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市场调查报告书

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1643901

全球家庭检测套件市场 - 2025-2033

Global At-home Testing Kits Market - 2025-2033

出版日期: 2025年01月27日 | 出版商:

DataM Intelligence | 英文 200 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2024年，全球家庭检测套件市场规模达到95.3亿美元，预计2033年将达到172.5亿美元，2025-2033年预测期间复合年增长率为7.1%。

家用测试套件，也称为家庭测试套件或家庭诊断套件，是一种医疗用品，使人们能够在舒适的家中针对许多健康问题进行特定的测试或筛检。这些套件通常包括所有必需的工具、全面的说明以及用于将样品发送到检查地点的预付费包装。这些套件为用户提供了一种简单而保密的方式来检查他们的健康状况，而无需前往医疗机构。

技术进步是预测期内推动全球家庭检测套件市场的驱动因素。例如，Masimo 宣布 MightySat Medical 获得 FDA 批准，使其成为第一个也是唯一获得 FDA 批准的无需处方即可使用的医用指尖脉搏血氧仪。该许可证使用户有权使用由 Masimo SET 脉搏血氧仪驱动的脉搏血氧仪医疗设备。技术的不断进步使测试程序变得简单高效，人们正在转向这些测试套件，这增加了需求并推动了全球家庭测试套件市场。

市场动态：

驱动程式和限制

技术进步

技术进步预计将成为全球家庭检测套件市场成长的重要因素。随着医疗保健产业的发展，对快速、准确且易于存取的诊断解决方案的需求不断增长。生物感测器、微流体和晶片实验室系统等众多技术进步改善了诊断，使其更加高效和可靠。例如，2024年9月，雅培实验室宣布在美国推出非处方连续血糖监测仪Lingo。 Abbott 的主要目标之一是通知 Lingo 使用者有关血糖峰值的信息，即当血液中的糖含量突然上升并随后下降时，就会发生这种情况。

此外，DEXIS 于 2024 年 8 月推出了 DEXIS Connect Pro，这是一个针对 DEXIS CBCT 和口内感测器设备的新型主动服务平台，专注于增加设备的正常运行时间。这个独特的平台使用物联网 (IoT) 技术来持续监控这些设备的运作状况，确保它们以最佳状态运作。 DEXIS Connect Pro 旨在透过自动识别潜在问题并根据需要安排援助或设备更换来大幅延长设备的正常运作时间，这对于依赖一致功能来提供患者护理的牙科诊所至关重要。技术的不断进步使测试程序变得简单高效，人们正在转向这些测试套件，这增加了需求并推动了全球家庭测试套件市场。

严格的监管要求

严格的监管要求等因素预计将阻碍全球家庭检测套件市场。这些套件被归类为医疗器械，必须经过美国 FDA 等监管机构和其他国家同等机构的严格审批流程。核准程序通常包括严格的临床验证，以确保测试产生准确可靠的结果。然而，各地区的监管环境差异很大，导致市场环境分散。这种差异使得在多个地区同时寻求许可的公司的程序变得复杂，因为他们必须管理适合每个地区的不同监管框架、文件要求和临床试验协议。这些严格的监管要求阻碍了全球家庭检测套件市场。

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At-home testing kits, also known as home test kits or home diagnostic kits, are medical supplies that enable people to perform particular tests or screenings for a number of health concerns from the comfort of their own homes. These kits generally include all essential tools, comprehensive instructions, and prepaid packaging for sending samples to the place where the examination is done. These kits give users a simple and confidential way to check their health without having to visit a healthcare facility.

Technological advancements are the driving factor that drives the global at-home testing kits market over the forecast period. For instance, Masimo announced that MightySat Medical received FDA clearance, making it the first and only FDA-cleared medical fingertip pulse oximeter available without a prescription. This clearance entitles users to a pulse oximeter medical device powered by Masimo SET pulse oximetry. The increasing technological advancements make the testing procedures simple and efficient, and people are shifting towards these testing kits, which increases the demand and drives the Global At-home testing kits market.

Market Dynamics: Drivers & Restraints

Technological advancements

Technological advancements are expected to be a significant factor in the growth of the global at-home testing kits market. As the healthcare sector evolves, there is a growing demand for rapid, accurate, and easily accessible diagnostic solutions. Numerous technological advancements, such as biosensors, microfluidics, and lab-on-a-chip systems, have improved diagnostics, making them more efficient and reliable. For instance, in September 2024, Abbott Laboratories announced the launch of Lingo, an over-the-counter continuous glucose monitor, in the United States. One of Abbott's key objectives is to notify Lingo users about glucose spikes, which occur when the quantity of sugar in the bloodstream suddenly rises and subsequently decreases.

Moreover, in August 2024, DEXIS launched DEXIS Connect Pro, a new proactive service platform for DEXIS CBCT and Intraoral Sensor Devices that focuses on increasing device uptime. This exclusive platform uses Internet of Things (IoT) technology to continuously monitor the health of these devices, ensuring they function optimally. DEXIS Connect Pro aims to greatly enhance device uptime by automatically identifying potential problems and scheduling assistance or equipment replacements as needed, which is critical for dental offices that rely on consistent functioning to deliver patient care. The increasing technological advancements make the testing procedures simple and efficient, and people are shifting towards these testing kits, which increases the demand and drives the Global At-home testing kits market.

Stringent regulatory requirements

Factors such as stringent regulatory requirements are expected to hamper the global at-home testing kits market. These kits are categorized as medical devices and must go through stringent approval processes from regulatory agencies like the FDA in the United States and equivalent authorities in other countries. The approval procedure usually includes rigorous clinical validation to ensure that the tests produce accurate and reliable results. However, the regulatory landscape differs significantly among regions, resulting in a fragmented market environment. This discrepancy complicates the procedure for companies seeking simultaneous licenses in several regions, as they must manage diverse regulatory frameworks, documentation requirements, and clinical trial protocols appropriate to each region. These stringent regulatory requirements hamper the global at-home testing kits market.

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Segment Analysis

The Global At-home Testing Kits Market is segmented based on Product Type, Application, Sample, Distribution Channel, And Region.

Blood glucose testing segment is expected to dominate the global At-home testing kits market share.

Blood glucose testing is anticipated to dominate the global At-home Testing Kits market owing to increased diabetes prevalence, technological improvements, and an increase in demand for rapid diagnostic solutions. Diabetes remains a huge public health challenge around the world, thus effective management strategies are more important than ever. The increasing prevalence is one of the major reasons for the dominance of this segment. For instance, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population. The rising number of diabetes cases increases the need for blood glucose testing and it increases the demand for blood glucose testing devices making this segment the most dominant.

In recent times, there have been launches and FDA approvals of blood glucose testing devices. For instance, in September 2024, Abbott Laboratories announced that its over-the-counter continuous glucose monitor Lingo is available in the U.S. One of Abbott's primary goals is to help Lingo users learn about glucose spikes, which occur when the amount of sugar present in the bloodstream rapidly increases and then decreases. Technological advancements and an increasing number of diabetes among the population increase the demand for blood glucose testing, making this segment the most dominating in the global at-home testing kits market.

Geographical Analysis

North America is expected to hold a significant position in the global at-home testing kits market share.

North America will likely account for a significant share of the global at-home testing kits market, owing to strong healthcare infrastructure, rising incidence of chronic diseases, and technological improvements. The increased prevalence of chronic diseases, such as diabetes, cardiovascular problems, and infectious diseases, is a major driver of market expansion in North America. For instance, according to the Centers for Disease Control and Prevention, in 2024 more than 38 million Americans have diabetes (about 1 in 10), and about 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens, and young adults are also developing it. This upsurge increases the need for quick and efficient diagnostics which increases the demand for at-home testing kits in this region.

There are recent launches in this region due to the presence of major players. For instance, in June 2024, Prevounce Health announced the launch of its first remote blood glucose monitoring device, Pylo GL1-LTE. The blood glucose meter has been scientifically tested and linked to numerous cellular networks to guarantee more dependable data transmission across the United States. The GL1-LTE is compatible with the Prevounce remote care management platform and may be integrated with other health software using the Pylo cloud API. Prevounce's Pylo cellular-connected devices include blood pressure monitors and weight scales. The technological advancements, make testing procedures easy and efficient and it increases the demand for the at-home testing kits and drives the market in this region.

Asia Pacific is growing at the fastest pace in the global at-home testing kits market.

The Asia Pacific region is emerging as the fastest-growing market for at-home testing kits, owing to rising healthcare funds, increased awareness of early disease diagnosis, the demand for quick and precise diagnostic results, and technological advancements. The need for at-home testing kits has increased as these kits have proven invaluable for the early diagnosis and monitoring of a variety of health disorders, thereby improving disease management results throughout the region.

There are recent launches of devices in this region making it the fastest-growing region. For instance, in September 2024, Mankind Pharma Ltd. announced the launch of its latest innovation, RAPID NEWS self-test kits, which are intended to address common health conditions such as dengue, urinary tract infections (UTIs), and early menopause. This launch is a significant step toward accessible healthcare, with the goal of providing citizens across India with convenient, confidential, and rapid testing alternatives. The increasing demand for at-home testing kits and the technological advancements drive the market in this region.

Competitive Landscape

The major global players in the global at-home testing kits market are Abbott, F. Hoffmann-La Roche, BD, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher Corporation, SEKISUI Diagnostics, Trinity Biotech, Beckman Coulter, Inc., Nova Biomedical among others.

Emerging Players

PocDoc, Biocode, Sense4Med among others

Key Developments

In August 2024, The Dengue NS1 Antigen Self-Test is a proactive tool that detects the dengue NS1 antigen in patients as soon as symptoms occur. This early detection capability allows people to take charge of their health and seek urgent medical attention. The NS1 antigen can be found in both primary and subsequent dengue infections.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global at-home testing kits market report delivers a detailed analysis with 70+ key tables, more than 50+ visually impactful figures, and 200 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Application
3.3. Snippet by Sample
3.4. Snippet by Distribution Channel
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Technological Advancements
- 4.1.3. Restraints
- 4.1.4. Stringent Regulatory Requirements
- 4.1.5. Opportunity
- 4.1.6. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Product Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Digital Monitoring Instruments*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Strips
6.4. Test Panels
6.5. Sample Collection Kits
6.6. Others

7. By Application

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 7.1.2. Market Attractiveness Index, By Application
7.2. Blood Glucose Testing*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Pregnancy & Fertility Testing
7.4. Cancer Testing
7.5. Drug Abuse Testing
7.6. Cholesterol Testing
7.7. Others

8. By Sample

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 8.1.2. Market Attractiveness Index, By Sample
8.2. Urine*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Blood
8.4. Saliva
8.5. Vaginal swab
8.6. Others

9. By Distribution Channel

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 9.1.2. Market Attractiveness Index, By Distribution Channel
9.2. Hospital Pharmacies*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Retail Pharmacies
9.4. Online Pharmacies

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Sample
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Abbott*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. F. Hoffmann-La Roche
12.3. BD
12.4. Siemens Healthcare Private Limited
12.5. Bio-Rad Laboratories, Inc.
12.6. Danaher Corporation
12.7. SEKISUI Diagnostics
12.8. Trinity Biotech
12.9. Beckman Coulter, Inc.
12.10. Nova Biomedical

LIST NOT EXHAUSTIVE