Regulatory Approvals for Innovative Blood-Based Diagnostics Drives the Blood Screening Market Growth

Blood screening market was valued at $3.7 billion in 2025 and is projected to reach $10.9 billion by 2035, growing at a CAGR of 11.3% during the forecast period (2026–2035). Regulatory clearance of novel blood-based diagnostics enhances market credibility and adoption, encouraging healthcare providers to incorporate them into routine practice and thereby fueling overall market growth. Such approvals diminish reliance on invasive therapies, increase access to earlier diagnosis, and increase payer and clinician confidence, all of which drive demand throughout screening, diagnostic, and monitoring applications.

Browse the full report description of “Blood Screening Market Size, Share & Trends Analysis Report by Product Type (Reagents & Kits, Instruments, and Software & Services) by Technology (Enzyme and Chemiluminescent immunoassays (EIA/CLIA), Nucleic Acid Amplification Testing (NAT), Chemiluminescence Immunoassay (CLIA), Western Blotting, and Next-Generation Sequencing (NGS)) and by End User (Blood Banks, and Hospitals & Diagnostic Laboratories) Forecast Period (2026-2035)” at https://www.omrglobal.com/industry-reports/blood-screening-market

For instance, in May 2025, the US Food and Drug Administration approved the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio for sale as the first in vitro diagnostic tool for the diagnosis of Alzheimer's disease. It tests the levels of two proteins, pTau217 and ?-amyloid 1-42, in human plasma and computes the ratio of their amount. This ratio is also associated with the presence or absence of amyloid plaques in the patient's brain, thereby reducing the need for PET scans. The same tests are applied to cerebrospinal fluid samples, drawn using an invasive lumbar puncture. The new Lumipulse test is less invasive and more accessible to patients.

Recent FDA Approvals of Blood-Based Diagnostic Tests

• In June 2025, the FDA approved a new blood test to diagnose Alzheimer's in its early stages, potentially benefiting more than 7 million US residents suffering from the illness.
• In August 2024, the FDA approved the Shield blood test for colon cancer screening, which is the second approved blood test to identify the lethal cancer. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio quantifies two proteins in human plasma, minimizing the role of PET scans. The test is a simple blood draw and less invasive than cerebrospinal fluid samples. If approved, it doubles the rate of survival for colorectal cancer, as only 40% of diagnoses are made in the early stage.

Market Coverage

• The market number available for – 2025-2035
• Base year- 2025
• Forecast period- 2026-2035
• Segment Covered-
  • By Product Type
  • By Technology
  • By End User
• Regions Covered-
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Competitive Landscape - Abbott Laboratories, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., Grifols S.A., Thermo Fisher Scientific Inc., among others.

Key questions addressed by the report.

• What is the market growth rate?
• Which segment and region dominate the market in the base year?
• Which segment and region will project the fastest growth in the market?
• Who is the leader in the market?
• How are players addressing challenges to sustain growth?
• Where is the investment opportunity?

Global Blood Screening Market Report Segment

By Product Type

• Reagents & Kits
• Instruments
• Software & Services

By Technology

• Enzyme and Chemiluminescent immunoassays (EIA/CLIA)
• Nucleic Acid Amplification Testing (NAT)
• Chemiluminescence Immunoassay (CLIA)
• Western Blotting
• Next-Generation Sequencing (NGS)

By End User

• Blood Banks
• Hospitals & Diagnostic Laboratories

Global Blood Screening Market Report Segment by Region

North America

• United States
• Canada

Europe

• UK
• Germany
• Italy
• Spain
• France
• Russia
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia and New Zealand
• ASEAN Economies
• Rest of Asia-Pacific

Rest of the World

• Latin America
• Middle East & Africa

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