In 2022, the Global Real-World Evidence Solutions Market generated revenue of US$ 1,522.2 million. The global market is estimated to witness remarkable growth and exceed US$ 5,810.6 million by 2031, growing at a robust compound annual growth rate (CAGR) of 16.5% during the forecast period from 2023 to 2031.
The global real-world evidence solutions market is projected to maintain a fast-paced growth trajectory and is forecasted to generate approximately US$ 1773.3 million in revenue by the end of 2023. This upward trend is due to the increasing need for medical insights, the growing digitization of healthcare data, and the rising prevalence of chronic diseases. The primary beneficiaries of real world evidence solutions are the healthcare, pharmaceutical, and medical device industries, which collectively account for around 52% of the market’s total revenue.
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The advancement and utilization of evidence to inform clinical decision-making form the foundation of medicine’s potential to enhance human health. For many years, the gold standard for generating evidence in evaluating medical products has been the randomized clinical trial (RCT). Nevertheless, there is increasing interest in the use of real-world data for evidence generation. Furthermore, during clinical trials, real-world evidence (RWE) can complement conventional outcome measurements by incorporating patient-generated data, such as patient-reported outcomes (PROs) or easily collectible biometric data between medical appointments.
High Cost of Clinical Trials and Limitations to Traditional RCTs: Accelerating Pace for Real World Evidence Solutions
Traditional randomized clinical trial (RCT) limitations include conduct in highly selected populations and specialized environments that require intensive monitoring to ensure adherence to study protocol, neither of which may represent everyday clinical practice.
While the limitations of traditional randomized clinical trials (RCTs) are widely recognized, the rapid pace of innovation in medical products has brought about additional challenges, many of which are related to the increasing costs associated with these trials.
The National Academy of Medicine has acknowledged that phase 3 trials have become exceptionally expensive. Assessments of the cost of bringing a new drug to market range from US$ 648 million to US$ 2.6 billion, and the cost of developing drugs has risen approximately 8.5% beyond inflation in recent years mainly because of increasing trial costs. This rise is due to the increasing administrative burden with more complex clinical trial protocols that use multiple assessments, increased responsibility by institutional review boards because of a lack of clarity about oversight mechanisms, and inefficient clinical trial monitoring.
Therefore, concerns have arisen that the increasing costs, complexity, and longer duration of traditional randomized clinical trials (RCTs) may not be able to keep up with the demand for evidence. Thus, in recent years, there has been a significant growth in the volume and complexity of electronic healthcare real-world data, which can be utilized for evaluating medical products using real-world evidence (RWE) approaches.
Oncology Therapeutic Area Contributed About US$ 507.8 Million to the Overall Market Revenue Share
The oncology sector is at the forefront of the market, with a market value of US$ 507.8 million in 2022. This significant market share can be attributed to the high volume of clinical trials focused on oncology and the increasing global incidence of cancer. According to Clinicaltrials.gov, as of February 8, 2022, there were over 87,366 cancer clinical studies in various stages of research.
The need for effective, evidence-based treatments for cancer is rising due to the growing incidence and burden of the disease. According to the National Library of Medicine, there were 18.1 million new cancer cases and 9.6 million deaths due to cancer globally in 2018. It is projected that the annual number of cancer cases will increase to 29 million by 2040
As the global burden of cancer continues to rise, the economic cost of cancer treatment also increases. According to the National Library of Medicine, the per-patient annualized average costs vary depending on the phase of treatment and the type of cancer. The highest costs were observed in the last year, followed by the initial and continuing phases. According to our survey, for medical services, the average costs were US$ 109,727, US$ 43,516, and US$ 5,518, respectively. For oral prescription drugs, the average costs were US$ 4,372, US$ 1,874, and US$ 1,041, respectively.
As the global burden of cancer continues to rise, there is a growing recognition that traditional clinical trials may not fully meet the evidentiary needs for regulatory assessment and clinical decision-making. This has led to an increasing interest in the potential of real-world data to generate real-world evidence that is suitable for cancer care. The use of real-world data can provide valuable insights into the effectiveness and safety of cancer treatments in real-world settings.
North America Leading the Global Real World Evidence Solutions Market
The real-world evidence (RWE) solutions market is expanding rapidly, with North America presently holding the top spot. A strong regulatory environment, a large number of real-world evidence (RWE) service providers, the existence of a well-established pharmaceutical industry in the area, together with substantial R&D spending are some of the factors propelling the market expansion.
The region has a strong healthcare infrastructure that makes it possible to gather and analyze enormous volumes of patient data. This data is the starting point for producing empirical evidence and obtaining insightful conclusions. Furthermore, North America has powerful data analytics capabilities that enable in-depth examination and interpretation of the gathered data.
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North America benefits from a regulatory framework that is conducive to advancements in real-world evidence (RWE). Regulatory agencies, such as the United States Food and Drug Administration (FDA), play a critical role in promoting the integration of RWE into clinical decision-making and drug development processes by providing frameworks and standards. The regulatory support instills trust in stakeholders, including insurers, pharmaceutical companies, and healthcare providers, which, in turn, drives the growth of the RWE solutions market in North America.
List of Key Companies Profiled:
- SAS
- Syneos Health
- IBM
- Anthem
- Clinigen Group
- Palantir Technologies
- Flatiron Health
- IQVIA
- ICON
- PAREXEL
- Optum
- Cognizant
- Oracle
- Clarivate plc
- Medpace Holding Corporation
- Elevance Health Inc
- Other Prominent Players
Market Segmentation Outline
The global real-world evidence solutions market segmentation focuses on Therapeutic Area, Component, End-User, and Region.
By Therapeutic area
- Cardiovascular Oncology
- Immunology
- Others
By Component
- Dataset
- Services
By End User
- Medical Devices
- Pharmaceutical
- Payers
- Others
By Region
- North America
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- The U.S.
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- Canada
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- Mexico
- Europe
- Western Europe
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- The UK
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- Germany
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- France
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- Italy
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- Spain
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- Rest of Western Europe
- Eastern Europe
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- Poland
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- Russia
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- Rest of Eastern Europe
- Asia Pacific
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- China
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- India
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- Japan
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- South Korea
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- Australia & New Zealand
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- ASEAN
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- Rest of Asia Pacific
- Middle East & Africa
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- UAE
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- Saudi Arabia
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- South Africa
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- Rest of MEA
- South America
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- Argentina
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- Brazil
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- Rest of South America
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