Saudi Arabia In-vitro Diagnostics Market Analysis by Mordor Intelligence
The Saudi Arabia in vitro diagnostics market size is estimated at USD 1.05 billion in 2025 and is forecast to reach USD 1.27 billion by 2030, advancing at a 3.86% CAGR during the period. Momentum stems from Vision 2030 reforms that elevate diagnostics from hospital cost centers to revenue-generating services, while the Saudi Genome Program accelerates adoption of molecular platforms. Supply of reagents remains buoyant because routine diabetes and cardio-metabolic screening consume large kit volumes. Point-of-care uptake quickens as 5G-enabled IoMT links rural devices to urban specialists, and stricter SFDA rules reward firms with robust compliance capabilities. Competitive intensity is moderate; multinationals hold strong footprints, yet Lifera and other domestic entrants gain ground under Saudization quotas.
Key Report Takeaways
- By test type, clinical chemistry led with 35.55% share in 2024, whereas molecular diagnostics is projected to post an 8.25% CAGR to 2030, the fastest in its group.
- By product, reagents and kits accounted for 68.53% revenue in 2024, while instruments are expected to register the highest 9.85% CAGR through 2030.
- By usability, disposable devices held 71.63% share in 2024; re-usable systems are forecast to expand at a 6.87% CAGR by 2030.
- By application, infectious disease testing commanded 43.13% of the Saudi Arabia in vitro diagnostics market share in 2024, whereas oncology testing is projected to climb at an 8.7% CAGR to 2030.
- By end user, laboratories represented 48.13% of 2024 revenue, yet home-care and point-of-care settings are poised for a 10.7% CAGR through 2030.
Saudi Arabia In-vitro Diagnostics Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising prevalence of diabetes & cardio-metabolic disorders | +0.8% | Riyadh, Jeddah, Dammam | Medium term (2-4 years) |
| Expansion of private healthcare facilities | +1.2% | Nationwide, early gains in major metros | Long term (≥ 4 years) |
| Adoption surge in point-of-care & home testing | +0.9% | National, rural connectivity emphasis | Short term (≤ 2 years) |
| Mandatory premarital & pre-employment screening | +0.4% | National | Medium term (2-4 years) |
| Saudi Genome Program fuels molecular demand | +0.7% | Research hubs, tertiary centers | Long term (≥ 4 years) |
| 5G-enabled IoMT connecting rural diagnostics | +0.5% | Remote regions | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Rising Prevalence of Diabetes & Cardio-Metabolic Disorders
Saudi Arabia allocates USD 26 billion yearly to diabetes management, translating into high volumes of glucose, HbA1c, and lipid tests across hospitals, pharmacies, and home settings. Continuous glucose monitoring attracts affluent populations seeking proactive care. Worksite wellness programs broaden point-of-care demand, and AI-driven analytics enrich diagnostic value by predicting glycemic excursions. Collectively these factors sustain consumable use and stabilize equipment refresh cycles across the Saudi Arabia in vitro diagnostics market.
Expansion of Private Healthcare Facilities
Vision 2030 aims to transition 290 hospitals and 2,300 primary centers into private management, reshaping revenue models toward fee-for-service diagnostics. Health clusters managed by the new Holding Company treat laboratories as profit centers, prompting procurement of high-throughput analyzers. At NEOM, an entirely digital hospital ecosystem illustrates end-to-end diagnostic integration and AI triage. International vendors partner with Saudi investors to localize assembly lines and satisfy Saudization quotas, reinforcing domestic capacity without diluting global quality standards.
Adoption Surge in Point-of-Care & Home Testing
King Faisal Specialist Hospital’s Virtual Care Centre monitored 180,000 patients in 2023, a ten-fold rise over 2021, proving scale for remote diagnostics. Pharmacies now deploy CLIA-waived blood glucose and lipid devices, while smartphone-based readers turn lateral-flow kits into connected platforms. SFDA accelerates approvals of low-risk devices, shortening market entry. Rural clinics linked through 5G networks transmit results instantly, enabling specialists to intervene sooner. These shifts democratize access and cement demand across the Saudi Arabia in vitro diagnostics market.
Mandatory Premarital & Pre-Employment Screening Programs
Legally required screens for hemoglobinopathies, infectious diseases, and drug use channel steady test volumes into both public and private labs. Disposable sample-collection kits dominate because single-use workflows mitigate contamination. Annual graduate intake from accredited lab programs still lags demand, urging automation to offset workforce gaps. Private employers increasingly contract central reference labs to process expansion-site samples, elevating throughput needs for high-capacity analyzers.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Limited reimbursement for advanced assays | -0.6% | Nationwide, private payors | Medium term (2-4 years) |
| Stringent SFDA approval timelines | -0.4% | National | Short term (≤ 2 years) |
| Skilled-lab workforce shortages | -0.7% | Nationwide, technical roles | Long term (≥ 4 years) |
| Geopolitical & cold-chain supply risks | -0.3% | Import-dependent segments | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
Limited Reimbursement for Advanced Assays
Private insurers reimburse basic panels at higher ratios than next-generation sequencing, discouraging rapid uptake of costly molecular tests. Hospitals navigating fee-for-service models hesitate to absorb uncovered expenses, slowing oncology companion-diagnostic diffusion. Negotiated volume discounts partially offset costs but squeeze smaller laboratories. Until coverage broadens, high-complexity testing remains concentrated in academic centers, tempering broader Saudi Arabia in vitro diagnostics market penetration.
Stringent SFDA Approval Timelines
SFDA’s alignment with EU MDR elevates documentation burdens, and medical device approvals average 35 working days even for well-prepared applicants. Firms lacking local regulatory teams encounter longer cycles, postponing revenue realization. Although the framework promotes safety and counters counterfeit imports, it can delay rollouts of incremental instrument upgrades. Established multinationals with ISO 13485 facilities navigate the pathway more smoothly, reinforcing incumbency advantages yet challenging newcomers.
Segment Analysis
By Test Type: Molecular Diagnostics Spurs Innovation
Clinical chemistry retained 35.55% of the Saudi Arabia in vitro diagnostics market share in 2024, reflecting sustained diabetes and lipid testing volumes. Molecular diagnostics, propelled by the Saudi Genome Program’s 100,000 whole-genome sequences, is forecast to log an 8.25% CAGR to 2030, elevating the Saudi Arabia in vitro diagnostics market size for advanced assays. Immunoassays benefit from expanded autoimmune and infectious disease profiling, while hematology tests anchor routine inpatient panels.
Investment in next-generation sequencers at King Faisal Specialist Hospital underpins personalized oncology care and pharmacogenomics. AI-enabled workflows shorten analysis times, and localized variant databases improve diagnostic accuracy for Saudi populations. As genomic literacy rises among clinicians, adoption of companion diagnostics for targeted therapies accelerates, reshaping laboratory menus across tertiary centers.
Note: Segment shares of all individual segments available upon report purchase
By Product: Instruments Record Fastest Upside
Reagents and kits comprised 68.53% of 2024 revenue, underpinned by recurring purchases for chronic disease monitoring. Instruments are projected to deliver a 9.85% CAGR through 2030, expanding the Saudi Arabia in vitro diagnostics market size for capital equipment across new hospital builds. Automation systems that integrate pre- and post-analytics attract labs grappling with workforce shortages.
Flagship projects, such as the 23-story oncology and liver center at KFSHRC, require consolidated analyzers capable of processing diverse test panels[1]King Faisal Specialist Hospital & Research Centre, “KFSHRC Recognized Among the World's Best Smart Hospitals for 2025,” kfshrc.edu.sa. Domestic distributors broaden service footprints to guarantee uptime, and cold-chain expansions safeguard reagent integrity, further enhancing instrument utilization rates.
By Usability: Disposables Prevail
Disposable devices captured 71.63% share in 2024 as infection-control priorities intensified post-COVID-19. Re-usable systems, however, are estimated to post a 6.87% CAGR through 2030, aided by sustainability mandates in private clusters. High-volume labs at King Saud University Medical City process 4,000 tubes daily, favoring pre-barcoded, single-use consumables that streamline traceability.
In remote clinics, handheld lateral-flow readers pair with disposable strips, delivering results within minutes. The hybrid model of disposable sample collection coupled with reusable digital readers gains momentum, reinforcing demand diversity within the Saudi Arabia in vitro diagnostics market.
By Application: Oncology Outpaces
Infectious disease testing maintained 43.13% of 2024 revenue, leveraging infrastructure built during the pandemic. Oncology assays, especially companion diagnostics for precision therapies, are set to rise at an 8.7% CAGR, enlarging the Saudi Arabia in vitro diagnostics market share for cancer applications.
KFSHRC’s production of radiopharmaceuticals such as Gallium-68 DOTATATE supports theranostic workflows, blending imaging with biomarker detection. Cardiometabolic panels remain essential in screening programs targeting a 29.13% cardiovascular mortality burden, while specialized toxicology tests expand in industrial zones of the Eastern Province.
Note: Segment shares of all individual segments available upon report purchase
By End User: Home-Care Rises Fastest
Laboratories generated 48.13% of 2024 revenue through a network led by Al Borg Diagnostics and Alfa Laboratory. Home-care and point-of-care venues are slated for a 10.7% CAGR, reflecting consumer demand for convenience and connectivity. Hospitals continue upgrading central labs into profit centers under the Holding Company model, while research institutes order specialty tests that align with the National Biotechnology Strategy.
Pharmacies emerge as decentralized hubs offering CLIA-waived services, and mobile phlebotomy startups collect samples door-to-door for elderly patients. These shifts diversify revenue streams across the Saudi Arabia in vitro diagnostics market.
Geography Analysis
Riyadh anchors demand with flagship institutions such as King Faisal Specialist Hospital, which logs 40,000 annual inpatient admissions and sustains complex test menus. Jeddah’s 537-bed KFSHRC facility amplifies western-region delivery, while the Eastern Province links diagnostics to petrochemical workforce health needs. Together, these metros generate the lion’s share of the Saudi Arabia in vitro diagnostics market size.
Remote areas housing 16% of the population lean on 5G-connected devices that forward data to central labs for confirmation, mitigating service gaps. NEOM showcases a digital blueprint that could replicate in secondary cities, decentralizing advanced testing. National reference networks ship cold-chain specimens overnight to Riyadh, and improved logistics trim turnaround times, encouraging clinicians nationwide to order broader panels.
Competitive Landscape
Market concentration is moderate; Abbott, Roche, and Siemens retain broad portfolios and service organizations. Al Borg Diagnostics capitalizes on 70-plus branches, and Lifera leverages sovereign investment to build local biomanufacturing. Saudization policies mandating 35-65% local staff compel multinationals to expand training academies, narrowing workforce deficits and aligning with localization goals.
Technology integration marks a key differentiator. KFSHRC achieved HIMSS Stage 7 analytics maturity and ranks among the world’s top 15 smart hospitals. Partnerships such as KFSHRC-Germfree modular ATMP manufacturing underscore convergence between diagnostics and advanced therapeutics. Vendors that bundle analyzers, reagents, and digital dashboards gain stickiness, while agile domestic players target niche molecular panels tailored to Saudi genomic variants.
Regulation simultaneously screens entrants and shields incumbents. ISO 13485-aligned factories, on-ground service hubs, and Arabic-language labeling speed approvals under the SFDA’s 35-day pathway[2]SGS Saudi Arabia, “Guide to Medical Devices Registration in Saudi Arabia 2024,” sgs.com. Firms that harmonize with EU MDR expedite dossier preparation, further stabilizing market positions within the Saudi Arabia in vitro diagnostics market.
Saudi Arabia In-vitro Diagnostics Industry Leaders
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Abbott Laboratories
-
Siemens Healthineers
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F. Hoffmann-La Roche Ltd
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Thermo Fisher Scientific
-
Danaher (Cepheid & Beckman Coulter)
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- September 2025: The SFDA cleared a blood-based pTau181 test that supports early Alzheimer’s detection, signaling regulator openness to novel protein biomarkers.
- September 2025: OmniPathology partnered with Delta Medical Laboratories to market an HPV swab test across Saudi Arabia, expanding molecular screening options.
Saudi Arabia In-vitro Diagnostics Market Report Scope
As per the scope of this report, in-vitro diagnostics refers to medical tests and procedures that analyze samples of tissues, blood, urine, and other bodily fluids to diagnose diseases, infections, or other medical conditions. These tests are performed outside the body in a laboratory setting, with the sample taken from the patient being analyzed in a controlled environment. The Saudi Arabia In-vitro Diagnostics Market is Segmented by Test Type (Clinical Chemistry, Molecular Diagnostics, Immuno Diagnostics, Haematology, and Other Types), Product (Instrument, Reagent, Other Product), Usability ( Disposable IVD Device and Reusable IVD Device), Application (Infectious Disease, Diabetes, Cancer/Oncology, Cardiology, and Other Applications), and End-User (Diagnostic Laboratories, Hospitals and Clinics, and Other End-users). The report offers the value (in USD) for the above segments.
| Clinical Chemistry |
| Molecular Diagnostics |
| Immuno-Diagnostics |
| Hematology |
| Other Types |
| Instruments |
| Reagents & Kits |
| Disposable IVD Devices |
| Re-usable IVD Devices |
| Infectious Disease |
| Diabetes |
| Oncology |
| Cardiology |
| Other Applications |
| Diagnostic Laboratories |
| Hospitals & Clinics |
| Home-Care & POC Settings |
| Other End-Users |
| By Test Type | Clinical Chemistry |
| Molecular Diagnostics | |
| Immuno-Diagnostics | |
| Hematology | |
| Other Types | |
| By Product | Instruments |
| Reagents & Kits | |
| By Usability | Disposable IVD Devices |
| Re-usable IVD Devices | |
| By Application | Infectious Disease |
| Diabetes | |
| Oncology | |
| Cardiology | |
| Other Applications | |
| By End-User | Diagnostic Laboratories |
| Hospitals & Clinics | |
| Home-Care & POC Settings | |
| Other End-Users |
Key Questions Answered in the Report
What is the projected value of the Saudi Arabia in vitro diagnostics market by 2030?
The market is forecast to reach USD 1.27 billion by 2030.
Which test type is growing fastest in Saudi laboratories?
Molecular diagnostics is expected to record an 8.25% CAGR through 2030.
Why are disposable IVD devices dominant in Saudi Arabia?
Infection-control protocols and high-volume screening programs favor single-use platforms that reduce cross-contamination.
How does Vision 2030 impact diagnostic services?
Privatization reforms treat labs as profit centers, spurring investment in high-throughput analyzers and advanced assays.
Which end-user segment is expanding quickest?
Home-care and point-of-care settings are poised for a 10.7% CAGR due to 5G-enabled connectivity.
What regulatory framework governs IVD approvals?
The SFDA applies EU MDR-aligned rules, with average device approvals finalized in about 35 working days.
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