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全球愛滋病毒自檢檢測套組市場規模（按檢測類型、樣本類型、應用、區域覆蓋範圍和預測）

Global HIV Self-Test Kits Market Size By Test Type (Rapid Test Kits, Laboratory-Based Test Kits), By Sample Type (Blood, Saliva), By Application (Home Testing, Laboratory Testing), By Geographic Scope And Forecast

出版日期: 2025年05月06日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

HIV自檢檢測套組市場規模及預測

2024 年 HIV 自檢檢測套組市場規模價值 28.7 億美元，預計到 2032 年將達到 199.7 億美元，在 2026-2032 年預測期內的複合年成長率為 30.29%。

HIV自檢檢測套組檢測套組是HIV預防和照護領域的重要進步，有助於早期發現和預防HIV，是對抗HIV疫情的寶貴資產。

這些方便、靈敏的工具使個人能夠獨立評估自己的愛滋病毒狀況，從而促進早期發現並促進及時獲得醫療服務。

HIV 自我檢測套組消除了檢測的地理障礙，使居住在偏遠和服務不足地區的人們更容易接受檢測。

自我測試使個人能夠保護自己的隱私並避免與傳統測試環境相關的潛在恥辱。

透過自我檢測及早發現愛滋病毒感染可以及時進行醫療干預，從而改善健康狀況並降低傳播風險。

儘管愛滋病毒自檢檢測套組通常具有較高的準確率，但仍必須密切注意所提供的說明，如果有任何疑問，請尋求醫療建議。

HIV 自我檢測套組可能無法檢測出最近的感染，因此人們應該在必要時到醫療機構重新接受檢測。

全球愛滋病毒自檢檢測套組市場動態

影響全球愛滋病毒自檢檢測套組市場的關鍵市場動態是：

關鍵市場促進因素

全球愛滋病毒感染率上升：全球愛滋病毒感染率上升推動了對自檢檢測套組的需求。聯合國愛滋病規劃署報告稱，2023年全球愛滋病毒感染者人數將達3,840萬，比2022年增加2%。 2024年1月15日，OraSure Technologies宣佈在東南亞推出其下一代OraQuick愛滋病毒自檢檢測套組，旨在改善高流行地區的檢測可及性。

提高意識，減少污名化：提高意識和減少污名化的努力有助於提高自我檢測。世界衛生組織報告稱，2023年全球愛滋病毒自我檢測率將比2022年增加25%。 2024年3月3日，蓋茲基金會承諾捐贈5,000萬美元，支持撒哈拉以南非洲地區進行愛滋病毒自我檢測宣傳活動，並與當地衛生組織合作，推動常規檢測的標準化。

HIV 自我檢測技術的創新：HIV 自我檢測套組的創新正在提高準確性和易用性。 FDA 於 2023 年核准了三種新的 HIV 自我檢測技術，增加了檢測選項。 2024 年 2 月 20 日，雅培實驗室推出了一款可連接智慧型手機的 HIV 自我檢測套組，用戶可以透過智慧型手機接收數位結果並與醫療保健提供者聯繫進行後續護理。

政府推動愛滋病毒自我檢測的措施：政府支持的增加正在擴大愛滋病毒自我檢測的可及性。美國衛生與公眾服務部在2023年為愛滋病毒自我檢測計畫撥款1.2億美元，比2022年增加15%。 2024年4月5日，英國政府宣佈在全國開展免費愛滋病毒自我檢測分發計劃，每年覆蓋100萬人。

主要問題

缺乏意識和污名化阻礙了檢測率的提高。許多面臨愛滋病毒感染風險的人不願接受檢測，因為他們沒有意識到檢測的重要性，或面臨與愛滋病毒相關的污名化。要消除這些障礙，需要加強公眾意識提升宣傳活動，並努力減少污名。

缺乏檢測機會阻礙早期診斷：檢測機會有限，尤其是在醫療資源匱乏和農村地區，可能會阻礙愛滋病毒感染的早期診斷。擴大檢測機會，包括透過社區項目，對於應對這項挑戰至關重要。

成本障礙阻礙檢測：HIV 自檢檢測套組的成本可能對某些人構成障礙，尤其是在低收入人群中，這可能會限制檢測機會並阻礙早期診斷。提供負擔得起或津貼的檢測方案有助於應對這項挑戰。

監管挑戰阻礙市場擴張：了解HIV自檢檢測套組的監管狀況可能很複雜，尤其對於在多個司法管轄區營運的製造商和經銷商。遵守監管要求會增加成本，並阻礙市場擴張。

主要趨勢

遠端醫療促進遠距檢測和諮詢：遠端醫療的發展正在促進遠距愛滋病毒檢測和諮詢。美國疾病管制與預防中心 (CDC) 報告稱，到 2023 年，愛滋病毒自我檢測後的遠端醫療諮詢將增加 40%。 2024 年 3 月 10 日，Hologic 與 Teladoc Health 合作推出了一項整合愛滋病毒自我檢測和虛擬諮詢的服務，為使用者提供全面的照護。

拓展分銷管道：多樣化的分銷管道正在改善愛滋病毒自檢檢測套組的可及性。世界衛生組織報告稱，到2023年，中低收入國家提供愛滋病毒自檢檢測套組的藥局數量將增加30%。 2024年1月30日，亞馬遜宣布將在其醫療保健產品線中納入經FDA核准的愛滋病毒自檢檢測套組，從而顯著擴大線上查詢及性。

精準涵蓋重點族群：自檢檢測套組的廣泛普及得益於對重點族群的精準推廣。 2024年2月5日，Biosure與巴西的一個LGBTQ+組織合作，免費分發了10萬份HIV自我檢測套組，重點致力於提高高風險族群的檢測率。

監管支持和簡化核准：支持性法規正在推動市場成長。歐洲藥品管理局於2023年核准了五種新的HIV自檢檢測套組，並簡化了核准流程。 2024年3月25日，世界衛生組織核准了Atomo Diagnostics公司的低成本HIV自我檢測檢測套組。

概述
北美洲
- 美國
- 加拿大
- 墨西哥
歐洲
- 德國
- 英國
- 法國
- 義大利
- 西班牙
- 其他歐洲國家
亞太地區
- 中國
- 日本
- 印度
- 其他亞太地區
拉丁美洲
- 巴西
- 阿根廷
- 其他拉丁美洲
中東和非洲
- 阿拉伯聯合大公國
- 沙烏地阿拉伯
- 南非
- 其他中東和非洲地區

第10章全球HIV自檢檢測套組市場的競爭格局

概述
各公司市場排名
重點發展策略
公司地理分佈
公司產業佈局
ACE矩陣

第11章公司簡介

OraSure Technologies Inc.
Atomo Diagnostics
Chembio Diagnostic Systems Inc.
Biosynex Group
BioSURE United Kingdom Ltd.
ECO Diagnostica
bioLytical Laboratories
Sedia Biosciences Corporation
Orangelife Comercio e Industria LTDA
WAMA Diagnostica

第12章重大進展

產品發布/開發
合併與收購
業務擴展
夥伴關係與合作

第13章附錄

相關調查

簡介目錄

Product Code: 40027

HIV Self-Test Kits Market Size And Forecast

HIV Self-Test Kits Market size was valued at USD 2.87 Billion in 2024 and is projected to reach USD 19.97 Billion by 2032, growing at a CAGR of 30.29% from 2026 to 2032.

HIV self-test kits represent a significant advancement in HIV prevention and care. HIV self-test kits serve as a valuable asset in combating the HIV epidemic by facilitating early detection and promoting prevention efforts.

These convenient and confidential tools empower individuals to assess their HIV status independently, facilitating early detection and facilitating timely access to medical care.

HIV self-test kits offer greater accessibility to individuals residing in remote or underserved regions, eliminating geographical barriers to testing.

Self-testing empowers individuals to maintain privacy and avoid the potential stigma associated with traditional testing settings.

Early detection of HIV infection through self-testing enables prompt medical intervention, leading to improved health outcomes and reduced transmission risk.

HIV self-test kits generally exhibit high accuracy rates, yet it remains essential to follow the provided instructions meticulously and seek medical consultation for any uncertainties.

HIV self-test kits may not detect recent infections, necessitating follow-up testing with a healthcare provider if necessary.

Global HIV Self-Test Kits Market Dynamics

The key market dynamics that are shaping the global HIV self-test kits market include:

Key Market Drivers

Increasing Prevalence of HIV Worldwide: The rising global HIV prevalence is driving demand for self-test kits. UNAIDS reported 38.4 million people living with HIV worldwide in 2023, a 2% increase from 2022. On January 15, 2024, OraSure Technologies announced the launch of its next-generation OraQuick HIV Self-Test in Southeast Asia, aiming to improve access to testing in high-prevalence regions.

Growing Awareness and Reducing Stigma: Efforts to raise awareness and reduce stigma are boosting self-testing adoption. The WHO reported a 25% increase in HIV self-testing volumes globally in 2023 compared to 2022. On March 3, 2024, the Gates Foundation pledged $50 million to support HIV self-testing awareness campaigns in sub-Saharan Africa, partnering with local health organizations to normalize regular testing.

Innovations in HIV Self-Test Technology: Innovations in HIV self-test kits are improving accuracy and user-friendliness. The FDA approved three new HIV self-test technologies in 2023, enhancing testing options. On February 20, 2024, Abbott Laboratories unveiled a smartphone-connected HIV self-test kit, allowing users to receive digital results and connect with healthcare providers for follow-up care.

Government Initiatives Promoting HIV Self-Testing: Increased government support is expanding access to HIV self-testing. The U.S. Department of Health and Human Services allocated $120 million for HIV self-testing programs in 2023, a 15% increase from 2022. On April 5, 2024, the UK government announced a nationwide free HIV self-test distribution program, aiming to reach 1 million people annually.

Key Challenges:

Limited Awareness and Stigma Hindering Testing Rates: Many individuals at risk for HIV infection may not be aware of the importance of testing or may face stigma associated with HIV, deterring them from seeking testing. Addressing these barriers requires increased public awareness campaigns and efforts to reduce stigma.

Lack of Access to Testing Facilities Hampering Early Diagnosis: Limited availability of testing facilities, particularly in underserved or rural areas, can hinder early diagnosis of HIV infection. Expanding access to testing facilities, including through community-based programs, is crucial for addressing this challenge.

Cost Barriers Obstructing Access to Testing: The cost of HIV self-test kits may be a barrier for some individuals, particularly in low-income communities. This can limit access to testing and prevent early diagnosis. Providing affordable or subsidized testing options can help address this challenge.

Regulatory Hurdles Challenging Market Expansion: Navigating the regulatory landscape for HIV self-test kits can be complex, especially for manufacturers and distributors operating in multiple jurisdictions. Compliance with regulatory requirements can increase costs and hinder market expansion.

Key Trends

Telemedicine Facilitating Remote Testing and Counseling: The growth of telemedicine is facilitating remote HIV testing and counseling. The CDC reported a 40% increase in telehealth consultations following HIV self-tests in 2023. On March 10, 2024, Hologic partnered with Teladoc Health to launch an integrated HIV self-testing and virtual counseling service, providing comprehensive care to users.

Expanding Distribution Channels: Diverse distribution channels are improving access to HIV self-test kits. The WHO reported a 30% increase in pharmacies offering HIV self-test kits in low- and middle-income countries in 2023. On January 30, 2024, Amazon announced the inclusion of FDA-approved HIV self-test kits in its healthcare product line, significantly expanding online access to testing.

Targeted Efforts to Reach Key Populations: Targeted efforts to reach key populations are driving self-test kit adoption. On February 5, 2024, BioSure partnered with LGBTQ+ organizations in Brazil to distribute 100,000 free HIV self-test kits, focusing on improving testing rates in high-risk communities.

Regulatory Support and Streamlined Approvals: Supportive regulations are accelerating market growth. The European Medicines Agency approved five new HIV self-test kits in 2023, streamlining the approval process. On March 25, 2024, the WHO prequalified a new low-cost HIV self-test from Atomo Diagnostics, paving the way for increased access in resource-limited settings and driving global market expansion.

Global HIV Self-Test Kits Market Regional Analysis

Here is a more detailed regional analysis of the global HIV self-test kits market:

North America

North America is dominating the HIV self-test kits market, driven by advanced healthcare infrastructure and strong awareness campaigns.

According to the Centers for Disease Control and Prevention (CDC), HIV self-testing in the United States increased by 35% in 2023 compared to the previous year, with over 2.5 million self-tests distributed.

The region's market leadership is also supported by favorable government policies and innovative public health initiatives.

Health Canada reported that 78% of new HIV diagnoses in 2023 were initially detected through self-testing, highlighting its effectiveness in early detection.

On March 15, 2024, Abbott Laboratories launched a nationwide campaign in collaboration with the U.S. Department of Health and Human Services, aiming to distribute 1 million free HIV self-test kits to underserved communities over the next year.

This initiative, coupled with the increasing integration of self-testing into routine healthcare practices, further solidifies North America's position at the forefront of the global HIV self-test kits market.

Asia-Pacific

The Asia-Pacific region is projected to experience a rapid CAGR growth during the forecast period, driven by the increasing awareness, government initiatives, and improving healthcare access.

According to the World Health Organization's Western Pacific Regional Office, HIV self-testing uptake in the region increased by 62% in 2023 compared to the previous year.

This growth was further accelerated on January 20, 2024, when the Chinese government announced a nationwide program to distribute 5 million free HIV self-test kits annually, partnering with local manufacturer Wondfo Biotech to ensure widespread availability.

The region's market expansion is also fueled by technological advancements and strategic collaborations. India's National AIDS Control Organisation reported a 45% increase in HIV self-testing among high-risk populations in 2023, largely attributed to mobile health initiatives.

On March 5, 2024, Mylan Pharmaceuticals (now part of Viatris) launched a smartphone-connected HIV self-test kit in Southeast Asia, starting with Thailand and Vietnam.

This innovation, coupled with a partnership announced on April 1, 2024, between the Bill & Melinda Gates Foundation and several APAC countries to subsidize self-test kits, underscores the region's potential for continued rapid growth in the HIV self-test kits market.

Global HIV Self-Test Kits Market: Segmentation Analysis

The Global HIV Self-Test Kits Market is segmented based on Test Type, Sample Type, Application, and Geography.

HIV Self-Test Kits Market, By Test Type

Rapid Test Kits
Laboratory-Based Test Kits

Based on Test Type, the Global HIV Self-Test Kits Market is bifurcated into Rapid Test Kits, Laboratory-Based Test Kits. The rapid test kits segment maintains a dominant position within the HIV self-test kit market, favored for their convenience, affordability, and ease of use. These tests offer rapid results, enabling prompt decision-making and access to medical care. However, the laboratory-based test kits segment is experiencing rapid growth, driven by their superior sensitivity and specificity, making them indispensable for confirming HIV diagnoses and monitoring viral load.

HIV Self-Test Kits Market, By Sample Type

Blood
Saliva
Urine

Based on Sample Type, the Global HIV Self-Test Kits Market is bifurcated into Blood, Saliva, Urine. The blood segment is dominating the HIV self-test kit market, driven by its high accuracy and reliability in detecting HIV antibodies. However, the saliva segment is experiencing rapid growth, as saliva-based tests offer a less invasive and more convenient option for testing.

HIV Self-Test Kits Market, By Application

Home Testing
Point-of-Care Testing
Laboratory Testing

Based on Application, the Global HIV Self-Test Kits Market is bifurcated into Home Testing, Point-of-Care Testing, Laboratory Testing. The home testing segment is currently dominating the HIV self-test kit market, driven by the convenience and privacy that self-testing offers. However, the point-of-care testing segment is experiencing rapid growth, as healthcare providers are increasingly adopting rapid HIV tests for quick and efficient diagnosis in clinical settings.

HIV Self-Test Kits Market, By Geography

North America
Europe
Asia Pacific
Rest of the world

Based on Geography, the Global HIV Self-Test Kits Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. The North American region continues to dominate the global HIV self-test kits market, driven by the advanced healthcare infrastructure and strong awareness campaigns. However, the Asia-Pacific region is projected to experience a rapid CAGR growth during the forecast period, driven by increasing awareness, government initiatives, and improving healthcare access.

Key Players

The "Global HIV Self-Test Kits Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are SD Biosensor, CTK Biotech, Genedrive Plc, Hyrex Diagnostics, Trinity Biotech, Mylan Laboratories, BioSure, PerkinElmer, Acon Laboratories, OraSure Technologies, Vestergaard Frandsen, Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, MP Biomedicals.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global HIV Self-Test Kits Market Key Developments

In February 2023, Mylab Discovery Solutions, announced the launch of three new rapid kits for the quick and early diagnosis of STIs, including as syphilis, hepatitis C virus, and HIV.
In November 2022, in an effort to further diagnostic solutions, Chembio Diagnostics applied for a CLIA waiver from the FDA for their DPP HIV-Syphilis System.

1 INTRODUCTION OF THE GLOBAL HIV SELF-TEST KITS MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL HIV SELF-TEST KITS MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porter's Five Force Model
4.4 Value Chain Analysis

5 GLOBAL HIV SELF-TEST KITS MARKET, BY TEST TYPE

5.1 Overview
5.2 Rapid Test Kits
5.3 Laboratory-Based Test Kits

6 GLOBAL HIV SELF-TEST KITS MARKET, BY SAMPLE TYPE

6.1 Overview
6.2 Blood
6.3 Urine
6.4 Saliva

7 GLOBAL HIV SELF-TEST KITS MARKET, BY APPLICATION

7.1 Overview
7.2 Home Testing
7.3 Point-of-Care Testing
7.4 Laboratory Testing

8 GLOBAL HIV SELF-TEST KITS MARKET, BY END-USER

8.1 Overview
8.2 Hospitals
8.3 Diagnostic Laboratories
8.4 Specialty Clinics
8.5 Research Institutes
8.6 Others

9 GLOBAL HIV SELF-TEST KITS MARKET, BY GEOGRAPHY

9.1 Overview
9.2 North America
- 9.2.1 The U.S.
- 9.2.2 Canada
- 9.2.3 Mexico
9.3 Europe
- 9.3.1 Germany
- 9.3.2 The U.K.
- 9.3.3 France
- 9.3.4 Italy
- 9.3.5 Spain
- 9.3.6 Rest of Europe
9.4 Asia Pacific
- 9.4.1 China
- 9.4.2 Japan
- 9.4.3 India
- 9.4.4 Rest of Asia Pacific
9.5 Latin America
- 9.5.1 Brazil
- 9.5.2 Argentina
- 9.5.3 Rest of LATAM
9.6 Middle East and Africa
- 9.6.1 UAE
- 9.6.2 Saudi Arabia
- 9.6.3 South Africa
- 9.6.4 Rest of the Middle East and Africa

10 GLOBAL HIV SELF-TEST KITS MARKET COMPETITIVE LANDSCAPE

10.1 Overview
10.2 Company Market Ranking
10.3 Key Development Strategies
10.4 Company Regional Footprint
10.5 Company Industry Footprint
10.6 ACE Matrix

11 COMPANY PROFILES

11.1 OraSure Technologies Inc.
- 11.1.1 Company Overview
- 11.1.2 Company Insights
- 11.1.3 Business Breakdown
- 11.1.4 Product Benchmarking
- 11.1.5 Key Developments
- 11.1.6 Winning Imperatives
- 11.1.7 Current Focus & Strategies
- 11.1.8 Threat from Competition
- 11.1.9 SWOT Analysis
11.2 Atomo Diagnostics
- 11.2.1 Company Overview
- 11.2.2 Company Insights
- 11.2.3 Business Breakdown
- 11.2.4 Product Benchmarking
- 11.2.5 Key Developments
- 11.2.6 Winning Imperatives
- 11.2.7 Current Focus & Strategies
- 11.2.8 Threat from Competition
- 11.2.9 SWOT Analysis
11.3 Chembio Diagnostic Systems Inc.
- 11.3.1 Company Overview
- 11.3.2 Company Insights
- 11.3.3 Business Breakdown
- 11.3.4 Product Benchmarking
- 11.3.5 Key Developments
- 11.3.6 Winning Imperatives
- 11.3.7 Current Focus & Strategies
- 11.3.8 Threat from Competition
- 11.3.9 SWOT Analysis
11.4 Biosynex Group
- 11.4.1 Company Overview
- 11.4.2 Company Insights
- 11.4.3 Business Breakdown
- 11.4.4 Product Benchmarking
- 11.4.5 Key Developments
- 11.4.6 Winning Imperatives
- 11.4.7 Current Focus & Strategies
- 11.4.8 Threat from Competition
- 11.4.9 SWOT Analysis
11.5 BioSURE United Kingdom Ltd.
- 11.5.1 Company Overview
- 11.5.2 Company Insights
- 11.5.3 Business Breakdown
- 11.5.4 Product Benchmarking
- 11.5.5 Key Developments
- 11.5.6 Winning Imperatives
- 11.5.7 Current Focus & Strategies
- 11.5.8 Threat from Competition
- 11.5.9 SWOT Analysis
11.6 ECO Diagnostica
- 11.6.1 Overview
- 11.6.2 Financial Performance
- 11.6.3 Product Outlook
- 11.6.4 Key Development
11.7 bioLytical Laboratories
- 11.7.1 Overview
- 11.7.2 Financial Performance
- 11.7.3 Product Outlook
- 11.7.4 Key Developments
11.8 Sedia Biosciences Corporation
- 11.8.1 Overview
- 11.8.2 Financial Performance
- 11.8.3 Product Outlook
- 11.8.4 Key Development
11.9 Orangelife Comercio e Industria LTDA
- 11.9.1 Overview
- 11.9.2 Financial Performance
- 11.9.3 Product Outlook
- 11.9.4 Key Development
11.10 WAMA Diagnostica
- 11.10.1 Overview
- 11.10.2 Financial Performance
- 11.10.3 Product Outlook
- 11.10.4 Key Development