Global HIV Rapid Test Kits Market - Focused Insights 2025-2030

MARKET INSIGHTS

The global HIV rapid test kits market was valued at USD 1.48 billion in 2024 and is expected to reach USD 1.81 billion by 2030, growing at a CAGR of 3.32% during the forecast period. The market is evolving rapidly, driven by the integration of digital technologies with HIV rapid test kits, growing development with types of sample-based HIV rapid test kits, and rising consumer preferences for HIV self-testing (HIVST).

Furthermore, the integration of cutting-edge technologies within the manufacturing process, thereby ensuring precision, quality, and sustainability of HIV rapid tests in several developed and developing countries. Manufacturers in the HIV rapid test kits market are increasingly focusing on customer-centric product development. This approach involves collecting and analyzing data from end users to inform design decisions as well as create products that align with customer needs and preferences.

Human immunodeficiency virus (HIV) rapid test kits are in-vitro diagnostics (IVD) products that detect either exposure or the presence of HIV in the blood, oral fluids (saliva), and urine. They yield results in 20–30 minutes. An HIV rapid self-test is a type of antibody test that can be used at home or in a private location. An HIV rapid test kit is one of the convenient and widely accepted IVD products used for HIV diagnosis at homes or any private place of an individual.

RECENT VENDORS ACTIVITIES

1. In 2023, BIOSYNEX a French company pioneer in the design and development of rapid test kits acquired one of the leading market players Chembio Diagnostics, which was one of the top market leaders in the global HIV rapid test kits market.
2. In 2022, the WHO partnered with the Clinton Health Access Initiative (CHAI), Wondfo Biotech Company, and MedAccess. These partnerships make available HIV-self-test kits for only $1 in the public sector in LMICs.

KEY TAKEAWAYS

1. Market Growth: The global HIV rapid test kits market was valued at USD 1.48 billion in 2024 and is expected to reach USD 1.81 billion by 2030, growing at a CAGR of 3.32% during the forecast period.
2. By Technology: The lateral flow immunoassay segment holds the largest market share. Ease of use and low cost are major factors that increase acceptance of lateral flow immunoassay technology in HIV rapid test kits.
3. By Sample Type: The oral-fluid sample segment shows the highest growth of 4.02%. The oral-fluid test has received support from public health officials and activists as it can increase the testing rate and awareness of HIV serostatus.
4. By Gender: In 2024, the women segment holds the largest market share as HIV is highly prevalent among women compared to men.
5. By Distribution Channel: The offline segment accounts for the largest market share. Offline distribution channels are the first point of resource for HIV testing. Most people choose medical pharmacies as the first care point to purchase HIV rapid test kits.
6. By Geography: North America dominates and holds the largest market share of over 30%. The market is growing due to to increasing prevalence of HIV and associated growing awareness about HIVST.
7. Growth Factor: The global HIV rapid test kits market is set to grow due to the rising promotion of HIVST with pre-exposure prophylaxis delivery integration and increasing government investments and initiatives.

MARKET TRENDS & DRIVERS

Number of Countries Adopting HIV Self-Testing Policies Rises Sharply

The World Health Organization (WHO) and Unitaid- a healthcare organization that supports and promotes HIVST reported that several countries recently adopted HIVST strategies. Compared to the previous decade, Unitaid reported the growing number of HIVST products entering the market along with an increase in the number of countries adopting HIVST. Since 2016, around 40 countries adopted HIVST strategies that ed to increase the adoption of HIV rapid test kits. In addition, the COVID-19 pandemic positively influenced the adoption of a rapid test kit use approach in infectious disease management. Based on that, an additional 48 countries have recently developed national HIV self-testing policies.

Introduction of Next-Generation HIV Rapid Test Kits

HIV rapid test kits have evolved into advanced forms of testing. The application of fourth-generation and fifth-generation rapid test kits is currently high in the market and is expected to become popular in upcoming years. This technology is more accurate and reliable for screening the acute HIV presence from samples. Fourth-generation HIV test kits easily detect HIV in less time and more accurately than other-generation technologies. This allows individuals to detect and treat sooner and potentially prevent the spread of infection to others. 5th Generation HIV rapid test kits are used to distinguish between HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen. These newly developed solutions offer more information about HIV status.

Rising Promotion of HIVST With Pre-Exposure Prophylaxis Delivery Integration

Self-testing is an early and widely adopted strategy worldwide in the HIV response and has since changed service delivery across many disease areas and conditions. While it was initially targeted to enable early diagnosis now it shifts to the prevent new infections. This new HIV preventive approach has led to the integration of HIVST policies with Pre-exposure prophylaxis (PrEP) delivery. PrEP is the application of antiretroviral medication by HIV-negative people to reduce the risk of HIV acquisition. For achievement of the first 95 targets, further growth in the HIV rapid test kits market is only expected when countries expand PrEP delivery and or with the uptake of HIVST. The first 95 target is one of the major approaches considered across the world to increase awareness, acceptance, and delivery of HIV diagnosis.

Government Initiatives And Investment

To improve the HIV status, globally several government initiatives were taken in recent years. These initiatives and associated investments aim to overcome the challenges associated with HIV testing and account for cost as well as increase access to HIV testing. Of these, some major initiatives are STAR Phase 3, ATLAS, and MTV Shuga. STAR initiative was started in 2005 to improve and increase the adoption of HIV self-testing in targeted countries. Now its Star Phase 3 part is supporting to increase acceptance of HIV self-testing in new 7 countries. It involves a further seven markets, including Mozambique, Cameroon, Tanzania, Nigeria, Uganda in Africa; and Indonesia and India in Asia. In these countries, the Star Phase 3 initiative invested around $16.9 million to establish the system, structure, and oversight mechanism essential for the long-term sustainability of HIVST, reported in 2021.

SEGMENTATION INSIGHTS

INSIGHTS BY TECHNOLOGY

The global HIV rapid test kits market by technology is segmented into lateral flow immunoassay and immunofiltration. In 2024, the lateral flow immunoassay segment will dominate and hold the largest market share. Lateral flow immunoassay also known as immunochromatographic assay technology, takes a specific time to determine the viral load from blood and oral fluid samples. This technology has been widely conjugated with HIV rapid test kits to minimize the test time and resources. The use of lateral flow immunoassay technology has steadily increased in HIV testing as it has directly impacted the development and sale of HIV rapid test kits. Furthermore, ease of use and low cost are major factors that increase acceptance of lateral flow immunoassay technology in HIV rapid test kits. Lateral flow immunoassay-based HIV rapid test kits offer more than 99% accuracy and 100 times higher sensitivity which gain high attention among medical professionals as well people.

INSIGHTS BY SAMPLE TYPE

 The global HIV rapid test kits market by sample type is categorized into blood, oral fluids, and urine. The oral fluids segment shows significant growth, growing at a CAGR of 4.02% during the forecast period. Oral fluid-based HIV rapid test kits have become more popular in the past few years. These tests have received support from public health officials and activists as they can increase testing rates and awareness of HIV serostatus. Health organizations reported that oral fluid-based HIV rapid testing demonstrates a significantly higher screening acceptance, completion, and test result return rate than routine blood/serum-based HIV testing. In addition, these test kits can produce substantial cost savings and reduce the global burden of HIV. A higher number of HIV rapid testing being done based on saliva sample loading. In recent years, with the increasing awareness among people, the demand for HIV rapid tests has increased. Most people are looking for convenient and private HIV testing, accelerating the growth of saliva sample-based HIV testing.

INSIGHTS BY GENDER

Based on gender, the women's segment accounted for the largest global HIV rapid test kits market share. HIV is more prevalent among women compared to men. Within the overall female population, younger women are considered to be at higher risk for HIV. Awareness of HIV rapid test kits is comparatively higher among women than men. Women commonly use point-of-care test kits (POCT), including pregnancy test kits, fertility test kits, and ovulation test kits. Awareness of POCT is one of the major factors driving the highest demand for HIV rapid test kits among women. Government support for HIV testing among pregnant women is a significant driver of revenue growth in this segment. In addition, many countries mandate HIV testing for pregnant women to reduce the risk of transmitting HIV to infants, thus helping segmental growth.

INSIGHTS BY DISTRIBUTION CHANNEL

Based on distribution, the offline segment holds the largest share of the global HIV rapid test kits market. Offline sales channels include medical shops, pharmacies, hospitals, clinics with associated pharmacies, pharma retailers, and retail sales channels. Offline distribution channels are the primary point of access for HIV testing. Most people choose medical pharmacies as their first point of care when purchasing HIV rapid test kits. The easy access and availability of these distribution channels are major factors driving sales through offline channels. The majority of HIV cases are found in LMICs, where pharmacies and medical shops are considered key distribution channels. Pharmacies and pharmacists help raise awareness and provide guidance on how to use the tests, which attracts the targeted population. Moreover, offline channels serve as the best alternative to conventional facility-based HIV testing and counseling. Offline stores offer significant advantages in developing regions for the distribution of HIV rapid test kits.

GEOGRAPHICAL ANALYSIS

North America dominates and holds the largest global HIV rapid test kits market share of over 30%. The North American market is one of the largest and most mature markets for HIV rapid test kits. The region has witnessed more than 1.3 million HIV cases and significant adoption of HIVST policies. The high acceptance of HIV rapid test kits and their associated cost-effectiveness account for the highest revenue growth. Furthermore, North America is home to several small, medium, and large market players who widely promote HIVST policies to combat HIV infection across the region. In North America, both the US and Canada are supporting HIVST policies, which fuel the demand for HIV rapid test kits. Since 2022, both countries have reported an increasing number of HIV cases compared to previous years. The implementation of HIVST policies is expected to further increase HIV testing volumes in the region.

The Europe HIV rapid test kits market shows prominent growth, with the highest CAGR of 5.90% during the forecast period. This growth is primarily driven by Eastern Europe, where the increasing prevalence of HIV and the rising acceptance and implementation of HIVST policies are key factors. In Europe, some countries—including Montenegro, Malta, Ireland, Lithuania, Iceland, Azerbaijan, and Finland—recorded the highest number of HIV diagnoses in a single year in 2023, compared to the past decade. The rapidly growing acceptance of HIVST policies, the rising prevalence of HIV infections, and the presence of high-risk populations are some of the leading factors accelerating market growth in Europe.

COMPETITIVE LANDSCAPE

The global HIV rapid test kits market report consists of exclusive data on 27 vendors. The market is characterized by diversified market players and high competition among players. The current market scenario is driving vendors to innovate and refine their unique value propositions to achieve a strong market presence. However, the market is also susceptible to the threat of infiltration by low-quality products. Major vendors in the market continually compete for leadership, with occasional surges of competition from local players. Abbott, Bio-Rad Laboratories, and BIOMÉRIEUX are three leading companies that account for the highest market share in the global HIV rapid test kits market. These vendors offer high-quality and reliable HIV rapid test kits that meet customer requirements and international regulations, while also improving product efficiency to strengthen their market position. These companies have strong brand recognition and a wide geographical reach across the global market. Additionally, strategies such as product launches and new product development with advanced technologies have intensified competition. The adoption of these strategies by major market players, along with their focus on expanding capabilities, has enabled them to capture a larger revenue share in the market. Furthermore, BIOSYNEX and OraSure Technologies are identified as rapidly growing vendors in the market.