REAL-WORLD DATA (RWD) MARKET ANALYSIS

The global real world data (RWD) market size is projected to grow from US$ 1.59 Bn in 2023 to US$ 4.07 Bn by 2030, at a CAGR of 14.4%. 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.

Global Real World Data (RWD) Market Regional Insights

• North America is expected to dominate the global real world data (RWD) market in 2023, with a market share of 5%. This is due to the region's well-developed healthcare industry, the increasing prevalence of chronic diseases, and the stringent regulations for drug approvals.
• Europe is expected to be the second-largest market for real world data (RWD) in 2023, with a market share of 28.5%. This is due to the region's strong focus on innovation and the increasing adoption of big data in healthcare.
• Asia Pacific is expected to be the fastest-growing market for global real world data (RWD) in 2023, with a CAGR of 10.5%. This is due to the region's large and growing population, the rising prevalence of chronic diseases, and the increasing government support for the use of RWD in healthcare decision-making.

Figure 1. Global Real World Data (RWD) Market Share (%), by Region, 2023

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Analyst View

The global real world data (RWD) market is experiencing significant growth due to the increasing prevalence of chronic diseases such as cancer, etc. and the growing demand for personalized medicine. The market is also being driven by the increasing adoption of global real world data (RWD) in the healthcare sector for decision-making processes, drug development, and approvals. In terms of challenges, data privacy and security concerns, along with the lack of standardized data collection methods, could potentially hinder market growth. Looking ahead, the market is expected to continue its growth trajectory, driven by technological advancements in data analytics and the increasing adoption of digital health technologies. The integration of artificial intelligence and machine learning with global real world data (RWD) is also expected to provide lucrative growth opportunities for the market.

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.
• Market Access and Reimbursement: Real-world evidence derived from RWD can be used to demonstrate the value and cost-effectiveness of drugs and medical devices to payers and health technology assessment agencies. This evidence can support market access and reimbursement negotiations, facilitating the inclusion of innovative therapies in healthcare coverage.
• Pharmacovigilance and Drug Safety Monitoring: Real-world data plays a crucial role in post-marketing surveillance and ongoing drug safety monitoring. RWD can help identify and monitor adverse events, drug interactions, and the long-term safety profiles of medications. This data can aid regulatory agencies, pharmaceutical companies, and healthcare providers in making informed decisions regarding drug safety and risk mitigation.

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.
• Focus on Data Quality and Standardization: Ensuring the quality and standardization of RWD has become a critical focus in the market. Efforts are being made to improve data integrity, completeness, and consistency across different data sources. Standardization initiatives, such as the use of common data models and terminologies, facilitate data interoperability, enhance data quality, and promote the comparability of findings across studies.
• Emphasis on Patient Privacy and Data Security: As the use of RWD increases, ensuring patient privacy and data security is paramount. Stricter regulations, such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the U.S., govern the collection, use, and sharing of patient data. Stakeholders are adopting robust data protection measures, including de-identification techniques and secure data storage and transfer protocols, to maintain patient confidentiality.

Global Real World Data (RWD) Market Restraints

• Data Quality and Completeness: Ensuring the quality, completeness, and reliability of real-world data remains a challenge. RWD is often collected from disparate sources with varying levels of data quality, standardization, and completeness. Inconsistent data collection practices, missing data elements, and data entry errors can impact the reliability and validity of the insights derived from RWD.
• Data Privacy and Regulatory Compliance: The use of real-world data raises concerns about patient privacy and data protection. Regulatory requirements, such as GDPR and HIPAA, impose strict rules on the collection, storage, and use of patient data. Compliance with these regulations adds complexity and cost to RWD initiatives, requiring robust data de-identification and security measures to protect patient privacy.
• Data Fragmentation and Interoperability: Real-world data is often fragmented across various healthcare systems, electronic health record platforms, and research databases. Lack of interoperability and data standardization hinder the seamless integration and analysis of RWD. The need to overcome technical and semantic barriers to data sharing and aggregation poses challenges to deriving meaningful insights from disparate data sources
• Selection Bias and Generalizability: RWD may suffer from selection bias, as it is typically derived from specific patient populations, healthcare settings, or regions. This may limit the generalizability of the findings to broader populations. It is crucial to consider the representativeness of the data and account for potential biases when interpreting and applying insights from RWD.

Figure 2. Global Real World Data (RWD) Market Share (%), by Application, 2023

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Recent Developments

New product launches

• On October 2, 2023, Oncology real-world data and analytics company COTA, announced the launch of Vista, a large-scale automated electronic health record (EHR) dataset. Cota developed Vista using automation to increase the pace, and therefore scale, of EHR data abstraction in order both to advance real-world evidence (RWE) insights in oncology and to pave the way for the development of trusted generative AI in cancer care.
• On August 23, 2023, Real-world evidence (RWE) leader, Target RWE, announced the launch of its pioneering suite of advanced analytical solutions. Designed to identify unmet needs and answer critical strategic questions along a pharmaceutical product's life cycle, the novel solutions visualize and analyze data using innovative epidemiological methods and sound statistical principles.
• On July 19, 2023, Compile, a novel provider of life sciences data products, announced the launch of Multi-Payer Complete Claims ReadyData, a dataset that will allow life sciences and biotech companies to conduct more granular analyses, leading to more optimized drug commercialization and reimbursement strategies.

Acquisition and partnerships

• On June 1, 2023, BC Platforms (BCP), a global leader in healthcare data management and analytics, announced the acquisition of 4Pharma Ltd, a well-established contract research organization providing medical research services to pharmaceutical, biotechnology, and medical device companies.
• In August 2022, Target RWE, a real-world evidence leader, announced its acquisition of the curation team (legacy Real World Data team) from Ciox Health, a healthcare information management company, which will expand the company's global real world data (RWD) (RWD) solutions and capabilities.
• In December 2021, Thermo Fisher Scientific Inc., the world leader in serving science, announced that it had completed its acquisition of PPD, Inc., a leading global provider of clinical research services to the biopharma and biotech industries, for US$17.4 billion. Through this acquisition, Thermo Fisher Scientific Inc. is expanding their value proposition for their biotech and pharmaceutical customers with the addition of PPD's leading clinical research services, which advances their work in bringing life-changing therapies to market, benefiting patients around the world.
• In December 2021, Oracle Corporation, a computer software company, acquired Cerner Corp., a provider of electronic health records (EHRs), to transform healthcare delivery by providing medical professionals with better information—enabling them to make better treatment decisions resulting in better patient outcomes.

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.

*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.