According to research from Fortune Business Insights, the global blood transfusion diagnostics market was valued at USD 5.70 billion in 2025, and it is expected to climb from USD 6.04 billion in 2026 to USD 8.98 billion by 2034, reflecting a compound annual growth rate (CAGR) of 5.1% over the forecast window. North America led all regions in 2025, holding roughly a 34.91% share of the market.
Blood transfusion diagnostics cover the panel of tests carried out on donated blood and its components before transfusion into a patient. Every unit of blood must be checked for blood group compatibility and screened for disease to guard against adverse reactions or infection transmission, making this testing a core part of transfusion medicine that confirms donor-recipient compatibility.
Growth Drivers
Fortune Business Insights attributes much of the market's expansion to growing demand for safe transfusions as chronic blood disorders become more common and surgical procedure volumes rise, alongside technological improvements and regulatory pressure that are sharpening the accuracy of blood screening.
A major contributor is the rising burden of blood-related conditions. Diseases such as hemophilia, cancer, thrombocytopenia, and chronic kidney disease are driving up demand for blood products and transfusions, with patients managing these conditions often needing transfusions on a recurring basis; rising volumes of childbirths, surgeries, and trauma cases add to this demand. The report cites CDC data indicating that about 14.0% of U.S. adults — some 35.5 million people — were living with chronic kidney disease as of 2023, and IHME figures showing nearly 2 billion people globally were affected by anemia as of September 2023, a condition often treated with red blood cell transfusions.
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Market Restraints and Challenges
Growth is tempered by cost and infrastructure barriers. Specialized testing equipment and kits carry high costs, and gaps in infrastructure and storage facilities in emerging economies — combined with a shortage of professionals trained to run automated diagnostic systems — hold back adoption in those markets.
The industry also faces a persistent safety challenge: despite major advances in testing technology, bacterial contamination of platelet components remains a top infectious risk, and health bodies such as the CDC note that sepsis can still occur even when mitigation strategies such as pathogen-inactivated platelets or negative rapid tests are in place. This keeps pressure on manufacturers and labs to continually refine screening sensitivity, which adds to costs.
Opportunities
Fortune Business Insights points to low- and middle-income countries as a key growth avenue, since their blood screening capacity and quality systems still trail high-income markets, even though bodies like the WHO recommend screening all donated blood for HIV, hepatitis B, hepatitis C, and syphilis under quality-assured conditions. This shortfall creates openings for suppliers of immunoassays, nucleic acid testing (NAT) platforms, blood grouping reagents, and automation tools that support the modernization of national blood services and hospital transfusion labs, particularly vendors offering affordable analyzers and reliable reagent supply and support.
Segment and Regional Highlights
By product, reagents and kits held the largest share in 2025 thanks to their repeat-purchase nature for ongoing screening and typing work, while the instruments segment is projected to grow at a 4.3% CAGR through the forecast period. By application, blood screening is expected to account for about 67.4% of the market in 2026, driven by the prevalence of transfusion-transmissible infections. By end-user, independent laboratories and blood banks led the market in 2025.
Regionally, the U.S. market is projected to reach USD 1.92 billion in 2026, while Europe is expected to reach roughly USD 1.83 billion and Asia Pacific about USD 1.49 billion in the same year.
Competitive Landscape
Immucor, Inc., Grifols, S.A., and Ortho Clinical Diagnostics held the largest combined market share globally in 2025, supported by broad product portfolios and extensive distribution networks. Other notable players named in the report include Bio-Rad Laboratories, F. Hoffmann-La Roche, QUOTIENT, Abbott, and Merck KGaA. Recent developments highlighted include Grifols' October 2025 expansion of DG Gel card and reagent red blood cell manufacturing at a new San Diego facility, following FDA approvals, and a strategic alliance between Grifols and Inpeco to build automated transfusion-medicine labs.
Outlook
With a steady 5.1% CAGR forecast through 2034, the blood transfusion diagnostics market is set to benefit from an aging population, rising chronic disease burden, and continued global emphasis on transfusion safety — even as cost pressures and residual infection risk keep the industry focused on further automation and testing innovation.