HIV自己検査キットの世界市場規模：検査タイプ別、サンプルタイプ別、用途別、地域範囲別および予測

HIV自己検査キットの市場規模と予測

HIV自己検査キット市場規模は、2024年に28億7,000万米ドルと評価され、2026～2032年にかけて30.29%のCAGRで成長し、2032年には199億7,000万米ドルに達すると予測されます。

HIV自己検査キットは、HIVの予防とケアにおける重要な進歩です。HIV自己検査キットは、早期発見と予防努力の促進により、HIV蔓延と闘う貴重な資産としての役割を果たします。

これらの便利で機密性の高いツールは、個人が独立してHIVの状態を評価する力を与え、早期発見を容易にし、医療へのタイムリーなアクセスを促進します。

HIV自己検査キットは、遠隔地や十分なサービスを受けていない地域に住む個人にとって、検査への地理的な障壁をなくし、より利用しやすくなります。

自己検査は、個人のプライバシーを守り、従来型検査環境に伴う潜在的なスティグマを回避する力を与えます。

自己検査によるHIV感染の早期発見は、迅速な医療介入を可能にし、健康状態の改善と感染リスクの低減につながります。

HIV自己検査キットは一般に高い正確率を示すが、提供された指示に細心の注意を払い、不明な点があれば医師の診察を受けることが不可欠であることに変わりはないです。

HIV自己検査キットは、最近の感染を検出できない可能性があるため、必要に応じて医療機関で再検査を受ける必要があります。

HIV自己検査キットの世界市場力学

世界のHIV自己検査キット市場を形成している主要市場力学は以下の通りです。

主要市場促進要因

世界のHIV有病率の増加：世界のHIV有病率の上昇が自己検査キットの需要を促進しています。UNAIDSの報告によると、2023年の世界のHIV感染者数は3,840万人で、2022年から2%増加しました。2024年1月15日、オラシュア・ Technologiesは、有病率の高い地域における検査へのアクセスを改善することを目的として、東南アジアにおける次世代型オラクイックHIV自己検査キットの発売を発表しました。

認知度の向上とスティグマの軽減：認知度の向上とスティグマの軽減に向けた取り組みが、自己検査の普及を後押ししています。WHOは、2023年のHIV自己検査数は2022年に比べて世界で25％増加すると報告しています。2024年3月3日、ゲイツ財団は、サハラ以南のアフリカにおけるHIV自己検査啓発キャンペーンを支援するために5,000万米ドルを拠出し、現地の保健機関と提携して定期検査を正常化することを約束しました。

HIV自己検査技術の革新：HIV自己検査キットの技術革新は、精度と使いやすさを向上させています。FDAは2023年に3つの新しいHIV自己検査技術を承認し、検査の選択肢を増やしました。2024年2月20日には、アボット・ラボラトリーズがスマートフォン接続型のHIV自己検査キットを発表し、ユーザーはデジタル結果を受け取り、ヘルスケアプロバイダと接続してフォローアップケアを受けることができます。

HIV自己検査を促進する政府の取り組み：政府の支援強化により、HIV自己検査へのアクセスが拡大しています。米国保健社会福祉省は、2023年にHIV自己検査プログラムに1億2,000万米ドルを割り当てたが、これは2022年から15％増加したものです。2024年4月5日、英国政府は、年間100万人を対象とした全国規模のHIV自己検査無料配布プログラムを発表しました。

主要課題

限られた認識とスティグマが検査率を妨げています。HIV感染リスクのある人の多くは、検査の重要性を認識していなかったり、HIVにまつわるスティグマに直面したりして、検査を受けることを躊躇しています。このような障壁に対処するためには、一般市民の意識向上キャンペーンを強化し、スティグマを軽減する努力が必要です。

検査施設へのアクセス不足が早期診断を妨げています。特に十分なサービスを受けていない地域や農村部では、検査施設へのアクセスが限られているため、HIV感染の早期診断が妨げられる可能性があります。地域密着型のプログラムを含め、検査施設へのアクセスを拡大することは、この課題に取り組む上で極めて重要です。

検査へのアクセスを妨げる費用の障壁：HIV自己検査キットの費用は、特に低所得者層では、一部の人にとって障壁となる場合があります。そのため、検査へのアクセスが制限され、早期診断が妨げられる可能性があります。手頃な価格または助成金付きの検査オプションを提供することで、この課題を解決することができます。

市場拡大を阻む規制上の課題：HIV自己検査キットの規制状況を把握することは、特に複数の管轄区域で事業を展開する製造業者や販売業者にとって複雑な場合があります。規制要件の遵守はコスト増となり、市場拡大の妨げとなります。

主要動向

遠隔医療による遠隔検査とカウンセリングの促進：遠隔医療の成長により、遠隔地でのHIV検査とカウンセリングが促進されています。CDCは、2023年にHIV自己検査後の遠隔医療相談が40%増加すると報告しています。2024年3月10日、ホロジックはTeladoc Healthと提携し、HIV自己検査とバーチャルカウンセリングのインテグレーションサービスを開始し、ユーザーに包括的なケアを記載しています。

流通チャネルの拡大：多様な流通チャネルがHIV自己検査キットへのアクセスを向上させています。WHOは、2023年に低・中所得国でHIV自己検査キットを提供する薬局が30％増加すると報告しています。2024年1月30日、AmazonはFDA承認のHIV自己検査キットを同社のヘルスケア製品ラインに含めることを発表し、検査へのオンラインアクセスが大幅に拡大しました。

主要人口に到達するための的を絞った取り組み：自己検査キットの普及を後押ししているのは、重要な人口集団を対象とした取り組みです。2024年2月5日、バイオシュアはブラジルのLGBTQ+団体と提携し、10万個のHIV自己検査キットを無料で配布し、リスクの高いコミュニティにおける検査率の向上に注力しました。

規制当局の支援と承認の合理化：支援的な規制が市場の成長を加速させています。欧州医薬品庁は、2023年に5つの新しいHIV自己検査キットを承認し、承認プロセスを合理化しました。2024年3月25日には、WHOがAtomo Diagnosticsの低価格のHIV自己検査キットを承認しました。

目次

第1章 HIV自己検査キットの世界市場導入

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 HIV自己検査キットの世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 HIV自己検査キットの世界市場：検査タイプ別

• 概要
• 迅速検査キット
• 検査室ベースの検査キット

第6章 HIV自己検査キットの世界市場：サンプルタイプ別

• 概要
• 血液
• 尿
• 唾液

第7章 HIV自己検査キットの世界市場：用途別

• 概要
• 在宅検査
• ポイントオブケア検査
• ラボ検査

第8章 HIV自己検査キットの世界市場：エンドユーザー別

• 概要
• 病院
• 診断ラボ
• 専門クリニック
• 研究機関
• その他

第9章 HIV自己検査キットの世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他の欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他のアジア太平洋
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
  • その他のラテンアメリカ
• 中東・アフリカ
  • アラブ首長国連邦
  • サウジアラビア
  • 南アフリカ
  • その他の中東・アフリカ

第10章 HIV自己検査キットの世界市場の競合情勢

• 概要
• 各社の市場ランキング
• 主要開発戦略
• 企業の地域別フットプリント
• 企業の産業フットプリント
• ACEマトリックス

第11章 企業プロファイル

• 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 主要開発

• 製品上市/開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第13章 付録

• 関連調査

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.

TABLE OF CONTENTS

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

12 KEY DEVELOPMENTS

• 12.1 Product Launches/Developments
• 12.2 Mergers and Acquisitions
• 12.3 Business Expansions
• 12.4 Partnerships and Collaborations

13 Appendix

• 13.1 Related Research