Global Blood Screening Industry in North America Trends: Region-Specific Insights 2025-2033

Key Insights

The North American blood screening market, valued at $7.15 billion in 2025, is projected to experience robust growth, driven by several key factors. The increasing prevalence of chronic diseases like colorectal cancer and the rising geriatric population significantly fuel demand for early detection and preventative screenings. Technological advancements in screening methods, such as the development of more sensitive and non-invasive stool-based tests and improved imaging techniques like CT colonography, contribute to market expansion. Furthermore, increasing awareness campaigns promoting regular health checkups and early disease detection are bolstering market growth. The market is segmented by screening test type (stool-based tests, stool DNA tests, colonoscopy, CT colonography, flexible sigmoidoscopy, and others) and end-user (hospitals, diagnostic centers/laboratories, and other end-users). Hospitals and diagnostic centers currently hold the largest market share due to their established infrastructure and expertise in performing these procedures.

The market's CAGR of 6.70% from 2019-2033 indicates sustained expansion. While challenges remain, including high costs associated with certain screening methods and potential limitations in accessibility, particularly in underserved populations, the overall growth trajectory remains positive. Future growth will likely be fueled by innovative screening technologies, improved reimbursement policies, and an increased focus on preventative healthcare. Competition among key players, including Quidel Corporation, Abbott Laboratories, and Exact Sciences Corporation, is driving innovation and creating a dynamic market landscape. The continued investment in research and development of advanced screening tools, alongside a broader emphasis on personalized medicine, will further shape the future of the North American blood screening market.

Blood Screening Industry in North America: A Comprehensive Market Report (2019-2033)

This in-depth report provides a comprehensive analysis of the North American blood screening industry, offering valuable insights for industry professionals, investors, and stakeholders. The study covers the period from 2019 to 2033, with 2025 as the base year and a forecast period extending to 2033. This report analyzes market dynamics, growth trends, leading segments, and key players, providing a detailed understanding of this rapidly evolving sector. The report segments the market by screening tests (stool-based tests, stool DNA tests, colonoscopy, CT colonography, flexible sigmoidoscopy, other products) and end-users (hospitals, diagnostic centers/laboratories, other end-users). Key players analyzed include Quidel Corporation, Novigenix SA, Abbott Laboratories, Siemens Healthineers AG, F Hoffmann-La Roche AG, Exact Sciences Corporation, Clinical Genomics Technologies Pty Ltd, EKF Diagnostics, MAINZ BIOMED N V, Sysmex Corporation, Epigenomics Inc, and Hemosure Inc.

Blood Screening Industry in North America Market Dynamics & Structure

The North American blood screening market is characterized by a moderate level of concentration, with several large multinational companies holding significant market share. Technological innovation, particularly in areas like liquid biopsies and advanced diagnostic tools, is a key driver of market growth. Stringent regulatory frameworks, including FDA approvals, significantly impact market entry and product adoption. Competition from substitute screening methods and the increasing prevalence of chronic diseases fuel market expansion. The market is witnessing a growing demand from an aging population and increasing awareness of preventative healthcare. Consolidation through mergers and acquisitions (M&A) is also a significant trend shaping the market landscape. The total M&A deal volume between 2019-2024 was estimated at xx Million USD.

• Market Concentration: Moderately concentrated, with top 5 players holding approximately xx% market share in 2024.
• Technological Innovation: Rapid advancements in molecular diagnostics, genomics, and AI-powered analysis are driving innovation.
• Regulatory Landscape: Stringent FDA regulations influence product development and market access.
• Competitive Substitutes: Traditional screening methods (e.g., colonoscopy) face competition from newer blood-based tests.
• End-User Demographics: Aging population and increased awareness of preventive healthcare drive demand.
• M&A Activity: Significant consolidation through acquisitions and partnerships.

Blood Screening Industry in North America Growth Trends & Insights

The North American blood screening market exhibited robust growth during the historical period (2019-2024), driven by factors such as technological advancements, increased screening rates, and rising healthcare expenditure. The market size reached xx Million units in 2024, exhibiting a CAGR of xx% during this period. Technological disruptions, such as the introduction of non-invasive blood tests, have significantly impacted market adoption. Consumer behavior is shifting towards preference for less-invasive, more convenient screening options. The forecast period (2025-2033) anticipates continued growth, driven by factors such as increasing awareness of early detection, technological improvements, and favorable regulatory support. The market is projected to reach xx Million units by 2033, with a projected CAGR of xx%. Market penetration is expected to increase from xx% in 2024 to xx% by 2033.

Dominant Regions, Countries, or Segments in Blood Screening Industry in North America

The United States dominates the North American blood screening market, driven by factors such as higher healthcare expenditure, advanced healthcare infrastructure, and greater awareness of preventative healthcare. Within the screening tests segment, stool-based tests currently hold the largest market share, followed by stool DNA tests. However, blood-based tests are anticipated to experience faster growth owing to their non-invasive nature and potential for early detection. Among end-users, hospitals and diagnostic centers/laboratories contribute the largest share, with growth expected to be fueled by increasing testing volumes and technological upgrades.

• Key Drivers: High healthcare spending, advanced infrastructure, increased awareness of early detection, technological advancements.
• Dominance Factors: Large market size, high adoption rates, and technological leadership in the United States.
• Growth Potential: Significant growth potential exists for blood-based tests and expansion into underserved populations.

Blood Screening Industry in North America Product Landscape

The blood screening product landscape is characterized by a diverse range of tests catering to various disease detection needs. Innovations include improved sensitivity and specificity, faster turnaround times, and the development of multiplex assays capable of detecting multiple biomarkers simultaneously. These advancements are driving improved diagnostic accuracy and efficiency. Liquid biopsies are emerging as a significant area of innovation, offering minimally invasive options for early cancer detection and monitoring. The unique selling propositions of these products include improved patient comfort, reduced procedure times, and higher diagnostic accuracy compared to traditional methods.

Key Drivers, Barriers & Challenges in Blood Screening Industry in North America

Key Drivers: Increasing prevalence of chronic diseases, rising healthcare expenditure, technological advancements, and favorable government policies promoting early disease detection are key drivers. The development of more sensitive and specific tests is accelerating adoption.

Key Barriers and Challenges: High costs associated with new technologies, stringent regulatory hurdles, reimbursement challenges, and competition from established screening methods pose significant challenges. Supply chain disruptions could also affect the availability of testing materials. The estimated impact of regulatory hurdles on market growth is approximately xx% reduction in market size.

Emerging Opportunities in Blood Screening Industry in North America

Untapped markets in underserved populations, the development of point-of-care testing devices, and increasing adoption of personalized medicine approaches present significant opportunities. The integration of AI and machine learning to enhance diagnostic accuracy and efficiency further fuels opportunities for growth. Expansion into new disease areas and development of home-based testing kits offer significant potential.

Growth Accelerators in the Blood Screening Industry in North America Industry

Technological breakthroughs in liquid biopsies and advanced diagnostic platforms are key growth accelerators. Strategic partnerships between technology providers and healthcare institutions enhance market reach and adoption. Expansion into new geographic markets and the development of innovative business models further accelerate market expansion.

Key Players Shaping the Blood Screening Industry in North America Market

• Quidel Corporation
• Novigenix SA
• Abbott Laboratories
• Siemens Healthineers AG
• F Hoffmann-La Roche AG
• Exact Sciences Corporation
• Clinical Genomics Technologies Pty Ltd
• EKF Diagnostics
• MAINZ BIOMED N V
• Sysmex Corporation
• Epigenomics Inc
• Hemosure Inc

Notable Milestones in Blood Screening Industry in North America Sector

• December 2022: Guardant Health, Inc. announced positive results from the ECLIPSE study, demonstrating the potential of its blood test for detecting colorectal cancer in average-risk adults. This significantly advances the field of early cancer detection.
• February 2022: The FDA approved QIAGEN Manchester Ltd.'s Therascreen KRAS RGQ PCR Kit for colorectal cancer screening, expanding the available options for clinicians.

In-Depth Blood Screening Industry in North America Market Outlook

The North American blood screening market is poised for substantial growth over the forecast period. Continued technological advancements, coupled with increasing awareness of preventative healthcare and the growing prevalence of chronic diseases, will drive significant market expansion. Strategic partnerships, new product launches, and expansion into underserved markets represent key strategic opportunities for market players. The market is expected to witness a period of sustained growth and innovation, shaping the future of disease detection and patient care.

Blood Screening Industry in North America Segmentation

• 1. Screening Tests
  • 1.1. Stool-based Tests
    • 1.1.1. Fecal Immunochemical Test (FIT)
    • 1.1.2. Guaiac-based Fecal Occult Blood Test (gFOBT)
    • 1.1.3. Stool DNA Test
  • 1.2. Colonoscopy
  • 1.3. CT Colonography (Virtual Colonoscopy)
  • 1.4. Flexible Sigmoidoscopy
  • 1.5. Other Screening Tests
• 2. End User
  • 2.1. Hospitals
  • 2.2. Diagnostic Centers/Laboratories
  • 2.3. Other End Users
• 3. Geography
  • 3.1. United States
  • 3.2. Canada
  • 3.3. Mexico

Blood Screening Industry in North America Segmentation By Geography

• 1. United States
• 2. Canada
• 3. Mexico