Real World Evidence Solutions Market

Pharmaceutical and Life Sciences Real World Evidence (RWE) Market by Applications (Early Stage Research, Clinical Development, Regulatory Approval, Pricing / Reimbursement, Post-Approval Studies), Real World Data Sources (Medical Claims, Clinical Trials, Clinical Setting, Patient Powered and Others), Key Therapeutic Areas, and Geography (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2021-2030

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In recent years, the healthcare industry has witnessed a number of efforts by stakeholders to utilize real world evidence-based insights in official decision making processes; several regulatory authorities / payers have also started acknowledging the potential of real world data and have begun considering insights generated from such data sources for various purposes.

-Head of Market Strategy, a UK-based small-sized real world data provider

Real World Evidence Solutions Market Overview

The real world evidence solutions market is estimated to be worth $1.3 billion in 2021 and is expected to grow at CAGR of 15% during the forecast period. Drug discovery and development is a complex and time intensive process that requires a significant amount of resources and capital investments (~USD 2.6 billion). In fact, on an average, the journey from establishment of initial proof-of-concept to product launch, takes around 10-12 years.

Moreover, regulatory approval is dependent on the results of randomized clinical trials (RCTs), which are estimated to account for a staggering 40% of the pharmaceutical industry’s budget in the US. It is also well known that clinical research is fraught with various other challenges, including inefficiencies in medical data management and processing, unforeseen delays, risk of failure / study termination and several patient recruitment and retention-related concerns. Further, since such trials are conducted under controlled conditions and involve a fairly homogenous patient population, there are chances that, post commercial launch, approved products fail to perform as expected. In this context, the application of insights from real world data, accrued from past trials, has been demonstrated to have the potential to save up to USD 1 billion per year.  In fact, real world evidence can actually complement results from controlled RCTs, thereby, validating the therapeutic potential of a new chemical / biological entity.

In December 2016, after the 21st Century Cures Act was passed, the United States Food and Drug Administration (USFDA) began considering the application of real world evidence pharma in healthcare decision-making. Ever since, pharmaceutical companies and health economists have developed advanced tools and analytical algorithms to mine pharmaceutical big data, in order to better understand the clinical value of product candidates targeting some of the rarest medical conditions. Presently, big pharmaceutical companies are estimated to spend nearly USD 20 million on an annual basis, on generating real world evidence to support their respective clinical development programs. Over time, insights from real world data have not only influenced product approval-related decisions, but also helped convince insurance provider / payers into offering reimbursement for new drugs / therapies. The growing adoption of artificial intelligence and machine learning in big data analysis, is anticipated to better inform future drug discovery initiatives, thereby, reducing the risk of product failure. The adoption of real world evidence pharma in healthcare decision making is projected to grow substantially as the healthcare industry shifts towards the personalized medicine.

There are more than 230 Comanies offering real world evidence tools/ services Life Sciences Real World Evidence Market as per Roots analysis. There are List of Platform and service provider in Life Sciences Real World Evidence Market. A detailed assessment of the current market landscape of companies that claim to offer real world evidence related solutions based on a number of relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of services offered (real world data, analytics, consulting and services), real world data sources (medical claims, clinical trials, clinical setting, pharmacy, patient-powered and others), and target application areas (early stage research, clinical development, regulatory submission / reimbursement / market access, and post-approval studies).

Key Companies in Real World Evidence Solutions Market

Examples of key real world evidence companies engaged in real world evidence solutions market (which have also been profiled in this market report; the complete list of real world evidence companies is available in the full report) include Clinerion, Clinigen Group, Cognizant Analytics, Evidera, HealthCore, IBM, ICON, IQVIA, Medpace, NorthWest EHealth, Optum Insight, Oracle, PAREXEL, Perkin Elmer, SAS, Syneos Health and TriNetX. This market report includes an easily searchable excel database of all the real world evidence companies providing real world data, analytics, consulting and real world evidence services, worldwide.

Recent Developments in Real World Evidence Solutions Market

Several recent developments have taken place in the field of real world evidence solutions market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In September 2023, HealthVerity announced the launch of HealthVerity Audience Manager that provides media agencies and life sciences organizations with a truly self-directed analytics environment that enables previously unattainable insights regarding patient behavior in combination with social determinants of health (SDOH), all in a privacy protected, HIPAA-compliant manner. 
  • In July 2023, nference entered into a strategic collaboration with Vanderbilt University Medical Center in order to advance real-world evidence generation in complex disease populations. 
  • In July 2023, Thermo Fisher Scientific acquired CorEvitas for the total amount of USD 912.5 million with an aim to strengthen its regulatory-grade, real-world evidence for approved medical treatments and therapies.

Scope of the Real World Evidence Solutions Market Report

The “Real World Evidence Solutions Market (2nd Edition), 2021-2030: Distribution by Type of Applications (Early Stage Research, Clinical Development, Regulatory Approval, Pricing / Reimbursement, Post-Approval Studies), Type of Real World Data Sources (Medical Claims, Clinical Trials, Clinical Setting, Patient Powered and Other Data Sources), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Neurological / Psychiatric Disorders, Oncological Disorders, Respiratory Disorders and Other Disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World)” market report features an extensive study of the current market landscape, market size, market share, market growth, market forecast, market outlook and future opportunities of the real world evidence solutions market. The market research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in real world evidence solutions market.

Clinical Activities which are ongoing in geographical area. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of companies that have acquired other firms, offering a means for other industry stakeholders to identify potential acquisition targets.

Amongst other elements, the market research report features:

  • A detailed assessment of the current market landscape of real world evidence companies that claim to offer real world evidence related solutions based on a number of relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of services offered (real world data, analytics, consulting and services), real world data sources (medical claims, clinical trials, clinical setting, pharmacy, patient-powered and others), and target application areas (early stage research, clinical development, regulatory submission / reimbursement / market access, and post-approval studies).
  • A detailed analysis of completed, ongoing and planned clinical trials conducted in the real world setting based on the multiple parameters, such as trial status, trial registration year, regional distribution, enrolled patient population, type of study, leading industry and non-industry players, emerging focus areas and key therapeutic areas.
  • A detailed publication analysis of more than 950 peer-reviewed, scientific articles that have been published between 2016 and September 2020, highlighting the research focus within the industry. It also highlights the key trends observed across publications, including information on type of publication, year of publication, study objective, popular keywords, types of real world datasets utilized, key disease indications, type of publisher, leading players (in terms of number of publications), region, and key journals (in terms of number of articles published in real world evidence solutions market and impact factor of the journal). 
  • A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of companies that have acquired other firms, offering a means for other industry stakeholders to identify potential acquisition targets. 
  • A social media analysis depicting prevalent and emerging trends, and the popularity of real world evidence solutions, as observed on the social media platform, Twitter. In addition to providing information on yearly trends related to the volume of tweets, the analysis highlights the most frequently talked about real world data sources, target applications, therapeutic areas, active players, and influential authors. The analysis was based on tweets posted on the platform in the last few years.
  • An in-depth analysis of recent events (summits / forums / conferences / annual meetings) that were organized for stakeholders in real world evidence solutions market, highlighting the evolution of discussion topics related to real world evidence. The analysis also provides details on type of event, regional distribution, emerging agendas, popular organizers, active industry and non-industry players, and a schematic mapping of upcoming events.
  • A comparative analysis to understand the needs of different stakeholders (manufacturers, regulators, payers, providers and patients) involved in real world evidence solutions market. 
  • Elaborate profiles of prominent real world evidence service providers. Each company profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key members of the executive team), details related to their respective portfolio of technologies / platforms / services, recent developments, and an informed future outlook.
  • An elaborate discussion on data governance and the existing regulatory framework related to real world evidence across various geographies, namely North America (the US and Canada), Europe (the UK, Germany, France, Spain and Italy), and Asia-Pacific and rest of the world (Australia, China and Japan).
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall real world evidence market.
  • An insightful discussion on how the recent COVID-19 pandemic likely to impact the real world evidence market, along with key initiatives undertaken by industry players to combat the challenges faced to the pandemic.
  • A list of recent use cases where real world evidence was leveraged by pharmaceutical / medical device companies, highlighting the ways in which companies have utilized such information to support regulatory decisions, advance disease understanding, and develop outcome-based reimbursement model.

The key objective of real world evidence market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for real world evidence market during the forecast period. We have developed informed estimates of the financial evolution of the market, over the forecast period 2021-2030. The market report also provides details on the likely distribution of the current and forecasted opportunity across [A] target application areas (early stage research, clinical development, regulatory approval, pricing / reimbursement, and post-approval studies), [B] type of real world data sources used (medical claims, clinical trials, clinical setting, patient-powered and other data sources), [C] therapeutic areas (autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, neurological / psychiatric disorders, oncological disorders, respiratory disorders and other disorders), and [D] geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our forecast model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of companies that have acquired other firms, offering a means for other industry stakeholders to identify potential acquisition targets. A list of recent use cases where real world evidence was leveraged by pharmaceutical / medical device companies, highlighting the ways in which companies have utilized such information to support regulatory decisions, advance disease understanding, and develop outcome-based reimbursement model. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] target application areas (early stage research, clinical development, regulatory approval, pricing / reimbursement, and post-approval studies), [B] type of real world data sources used (medical claims, clinical trials, clinical setting, patient-powered and other data sources), [C] therapeutic areas (autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, neurological / psychiatric disorders, oncological disorders, respiratory disorders and other disorders), and [D] geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World).

The opinions presented in this market research report were also influenced by discussions held with multiple stakeholders in real world evidence solutions market. The market report features detailed transcripts of interviews held with the following individuals (in alphabetical order):

  • Limor BH Epstein (Founder, Data2Life)
  • Anonymous (Vice President, A Big Pharmaceutical Company)
  • Wirth Peter (Vice President, RTI Health Solutions)
  • Douglas Drake (Senior Director, Clinerion) 
  • Fernando Santa (Chief Operating Officer, Adarna Health Data)
  • Jonathan Moshinsky (Chief Strategy Officer, uMotif)
  • Anonymous (Savana)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified. We have also isssued a press release for our report and is titled, Real World Evidence (RWE) Solutions Likely to Grow at a CAGR of 14.1% and Significantly Drive Healthcare Decision-Making, predicts Roots Analysis

Frequently Asked Questions

Question 1: What is real world evidence?

Answer: Real world evidence is the clinical data about the utilization and proven benefits / risks of a pharmaceutical product obtained from the analysis of real world data related to patient health status.

Question 2: How big is the real world evidence solutions market?

Answer: The real world evidence solutions market size is estimated to be worth $1.3 billion in 2021.

Question 3: What is the projected market growth of the real world evidence solutions market?

Answer: The real world evidence solutions market is expected to grow at compounded annual growth rate (CAGR) of 15% during the forecast period.

Question 4: Who are the leading companies in the real world evidence solutions market?

Answer: Examples of key companies engaged in real world evidence solutions market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Clinerion, Clinigen Group, Cognizant Analytics, Evidera, HealthCore, IBM, ICON, IQVIA, Medpace, NorthWest EHealth, Optum Insight, Oracle, PAREXEL, Perkin Elmer, SAS, Syneos Health and TriNetX.

Question 5: What is the cost saving potential associated with the use of real world evidence solutions in pharmaceutical industry?

Answer: Over USD 4.5 billion is the estimated cost saving potential associated with the use of real world evidence solutions in pharmaceutical industry.

Question 6: How many companies are currently engaged in the real world evidence solutions market?

Answer: Presently, over 230 companies are engaged in the real world evidence solutions market, offering real world evidence tools and services.

Question 7: How much annual expenditure is ascribed to generating real world evidence for clinical development programs?

Answer: Presently, big pharmaceutical companies are estimated to spend nearly USD 20 million on an annual basis, on generating real world evidence to support their respective clinical development programs.

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