Vietnam's expanding diagnostic laboratory sector is creating new opportunities for In Vitro Diagnostics Quality Control as healthcare providers place greater emphasis on accuracy, standardisation and reliability across clinical testing.
While there is currently no independently published Vietnam-specific valuation for the overall IVD Quality Control Market, analysis of regional market data and Vietnam's developing diagnostics sector indicates that the market could be worth approximately US$2–4 million in 2025, potentially reaching US$3–6 million by 2030.
IVD quality control is a comparatively small but essential part of the diagnostic laboratory ecosystem. Quality-control materials and systems allow laboratories to verify that instruments, reagents and testing processes are performing correctly, helping ensure that patient results are accurate and reproducible.
The market encompasses technologies and services including:
- Quality control materials
- Serum and plasma-based controls
- Whole-blood controls
- Urine-based controls
- Independent third-party controls
- Instrument-specific controls
- Quality assurance services
- QC data-management software
- External quality assessment
- Laboratory performance monitoring
Quality controls are used across virtually every major area of laboratory medicine, including clinical chemistry, immunoassays, molecular diagnostics, haematology, microbiology, coagulation and point-of-care testing.
Laboratory standardisation drives demand
One of the most important drivers is the increasing emphasis on laboratory quality and accreditation.
As laboratories adopt international standards such as ISO 15189, they require increasingly robust processes for monitoring test performance, documenting quality and identifying potential errors before patient results are released.
MarketsandMarkets identifies the increasing number of accredited clinical laboratories and demand for external quality-assessment programmes as major drivers of the international IVD QC market.
This trend is particularly relevant for developing diagnostic markets such as Vietnam, where investment in laboratory modernisation is increasing alongside the expansion of hospital and independent diagnostic services.
Third-party quality controls gain importance
Another significant development is the growth of independent third-party controls.
Unlike controls supplied specifically for an individual manufacturer's instrument or reagent, third-party controls can provide laboratories with an independent assessment of test-system performance.
MarketsandMarkets reports that third-party controls represented the largest manufacturer-type segment of the global IVD QC market in 2024, supported by their compatibility across different platforms, independence from instrument manufacturers and usefulness for accreditation and regulatory compliance.
For increasingly sophisticated Vietnamese laboratories operating equipment from multiple international manufacturers, these capabilities could become particularly valuable.
Molecular diagnostics increases QC complexity
The expansion of molecular diagnostics is also creating new quality-control requirements.
PCR and other molecular tests can provide extremely sensitive detection of infectious diseases, genetic abnormalities and cancer biomarkers. That sensitivity makes rigorous quality control particularly important, as small variations in samples, reagents or laboratory processes can potentially affect results.
MarketsandMarkets expects molecular diagnostics to be among the important growth areas within IVD quality control through 2030.
Vietnam's increasing adoption of molecular diagnostics, genomics and precision medicine therefore creates an expanding requirement for controls capable of validating these increasingly complex tests.
Automation and data management transform quality assurance
Quality control is also becoming more digital.
Modern QC software allows laboratories to collect results automatically, identify trends, monitor performance across multiple instruments and sites, and flag potential problems before they affect clinical results.
This is becoming increasingly important as large laboratories move towards automation, connected analysers and laboratory information systems.
Rather than quality control being a manual process performed independently on each instrument, laboratories are moving towards integrated quality-management environments incorporating instruments, controls, data analytics and laboratory software.
Point-of-care diagnostics create new requirements
The rapid development of point-of-care testing presents another opportunity.
Diagnostic testing is increasingly moving beyond central laboratories into emergency departments, clinics and other patient-care environments. Blood glucose testing, infectious disease testing, cardiac biomarkers and other assays can now be performed close to the patient.
However, decentralising testing also increases the challenge of ensuring consistent quality across potentially hundreds of devices and operators.
MarketsandMarkets identifies increasing adoption of point-of-care instruments as another factor supporting demand for robust quality-control solutions.
Global market to exceed US$2 billion
The wider international market demonstrates the growing importance of diagnostic quality assurance.
MarketsandMarkets estimates that the global IVD Quality Control Market will grow from US$1.65 billion in 2025 to US$2.15 billion by 2030, representing annual growth of 5.5%.
Grand View Research separately estimates that the Asia-Pacific market will reach US$320.5 million by 2030, compared with US$247.0 million in 2023.
For emerging Asia-Pacific markets, laboratory infrastructure development, increasing healthcare expenditure and the adoption of international quality standards are supporting continued demand for diagnostic quality assurance.
For Vietnam, the commercial opportunity extends across QC materials, molecular controls, third-party controls, laboratory software, proficiency testing, external quality assessment and specialist laboratory quality services.
As Vietnam's diagnostic infrastructure becomes increasingly sophisticated, ensuring the accuracy, consistency and reliability of laboratory results will become just as important as expanding testing capacity itself.
For IVD manufacturers, laboratory technology companies, quality-control specialists and diagnostic service providers, Vietnam therefore represents a relatively small today but strategically important market within the country's rapidly developing laboratory and diagnostics ecosystem.