HIV Or HB Or HCV Test Kits Market to hit USD$ 8842.48 million by 2031: Infectious Disease Testing Globally | Biopanda Reagents Ltd; Nanjing Synthgene Medical Technology Co., Ltd.; AccuBioTech Co., Ltd.; BioMérieux SA; QIAGEN

HIV/HBV/HCV Test Kits Market size was valued at USD 5722.49 million in 2022, and it is projected to reach USD 8842.48 million by the end of 2031, expected to grow at a CAGR of 5.7% during the forecasting period (2025-2031).

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United States: Recent Industry Developments

✅ November 2025: Abbott Laboratories launched a rapid multiplex test kit capable of simultaneously detecting HIV, HBV, and HCV with enhanced accuracy.

✅ October 2025: Quest Diagnostics expanded point-of-care testing services utilizing next-gen viral load test kits for early infection detection.

✅ September 2025: FDA approved new home-testing kits for HIV and Hepatitis B/C to improve accessibility and early diagnosis.

Japan: Recent Industry Developments

✅ November 2025: Fujirebio introduced advanced immunoassay kits with improved sensitivity for HBV and HCV detection in clinical settings.

✅ October 2025: Sysmex Corporation expanded its portfolio with integrated molecular diagnostic kits targeting co-infections of HIV and hepatitis viruses.

✅ September 2025: Japanese research institutions developed AI-assisted platforms to enhance interpretation accuracy of viral test results.

GCC: Recent Industry Developments

✅ November 2025: GCC health ministries launched regional screening programs using rapid HIV/HBV/HCV test kits to combat infectious diseases.

✅ October 2025: Local manufacturers partnered with global diagnostic firms to increase availability of affordable test kits across the Gulf.

✅ September 2025: UAE invested in healthcare infrastructure upgrades, integrating next-gen viral test technologies in public hospitals.

List of Top Key Player:

F. Hoffmann-La Roche Ltd; Bio-Rad Laboratories Inc.; Abbott Laboratories; Meridian Bioscience, Inc.; Biopanda Reagents Ltd; Nanjing Synthgene Medical Technology Co., Ltd.; AccuBioTech Co., Ltd.; BioMérieux SA; QIAGEN; Hologic Inc; and Creative Diagnostics.

Industry Developments:

1. Rapid diagnostic tests (RDTs) remain the largest segment due to ease of use and low cost, while molecular tests (PCR/NAAT) are gaining share because of higher sensitivity, especially for early infection and treatment monitoring.​

Key technology and product developments

1. Multiplex and bundled panels: WHO prequalified the first bundled set of three rapid diagnostic tests able to simultaneously detect HIV, HBV and syphilis for antenatal care, marketed as the Determine Antenatal Care Panel, marking a milestone for integrated maternal screening and "triple elimination" efforts.​

2. Point‐of‐care HCV RNA: The FDA granted marketing authorization to Cepheid's Xpert HCV test on the GeneXpert Xpress platform, the first point‐of‐care HCV RNA test usable in CLIA‐waived settings, enabling diagnosis and linkage to treatment in a single visit using fingerstick samples.​

3. Molecular and viral‐load tests: New and next‐generation quantitative HCV viral‐load assays (e.g., from Roche) have been cleared/approved to support treatment response monitoring in chronic HCV.​

WHO and guideline‐driven integration

1. WHO's Global HIV, Hepatitis and STIs Programme continues to emphasize integrated testing, with updated materials and a 2025 hepatitis programme overview linking HBV/HCV testing expansion to elimination goals.​

2. A WHO self‐testing implementation toolkit published in early 2025 provides operational guidance for HIV and HCV (plus syphilis) self‐testing, supporting scale‐up of lay‐user kits and decentralized models.​

Emerging themes: access, POC and procurement

1. Point‐of‐care and self‐testing: Market analyses highlight point‐of‐care RDTs and self‐tests as critical for reaching high‐risk and marginalized populations, cutting time to diagnosis and reducing reliance on central labs.​

2. Public tenders and integrated panels: Government procurements, such as a 2025 state tender in India for rapid HIV/syphilis/HBV/HCV kits, illustrate how buyers are moving toward multi‐analyte panels to support broad screening in public health programmes

Forecast Projection:

The Global HIV/HBV/HCV Test Kits Market is poised for significant growth between 2025 and 2031. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.

Market Intelligence Research Process:

The HIV/HBV/HCV Test Kits Market research report by DataM Intelligence combines primary and secondary data to deliver deep, actionable insights. It examines the full spectrum of factors shaping the industry, from government regulations and market conditions to competitive dynamics, historical trends, technological breakthroughs, upcoming innovations, and potential challenges. This comprehensive analysis not only highlights growth prospects but also identifies barriers, equipping businesses to navigate market volatility and capitalize on emerging opportunities.

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Key Segmentation:

By Test Type: (Rapid Test Kits, Assay Based Test Kits)

By Sample Type: (Saliva, Blood, Urine)

By End-User: (Hospitals, Diagnostic Laboratories, Clinics, Government Organizations and NGO's, Others)

Growth Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Key regulatory approvals (HIV / HBV / HCV diagnostics)
HIV diagnostics:

✅ The FDA approved the INSTI HIV Self Test via PMA in October 2025, authorizing a single‐use rapid self‐test for HIV‐1 antibodies that can be distributed for lay use in non‐laboratory settings.​

✅ FDA's 2025 biological device approvals list also includes updated HIV combo assays (antigen/antibody and NAT) for diagnosis and viral‐load monitoring on automated analyzers, reinforcing lab‐based testing capacity.​

HCV diagnostics:

✅ On 26 June 2024 (driving implementation through 2025), the FDA permitted marketing of Cepheid's Xpert HCV RNA test on the GeneXpert Xpress platform, the first HCV RNA assay authorized for use in CLIA‐waived point‐of‐care settings with fingerstick blood and ~1‐hour turnaround.​

✅ National policy updates, such as Australia's 2025 National Hepatitis C Testing Policy, explicitly recognize and approve point‐of‐care HCV antibody and RNA tests under the TGA, encouraging wider decentralized use.​

Integrated/other approvals:

✅ On 10 July 2025, WHO prequalified the first bundled set of three HIV/hepatitis B/syphilis rapid diagnostic tests for antenatal care (Determine Antenatal Care Panel), supporting integrated triple‐elimination strategies.

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Point‐of‐care molecular HCV tests authorized/used in 2025

Cepheid Xpert HCV RNA (GeneXpert Xpress):

✅ FDA marketing authorization with CLIA waiver enables use in substance‐use clinics, correctional facilities, syringe‐service programs, EDs, urgent care, and doctor's offices, supporting "test‐and‐treat in one visit" models.​

✅ The assay detects all major HCV genotypes from fingerstick blood in about an hour and is specifically positioned for active case finding at point of care.​

Other POC molecular HCV use cases:

✅ National hepatitis testing policy in Australia notes that both POC antibody and RNA tests have TGA approval, and recommends their use to expand testing among people who decline traditional lab‐based testing

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Procurement, supply and value‐chain developments
WHO‐guided procurement:

✅ WHO outlines criteria for selecting/purchasing HIV, HBsAg and HCV in vitro diagnostics (sensitivity, specificity, invalid rates) and links eligibility for WHO and donor procurement to WHO prequalification status.​

✅ A 2025 global reporting framework for HIV, viral hepatitis and STIs reinforces use of WHO‐prequalified test lists for national procurement planning.​

Local production and supply‐chain resilience:

✅ WHO and the Global Fund highlight a shift toward local manufacturing in Africa: by mid‐2025, African‐produced HIV medicines and rapid tests are beginning to enter national programmes, with Codix Bio (Nigeria) sublicensed to manufacture HIV rapid diagnostic tests.​

✅ WHO explicitly frames locally produced HIV RDTs as a way to increase affordability and reduce vulnerabilities and delays in diagnostic supply chains, urging advanced market commitments and fair procurement policies.​

Programme‐level procurement trends:

1. Country tenders (for example, India's 2025 procurement of combined HIV/syphilis/HBV/HCV rapid tests) indicate a move toward multi‐analyte panels, which simplify logistics and improve coverage in public screening campaigns.​

2. WHO also encourages adoption of HIV self‐tests to mitigate human‐resource gaps and buffer stock‐out risks for first‐line RDTs in national algorithms, integrating self‐testing into procurement and distribution plans.

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