The Deep Drivers Behind the Surge in Real-World Evidence (RWE) and Its Integration with AI: An Authoritative Data Analysis Report for 2025–2026

Real-world evidence (RWE) experienced explosive growth in 2025–2026. According to the latest data from multiple authoritative institutions, the global market size for RWE solutions reached USD 3.03–4.74 billion in 2025, with projections indicating it will exceed USD 6.0–10.8 billion by 2030–2035—maintaining a high compound annual growth rate (CAGR) of 8.4%–14.8%. This growth is not driven by a single factor but rather stems from the synergistic convergence of four key forces: regulatory policy breakthroughs, deep integration with AI technologies, maturation of data infrastructure, and upgrading industry demand. Based on the most recent regulatory policies, authoritative market data, and empirical hiring-market evidence from Q1 2025–2026, this article systematically analyzes the core logic behind RWE’s rapid rise. I. Regulatory Policy Level: A Historic Breakthrough in 2025 1. U.S. FDA: Landmark Policy Liberalization On December 18, 2025, the FDA issued the final version of its guidance document, "Using Real-World Evidence to Support Regulatory Decision-Making for Medical Devices"—its most significant update since 2017, marking a qualitative transformation in the RWE regulatory framework. Key Breakthroughs: • Elimination of mandatory individual-level patient data submission: Previously, the FDA required RWE submissions to include “individual-level private confidential information,” rendering large-scale aggregate databases impractical. The 2025 update explicitly permits de-identified databases—including the Surveillance, Epidemiology, and End Results (SEER) Program, hospital system databases, and insurance claims databases. • Dual-pillar evaluation framework—“Applicability and Reliability”: A structured assessment framework covering data accessibility, timeliness, population representativeness, data provenance, and quality assurance. • Adoption of causal diagrams as a methodological standard: Mandating the use of directed acyclic graphs (DAGs) to identify confounding factors, thereby enhancing the rigor of study design. Quantified Policy Impact: • Between 2016 and 2025, only 35 drug/biologic/vaccine applications included RWE; meanwhile, over 250 premarket authorizations for medical devices leveraged RWE. • The FDA projects the new guidance will increase RWE usage in drug applications by 3–5 times, significantly accelerating approvals in oncology and rare diseases. FDA Commissioner Marty Makary stated unequivocally: “We are removing unnecessary barriers to unlock the immense potential of real-world evidence—so patients can access life-changing treatments faster.” 2. European Medicines Agency (EMA): Full Operational Launch of the DARWIN EU Network The mid-2025 progress report confirmed critical milestones achieved by EMA’s DARWIN EU network: | Metric | 2024 Data | 2025 Data | Growth | |--------|-----------|-----------|--------| | Data Partners | Not specified | 30 | — | | Covered Population | 160 million | 180 million (across 16 countries) | +12.5% | | Research Projects | 47 | Significant expansion | — | Key 2025 Advancements: • Full implementation of the Clinical Trials Regulation (CTR): The transition period ended in January 2025, with over 5,000 clinical trials migrated to the Clinical Trials Information System (CTIS). • Joint EMA–HMA AI Work Plan released: The “Pharmaceutical Regulatory Data and AI by 2028” roadmap explicitly positions the integration of RWE and AI as a cornerstone tool for regulatory decision-making. • Full rollout of the European Shortages Monitoring Platform (ESMP): Mandated for marketing authorization holders starting February 2025—making RWE application in pharmacovigilance a legal requirement.

Dave Fildes, Vice President of Investor Relations: Our earnings guidance incorporates observed order trends to date and assumptions we consider reasonable. However, actual results are inherently unpredictable and may be materially affected by numerous factors, including: fluctuations in foreign exchange rates and energy prices; changes in the global economic and geopolitical environment; tariffs and trade policies; volatility in resources and supply chains (including memory chips); shifts in customer demand and consumer spending (including concerns about recession, inflation, interest rates, and regional labor market constraints); global events; the pace of growth in internet and online commerce; the development of cloud services and emerging technologies; and other factors detailed in our filings with the SEC. Our earnings guidance assumes that we will not complete any additional business acquisitions, restructurings, or legal settlements. Because demand for our products and services cannot be predicted with precision, actual results may differ materially from our guidance. Andy Jassy, Chief Executive Officer: Revenue and Profit Overview This quarter’s revenue totaled $201.9 billion, up 12% year-on-year; operating profit was $28.1 billion, up 61% year-on-year. Q3 marked another strong quarter for Amazon. AWS Business AWS’s strategy is progressing effectively. Despite facing a high year-over-year base due to massive capacity expansion in the prior-year period, AWS achieved a 39.3% year-on-year growth rate—the sixth consecutive quarter of acceleration and the fastest growth in nearly five years. Backlog stood at $578 billion, growing at triple-digit rates year-on-year, with a diversified structure. We install an AI accelerator approximately every 14 seconds—and capacity is essentially fully consumed the moment it comes online. Core compute and storage businesses both posted their fastest revenue growth in recent years. Our core business has sustained high operating margins over the long term, while AI business margins are improving rapidly—progressing far ahead of where core business margins stood at comparable stages of development—even amid rising costs for critical components like memory and substantial depreciation pressure from capital expenditures. We continue to accelerate the payback cycle for capital expenditures and are more confident than ever that our investments in AWS will generate a significantly larger business scale than we envisioned two years ago—delivering higher revenue, free cash flow, and return on invested capital. AWS is building a powerful flywheel effect—echoing Jim Collins’ description in *Good to Great*: Leading capabilities, security, and operational performance drive customers to migrate their applications and data to AWS; customer migration, in turn, fuels AI demand, as customers seek to deploy production inference adjacent to their data and applications; surging AI demand then drives further core AWS demand, as AI relies on core services for reinforcement learning, post-training, and tool invocation; and all of this reinforces our ongoing reinvestment across the full breadth of AWS capabilities. This stands in stark contrast to models centered solely on GPU hosting or short-term data center capacity leasing—it is instead a long-term platform strategy designed to broadly empower customers to innovate and iterate on user experiences, operate reliably, and build durable, multi-year partnerships.

RWE Posts 9-Month Core Earnings Above Expectations on Favourable Conditions

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Germany's largest power producer RWE reported adjusted core earnings of €4.58 billion for the first nine months, exceeding analyst expectations due to favorable wind conditions. The company also confirmed its full-year guidance and dividend target.

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RWE Posts 9-Month Core Earnings Above Expectations on Favourable Conditions

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