The clinical trials market size is estimated to grow from USD 48.68 billion in 2022 at 5.6% CAGR (2023-2032) to reach an estimated USD 83.55 billion by 2032, as a result of growing demand for personalized medicines, rising investment in R&D, and adoption of decentralized clinical trials.
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41% of the clinical trial outcomes were submitted to the ClinicalTrials.gov federal database in the fiscal year 2022, with a rise from 34% in 2021
Clinical trials refer to a medical research study that evaluates the safety and effectiveness of new drugs, medical devices, diagnostic tools, or other medical interventions in humans. Clinical trials are conducted in phases, each with specific objectives and designs. Clinical trials are critical in advancing medical knowledge and improving patient care by identifying new and effective treatments, improving existing treatments, and identifying potential risks or side effects of medical interventions. The clinical trials market includes various participants, including pharmaceutical and biotechnology companies, contract research organizations (CROs), academic research institutions, regulatory bodies, and healthcare providers.
The government is exclusively making efforts to drive the clinical trials market growth. They are allocating new resources to data collection & scientific infrastructure, strengthening the protection of intellectual property, and affording access to patient populations. The R&D environment is also improving steadily across the globe. The world is hosting a growing pool of scientific & development expertise, adoption of advanced technology & quality clinical outsourcing providers. In addition, the various amendments made by the regulatory market to change the clinical trials evaluation standards is driving the market growth. Most countries are now focused on more efficient registration & approval processes with a raft of significant improvements introduced worldwide. Governments across the world are investing in new resources to support data collection and scientific infrastructure, which is helping to create a more efficient and effective clinical trial process. In addition, governments are taking steps to strengthen the protection of intellectual property, which is crucial for promoting innovation and attracting investment in the clinical trials market.
Furthermore, favorable government support and stringent regulations in clinical trials are anticipated to boost the demand. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to speed up the development of treatment for the global disease caused by the coronavirus. Moreover, ClinicalTrials.gov has published a database of around 448,686 privately and publicly funded clinical studies around the globe in 221 countries. And according to them, there has been a significant increase in the number of clinical trials performed over the years.
The clinical trials market is driven by several factors, including the increasing prevalence of chronic diseases, the growing demand for personalized medicine, and the need for innovative and effective treatments. With the increasing focus on precision medicine and personalized healthcare, there is a growing demand for clinical trials that can identify biomarkers and other patient-specific factors that can be used to tailor treatments to individual patients. In addition, the clinical trials market is also being shaped by the increasing use of technology and data analytics to improve trial design and patient recruitment, as well as the use of virtual and decentralized clinical trials to reduce costs and increase patient access.
Another important factor driving the growth of the clinical trials market is the increasing access to patient populations. Governments are taking steps to improve patient access to clinical trials by funding programs that encourage patient participation and by creating incentives for healthcare providers to participate in clinical trials. The R&D environment is also improving steadily across the globe. Many countries are hosting a growing pool of scientific and development expertise, and the adoption of advanced technology is making it easier to conduct clinical trials and collect data. In addition, quality clinical outsourcing providers are becoming more widely available, making it easier for companies to conduct clinical trials in multiple locations around the world.
A modern approach that focuses on placing the patient at the center of the trial design and execution, with the aim of improving patient outcomes and satisfaction. Patients are involved in the trial design process from the outset, providing input on study protocols, patient information materials, and other aspects of the trial. With a focus on patient engagement and retention throughout the trial, efforts are made to enlist a diverse and representative patient population. In order to execute patient-friendly trial designs, the needs and preferences of patients are kept in mind, with a focus on minimizing the burden and inconvenience for patients. In addition, patient advocacy groups are often involved in the clinical trial process, advocating for patient needs and interests and providing support and resources to patients throughout the trial. By executing patient-friendly trial designs, companies can improve patient recruitment and retention rates, leading to more accurate and reliable data.
Companies that prioritize patient engagement and satisfaction are more likely to build goodwill and positive relationships with patients, which can have long-term benefits for the company. Furthermore, reaching out to patients where they are while performing clinical trials is the future of clinical trials. Some of the ways in which the future trial model is seeking to meet patients where they are include:
Virtual and decentralized trials: With the help of technology, clinical trials can be conducted virtually or decentralized, enabling patients to participate from the comfort of their own homes. This can increase participation rates, particularly among patients who live far from trial sites, have mobility issues, or have other health concerns that make it difficult to travel to study centers.
Real-world evidence: Real-world evidence (RWE) is data collected outside of traditional clinical trial settings, such as electronic health records, patient-generated health data, and other sources. By incorporating RWE into clinical trials, researchers can get a more comprehensive understanding of patient experiences and outcomes, which can help to improve trial design and recruitment.
Patient engagement: Engaging patients in the trial process, by providing regular updates, soliciting feedback, and offering support, can help to build trust and increase patient participation in trials.
The growing prevalence of disease and incidence of new diseases is expected to give a further boost to the clinical trial market. For instance, according to the WHO statistics reported in September 2022, Non-communicable diseases (NCDs) kill 41 million people each year, equivalent to 74% of all deaths globally. In addition, according to WHO estimates for 2021, 1.5 million people were newly infected with HIV.
Figure: New HIV Infections per 1000 Uninfected Population (2021)
The worldwide population has varied disease profiles with emerging countries having the most diverse disease profile. This is expected to boost the clinical trial of new or rare diseases which otherwise would not have found any sponsors. More patients having a specific disease would act as a stimulus for biopharmaceutical companies to invest more in clinical trials for a disease segment. A diverse population would also mean easy recruitment of patients and a faster clinical trial process. Rare diseases are given the status of “Orphan disease” in U.S. and biopharmaceutical companies who sponsor clinical trials for Orphan drugs would get incentives for the process. This trend is likely to have a positive impact on clinical trials for rare diseases thereby increasing the global clinical trials market.
In addition, advancements in medical technology and innovative research approaches have made it possible to conduct clinical trials for a wider range of diseases and conditions, including rare and orphan diseases that were previously difficult to study. This has opened up new opportunities for pharmaceutical companies and clinical research organizations to develop treatments for previously untreatable or poorly treated conditions. Moreover, the increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases has also contributed to the growth of the clinical trial market. The burden of these diseases on healthcare systems and patients is significant, and there is a growing need for innovative and effective treatments that can improve patient outcomes and quality of life.
As new diseases emerge and existing diseases evolve, there is a growing need for effective treatments that can improve patient outcomes and quality of life. This has led to an increase in demand for clinical trials that can test the safety and efficacy of new treatments. As a result, there has been a corresponding increase in the number of clinical trials being conducted globally, with many countries investing in research and development to address the growing demand.
The paradigm shift towards personalized medicine is expected to have a positive impact on the clinical trial market. The classic clinical trial process is carried out on thousands of people while personalized medicine will focus only on the effect of drugs on individual patients for a specific period. Very few medicines in the development phase pass all phases of a clinical trial due to the traditional clinical trial approach. The mentality of “one size will fit all” is acting as a barrier for drugs that are currently in pipeline but would never see the day. The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.
The use of digital health technologies, such as wearables, sensors, and mobile apps, has enabled researchers to collect large amounts of real-time patient data, which can be used to design more efficient and effective clinical trials. Digital health technologies have the potential to improve clinical trials in a number of ways such as improved patient monitoring, enhanced patient engagement, precise data collection, improved trial design, and faster recruitment. Digital health technologies have enabled decentralized clinical trials, where patients can participate in clinical trials from their own homes using mobile apps, wearables, and telemedicine. This has the potential to reduce the cost and time required for clinical trials and increase patient participation.
Regulators have recognized the potential of digital health technologies to improve clinical trials and have been increasingly accepting of digital health-tech results as evidence of improved treatment effectiveness. The vast amounts of data generated by digital health technologies can be analyzed using AI and machine learning algorithms to identify patterns and generate insights. This has the potential to improve the design and implementation of clinical trials, as well as the evaluation of treatment effectiveness.
Digital health technologies are enabling a more patient-centric approach to clinical trials, where patients have more control over their participation and can provide feedback on the design and implementation of clinical trials. This has the potential to improve patient engagement and retention in clinical trials. In addition, Regulators are increasingly using real-world evidence generated by digital health technologies to evaluate treatment effectiveness. This has the potential to reduce the cost and time required for clinical trials and enable faster regulatory approval of treatments. This has created opportunities for innovative companies in the digital health space to partner with pharmaceutical companies and CROs to conduct more efficient and effective clinical trials, ultimately leading to faster drug development and improved patient outcomes.
The COVID-19 pandemic has had a significant impact on the clinical trial industry, leading to the widespread adoption of decentralized clinical trials (DCTs). DCTs are trials that use digital technologies and remote monitoring to reduce the need for patients to travel to clinical sites and allow them to participate in trials from the comfort of their own homes. The COVID-19 pandemic has accelerated the adoption of DCTs and highlighted the potential benefits of these trials for improving patient access and engagement, reducing costs, and enhancing trial efficiency and flexibility. Several market players started providing decentralized clinical trials for patient convenience. For instance, the Northwell Health hospital system in New York started a clinical trial to see if the over-the-counter drug famotidine (also known as Pepcid) minimizes the severity of COVID-19 in symptomatic individuals who do not need to be hospitalized, in January 2021.
In April 2020, the National Institute of Health in collaboration with the Foundation for the NIH (FNIH) launched a public-private partnership to accelerate treatment & vaccine options for Coronavirus. It included the European Medicines Agency, the U.S. FDA, the Centers for Disease Control and Prevention, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, and more than a dozen of biopharmaceutical companies to develop a global strategy for a synchronized research response to the global pandemic. The planned collaboration "Accelerating COVID-19 Therapeutic Interventions & Vaccines (ACTIV)" is designed to create a joint structure for focusing on streamlining clinical trials, drug and vaccine candidates, leveraging assets, and coordinating regulatory processes among all partners to respond quickly to both present and potential pandemics.
The COVID-19 pandemic has disrupted the clinical trial industry, forcing players to adopt decentralized clinical trials that allow patients to participate in trials from the comfort of their homes. This trend has been driven by the need to improve patient access and engagement, reduce costs, and enhance trial efficiency and flexibility. The adoption of decentralized clinical trials has been further accelerated by the National Institute of Health's public-private partnership with several biopharmaceutical companies to develop a global strategy for a synchronized research response to the pandemic. This partnership has led to the development of a collaborative framework for prioritizing drug and vaccine candidates, coordinating regulatory processes, streamlining clinical trials, and leveraging assets among all partners to quickly respond to the current and future pandemics.
By adopting digital technologies and remote monitoring, clinical trial players can improve patient engagement and retention, reduce trial costs, and increase efficiency. Furthermore, the use of decentralized clinical trials is likely to continue even after the pandemic, as players seek to improve patient access and engagement while reducing costs and increasing efficiency. As such, companies that embrace decentralized clinical trials are likely to be well-positioned to meet the evolving needs of patients and improve their bottom lines.
The Solidarity Clinical Trials have used a randomized controlled trial design, which is considered the gold standard for evaluating the effectiveness of medical treatments. The use of this design has allowed for rigorous evaluation of different treatments for COVID-19. It is an international clinical trial launched by the WHO to find effective treatment against COVID-19. It included comparing four treatment options against the standard of care to evaluate their effectiveness against Coronavirus. Solidarity clinical trials were meant to discover if any of the drugs improve survival or slow down the progression of the disease. The trials had been conducted in a relatively short period of time, which has allowed for the rapid generation of evidence on the safety and efficacy of different treatments for COVID-19. This has been particularly important given the urgent need for effective treatments for the disease. During March, the funding for the Solidarity trial reached USD 108 million from 203,000 individual donations, governments, and charitable organizations with 45 countries involved in financing.
According to WHO, as of April 21st, 2020, around 100 countries participated in the trial and were working together to find effective therapeutics as early as possible. As per the WHO’s Director, by 18th March 2020, the ten countries that took part in the clinical trial are Thailand, Switzerland, Spain, South Africa, Norway, Iran, France, Canada, Bahrain, And Argentina.
There have been significant advancements in technology over the past two years that have impacted the clinical trial industry. For example, the use of artificial intelligence and machine learning algorithms for patient recruitment, data analysis, and personalized medicine is becoming more widespread. The use of artificial intelligence and machine learning algorithms has become increasingly popular in the industry. These technologies have enabled more efficient and effective patient recruitment, improved data analysis, and enabled personalized medicine. This has led to a more accurate and comprehensive analysis of trial data and improved patient outcomes. The COVID-19 pandemic has accelerated many of these changes and highlighted the importance of agility, flexibility, and patient-centricity in the clinical trial process. In addition, prominent market players have adopted several growth strategies in the clinical trials market in recent years.
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.