Clinical researchers frequently use real-world evidence to complement data generated from randomized controlled trials (RCTs). With the passage of the 21st Century Cures Act, the U.S. Food and Drug Administration (FDA) acknowledged a larger role in using real-world data and real-world evidence to support regulatory decision-making.
The burden of chronic diseases is large in the U.S. The number of people with chronic conditions in the U.S. was around 157 million in 2020, and by 2030 this number is expected to reach 171 million (source: RAND Corporation). Furthermore, according to the U.S. Centers for Disease Control and Prevention (CDC), in 2019, more than 130 million adults had diabetes or prediabetes in the U.S. In 2019, around 1.4 million people of age 18 years and older were diagnosed with diabetes in the U.S. (Source: U.S. CDC).
According to the U.S. Census Bureau - Senior Report 2021, more than 54 million adults aged 65 and over live in the U.S., accounting for about 16.5% of the nation’s population. Thus, the large prevalence of chronic diseases and the rising geriatric population increase the burden of various age-related chronic diseases, further boosting the demand for RWE solutions in the country.
The prevalence of infectious diseases is rising in the U.S. These are mainly caused by organisms, such as bacteria, viruses, fungi, or parasites. The increasing burden of infectious diseases in the U.S. is expected to accelerate the generation of healthcare data, driving the RWE solutions market in the U.S. According to the U.S. Department of Health & Human Services, the number of HIV-positive patients in the country is growing at a CAGR of 2.5%. The number of HIV-positive patients in the U.S. was estimated to be around 1,200,000 and 1,162,000 in 2020 and 2019, respectively (source: U.S. Department of Health & Human Services). It is assumed that 40% of new HIV infections in the U.S. are transmitted by people living with undiagnosed HIV (source: U.S. Centers for Disease Control and Prevention (CDC)). Similarly, according to the U.S. Centers for Disease Control and Prevention (CDC), the number of hepatitis A virus infections in the U.S. increased from 2,800 in 2015 to 19,800 in 2020. In addition, the U.S also has one of the highest numbers of COVID-19 confirmed cases globally. As of 27h September 2022, the country had registered around 94.8 million confirmed cases of COVID-19 (source: WHO).
The government of the U.S. is increasingly focusing on adopting novel technologies to counter and efficiently handle the growing burden of chronic and infectious diseases. The American Medical Association has supported RWD and RWE to improve outcomes and telemedicine in managing patients with chronic diseases. Many researchers and scientists are eager to use real-world data and evidence to address health disparities, improving patient outcomes equitably across the board.
Real-world data helps provide more accurate, diverse insights on the safe and effective use of innovations and helps reduce the costs and delays associated with drug development and post-marketing studies. Moreover, the evidence generated from the data can be used as a conditional requirement in licensing to support reimbursement by healthcare payers. Thus, the growing burden of chronic and infectious diseases is expected to increase the demand for research studies and generate a large volume of data for real-world evidence resulting in higher demand for RWE solutions. Thus, the U.S. RWE solutions market is projected to reach $2.22 billion by 2029, at a CAGR of 13.1% from 2022 to 2029, according to Meticulous Research®.
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