Real World Data (RWD) Market Analysis & Forecast: 2025-2032

Real World Data (RWD) Market Analysis & Forecast: 2025-2032

Real World Data (RWD) Market size is estimated to be valued at USD 2.38 Bn in 2025 and is expected to reach USD 6.1 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of 14.4% from 2025 to 2032.

Key Takeaways

• By Application, the Post-Market Surveillance segment is projected to hold the largest share of the Real-world Data Market at approximately 30% by 2025, driven by the increasing need for continuous safety monitoring and effectiveness assessment of marketed drugs and medical devices.
• By Region, North America is forecasted to lead the global Real-world Data Market outlook in 2025 with an estimated market share of around 42.5%, supported by advanced healthcare infrastructure, widespread adoption of electronic health records (EHRs), and strong regulatory frameworks promoting real-world evidence (RWE) use.
• Europe is positioned as the second-largest market, expected to hold a market share of approximately 28.5% in 2025, owing to growing investments in digital health technologies and increasing collaborations among healthcare stakeholders.
• The Asia Pacific region is emerging as the fastest-growing market with a robust compound annual growth rate (CAGR) of 10.5% anticipated through 2025, propelled by rising healthcare expenditure, expanding digital infrastructure, and government initiatives encouraging RWD adoption.

Market Overview

The increasing adoption of RWD in drug development and approvals, market access, and post-market surveillance is driving the growth of the market. RWD is data collected from real-world settings, such as electronic health records (EHRs), claims data, and patient registries. It can be used to generate evidence on the safety and efficacy of drugs and medical devices, as well as to assess the impact of treatments on patient outcomes.

Current Events and Its Impact on the Real World Data (RWD) Market

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Pipeline Analysis

The Real-world Data (RWD) market growth is supported by a robust pipeline of pharmaceutical candidates across multiple phases of clinical development. These candidates are expected to generate substantial real-world evidence upon approval and commercialization, enhancing insights into safety, efficacy, and treatment outcomes in diverse patient populations.

Phase III Candidates:

• Tezepelumab — Innovator & Sponsor: Amgen and AstraZeneca
• Efgartigimod — Innovator & Sponsor: Argenx

Phase II Candidates:

• Deucravacitinib — Innovator & Sponsor: Bristol Myers Squibb
• Zuranolone — Innovators & Sponsors: Sage Therapeutics and Biogen
• Masitinib — Innovator & Sponsor: AB Science

Phase I Candidates:

• ALLO-715 — Innovator & Sponsor: Allogene Therapeutics
• NBIb-1817 (Xenon1817) — Innovator: Xenon Pharmaceuticals; Sponsor: Neurocrine Biosciences
• OP-1250 — Innovator & Sponsor: Olema Pharmaceuticals

Preclinical Candidates:

• BDTX-1535 — Innovator & Sponsor: Black Diamond Therapeutics
• DSP-0038 — Innovator & Sponsor: Sumitomo Dainippon Pharma
• NX-1607 — Innovator & Sponsor: Nkarta Therapeutics

These pipeline molecules span various therapeutic areas, reflecting the growing interest of sponsors and innovators in leveraging RWD to support regulatory approvals, post-marketing surveillance, and personalized medicine strategies.

Patent Landscape

The RWD market forecast is experiencing a rapidly evolving and expanding ecosystem of patents which is fuelled by investments from industry leaders and new market entrants seeking to gain competitive edges in analytic, integration, and application technologies. Patents concerning RWD are mainly concerned with advancements in infrastructure of data collection systems, data anonymization, AI-based analytics, and interoperability issues.

Furthermore, some of the world’s largest pharmaceutical companies, IT business firms, and healthcare analytics companies are actively patenting new algorithms and platforms to automate real-world evidence generation, enrich the data, and ensure compliance with regulatory requirements. Recent patents also focus on the use of blockchain and other safe methods of data sharing to remove privacy and security risks associated with sensitive health information, enhancing the overall privacy and security of health data.

The geographic concentration of this patenting activity is in North Amercia and Europe, where there are advance and well-defined regulatory frameworks for patents and high-quality intellectual property systems. However, the new patent applications from Asia Pacific jurisdictions suggest some increased interest and innovative activity in the RWD technologies in this region.

In general, the evolving patents’ geography and focus of emerging patents indicate an increased competition in the RWD markets and frontiers highlights the growing importance of intellectual property related to technological development and market differentiation.

Reimbursement Scenario

The reimbursement dynamics of Real-world Data (RWD) is influenced by a myriad of coding schemes, guidelines, and insurance models across the globe. Critical coding frameworks like RWD's ICD-10, CPT, and HCPCS provide appropriate classification of services tied to RWD’s ancillary services and data privacy legislations like GDPR in Europe as well as HIPAA in the US safeguards the data.

FDA (U.S.), EMA (Europe), and PMDA (Japan), as regulatory authorities, are key players utilizing RWD for decisions related to drug and device approval and reimbursement for both purposes. HTA bodies evaluate the clinical and economic value of interventions that have RWD applied to them for informing coverage policies.

In regards to spending, RWD associated expenditures only account for a minute portion of global healthcare spending: 1-2% of Medicare’s $799.4 billion in the US, approximately 0.5-1% of NHS £129.7 billion budget from the UK, along with similar portions from Japan and Australia. It’s estimated that China’s Basic Medical Insurance system spends around 0.3-0.5% of their total budget on RWD-related services.

While the direct costs of RWD are low, their importance is growing due to increased use of RWD in regulatory approvals and value-based care. This emerging context of reimbursement policy signals a paradigm shift in the value of RWD in the health care system.

Prescribers’ Preferences for Real World Data (RWD)

The Real-World Data (RWD) supplement is pivotal for healthcare providers and practitioners as a patient’s condition changes. A clinician's dependability on RWD shifts depending on the particular line of treatment as well as the disease stage. While first-line treatments adhere strongly to clinical trials and set guidelines, there is more RWD reliance when it comes to second line and later treatments due to necessity and importance of insight into how medications work and their safety in “real-life” situations as opposed to trial settings.

The disease progressing also changes the RWD spectrum that is used; early-stage disease management tends to follow evidence that comes from clinical trials, while more advanced or complicated stages will rely heavily on RWD to fine-tune the required therapies. For instance, prescribers tend to use established medications where dominant trials support their efficacy, but further down the timeline may change their stance and look at other options which RWD showcases performing better via alternative or combination therapies.

Other reasons changing preferring RWD includes patient characteristics (age group, existing illness, ethnicity), the type of practice (academic or community practice), provided incentives by the healthcare system (value based or fee-for-service models), and the use of RWD in the form of electronic health records and other decision-support tools.

Overall in these case scenarios, where there are boundaries to evidence, prescribers have shown to depend more on RWD incorporating more of it when it comes to creating more personalized approaches to treatment plans.

Segment Analysis

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Global Real World Data (RWD) Market Insights, by Application

In terms of Application, Post Market Surveillance segment is projected to hold the largest Real World Data (RWD) market share of approximately 30% by 2025, driven primarily by the increasing regulatory emphasis on ongoing safety and performance monitoring of products after their release. As regulatory authorities intensify post-market requirements to ensure continuous compliance and mitigate risks, organizations are prioritizing comprehensive surveillance strategies.

Post market surveillance systems enable manufacturers and regulatory bodies to systematically collect, analyze, and act on real-world data related to product performance and adverse events. These systems enhance transparency by facilitating timely identification of safety concerns, thereby protecting end-users and supporting proactive risk management.

Furthermore, the integration of advanced data analytics and real-time reporting tools strengthens decision-making processes, ensuring swift corrective actions and regulatory compliance. Consequently, the growing focus on patient safety and regulatory oversight continues to drive the adoption of post market surveillance solutions across industries.

Regional Insights

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North America Real World Data (RWD) Market Analysis and Trends

North America is forecasted to lead the global real world data market demand in 2025, holding a market share of approximately 42.5%. This leadership is driven by the region’s advanced healthcare infrastructure, well-established pharmaceutical and biotechnology sectors, and stringent regulatory frameworks governing drug approvals and clinical research.

The U.S. and Canada are key contributors to market growth, supported by increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular conditions, which demand comprehensive real world evidence for improved patient outcomes.

The region benefits from sophisticated health IT systems, extensive electronic health record (EHR) adoption, and strong government initiatives promoting the integration of real world data into healthcare decision-making. Additionally, investments in data privacy and security frameworks facilitate the ethical and compliant use of large-scale health datasets, further accelerating RWD market expansion.

Europe Real World Data (RWD) Market Analysis and Trends

Europe is positioned as the second-largest real world data market value in 2025, with an anticipated share of 28.5%. The region’s prominence stems from its robust focus on healthcare innovation and widespread adoption of big data analytics in clinical research and policy formulation. Countries such as Germany, the UK, France, and the Nordic nations are spearheading efforts to harness RWD to enhance healthcare delivery, regulatory evaluations, and pharmacovigilance.

Strong collaborations between public health agencies, research institutions, and private sector players foster a conducive environment for RWD utilization. Additionally, Europe’s progressive regulatory landscape, including frameworks like the General Data Protection Regulation (GDPR), balances data accessibility with patient privacy, enabling trust and transparency in real world evidence generation.

Asia Pacific Real World Data (RWD) Market Analysis and Trends

Asia Pacific is emerging as the fastest-growing region in the global real world data market, with a robust CAGR of 10.5% anticipated through 2025. This rapid expansion is fueled by the region’s large and diverse population base, increasing burden of chronic and lifestyle diseases, and expanding healthcare infrastructure. Key markets such as China, India, Japan, and Southeast Asia are witnessing growing government support and strategic initiatives to integrate RWD in clinical research and healthcare policymaking.

The rise in digital health adoption, improvements in health data digitization, and the growing presence of local and multinational pharma companies investing in real world evidence capabilities further accelerate market growth. Additionally, increasing awareness about the benefits of RWD in improving treatment effectiveness and reducing healthcare costs drives its adoption across public and private healthcare sectors.

Market Report Scope

Global Real World Data (RWD) Market Drivers

• Increasing Adoption of Electronic Health Records (EHRs): 

The widespread adoption of electronic health records by healthcare providers has led to the accumulation of vast amounts of patient data. This data, when aggregated and anonymized, can provide valuable insights into real-world patient outcomes, treatment patterns, and disease progression.

For instance, on January 16, 2023, Fujitsu, the information and communications technology equipment and services corporation, and Sapporo Medical University announced the launch of a joint project to realize data portability for patients’ healthcare data, including electronic health records (EHRs) (2) and personal health records (PHRs).

• Growing Demand for Evidence-Based Medicine:

There is a growing emphasis on evidence-based medicine, which relies on real-world evidence (RWE) derived from RWD. Stakeholders in healthcare, including regulators, payers, and healthcare providers, are recognizing the importance of using real-world data to make informed decisions about treatment effectiveness, comparative effectiveness, safety, and cost-effectiveness.

For instance, on January 16, 2023, according to an article published in the Nature Medicine journal, advances in wearable technologies, data science, and machine learning have begun to transform evidence-based medicine, offering a tantalizing glimpse into a future of next-generation ‘deep’ medicine. Moreover, bringing a drug successfully through all phases of drug development into the clinic costs more than 5–2.5 billion dollars. Therefore, innovative strategies are needed to engage patients and generate the necessary evidence to propel new advances.

• Regulatory Support and Guidance:

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recognized the value of real-world evidence in regulatory decision-making. They have provided guidelines and frameworks for the use of RWD and real world evidence (RWE) in regulatory submissions, drug approvals, and post-market surveillance, further driving the demand for real-world data.

• Advancements in Data Analytics and Technologies:

The advancement of data analytics tools and technologies, such as artificial intelligence (AI), machine learning (ML), and big data analytics, has facilitated the extraction of meaningful insights from large and complex real-world datasets. These technologies enable the analysis of RWD to identify treatment patterns, patient subgroups, adverse events, and other clinically relevant information.

Global Real World Data (RWD) Market Opportunities

• Drug Development and Clinical Trials:

Real-world data can be leveraged to optimize the drug development process and enhance clinical trial design. RWD can be used to identify target populations, understand disease progression, assess treatment effectiveness, and identify potential safety concerns. By integrating real-world evidence into clinical trials, researchers can enhance trial efficiency, recruit appropriate patients, and generate robust outcomes.

For instance, in June 2022, AbbVie Inc., a pharmaceutical company, announced the launch of AbbVie Research Collaborative, a health data platform that enables adults anywhere in the U.S. to partner with AbbVie’s world-class scientific researchers. Collaborative participants contribute their real-world health data, such as genetic, lifestyle, and exercise information, medical records, and more, to provide a more comprehensive picture of their health. Real-world health data empowers researchers to find health and disease patterns they may not see within a clinical trials.

• Comparative Effectiveness Research:

Real-world data enables comparative effectiveness research, which focuses on comparing the benefits and risks of different treatment options in real-world settings. RWD allows for the assessment of treatment effectiveness, safety, and patient outcomes across diverse patient populations, thereby providing valuable insights for healthcare decision-making.

For instance, in August 2020, the Medical Device Innovation Consortium (MDIC) announced the launch of its real world evidence (RWE) Framework for regulatory decision-making for in vitro diagnostics.

Global Real World Data (RWD) Market Trends

• Increased Integration of Data Sources:

There is a growing trend of integrating multiple data sources to gain a comprehensive view of patient health and outcomes. This includes combining electronic health records (EHRs), claims data, patient registries, wearable devices, social media data, and genomic information. Integrating diverse data sources allows for a more holistic analysis and provides richer insights into real-world patient experiences and outcomes.

• Advancements in Data Analytics and AI:

The global real world data (RWD) market is witnessing rapid advancements in data analytics tools and techniques, including artificial intelligence (AI) and machine learning (ML). These technologies enable more sophisticated analysis of large and complex datasets, uncovering patterns, trends, and correlations that may not be apparent with traditional statistical approaches. AI and ML algorithms can assist in data integration, predictive modeling, risk stratification, and decision support.

For instance, in August 2021, Syneos Health, a pharmaceutical company, partnered with Aetion, a health care technology company to provide a real-world evidence solution and offer analytical-driven data and regulatory-grade data.

Analyst Viewpoint

• The Real-world Data (RWD) market is on a strong growth trajectory, fueled by rising demand for evidence-based decision-making in healthcare and increasing deployment of electronic health records (EHRs).
• RWD is becoming central to drug discovery, clinical trials, and post-marketing surveillance, as stakeholders seek to understand patient outcomes and real-world treatment effectiveness.
• The need for personalized medicine and the management of chronic diseases are significantly accelerating RWD adoption across healthcare systems.
• Key growth inhibitors include persistent concerns over data privacy and security, lack of standardization in data formats, and limited interoperability across platforms.
• High infrastructure costs and technical barriers may slow adoption among smaller healthcare providers and systems with limited digital maturity.
• Despite these challenges, the market is ripe with innovation potential—especially through AI and machine learning integration, which are transforming data analysis, pattern recognition, and predictive insights.
• Collaboration between pharmaceutical companies, healthcare providers, and payers is strengthening the ecosystem, driving the development of advanced analytics and visualization platforms.
• North America continues to lead the global RWD landscape, thanks to robust healthcare infrastructure, high digital penetration, and regulatory support.
• Asia-Pacific is emerging as the fastest-growing region due to surging healthcare investment, government-backed digital health initiatives, and increasing disease burden in populous countries like India and China.

Real-world Data (RWD) Market: Key Developments

• On April 15, 2025, IQVIA launched a next-generation RWD analytics platform powered by AI and natural language processing (NLP), aimed at accelerating real-world evidence generation for life sciences companies. The platform offers enhanced data harmonization and faster insights across multi-source datasets.
• In March 2025, Flatiron Health announced a strategic partnership with major oncology networks in the U.S. to expand its real-world oncology data ecosystem. The collaboration will support broader integration of EHR-derived clinical data to enhance cancer treatment analytics and drug development.
• On February 6, 2025, Optum introduced a blockchain-based RWD sharing platform designed to improve data transparency, traceability, and patient consent management. This initiative marks a key step toward securing large-scale real-world healthcare data collaborations.
• In January 2025, HealthVerity unveiled a cloud-native RWD marketplace offering de-identified, linked data assets from over 100 sources. The platform aims to simplify access to real-world datasets for pharmaceutical, payer, and provider stakeholders.

Market Segmentation:

• By Component:
  • Services
  • Datasets
    • Clinical settings Data
    • Claims & Billing Data
    • Pharmacy Data
    • Registry-Based Data
    • Patient-Powered Data
• By Application:
  • Drug development and approvals
  • Market access and reimbursement/coverage decisions
  • Post-market surveillance
  • Clinical research
  • Other applications
• By End User:
  • Pharmaceutical and medical device Companies
  • Healthcare payers
  • Healthcare providers
  • Government agencies
  • Others
• By Region:
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa
• Top companies in Global Real World Data (RWD) Market
  • IQVIA Holdings Inc.
  • Optum, Inc. (a subsidiary of UnitedHealth Group)
  • Cerner Corporation
  • Flatiron Health, Inc.
  • IBM Corporation
  • Tempus Labs Inc.
  • Syneos Health Inc.
  • Evidera, Inc.
  • Palantir Technologies Inc.
  • SAS Institute Inc.

Sources:

Primary Research Interviews

• Key Opinion Leaders (KOLs)
• Industry Experts
• Healthcare Professionals
• Regulatory Bodies
• Others

Databases

• National Health and Nutrition Examination Survey (NHANES)
• FDA Adverse Event Reporting System (FAERS)
• Centers for Medicare & Medicaid Services (CMS)
• Clinical Practice Research Datalink (CPRD)
• Others

Magazines

• Healthcare Informatics
• Medical Economics
• Health Data Management
• Healthcare IT News
• Others

Journals

• Journal of the American Medical Informatics Association (JAMIA)
• JMIR Medical Informatics
• BMC Medical Informatics and Decision Making
• Others

Newspapers

• The Wall Street Journal
• The New York Times
• Financial Times
• The Washington Post
• Others

Associations

• Healthcare Information and Management Systems Society (HIMSS)
• American Medical Informatics Association (AMIA)
• Medical Device Manufacturers Association (MDMA)
• HL7 International
• Others

Public Domain Sources

• World Health Organization (WHO)
• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention (CDC)
• European Medicines Agency (EMA)
• Others

Proprietary Elements

• CMI Data Analytics Tool
• Proprietary CMI Existing Repository of information for last 8 years

*Definition: Real-world data (RWD) refers to data collected from a variety of sources that reflect a patient's health status and/or the delivery of health care in real-world settings. Real-world data is gathered from various sources such as electronic health records (EHRs), claims and billing activities, product and disease registries, patient-related activities in outpatient or inpatient settings, health monitoring devices, and other sources, in contrast to data from traditional clinical trials, which are collected under controlled conditions. Using this data, real-world evidence (RWE) regarding a product's use and any advantages or disadvantages is produced for use in healthcare analysis and decision-making.