Real World Evidence Solutions Market

According to Stratistics MRC, the Global Real World Evidence Solutions Market is accounted for $18.4 billion in 2023 and is expected to reach $61.2 billion by 2030 growing at a CAGR of 18.7% during the forecast period. Healthcare data from a range of non-traditional clinical research settings, including electronic medical records (EMRs), billing and claim data, product and disease registries, and data gathered by mobile devices and health apps, are referred to as real-world evidence solutions. RWE solutions encompass a range of tools and methodologies that harness data from sources such as electronic health records, claims databases, and patient registries to generate insights into the safety, efficacy, and cost-effectiveness of medical interventions outside the controlled environment of clinical trials.

According to the World Ageing Population report, in 2020 highlights, approximately 727 million people living worldwide were aged 65 years and above, and the number is expected to reach 1.5 billion by 2050.

Market Dynamics: 

Driver: 

Growing focus on patient-centric healthcare

In traditional clinical trials, patients' experiences and outcomes may not fully reflect real-world scenarios. With the shift towards patient-centric care, there's an increasing recognition of the importance of understanding how treatments perform in the everyday lives of patients. RWE solutions play a crucial role in this paradigm by harnessing real-world data from sources such as electronic health records, patient registries, and wearable devices. Additionally, by analyzing this data, healthcare stakeholders gain insights into patient preferences, treatment adherence, and real-world effectiveness of interventions.

Restraint:

High implementation costs

Establishing robust RWE capabilities necessitates substantial investments in infrastructure, technology, talent acquisition, and ongoing maintenance. Developing the necessary data infrastructure to collect, integrate, and analyze diverse sources of real-world data requires significant financial resources. However, implementing advanced analytics tools and methodologies, such as machine learning and natural language processing, incurs considerable expenses in software licensing, customization, and training. Building multidisciplinary teams comprising data scientists, biostatisticians, and domain experts adds to the overall cost of RWE initiatives.

Opportunity:

Advancements in data analytics

As the volume and complexity of healthcare data continue to increase exponentially, innovations in data analytics empower stakeholders to extract meaningful insights from large-scale real-world datasets. Techniques such as machine learning, artificial intelligence, and natural language processing enable the identification of patterns, correlations, and trends within diverse sources of real-world data, including electronic health records, claims databases, and patient registries. These analytical capabilities not only facilitate the generation of robust real-world evidence but also enhance the efficiency and accuracy of data analysis processes.

Threat:

Privacy and data security concerns

With the increasing reliance on real-world data (RWD) for healthcare decision-making, ensuring the privacy and security of sensitive patient information becomes paramount. Compliance with stringent data protection regulations, such as GDPR and HIPAA, adds complexity and cost to RWE initiatives. Stakeholders must navigate ethical and legal considerations surrounding patient data usage, sharing, and protection. The potential risks of data breaches, unauthorized access, and misuse of personal health information further exacerbate these concerns, eroding trust and confidence in RWE solutions.

Covid-19 Impact: 

As the healthcare industry faced unprecedented challenges, the demand for real-world data (RWD) surged, driving the adoption of RWE solutions for understanding the impact of the virus, assessing treatment effectiveness, and informing public health responses. RWE played a crucial role in evaluating the safety and efficacy of existing drugs for repurposing, facilitating rapid clinical decision-making amidst the urgency of the pandemic. However, the pandemic also highlighted existing disparities in data access, quality, and infrastructure, exacerbating challenges in leveraging Real World Evidence Solutions effectively.

The Medical Device Development segment is expected to be the largest during the forecast period

Medical Device Development segment is expected to hold the largest share during the forecast period as regulatory agencies increasingly require robust real-world data to support the approval and post-market surveillance of medical devices. RWE solutions enable manufacturers to generate evidence on device safety, effectiveness, and real-world performance, aligning with regulatory expectations and expediting market access. Additionally, the shift towards value-based healthcare and the emphasis on patient outcomes necessitate comprehensive evidence beyond traditional clinical trials.

The Data Sets segment is expected to have the highest CAGR during the forecast period

Data Sets segment dominated the largest share of the market throughout the extrapolated period, due to its crucial role in providing the foundation for generating actionable insights. With the increasing availability of diverse and expansive data sets from sources such as electronic health records (EHRs), claims databases, patient registries, wearables, and social determinants of health, the potential for RWE generation has expanded dramatically. Furthermore, these rich data sets offer a comprehensive view of patient populations, treatment pathways and healthcare outcomes in real-world settings.

Region with largest share:

Asia Pacific region commanded the largest market share over the projection period, as rapid urbanization, population growth, and increasing healthcare expenditure in countries like China, India, Japan, and South Korea have heightened the demand for evidence-based healthcare solutions. Regulatory reforms and initiatives promoting the use of Real World Evidence Solutions in healthcare decision-making have accelerated market growth in the region. Moreover, the regional expansion of digital health infrastructure and adoption of electronic health records are generating vast amounts of real-world data, creating opportunities for RWE utilization.

Region with highest CAGR:

Asia Pacific region is projected to witness profitable growth throughout the domination period, due to implementing policies and initiatives that promote the use of RWE for drug approval, market access and post-market surveillance. Regulatory reforms in China, including the acceptance of foreign clinical trial data and the establishment of a faster drug approval process, have encouraged the adoption of RWE solutions by pharmaceutical companies. Additionally, initiatives in India aimed at streamlining regulatory processes and promoting innovation are creating a conducive environment for RWE utilization.

Key players in the market

Some of the key players in Real World Evidence Solutions market include Cegedim Health Data, Clinigen Group plc, Flatiron Health Inc, IBM Corporation, IQVIA Holdings Inc, Medpace Holdings Inc, Parexel International Corporation, PerkinElmer Inc, PPD Inc and Syneos Health.

Key Developments:

In August 2023, Targe RWE launched an innovative line of cutting-edge analytical solutions that utilize advanced epidemiological techniques and reliable statistical principles to visualize and analyze data, addressing unmet needs and strategic concerns throughout the pharmaceutical product life cycle.

In June 2023, Thermo Fisher Scientific announced a definitive agreement to acquire CorEvitas, LLC, valued at USD 912.5 million in cash, from Audax Private Equity.

In November 2022, Castor, a provider of hybrid and decentralized clinical trial technology solutions, launched a new offering to simplify post-marketing clinical trials.

In September 2022, Lumanity, Inc. announced the creation of a new global practice composed of the U.S. and Europe-based experts in real world evidence. The aim was to help clients identify the correct real world data (RWD) and methodologies.

In September 2022, Verantos announced the launch of the Verantos Evidence Platform. This system has allowed pharmaceutical companies to generate real world evidence solutions with highly defined standards, which are approved by the U.S. FDA.

In June 2022, Dubai Health Authority (DHA) and its health insurance regulatory body launched a “first-of-its-kind” digital-led program to adopt value-based healthcare in the state.

In May 2022, Pfizer Inc. presented positive real world evidence for its combination therapy to treat metastatic breast cancer at ESMO Breast Cancer 2022. The combination therapy includes IBRANCE (palbociclib) and an aromatase inhibitor.

In March 2022, ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), in partnership with the Bristol Myers Squibb-Pfizer Alliance, announced the launch of a new “About Real World Evidence” microsite.

In March 2022, the collaboration between Thermo Fisher and Symphogen has been expanded to include improved data workflow, which aids in the discovery and development of innovative cancer treatments.

In January 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
• Other Components 

Deployments Covered:
• Cloud-based
• On-premise

Applications Covered:
• Medical Device Development
• Drug Development
• Post-Market Survelliance
• Clinical and Regulatory Decision Making
• Other Applications

End Users Covered:
• Healthcare Providers
• Healthcare Payers
• Healthcare Companies
• Pharmaceuticals
• Patient Advocacy Groups
• Other End Users

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

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- 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

Free Customization Offerings: 
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances