Decentralized Clinical Trials (DCTs) Market to Grow $38.2 Bn by 2034

Decentralized Clinical Trials (DCTs) Market Size, Trends and Future Growth

The global decentralized clinical trials (DCTs) market was estimated at US$ 8.29 billion in 2023 and is projected to grow to US$ 38.2 billion by 2034, rising at a compound annual growth rate (CAGR) of 14.9% from 2024 to 2034. The demand for DCTs is increasing because they do not require patients or volunteers to conduct the research. This becomes more important considering the fact that many clinical trials are being conducted.

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Market Overview

DCTs are studies in which the need for the physical presence of patients in hospital-based trials is reduced or eliminated. For conducting DCTs, digital tools such as wearable devices, e-consent, apps, Electronic Patient-Reported Outcomes (ePRO), trial activities at the patient’s home, and telemedicine are used. The decentralized clinical trials (DCTs) market encompasses dedicated staff & infrastructure, partnerships between research sites, adequate regulatory frameworks, sponsors, and patients. The major driving factor of the market is reduced dependency on hospital sites, which improved patient participation and diversity. DCTs have become more useful in cases of disabled & elderly people and people who need to travel long distances for research.

Decentralized Clinical Trials (DCTs) Market Trends

• In August 2024, with a potential value of up to $100 million for the D-COHRe initiative, this first-of-its-kind partnership between Walgreens and the US government intends to conduct studies over a five-year period and overcome obstacles in decentralized clinical trial access.
• In May 2022, $40 million was raised by the decentralized clinical trial startup Curebase in a Series B financing headed by Industry Ventures. With this round, Curebase has raised $59 million in total.

AI & Machine Learning Creates New Era for DCTs

DCTs might be completely transformed by utilizing the latest advancements in artificial intelligence (AI), computing technology, and remote monitoring. AI-based sensors and wearables increase patient monitoring, which is especially relevant to decentralized trials. AI technologies also result in smaller trial sizes and shorter trial lengths. AI analysis makes it easier to meet the statistical requirements of clinical trials by facilitating the growing production of data from remote monitoring and electronic patient-reported outcomes gathering.

For instance,

• In February 2024, in an announcement, Castor and Microsoft detailed their partnership to leverage Azure to apply cutting-edge artificial intelligence (AI) to decentralized clinical trials. Castor is a patient-centric clinical trial platform provider that focuses on creating technology that eases the load on research teams, sponsors, and patients.

Data Privacy and Concerns

Ensuring compliance remains one of the top operational issues when companies implement decentralized trial methods. Although remote data collection can improve patient compliance, it presents some challenges in other areas, such as data privacy and authentication. Privacy laws and legal considerations are already quite complex. They not only vary from country to country but can also be handled differently at various clinical sites. Integrating more diverse ways of collecting data into a trial and moving that data collection from the clinic to a patient’s home introduces even more privacy considerations.

Regional Insights

North America Dominated the decentralized clinical trials (DCTs) market in 2023. North America has a strong presence in the healthcare, biotechnology, and pharmaceutical industries. These industries continuously focus on clinical trials to develop new drugs, therapeutics, medical devices & equipment, and other things to improve healthcare. Apart from this, the region also promotes technological advancements that help to grow the market in less time.

The U.S. held the largest share of the decentralized clinical trials (DCTs) market in North America. The FDA believes that DCTs have significant potential advantages and utility. The Food and Drug Administration (FDA) in the United States is implementing more measures in May 2023 to facilitate decentralized clinical trials (DCTs) for medications, biologics, and devices in which part or all of the trial's operations take place at sites other than conventional clinical trial sites. A new guideline issued by the government offers suggestions to sponsors, investigators, and other relevant parties on how to use DCTs to promote medical product development and research.

The Regulatory Innovation Agenda for health goods by the Government of Canada is built upon five main pillars. Modernizing the laws governing clinical trials is one of those cornerstones. The Canadian people will gain from this pillar, which is a top priority for the federal government. Significant progress has been made in the development and implementation of decentralized clinical trials (DCTs) in Canada as a result of the worldwide COVID-19 pandemic.

Asia Pacific is expected to grow at the fastest rate during the forecast period. The growing number of diseases and disorders is promoting the growth of the decentralized clinical trials (DCTs) market in Asia Pacific. All the stakeholders are taking an interest in conducting DCTs to achieve better therapeutics and tackle the growing prevalence of diseases. The major diseases that are growing in the Asia Pacific are diabetes, cancer, cardiovascular diseases, and infectious diseases.

China is becoming more and more interested in the DCT concept. The Chinese Journal of New Drugs and Clinical Remedies recently released an article titled Expert Consensus on Decentralized and Digitalized Clinical Trials, which was co-authored by the Shanghai Pharmaceutical Association and the DIA China Digital Health Community (DHC) and published in Chinese. In China, digitalized clinical trials, or DCT, are synonymous with decentralized clinical trials.

Segmental Insights

By type, the interventional segment dominated the decentralized clinical trials (DCTs) market and is expected to grow at the fastest rate during the forecast period. Clinical trials, including interventions, are essential to the progress of medicine. They offer solid scientific proof of whether novel therapies are safer or more effective than those already in use. In order to guarantee that patients have access to improved care, this data serves as the foundation for regulatory approval of novel medicines.

By application, the oncology segment dominated the decentralized clinical trials (DCTs) market in 2023. Better treatments are needed for cancer, which is fast rising to the top of the healthcare priority list. This requires ongoing research and development. The community is where around 85% of cancer care is provided and received. Therefore, ensuring that local healthcare professionals have access to clinical trials is essential to enhancing equitable access to research and innovative treatments.

By Application, the cardiovascular segment is expected to grow at a significant rate during the predicted timeframe. Since cardiovascular disease is still the world's largest cause of death, it is imperative that therapeutic approaches continue to progress. Clinical trials are essential for integrating new medical discoveries into patient treatment, but conventional trial designs are frequently limited by factors such as size, length, and funding. Decentralized clinical trials, which are part of home-based care, facilitate better recruitment of different groups, lessen the load on patients and health systems, and let clinicians and researchers meet patients where they are.

For instance,

• In October 2022, Curavit Clinical Research and 1nHealth partnered to expedite the digital recruitment of patients for decentralized clinical trials, or DCTs. Curavit's DCT technology and 1nHealth combine to expedite trial enrollment and enhance retention. The study of an experimental digital therapeutics (DTx) for chronic cardiovascular disease at Lark Health is the first project in which Curavit and 1nHealth are working together.

Recent Developments

• In August 2024, the industry-leading clinical trial technology platform, Medable Inc., today unveiled Medable Studio, an all-in-one tool for setting up, translating, validating, and introducing eCOA Plus (eCOA, eConsent, Televisit, and Sensors) into clinical trials.
• In July 2024, Walgreens will receive $25 million in Project NextGen money from the Administration for Strategic Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA) to undertake a decentralized clinical trial, with the goal of expanding access to clinical trials.
• In February 2024, Syneos Health®, a premier fully integrated biopharmaceutical solutions company, launched a decentralized clinical trial (DCT) site network to encourage suitable DCT uptake and facilitate the provision of high-quality DCTs and digital health technology solutions.

Top Companies in the Decentralized Clinical Trials (DCTs) Market

• IQVIA
• Labcorp
• ICON
• Covance
• CRF Health
• Parexel
• LEO Innovation Lab
• Thermo Fisher
• Huma
• Oracle
• Medidata
• PRA Health Sciences
• Clinical Ink
• Signant Health
• Medable
• Science 37

Segments Covered in the Report

By Type

• Interventional
• Observational
• Expanded Access

By Application

• Oncology
• Cardiovascular
• Others

By Region

• North America
  • U.S.
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)  
  • South Africa 
  • UAE 
  • Saudi Arabia 
  • Kuwait