시장보고서
상품코드
1858294

세계의 체외진단(IVD) 검사용 재택 및 자택 채취 시장(2025-2030년)

Global Market for At-Home and Home Collection In Vitro Diagnostic (IVD) Testing, 2025-2030

발행일: | 리서치사: Kalorama Information | 페이지 정보: 영문 125 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    



※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

헬스케어의 편의성 혁명이 도래하고 있으며, 그 중심에 진단약이 있습니다. "세계의 체외진단(IVD) 검사용 재택 및 자택 채취 시장(2025-2030년)은 진단약 업계에서 가장 빠르게 발전하고 있는 분야 중 하나입니다. 체외진단(IVD) 검사의 종합적인 분석을 제공합니다. Kalorama Information의 이 보고서는 환자가 검사 및 치료에 참여하는 방식을 변화시키는 기술, 시장 세력, 소비자 행동에 대해 전해드립니다.

진단약 개발자, 투자자, 헬스케어 전략가들에게 "세계의 체외진단(IVD) 검사용 재택 및 자택 채취 시장(2025-2030년)은 가정용 진단 제품이 틈새 시장을 넘어 현대 의료 서비스 제공의 핵심 요소로 자리 잡고 있으며, 세계 체외진단 시장 전망 성장 동력이 되고 있다는 것을 이해하는 데 필수적인 인사이트를 제공합니다.

이 보고서는 COVID-19 팬데믹(세계적 대유행)을 계기로 자가 검사에 대한 사회적 신뢰가 높아짐에 따라 감염병 감지, 만성질환 관리, 종양학, 유전자 검사, 웰니스 스크리닝의 전망을 어떻게 재구성하고 있는지를 살펴봅니다. 포도당 모니터링과 임신 검사가 여전히 이 카테고리의 중심이지만, 타액과 소변에서 호흡 분석에 이르기까지 비침습적 샘플링 방법의 혁신으로 인해 더 광범위한 검사가 클리닉에서 가정으로 이동하고 있습니다.

세계 가정용 체외진단용 의약품(IVD) 검사 시장은 크게 다음과 같은 몇 가지 분야로 나뉩니다.

  • 유전자
  • 포도당/HbA1c
  • 감염성 질환
  • 기타 분야
    • 임신과 불임
    • 응고
    • 변잠혈
    • 콜레스테롤
    • 약물 남용

각 시장 부문에는 미국, 유럽, 중동 및 아프리카(EMEA), 아시아태평양, 기타 아시아태평양을 포함한 세계 주요 지역의 2025년 매출 데이터와 2030년까지의 동향 예측, 규제 동향, 임상 관행, 최근 제품 승인에 대한 상세한 분석이 포함되어 있습니다. 분석이 포함되어 있습니다. 이번 조사에서는 주요 시장 리더와 신흥 경쟁자들을 소개하고, 기술 발전, 소비자 수용, 비용에 대한 고려가 어떻게 성장을 가속하고 경쟁을 형성하고 있는지 평가합니다.

또한 두 가지 주요 부문을 구분하고 있습니다.

  • 가정용 체외진단 검사 - 완전 자가 관리형 검사로 즉시 결과를 얻을 수 있습니다(임신 검사, 혈당 모니터링 등).
  • 자가채취 IVD 검사 - 환자가 검체를 채취하여 분석을 위해 검사기관에 보내는 검사(분변잠혈검사, 유전자검사, 감염검사 등).

조사 범위 및 방법

이 보고서는 1차 및 2차 조사를 결합하여 2025년을 기준 연도로 삼아 신뢰할 수 있는 시장 규모, 경쟁 정보 및 성장 예측을 제공합니다. 2030년까지의 예측에는 CAGR 및 지역별 성과 지표가 포함됩니다.

수요 증가에도 불구하고 비용 효과 분석, 상환 모델, 규제 및 프라이버시 프레임워크 등 도입 속도를 좌우할 수 있는 여러 가지 이슈가 진행 중임을 인지하고 있습니다.

목차

제1장 개요

제2장 서론

  • 재택 IVD 검사의 개요
    • 시장 부문
    • 시장의 진화
    • 역사적 배경
    • 시장 성장 촉진요인
    • 주요 참여 기업
  • 문제와 동향
    • COVID-19의 진화
    • 재택 검사의 환급
    • 연속 혈당 모니터
    • 감염증
    • 만성질환 모니터링
    • 유전 적
    • 재택 IVD 검사 촉진요인과 과제
    • 자택에서의 검사의 주요 이점
    • 재택 검사의 주요 과제
  • 유전학
  • 자택 채취

제3장 재택 IVD 검사

  • 서론
    • 당뇨병
    • 임신과 생식능력
    • 감염증
    • HIV
    • COVID-19로 인플루엔자
    • 응고
    • 변잠혈
    • 콜레스테롤
    • 남용 약물
  • 재택 IVD 검사 시장(검사 유형별)
  • 재택 IVD 검사 시장(샘플 유형별)
    • 혈액 샘플
    • 조직액 샘플
    • 뇨샘플
    • 구강/타액 샘플
    • 비강 샘플
    • 변샘플
    • 기타

제4장 재택 IVD 검사

  • 서론
    • 임신과 생식능력
    • 감염증
    • HIV
    • HPV와 기타 성감염증
    • 간염
    • COVID-19
    • COVID-19로 인플루엔자
    • 변잠혈
    • 콜레스테롤
    • 유전학
    • 기타
  • 자택 채취 IVD 검사 시장(검사 유형별)
    • 프라이버시 유전자 검사
  • 샘플 유형별 가정용 컬렉션 테스트 시장
    • 혈액 샘플
    • 뇨샘플
    • 구강/타액 샘플
    • 비강 샘플
    • 변샘플
    • 기타

제5장 시장 참여 기업

  • 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

제6장 시장 분석

  • 시장 개요
  • 테스트 유형별 시장 부문
  • 글루코오스와 HbA1c
  • 감염증
  • 유전
  • 기타 지역
  • 유통시장
  • 지역별 시장
  • 경쟁 분석
KSA 25.11.17

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 (%)
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