism, conjunctivitis, cataracts, macular edema, diabetic retinopathy, macular degeneration and other indications are fueling growth of this segment. According to the International Agency for the Prevention of Blindness data, there were 253 million visually impaired people worldwide by 2015. By 2020, among the global population who were blind (38.5 million), the number of patients blind because of cataract is anticipated were 13.4 million.


• Others


• The other indications include rare diseases that are related to therapeutic areas of orthopedics, psychiatry, dermatology, urology, and thrombosis.

• North America
  
  
  
  • North America held the largest market share in virtual clinical trials market in 2020. Presence of key players like Medable, Inc. (US), Oracle Corporation (US), IQVIA Holdings, Inc. (US), Syneos Health (US), PPD, Inc. (US) and Medpace Holdings, Inc. (US) is one of the key factors contributing to market growth. Moreover, higher percentage of clinical trials are currently ongoing in the US. The increasing R&D investment drives the virtual clinical trials market in the region. For instance, according to American Association for the Advancement of Science (AAAS), the funding for National Institutes of Health (NIH) for fiscal year 2022 was increased by 15% compared to fiscal year 2021.
  
  
  
  


• Europe
  
  
  
  • The Europe virtual clinical trials market held a significant market share in 2020. The virtual clinical trials in Europe are expected to increase with support from Innovative Medicines Initiative, European Federation of Pharmaceutical Industries and Associations, Electronic Components and Systems for European Leadership, Medical Products Agency and Clinical Trial Facilitation Group.
  
  
  
  


• Asia-Pacific
  
  
  
  • The rapid growth of the Asia-Pacific market is due to the developing infrastructure for research and increasing contract research organizations, and an increase in the number of academic institutes. Countries like Japan have well developed research infrastructure along with the presence of key pharmaceutical companies, whereas India is rapidly developing in the healthcare R&D space. China had spent the highest R&D expenditure up till 2020 which had increased by 10.3% reaching upto USD 378 billion. These factors enable the Asia-Pacific region to grow at the highest CAGR during forecast period.
  
  
  
  


• Rest of the World
  
  
  
  • The Rest of the World region is segmented into the Middle East, Africa, and Latin America. The virtual clinical trials market in the region is driven by technological developments and the growing number of research studies. Government initiatives to bring technological advancements in the region and global players expanding R&D capabilities in the region, drive growth for market.
  
  
  
  

• The global virtual clinical trials market is characterized by the presence of many global, regional, and local vendors catering to the demand created by research scientists and pharmaceutical and biotechnology companies operating in the industry. The growing demand for virtual clinical trial services from pharmaceutical and biotechnology companies is propelling the virtual clinical trials market growth. The market is highly competitive, with players competing and partnering to gain a substantial market share. For instance, in July 2020, IQVIA (US) came into a partnership agreement with AstraZeneca plc (UK). IQVIA aimed to enroll the U.S. study participants who received medication onto its virtual clinical trial platform. The prominent players are involved in strategic agreements and joint ventures to sustain their market positions.

• Oracle Corporation (US)


• IQVIA Holdings, Inc. (US)


• Dassault Systemes SE (France)


• Medpace Holdings, Inc. (US)


• Icon plc (UK)


• Laboratory Corporation of America Holdings (US)


• Parexel International Corporation (US)


• Medable, Inc. (US)


• Clinical Ink, Inc. (US)


• Wuxi AppTech (China)

• Laboratory Corporation of America Holdings (US) announced in July 2020 that its contract research organization, Covance, partnered with digital clinical trial software maker Medable Inc. (US) to allow clinical trial participants to engage with trials remotely


• In January 2021, ICON plc (Ireland) provided clinical trial services to the Pfizer Inc. (US) and BioNTech SE (Germany) which included a high level of remote clinical monitoring for late-stage study of a COVID-19 vaccine


• In February 2020, IQVIA (US) launched Avacare Clinical Research Network, an advanced analytics based tool to deliver artificial intelligence-powered patient referrals and data-driven enrollment trends

• The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID-19 on the market.

• The scope of the global virtual clinical trials market study includes market size analysis and a detailed analysis of the manufacturer's products and strategies. The market has been segmented based on study type, phase, indication, and region.

• Interventional


• Observational


• Others

• Phase 1


• Phase 2


• Phase 3


• Phase 4

• Oncology


• Cardiovascular


• Immunology


• Gastrointestinal


• Respiratory


• Endocrinology


• Ophthalmology


• Others

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America