September 2024
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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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.
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.
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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.
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.
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.
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Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.