The global hiv diagnostics market size was estimated at USD 1.1 billion in 2024 and is projected to reach USD 1.55 billion by 2030, growing at a CAGR of 5.0% from 2025 to 2030.  Market growth is expected to be driven by increasing awareness, rising disease prevalence, and the continuous need for improved diagnostic tools. In addition, rising investments in healthcare infrastructure and technological advancements in diagnostic methods are anticipated to further accelerate industry expansion in the coming years.

According to data published by UNAIDS in 2024, approximately 39.9 million people worldwide were living with HIV by the end of 2023, with 1.3 million newly diagnosed cases reported in the same year. These figures highlight the persistent global burden of the disease and the urgent need for more efficient, affordable, and accessible diagnostic solutions, particularly in highly affected regions. However, the limited availability of resources continues to pose significant challenges in conducting complex screening, staging, and monitoring procedures, which are essential for timely detection and treatment planning.

Another major barrier to market growth is the shortage of testing laboratories and skilled healthcare professionals, particularly in low- and middle-income countries. This lack of infrastructure and expertise restricts the widespread use of advanced laboratory-based diagnostic technologies. Nonetheless, these limitations have spurred innovation, leading to the development of portable, easy-to-use point-of-care (POC) and rapid diagnostic tests. Such solutions have proven to be effective in resource-limited settings, as they allow for faster detection, improved accessibility, and minimal dependence on specialized equipment or training.

Currently, several leading market players are focusing on developing next-generation POC and rapid HIV diagnostic tests, many of which are in the pipeline and expected to gain regulatory approvals across different regions. These upcoming product launches are likely to expand the overall range of diagnostic offerings and significantly improve global accessibility.

Although there is still no definitive cure for HIV, continuous advancements in treatment options and the development of innovative therapeutic medicines are strengthening the fight against the disease. When paired with early and accurate diagnostic testing, these advancements can greatly improve disease management, enhance patient outcomes, and ultimately support the overall efforts to control the HIV epidemic worldwide.

Key Market Trends & Insights:

• In 2024, North America held a substantial position in the global HIV diagnostics industry, accounting for a revenue share of 26.9%. The region’s dominance can be attributed to the presence of well-established healthcare infrastructure, favorable reimbursement policies, and rising awareness regarding early HIV detection and treatment. Within North America, the U.S. emerged as a key contributor to market growth. The HIV diagnostics industry in the U.S. is projected to expand significantly during the forecast period, driven by the high prevalence of HIV cases, increasing government initiatives to enhance testing rates, and the availability of advanced diagnostic technologies.

• By product, the consumables segment represented the largest share of the market in 2024, accounting for 49.5% of total revenue. This strong performance is primarily due to the repeated use of consumables such as reagents, kits, and cartridges in various diagnostic procedures. The growing demand for reliable testing materials to support large-scale screening and monitoring programs has further reinforced the dominance of this segment.

• When analyzed by mode of testing, the lab-based segment accounted for the largest revenue share of 92.9% in 2024. The continued reliance on centralized laboratories for accurate, sensitive, and confirmatory diagnostic results has maintained the dominance of this segment. Despite the emergence of point-of-care testing, laboratory-based methods remain the gold standard, especially for confirmatory testing and advanced monitoring, which explains their significant market share.

• Based on test type, antibody tests led the market in 2024, capturing the largest revenue share of 56.6%. Antibody testing continues to dominate due to its widespread availability, cost-effectiveness, and high adoption rate as the initial screening method for HIV detection. These tests are often the first step in diagnostic algorithms across many regions, making them a crucial driver of revenue within the industry.

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Market Size & Forecast:

• 2024 Market Size: USD 1.1 Billion

• 2030 Projected Market Size: USD 1.55 Billion

• CAGR (2025-2030): 5.0%

• North America: Largest market in 2024

Key Companies & Market Share Insights:

Key players in the HIV diagnostics market are increasingly prioritizing clinical research and the advancement of CD4, p24 antigen, and viral load testing methodologies. Their primary focus is on simplifying implementation processes, enhancing portability, and improving accessibility of these diagnostic tools. Such efforts are aimed at addressing the existing unmet needs in HIV treatment and prevention, particularly in regions with limited resources where conventional laboratory-based testing poses significant challenges.

A noteworthy example of these initiatives was observed in November 2024, when Gilead Sciences, Inc. announced plans to present more than 40 research findings at the HIV Glasgow 2024 congress. This large body of research underscores the company’s dedication to advancing person-centered drug development strategies. Among their highlighted innovations is the investigation of Lenacapavir, a novel treatment that holds the potential to provide a twice-yearly HIV prevention option, thereby significantly reducing the treatment burden for patients. Additionally, real-world data from the BICSTaR study demonstrated the effectiveness of their drug Biktarvy, reinforcing its role in improving patient outcomes in HIV management.

Such advancements not only emphasize the industry’s commitment to developing innovative therapeutic and diagnostic solutions but also pave the way for the introduction of new products in the global market. These developments are expected to expand the range of available options, improve treatment adherence, and strengthen overall strategies for HIV care and prevention in the coming years.

Key Players

• Alere Inc.

• Abbott

• Bristol-Myers Squibb Company

• Janssen Global Services, LLC

• Gilead Sciences, Inc.

• Merck & Co. Inc.

• VIIV Healthcare

• BD

• Beckman Coulter, Inc.

• Sysmex Europe SE

• Apogee Flow Systems

• Point Care

• Zyomtronix, Inc.

• Mylan N.V.

• F. Hoffmann-La Roche Ltd.

• Siemens Healthcare GmbH

• QIAGEN

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Conclusion:

The HIV diagnostics market is on a steady growth path, driven by increasing demand for accessible, accurate, and early detection tools. Innovation in product offerings—especially in point-of-care, rapid, and self-testing—along with strong support from public health initiatives, are helping to bridge gaps in regions with limited laboratory infrastructure. While laboratory-based diagnostics continue to dominate due to their precision, there is clearly rising momentum behind more portable, user-friendly solutions. The competitive landscape remains active, with key players investing in new technologies and forming partnerships to address both diagnostic and treatment needs. Emerging markets and expanding awareness are expected to sustain growth moving forward.