全球居家体外诊断 (IVD) 检测市场(2025-2030 年)
市场调查报告书
商品编码
1858294

全球居家体外诊断 (IVD) 检测市场(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个工作天内

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简介目录

医疗保健领域的便利化革命正在到来,而诊断正是这场革命的核心。 "全球居家体外诊断 (IVD) 检测市场(2025-2030 年)" 对体外诊断 (IVD) 检测进行了全面分析,IVD 检测是诊断行业增长最快的领域之一。这份由 Kalorama Information 发布的报告探讨了正在改变患者与检测和护理互动方式的技术、市场力量和消费者行为。

对于诊断开发人员、投资者和医疗保健策略家而言, "全球居家体外诊断 (IVD) 检测市场(2025-2030 年)" 提供了重要的洞察,帮助他们了解居家诊断如何超越小众应用,成为现代医疗保健服务的核心组成部分,并成为全球体外诊断市场未来成长的关键驱动力。

在新冠疫情之后,本报告探讨了社会对自我检测日益增长的信任如何重塑传染病检测、慢性病管理、肿瘤学、基因检测和健康筛检的模式。虽然血糖监测和妊娠检测仍然是这一领域的核心,但从唾液和尿液到呼气分析等非侵入性采样方法的创新,正在将更广泛的检测从诊所转移到家庭。

全球家用体外诊断 (IVD) 检测市场可大致分为以下几个细分市场:

  • 遗传学
  • 血糖/糖化血红素 (HbA1c)
  • 传染病
  • 其他领域
    • 怀孕与不孕症
    • 凝血
    • 粪便隐血
    • 胆固醇
    • 滥用药物

每个细分市场都包含对监管趋势、临床实践和近期产品批准的详细分析,以及截至 2025 年的销售数据和截至 2030 年的预测趋势,涵盖全球主要地区,包括美国、欧洲、中东和非洲 (EMEA)、亚太地区以及其他亚太地区。本研究概述了主要市场领导者和新兴竞争对手,并评估了技术进步、消费者接受度和成本因素将如何推动成长并塑造竞争格​​局。

我们也区分了两个主要细分市场:

  • 家庭体外诊断检测 - 完全由患者自行操作的检测,可立即获得结果(例如,妊娠测试和血糖监测)。
  • 居家采集体外诊断检测 - 患者自行采集样本并送至实验室进行分析(例如,粪便隐血试验、基因检测、传染病检测)。

范围与方法

本报告结合一手和二手研究,以2025年为基准年,提供可靠的市场规模、竞争情报和成长预测。 2030年的预测包括复合年增长率 (CAGR) 和区域绩效指标。

儘管需求不断增长,但我们也意​​识到持续存在的挑战,包括成本效益分析、报销模式以及监管和隐私框架,这些都可能影响市场普及的速度。

目录

第1章 摘要整理

第2章 简介

  • 家庭IVD检验概要
    • 市场区隔
    • 市场演进
    • 历史背景
    • 推动市场要素
    • 主要加入企业
  • 问题和趋势
    • COVID-19演进
    • 家庭检验的退还
    • 持续血糖监测仪
    • 感染疾病
    • 癌症
    • 慢性疾病监测
    • 遗传的
    • 家庭IVD检验的推动因素与课题
    • 在家的检验主要的优点
    • 家庭检验主要课题
  • 遗传学
  • 自己的家采取

第3章 家庭IVD检验

  • 简介
    • 糖尿病
    • 妊娠和生殖能力
    • 感染疾病
    • HIV
    • COVID-19和流感
    • 凝固
    • 粪便潜血
    • 胆固醇
    • 滥用药物
  • 家庭IVD检验市场(各检验类型)
  • 家庭IVD检验市场(样品各类型)
    • 血液样品
    • 组织液样品
    • 尿样品
    • 口腔/唾液样品
    • 鼻腔样品
    • 航班样品
    • 其他

第4章 家庭IVD检验

  • 简介
    • 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
    • 粪便潜血
    • 胆固醇
    • 遗传学
    • 其他
  • 自己的家采取IVD检验市场(各检验类型)
    • 隐私遗传基因检验
  • 样品各类型家用蒐集试验市场
    • 血液样品
    • 尿样品
    • 口腔/唾液样品
    • 鼻腔样品
    • 航班样品
    • 其他

第5章 市场参与企业

  • 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 市场分析

  • 市场概要
  • 试验各类型市场区隔
  • 葡萄糖和HbA1c
  • 感染疾病
  • 遗传
  • 其他地区
  • 流通市场
  • 各地区市场
  • 竞争分析
简介目录
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 (%)