Global In-vitro Colorectal Cancer Screening Tests Market by Test Type (Fecal Immunochemical Test (FIT), Stool DNA Test, Guaiac-based Fecal Occult Blood Test (gFOBT)), by Technology (Enzyme Immunoassay (EIA), Polymerase Chain Reaction (PCR)), by End-Use (Hospitals, Diagnostic Laboratories), and by Region; Insights & Forecast (2024 – 2030)

As per Intent Market Research, the In-vitro Colorectal Cancer Screening Tests Market was valued at USD 5.4 Billion in 2024-e and will surpass USD 8.6 Billion by 2030; growing at a CAGR of 8.2% during 2025 - 2030.

The in-vitro colorectal cancer screening tests market is experiencing significant growth due to the increasing demand for early detection of colorectal cancer, a leading cause of cancer-related deaths globally. These screening tests are non-invasive and are primarily used for the detection of potential abnormalities, providing an effective means of identifying individuals at higher risk for colorectal cancer. With advancements in technology, these tests are becoming more accurate, efficient, and accessible, thereby contributing to the overall market expansion. The growing awareness about the importance of early cancer detection, coupled with rising health consciousness, further bolsters the demand for such diagnostic tools.

Fecal Immunochemical Test (FIT) is Fastest Growing Owing to Its Non-Invasive Nature

Among the various test types available for colorectal cancer screening, the fecal immunochemical test (FIT) is witnessing the fastest growth. FIT is a non-invasive test that detects occult blood in stool, which is one of the earliest indicators of colorectal cancer. The test's growing popularity can be attributed to its ease of use, affordability, and high sensitivity for detecting blood in the stool, making it a preferred choice for both patients and healthcare providers. Furthermore, FIT's ability to detect colorectal cancer at an early stage is a key factor driving its adoption in routine screening programs, especially in high-risk populations.

Polymerase Chain Reaction (PCR) Technology is Largest Owing to Its High Sensitivity

The polymerase chain reaction (PCR) technology is the largest segment in the in-vitro colorectal cancer screening tests market, driven by its unparalleled sensitivity and precision in detecting genetic mutations associated with colorectal cancer. PCR allows for the amplification and detection of DNA or RNA from stool samples, providing accurate results even with a small number of cancerous cells present. Its ability to identify gen

etic markers specific to colorectal cancer gives it a significant advantage in early detection, making it a vital tool in personalized medicine and targeted therapies.

Hospitals are Largest End-Use Industry Due to High Volume of Screening

Hospitals are the largest end-use industry for in-vitro colorectal cancer screening tests. This is due to the high volume of patients seeking screening as part of routine check-ups or for early detection of cancer, particularly among those with a family history of colorectal cancer. Hospitals have the necessary infrastructure, skilled professionals, and diagnostic equipment to conduct these tests at scale, making them the primary setting for most colorectal cancer screenings. Additionally, hospitals are increasingly integrating these tests into their cancer prevention programs, further driving the growth of this segment.

North America is the Largest Region Driven by High Awareness and Healthcare Infrastructure

North America is the largest region in the in-vitro colorectal cancer screening tests market, with the United States leading the charge. This is largely due to the high awareness levels regarding colorectal cancer and the availability of advanced healthcare infrastructure that supports the adoption of early detection tests. The region also benefits from robust reimbursement policies and government initiatives that encourage regular screenings, particularly for individuals aged 50 and above. The presence of key market players and ongoing research and development activities further contribute to the region's dominance in this market.

Leading Companies and Competitive Landscape

The in-vitro colorectal cancer screening tests market is highly competitive, with several prominent companies driving innovation and expansion. Key players include Abbott Laboratories, F. Hoffmann-La Roche AG, Exact Sciences Corporation, and Thermo Fisher Scientific, among others. These companies are focusing on enhancing their product offerings through technological advancements such as the development of more accurate PCR-based tests and improved fecal immunochemical test kits. Additionally, partnerships and collaborations with hospitals and diagnostic laboratories are crucial strategies adopted by market players to expand their reach and enhance customer access to screening services. The competitive landscape is marked by a strong emphasis on product innovation, regulatory approvals, and increasing healthcare partnerships to capitalize on the growing demand for early cancer detection.

Recent Developments:

  • Exact Sciences launched an updated version of its Cologuard stool DNA test, improving its accuracy in detecting colorectal cancer in early stages.
  • Abbott Laboratories received FDA approval for its new stool-based colorectal cancer test, offering a more affordable option for early detection.
  • Roche Diagnostics acquired a leading molecular diagnostics company to strengthen its colorectal cancer screening portfolio with innovative PCR-based tests.
  • Quest Diagnostics expanded its colorectal cancer screening services by integrating at-home testing kits with its laboratory services.
  • Hologic Inc. launched a new multi-target stool DNA test aimed at improving the detection rate of colorectal cancer through its advanced molecular platform.

List of Leading Companies:

  • Abbott Laboratories
  • Exact Sciences Corporation
  • Roche Diagnostics
  • Quest Diagnostics
  • Hologic Inc.
  • F. Hoffmann-La Roche Ltd.
  • CardioDx, Inc.
  • Sierra Diagnostics
  • Cigna Corporation
  • LabCorp
  • Cologuard (Exact Sciences)
  • Eiken Chemical Co. Ltd.
  • Epigenomics AG
  • MDXHealth
  • Biocartis

Report Scope:

Report Features

Description

Market Size (2024-e)

USD 5.4 Billion

Forecasted Value (2030)

USD 8.6 Billion

CAGR (2025 – 2030)

8.2%

Base Year for Estimation

2024-e

Historic Year

2023

Forecast Period

2025 – 2030

Report Coverage

Market Forecast, Market Dynamics, Competitive Landscape, Recent Developments

Segments Covered

Global In-vitro Colorectal Cancer Screening Tests Market by Test Type (Fecal Immunochemical Test (FIT), Stool DNA Test, Guaiac-based Fecal Occult Blood Test (gFOBT)), by Technology (Enzyme Immunoassay (EIA), Polymerase Chain Reaction (PCR)), by End-Use (Hospitals, Diagnostic Laboratories), and by Region

Regional Analysis

North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, South Korea, Australia, India, and Rest of Asia-Pacific), Latin America (Brazil, Argentina, and Rest of Latin America), Middle East & Africa (Saudi Arabia, UAE, Rest of Middle East & Africa)

Major Companies

Abbott Laboratories, Exact Sciences Corporation, Roche Diagnostics, Quest Diagnostics, Hologic Inc., F. Hoffmann-La Roche Ltd., Sierra Diagnostics, Cigna Corporation, LabCorp, Cologuard (Exact Sciences), Eiken Chemical Co. Ltd., Epigenomics AG, Biocartis

Customization Scope

Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements

1. Introduction

   1.1. Market Definition

   1.2. Scope of the Study

   1.3. Research Assumptions

   1.4. Study Limitations

2. Research Methodology

   2.1. Research Approach

      2.1.1. Top-Down Method

      2.1.2. Bottom-Up Method

      2.1.3. Factor Impact Analysis

  2.2. Insights & Data Collection Process

      2.2.1. Secondary Research

      2.2.2. Primary Research

   2.3. Data Mining Process

      2.3.1. Data Analysis

      2.3.2. Data Validation and Revalidation

      2.3.3. Data Triangulation

3. Executive Summary

   3.1. Major Markets & Segments

   3.2. Highest Growing Regions and Respective Countries

   3.3. Impact of Growth Drivers & Inhibitors

   3.4. Regulatory Overview by Country

4. In-vitro Colorectal Cancer Screening Tests Market, by Test Type (Market Size & Forecast: USD Million, 2023 – 2030)

   4.1. Fecal Immunochemical Test (FIT)

   4.2. Stool DNA Test

   4.3. Guaiac-based Fecal Occult Blood Test (gFOBT)

   4.4. Others

5. In-vitro Colorectal Cancer Screening Tests Market, by Technology (Market Size & Forecast: USD Million, 2023 – 2030)

   5.1. Enzyme Immunoassay (EIA)

   5.2. Polymerase Chain Reaction (PCR)

   5.3. Others

6. In-vitro Colorectal Cancer Screening Tests Market, by End-Use (Market Size & Forecast: USD Million, 2023 – 2030)

   6.1. Hospitals

   6.2. Diagnostic Laboratories

   6.3. Others

7. Regional Analysis (Market Size & Forecast: USD Million, 2023 – 2030)

   7.1. Regional Overview

   7.2. North America

      7.2.1. Regional Trends & Growth Drivers

      7.2.2. Barriers & Challenges

      7.2.3. Opportunities

      7.2.4. Factor Impact Analysis

      7.2.5. Technology Trends

      7.2.6. North America In-vitro Colorectal Cancer Screening Tests Market, by Test Type

      7.2.7. North America In-vitro Colorectal Cancer Screening Tests Market, by Technology

      7.2.8. North America In-vitro Colorectal Cancer Screening Tests Market, by End-Use

      7.2.9. By Country

         7.2.9.1. US

               7.2.9.1.1. US In-vitro Colorectal Cancer Screening Tests Market, by Test Type

               7.2.9.1.2. US In-vitro Colorectal Cancer Screening Tests Market, by Technology

               7.2.9.1.3. US In-vitro Colorectal Cancer Screening Tests Market, by End-Use

         7.2.9.2. Canada

         7.2.9.3. Mexico

    *Similar segmentation will be provided for each region and country

   7.3. Europe

   7.4. Asia-Pacific

   7.5. Latin America

   7.6. Middle East & Africa

8. Competitive Landscape

   8.1. Overview of the Key Players

   8.2. Competitive Ecosystem

      8.2.1. Level of Fragmentation

      8.2.2. Market Consolidation

      8.2.3. Product Innovation

   8.3. Company Share Analysis

   8.4. Company Benchmarking Matrix

      8.4.1. Strategic Overview

      8.4.2. Product Innovations

   8.5. Start-up Ecosystem

   8.6. Strategic Competitive Insights/ Customer Imperatives

   8.7. ESG Matrix/ Sustainability Matrix

   8.8. Manufacturing Network

      8.8.1. Locations

      8.8.2. Supply Chain and Logistics

      8.8.3. Product Flexibility/Customization

      8.8.4. Digital Transformation and Connectivity

      8.8.5. Environmental and Regulatory Compliance

   8.9. Technology Readiness Level Matrix

   8.10. Technology Maturity Curve

   8.11. Buying Criteria

9. Company Profiles

   9.1. Abbott Laboratories

      9.1.1. Company Overview

      9.1.2. Company Financials

      9.1.3. Product/Service Portfolio

      9.1.4. Recent Developments

      9.1.5. IMR Analysis

    *Similar information will be provided for other companies 

   9.2. Exact Sciences Corporation

   9.3. Roche Diagnostics

   9.4. Quest Diagnostics

   9.5. Hologic Inc.

   9.6. F. Hoffmann-La Roche Ltd.

   9.7. CardioDx, Inc.

   9.8. Sierra Diagnostics

   9.9. Cigna Corporation

   9.10. LabCorp

   9.11. Cologuard (Exact Sciences)

   9.12. Eiken Chemical Co. Ltd.

   9.13. Epigenomics AG

   9.14. MDXHealth

   9.15. Biocartis

10. Appendix

A comprehensive market research approach was employed to gather and analyze data on the In-vitro Colorectal Cancer Screening Tests Market. In the process, the analysis was also done to analyze the parent market and relevant adjacencies to measure the impact of them on the In-vitro Colorectal Cancer Screening Tests Market. The research methodology encompassed both secondary and primary research techniques, ensuring the accuracy and credibility of the findings.

Research Approach -

Secondary Research

Secondary research involved a thorough review of pertinent industry reports, journals, articles, and publications. Additionally, annual reports, press releases, and investor presentations of industry players were scrutinized to gain insights into their market positioning and strategies.

Primary Research

Primary research involved conducting in-depth interviews with industry experts, stakeholders, and market participants across the E-Waste Management ecosystem. The primary research objectives included:

  • Validating findings and assumptions derived from secondary research
  • Gathering qualitative and quantitative data on market trends, drivers, and challenges
  • Understanding the demand-side dynamics, encompassing end-users, component manufacturers, facility providers, and service providers
  • Assessing the supply-side landscape, including technological advancements and recent developments

Market Size Assessment

A combination of top-down and bottom-up approaches was utilized to analyze the overall size of the In-vitro Colorectal Cancer Screening Tests Market. These methods were also employed to assess the size of various subsegments within the market. The market size assessment methodology encompassed the following steps:

  1. Identification of key industry players and relevant revenues through extensive secondary research
  2. Determination of the industry's supply chain and market size, in terms of value, through primary and secondary research processes
  3. Calculation of percentage shares, splits, and breakdowns using secondary sources and verification through primary sources

Bottom Up and Top Down -

Data Triangulation

To ensure the accuracy and reliability of the market size, data triangulation was implemented. This involved cross-referencing data from various sources, including demand and supply side factors, market trends, and expert opinions. Additionally, top-down and bottom-up approaches were employed to validate the market size assessment.

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