As 2025 draws to a close, Saudi Arabia’s market access landscape looks very different from just a few years ago. What used to be driven mainly by external reference pricing and tendering is rapidly evolving into a value-based, evidence-led environment aligned with Vision 2030 and the Health Sector Transformation Program.
For pharma, biotech, and medtech companies, the Kingdom is no longer a “nice-to-have” MENA launch market – it’s becoming a strategic test bed for value-based access models.
Below is a practical wrap-up of 2025 and what to expect in 2026.
1. 2025 in Review: A Pivotal Year for Market Access
Three shifts defined 2025 in Saudi Arabia:
- Economic Evaluation Studies (EES) move from “optional” to “obligatory”
- The Saudi Food & Drug Authority (SFDA) published detailed Economic Evaluation Studies (EES) guidelines to standardise how value is assessed for medicines.
- Updated guidance makes EES mandatory for all human pharmaceuticals undergoing new registration, price re-evaluation, or price renewal from 1 July 2025.
- This anchors a formal move towards value-based pricing and reimbursement, beyond pure external reference pricing.
- NUPCO’s role as value-focused gatekeeper strengthens
- The National Unified Procurement Company (NUPCO) remains the exclusive centralised purchaser for public-sector pharmaceuticals and devices.
- Procurement is increasingly built around unified tenders, framework agreements, and strategic purchasing to drive savings and standardisation.
- In 2024, NUPCO piloted value-based purchasing tenders for medical devices – the first of their kind in the region – signalling a shift from price-only to outcome-linked contracts.
- HTA and value-based healthcare become structural, not just conceptual
- Under Vision 2030, Saudi Arabia has committed to moving from volume to value-based healthcare, requiring formal health technology assessment (HTA) capacity.
- A central HTA framework is being set up under the Ministry of Health to inform pricing, reimbursement, and adoption decisions.
Add to this the broader push to localise manufacturing and strengthen domestic pharma and biologics production, and you have a market that is larger, more strategic, and more demanding.
2. What Changed for 2025 Launches – On the Ground
For companies launching or managing portfolios in 2025, several practical implications showed up:
- HEOR & RWE became front-loaded
- EES requirements meant that health economics and outcomes research (HEOR) can no longer be an afterthought; local adaptations of cost-effectiveness and budget impact models are now a prerequisite for SFDA pricing files.
- Pricing & Market Access (P&MA) moved closer to clinical and medical affairs
- Because EES demands robust clinical and economic evidence, cross-functional coordination (medical, regulatory, HEOR, market access) had to start months earlier than before.
- Stakeholder mapping grew more complex
- Success now depends on understanding the roles and expectations of:
- SFDA – registration, pricing, and economic evaluation
- NUPCO – central procurement, unified and value-based tenders
- Council of Health Insurance (CHI) – benefit design and reimbursement in the private sector
- Emerging HTA structures – evidence-based recommendations feeding into these decisions
- Success now depends on understanding the roles and expectations of:
- Formularies became more sophisticated
- In parallel with long-standing national and institutional formularies, CHI has been developing a national value-based insurance drug formulary to standardise private-sector coverage and promote equity.
In short: 2025 was the year where “price” stopped being enough – evidence of value became the currency.
3. 5 Trends to Watch in 2026
Looking ahead to 2026, several trends are likely to shape the next phase of market access in Saudi Arabia.
- More rigorous EES and HTA expectations
- With EES mandatory from mid-2025, 2026 will be the first full year where all significant launches are assessed under the new framework.
- Expect: more scrutiny of model structure, assumptions, and comparators; stronger preference for Saudi-specific inputs, including epidemiology, costs, and practice patterns; increasing alignment between SFDA economic evaluations and the emerging national HTA processes
- Expansion of value-based and risk-sharing agreements
- Building on NUPCO’s pilot value-based device tenders and its centralised procurement power:
- Expect more: outcome-based contracts (e.g., pay-for-performance, “no-cure-no-pay” concepts) for high-cost specialties; framework agreements with performance guarantees and volume/price corridors; linking tender awards not just to price, but to clinical outcomes and total cost of care
- For companies, this means being ready with measurable outcomes, data-collection plans, and contractual flexibility.
- Convergence of public and private access standards
- CHI’s value-based formulary for the private sector aims to align coverage with evidence-based, equitable access.
- As HTA structures mature, recommendations are likely to influence both: public-sector procurement (NUPCO, MOH & other government providers); private payers regulated by CHI
- This will gradually reduce fragmentation and make HTA outcomes the common denominator across sectors.
- Data, digital, and AI as enablers of value
- Vision 2030’s digital health agenda, the NPHIES platform, and growing investments in AI are setting the stage for: richer real-world data for monitoring outcomes and utilisation; advanced analytics for cost drivers, adherence, and pathway optimisation; improved ability to operationalise value-based contracts with real metrics
- Market access teams should anticipate more requests for data sharing, dashboards, and RWE collaboration to support pricing and reimbursement discussions.
- Localisation as a core access lever
- Government strategies explicitly promote domestic manufacturing, technology transfer, and local value creation in pharma and biopharma.
- Over 2026, localisation is likely to become: a differentiator in tenders and pricing negotiations; a factor in long-term partnership decisions (e.g., local fill-finish, packaging, secondary manufacturing, or R&D hubs)
- Access strategy in KSA is increasingly tied to industrial strategy – not just clinical value.
4. Practical To-Do List for Market Access Teams in 2026
To be competitive in this evolving landscape, organisations can focus on the following:
- Upgrade HEOR & EES capabilities
- Design access strategies “from value backwards”
- Prepare for value-based agreements
- Strengthen local partnerships
- Invest in internal education on KSA specifics
5. Final Thought: Saudi Arabia as a Regional Access Blueprint
Saudi Arabia is no longer simply the largest GCC market; it is becoming a reference model for structured, value-based market access in the region.
For organisations willing to adapt – by investing in evidence, outcomes, and genuine partnership – 2026 offers an opportunity to:
- Shape how value is defined and rewarded
- Build sustainable access models
- Position the Kingdom as a launchpad for innovative therapies across MENA
The bar is rising. But so is the opportunity.