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Clinical researchers often use real-world evidence (RWE) to enhance data from randomized controlled trials (RCTs). The 21st Century Cures Act has encouraged the U.S. Food and Drug Administration (FDA) to take a more active role in utilizing real-world data and evidence for regulatory decision-making.
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Chronic diseases pose a significant challenge in the U.S., with approximately 157 million individuals affected in 2020. This number is projected to rise to 171 million by 2030 (source: RAND Corporation). Additionally, the U.S. Centers for Disease Control and Prevention (CDC) reported that over 130 million adults had diabetes or prediabetes in 2019, with around 1.4 million new diabetes diagnoses that year (source: U.S. CDC).
According to the U.S. Census Bureau’s Senior Report 2021, more than 54 million adults aged 65 and older reside in the U.S., representing about 16.5% of the population. The high prevalence of chronic diseases, coupled with an increasing elderly population, heightens the burden of age-related chronic conditions, thereby driving demand for RWE solutions.
Infectious diseases are also on the rise in the U.S., primarily caused by bacteria, viruses, fungi, and parasites. This growing burden is expected to accelerate healthcare data generation, further propelling the RWE solutions market. The U.S. Department of Health & Human Services reports that the number of HIV-positive individuals is growing at a CAGR of 2.5%. In 2020, approximately 1.2 million people were living with HIV in the U.S., up from 1.16 million in 2019 (source: U.S. Department of Health & Human Services). It is estimated that 40% of new HIV infections are transmitted by individuals who are undiagnosed (source: CDC). Furthermore, hepatitis A virus infections rose from 2,800 in 2015 to 19,800 in 2020. The U.S. also has one of the highest confirmed COVID-19 case counts globally, with around 94.8 million cases reported as of September 27, 2022 (source: WHO).
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The U.S. government is increasingly investing in innovative technologies to effectively manage the growing burden of chronic and infectious diseases. The American Medical Association advocates for the use of real-world data and evidence to enhance patient outcomes and telemedicine for chronic disease management. Researchers are keen to leverage RWE to address health disparities and improve outcomes for all patients.
Real-world data provides more accurate and diverse insights into the safe and effective use of medical innovations, helping to reduce costs and delays associated with drug development and post-marketing studies. This evidence can also serve as a conditional requirement for licensing and support reimbursement from healthcare payers. As the burden of chronic and infectious diseases continues to grow, the demand for research studies will increase, generating significant volumes of data for real-world evidence. Consequently, the U.S. RWE solutions market is projected to reach $2.22 billion by 2029, with a CAGR of 13.1% from 2022 to 2029, according to Meticulous Research®.
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