Real-world evidence (RWE) is clinical evidence
gathered via real-world data (RWD) analysis on a medical product’s use and
potential benefits or risks. 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). For example, the role of RWE in drug development is expanding
as RWE studies are significantly less costly and time-consuming than RCTs,
providing easier access to long-term effectiveness data and helping overcome
some of the feasibility barriers of running RCTs. RWE is regularly utilized in
the drug development & approval process to inform aspects of drug
development, such as the natural history and epidemiology of a disease, and to
provide data on treatment pathways and comparator interventions in clinical
practice.
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.
To gain more insights into the market with a detailed table of content
and figures, click here: https://www.meticulousresearch.com/product/Real-World-Evidence-Solutions-Market-4954?utm_source=Blog&utm_medium=Social&utm_campaign=Product&utm_content=22-12-2021
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.
TOP
10 COMPANIES IN REAL WORLD EVIDENCE (RWE)SOLUTIONS MARKET
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
- 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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