Why Global Health Agencies Are Demanding
Real-World Evidence in 2025 And What It Means for Market Access
In 2025, healthcare is no longer defined by clinical trial results alone.
Across the globe, regulatory bodies and health technology assessment (HTA) agencies are making one thing crystal clear: Real-World Evidence (RWE) is now a non-negotiable requirement for market access, pricing, and reimbursement decisions.
The question is simple: Will your data strategy be ready when they come asking?
At WLCUS we are excited to spotlight these cutting-edge trends at our upcoming Global RWE & Market Access Summit 2025, bringing together industry leaders to explore the future of healthcare innovation.
The Global Shift: From Trials to Real Life
While randomized controlled trials (RCTs) have long been the gold standard, they often fall short of representing how treatments perform in everyday settings. This is why:
- EMA, FDA, NICE, PMDA, and Health Canada now actively encourage RWE submissions.
- NICE’s new manual on health technology evaluations stresses the “real-world” applicability of data.
- The WHO is pushing for global alignment on real-world data standards.
For healthcare innovators, this isn’t an option anymore — it’s the new access barrier to cross.
Key New Expectations:
- Post-launch evidence generation (PLEG) plans.
- Integration of wearables, remote monitoring, and decentralized trial data.
- Patient-Reported Outcomes (PROs) as part of evidence packages.
Why Real-World Evidence Now Sits at the Heart of HTA
When evaluating a new therapy, HTA agencies increasingly demand:
- Long-term effectiveness and safety data in real-world populations.
- Comparative effectiveness research (CER) — not just vs. placebo, but vs. standard-of-care.
- Health Economics and Outcomes Research (HEOR) models powered by real-world inputs.
- Evidence of health equity, based on social determinants of health (SDoH).
Simply put: If your market access dossier lacks strong RWE, your chances of success plummet.
RWE-Driven Market Access: What Top Pharma Companies Are Doing
Leaders in pharma and biotech are:
- Building RWE Centers of Excellence.
- Investing in partnerships with digital health and wearable device companies.
- Embedding real-world data strategies at early development stages, not post-launch.
- Training HEOR and Market Access teams to use AI-powered RWE analytics platforms.
If you’re not investing in RWE excellence today, you’re preparing to lose tomorrow.
Why Real-World Evidence is Central to Healthcare Innovation?
The future of RWE isn’t just observational studies. It’s a dynamic fusion of:
- Real-time data streams from patients’ devices.
- AI-generated predictive models.
- Blockchain for trusted healthcare data sharing.
- Diversity-driven datasets ensuring equitable access.
Success in 2025 = Clinical Data + Real-World Data + AI-Powered Insights.
Are You Ready to Compete in the RWE Revolution?
At WLCUS, we’re bringing together the world’s top experts at the Global RWE & Market Access Summit 2025 to dive deep into:
- How to build regulatory-grade RWE portfolios.
- How to align RWE with HEOR and HTA expectations.
- How to use RWE for outcome-based pricing negotiations.
👉 Join us and be part of healthcare’s future. Request the full agenda now!