HIV 자가 검사 시장 규모, 점유율, 동향 분석 보고서 : 유형별, 기술별, 유통 채널별, 지역별, 부문별 예측(2025-2033년)

HIV Self-testing Market Summary

The global HIV Self-testing market size was estimated at USD 211.55 million in 2024 and is expected to reach USD 643.41 million by 2033, growing at a CAGR of 13.55% from 2025 to 2033. This growth is fueled by an increasing emphasis on early HIV detection, rising HIV prevalence, and a global shift toward personal, confidential health solutions.

Over 100 countries have adopted HIVST policies, and more than 20 million kits were distributed globally in 2023 alone. The affordability and scalability of rapid diagnostic kits have made them integral in both developed and developing health systems. As of the most recent estimates, approximately 40.8 million people worldwide are living with HIV, including 1.4 million children between the ages of 0 and 14. In 2024 alone, there were about 1.3 million new HIV infections, with 120,000 cases occurring in children. That same year, an estimated 630,000 people died from HIV-related causes, including 75,000 children. Since the beginning of the HIV epidemic, it is estimated that 44.1 million people have lost their lives due to HIV-related illnesses. Despite the ongoing impact, global progress has been substantial over the past decade and a half. Between 2010 and 2024, the number of new HIV infections decreased by approximately 40%, dropping from 2.2 million to 1.3 million annually. During the same period, HIV-related deaths fell by 54%, declining from 1.4 million to 630,000. These reductions reflect the success of widespread awareness, prevention efforts, antiretroviral therapy scale-up, and increasing adoption of strategies such as HIV self-testing, which have contributed to earlier diagnosis and treatment initiation.

One of the strongest drivers of the HIV self-testing market is the rising demand for discreet, accessible, and user-friendly diagnostic options, particularly in populations facing stigma or barriers to clinic-based testing. According to UNAIDS, nearly 40% of people living with HIV globally remain undiagnosed, a gap largely attributed to fear of discrimination, social stigma, and inconvenient access to health facilities. HIV self-tests provide a private, at-home alternative that empowers individuals to know their status without fear. Saliva-based kits such as OraQuick In-Home HIV Test have become popular for their non-invasive nature, simplicity, and 20-minute result window. In regions such as Sub-Saharan Africa, where HIV prevalence is highest, self-testing has been pivotal: countries like Kenya, Malawi, and South Africa have scaled up national HIVST programs through community and NGO distribution. In high-income countries, rising e-commerce penetration has enabled widespread access to HIV self-tests via online pharmacies. This combination of anonymity, convenience, and technological simplicity is not only improving diagnosis rates but also fundamentally shifting how public health systems approach HIV prevention and treatment linkage.

Technological advancements are transforming HIV self-testing into a more accurate, efficient, and user-centric process. The most common format-lateral flow immunoassays (LFA)-uses a simple strip that detects HIV-1/2 antibodies through a saliva or finger-prick blood sample. These tests deliver results in 15-20 minutes, and newer devices incorporate all-in-one integrated systems, such as Atomo's HIV Self-Test, which combines lancet, buffer, and strip in a single device. In addition, smartphone-linked digital self-tests are being piloted, allowing users to scan results, receive guided instructions, and access telehealth services-enhancing test reliability and post-test linkage to care. In clinical trials, smartphone-based readers have shown >98% concordance with trained visual interpretation. Furthermore, innovations in microfluidics and nano-based detection promise to make future HIVST kits even more sensitive and early-stage infection-aware. The industry is also shifting toward combination kits (e.g., HIV + syphilis), especially in areas with co-infection burdens. These technological improvements not only reduce human error but also make self-testing viable in low-literacy populations, further expanding its global reach.

Global HIV Self-testing Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global HIV self-testing market based on type, technology, distribution channel, and region:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Blood-based Kits
• Saliva-based Kits
• Technology Outlook (Revenue, USD Million, 2021 - 2033)
• Immunofiltration Assays
• Lateral Flow Assays (LFA)
• Other Rapid Diagnostic Technologies
• Distribution Channel Outlook (Revenue, USD Million, 2021 - 2033)
• Retail and Online Pharmacies
• Hospitals and Diagnostics Laboratories
• NGO/ Community-based Distribution
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. HIV Self-testing Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Type Segment
    • 1.1.1.2. Technology Segment
    • 1.1.1.3. Sample Type segment
    • 1.1.1.4. Distribution Channel Segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
• 1.10. List of Secondary Sources
• 1.11. List of Abbreviations

Chapter 2. HIV Self-testing Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Type and Technology Snapshot
• 2.3. Distribution Channel Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. HIV Self-testing Market Variables, Trends, & Scope

• 3.1. Market Segmentation and Scope
• 3.2. Market Lineage Outlook
  • 3.2.1. Parent Market Outlook
  • 3.2.2. Related/Ancillary Market Outlook
• 3.3. Market Dynamics
• 3.4. Market Drivers Analysis
  • 3.4.1. Rising HIV awareness and government initiatives
  • 3.4.2. High demand for privacy and convenience
  • 3.4.3. Technological advancements in test kits
• 3.5. Market Restraint Analysis
  • 3.5.1. Regulatory and approval challenges
  • 3.5.2. Risk of misuse or misinterpretation
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis
• 3.8. Pipeline Analysis

Chapter 4. HIV Self-testing Market: Type Estimates & Trend Analysis

• 4.1. HIV Self-testing Market: Type Movement Analysis
• 4.2. Blood-based Kits
  • 4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.3. Saliva-based Kits
  • 4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. HIV Self-testing Market: Technology Estimates & Trend Analysis

• 5.1. HIV Self-testing Market: Technology Movement Analysis
• 5.2. Immunofiltration Assays
  • 5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.3. Lateral Flow Assays (LFA)
  • 5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Other Rapid Diagnostic Technologies
  • 5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. HIV Self-testing Market: Distribution Channel Estimates & Trend Analysis

• 6.1. HIV Self-testing Market: Distribution Channel Movement Analysis
• 6.2. Retail and Online Pharmacies
  • 6.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.3. Hospitals and Diagnostics Laboratories
  • 6.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.4. NGO/Community-Based Distribution
  • 6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. HIV Self-testing Market: Regional Business Analysis

• 7.1. Regional Market Snapshot
• 7.2. North America
  • 7.2.1. North America HIV Self-testing Market Estimates And Forecast, 2021 - 2033 (USD Million)
  • 7.2.2. U.S.
    • 7.2.2.1. U.S. HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.2.2.2. Key Country Dynamics
    • 7.2.2.3. Regulatory Framework
    • 7.2.2.4. Reimbursement Scenario
    • 7.2.2.5. Competitive Scenario
  • 7.2.3. Canada
    • 7.2.3.1. Canada HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.2.3.2. Key Country Dynamics
    • 7.2.3.3. Regulatory Framework
    • 7.2.3.4. Reimbursement Scenario
    • 7.2.3.5. Competitive Scenario
  • 7.2.4. Mexico
    • 7.2.4.1. Mexico HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.2.4.2. Key Country Dynamics
    • 7.2.4.3. Regulatory Framework
    • 7.2.4.4. Reimbursement Scenario
    • 7.2.4.5. Competitive Scenario
• 7.3. Europe
  • 7.3.1. Europe HIV Self-testing Market, 2021 - 2033 (USD Million)
  • 7.3.2. UK
    • 7.3.2.1. UK HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.2.2. Key Country Dynamics
    • 7.3.2.3. Regulatory Framework
    • 7.3.2.4. Reimbursement Scenario
    • 7.3.2.5. Competitive Scenario
  • 7.3.3. Germany
    • 7.3.3.1. Germany HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.3.2. Key Country Dynamics
    • 7.3.3.3. Regulatory Framework
    • 7.3.3.4. Reimbursement Scenario
    • 7.3.3.5. Competitive Scenario
  • 7.3.4. Spain
    • 7.3.4.1. Spain HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.4.2. Key Country Dynamics
    • 7.3.4.3. Regulatory Framework
    • 7.3.4.4. Reimbursement Scenario
    • 7.3.4.5. Competitive Scenario
  • 7.3.5. France
    • 7.3.5.1. France HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.5.2. Key Country Dynamics
    • 7.3.5.3. Regulatory Framework
    • 7.3.5.4. Reimbursement Scenario
    • 7.3.5.5. Competitive Scenario
  • 7.3.6. Italy
    • 7.3.6.1. Italy HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.6.2. Key Country Dynamics
    • 7.3.6.3. Regulatory Framework
    • 7.3.6.4. Reimbursement Scenario
    • 7.3.6.5. Competitive Scenario
  • 7.3.7. Denmark
    • 7.3.7.1. Denmark HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.7.2. Key Country Dynamics
    • 7.3.7.3. Regulatory Framework
    • 7.3.7.4. Reimbursement Scenario
    • 7.3.7.5. Competitive Scenario
  • 7.3.8. Sweden
    • 7.3.8.1. Sweden HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.8.2. Key Country Dynamics
    • 7.3.8.3. Regulatory Framework
    • 7.3.8.4. Reimbursement Scenario
    • 7.3.8.5. Competitive Scenario
  • 7.3.9. Norway
    • 7.3.9.1. Norway HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.3.9.2. Key Country Dynamics
    • 7.3.9.3. Regulatory Framework
    • 7.3.9.4. Reimbursement Scenario
    • 7.3.9.5. Competitive Scenario
• 7.4. Asia Pacific
  • 7.4.1. Asia Pacific HIV Self-testing Market, 2021 - 2033 (USD Million)
  • 7.4.2. Japan
    • 7.4.2.1. Japan HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.2.2. Key Country Dynamics
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. Reimbursement Scenario
    • 7.4.2.5. Competitive Scenario
  • 7.4.3. China
    • 7.4.3.1. China HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.3.2. Key Country Dynamics
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Reimbursement Scenario
    • 7.4.3.5. Competitive Scenario
  • 7.4.4. India
    • 7.4.4.1. India HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.4.2. Key Country Dynamics
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Reimbursement Scenario
    • 7.4.4.5. Competitive Scenario
  • 7.4.5. South Korea
    • 7.4.5.1. South Korea HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.5.2. Key Country Dynamics
    • 7.4.5.3. Regulatory Framework
    • 7.4.5.4. Reimbursement Scenario
    • 7.4.5.5. Competitive Scenario
  • 7.4.6. Thailand
    • 7.4.6.1. Thailand HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.6.2. Key Country Dynamics
    • 7.4.6.3. Regulatory Framework
    • 7.4.6.4. Reimbursement Scenario
    • 7.4.6.5. Competitive Scenario
  • 7.4.7. Australia
    • 7.4.7.1. Australia HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.4.7.2. Key Country Dynamics
    • 7.4.7.3. Regulatory Framework
    • 7.4.7.4. Reimbursement Scenario
    • 7.4.7.5. Competitive Scenario
• 7.5. Latin America
  • 7.5.1. Latin America HIV Self-testing Market, 2021 - 2033 (USD Million)
  • 7.5.2. Brazil
    • 7.5.2.1. Brazil HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.5.2.2. Key Country Dynamics
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Reimbursement Scenario
    • 7.5.2.5. Competitive Scenario
  • 7.5.3. Argentina
    • 7.5.3.1. Argentina HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.5.3.2. Key Country Dynamics
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Reimbursement Scenario
    • 7.5.3.5. Competitive Scenario
• 7.6. MEA
  • 7.6.1. MEA HIV Self-testing Market, 2021 - 2033 (USD Million)
  • 7.6.2. South Africa
    • 7.6.2.1. South Africa HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.6.2.2. Key Country Dynamics
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Reimbursement Scenario
    • 7.6.2.5. Competitive Scenario
  • 7.6.3. Saudi Arabia
    • 7.6.3.1. Saudi Arabia HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.6.3.2. Key Country Dynamics
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Reimbursement Scenario
    • 7.6.3.5. Competitive Scenario
  • 7.6.4. UAE
    • 7.6.4.1. UAE HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.6.4.2. Key Country Dynamics
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. Reimbursement Scenario
    • 7.6.4.5. Competitive Scenario
  • 7.6.5. Kuwait
    • 7.6.5.1. Kuwait HIV Self-testing Market, 2021 - 2033 (USD Million)
    • 7.6.5.2. Key Country Dynamics
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Reimbursement Scenario
    • 7.6.5.5. Competitive Scenario

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. New Product Launch
  • 8.2.2. Partnerships
  • 8.2.3. Acquisition
  • 8.2.4. Collaboration
  • 8.2.5. Funding
• 8.3. Key Company Market Share Analysis, 2024
• 8.4. Company Heat Map Analysis
• 8.5. Company Profiles
  • 8.5.1. OraSure Technologies, Inc.
    • 8.5.2.1. Company Overview
    • 8.5.2.2. Financial Performance
    • 8.5.2.3. Product Benchmarking
    • 8.5.2.4. Strategic Initiatives
  • 8.5.3. BioSURE HIVST
    • 8.5.3.1. Company Overview
    • 8.5.3.2. Financial Performance
    • 8.5.3.3. Product Benchmarking
    • 8.5.3.4. Strategic Initiatives
  • 8.5.4. Atomo Diagnostics
    • 8.5.4.1. Company Overview
    • 8.5.4.2. Financial Performance
    • 8.5.4.3. Product Benchmarking
    • 8.5.4.4. Strategic Initiatives
  • 8.5.5. Chembio Diagnostics, Inc.
    • 8.5.5.1. Company Overview
    • 8.5.5.2. Financial Performance
    • 8.5.5.3. Product Benchmarking
    • 8.5.5.4. Strategic Initiatives
  • 8.5.6. SD Biosensor, INC.
    • 8.5.6.1. Company Overview
    • 8.5.6.2. Financial Performance
    • 8.5.6.3. Product Benchmarking
    • 8.5.6.4. Strategic Initiatives
  • 8.5.7. CTK Biotech, Inc.
    • 8.5.7.1. Company Overview
    • 8.5.7.2. Financial Performance
    • 8.5.7.3. Product Benchmarking
    • 8.5.7.4. Strategic Initiatives
  • 8.5.8. genedrive plc
    • 8.5.8.1. Company Overview
    • 8.5.8.2. Financial Performance
    • 8.5.8.3. Product Benchmarking
    • 8.5.8.4. Strategic Initiatives
  • 8.5.9. Hydrex Diagnostics Sp.
    • 8.5.9.1. Company Overview
    • 8.5.9.2. Financial Performance
    • 8.5.9.3. Product Benchmarking
    • 8.5.9.4. Strategic Initiatives
  • 8.5.10. Trinity Biotech
    • 8.5.10.1. Company Overview
    • 8.5.10.2. Financial Performance
    • 8.5.10.3. Product Benchmarking
    • 8.5.10.4. Strategic Initiatives
  • 8.5.11. Abbott
    • 8.5.11.1. Company Overview
    • 8.5.11.2. Financial Performance
    • 8.5.11.3. Product Benchmarking
    • 8.5.11.4. Strategic Initiatives