Human Immunodeficiency Virus (HIV) Diagnosis Market Report 2026

The human immunodeficiency virus (hiv) diagnosis market size has grown rapidly in recent years. It will grow from $4.67 billion in 2025 to $5.19 billion in 2026 at a compound annual growth rate (CAGR) of 11%. The growth in the historic period can be attributed to global prevalence of hiv infections, government-led hiv screening programs, increased availability of rapid diagnostic kits, expansion of diagnostic laboratory infrastructure, growing public health awareness initiatives.

The human immunodeficiency virus (hiv) diagnosis market size is expected to see strong growth in the next few years. It will grow to $7.4 billion in 2030 at a compound annual growth rate (CAGR) of 9.3%. The growth in the forecast period can be attributed to rising demand for early hiv detection, increasing adoption of self-test kits, expansion of point-of-care diagnostic technologies, growing focus on hiv prevention and monitoring, increasing investments in infectious disease diagnostics. Major trends in the forecast period include increasing adoption of rapid and point-of-care hiv testing, growing emphasis on early and routine hiv screening, rising demand for self-testing and home-based diagnostics, expansion of integrated hiv testing and counseling services, increasing focus on data-driven hiv surveillance and reporting.

The increasing rate of blood donation is expected to drive the growth of the HIV diagnosis market in the coming years. Blood donation is the voluntary act of giving blood via phlebotomy, where blood is collected from a vein using a needle. Growth in blood donation is supported by advancements in medical technology, community engagement, and improved donor recruitment and retention strategies. A larger pool of donated blood increases the availability of samples for HIV testing, allowing for more comprehensive screening for HIV antibodies or antigens and improving the accuracy and reliability of diagnosis. For example, NHS Blood and Transplant, a UK-based government agency, reported an increase in new blood donors from 119,016 in 2022-2023 to 119,371 in 2023-2024. Therefore, rising blood donation is contributing to the expansion of the HIV diagnosis market.

Key players in the HIV diagnosis market are also focusing on developing long-acting, highly effective prevention and treatment solutions, expanding access through supportive reimbursement programs, and advancing innovative clinical strategies to improve adherence and reduce new HIV infections. For instance, in June 2025, Gilead Sciences, a US-based healthcare company, received FDA approval for Yeztugo (lenacapavir), the first and only twice-yearly injectable PrEP option. Phase 3 PURPOSE 1 and PURPOSE 2 trials demonstrated exceptional efficacy, with ≥99.9% of participants remaining HIV-negative. The long-acting injection addresses barriers such as adherence challenges, stigma, and limited awareness that restrict current PrEP use. Gilead is implementing broad access measures, including insurance partnerships, co-pay support for eligible patients, and free access for uninsured individuals through assistance programs.

In July 2025, Future Pak, a US-based contract development and manufacturing organization (CDMO), acquired Theratechnologies Inc. for up to $254 million. Through this acquisition, Future Pak aims to strengthen its position in the HIV therapeutics market by integrating Theratechnologies’ marketed HIV drugs, including Trogarzo and Egrifta, and leveraging the company’s commercialization expertise to drive further growth. Theratechnologies, headquartered in Canada, is a biopharmaceutical company known for its HIV-focused portfolio, including the monoclonal antibody Trogarzo (ibalizumab) and the HIV-associated lipodystrophy treatment Egrifta (tesamorelin).

Major companies operating in the human immunodeficiency virus (hiv) diagnosis market are Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers, Roche Diagnostics, Becton Dickinson and Company, Hologic Inc., bioMérieux SA, Beckman Coulter Inc., Bio-Rad Laboratories Inc., QIAGEN N.V., Bio-Techne Corporation, Alere Inc., Cepheid Inc., OraSure Technologies Inc., Advanced Instruments Inc., BBI Solutions, Chembio Diagnostic Systems Inc., BioLytical Laboratories Inc., Avioq Inc., Advanced Molecular Diagnostics, Atila BioSystems Inc.

North America was the largest region in the HIV diagnosis market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the human immunodeficiency virus (hiv) diagnosis market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the human immunodeficiency virus (hiv) diagnosis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Tariffs are impacting the hiv diagnosis market by increasing the cost of imported diagnostic instruments, reagents, test kits, and molecular testing equipment used in laboratory and point-of-care settings. These impacts are most pronounced in lab-based testing segments and in regions such as North America and Europe that rely on global diagnostics supply chains. Higher procurement costs may affect testing budgets; however, tariffs are also encouraging local manufacturing of test kits, regional sourcing of consumables, and adoption of cost-effective rapid testing solutions, supporting long-term supply stability.

The human immunodeficiency virus (hiv) diagnosis market research report is one of a series of new reports that provides human immunodeficiency virus (hiv) diagnosis market statistics, including human immunodeficiency virus (hiv) diagnosis industry global market size, regional shares, competitors with a human immunodeficiency virus (hiv) diagnosis market share, detailed human immunodeficiency virus (hiv) diagnosis market segments, market trends and opportunities, and any further data you may need to thrive in the human immunodeficiency virus (hiv) diagnosis industry. This human immunodeficiency virus (hiv) diagnosis market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Human immunodeficiency virus (HIV) diagnosis refers to the process of determining whether an individual is infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). This process involves testing for the presence of HIV antibodies, antigens, or viral genetic material in blood, saliva, or other bodily fluids.

The primary products used for HIV diagnosis include consumables, instruments, and software and services. Consumables consist of materials, supplies, or items that are used up during testing procedures. Diagnostic products can be administered through various methods, including self-testing and laboratory-based testing. Key end users of these products include diagnostic laboratories, hospitals, and research institutions.

The human immunodeficiency virus (HIV) diagnosis market consists of revenues earned by entities by providing services such as HIV testing, pre-test counseling, post-test counseling, laboratory-based testing, point-of-care testing, partner notification services, and linkage to care services. The market value includes the value of related goods sold by the service provider or included within the service offering. The human immunodeficiency virus (HIV) diagnosis market also includes sales of diagnostic kits, testing equipment such as enzyme-linked immunosorbent assay (ELISA) readers and polymerase chain reaction (PCR) machines, point-of-care testing devices, laboratory equipment like centrifuges and microscopes. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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