Top 10 Companies in the HIV Diagnostic Kit Industry (2025): Market Leaders Transforming Global Disease Detection

The Global HIV Diagnostic Kit Market was valued at USD 4,215 million in 2023 and is projected to reach USD 9,306.82 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 9.20% during the forecast period (2023-2032). This expansion is driven by increasing HIV screening initiatives, technological advancements in rapid testing, and rising government funding for early diagnosis programs worldwide.

North America currently leads the market with a valuation of USD 1,278.36 million in 2023, growing at a CAGR of 7.89% through 2032. As healthcare systems prioritize infectious disease management, diagnostic companies are innovating with faster, more accurate testing solutions. Below, we analyze the Top 10 Companies in the HIV Diagnostic Kit Industry that are shaping the future of HIV detection and prevention.


🔟 10. Zyomyx Incorporation

Headquarters: Fremont, California, USA
Key Offering: Immunoassay-based HIV test systems

Zyomyx specializes in advanced protein microarray technologies for HIV diagnostics. Their platform enables high-throughput screening with improved sensitivity compared to conventional ELISA tests.

Innovation Highlights:

  • Microarray-based multiplex testing capabilities
  • Point-of-care diagnostic solutions for resource-limited settings
  • Partnerships with global health organizations for test distribution

Download FREE Sample Report: HIV Diagnostic Kit Market – View Detailed Research Report


9️⃣ 9. Chembio Diagnostic Systems

Headquarters: Medford, New York, USA
Key Offering: DPP® HIV-1/2 rapid tests

Chembio is a leader in rapid HIV diagnostic solutions, particularly for emerging markets. Their Dual Path Platform technology delivers results in under 20 minutes with laboratory-quality accuracy.

Innovation Highlights:

  • WHO-prequalified HIV tests
  • CLIA-waived rapid tests for non-laboratory settings
  • Active in over 65 countries

8️⃣ 8. Sysmex Corporation

Headquarters: Kobe, Japan
Key Offering: Automated HIV-1/HIV-2 testing systems

Sysmex integrates HIV diagnostics with its established hematology analyzers, providing comprehensive solutions for clinical laboratories and blood banks.

Innovation Highlights:

  • High-volume testing capabilities
  • Integrated quality control systems
  • Strong presence in Asia-Pacific markets

7️⃣ 7. Hologic, Inc.

Headquarters: Marlborough, Massachusetts, USA
Key Offering: Aptima® HIV-1 Quant Dx assay

Hologic provides molecular diagnostic solutions for HIV detection and monitoring, including viral load quantification critical for treatment management.

Innovation Highlights:

  • FDA-approved viral load monitoring
  • Automated high-throughput systems
  • Early infant diagnosis solutions

Download FREE Sample Report: HIV Diagnostic Kit Market – View Detailed Research Report


6️⃣ 6. Qiagen N.V.

Headquarters: Venlo, Netherlands
Key Offering: artus® HIV-1 QS-RGQ test kit

Qiagen’s molecular diagnostics portfolio includes CE-marked HIV testing solutions that combine automation with high specificity for multiple HIV strains.

Innovation Highlights:

  • Integrated sample-to-result workflows
  • Solutions for blood donor screening
  • Point-of-care molecular diagnostics

5️⃣ 5. Gilead Sciences

Headquarters: Foster City, California, USA
Key Offering: Companion diagnostics for HIV therapeutics

While primarily known for HIV treatments, Gilead has developed diagnostic solutions that complement its antiretroviral drugs to optimize patient management.

Innovation Highlights:

  • Integrated treatment-diagnostic solutions
  • Research partnerships for next-gen testing technologies
  • Global access programs in developing nations

4️⃣ 4. Johnson & Johnson

Headquarters: New Brunswick, New Jersey, USA
Key Offering: HIV self-testing solutions

J&J’s consumer health division offers innovative at-home HIV testing kits that balance privacy with clinical-grade accuracy.

Innovation Highlights:

  • Over-the-counter diagnostic solutions
  • Telemedicine integration for positive results
  • User-friendly design for non-clinical settings

3️⃣ 3. Roche Diagnostics

Headquarters: Basel, Switzerland
Key Offering: Cobas® HIV tests

Roche delivers high-performance HIV diagnostic systems combining automation with industry-leading sensitivity for laboratory environments.

Innovation Highlights:

  • Fully automated testing platforms
  • High-volume testing capabilities
  • Integrated data management systems

Download FREE Sample Report: HIV Diagnostic Kit Market – View Detailed Research Report


2️⃣ 2. BD Biosciences

Headquarters: Franklin Lakes, New Jersey, USA
Key Offering: Flow cytometry-based HIV monitoring

BD provides advanced solutions for HIV cell counting and monitoring critical for disease progression tracking.

Innovation Highlights:

  • Gold standard CD4+ counting technology
  • Point-of-care monitoring solutions
  • Data integration with EHR systems

1️⃣ 1. Abbott Healthcare

Headquarters: Chicago, Illinois, USA
Key Offering: ARCHITECT HIV Ag/Ab Combo assay

Abbott leads the market with its comprehensive HIV diagnostic solutions, offering both laboratory and point-of-care testing platforms.

Innovation Highlights:

  • Fourth-generation HIV antigen/antibody detection
  • Early infection detection capability
  • Global distribution network across 130+ countries

Read Full Report: HIV Diagnostic Kit Market – View Detailed Research Report


🌍 Outlook: The Future of HIV Diagnostics Is Faster and More Accessible

The HIV diagnostic market is undergoing significant transformation with the integration of cutting-edge technologies and expanded testing accessibility.

📈 Key Trends Shaping the Market:

  • Expansion of self-testing solutions globally
  • Integration of AI for test interpretation
  • Development of multi-disease testing platforms
  • Increased focus on early infant diagnosis

Read Full Report: HIV Diagnostic Kit Market – View Detailed Research Report