Rockville, Maryland, United States – September 8, 2026 – The U.S. Centers for Medicare & Medicaid Services selected 15 high-cost Medicare Part B and Part D drugs for the third cycle of its Medicare Drug Price Negotiation Program in January 2026, with the selected medicines accounting for about USD 27 billion in Medicare spending between November 2024 and October 2025. The development reinforces the need for pharmaceutical companies to prepare evidence on clinical outcomes, economic value, and budget impact before pricing and reimbursement discussions.

According to Fact.MR, the global health economics and outcomes research services market is valued at USD 2.8 billion in 2026 and is projected to reach USD 7.9 billion by 2036, expanding at a 10.9% CAGR. The market was valued at USD 2.5 billion in 2025, creating an estimated absolute opportunity of USD 5.1 billion between 2026 and 2036.

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Why HEOR Is Moving Earlier in Drug Development

Health economics and outcomes research is increasingly being planned alongside clinical development rather than after regulatory approval.

Pharmaceutical sponsors need evidence that explains not only whether a therapy works, but how its outcomes compare with existing treatment pathways and what those outcomes mean for healthcare budgets.

This becomes particularly important as payers and health technology assessment bodies evaluate therapies using comparative effectiveness, cost-effectiveness, quality-of-life outcomes, budget impact, and real-world evidence.

The Organisation for Economic Co-operation and Development reported that OECD countries spent 9.3% of GDP on health in 2024, keeping affordability and value-for-money considerations central to healthcare planning.

For sponsors, the commercial consequence is straightforward: economic evidence must often be designed before pivotal trials finish because changing endpoints or data-collection strategies late in development can create additional cost and delay.

Health Economics Studies Hold the Largest Service Share

Health Economics Studies are projected to account for 39.0% of the market in 2026, making them the leading service offering.

These studies provide the economic evidence needed to compare treatments, estimate healthcare resource utilization, assess costs, and support reimbursement decisions.

Cost-effectiveness modeling and budget-impact analysis are particularly important when payers must determine whether a new therapy provides sufficient value relative to established alternatives.

The market is therefore shifting toward evidence packages that connect clinical endpoints with payer-specific economic consequences.

“HEOR must be planned alongside clinical development when a sponsor expects payer scrutiny at launch,” said Shambhu Nath Jha, Sr. Consultant at Fact.MR. “Evidence packages that connect trial endpoints, real-world outcomes and budget impact to a specific reimbursement setting are more useful than generic value claims.”

Cost-effectiveness Analysis Leads Application Demand

Cost-effectiveness Analysis is projected to represent 36.0% of application demand in 2026, the largest application category.

Cost-effectiveness analysis allows payers and healthcare organizations to compare treatment outcomes against the costs associated with competing interventions.

The approach becomes especially relevant when new therapies command premium prices or address conditions where multiple treatment pathways are available.

For service providers, this creates demand for models that can be adapted to different countries. A model built for one reimbursement environment may require changes to drug prices, healthcare resource utilization, comparators, treatment pathways, discounting assumptions, and local epidemiology before it can support another country's submission.

Pharmaceutical Companies Remain the Largest Buyers

Pharmaceutical companies are expected to account for 41.0% of the market in 2026, the largest end-user share.

Drug developers have to build evidence packages across multiple stages, from early clinical development and payer engagement to launch planning and post-marketing evidence generation.

The increasing importance of real-world evidence adds another layer. Once a therapy enters routine care, observational data can help sponsors evaluate treatment patterns, outcomes, resource utilization, adherence, and comparative effectiveness.

The European Medicines Agency recommended 104 medicines for marketing authorisation in 2025, including 38 with new active substances, creating an ongoing pipeline of products that require market-access and reimbursement evidence after regulatory review.

Project-Based Services Dominate Delivery

Project-based services are projected to capture 48.0% of the market in 2026.

HEOR requirements frequently correspond to specific development or reimbursement milestones. Sponsors may commission a cost-effectiveness model, systematic literature review, budget-impact assessment, patient-reported outcomes study, or market-access dossier for a defined product and geography.

This delivery structure allows pharmaceutical companies to access specialist expertise without maintaining every HEOR capability internally.

It also increases competition among service providers. Buyers can compare vendors based on therapeutic-area expertise, methodological depth, country knowledge, evidence quality, turnaround time, and ability to work alongside market-access teams.

Decision Analytic Modeling Leads Research Methodology

Decision Analytic Modeling is forecast to account for 44.0% of the market in 2026, making it the leading research methodology.

Decision models can connect clinical outcomes, treatment pathways, healthcare resource use, costs, and longer-term consequences.

Markov models and discrete-event simulations can be used to represent disease progression and alternative treatment pathways, while sensitivity analysis helps assess how changes in assumptions affect economic conclusions.

The quality of the underlying evidence remains critical. Payers can challenge models when assumptions are insufficiently transparent or when comparative inputs are weak.

This makes model transparency and documentation important procurement criteria for pharmaceutical sponsors.

Real-World Evidence Creates the Next Growth Layer

Real-world evidence is becoming an increasingly important component of HEOR programs.

Clinical trials operate under controlled conditions, while routine-care data can reveal how treatments perform across broader patient populations and healthcare settings.

Claims databases, patient registries, electronic health records, and patient-reported outcomes can contribute to post-marketing outcomes research and comparative effectiveness studies.

Fact.MR identifies AI-assisted evidence synthesis, local payer dossier adaptation, RWE model updates, and integrated market-access support as important areas of opportunity.

AI-assisted literature screening can shorten evidence-review cycles, but human methodological oversight remains essential when study eligibility, bias assessment, model assumptions, and evidence interpretation affect payer submissions.

United States Leads Country Growth

The United States is projected to expand at an 11.8% CAGR from 2026 to 2036, the fastest growth rate among the countries profiled by Fact.MR.

The country's large payer ecosystem and increasing focus on drug affordability create substantial demand for economic evidence.

Germany follows at 11.4% CAGR, while the United Kingdom is projected to grow at 10.9%. Canada is forecast at 10.5%, France at 10.0%, Japan at 9.6%, and Australia at 9.2% through 2036.

Comparable growth rates mask different operating requirements. Payer structures, HTA procedures, evidence standards, pricing systems, and healthcare-resource costs differ across countries, requiring sponsors to localize evidence rather than simply translate a global model.

Competitive Landscape

Key companies identified by Fact.MR include IQVIA Holdings Inc., ICON plc, Syneos Health, Parexel International Corporation, Cytel Inc., RTI Health Solutions, Oracle Corporation (Oracle Life Sciences), Costello Medical, and Axtria Inc.

Competition is primarily service-led. Providers differentiate through health-economic modeling, real-world evidence capabilities, market-access expertise, patient-centered outcomes research, therapeutic-area knowledge, and geographic coverage.

The strongest providers can connect clinical evidence with payer requirements instead of treating HEOR as an isolated analytical function.

For pharmaceutical companies, this integration can reduce duplication between clinical development, evidence generation, pricing, and market-access teams.

Health Economics and Outcomes Research Services Market Snapshot

2025 market value: USD 2.5 billion
2026 market value: USD 2.8 billion
2036 projected value: USD 7.9 billion
CAGR, 2026–2036: 10.9%
Absolute opportunity: USD 5.1 billion
Leading service offering: Health Economics Studies, 39.0%
Leading application: Cost-effectiveness Analysis, 36.0%
Leading end user: Pharmaceutical Companies, 41.0%
Leading delivery model: Project-based Services, 48.0%
Leading methodology: Decision Analytic Modeling, 44.0%
Fastest-growing profiled country: United States, 11.8% CAGR
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Report Scope and Methodology

The Fact.MR study evaluates the health economics and outcomes research services market across service offering, application, end user, delivery model, research methodology, and region.

Service offerings include Health Economics Studies, Real-world Evidence Services, Market Access Services, and Patient-reported Outcomes Services.

Applications include Cost-effectiveness Analysis, Post-marketing Outcomes Research, Value Demonstration, and Clinical Outcomes Assessment. End users include pharmaceutical companies, contract research organizations, government agencies, and hospitals.

Delivery models cover project-based services, outsourced research services, strategic advisory services, and digital research platforms. Research methodologies include decision analytic modeling, observational study analytics, health technology assessment frameworks, and patient-centered outcomes research.

Fact.MR combines market assessment with payer, regulatory, healthcare-system, company, and industry evidence to evaluate demand across the forecast period and country-level reimbursement environments.

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About Fact.MR

Fact.MR is an initiative of Eminent Research and Advisory Services, providing market intelligence and syndicated research across healthcare, food and beverage, consumer goods, technology, industrial goods, and other sectors. The company operates from offices in Rockville, Maryland, United States, and Dublin, Ireland.

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Disclosure

This release is based on Fact.MR syndicated research. Market figures represent estimates and forecasts available as of the publication date and may be revised as additional information becomes available.