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Real World Evidence (RWE) Solutions Market

Real World Evidence (RWE) Solutions Market: Introduction by Component (Services, Data Sets), Application (Drug Development, Medical Device Development), End-User, and Region — Forecast till 2030

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Market Snapshot

market snapshot
Base Year:
Study Period:
8.2 %
Fastest Growing Market:
Asia Pacific
Largest Market:
North America

The global real world evidence solutions market size was valued at USD 39.75 billion in 2021. It is projected to reach USD 80.79 billion by 2030, growing at a CAGR of 8.2% during the forecast period (2022–2030). Real-world data (RWD) is used to examine health outcomes and assist patients in receiving the best care. Electronic health records (EHR), healthcare claims and billing management systems, registries, patient-provided data, mobile devices, and other resources are analyzed to generate real-world evidence. It can come from both experimental and observational research and databases. Real-world evidence (RWE) offers solutions to these issues and a more comprehensive evaluation of pharmaceutical effects. It is anticipated that the global market for evidence outcomes will grow significantly over the projection period due to regulatory bodies' promotion of real-world evidence solutions.

Regulators utilize real-world evidence to monitor the safety of drugs on the market by combining classic pharmacovigilance methods with modern digital tools. In addition, regulators are willing for real-world evidence to play a critical role in their operations. However, industry expansion is expected to be stimulated by delays in medication development, which would increase development costs. Currently, real-world evidence is utilized in pre-approved efficacy determinations.

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Market Dynamics

Global Real World Evidence Solutions Market Drivers

Potential of Real-World Evidence in Reducing Drug Development Costs and Quickening Drug Development Process

According to a report issued by the Tufts Center for the Study of Medicine Development (CSDD), the median cost of introducing a new drug to the market is USD 985 million, and the average cost was USD 1.3 billion, which was significantly lower than earlier estimates of USD 2.80 billion. As the number of RWD increases and their accessibility improves, businesses will be able to utilize RWEs sooner in the product lifecycle to expedite the development and reduce costs. IQVIA (US) partnered with AP-HP, enabling IQVIA to enhance the number of complicated clinical trials and real-world evidence studies in France and Europe. Delays in patient recruitment can destroy a trial, research, and development program because 80% of clinical studies fall short of their initial enrollment targets. Healthcare providers are investing more in health information systems, enabling them to follow and communicate with patients more effectively. The escalating cost of drug development and avoidable delays have shifted the emphasis to real-world evidence as a supplement to existing clinical trials to expedite medication development.

Growing Population of Senior Citizens Worldwide to Boost Market Progress

In numerous nations across the globe, the majority of the population consists of people aged 65 and above. Population aging needs continual, long-term care; hence, the market demands additional medical devices for healthcare. The market demand for contemporary medical healthcare devices and therapies is growing due to an aging population and a changing lifestyle that causes most older adults to suffer from chronic diseases like diabetes. Additionally, as the prevalence of rare diseases and the trend toward personalized healthcare increase, universal health care, and research organizations may encounter challenges like high costs and long wait times for patient treatments. During the forecast period, the growing prevalence of chronic diseases such as cancer and diabetes, among others, would propel the rise of the market for real world evidence solutions.

Global Real World Evidence Solutions Market Restraints

Lack of Interest in Using Real-World Research to Restrict Market Growth

Despite the widespread adoption of real-world evidence, specific stakeholders are hesitant to use them. In addition to RWE, payers prefer randomized clinical trials (RCTs) over external observational data to guide drug coverage choices. Multiple standards and approaches exist for analyzing real-world clinical evidence. US health plan payers utilize different approaches and evidence to cover pharmaceuticals. Variations in PTA can affect reimbursement, patient access, and health plan outcomes. Thus, stakeholders are hesitant to use unstandardized data. Companies are hesitant to embrace real-world evidence tactics because regulatory advice is still developing. Statistical validity isn't universally acknowledged for managing data gaps and discrepancies. Such challenges would hamper real world evidence solutions market expansion in the foreseeable future.

Global Real World Evidence Solutions Market Opportunities

Increasing Emphasis on Real-World Evidence End-to-End Services to Spur Market Opportunities

"Value" is being closely examined globally as financial healthcare players investigate novel solutions to the unsustainable cost burden and relatively low return on investment. Businesses need a strong evidence lifecycle management capability to prove value. This has created an opportunity for an end-to-end approach to leverage a life sciences organization's data, evidence, and knowledge assets, eliminating traditional silos and enabling insight-driven decision-making from the research and development phase to the product commercialization phase. This includes building an effective governance plan, utilizing technologies such as cloud and self-service analytics, and giving the capacity to connect data sets and comprehend the relevant resources for the required analysis.


Segmental Analysis of the Global RWE Solutions Market

The global real world evidence solutions market comprises components, end-user, and applications.

By Components

Based on components, the RWE solutions market is further divided into services and data sets.

The services segment had the highest revenue share due to the widespread adoption of real-world services by pharmaceutical and biotechnology businesses and healthcare providers. IQVIA, Syneos Health, and ICON plc offer end-to-end real-world evidence solutions and late-phase services, including research planning, protocol preparation, clinical study management, and reporting. The rising need for comprehensive evidence services across the product lifecycle will likely offer opportunities for real-world evidence solutions providers to enhance their investments. The data sets segment includes clinical settings, claims, pharmacy, and patient-generated data. This category is predicted to rise because of the increased volume of data collected by healthcare facilities and the rising demand for new epidemiological insights.

By Application

Based on application, the RWE solutions market is further categorized into drug development and approvals, medical device development and approvals, reimbursement/coverage and regulatory decision making, and post-market safety and adverse events monitoring.

The drug development and approvals segment has the most significant revenue share. Real-world evidence solutions enable pharmaceutical companies, healthcare providers, and payers to manage operations effectively and accelerate medication research and approval. Due to the need to produce vaccines and medications during the COVID-19 pandemic, the leading healthcare businesses desired to expand the usage of real-world evidence beyond standard safety-related applications. In March 2021, CDC research utilizing RWE determined that mRNA COVID-19 vaccinations effectively averted SARS-CoV-2 infections among first responders, healthcare staff, and other vital workers who received the first vaccine rollout. The reimbursement and regulatory decision-making segment are anticipated to increase at a CAGR of 8.5% due to the increasing emphasis on clinical value evidence for coverage decisions and the rising therapy costs. During the projection period, the post-market safety and adverse event monitoring segment are predicted to expand significantly.

By End-User

Based on end-user, the RWE solutions market is subdivided into pharmaceutical and medical device companies, healthcare payers, and healthcare providers.

The segment is dominated by pharmaceutical and medical devices during the forecast period. This is attributed to the growing importance of RWE studies in drug approval, real-world performance evaluation, and drug recall prevention. The identification of the patient cohort most likely to benefit from an intervention, regulatory approvals, and additional data from randomized controlled trials, reimbursement efforts, and the expansion of indications of use. The healthcare payers segment is expected to grow at an 8.4% CAGR due to increased payer awareness of medical device/drug safety's importance and adverse effects and a favorable reimbursement scenario, particularly in developed countries.


Regional Analysis of the Global RWE Solutions Market

The global real world evidence solutions market is segmented into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

Real World Evidence Solutions Market Regional Analysis

Regional Growth Insights Request Sample Pages

North America accounted for the most significant revenue share, and a substantial portion of the North American market is attributable to key competitors in the United States. An increasing number of real-world evidence service providers and favorable regional government regulations are anticipated to assist the market's growth. In addition, the shift from volume-based to value-based care is anticipated to fuel market expansion. In addition, the expanding geriatric population and the resulting rise in the prevalence of chronic diseases are major drivers driving the expansion of this market.

Asia Pacific is expected to have the highest CAGR of 11.0% during the forecast period due to increased government initiatives for implementing real-world evidence studies and several contract research and manufacturing businesses in countries such as China and India. It is anticipated that rising demand for better healthcare services would also contribute to market expansion.


Competitive Players in the Global RWE Solutions Market

The global RWE solutions market major key players are

  • Clinigen Group plc
  • Cognizant Technology Solution Corporation
  • PerkinElmer Inc.
  • IBM Corporation
  • Flatiron Health Inc.
  • ICON plc
  • IQVIA Holdings Inc.
  • Medpace Holdings Inc.
  • PAREXEL International Corporation
  • Oracle Corporation
  • PPD Inc.
  • Symphony Innovation LLC
  • SAS Institute Inc.
  • UnitedHealth Group


Recent Developments

  • May 2022- Clinigen Limited (‘Clinigen’ or the ‘Company’), the global pharmaceutical services company, announces it has nearly doubled its US site capacity to better service large-scale clinical trials.
  • March 2022- Cognizant Collaborates with Microsoft to Offer New Virtual Healthcare Solution for Remote Patient Monitoring and Improved Care.
  • June 2022- PerkinElmer and Novartis Collaborate to Address the Unmet Need of Sickle Cell Disease in Sub-Saharan Africa.
  • May 2022- IBM and Red Hat Technology Launch to Space on EnduroSat's Shared Sat Service.


Global Real World Evidence Solutions Market: Segmentation

By Component

  • Services
  • Data Sets

By Application

  • Drug Development and Approvals
  • Medical Device Development and Approvals
  • Reimbursement/Coverage and Regulatory Decision Making
  • Post Market Safety and Adverse Events Monitoring

By End-User

  • Pharmaceutical and Medical Device Companies
  • Healthcare Payers
  • Healthcare Providers

By Regions

  • North America
  • Europe
  • Asia-Pacific
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