According to a new market research report titled “RWE Solutions Market by Component (Datasets [Clinical, Claims, Pharmacy, Integrated], Services), Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers) — Global Forecast to 2028”, published by Meticulous Research®, the real-world evidence solutions market is expected to grow at a CAGR of 11.8% from 2021–2028 to reach $4.4 billion by 2028.
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Real-world evidence
(RWE) is clinical evidence gathered via Real World Data (RWD) analysis on the
use and potential benefits or risks of a medical product. RWE can be produced
through various study designs or analyses, including but not limited to
randomized trials, large simple trials, pragmatic trials, and observational
studies (prospective or retrospective). RWE has several applications, including
drug development life cycles, shortening development timelines, reducing the
costs of clinical trials, and improving the probability of technical and
regulatory success. The growth of this market is primarily driven by key
factors such as the rapid growth of large data in healthcare, the shift from
volume to value-based care, and the rising focus towards personalized
healthcare.
Impact of COVID-19 on
RWE Solutions Market
The key players
operating in the RWE solutions market experienced an initial market shrinkage
due to uncertainties associated with the impact of the COVID-19 pandemic. The
market shrinkage was mainly due to significant restrictions on travel in many
countries, shifting of resources on COVID-19 treatments in healthcare settings,
and limited access to hospitals. These factors affected the amount of
real-world data generated globally.
However, after the
initial shrinkage, real-world evidence (RWE) is set to become the most
influential emerging technology to fight against the COVID-19 outbreak.
Real-world evidence solutions can provide valuable insights to better
understand, monitor, and prepare for the challenges caused by the COVID-19
pandemic. RWD has been used increasingly to map the progression of the disease
and to discover vaccines and immediate treatments. Thus, the effectiveness of
the use of RWD made a significant impact during the pandemic and continues to
play a significant role in the treatment of infected patients.
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RWE Solutions Market:
Future Outlook
The RWE Solutions
Market is segmented by component (datasets and consulting services),
application (market access & reimbursement/coverage decisions, drug
development & approvals, post market surveillance, medical device
development & approvals, and other applications), end user (pharmaceutical,
biotechnology, and medical device companies, healthcare payers, healthcare providers,
and other end users), and geography (North America, Asia-Pacific, Europe, Latin
America, and the Middle East & Africa).
Based on component,
the datasets segment is estimated to account for a larger share of the overall
RWE solutions market in 2021. The large share of this segment is mainly
attributed to the growing amount of medical data generated in hospitals and the
increasing dependence of outcome-based studies on real-world data. EHRs are the
most commonly used form of healthcare database that helps in conducting
outcome-based studies. EHR data is playing an increasingly vital role in
collecting and generating actionable information at the FDA. Governments across
the world are undertaking initiatives to increase the adoption of EHR/EMR data.
For instance, in September 2020, to digitalize the entire healthcare ecosystem
of India, the Ministry of Health and Family Welfare (MoHFW) released a draft
policy termed the Health Data Management Policy. However, the consulting
services segment is expected to witness the fastest growth rate during the
forecast period. Real-world evidence consulting service providers make use of
robust real-world datasets generated by conducting prospective/observational
studies to offer customized consulting services to generate
fit-for-purpose data and insights for their stakeholders instead of providing
terabytes of data.
Based on application,
the market access & reimbursement/coverage decisions segment is estimated
to account for the largest share of the RWE solutions market in 2021. The
pharmaceutical, biotech, and medical device industries face unprecedented
challenges due to the global economic crisis, COVID-19 pandemic, and concerns
about escalating healthcare costs. Due to rising therapy costs, healthcare
payers are increasingly focused on evidence of clinical value for making
decisions associated with providing coverage. RWE helps provide a means for
demonstrating value, ranging from confirming randomized trial benefits in
real-world populations to a fuller characterization of resource impacts. RWE is
being increasingly considered by both industry and payers. Payers use the data
to support coverage decisions, develop guidelines and decision support tools
for use in clinical practice, generate estimates of the potential population
they cover that could require the treatment, and estimate potential costs and
cost offsets. However, the drug development & approvals segment is expected
to witness the fastest growth rate during the forecast period.
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Based on end user, the
pharmaceutical, biotechnology, & medical device companies segment is
expected to witness the fastest growth rate during the forecast period. Rising
pharmaceutical R&D spending is the major factor attributed to the growth of
this segment. The cost of developing a new drug was more than $2,600 million in
2020 compared to $802 million in 2003. This increase in drug development costs
reflects various technical, regulatory, and economic challenges pharmaceutical
R&D pipelines face. The global R&D spending in 2021 surged by 7.0%
($212 billion) compared to 2020. Real-world evidence helps in understanding
real-life clinical practices and actual health outcomes of drugs. It also helps
generate broader scientific evidence and commercial insights, valuable for the
pharmaceutical industry.
Geographically, North
America is estimated to command the largest share of the global RWE solutions
market in 2021, followed by Asia-Pacific, Europe, Latin America, and the Middle
East & Africa. However, Asia-Pacific region is expected to be the
fastest-growing regional market due to growing demand from payers for data that
defines the value and effectiveness of medicines, growing demand in conducting
real-world studies in drug R&D, and increasing government interest in using
real-world studies for regulatory decision-making.
Key companies
operating in the global RWE solutions market are IQVIA Holdings Inc. (U.S.),
ICON plc (Ireland), PPD, Inc. (U.S.), SYNEOS HEALTH, INC. (U.S.), CLARIVATE PLC
(U.S.), Medpace Holdings Inc. (U.S.), Symphony Innovation, LLC (U.S.), Clinigen
Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM
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 (U.S.) among others.
To gain more insights
into the market with a detailed table of content and figures, click here:
Scope of the Report
RWE Solutions Market,
by Component
- Datasets
- Disparate
Datasets
- EMR/EHR/Clinical
Data
- Claims
& Billing Data
- Pharmacy
Data
- Product/Disease
Registries Data
- Other Disparate
Datasets
- Integrated
Datasets
- Consulting
& Analytics
(Note: Other Disparate
Datasets include data generated from mobile devices, wearable devices, and
social media)
RWE Solutions 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
- Other
Applications
(Note: Other
Therapeutic Areas include infectious diseases, musculoskeletal disorders,
dermatological diseases, and respiratory diseases, Other Applications include
regulatory and clinical decision-making)
RWE Solutions Market,
by End User
- Pharmaceutical,
Biotechnology, and Medical Device Companies
- Healthcare
Payers
- Healthcare
Providers
- Other End
Users
(Note: Other end users
include academic research institutions, patient advocacy groups, regulators,
and health technology assessment agencies)
RWE Solutions 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
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