If you import or distribute medicines and medical devices in Saudi Arabia, European SMEs are an obvious sourcing option: specialised, certified and often open to local partners. In 2024 the Saudi pharmaceutical market was worth $10.5-12 billion, depending on the source, and the GCC $23.7 billion according to BioNixus. But most of these manufacturers have no Saudi entity and no budget to set one up. Here are the numbers, the rules and the steps that make a European supplier ready to sell to you.
Key points
- The Saudi pharmaceutical market was worth $10.5-12 billion in 2024; the GCC $23.7 billion, forecast at $37 billion by 2030 (market estimates).
- The 40% local-share target was reached in 2025, according to Aljazira Capital: import demand now concentrates on complex products and devices.
- About 90% of medical devices are imported; each needs SFDA authorisation (MDMA) and a Saudi authorised representative.
- Public tenders run through NUPCO and Etimad, with a 10% price preference for national products.
- A European SME can enter step by step: a non-exclusive distributor, one product, shared costs, selected tenders.
A $10bn+ market that imports most of its devices
Estimates of the Saudi pharmaceutical market do not agree. For 2024 Fortune Business Insights gives $10.5 billion, Credence Research $12.04 billion and Ardent Advisory $12.9 billion: sources measure different things, such as sales, spending or modelled revenue. Forecast growth runs from 6% to 9% a year; Aljazira Capital expects 8.9% from 2025 to 2029, reaching about $21 billion.
The device picture is starker. Ardent Advisory reports that in 2023 the Kingdom imported 90% of the devices it uses, mainly from the United States and Europe. GCC pharmaceutical imports reached $15 billion in 2024, with a trade deficit of $12.8 billion, about half of it Saudi.
The Gulf buys almost everything from abroad
Chart data
| Indicatore | Valore |
|---|---|
| GCC pharmaceutical market | 23.7bn $ |
| GCC pharmaceutical imports | 15bn $ |
| Saudi medical devices that are imported | 90% |
The 40% target is met: where demand moves
The Kingdom aimed to raise local pharmaceutical production from 20% to 40% by 2030. Sources do not make clear whether this is an official Vision 2030 indicator or what it measures, so it is best read as an industrial-policy goal. According to Aljazira Capital, local companies' share by value rose from 35% in 2024 to 40% in 2025, five years early. By volume it reached 65%.
Local companies' share of the Saudi pharmaceutical market
% of total market
Chart data
| Voce | By value | By volume |
|---|---|---|
| 2024 | 35% | 58% |
| 2025 | 40% | 65% |
That does not close the door on imports. "Local companies" does not mean "made in the Kingdom", and value stays in complex products: biologics, vaccines, specialty therapies, the focus of the National Biotechnology Strategy launched on 25 January 2024. For devices, local coverage is much lower: Ken Research estimates 16.9% of demand in 2025.
Insulin shows the model. In October 2023 the Ministry of Health announced a preliminary localisation agreement with NUPCO, Sudair Pharmaceuticals and Sanofi, built on public purchasing power and knowledge transfer. Suppliers that bring know-how and production capacity become partners, not just sellers of finished goods. Our Libya briefing shows the same logic in a neighbouring market.
The GCC: six markets, six doors
Saudi Arabia is the largest market, not the only one. According to BioNixus, the UAE was worth about $4.5 billion in 2024, Kuwait $1.9 billion, Qatar $1.6 billion, Oman $1.4 billion and Bahrain $0.9 billion. These are single-vendor estimates, which the source itself calls reference figures rather than audited totals.
GCC: market size and import dependence, 2024
| Country | Pharmaceutical market ($bn) | Import dependence |
|---|---|---|
| Saudi Arabia | about 11 | 70-80% |
| United Arab Emirates | about 4.5 | 80% |
| Kuwait | about 1.9 | 80% |
| Qatar | about 1.6 | 97% |
| Oman | about 1.4 | 95% |
| Bahrain | about 0.9 | 91% |
The sources consulted do not document automatic recognition of a Saudi registration in the other five countries. Treat each market as a separate route.
What a European supplier needs before you can sell its products
For devices, nothing is sold without a Medical Device Marketing Authorization (MDMA) from the SFDA, the Saudi food and drug authority. A CE mark does not replace it: each device needs a separate Saudi approval. The manufacturer also needs an authorised representative, a legal entity based in the Kingdom, appointed in writing and licensed by the SFDA. A Saudi importer or distributor is the natural candidate, but the role is regulated and distinct from commercial distribution.
The MDMA fee runs from SAR 15,000 to 23,000 depending on risk class A to D. The SFDA fee table gives 35 working days for class A, while an industry analysis from February 2025 puts the whole process at three to four months. For medicines, the sources consulted do not allow reliable fees or timelines: ask the SFDA.
Then tenders. NUPCO, the unified healthcare purchaser, selects qualified suppliers, and bids go through Etimad, the Ministry of Finance platform. The local-content regulation gives national products a 10% price preference. No standard payment term appears in the sources: read it in each tender.
How to qualify and onboard a European SME
Start by checking who the manufacturer is, what it makes and which certificates and regulatory files it holds. Verifying an Italian manufacturer before paying a deposit is the first step, and our sourcing guide for Italian device makers shows what to ask for.
Then agree a non-exclusive arrangement with sales targets and exit rules. According to the US International Trade Administration guide, updated on 19 May 2026, the law does not require exclusivity, although Saudi agents prefer it. Ending a relationship can be complicated, and an agent may ask for end-of-term compensation, so have a Saudi lawyer review the contract. Begin with one product: the one with the best margin and the least local competition. Share the costs of research, translation and joint missions with other suppliers, while each manufacturer keeps its own regulated role. Bid only where product, price and stock hold up.
A sourcing partner can act as an independent filter before you sign. That is the work of supplier scouting in the medical devices sector.
Conclusions
The Saudi market is not closed to European SMEs: it has become more selective. Local production has grown and large groups dominate tenders. Room remains in complex products, devices and niches where nobody yet produces locally. Entry is costly for a manufacturer acting alone and manageable with a local partner and a step-by-step plan. Before approaching a supplier, ask what it sells: a product the Kingdom imports today, or a capability it will want to produce tomorrow. Market estimates come from research firms and differ in definition and method: read them as orders of magnitude. Data updated to October 2026.
