Global Real World Evidence (RWE) Solutions Market Analysis

Global Real World Evidence (RWE) Solutions Market Executive Summary

The Global Real World Evidence (RWE) Solutions Market is projected to grow from $79.7 Bn in 2022 to $42.4 Bn by 2030, registering a CAGR of 8.2% during the forecast period of 2022 - 2030.

The global real-world evidence (RWE) solutions market is a growing industry that provides valuable insights into the effectiveness and safety of medical treatments and interventions. RWE is generated from various sources, including electronic health records, claims data, and patient-generated data, and it can be used to inform decision-making in various settings, such as clinical trials, drug development, and market access.

The market for RWE solutions is driven by the increasing demand for more efficient and cost-effective methods of generating evidence, as well as the growing importance of real-world data in regulatory decision-making. Additionally, advancements in digital technology and the increasing adoption of electronic health records are expected to drive growth in the RWE solutions market.

The market can be segmented by type of solution, end-user, and geography. The types of RWE solutions include data management and analytics, outcomes research, and registries. The end-users of RWE solutions include pharmaceutical companies, healthcare providers, and payers. Geographically, the market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World.

The major players in the RWE solutions market include IQVIA, Syneos Health, Parexel, Covance, and IMB, among others. These companies offer a range of RWE solutions and services to meet the needs of the industry.

Overall, the global RWE solutions market is expected to continue its growth trajectory in the coming years, driven by the increasing demand for real-world data in the healthcare industry and the continued advancement of digital technology.

Market Dynamics

Current Global Real World Evidence (RWE) Solutions Market Trends

Here are some current trends in the global real-world evidence (RWE) solutions market:

Increased focus on patient-generated data: There is a growing interest in incorporating patient-generated data into RWE studies. This includes data from wearable devices, mobile health apps, and patient-reported outcome measures, which can provide more comprehensive and accurate information about a patient's health status and treatment response.

Integration of artificial intelligence (AI) and machine learning (ML): AI and ML are being increasingly used in RWE solutions to analyze large amounts of data, identify trends, and generate insights. These technologies are being used to streamline data management and analysis, improve the accuracy of predictive modeling, and support decision-making in the healthcare industry.

Expansion of telemedicine: The COVID-19 pandemic has accelerated the adoption of telemedicine, and this trend is expected to continue in the coming years. Telemedicine can provide valuable RWE data, such as remote monitoring data, which can inform decision-making in areas such as drug development and market access.

Emphasis on real-world endpoints: There is a growing focus on using real-world endpoints, such as patient-reported outcomes and health-related quality-of-life measures, in RWE studies. These endpoints provide a more comprehensive picture of the benefits and risks of medical treatments and interventions and can inform decision-making in areas such as regulatory approval and reimbursement.

Growing demand for RWE in Asia-Pacific: The Asia-Pacific region is expected to see significant growth in the RWE solutions market in the coming years, driven by the increasing demand for real-world data in the healthcare industry and the expanding healthcare infrastructure in the region.

Real World Evidence (RWE) developments in the international context for regulatory decision-making

Global Real World Evidence (RWE) Solutions Market Drivers

Here are some of the key drivers of the global real-world evidence (RWE) solutions market:

Increasing demand for cost-effective clinical trials: RWE solutions can provide valuable information about the effectiveness and safety of medical treatments and interventions, which can inform decision-making in clinical trials. By incorporating RWE data into clinical trials, pharmaceutical companies can reduce the cost and time required to develop new treatments, which is a key driver of the RWE solutions market.

The growing importance of real-world data in regulatory decision-making: Regulatory authorities are increasingly relying on RWE data to inform their decision-making, particularly in areas such as drug approval and reimbursement. This trend is driving the growth of the RWE solutions market, as pharmaceutical companies seek to generate high-quality RWE data to support their regulatory submissions.

Adoption of electronic health records (EHRs): The increasing adoption of EHRs is creating a wealth of real-world data that can be used to inform decision-making in the healthcare industry. This trend is driving the growth of the RWE solutions market, as companies seek to develop solutions to manage, analyze, and extract insights from this data.

Advancements in digital technology: Advances in digital technology, such as artificial intelligence (AI) and machine learning (ML), are enabling the more efficient and effective generation of RWE data. This trend is driving the growth of the RWE solutions market, as companies seek to leverage these technologies to generate insights from real-world data.

Expansion of telemedicine: The COVID-19 pandemic has accelerated the adoption of telemedicine, and this trend is expected to continue in the coming years. Telemedicine can provide valuable RWE data, such as remote monitoring data, which can inform decision-making in areas such as drug development and market access.

Global Real World Evidence (RWE) Solutions Market Restraints

Here are some of the key restraints of the global real-world evidence (RWE) solutions market:

Data privacy and security concerns: The use of real-world data raises concerns about data privacy and security, as patients' personal and sensitive health information is at risk of being misused or compromised. This is a key restraint on the growth of the RWE solutions market, as companies must ensure that they have robust data privacy and security measures in place to protect patient data.

Lack of standardization in RWE data: There is currently a lack of standardization in the data generated from RWE studies, which can make it difficult to compare and combine data from different sources. This is a key restraint on the growth of the RWE solutions market, as companies must develop solutions to standardize and harmonize RWE data.

Limited access to real-world data: There are often barriers to accessing real-world data, such as data sharing agreements, data ownership rights, and data privacy regulations. These barriers can make it difficult to generate high-quality RWE data, which is a key restraint on the growth of the RWE solutions market.

Challenges in data quality: Real-world data can be of varying quality, with potential biases and inaccuracies. This is a key restraint on the growth of the RWE solutions market, as companies must develop methods to ensure the quality and accuracy of RWE data.

Regulatory barriers: The regulatory approval process for RWE studies can be complex and time-consuming, which can delay the development and availability of RWE data. This is a key restraint on the growth of the RWE solutions market, as companies must navigate the regulatory landscape to generate high-quality RWE data.

RWE Accelerates Approval in Early Benefit Assessment

It is believed that incorporating RWE into early evaluations of more recent medications might accelerate the approval of efficient treatments and lower drug development costs. The German Joint Federal Committee, which hired the Institute for Quality and Efficiency in Health Care, commissioned this issue in 2020 to be presented as an extra benefit of RWE in the early benefit evaluation of medications. In 2020, a scientific rapid report on the assessment of medical research with the goal of determining the benefits of medications was published. According to the report's findings, typical trials for uncommon illnesses were often either too short or neglected to gather patient-relevant outcomes. Therefore, the study recommended the incorporation of healthcare research data for the early benefit evaluation of pharmaceuticals, such as findings from comparative studies, data collected from electronic patient records, and billing data from health insurance firms (all as per definition RWE sources).

In this domain, it is acknowledged that the data situation is inadequate for expedited approval and for medications related to the market for uncommon diseases. EHR and illness registries would be very helpful for rare disease research, which is often restricted to case studies or studies with tiny patient numbers, to acquire insights into epidemiology, therapy, and results in this area. Additionally, because of the outdated ICD-10 rule, uncommon illnesses are now underrepresented in databases or records. Due to the new ICD-11 regulations that will go into effect in 2022, there will be fresh and about 10 times more data accessible on these disorders, and it will be feasible to investigate novel therapy routes thanks to RWE.

Competitive Landscape

Here are some of the top key players in the global real-world evidence (RWE) solutions market:

• IQVIA (US)
• IBM Corporation (US)
• ICON plc. (Ireland)
• PAREXEL International Corporation (US)
• PPD, LLC (US)
• Optum, Inc. (US)
• Cognizant Technology Solutions Corporation (US)
• Oracle Corporation (US)
• SAS Institute Inc. (US)
• Syneos Health, Inc. (US)
• Anthem, Inc. (US)
• Clinigen Group plc. (UK)
• Medpace Holdings Inc. (US)
• Flatiron Health, Inc. (US)

These companies are among the leading providers of RWE solutions and services, offering a range of solutions to help pharmaceutical companies generate high-quality RWE data to support clinical trials and regulatory submissions. These companies have strong market positions and a reputation for delivering innovative solutions, which has helped to establish them as key players in the RWE solutions market.

Healthcare Policies and Regulatory Landscape

The Global Real World Evidence (RWE) Solutions Market in the healthcare industry is influenced by various healthcare policies and regulations. The regulations surrounding RWE solutions vary by country but generally focus on ensuring the quality and validity of the data used for decision-making.

In the US, the Food and Drug Administration (FDA) has taken a proactive approach to promote the use of RWE by issuing guidance documents that outline the agency's expectations for the use of RWE in regulatory decision-making. Additionally, the 21st Century Cures Act and the FDA Reauthorization Act of 2017 provide a framework for the use of RWE in regulatory decision-making and provide funding for the development of new RWE sources and methods.

In Europe, the European Medicines Agency (EMA) has also issued guidance on the use of RWE in regulatory decision-making. The EMA recognizes the potential of RWE to provide valuable insights into the real-world benefits and risks of treatments and is working to promote the use of RWE in regulatory decision-making.

In addition to regulatory guidance, healthcare policies, and reimbursement policies also play a significant role in shaping the RWE solutions market. Reimbursement policies determine the amount that healthcare providers are reimbursed for providing a particular service or treatment. This, in turn, affects the demand for RWE solutions, as the ability to demonstrate the real-world effectiveness and value of treatments can be used to justify higher reimbursement rates.

In conclusion, healthcare policies and the regulatory landscape have a significant impact on the RWE solutions market. The growing recognition of the value of RWE in regulatory decision-making and the increased emphasis on demonstrating the real-world effectiveness and value of treatments are driving growth in the RWE solutions market.