체외 대장암 스크리닝 검사 시장 예측(-2032년) - 검사 유형별, 영상 유형별, 제공 방법별, 용도별, 최종사용자별, 지역별 분석

According to Stratistics MRC, the Global In-vitro Colorectal Cancer Screening Tests Market is accounted for $1.29 billion in 2025 and is expected to reach $2.17 billion by 2032 growing at a CAGR of 7.7% during the forecast period. In-vitro colorectal cancer screening tests are non-invasive diagnostic procedures that analyze biological samples typically stool or blood outside the body to detect early signs of colorectal cancer. These tests identify biomarkers such as occult blood, DNA mutations, or protein indicators associated with malignancies or precancerous polyps. Common methods include fecal occult blood tests (FOBT), fecal immunochemical tests (FIT), and DNA-based assays. Designed for routine screening, they support early detection, improve treatment outcomes, and reduce mortality by identifying cancer before symptoms appear

According to article in The Lancet Oncology, multitarget stool DNA tests (such as Cologuard) showed a sensitivity of over 90% for detecting colorectal cancer and around 42% for advanced adenomas.

Market Dynamics:

Driver:

Rising incidence and prevalence of colorectal cancer

Early detection is becoming a top priority for healthcare providers aiming to improve patient outcomes and reduce treatment costs. As public health programs continue emphasizing routine screening for individuals aged 45 and above, test volumes are expected to rise substantially. Moreover, awareness initiatives by cancer associations and governmental bodies are bolstering demand for non-invasive testing. This trend is further supported by the growing recognition of screening as a preventive strategy rather than a reactive measure.

Restraint:

Lower sensitivity and specificity of traditional tests

Conventional screening options, such as guaiac-based tests or outdated fecal assays, often suffer from limited sensitivity and specificity, resulting in false positives or missed diagnoses. These shortcomings can erode clinician and patient confidence in the tests, discouraging adoption in favor of more definitive diagnostics like colonoscopy. Additionally, the risk of under-detection due to low biomarker visibility may lead to disease progression in asymptomatic patients.

Opportunity:

Expansion into underserved and low-resource settings

Populations in rural or low-resource settings often lack access to advanced diagnostic infrastructure, creating a large untapped market. Portable, self-administered kits that require minimal expertise can bridge this gap, especially when distributed through government-backed community health programs. As public-private partnerships expand, stakeholders are increasingly focused on improving healthcare equity by tailoring screening solutions to diverse socioeconomic contexts.

Threat:

Misinterpretation of results and over-diagnosis/under-diagnosis

Inaccurate results may lead to over-diagnosis, subjecting patients to invasive interventions, or under-diagnosis, delaying treatment and worsening prognosis. Variability in test performance across populations adds to clinical complexity, requiring cautious application and expert oversight. Additionally, non-standardized guidelines across healthcare systems contribute to confusion in result interpretation and follow-up protocols. These factors heighten liability concerns and emphasize the need for clinician training and better validation protocols.

Covid-19 Impact:

The COVID-19 pandemic introduced disruptions to cancer screening services worldwide, delaying early diagnosis of colorectal conditions. Lockdowns and restricted hospital access led to a decline in routine check-ups, causing a backlog of undiagnosed cases. On the other hand, the pandemic highlighted the value of home-based and remote diagnostics, prompting renewed interest in self-collection kits and telehealth-integrated testing. This shift in behavior is likely to have lasting effects on screening strategies and could serve as a growth accelerator for in-vitro solutions.

The fecal occult blood test (FOBT) segment is expected to be the largest during the forecast period

The fecal occult blood test (FOBT) segment is expected to account for the largest market share during the forecast period due to its cost-effectiveness, wide availability, and non-invasive nature. Used as a frontline screening tool in numerous national cancer prevention programs, FOBTs are easily distributed and administered. Their convenience and minimal infrastructure requirements make them ideal for large-scale deployments across both developed and emerging markets.

The marcareplex segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the marcareplex segment is predicted to witness the highest growth rate driven by its multiplex biomarker approach and high diagnostic precision. These advanced assays can detect multiple cancer-specific markers simultaneously, providing a more comprehensive risk assessment. Their efficiency in identifying early-stage malignancies makes them attractive for clinical labs seeking accurate yet scalable testing solutions.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share attributed to well-established screening guidelines and expansive health coverage systems. Widespread awareness campaigns and proactive screening initiatives by agencies like the CDC and ACS have boosted participation rates across demographics. Strong funding for cancer prevention research and early technology adoption further enhance the regional market outlook.

Region with highest CAGR:

Over the forecast period, the Europe region is anticipated to exhibit the highest CAGR owing to increased public health initiatives and growing emphasis on preventive diagnostics. Countries such as Germany, the U.K., and France are expanding national cancer screening programs to include high-risk populations. Technological innovation, particularly in biomarker discovery and AI-driven analytics, is gaining traction in the region's med-tech ecosystem.

Key players in the market

Some of the key players in In-vitro Colorectal Cancer Screening Tests Market include Sysmex Corporation, Siemens Healthcare GmbH, Randox Laboratories Ltd., Quest Diagnostics Incorporated, OncoCyte Corporation, Merck KGaA, Kyowa Kirin Co., Ltd., Invitae Corporation, Immunostics Inc., Illumina, Inc., Hologic, Inc., Genomic Health, Inc., F. Hoffmann-La Roche AG, Exact Sciences Corporation, Epigenomics AG, Eiken Chemical Co., Ltd., Bio-Rad Laboratories, Inc., Beckman Coulter Inc. and Abbott Laboratories.

Key Developments:

In June 2025, Illumina agreed to buy proteomics company SomaLogic for $350 million plus milestones, bolstering its multiomics capabilities. The deal enhances its strategy across genomics, proteomics, and personalized medicine

In May 2025, Siemens Healthineers launched the first U.S. Mobile Stroke Unit equipped with a Somatom On.site CT scanner to deliver advanced stroke diagnostics at UCLA Health. This rapid-response ambulance aims to reduce treatment delays and improve outcomes.

Test Types Covered:

• Fecal Occult Blood Test (FOBT)
• Stool DNA Test (sDNA)
• Biomarker Tests (Blood-based Tests)
• Other Test Types

Imaging Types Covered:

• Colonoscopy
• Proctoscopy
• CT Scan
• Ultrasound
• PET Scan
• MRI

Mode of Offerings Covered:

• Physician-Led Screening
• Direct-to-Consumer (DTC) Home Testing

Applications Covered:

• MarCarePlex
• Cologic
• Colox
• miRDIGN
• PanCDx
• MeSorce CRC

End Users Covered:

• Hospitals
• Clinics
• Diagnostic Laboratories
• Ambulatory Surgical Centers
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global In-vitro Colorectal Cancer Screening Tests Market, By Test Type

• 5.1 Introduction
• 5.2 Fecal Occult Blood Test (FOBT)
  • 5.2.1 Guaiac FOBT (gFOBT)
  • 5.2.2 Fecal Immunochemical Test (FIT or iFOBT)
• 5.3 Stool DNA Test (sDNA)
  • 5.3.1 Multitarget Stool DNA Testing
  • 5.3.2 Methylated Gene Testing
  • 5.3.3 Panel DNA Tests
• 5.4 Biomarker Tests (Blood-based Tests)
  • 5.4.1 Tumor M2-PK Stool Test
  • 5.4.2 Transferrin Assays
  • 5.4.3 Plasma Methylated SEPT9 DNA Assay
  • 5.4.4 Liquid Biopsy
• 5.5 Other Test Types

6 Global In-vitro Colorectal Cancer Screening Tests Market, By Imaging Type

• 6.1 Introduction
• 6.2 Colonoscopy
• 6.3 Proctoscopy
• 6.4 CT Scan
• 6.5 Ultrasound
• 6.6 PET Scan
• 6.7 MRI

7 Global In-vitro Colorectal Cancer Screening Tests Market, By Mode of Offering

• 7.1 Introduction
• 7.2 Physician-Led Screening
• 7.3 Direct-to-Consumer (DTC) Home Testing

8 Global In-vitro Colorectal Cancer Screening Tests Market, By Application

• 8.1 Introduction
• 8.2 MarCarePlex
• 8.3 Cologic
• 8.4 Colox
• 8.5 miRDIGN
• 8.6 PanCDx
• 8.7 MeSorce CRC

9 Global In-vitro Colorectal Cancer Screening Tests Market, By End User

• 9.1 Introduction
• 9.2 Hospitals
• 9.3 Clinics
• 9.4 Diagnostic Laboratories
• 9.5 Ambulatory Surgical Centers
• 9.6 Other End Users

10 Global In-vitro Colorectal Cancer Screening Tests Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Sysmex Corporation
• 12.2 Siemens Healthcare GmbH
• 12.3 Randox Laboratories Ltd.
• 12.4 Quest Diagnostics Incorporated
• 12.5 OncoCyte Corporation
• 12.6 Merck KGaA
• 12.7 Kyowa Kirin Co., Ltd.
• 12.8 Invitae Corporation
• 12.9 Immunostics Inc.
• 12.10 Illumina, Inc.
• 12.11 Hologic, Inc.
• 12.12 Genomic Health, Inc.
• 12.13 F. Hoffmann-La Roche AG
• 12.14 Exact Sciences Corporation
• 12.15 Epigenomics AG
• 12.16 Eiken Chemical Co., Ltd.
• 12.17 Bio-Rad Laboratories, Inc.
• 12.18 Beckman Coulter Inc.
• 12.19 Abbott Laboratories