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全球居家體外診斷 (IVD) 檢測市場（2025-2030 年）
市場調查報告書
商品編碼
1858294

全球居家體外診斷 (IVD) 檢測市場（2025-2030 年）

Global Market for At-Home and Home Collection In Vitro Diagnostic (IVD) Testing, 2025-2030
出版日期: | 出版商: Kalorama Information | 英文 125 Pages | 商品交期: 最快1-2個工作天內

價格
簡介目錄

醫療保健領域的便利化革命正在到來，而診斷正是這場革命的核心。 "全球居家體外診斷 (IVD) 檢測市場（2025-2030 年）" 對體外診斷 (IVD) 檢測進行了全面分析，IVD 檢測是診斷行業增長最快的領域之一。這份由 Kalorama Information 發布的報告探討了正在改變患者與檢測和護理互動方式的技術、市場力量和消費者行為。

對於診斷開發人員、投資者和醫療保健策略家而言， "全球居家體外診斷 (IVD) 檢測市場（2025-2030 年）" 提供了重要的洞察，幫助他們了解居家診斷如何超越小眾應用，成為現代醫療保健服務的核心組成部分，並成為全球體外診斷市場未來成長的關鍵驅動力。

在新冠疫情之後，本報告探討了社會對自我檢測日益增長的信任如何重塑傳染病檢測、慢性病管理、腫瘤學、基因檢測和健康篩檢的模式。雖然血糖監測和妊娠檢測仍然是這一領域的核心，但從唾液和尿液到呼氣分析等非侵入性採樣方法的創新，正在將更廣泛的檢測從診所轉移到家庭。

全球家用體外診斷 (IVD) 檢測市場可大致分為以下幾個細分市場：

  • 遺傳學
  • 血糖/糖化血紅素 (HbA1c)
  • 傳染病
  • 其他領域
    • 懷孕與不孕症
    • 凝血
    • 糞便隱血
    • 膽固醇
    • 濫用藥物

每個細分市場都包含對監管趨勢、臨床實踐和近期產品批准的詳細分析，以及截至 2025 年的銷售數據和截至 2030 年的預測趨勢，涵蓋全球主要地區，包括美國、歐洲、中東和非洲 (EMEA)、亞太地區以及其他亞太地區。本研究概述了主要市場領導者和新興競爭對手，並評估了技術進步、消費者接受度和成本因素將如何推動成長並塑造競爭格​​局。

我們也區分了兩個主要細分市場：

  • 家庭體外診斷檢測 - 完全由患者自行操作的檢測，可立即獲得結果（例如，妊娠測試和血糖監測）。
  • 居家採集體外診斷檢測 - 患者自行採集樣本並送至實驗室進行分析（例如，糞便隱血試驗、基因檢測、傳染病檢測）。

範圍與方法

本報告結合一手和二手研究，以2025年為基準年，提供可靠的市場規模、競爭情報和成長預測。 2030年的預測包括複合年增長率 (CAGR) 和區域績效指標。

儘管需求不斷增長，但我們也意​​識到持續存在的挑戰，包括成本效益分析、報銷模式以及監管和隱私框架，這些都可能影響市場普及的速度。

目錄

第1章 摘要整理

第2章 簡介

  • 家庭IVD檢驗概要
    • 市場區隔
    • 市場演進
    • 歷史背景
    • 推動市場要素
    • 主要加入企業
  • 問題和趨勢
    • COVID-19演進
    • 家庭檢驗的退還
    • 持續血糖監測儀
    • 感染疾病
    • 癌症
    • 慢性疾病監測
    • 遺傳的
    • 家庭IVD檢驗的推動因素與課題
    • 在家的檢驗主要的優點
    • 家庭檢驗主要課題
  • 遺傳學
  • 自己的家採取

第3章 家庭IVD檢驗

  • 簡介
    • 糖尿病
    • 妊娠和生殖能力
    • 感染疾病
    • HIV
    • COVID-19和流感
    • 凝固
    • 糞便潛血
    • 膽固醇
    • 濫用藥物
  • 家庭IVD檢驗市場(各檢驗類型)
  • 家庭IVD檢驗市場(樣品各類型)
    • 血液樣品
    • 組織液樣品
    • 尿樣品
    • 口腔/唾液樣品
    • 鼻腔樣品
    • 航班樣品
    • 其他

第4章 家庭IVD檢驗

  • 簡介
    • 妊娠和生殖能力
    • 感染疾病
    • HIV
    • HPV及其他性感染疾病
    • 肝炎
    • COVID-19
    • COVID-19和流感
    • 糞便潛血
    • 膽固醇
    • 遺傳學
    • 其他
  • 自己的家採取IVD檢驗市場(各檢驗類型)
    • 隱私遺傳基因檢驗
  • 樣品各類型家用蒐集試驗市場
    • 血液樣品
    • 尿樣品
    • 口腔/唾液樣品
    • 鼻腔樣品
    • 航班樣品
    • 其他

第5章 市場參與企業

  • 23andMe, Inc
  • Abbott Diagnostics
  • Abingdon Health Ltd.
  • ACON Laboratories, Inc.
  • ARKRAY, Inc.
  • Ascensia Diabetes Care Holdings AG
  • Atomo Diagnostics
  • Becton Dickinson
  • binx healt
  • Biomerica, Inc.
  • Biosynex SA
  • Church & Dwight Co. Inc
  • Color Health, Inc.
  • Dexcom, Inc.
  • EasyDNA
  • Everly Health
  • Exact Sciences
  • GeneDx
  • Helena Laboratories
  • Hemosure, Inc.
  • Laboratory Corporation of America
  • Medichecks.com Ltd.
  • Myriad Genetics, Inc.
  • Natera
  • OraSure Technologies, Inc.
  • Polymedco, Inc
  • Preventis GmbH
  • Prima Lab SA
  • Quest Diagnostics, Inc.
  • QuidelOrtho Corporation
  • Roche Diagnostic Corporation
  • Siemens Healthineers GmbH
  • Swiss Precision Diagnostics GmbH
  • Trividia Health
  • VedaLab

第6章 市場分析

  • 市場概要
  • 試驗各類型市場區隔
  • 葡萄糖和HbA1c
  • 感染疾病
  • 遺傳
  • 其他地區
  • 流通市場
  • 各地區市場
  • 競爭分析
簡介目錄
Product Code: 25-076KA

The convenience revolution in healthcare has arrived-and diagnostics are at the center of it. "The Global Market for At-Home and Home Collection In Vitro Diagnostic (IVD) Testing, 2025-2030" provides a comprehensive analysis of one of the fastest-evolving sectors of the diagnostics industry. Covering both self-administered over-the-counter (OTC) tests and home collection kits analyzed in central laboratories, this Kalorama Information report examines the technologies, market forces, and consumer behaviors transforming how patients engage with testing and care.

For diagnostic developers, investors, and healthcare strategists, "The Global Market for At-Home and Home Collection In Vitro Diagnostic (IVD) Testing, 2025-2030" provides the essential insight needed to understand how home diagnostics are moving beyond niche applications to become a core component of modern healthcare delivery-and a key driver of the global IVD market's future growth.

Building on the momentum sparked by the COVID-19 pandemic, the report explores how growing public confidence in self-testing is reshaping the landscape of infectious disease detection, chronic disease management, oncology, genetic testing, and wellness screening. While glucose monitoring and pregnancy testing continue to anchor the category, innovations in non-invasive sampling methods-from saliva and urine to breath analysis-are enabling a broader range of tests to move from clinic to home.

The global Home IVD testing market is segmented into several broad areas, including:

  • Genetic
  • Glucose/ HbA1c
  • Infectious disease
  • Other areas
    • Pregnancy and Fertility
    • Coagulation
    • Fecal Occult Blood
    • Cholesterol
    • Drugs of Abuse

Each market segment includes a detailed analysis of regulatory trends, clinical practices, and recent product approvals, along with 2025 sales data and forecasts through 2030 across major world regions, including the United States, EMEA, Asia Pacific, and the Rest of World. The study profiles key market leaders and emerging competitors, evaluating how technological advances, consumer acceptance, and cost considerations will drive growth and shape competition.

The report also distinguishes between the two major segments:

  • At-Home IVD Tests - fully self-administered tests providing immediate results (e.g., pregnancy and glucose monitoring).
  • Home Collection IVD Tests - tests where patients collect samples and send them to a laboratory for analysis (e.g., fecal occult blood, genetic, and infectious disease testing).

Scope and Methodology

Using a combination of primary interviews and secondary research, the report delivers reliable market sizing, competitive intelligence, and growth projections based on 2025 as the base year. Forecasts through 2030 include compound annual growth rates (CAGRs) and regional performance indicators.

Despite the growing demand, the report also acknowledges ongoing challenges in cost-benefit analysis, reimbursement models, and regulatory and privacy frameworks that may shape the pace of adoption.

Table of Contents

Chapter 1: Executive Summary

  • Industry at a Glance
  • Size and Growth of the Market
    • Figure 1-1: Global Home IVD Market by Key Segment, 2022-2025 ($ million) [Genetic, Glucose/HbA1c, Infectious Disease, Other Areas]
  • Key Issues and Trends Affecting the Market
  • Competitive Outlook
  • Conclusion Highlights
  • About Kalorama Information

Chapter 2: Introduction

  • Home IVD Testing Overview
    • Market Segments
    • Market Evolution
    • Historical Context
    • Market Drivers
    • Key Players
  • Issues and Trends
    • COVID-19 Evolution
      • Figure 2-1: Home COVID-19 Test Distribution of Sales, by Vendor, 2025 (%)
    • Reimbursement for Home Tests
    • Continuous Glucose Monitors
      • Figure 2-2: Continuous Glucose Monitor Access for Medicaid Beneficiaries Living with Diabetes: State-By-State Coverage
    • Infectious Disease
    • Cancer
    • Chronic Disease Monitoring
    • Genetic
    • Home IVD Testing Drivers and Challenges
      • Figure 2-3: Benefits and Challenges to Home Testing, 2025
    • Key Benefits of Home Testing
    • Key Challenges of Home Testing
  • Genetics
    • Table 2-1: Home Genetic Laboratory Testing, Market Drivers and Barriers
  • Home Collection

Chapter 3: At-Home IVD Tests

  • Introduction
    • Diabetes
      • Table 3-1: Selected Glucose At-Home Testing Meter Innovations
    • Pregnancy and Fertility
    • Infectious Disease
    • HIV
    • COVID-19 & Flu
      • Table 3-2: Selected Molecular COVID-19 and COVID-19 & Flu A/B At-Home Tests for SARS-CoV-2, 2024-2025
      • Table 3-3: Selected Antigen COVID- 19 and COVID-19 & Flu A/B At-Home Tests for SARS-CoV-2, 2024-2025
    • Coagulation
    • Fecal Occult Blood
    • Cholesterol
    • Drugs of Abuse
  • At-Home IVD Test Market by Test Type
    • Table 3-4: Global At-Home IVD Market, by Test Type, 2025 ($ billion) [Glucose, Infectious Disease, Other]
    • Figure 3-1: Global At-Home IVD Market by Distribution of Sales, by Segment, 2025 (%) [Cholesterol, Coagulation, COVID-19+, Drug of Abuse, FOB, Glucose, HIV, Other Infections, Pregnancy & Fertility, Other]
  • At-Home IVD Tests Market by Sample Type
    • Table 3-5: Global At-Home IVD Market, by Sample Type, 2025 ($ billion) [Blood, Interstitial Fluid, Nasal, Oral/Saliva, Stool, Urine, Other]
    • Figure 3-2: Global At-Home IVD Market by Distribution of Sales, by Sample Type, 2020 and 2025 (%) [Blood, Interstitial Fluid, Nasal, Oral/Saliva, Stool, Urine, Other]
    • Figure 3-3: Year-over-Year Growth for At-Home IVD Markets, '23-24 & '24-25 (%) [Cholesterol, Coagulation, COVID-19, Drugs of Abuse, Fecal Occult Blood (FOB), Glucose, HIV, Infectious Disease, Pregnancy & Fertility, Other]
    • Blood Samples
      • Figure 3-4: Estimated Distribution of Blood Sample Sales, by Test Type, 2025 (%) [Cholesterol, Coagulation, Glucose, Other]
    • Interstitial Fluid Samples
    • Urine Samples
      • Figure 3-5: Estimated Distribution of Urine Sample Sales, by Test Type, 2025 (%) [Drugs of Abuse, Infectious Disease, Pregnancy, Other]
    • Oral/Saliva Samples
      • Figure 3-6: Estimated Distribution of Oral/Saliva Sample Sales, by Test Type, 2025 (%) [COVID-19, Drugs of Abuse, HIV, Other]
    • Nasal Samples
      • Figure 3-7: Estimated Distribution of Nasal Sample Sales, by Test Type, 2025 (%) [COVID-19, Other]
    • Stool Samples
      • Figure 3-8: Estimated Distribution of Stool Sample Sales, by Test Type, 2025 (%) [Fecal Occult Blood (FOB), Other]
    • Other

Chapter 4: Home Collection IVD Tests

  • Introduction
    • Pregnancy and Fertility
    • Infectious Disease
    • HIV
    • HPV and Other STDs
    • Hepatitis
    • COVID-19
    • COVID-19 & Flu
    • Fecal Occult Blood
    • Cholesterol
    • Genetics
    • Other
  • Home Collection IVD Test Market by Test Type
    • Table 4-1: Global Home Collection IVD Market, by Test Type, 2025 ($ billion) [Genetics, Infectious Disease, Other Areas]
    • Figure 4-1: Global Home IVD Market by Distribution of Sales, by Segment, 2025 (%) [Cholesterol, Coagulation, COVID-19, Drug of Abuse, FOB, Glucose, HbA1c, HIV, Other Infections, Pregnancy & Fertility, Other]
    • Privacy Genetic Testing
  • Home Collection Tests Market by Sample Type
    • Table 4-2: Global Home Collection IVD Market, by Sample Type, 2025 ($ billion) [Blood, Nasal, Oral/Saliva, Stool, Urine, Other]
    • Figure 4-2: Global Home Collection IVD Market by Distribution of Sales, by Sample Type, 2020 and 2025 (%) [Blood, Nasal, Oral/Saliva, Stool, Urine, Other]
    • Figure 4-3: Year-over-Year Growth for Home Collection IVD Markets, '23-24 and '24-25 (%) [Cholesterol, Coagulation, COVID-19, Drugs of Abuse, Fecal Occult Blood (FOB), Genetic, HbA1c, HIV, Infectious Disease, Pregnancy & Fertility, Other]
    • Blood Samples
      • Figure 4-4: Estimated Distribution of Blood Sample Sales, by Test Type, 2025 (%) [Cholesterol, Fertility, Genetic, Glucose/HbA1c, Infectious Disease - STD Blood Spot, Tumor Marker - PSA Blood Spot, Other - Hormone]
    • Urine Samples
      • Figure 4-5: Estimated Distribution of Urine Sample Sales, by Test Type, 2025 (%) [Infectious Disease - STD, Pregnancy/Fertility, Other - Heavy Metals, Hormone, Nutrition]
    • Oral/Saliva Samples
      • Figure 4-6: Estimated Distribution of Oral/Saliva Sample Sales, by Test Type, 2025 (%) [COVID-19, Drugs of Abuse, Fertility, Genetic, HIV, Other - Hormone, Nutrition, Medication Match]
    • Nasal Samples
      • Figure 4-7: Estimated Distribution of Nasal Sample Sales, by Test Type, 2025 (%) [COVID-19, Other]
    • Stool Samples
      • Figure 4-8: Estimated Distribution of Stool Sample Sales, by Test Type, 2025 (%) [Fecal Occult Blood (FOB), Infectious Disease - Pathogen ID, Other - Heavy Metals]
    • Other

Chapter 5: Market Participants

  • 23andMe, Inc
    • Table 5-1: 23andMe Corporate Summary
    • Company Overview
      • Table 5-2: 23andMe Genetic Tests with FDA Marketing Authorization
  • Abbott Diagnostics
    • Table 5-3: Corporate Summary
    • Company Overview
    • Performance Review
      • Table 5-4: Abbott Revenues, 2020-2024 ($ million)
  • Abingdon Health Ltd.
    • Table 5-5: Abingdon Health Corporate Summary
    • Company Overview
  • ACON Laboratories, Inc.
    • Table 5-6: ACON Laboratories Corporate Summary
    • Company Overview
  • ARKRAY, Inc.
    • Table 5-7: ARKRAY Corporate Summary
    • Company Overview
  • Ascensia Diabetes Care Holdings AG
    • Table 5-8: Ascensia Diabetes Care Corporate Summary
    • Company Overview
  • Atomo Diagnostics
    • Table 5-9: Atomo Corporate Summary
    • Company Overview
  • Becton Dickinson
    • Table 5-10: Becton Dickinson Corporate Summary
    • Company Overview
    • Performance Review
      • Table 5-11: BD Corporation Revenue, 2020-2024 ($ billion)
  • binx health
    • Table 5-12: binx health Corporate Summary
    • Company Overview
  • Biomerica, Inc.
    • Table 5-13: Biomerica Corporate Summary
    • Company Overview
    • Company Financials
      • Table 5-14: Biomerica Corporation Revenue, 2020-2024 ($ million)
  • Biosynex SA
    • Table 5-15: Biosynex Corporate Summary
    • Company Overview
  • Church & Dwight Co. Inc
    • Table 5-16: Church & Dwight Corporate Summary
    • Company Overview
    • Performance Review
      • Table 5-17: Church and Dwight Revenues, 2020-2024 ($ million)
  • Color Health, Inc.
    • Table 5-18: Color Health Corporate Summary
    • Company Overview
  • Dexcom, Inc.
    • Table 5-19: Dexcom Corporation Corporate Summary
    • Company Overview
  • Performance Review
    • Table 5-20: Dexcom Revenues, 2020-2024 ($ million)
  • EasyDNA
    • Table 5-21: EasyDNA Corporate Summary
    • Company Overview
  • Everly Health
    • Table 5-22: Everly Health Corporate Summary
    • Company Overview
  • Exact Sciences
    • Table 5-23: Exact Sciences Corporate Summary
    • Company Overview
    • Performance Review
      • Table 5-24: Exact Sciences Revenues (2020-2024) ($ million)
  • GeneDx
    • Table 5-25: GeneDx Corporate Summary
    • Company Overview
  • Helena Laboratories
    • Table 5-26: Helena Laboratories Corporate Summary
    • Company Overview
  • Hemosure, Inc.
    • Table 5-27: Hemosure Corporate Summary
    • Company Overview
  • Laboratory Corporation of America
    • Table 5-28: Laboratory Corporation of America Corporate Details
    • Company Overview
    • Performance Review
      • Table 5-29: Labcorp Revenue History, 2020-2024 ($ million)
  • Medichecks.com Ltd.
    • Table 5-30: Medichecks Corporate Summary
    • Company Overview
  • Myriad Genetics, Inc.
    • Table 5-31: Myriad Genetics Corporate Summary
  • Company Overview
    • Performance Review
      • Table 5-32: Myriad Diagnostics Revenue, 2020-2024 ($ million)
  • Natera
    • Table 5-33: Natera Corporate Summary
    • Company Overview
    • Performance Review
      • Table 5-34: Natera Revenue History, 2020-2024 ($ million)
  • OraSure Technologies, Inc.
    • Table 5-35: OraSure Technologies Summary
    • Company Overview
    • Performance Review
      • Table 5-36: OraSure Revenues, 2020-2024 ($ million)
  • Polymedco, Inc
    • Table 5-37: Polymedco Corporate Summary
    • Company Overview
  • Preventis GmbH
    • Table 5-38: Preventis Corporate Summary
    • Company Overview
  • Prima Lab SA
    • Table 5-39: Prima Corporate Summary
    • Company Overview
  • Quest Diagnostics, Inc.
    • Table 5-40: Quest Diagnostics Corporate Details
    • Company Overview
  • Performance Review
    • Table 5-41: Quest Diagnostics Revenue History, 2020-2024 ($ million)
  • QuidelOrtho Corporation
    • Table 5-42: QuidelOrtho Corporate Summary
    • Company Overview
  • Performance Review
    • Table 5-43: QuidelOrtho Revenues, 2020-2024 ($ million)
  • Roche Diagnostic Corporation
    • Table 5-44: Roche Diagnostic Corporate Summary
    • Company Overview
  • Performance Review
    • Table 5-45: Roche Diagnostics, 2020-2024 (CHF billion)
  • Siemens Healthineers GmbH
    • Table 5-46: Siemens Healthineers Corporate Summary
    • Company Overview
  • Performance Review
    • Table 5-47: Siemens Healthineers Revenue History, 2020-2024 (Euro million)
  • Swiss Precision Diagnostics GmbH
    • Table 5-48: Swiss Precision Diagnostics Corporate Summary
    • Company Overview
  • Trividia Health
    • Table 5-49: Trividia Health Corporate Summary
    • Company Overview
  • VedaLab
    • Table 5-50: VedaLab Corporate Summary
    • Company Overview

Chapter 6: Market Analysis

  • Market Overview
    • Figure 6-1: Global Home IVD Market, 2025-2030 ($ million) [Genetic, Infectious Disease, Other Areas]
  • Market Segment by Test Type
    • Figure 6-2: Global Home IVD Market by Test Type, 2022-2025 ($ million) [Genetic, Glucose/HbA1c, Infectious Disease, Other Areas]
    • Figure 6-3: Global Home IVD Market, by General Test Segment, 2025 (%) [Genetic, Glucose/HbA1c, Infectious Disease, Other Areas]
  • Glucose & HbA1c
    • Table 6-1: Estimated Global Home IVD Glucose & HbA1c Testing Market, 2025-2030 ($ million)
  • Infectious Disease
    • Table 6-2: Estimated Global Home IVD Infectious Disease Testing Market, 2025-2030 ($ million)
  • Genetic
    • Table 6-3: Estimated Global Home IVD Genetic Testing Market, 2025-2030 ($ million)
  • Other Areas
    • Table 6-4: Estimated Global Home IVD Other Testing Market, 2025-2030 ($ million)
  • Market by Distribution
  • Market by Region
    • Figure 6-4: Estimated Global Home IVD Testing Market, by Region, 2023-2025 ($ million) [APAC, EMEA, United States, Rest of World]
  • Competitive Analysis
    • Figure 6-5: Estimated Global Home IVD Testing Market, Top Vendor Market Share, 2025 (%)