Blood Screening Industry in North America in Focus: Growth Trajectories and Strategic 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 a rising prevalence of chronic diseases like colorectal cancer and an aging population necessitating increased screening rates. Technological advancements in screening methodologies, such as the development of more sensitive and specific stool-based tests and non-invasive DNA screening, are further fueling market expansion. The increasing adoption of advanced diagnostic techniques like CT colonography and the growing preference for minimally invasive procedures contribute significantly to the market's positive trajectory. Hospitals and diagnostic centers are the primary end-users, reflecting the importance of established healthcare infrastructure in screening procedures. However, market growth may face certain challenges, including the relatively high cost of some advanced screening tests and potential limitations in accessibility for certain patient populations. Nevertheless, the consistent increase in health awareness and government initiatives promoting preventative healthcare are expected to offset these constraints.

The market's compound annual growth rate (CAGR) of 6.70% from 2025 to 2033 suggests a considerable expansion in market size within the forecast period. This steady growth is fueled by several factors including the continuous development and adoption of improved screening technologies, expanding reimbursement policies that enhance test accessibility, and a greater emphasis on early disease detection and preventative care strategies. Competition among major players like Quidel Corporation, Abbott Laboratories, and Exact Sciences Corporation will likely drive innovation and improve test affordability. Furthermore, the market is segmented by screening test type (stool-based, stool DNA, colonoscopy, etc.) and end-user (hospitals, diagnostic centers, etc.), offering various opportunities for targeted market penetration and strategic growth across different segments. The robust market growth is expected to continue throughout the forecast period, significantly boosting the overall market size and strengthening North America's position as a key player in the global blood screening landscape.

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

This comprehensive report provides an in-depth analysis of the North American blood screening industry, encompassing market dynamics, growth trends, dominant segments, and key players. The study period covers 2019-2033, with 2025 as the base and estimated year. This report is invaluable for industry professionals, investors, and strategists seeking to understand and capitalize on opportunities within this rapidly evolving market. We analyze both parent markets (diagnostic testing) and child markets (specific blood tests for various diseases) to provide a holistic view.

Blood Screening Industry in North America Market Dynamics & Structure

The North American blood screening market is characterized by moderate concentration, with several large players dominating alongside a number of smaller, specialized companies. Technological innovation, particularly in areas like liquid biopsy and advanced molecular diagnostics, is a significant driver of growth. Stringent regulatory frameworks, including FDA approvals, influence product development and market access. Competitive pressures from established players and emerging technologies necessitate continuous innovation. The market also experiences mergers and acquisitions (M&A) activity, driven by companies seeking expansion and technological enhancement. End-user demographics are shifting towards an aging population with increased preventative healthcare awareness.

• Market Concentration: Moderately concentrated, with top 5 players holding approximately xx% market share in 2025.
• Technological Innovation: Rapid advancements in genomics, molecular diagnostics, and AI are transforming blood screening capabilities.
• Regulatory Framework: FDA approvals and compliance are critical for market entry and product success. Stricter regulations are expected to impact smaller companies disproportionately.
• Competitive Substitutes: Other diagnostic methods (e.g., colonoscopy, imaging) create competitive pressure.
• End-User Demographics: Aging population and increased awareness of preventative health drive market growth.
• M&A Activity: xx major M&A deals recorded between 2019-2024, with an estimated xx deals projected for 2025-2033. Driving factors include access to new technologies and expanded market reach.

Blood Screening Industry in North America Growth Trends & Insights

The North American blood screening market experienced significant growth between 2019 and 2024, driven by factors such as increasing prevalence of chronic diseases, rising healthcare expenditure, and technological advancements. The market is projected to continue its expansion, with a Compound Annual Growth Rate (CAGR) of xx% from 2025 to 2033, reaching a market size of xx Million units by 2033. Increased adoption of non-invasive blood tests, improved accuracy and sensitivity of diagnostic tools, and growing awareness among consumers are driving this expansion. Technological disruptions, including the introduction of next-generation sequencing (NGS) and liquid biopsy techniques, are further accelerating market growth. Consumer behavior is shifting towards greater acceptance and demand for convenient, early-stage disease detection through blood screening. Market penetration of blood-based cancer screening, for example, is expected to reach 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 high healthcare expenditure, advanced healthcare infrastructure, and a large aging population. Within the market segments, Stool-based tests and Stool DNA tests for colorectal cancer screening show the highest growth potential, fueled by increased awareness and improved accuracy of these tests. Hospitals and diagnostic centers/laboratories represent the largest end-user segments, owing to their established infrastructure and expertise in handling complex diagnostic tests.

• Dominant Region: United States, accounting for approximately xx% of the market in 2025.
• Leading Segment (Screening Tests): Stool-based tests and Stool DNA tests, driven by the prevalence of colorectal cancer and improved early detection capabilities.
• Key End-User: Hospitals and Diagnostic Centers/Laboratories, due to established infrastructure and expertise.
• Growth Drivers: Increased government funding for cancer screening programs, rising prevalence of chronic diseases, technological advancements in diagnostics, and improved patient access.

Blood Screening Industry in North America Product Landscape

The blood screening market offers a diverse range of products, including tests for various cancers (colorectal, lung, etc.), infectious diseases, and genetic disorders. Recent innovations focus on improving test sensitivity, specificity, and ease of use. Liquid biopsies, using circulating tumor DNA (ctDNA), represent a significant advancement, offering minimally invasive early-stage cancer detection. These tests are characterized by their ability to provide accurate and timely diagnoses, reducing the need for more invasive procedures. The market also features rapid and point-of-care diagnostic solutions, expanding access to testing in diverse settings. Key selling propositions revolve around improved accuracy, non-invasive procedures, and faster results.

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

Key Drivers: Technological advancements (e.g., NGS, liquid biopsy), rising prevalence of chronic diseases, increased government funding for healthcare, and rising consumer awareness of preventative healthcare.

Key Challenges: High cost of advanced technologies, regulatory hurdles for new test approvals, reimbursement challenges, and competition from established diagnostic methods (e.g., colonoscopy). Supply chain disruptions, especially during periods of high demand, can cause temporary shortages of testing materials. The overall regulatory burden can slow down innovation and market entry for smaller companies. Competition from established players with extensive distribution networks presents a major challenge for smaller players.

Emerging Opportunities in Blood Screening Industry in North America

Untapped markets include personalized medicine applications, leveraging genetic information for targeted screening. Innovation opportunities lie in developing more sensitive and specific tests for early-stage disease detection, and developing point-of-care diagnostics for improved access in underserved areas. Growing consumer preferences for convenient, at-home testing solutions also present substantial growth opportunities.

Growth Accelerators in the Blood Screening Industry in North America Industry

Technological breakthroughs in areas like liquid biopsy and AI-powered diagnostics will significantly accelerate market growth. Strategic partnerships between diagnostic companies and healthcare providers will streamline access to testing and broaden market reach. Expansion strategies targeting underserved populations and geographical areas will unlock substantial growth potential.

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 its ECLIPSE study, demonstrating the potential of its blood test for detecting colorectal cancer in average-risk adults. This significantly boosts the acceptance and market potential of blood-based cancer screening.
• February 2022: FDA approval of the Therascreen KRAS RGQ PCR Kit by QIAGEN Manchester Ltd. for colorectal cancer screening expands the available options for clinicians and enhances the accuracy of colorectal cancer diagnosis.

In-Depth Blood Screening Industry in North America Market Outlook

The North American blood screening market is poised for substantial growth, driven by continued technological advancements, increased healthcare spending, and a growing awareness of preventative healthcare. Strategic opportunities exist in developing innovative diagnostic solutions, expanding market access, and establishing strategic partnerships to capture a larger share of this expanding market. The future market potential is significant, particularly for non-invasive liquid biopsy tests and personalized medicine applications.

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