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1643901

全球家庭檢測套件市場 - 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個工作天內

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簡介目錄

2024年，全球家庭檢測套件市場規模達到95.3億美元，預計2033年將達到172.5億美元，2025-2033年預測期間複合年成長率為7.1%。

家用測試套件，也稱為家庭測試套件或家庭診斷套件，是一種醫療用品，使人們能夠在舒適的家中針對許多健康問題進行特定的測試或篩檢。這些套件通常包括所有必需的工具、全面的說明以及用於將樣品發送到檢查地點的預付費包裝。這些套件為用戶提供了一種簡單而保密的方式來檢查他們的健康狀況，而無需前往醫療機構。

技術進步是預測期內推動全球家庭檢測套件市場的促進因素。例如，Masimo 宣布 MightySat Medical 獲得 FDA 批准，使其成為第一個也是唯一獲得 FDA 批准的無需處方即可使用的醫用指尖脈搏血氧儀。該許可證使用戶有權使用由 Masimo SET 脈搏血氧儀驅動的脈搏血氧儀醫療設備。技術的不斷進步使測試程序變得簡單高效，人們正在轉向這些測試套件，這增加了需求並推動了全球家庭測試套件市場。

市場動態：

驅動程式和限制

技術進步

技術進步預計將成為全球家庭檢測套件市場成長的重要因素。隨著醫療保健產業的發展，對快速、準確且易於存取的診斷解決方案的需求不斷成長。生物感測器、微流體和晶片實驗室系統等眾多技術進步改善了診斷，使其更加高效和可靠。例如，2024年9月，雅培實驗室宣佈在美國推出非處方連續血糖監測儀Lingo。 Abbott 的主要目標之一是通知 Lingo 使用者有關血糖峰值的資訊，即當血液中的糖含量突然上升並隨後下降時，就會發生這種情況。

此外，DEXIS 於 2024 年 8 月推出了 DEXIS Connect Pro，這是一個針對 DEXIS CBCT 和口內感測器設備的新型主動服務平台，專注於增加設備的正常運行時間。這個獨特的平台使用物聯網 (IoT) 技術來持續監控這些設備的運作狀況，確保它們以最佳狀態運作。 DEXIS Connect Pro 旨在透過自動識別潛在問題並根據需要安排援助或設備更換來大幅延長設備的正常運作時間，這對於依賴一致功能來提供患者護理的牙科診所至關重要。技術的不斷進步使測試程序變得簡單高效，人們正在轉向這些測試套件，這增加了需求並推動了全球家庭測試套件市場。

嚴格的監管要求

嚴格的監管要求等因素預計將阻礙全球家庭檢測套件市場。這些套件被歸類為醫療器械，必須經過美國 FDA 等監管機構和其他國家同等機構的嚴格核准流程。核准程序通常包括嚴格的臨床驗證，以確保測試產生準確可靠的結果。然而，各地區的監管環境差異很大，導致市場環境分散。這種差異使得在多個地區同時尋求許可的公司的程序變得複雜，因為他們必須管理適合每個地區的不同監管框架、文件要求和臨床試驗協議。這些嚴格的監管要求阻礙了全球家庭檢測套件市場。

有關此報告的更多詳細資訊 - 索取樣本

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