Real-world Data (RWD) Market by Source (EMR, Claims, Pharmacy, Disease Registries), Application [Market Access, Drug Development & Approvals (Oncology, Neurology), Post Market Surveillance], End User (Pharma, Payers, Providers) - Global Forecast to 2029

The Real-world Data (RWD) Market is projected to grow at a CAGR of 7.4% from 2022 to 2029 to reach $1.66 billion by 2029. Real-world data (RWD) has become a powerful tool in the life sciences industry by pharmaceutical, biotechnology, & medical device companies; healthcare payers; healthcare providers; and other end users (academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies) to add value at every stage of the drug development lifecycle from understanding unmet healthcare needs and defining the patient journey to supporting regulatory submissions and post-market studies, offering value to payers, and defining market strategies.

Rapidly growing big data in healthcare, shift from volume to value-based care, and rising focus on personalized healthcare have positively impacted the RWD market. However, the lack of standardized methodologies to generate RWD poses a market challenge.

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The Rising Adoption of Wearable Devices and Artificial Intelligence in RWD Creates Opportunities in the Market

The use of computers, mobile devices, wearables, and other biosensors to gather & store massive amounts of health-related data has rapidly accelerated. This data holds the potential to better design and conduct clinical trials & studies in the healthcare setting to answer questions previously thought infeasible. Additionally, with the development of sophisticated, new analytical capabilities, we can better analyze these data and apply the results of our analysis to medical product development and approval.

Real-world data generated from wearable devices & mobile apps and novel clinical trials are transforming the future of the healthcare industry. The role of wearable devices is also emerging in collecting real-world data. Wearable devices are clinically useful for better monitoring real-time, long-term, dynamic & pathological processes. These are convenient for managing chronic illnesses such as cardiovascular diseases, sleep disorders, and cognitive impairment. Recently, there has been a growing adoption of health and wellness devices to track fitness activities, sleeping habits, body temperature, and heart rate.

In the last few years, wearable device adoption has increased along with the growing adoption of healthcare apps. The wearables industry is constantly changing and continuously evolving. However, the wearables market is still growing and is currently dominated by health, wellness, and activity tracking devices. For instance, in March 2020, Fitbit Inc. (U.S.) launched Fitbit Charge 4, the most advanced health & fitness tracker with built-in GPS, active zone minutes, and sleep tools.

Artificial intelligence (AI), especially machine- and deep-learning (ML/DL) methods, have been increasingly used across many stages of the drug development process. Advancements in AI have also provided new strategies to analyze large and multidimensional RWD. AI’s ground-breaking leaps in protein structure identification and advances in regulations on the potential use of real-world evidence provide healthcare research organizations with access to real-world data to accelerate clinical trial processes. For instance, in 2021, Savana, a leader in Deep Real-world Evidence clinical research and BREATHE – The Health Data Research Hub for Respiratory Health partnered to further the use of EHR data for vital respiratory research.

Key Findings in the Global RWD Market Study

EMR/EHR/Clinical Data Generated Larger Proportion of Revenue Compared to Claims & Billing Data, Pharmacy Data, Product/Disease Registries Data, Genomics Data, and Other Datasets

In 2022, the EMR/EHR/clinical data segment is estimated to account for the largest market share of the RWD market owing to the significant amounts of data generated in hospitals, the increasing adoption of HER/EMR in hospitals, and the increased use of clinical data for RWE generation.

Market Access & Reimbursement/Coverage Decisions to Dominate the RWD Market

In 2022, the market access & reimbursement/coverage decisions segment is estimated to account for the largest share of the RWD market. The large market share of this segment is attributed to the increasing demand for real-world data to accelerate market access & reimbursement/coverage decisions, increasing investments by biopharmaceutical companies in R&D, and the growing inclination of regulatory bodies toward using real-world data studies.

Pharmaceutical & Medical Device Companies Segment to Register Largest Market Share of the RWD market by 2029

In 2022, the pharmaceutical & medical device companies segment is estimated to account for the largest market share of the RWD market. The large market share of this segment is attributed to the increasing importance of RWD in drug development & approvals, and the growing need to avoid costly drug recalls and assess drug performance in real-world settings.

North America to Dominate the RWD Market

In 2022, North America is estimated to command the largest market share of the global RWD market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The rising burden of chronic diseases in the geriatric population, shift towards value-based care, growth of personalized healthcare, availability of electronic datasets, a well-developed healthcare industry, and rising big data in healthcare are some of the major factors expected to drive the growth of this regional segment during the forecast period. Additionally, rising R&D expenditure by biopharma companies, greater emphasis on early drug/device development & approvals, presence of major RWE players in the region, and implementation of the 21st Century Cures Act (December 2016) and FDA’s Framework for RWE (December 2018) in the U.S. are also stimulating the growth of this region.

Key Players

The report includes a competitive landscape based on an extensive assessment of the key strategic developments adopted by leading market participants in the industry over the past four years. The key players profiled in the global RWD market report are Anthem, Inc. (U.S.), IQVIA Holdings Inc. (U.S.), ICON plc (Ireland), PPD Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), and Flatiron Health, Inc. (U.S.).

Scope of the Report

RWD Market, by Source

• EMR/EHR/Clinical Data
• Claims & Billing Data
• Pharmacy Data
• Product/Disease Registries Data
• Genomics Data
• Other Datasets
  (Note – Other Datasets segment includes data generated from mobile devices, wearable devices, and social media)

RWD Market, by Application

• Market Access & Reimbursement/Coverage Decisions
• Drug Development & Approvals
  • Oncology
  • Neurology
  • Immunology
  • Cardiovascular Diseases
  • Other Therapeutic Areas
• Post-market Surveillance
• Medical Device Development & Approvals
• Regulatory and Clinical Decision-Making
  (Note – Other Therapeutic Areas majorly include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases)

RWD Market, by End User

• Pharmaceutical, Biotechnology, and Medical Device Companies
• Healthcare Payers
• Healthcare Providers
• Other End Users
  (Note – Other end users majorly include academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies)

RWD Market, by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • Japan
  • China
  • India
  • South Korea
  • Taiwan
  • Singapore
  • Rest of APAC (RoAPAC)

• Latin America
• Middle East & Africa

Key questions answered in the report: