The value of and need for Real-World Evidence (RWE) is growing in biopharma: one study predicts that the global market will see a 15 percent compound annual growth rate (CAGR) from 2019 to 2024, reaching $1.64 billion1. Across the lifecycle — from research and development (R&D), to pre-launch and launch phases, to post-market surveillance and commercial performance — RWE has shown immense value for companies that have invested the resources to track, measure, and apply it meaningfully. To explore the state of the industry and identify RWE trends, SHYFT Analytics, a Medidata Company, commissioned in-depth interviews with 20 RWE decision-makers across large, mid-size, and small biopharma companies.
Our research found that the majority of biopharmas currently do not have dedicated functional groups responsible for RWE, but rather multiple stakeholders that generate and use RWE. Within organizations of all sizes, RWE is being used across the product lifecycle, more heavily in the post-approval or commercial phase to understand the competitive market landscape and support product value.
Nearly all study respondents currently use or have used third-party partners for RWD and RWE access, analysis, and application. It is common even for large companies with dedicated teams to seek the expertise of a partner in certain scenarios. This helps to maximize both internal and external resources while cutting costs and turnaround time.
“We’ve determined that the actual process of doing advanced analytics on data is not necessarily our biggest competitive advantage. That is something that the vendors are best-suited to do. However, we do need people that can interpret that data and/or strategize how we need to analyze it. For that, we have internal experts.”
— Group Manager (large biopharma)
As the biopharma industry evolves, so too will the approaches and partnerships that transmute real-world insights into feasible, actionable, and profitable business strategies.
Internal vs. Outsourced Analytics Approach
When asked if their organization’s RWE analytics are primarily internal, outsourced, or a combination, 45% reported a combination, 40% reported mostly outsourcing, and the remaining 15% reported mostly relying on internal teams and resources.
20% of all respondents have generated or currently generate their own RWD and RWE through methods like conducting studies and creating proprietary apps for patient use.
Other internal activities include:
- RWD subscriptions and other purchases that facilitate ongoing internal data access (10% of all respondents)
- Interpreting and analyzing results (10%)
- Identifying the critical questions and hypotheses to be investigated (5%)
- Integrating data (5%)
- Navigating safety and regulatory issues (5%)
Outsourced activities include:
- Data analysis and modeling (55% of all respondents)
- Purchase or collection of project-specific data (35%)
- Data integration (10%)
- Generating insights from findings (5%)
- Publication planning (5%)
Selection of RWE Solutions
A minority of large biopharmas have the resources and bandwidth for a platform-only RWE solution, as opposed to a “platform and services” model that includes an analytics platform and additional support services for training, consultation, RWD analysis, and RWE generation. These companies reported confidence in their ability to leverage a self-service RWD analytics platform.
However, most respondents prefer the “platform and services” model. They feel that there would be a learning curve for using a robust end-to-end platform, and so ease of use can be a factor that increases an organization’s confidence and ability to leverage a platform autonomously.
In order to provide value to their companies, respondents would primarily like to see that potential solutions can integrate with existing systems and data.
“We’d look for a solution that can import data from multiple sources, it can do the analytics and export that under a certain node that can then answer questions around refining the patient cohort around, for example, a Phase IV study around adverse event reporting. So, it needs to be an enterprise-level solution that can bring in our pre-existing solutions and make them more efficient and effective.”
— Associate Director (large biopharma)
The value of RWE is coming into focus and the potential is great, but many challenges remain. Regardless of whether they have a robust internal team or a complete reliance on partners, biopharmas are in search of a collaborative and dynamic “platform and services” RWE model — one that provides the data collection, aggregation, and analytics capabilities that are only provided by an organization that specializes in RWE. This model helps to solve upstream RWD challenges such as collecting, validating, managing, and centralizing data, while ensuring that organizations receive guidance in analysis of this data, generation of meaningful RWE, and appropriate application and monitoring across use cases.
Biopharma companies will continue to seek partners with this balance of technology and expertise that offers the ability to grow with their unique needs, as well as the transforming competitive landscape. In turn, companies can stay competitive and profitable each step of the way.
Read more in the whitepaper “The State of Real-World Evidence in Biopharma”. The market perspective report contextualizes the findings from this research and provides a snapshot of where the industry is now, where it is heading, and how companies are allocating their resources to adapt and grow.
“Real-World Evidence (RWE) Solutions Market – Global Opportunity Analysis and Industry Forecast (2019 – 2024).” Meticulous Research, Feb. 2019, https://www.meticulousresearch.com/product/Real-World-Evidence-Solutions-Market-4954