Real-World Evidence Market Forecasts to 2030 - Global Analysis By Component (Services and Data Sets), By Application, By End User and By Geography

According to Stratistics MRC, the Global Real-World Evidence Market is accounted for $1.7 billion in 2023 and is expected to reach $4.5 billion by 2030 growing at a CAGR of 14.8% during the forecast period. Real-world evidence (RWE) is data collected outside traditional clinical trials, providing insights into a treatment's effectiveness in real-world settings. Its uses include informing healthcare decisions, understanding treatment outcomes, and assessing long-term patient outcomes.

According to Clinicaltrials.gov, as of February 2022, there are around 87,366 cancer clinical trials across different phases of development.

Market Dynamics:

Driver:

Cost-efficiency and time savings

Compared to traditional clinical trials, utilizing real-world data for research and decision-making significantly reduces the time and financial investments required. RWE allows for continuous monitoring of treatment outcomes in diverse populations, providing timely insights at a fraction of the cost. This efficiency is particularly appealing to pharmaceutical companies, regulators, and healthcare stakeholders, fostering a shift toward evidence generation that is not only more economical but also aligns with the increasing demand for agile and adaptive approaches in the evolving healthcare landscape.

Restraint:

Data quality and standardization

Variability in data collection methods, formats, and quality across diverse healthcare systems can result in inconsistencies and limitations in the reliability of real-world data. Incomplete or non-standardized information hinders the robustness of RWE, impacting its credibility for decision-making. Efforts to establish standardized data collection practices, improve data quality through validation processes, and enhance interoperability among different healthcare systems are imperative.

Opportunity:

Expanded focus on patient-centric healthcare

Healthcare systems increasingly prioritize patient outcomes and experiences, the demand for real-world data to understand treatment effectiveness, safety, and patient preferences grows. RWE offers a valuable tool to capture insights directly from patients' everyday experiences, aligning with the broader shift towards personalized and patient-centered care. The integration of patient-reported outcomes and real-world evidence enhances the holistic understanding of treatments, fostering more patient-centric decision-making and facilitating the development of therapies that better meet the needs and expectations of diverse patient populations.

Threat:

Privacy and security concerns

The utilization of sensitive patient data raises ethical and regulatory challenges, with the potential for breaches compromising patient confidentiality. Striking a delicate balance between extracting valuable insights from real-world data and safeguarding patient privacy becomes crucial. Stringent data protection regulations, like GDPR and HIPAA, impose strict requirements, adding complexity to RWE initiatives. The threat of data breaches not only jeopardizes patient trust but also raises legal and compliance issues for stakeholders.

COVID-19 Impact:

The COVID-19 pandemic has accelerated the importance of Real-World Evidence (RWE) in healthcare decision-making. The urgent need for rapid insights into treatment effectiveness and outcomes has underscored the value of leveraging real-world data. The pandemic has prompted increased collaboration between stakeholders, including regulatory bodies, to utilize RWE for evaluating the impact of interventions. While the crisis has highlighted the potential of RWE, it has also revealed challenges such as data quality issues and the need for standardized methodologies, emphasizing the ongoing efforts required to fully harness the potential of real-world evidence in a public health crisis.

The drug development and approvals segment is expected to be the largest during the forecast period

Drug development and approvals in the market is expected to hold a significant share. Pharmaceutical companies leverage RWE to complement traditional clinical trial data, offering a more comprehensive understanding of a drug's effectiveness and safety across diverse patient populations. Regulatory bodies increasingly recognize the significance of RWE in making informed decisions during the drug approval process, enabling a more efficient and patient-centered approach to drug development, regulatory submissions, and post-market surveillance. The integration of RWE enhances the evidence base, contributing to more informed healthcare decisions and improved patient outcomes.

The pharmaceutical & medical device companies segment is expected to have the highest CAGR during the forecast period

During the anticipated period, the pharmaceutical & medical device companies segment is expected to increase at the most effective rate. RWE enables these companies to assess the effectiveness and safety of treatments in diverse patient populations, supporting regulatory submissions and market access. It facilitates a more comprehensive understanding of product performance beyond controlled clinical trials, influencing decision-making throughout the product lifecycle. The integration of RWE empowers pharmaceutical and medical device companies to make informed strategic decisions, navigate regulatory landscapes, and demonstrate the real-world impact of their innovations in healthcare.

Region with largest share:

During the forecast period, it is expected that the North American market will hold a majority of the market share. The region's advanced electronic health records (EHR) systems and widespread adoption of health informatics contribute to a rich source of real-world data. Regulatory support for incorporating RWE into decision-making processes, coupled with a strong emphasis on healthcare innovation, positions North America at the forefront of leveraging real-world evidence to inform clinical practices, drug development, and health policy decisions.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period. Increasing healthcare digitization, rising demand for evidence-based decision-making, and expanding healthcare infrastructures contribute to the region's adoption of RWE. The diverse patient populations across countries present an opportunity to generate valuable insights. However, challenges include varying regulatory landscapes and data privacy concerns. As the region continues to prioritize healthcare advancements, collaborations, and technology integration, the utilization of real-world evidence is poised to play a pivotal role in shaping healthcare strategies and policies in Asia Pacific.

Key players in the market:

Some of the key players in Real-World Evidence market include Cegedim Health Data, PerkinElmer, Inc., IBM, Syneos Health, Icon Plc., PPD, Inc., IQVIA, Medpace, Parexel International Corporation and Oracle.

Key Developments:

In August 2022, Trinity Life Sciences (US), announced a partnership with Bain & Company (US). The partnership is intended to pair the extensive experience of Bain & Company (US) in the Life Sciences value chain with the evidence-based solutions of Trinity Life Sciences (US).

In July 2022, TriNetX LLC announced the collaboration with Pediatric Medical Centers (US), to help Pediatric Medical Centers including Children's National Hospital (US), WVU Medicine Children's (US), and John Hopkins All Children Hospitals (US), to improvise the investor-initiated research utilizing the pediatric real-world data.

In June 2022, IQVIA partnered with Argenex SE for accelerating the clinical development of new indications for VYVGART. Furthermore, it will leverage its scientific advice and technology in supporting clinical development by Argenx.

Components Covered:

• Services
• Data Sets

Applications Covered:

• Drug Development And Approvals
• Post-Market Surveillance
• Market Access Reimbursement/Coverage Decision Making
• Clinical And Regulatory Decision-Making
• Other Applications

End Users Covered:

• Pharmaceutical & Medical Device Companies
• Healthcare Providers
• Healthcare Payers
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
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• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

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