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Market Trends and Insights

Rising blood donations leading to higher transfusion screenings

Group-donation campaigns, such as China’s 2025 initiative that rewards repeat donors, are reversing the pandemic dip in supply and creating fresh demand for scalable screening. A parallel shift by the United States Food and Drug Administration (FDA) to risk-based donor assessment removes categorical deferrals for men who have sex with men, enlarging the eligible pool while increasing the complexity of per-unit screening.^{[1]U.S. Food and Drug Administration, “Laboratory Developed Tests Regulatory Impact Analysis,” fda.gov} Together, higher volumes and donor diversity are encouraging blood establishments to adopt fully automated assays and robotics so that throughput rises without compromising sensitivity.

Greater prevalence of transfusion-transmissible infections

The Centers for Disease Control and Prevention (CDC) issued a 2025 alert after 13 million dengue cases occurred in the Americas during 2024, more than twice the prior year.^{[2]Centers for Disease Control and Prevention, “Ongoing Risk of Dengue Virus Infections,” cdc.gov}Concurrent West Nile outbreaks in Bulgaria and isolated monkeypox transmissions through platelet products underline the need for multiplex assays that go beyond the HIV-HBV-HCV triad. Rapid expansion of such panels has lifted demand for NAT reagents that can screen for emerging flaviviruses, orthopoxviruses, and region-specific pathogens within one workflow.

Stricter regulatory guidelines for blood safety

The new European Regulation (EU) 2024/1938 sets harmonized oversight standards effective 2027, while updated FDA guidance for blood establishments focuses on donor qualification, platelet collection and hepatitis B procedures.^{[3]AABB, “AI and Data Sciences in Blood Banking,” aabb.org} These rules accelerate investment in quality-management systems, automated documentation, and validated screening platforms. Vendors able to provide turnkey compliance features and audit-ready software modules gain a competitive edge.

Technological advances in screening methods

FDA approval of the cobas Malaria NAT test—the first molecular assay cleared for U.S. donors—illustrates regulators’ openness to high-sensitivity molecular diagnostics. Portable systems, such as Dragonfly, now deliver 96.1% orthopoxvirus sensitivity in under 40 minutes, making near-patient molecular testing viable. At the same time, metagenomic sequencing detects 74.0% of sepsis pathogens versus 41.1% by culture, offering a blueprint for future integrated blood-bank workflows.

High capital and consumable costs

Compliance with the newly finalized LDT rule will cost the U.S. screening sector an estimated USD 566 million to USD 3.56 billion each year, according to FDA modelling. Emerging economies struggle even more because NAT platforms require significant upfront spending and high-grade cold-chain reagents. Although microfluidic chips have driven per-test costs down to USD 9.5, overall affordability remains a challenge for smaller blood centres.

Limited skilled workforce and lab infrastructure

Expertise in molecular diagnostics is scarce outside tier-one hospitals. Rural Asia-Pacific labs face difficulties staffing technologists trained to run real-time PCR, interpret mNGS data, or maintain closed-system robotics. Without targeted training and tele-mentoring, decentralization may stall.

*Our forecasts treat driver/restraint impacts as directional, not additive. The impact forecasts reflect baseline growth, mix effects, and variable interactions.

Blood Screening Market Segment Analysis

Reagents and kits retained 55.62% of blood screening market share in 2025 due to recurring demand for NAT, immunoassay and confirmatory components. Their dominance is reinforced by batch-specific regulatory validation that locks in proprietary formulations. The instruments category is expanding at 9.78% CAGR as laboratories upgrade to fully automated NAT workcells and next-generation immunoassay analyzers that integrate robotic pipetting, bar-code tracking and LIS connectivity.

A surge in AI-enabled middleware is also notable; OneBlood’s deployment cut inventory levels by 40%, proving the operational value of real-time analytics. Software & services revenues therefore accelerate as blood banks seek predictive dashboards and automated deviation reporting, a trend likely to outpace reagent growth beyond 2028. Meanwhile, the emergence of portable molecular diagnostic devices, typified by the Dragonfly platform, suggests that decentralized testing could further fragment the instruments sub-segment over the long term.

NAT maintained a robust 41.88% share of the blood screening market in 2025 as its capacity to detect viral nucleic acids during window periods remains unmatched for HIV-1/2, HBV and HCV. Nevertheless, next-generation sequencing is scaling quickly at an 11.02% CAGR. mNGS can uncover unexpected pathogens, pinpoint co-infections and support genomic surveillance during outbreaks, evidenced by a 74.0% detection rate in sepsis studies.

Traditional enzyme immunoassays (ELISA/CLIA) still dominate in lower-resource settings because of lower instrumentation costs and simpler workflows. Rapid tests fill emergency needs but struggle with sensitivity versus NAT. Western blot retains a niche for confirmatory HIV workups. As AI tools mine large molecular datasets, labs may unify NAT and NGS within a common informatics layer, eventually blurring the boundaries between technologies.

Infectious-disease panels accounted for 49.05% of revenue in 2025 and will grow at a 12.12% CAGR through 2031. Dengue’s surge to 13 million cases in the Americas during 2024 drove immediate demand for flavivirus NAT panels. Widening West Nile and Zika footprints similarly elevate the need for multiplex assays.

Blood-group typing continues to be indispensable for compatibility, while rare-antigen genotyping serves complex transfusion cases, especially in multi-ethnic populations. Roche’s cobas Malaria test, cleared in 2024, broadens screening for travelers and immigrants from endemic areas. Taken together, these advances reinforce the case for syndromic panels capable of processing multiple targets in a single run, streamlining both cost and logistics.

Blood banks processed 58.15% of global donations in 2025, reflecting their integrative role in collection, testing, processing and distribution. Yet testing decentralization is accelerating: clinical laboratories will expand at 10.22% CAGR to 2031 as hospital networks outsource specialty NAT and mNGS work to reference labs equipped with high-throughput sequencers.

University Hospitals Blood Bank recorded a 7% rise in samples and activated 323 massive-transfusion protocols in 2024, illustrating the growing testing burden on tertiary centers. Private-sector consolidation is also reshaping the end-user landscape, highlighted by Quest Diagnostics’ USD 985 million purchase of LifeLabs to extend advanced diagnostics into Canada. Plasma-fractionation facilities continue to demand stringent viral clearance, sustaining high-specificity NAT reagent consumption.

Geography Analysis

North America Blood Screening Market

North America held 35.10% of the blood screening market in 2025. The FDA’s risk-based donor eligibility guidance, AI-assisted inventory management, and ongoing implementation of LDT oversight collectively maintain the region’s technology edge. Canada’s diagnostics sector expanded after Quest Diagnostics took full control of LifeLabs, deepening molecular-testing capacity and cross-border sample logistics. Meanwhile, Mexico is improving rural donation infrastructure, which lifts demand for mid-tier immunoassay analyzers.

APAC Blood Screening Market

Asia-Pacific is the growth engine, projected at a 9.86% CAGR to 2031. Japan’s 2025 hemoglobin-vesicle trial—the world’s first artificial-blood clinical study—could eventually reduce dependence on donor supply and lengthen storage life to two years at room temperature. India’s Quick Vitals facial-scan platform delivers non-invasive hemogram readouts within a minute and is being piloted in public hospitals, underscoring the region’s openness to disruptive diagnostics. China’s national carrier rate of 8.95% for thalassemia points to substantial prenatal and donor screening volume, while ongoing group-donation campaigns expand collection points in second-tier cities.

Europe Blood Screening Market

Europe shows steady progress under Regulation (EU) 2024/1938, which pools oversight across member states and allocates funds for crisis readiness. Germany and France are trial-ling pathogen-reduced platelets alongside traditional screening, whereas Bulgaria’s West Nile outbreak prompted expanded NAT panels at regional blood bank. The regulation’s unified guidance will streamline vendor approvals, encouraging pan-European platform standardization.

Regulatory Landscape

Blood screening is regulated through evolving IVD and blood establishment requirements that focus on transfusion safety, traceability, and validated performance for assays used on donated blood and components. In the United States, FDA guidance continues to shape donor testing workflows, including updates related to hepatitis B and transfusion-transmitted malaria screening, while AABB-led implementation tools track agency positions; for example, AABB updated Ebola-related donor screening materials in July 2026 to reflect FDA guidance, with a short implementation window for blood establishments.

In Europe, oversight is framed by the EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) and transitional changes under Regulation (EU) 2024/1860 adopted in June 2024 to mitigate device shortages and address Eudamed delays. This reinforces the need for proactive technical file maintenance and notified-body capacity planning. Standards bodies are also tightening technical expectations, with ISO publishing ISO 15193:2026 and ISO 15194:2026 in June 2026, emphasizing reference measurement procedures and certified reference materials that influence analytical traceability requirements in submissions.

Value Chain Analysis

The blood screening value chain begins with specialized raw materials and biological inputs (antibodies, antigens, enzymes, calibrators, controls, and reference materials), followed by assay design, validation, and regulated manufacturing of reagents and kits, as well as instruments. Distribution then relies on cold-chain capable logistics to blood banks, hospital transfusion units, clinical laboratories, and plasma fractionation centers. The downstream workflow covers sample collection, accessioning and labeling, screening (often NAT plus immunoassays), confirmatory testing, documentation in quality systems and LIS, and release decisions governed by regulatory and accreditation requirements.

Constraints often come from concentration of critical inputs (for example, molecular-grade components used in NAT), lot-to-lot release and validation lead times, and temperature-controlled distribution, which can disrupt continuity of screening programs in import-dependent regions. Manufacturers are responding with supply resilience and localized production, illustrated by Grifols opening a new San Diego facility in October 2025 to produce DG Gel cards and reagent red blood cells, aimed at improving domestic availability and reducing dependency risks. Service, software, and automation partners increasingly sit alongside reagent and instrument suppliers as blood centers adopt integrated workcells and inventory optimization to manage staffing shortages and compliance documentation.

Market Opportunities and Future Outlook

Workflow consolidation and automation create opportunity for suppliers that can combine high-throughput molecular screening with compliance-ready software, particularly as quality expectations tighten. In the United States, the FDA Quality Management System Regulation (QMSR) took effect in February 2026, aligning device quality system requirements with ISO 13485:2016 and increasing the operational value of validated, audit-ready platforms that reduce manual documentation and support standardized change control across multi-site blood organizations.

Product-led opportunities also show up in multi-target and outbreak-relevant screening expansions. Roche launched the cobas MPX-E assay in March 2026 as a 4-in-1 donor screening test (HIV, HCV, HBV, and HEV) for use on the cobas x800 family, supporting laboratories looking to reduce runs and simplify reagent management. Grifols received FDA approval in April 2026 for the Procleix Plasmodium Assay on the Procleix Panther System, adding a molecular option for malaria donor screening. These updates reinforce momentum for scalable NAT menus, middleware that links instruments to LIS and quality systems, and regional manufacturing strategies that reduce cold-chain and import friction in high-volume blood screening programs.