Real-World Evidence Is Consolidating And Pharma’s Playbook May Never Be the Same

On May 15 2025, Datavant announced its agreement to acquire Aetion, the real-world evidence (RWE) analytics firm whose platform is used by the FDA, NICE, and top biopharma companies. The combination is about strategic control. By merging the largest health data exchange with one of the most regulator-trusted analytics engines, Datavant is quietly building the first end-to-end evidence-generation stack designed to own the post-trial pharma lifecycle.

From Tokenization to Submission: A Closed RWE Loop

Datavant currently connects over 500 real-world data sources, including EHRs, claims, labs, imaging, pharmacy transactions, genomics, and mortality data. Much of this infrastructure came via its 2021 merger with Ciox Health, enabling a robust footprint in tokenized medical records exchange.

Aetion, for its part, has spent the past decade refining its science-first platform for creating fit-for-purpose RWE studies. The company has published jointly with the FDA, collaborated with international regulators, and earned a place in payer coverage workflows. Its cloud-native modeling interface allows users to run comparative effectiveness studies, emulate trial cohorts, and validate endpoints across hundreds of real-world datasets.

Together, they now control not just the data pipes, but also the statistical engines that transform messy observational data into regulator-grade insights. As Datavant’s press release stated, the combined platform will allow life sciences organizations to “connect, analyze, and act” on health data, all under one vendor relationship.

Neutrality Is Dead: The Risks of RWE Bundling

For over a decade, pharma companies have relied on a modular ecosystem of data brokers, analytics vendors, and HEOR consultants. You sourced your patient data from Symphony or Komodo, licensed a statistical platform like Panalgo or Aetion, and perhaps hired Evidera to present it to payers.

That ecosystem is collapsing. In a world where Datavant provides both the underlying data and the interpretive models, life sciences firms face several risks:

• Pricing leverage as more product lines are bundled
• Reduced independence in methods or assumptions
• Harder audit trails for internal regulatory reviewers
• Conflicts of interest when the same vendor feeds both payer analytics and sponsor analytics

This shift echoes what happened when Roche acquired Flatiron Health: sponsors lost a neutral analytics provider, and Flatiron’s outputs became perceived as Roche-aligned. The difference here is scale. Datavant touches hundreds of payer, provider, and life science entities — and now gains an analytics layer with regulatory precedent.

Revenue Model: From Data as a Service to Evidence as a Product

Unlike CROs or consulting firms, RWE platforms scale with margin. The new Datavant-Aetion entity can generate revenue through:

• Subscriptions to linked, tokenized datasets
• Licensing of cohort building and modeling software
• High-value regulatory submissions (e.g., label expansions)
• Custom studies for payers, PBMs, and IDNs

This model reflects a broader transition from “data as exhaust” to “evidence as product.” The FDA’s 2023 draft guidance on the use of RWE in regulatory decision-making signaled clear acceptance of external data for safety and effectiveness evidence, provided it meets traceability and transparency standards.

According to Grand View Research, the global RWE market is expected to grow at a 14.2 percent CAGR through 2030, reaching over $6.5 billion annually. Verticalized players are best positioned to capture that growth.

Market Reactions and Competitive Countermoves

This acquisition puts pressure on several competitors:

• Komodo Health may accelerate development of its own analytics stack or seek acquisition of a transparent modeling vendor
• Truveta, backed by health systems, could lean on its real-time Epic EHR feeds to compete on data freshness and provenance
• IQVIA and Optum Life Sciences may face calls to unbundle their platforms or disclose more about their black-box methodologies

Meanwhile, regulators and academic researchers are beginning to ask whether a vertically integrated RWE vendor should be subject to disclosure requirements, given its potential influence over coverage decisions, safety signals, and post-approval label updates.

Implications for Pharma and the Evidence Economy

Datavant is betting that pharma wants fewer vendors and faster answers. If a biopharma sponsor can go from question to regulatory submission in 10 weeks rather than 10 months, the platform becomes indispensable. But that speed comes with trade-offs: less methodological flexibility, greater dependency on vendor roadmap, and the loss of in-house modeling capacity.

This is not just a consolidation play. It is the beginning of a new model where evidence generation becomes its own revenue stream, bundled, brokered, and productized.