Real-world evidence (RWE) offer the potential to help inform and potentially improve Healthcare Decisions.

 

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.

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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.

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
• 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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Next Generation Sequencing (NGS) Services Market - Global Opportunity Analysis and Industry Forecast (2018-2023)

Global NGS services market has shown strong growth pattern in recent year’s majorly due plummeting cost of sequencing, need of skilled professionals for efficient NGS sample preparation and analysis, technological advancements in NGS services, increase in genome mapping programs, high cost of sequencing infrastructures are expected to boost the demand for NGS services across the globe. However, installation of in-house sequencing facilities in hospitals and universities for genome testing may obstruct the growth of NGS services to some extent.

Meticulous Research® in its latest publication on global NGS services market states that the global NGS services market will increase at a CAGR of 20.1% from 2018 to 2023 to reach USD 2,921.4 million by 2023. The recent advances in the field of genomics research over the past years have led to substantial reduction in the cost of genome sequencing. The NGS technology has reduced the cost and increased the speed of DNA sequencing significantly.

Meticulous Research states that “In genomics research field, sequencing is being applied not only to assemble genomes and to investigate the genetic basis of human diseases, but also to understand the diverse nature of reproductive medicine, oncology and infectious diseases. The cheaper genome sequencing could revolutionize healthcare, allowing doctors to prescribe individualized treatment options for patients. Also, this would enable faster progress in clinical research, pushing research for cancer and other genetically linked diseases forward”.

The cost of sequencing closely followed a Moore’s law trajectory over the years before 2008; however, the introduction of NGS technologies caused costs to fall faster than would be expected by Moore’s law. In 2003, the first time the human genome was sequenced for a price of $2.7 billion. Later, the price of sequencing an average human genome declined from about USD10million to a few thousands in just 6 years of duration (2007-2013). Further to this declining price trend, in January 2017, Illumina debuted a new sequencing machine, the NovaSeq (NovaSeq 5000 and NovaSeq 6000), which has ability to sequence an entire genome for less than USD 100 in fewer than 60 minutes.

The report provides meticulous analysis of global NGS services market by segmenting it on the basis of service type (targeted sequencing, rna sequencing, exome sequencing, de novo sequencing, chip-sequencing, whole genome sequencing, methyl sequencing, and other services), technology [sequencing by synthesis (sbs), ion semiconductor sequencing (ios), single molecule real time sequencing (smrt), nanopore sequencing, and true single molecule sequencing (tsms)], application (diagnostics, drug discovery, biomarker discovery, agriculture & animal research, and other applications), end user (academic& research institutes, pharmaceuticals & biotechnology industry, hospitals & clinics and other end users), and geography.

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The key players analyzed in the global NGS services market are Illumina, Inc. (U.S.), Qiagen N.V. (The Netherlands), PerkinElmer, Inc. (U.S.), Eurofins Scientific SE (Luxembourg), GATC Biotech AG (Germany), Macrogen, Inc. (South Korea), Genotypic Technology Pvt. Ltd. (India), GENEWIZ, Inc. (U.S.), Beijing Genomics Institute (BGI) (China), SciGenom Labs Pvt. Ltd. (India), MedGenome (India), DNA Link, Inc. (South Korea), Otogenetics Corporation (U.S.), Novogene Corporation (China), LGC Limited (U.K.), CD Genomics (U.S.), and SeqLL, LLC (U.S.)

Key questions answered in the report-

Growing genomics research in academic and research institutes and outsourcing of genome testing in biopharmaceutical & biotechnology industry to drive the adoption of NGS services

-How does the penetration of NGS services in biopharmaceutical industry differ from that in diagnostics and biomarker discovery applications?
-What impact does this have on the adoption of NGS services in comparison to other conventional technologies for detection of genetic mutations?

Agriculture & animal research account for a relatively small proportion of all applications of NGS services globally
-What factors contribute to the infrequent usage of NGS services for agriculture & animal research?
-Conversely, which geographic segment is expected to experience the fastest growth for agriculture & animal research?

The North American NGS services market favors both larger and local manufacturers that compete in multiple segments
-Who are the top competitors in this market and what strategies do they employ to gain shares?
-What is driving growth and which market segments have the most potential for revenue expansion during the forecast period?
-What strategies must companies adopt who are looking to enter this market and compete effectively?
-What are the major drivers, restraints, opportunities, and challenges in the global NGS services market?
-Who are the major players in various countries and what share of the market do they hold?
-What are the geographical trends and high growth regions/ countries?

Recent new service launches, acquisitions, collaborations, partnerships, and expansions have taken place in the NGS services space.
-What companies have recently merged/acquired and how will these unions affect the competitive landscape of the NGS services space?
-What companies have created partnerships and how will these partnerships promote a competitive advantage?
-Who are the major players in the global NGS services market and what share of the market do they hold?
-What are the local emerging players in the global NGS services market and how do they compete with the global players?

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About Meticulous Research®

Meticulous Research® was founded in 2010 and incorporated as Meticulous Market Research Pvt. Ltd. in 2013 as a private limited company under the Companies Act, 1956. Since its incorporation, with the help of its unique research methodologies, the company has become the leading provider of premium market intelligence in North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa regions.

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