RWE Oncology Market
Number of pages: 100 | Report Format: PDF | Published date: April 20, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
|
Report Attribute |
Details |
|
Market Size Value in 2022 |
US$ 560.20 million |
|
Revenue Forecast in 2031 |
US$ 2,155.6 million |
|
Growth Rate |
14.3% |
|
Base Year for Estimation |
2022 |
|
Forecast Period |
2023 to 2031 |
|
Historical Year |
2021 |
|
Segments Covered |
Component, Application, End User and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global RWE oncology was valued at US$ 560.20 million in 2022 and is expected to register a revenue CAGR of 14.3% to reach US$ 2,155.6 million by 2031.
RWE Oncology Market Fundamentals
The FDA defines real-world data (RWD) as data relating to patient health status and/or the delivery of health care that is routinely collected from a variety of sources, and real-world evidence (RWE) is clinical evidence about the usage and potential benefits or risks of a medical product that is derived from RWD analysis. The goal of the Oncology Center of Excellence Real World Evidence Program, following the 21st Century Cures Act, is to engage in evidence development modernization through scientific collaboration and policy development to advance the appropriate fit-for-purpose application of RWD to generate RWE for regulatory purposes.
Traditionally, randomized controlled clinical trials (RCTs) were regarded as the greatest degree of evidence for defining the efficacy of therapies before their use in clinical practice. However, in oncology, as in other domains of medicine, the examination of real-world evidence (RWE) to address relevant clinical and policy issues that cannot be directly answered using RCT data has significantly grown in recent years.
Among the many RWE applications presented in recent years, the following are worth considering: (a) RWE was conducted after RCTs to better identify treatment success in clinical practice. (b) RWE to describe the dependability and transferability of complex procedures in clinical practice, such as molecular diagnostics and multimodal treatments; (c) RWE to define the effectiveness of interventions in settings where RCT are (still) not available, typically in the case of rare molecular subgroups were conducting “traditional” RCTs can be particularly difficult; and (d) RWE to better define treatment safety, particularly in terms of long term adverse events.
RWE evidence is more likely to reflect true treatment effects. It is easier to generalize than evidence from standardized clinical trial data. RWE’s capabilities are in mapping the reality of health care, offering insights into therapeutic courses, and identifying specific subgroups with various comorbidities. Furthermore, it allows for researching illnesses in extremely small or highly particular patient populations. Furthermore, RWE may be used to examine the decrease of solely chosen patient collectives and the effectiveness of therapies under normal settings. Furthermore, RWE studies aid in the provision of information regarding illness risks, the improvement of diagnostics, the identification of overuse and underuse, and the development of practical solutions.
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RWE Oncology Market Dynamics
Factors like increased cancer prevalence, rapidly advancing big data in healthcare, the transition from volume to value-based treatment, and a growing emphasis on customized healthcare are driving the market revenue expansion. Furthermore, growing markets, a greater emphasis on end-to-end RWE services, and increased usage of mobile apps, wearable devices, and AI in RWE will likely present considerable growth potential for market participants and new entrants.
Successful biopharmaceutical companies have invested in the premise that RWE is a crucial component of development and life cycle management and have committed to this by creating large-scale RWE-generation capabilities. Providers have also used RWE to inform clinical practice, and clinical guidelines (for example, the National Comprehensive Cancer Network) are increasingly incorporating RWE-generated findings. Recognizing the need for a more flexible framework for therapy evaluation, authorities are creating methods to include RWE in decision-making, as described in frameworks like the 21st Century Cures Act. These shifts are accompanied by the rise of high-quality data providers, particularly those with unique data sources and analytic methodologies.
RWE has various uses throughout clinical development, including the first finding. Oncology research is becoming more individualized and precise, with fewer and more complex indications defined by genetic abnormalities and markers. RWE can derisk early discovery aspects by focusing on identifying high-responding patient populations. RWE analysis can uncover treatment response and resistance indicators using robust genomic sequencing data and longitudinal clinical data to enhance a drug development approach. One top pharmaceutical firm, for example, recently used a clinico-genomic database containing tumor sequencing data from over 2,000 patients with advanced non-small cell lung cancer to identify and define genetic profiles of patients with fast progression or otherwise poor prognosis. Such data can be used to guide biomarker targets of interest and, in the future, may assist more targeted drug development.
RWE Oncology Market Ecosystem
The global RWE oncology market is analyzed from four perspectives: component, application, end-user, and region.
RWE Oncology Market by Component
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Based on the components, the global RWE oncology market is segmented into real-world datasets, real-world consulting & analytics services. The real-world datasets are further segmented into disparate datasets and integrated datasets. The disparate datasets are again segmented into EMR/EHR/clinical data, claims & billing data, pharmacy data, cancer registries, and other disparate datasets.
The RWE oncology market is expected to be dominated by the real-world datasets segment. The expanding volume of medical data generated by hospitals, increasing reliance on outcome-based research on real-world data, and increased need for information on drug safety among payers, regulatory bodies, and providers all contribute to this segment’s substantial market revenue share.
RWE Oncology Market by Application
Based on the applications, the global RWE oncology market is segmented into drug development & approvals, market access & reimbursement/coverage decisions, post-market surveillance, medical device development & approvals, and other applications.
The RWE oncology market is expected to be dominated by the drug development and approvals segment, with the largest revenue share. This segment’s substantial revenue share may be ascribed to the increasing number of cancer patients, which has compelled pharmaceutical and biopharmaceutical firms to focus on cancer medicine development. The successful use of RWE may greatly speed the pace of discovery, permit medication approvals, and aid in understanding the impact of novel cancer medicines, hence accelerating the revenue growth of this segment.
RWE Oncology Market by End User
Based on the end users, the global RWE oncology market is segmented into pharmaceutical, biotechnology, medical device companies, healthcare payers, healthcare providers, and others.
Pharmaceutical and medical device companies are expected to have the greatest proportion of the RWE oncology market revenue share. The relevance of RWE studies in cancer medication development and approvals and the rising need to minimize costly drug recalls and analyze drug efficacy in real-world situations account for this segment’s substantial market revenue share.
RWE Oncology Market by Region
Based on region, the global RWE oncology market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
The RWE oncology market is expected to be dominated by North America, followed by Europe. The increasing number of cancer cases, stringent drug approval regulations, implementation of the 21st Century Cures Act, increased use of electronic datasets, advanced healthcare industry, and the growing amount of big data in healthcare all contribute to North America’s high market revenue growth. Access to the market and reimbursement face rising therapeutic costs, and payers increasingly demand clinical value proof before offering coverage. These pressures are especially noticeable in cancer, where numerous high-cost medicines with identical modes of action compete for market dominance. For example, the PD-(L)1 inhibitor class contains five approved treatments and others under development. RWE enables the proof of value, from proving randomized trial benefits in real-world populations to a more comprehensive assessment of resource impact. In PD-(L)1s, RWE may be used to differentiate them. RWE has lately been utilized to support value-based and other unique contractual structures for biopharmaceutical firms and suppliers by offering a mutually agreed upon measuring technique driving regional revenue growth.
During the forecast period, Asia Pacific is expected to be the fastest-growing region. Factors such as the increasing number of clinical trials, increased government initiatives for adopting RWE oncology studies, rising incidences of chronic diseases, rising demand for better healthcare services, and an aging population all support the growth of the Asia Pacific RWE oncology market. Furthermore, nations in the area with well-established clinical trial infrastructure, a strong medical workforce, solid healthcare capabilities, and high-quality standards, such as Japan and China, are helping market revenue expansion in the Asia Pacific.
RWE Oncology Competitive Landscape
The prominent market players operating in the global RWE oncology market include,
RWE Oncology Strategic Development
The FDA defines real-world data (RWD) as data relating to patient health status and/or the delivery of health care that is routinely collected from a variety of sources, and real-world evidence (RWE) is clinical evidence about the usage and potential benefits or risks of a medical product that is derived from RWD analysis.
The real-world datasets segment leads the global RWE oncology market with the largest revenue share.
The expected size of the global RWE oncology market in 2031 is 2,155.64 million.
The expected revenue CAGR of the RWE oncology market during the forecast period is 14.3%.
The prominent market players operating in the global RWE oncology market include IQVIA Holdings Inc., SYNEOS HEALTH, INC., and CLARIVATE PLC.
*Insights on financial performance are subject to the availability of information in the public domain