Blood Transfusion Diagnostics Market: as mandatory pre-transfusion testing and nucleic acid donor screening create a legally guaranteed demand floor, automated immunohematology instrument placements are locking in multi-year reagent contracts, so instrument-reagent pull-through compounds across each contract term, and genomic blood typing is beginning to widen the addressable testing menu beyond serology alone.

The global blood transfusion diagnostics market size was USD 4.40 Billion in 2025 and is expected to register a revenue CAGR of 5.8% during the forecast period.Market revenue growth is driven by factors such as mandatory pre-transfusion compatibility testing requirements, expanding nucleic acid testing adoption at national blood safety programmes, and automated immunohematology instrument placements generating long-term reagent contracts.The first driving factor is the legally mandated nature of pre-transfusion testing, which requires compatibility testing and infectious disease donor screening before every transfusion episode.The WHO Global Status Report on Blood Safety and Availability indicates that 118.5 million blood donations are collected globally each year, with pre-transfusion testing required for every donated unit before release.The second driving factor is expanding nucleic acid testing adoption at national blood safety programmes upgrading from serological testing alone.Grifols reported EUR 7,524 Million in total group revenue for 2025 at 7% growth, with its Diagnostic division posting double-digit growth in Blood Typing Solutions across North America, Latin America, and Europe.The third driving factor is automated immunohematology instrument placements that generate long-term reagent pull-through under multi-year blood bank supply contracts.QuidelOrtho reported that its Immunohematology business grew 4% in the fourth quarter of 2024, reflecting sustained recurring reagent revenue from its installed Ortho Vision Max analyzer base.These are some of the key factors driving revenue growth of the market.

A second layer of demand comes from the way a single automated immunohematology instrument placement widens its addressable revenue every year of its multi-year supply contract, without the manufacturer having to win a new blood bank account from zero.Once a blood bank standardises on an automated analyzer platform such as Eflexis or Ortho Vision Max, each subsequent testing cycle draws reagents from the same locked-in supplier for the duration of the typically three-to-five-year contract, so instrument-reagent pull-through compounds in value as the installed base grows without requiring a new procurement cycle for each account.As a result, demand and revenue share are concentrating around vendors with the broadest automated analyzer installed base, that hold the most blood bank tender contracts, and the forecast tilts toward these instrument-anchored reagent franchises rather than reagent-only suppliers competing purely on price.For instance, in June 2025, Devyser, Sweden, launched Devyser Genomic Blood Typing globally, a next-generation sequencing-based assay covering red blood cell, human platelet antigen, and human neutrophil antigen systems in a single streamlined test, widening the addressable testing menu on top of the existing serological reagent pull-through model without displacing it.These are some of the key factors driving revenue growth of the market.

Because the WHO reports that blood donation rates in low-income countries average only 4.6 donations per 1,000 population compared to 31.5 per 1,000 in high-income countries, the transfusion volume that generates pre-transfusion testing demand remains structurally limited in the regions with the greatest unmet clinical need.

Donor screening portfolio rationalisation is a second constraint, because QuidelOrtho disclosed a 40% quarterly decline in Donor Screening revenue as it wound down its US donor screening portfolio, reflecting competitive displacement in the NAT segment.

Reagent price compression is a third constraint, since long-term blood bank tender contracts and competitive bidding constrain reagent price escalation beyond inflation levels, limiting the margin upside vendors can capture even as instrument placements grow.

These factors substantially limit blood transfusion diagnostics market growth over the forecast period.

The clearest driver of demand is the razor-and-blade economics of automated immunohematology instrument placement, where each analyzer win locks in years of recurring reagent revenue. An automated analyzer only converts into durable reagent revenue if the instrument-reagent pairing is proprietary, and Grifols' Eflexis and DG Gel card system is exactly that kind of locked pairing, so every new blood bank tender win compounds into a multi-year reagent supply contract. Grifols' Blood Typing Solutions segment delivered double-digit revenue growth in key countries across North America, Latin America, and Europe, with EUR 7,524 Million in total 2025 group revenue at 7% growth. The company commenced production of DG Gel cards at a new manufacturing facility in San Diego, California, expanding US domestic supply capacity to support continued blood bank tender wins. The effect on the market is that reagent revenue is increasingly predictable and contractually locked in for the vendors winning current-generation analyzer placements. These are some of the key factors driving revenue growth of the market.

The second driver is the progressive replacement of serological-only donor screening with mandatory nucleic acid testing across national blood safety programmes. NAT screening detects transfusion-transmissible infections during the window period before antibody seroconversion when serological tests alone would produce false negatives, so national blood safety regulators increasingly treat NAT adoption as a patient-safety requirement rather than an optional upgrade. Grifols' Procleix Panther System, developed in collaboration with Hologic, achieved 80% market share at Singapore Blood Services Group and 100% share in countries where NAT screening is mandatory. In March 2026, Roche launched its cobas MPX-E assay, a 4-in-1 donor screening test detecting HIV, hepatitis B, hepatitis C, and hepatitis E in a single workflow, extending multiplexed NAT screening to a pathogen, hepatitis E, not previously covered by standard donor panels. The effect on the market is that NAT donor screening technology is both deepening within markets that already mandate it and expanding into new transfusion-transmissible pathogens. These are some of the key factors driving revenue growth of the market.

“Grifols achieved 100% market share in every country where NAT screening technology is mandatory for blood donations, confirming NAT adoption as a structural, not optional, revenue driver.”

However, the blood transfusion diagnostics market faces severe adoption constraints from QuidelOrtho's US donor screening portfolio wind-down, persistent donor shortages, and long-term reagent contract pricing compression.

Because QuidelOrtho disclosed a 40% quarterly decline in Donor Screening revenue as it wound down its US donor screening portfolio, competitive displacement in the NAT segment, where Grifols Procleix and other platforms have achieved dominant positions, is reshaping US blood centre procurement.

Donor shortage is a second constraint, because the WHO Global Blood Safety Report documents that 54 countries still rely solely on voluntary non-remunerated donors while maintaining collection rates below 10 donations per 1,000 population, constraining transfusion testing volume growth precisely where demographic need is greatest.

Reagent price compression is a third constraint, since long-term blood bank tender contracts and competitive bidding constrain reagent price escalation beyond inflation levels, so vendors capture instrument placement growth without a proportional margin gain.

These factors substantially limit blood transfusion diagnostics market growth over the forecast period.

Based on end-use, the global blood transfusion diagnostics market is segmented into blood banks and transfusion centres, hospitals and surgical centres, plasma fractionation centres, and reference laboratories. Blood banks and transfusion centres account for the largest revenue share. The American Red Cross, which collects approximately 40% of the US blood supply through approximately 200 collection sites, represents the single largest institutional reagent procurement account in the US transfusion diagnostics market. Hospitals and surgical centres are expected to register a rapid revenue growth rate, driven by satellite blood bank testing systems and point-of-care pre-transfusion compatibility testing at trauma centres and cardiac surgery programmes.

Based on regional analysis, the blood transfusion diagnostics market in North America accounted for the largest revenue share in 2025. The United States drives the regional position through the highest blood transfusion volume globally, with the American Red Cross reporting approximately 6.8 million units of red blood cells transfused annually, and the most concentrated blood bank procurement infrastructure among three national blood centre organisations. Grifols' Blood Typing Solutions segment reported double-digit growth in North America, with the San Diego DG Gel production facility directly serving the US blood bank customer base, while QuidelOrtho's October 2025 FDA approval of its MTS DAT Card reinforced its hospital transfusion laboratory position. The concentration of FDA-cleared transfusion diagnostic platforms in the United States also means new products are often launched in the United States first.

The market in Europe is expected to register a steady revenue growth rate in the global blood transfusion diagnostics market over the forecast period.

Germany, France, and the United Kingdom represent the three largest national blood transfusion diagnostics markets within Europe. Grifols' Blood Typing Solutions segment reported double-digit growth in EMEA, supported by blood bank tender awards in Germany and France, while Roche's March 2026 cobas MPX-E launch reached CE mark availability in Europe ahead of other regions. Iran-US sanctions and their indirect effect on Strait of Hormuz shipping have raised freight and import costs for the biological raw materials used in antisera and gel card reagent manufacturing, a disruption that has run through 2026 and maintains reagent input costs above pre-2022 baseline levels for European manufacturers.

The market in Asia Pacific is expected to register a rapid revenue growth rate in the global blood transfusion diagnostics market over the forecast period.

Japan, China, and Australia represent the three largest national blood transfusion diagnostics markets within the region. The Japan Red Cross Society's nationwide implementation of Grifols Procleix NAT technology represents the largest single NAT deployment in Asia Pacific, while China's National Health Commission blood safety regulations requiring infectious disease NAT screening at provincial blood centres are driving instrument and reagent procurement. The region's progressive shift from serological-only to NAT-mandatory screening leaves more structural room for growth than in the already NAT-saturated North American and European markets.

The market in Latin America is expected to register a moderate revenue growth rate in the global blood transfusion diagnostics market over the forecast period.

Brazil and Mexico represent the two largest national blood transfusion diagnostics markets within the region. Grifols' Blood Typing Solutions segment reported double-digit growth in Latin America, driven by blood bank tender awards and expansion of DG Gel card supply to Brazilian and Mexican regional blood centres. Iran-US sanctions and their indirect effect on Strait of Hormuz shipping have maintained elevated import costs for blood typing reagents and NAT screening consumables entering Brazilian distribution networks, a disruption that has run through 2026 and slows procurement for regional blood centres beyond the largest federal networks.

The market in Middle East and Africa is expected to register a moderate revenue growth rate in the global blood transfusion diagnostics market over the forecast period.

Saudi Arabia and South Africa represent the primary commercial markets within the region. The Saudi Ministry of Health's Vision 2030 health sector investment programme includes upgrading blood bank infrastructure at King Faisal Specialist Hospital and regional blood centres, and Saudi Arabia is the most established market on the continent for automated immunohematology and NAT donor screening, while South Africa and the wider sub-Saharan region are still building the basic serological testing infrastructure NAT adoption assumes.