United States HIV Diagnostics Testing Market with CAGR of 6.3% during 2022-2029 - Exclusive Report by DatamIntelligence

"HIV Diagnostics Testing Market is Predicted to reach at a CAGR of 6.3% during the forecast period (2022-2029)." As per DataM intelligence research report

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United States: Recent Industry Developments

✅ In October 2025, the U.S. Food and Drug Administration (FDA) approved the INSTI® HIV Self Test by bioLytical Laboratories, making it the fastest at-home HIV test available, delivering results in just one minute. This advancement aims to increase accessibility and convenience for individuals seeking HIV testing.

✅ In June 2025, the FDA approved Gilead Sciences' Yeztugo (lenacapavir), a twice-yearly injectable HIV prevention option. This long-acting pre-exposure prophylaxis (PrEP) offers a new choice for individuals at risk of HIV, providing extended protection with fewer doses.

✅ In April 2025, Northwestern University researchers developed a new HIV diagnostic technology capable of detecting multiple HIV antigens at high sensitivity within minutes. The project received $15 million in funding from the National Institutes of Health (NIH) to advance rapid HIV detection capabilities in clinical settings.

✅ In March 2025, the FDA granted Breakthrough Device Designation to Chembio's SURE CHECK® HIV Self-Test, a rapid, single-use immunochromatographic test designed for over-the-counter use. Chembio received $10 million in venture funding to accelerate commercialization.

Japan: Recent Industry Developments

✅ In October 2025, Japan's National Institute of Infectious Diseases (NIID) initiated a nationwide pilot program to evaluate the effectiveness of rapid HIV self-testing kits in rural and underserved areas. The initiative received ¥500 million in government funding to support early detection and treatment.

✅ In August 2025, a consortium of Japanese medical technology companies launched a collaborative project to develop an AI-powered HIV diagnostic platform. The project secured ¥1.2 billion in investment to enhance diagnostic accuracy and streamline testing processes in clinical laboratories.

✅ In June 2025, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of a new HIV diagnostic assay for point-of-care testing. The assay, developed by a Japanese biopharmaceutical company, offers rapid and reliable results, facilitating timely clinical decision-making.

✅ In April 2025, a Japanese research institute published a study demonstrating the efficacy of a novel HIV diagnostic method utilizing nanotechnology. The project received ¥300 million in research grants to further develop early-stage HIV detection technologies.

HIV Diagnostics Testing Market: Drivers

The HIV diagnostics testing market is witnessing robust growth, driven by increasing prevalence of HIV/AIDS, rising awareness of early detection, and growing demand for accurate, rapid, and point-of-care testing solutions. HIV diagnostics, including ELISA, rapid tests, nucleic acid tests (NAT), and Western blot assays, play a crucial role in early diagnosis, monitoring viral load, and guiding antiretroviral therapy. Advances in molecular diagnostics, point-of-care devices, and multiplex testing platforms are enhancing accuracy, sensitivity, and turnaround times, enabling timely clinical intervention. Expansion of healthcare infrastructure, government screening programs, and global initiatives for HIV prevention and treatment are further supporting market adoption. Growing focus on early detection, preventive care, and reducing HIV transmission is boosting demand for advanced diagnostic solutions worldwide.

Leading companies, including Abbott Laboratories, Roche Diagnostics, Hologic, and Bio-Rad Laboratories, are developing innovative HIV diagnostic tests with improved sensitivity, automation, and ease of use for laboratory and point-of-care settings. Research into rapid molecular assays, self-testing kits, and multiplex platforms is expanding clinical applications and accessibility. Strategic collaborations between diagnostic companies, healthcare providers, and public health organizations are accelerating product development, adoption, and outreach programs. Increasing emphasis on early diagnosis, patient-centric care, and disease surveillance is driving market growth. With continuous technological advancements, rising HIV awareness, and expanding healthcare initiatives, the HIV diagnostics testing market is poised for sustained global growth.

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HIV Diagnostics Testing Market: Major Players

Siemens Healthineers, F. Hoffmann-La Roche Ltd, Abbott Laboratories, Danaher Corporation, Thermo-Fisher Scientific Inc., Merck KGaA, Becton, Dickinson & Company, Hologic Inc., JOYSBIO (Tianjin) Biotechnology Co., Ltd., and Bio-Rad Laboratories

Segment Covered in the HIV Diagnostics Testing Market:

➥ By Product: Consumables, Assays and Kits & Reagents, Other Consumables, Instruments, Software & Services

➥ By Test Type: Antibody Tests, Viral Load Tests, CD4 Tests, Other

➥ By Application: Diagnostic Laboratories, Hospitals, Other

Research Process:

Both primary and secondary data sources have been used in the HIV Diagnostics Testing Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

Most Frequently Asked Questions in the HIV Diagnostics Testing Market Research Industry:

➠ Who leads the HIV Diagnostics Testing industry and what's their competitive positioning regarding capacity, performance, and profitability?
➠ What growth opportunities and market challenges do HIV Diagnostics Testing market vendors face?
➠ Which segments show the highest growth potential and market share distribution?
➠ What factors are driving or limiting HIV Diagnostics Testing market growth?
➠ What are the dominant sales and distribution strategies in the HIV Diagnostics Testing industry?

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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)

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✅ Competitive Landscape
✅ Technology Roadmap Analysis
✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Consumer Behavior & Demand Analysis
✅ Import-Export Data Monitoring
✅ Live Market & Pricing Trends

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