Immunohematology Market Size (2025 – 2030)

The Global Immunohematology Market was valued at USD 2.0 Billion in 2024 and is projected to reach a market size of USD 3.07 Billion by the end of 2030. Over the forecast period of 2025-2030, the market is projected to grow at a CAGR of 7.35%.

The immunohematology market, often referred to as the cornerstone of transfusion medicine and blood banking, represents a critical and non-negotiable segment of the in-vitro diagnostics (IVD) landscape. This field is dedicated to the study of antigen-antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders. At its core, the market provides the essential tools—reagents, sophisticated analyzers, and data management software—required to ensure the safety, compatibility, and efficacy of blood transfusions. Every unit of blood collected and every patient receiving a transfusion relies on immunohematology testing to prevent potentially fatal hemolytic transfusion reactions. This includes fundamental procedures like ABO and Rh (D) blood grouping, as well as more complex antibody screening, identification of clinically significant antibodies, and cross-matching to confirm compatibility between donor and recipient. The current market dynamic is characterized by a profound and accelerating technological schism between traditional, manual methods and modern, high-throughput automation.

Key Market Insights:

• In the broader diagnostics industry (which underpins immunohematology as a diagnostic segment), a shift toward prevention, wellness, digital diagnostics, and more accessible testing is driving strategic change. According to Deloitte, Diagnostics companies are seeing increasing demand for convenient, accessible, affordable tests that deliver actionable results quickly.
• The global capacity for immunohematology testing reached new heights in 2024, with blood bank analyzers processing an estimated 2.1 million tests per day worldwide.
• Fueled by rising donations and stringent safety protocols, over 120 million blood donations were screened globally in 2024 using immunohematology platforms.
• The screening of donations, combined with patient-side testing, contributed to a total annual consumption of more than 200 million individual immunohematology tests (including cross-matching and antibody screening) in 2024.
• The Reagents segment continues to be the financial bedrock of the market, commanding an estimated 63.4% of the total market revenue in 2024, driven by its high-volume, recurring use in every test performed.
• In 2024, the "Investigation of Immune Hemolysis" application, a critical diagnostic procedure for conditions like autoimmune hemolytic anemia, represented a significant 28.4% share of the application-based market.

Market Drivers:

A primary engine for the market is the relentless and growing demand for blood transfusions.

This is a direct consequence of two parallel trends: the rising global incidence of hematological disorders such as leukemia, sickle cell disease, and thalassemia, which require chronic transfusion support, and the increasing volume of complex surgical interventions. Procedures like organ transplants, major trauma care, and cardiovascular surgeries are fundamentally dependent on the availability of safe, cross-matched blood, creating a non-negotiable, baseline demand for immunohematology testing.

The market is being propelled forward by a powerful technological shift.

First, the widespread adoption of fully automated analyzers addresses critical laboratory needs for higher throughput, reduced human error, and 24/7 operational capability. This automation drive is crucial for cost-efficiency and standardization. Second, the "paradigm shift" to molecular immunohematology (genotyping) is redefining precision. It allows for the identification of rare blood groups and complex antigen profiles that serology cannot resolve, moving transfusion medicine into the era of personalized and preventative patient matching.

Market Restraints and Challenges:

The most significant barrier to market entry and expansion remains the exorbitant capital investment required for high-throughput, fully automated immunohematology analyzers. This cost is often prohibitive for smaller hospitals, independent laboratories, and healthcare systems in emerging economies. Compounding this is a stringent and complex regulatory landscape, such as the EU's In Vitro Diagnostic Regulation (IVDR), which increases the cost, time, and complexity of bringing new technologies and reagents to market, potentially stifling innovation and delaying patient access.

Market Opportunities:

Immense opportunity lies in the burgeoning field of Point-of-Care (POC) immunohematology. The development of rapid, portable, and accurate analyzers for use in emergency rooms, trauma centers, and rural clinics could revolutionize emergency transfusion decisions. Furthermore, the growing emphasis on personalized medicine creates a vast new market for molecular genotyping, especially for managing chronically transfused patients and building comprehensive rare-donor registries. This, combined with the large, untapped potential of emerging markets that are actively modernizing their blood bank infrastructure, presents a long-term, high-growth frontier.

IMMUNOHEMATOLOGY MARKET REPORT COVERAGE:

Immunohematology Market Segmentation:

Immunohematology Market Segmentation by Product Type:

• Reagents
• Analyzers
  • Fully Automated Analyzers
  • Semi-Automated & Manual Analyzers
• Software & Services

The Reagents segment is the most dominant, consistently accounting for the largest revenue share (approx. 63.4% in 2024). This dominance is structural, as reagents are high-volume consumables required for every single test performed on every analyser, leading to a massive and recurring revenue stream that eclipses the one-time sale of instruments.

The Analyzers segment, specifically Fully Automated Analyzers, is the fastest growing. This growth is driven by the industry-wide migration away from manual testing. Laboratories are aggressively investing in automation to handle increasing test volumes, reduce labor costs, and enhance the accuracy and standardization of results, making these systems the priority for capital expenditure.

Immunohematology Market Segmentation by Technology:

• Gel System
• Microplate
• Solid Phase
• Polymerase Chain Reaction (PCR)

The Gel System and Microplate segments are the most dominant technologies, representing the established workhorses of modern serological testing. These methods are integrated into the majority of semi-automated and fully-automated platforms currently in use, offering a proven, reliable, and cost-effective solution for routine blood grouping and antibody screening.

The Polymerase Chain Reaction (PCR) segment is the fastest-growing technology. It is the engine of the shift toward molecular immunohematology. Its ability to perform precise blood group genotyping, irrespective of a patient's transfusion status, makes it the gold standard for complex cases and is seeing rapid adoption in reference labs and large hospital centers.

Immunohematology Market Segmentation by Application:

• Blood Typing (ABO & Rh)
• Antibody Screening
• Cross-matching
• Perinatal Testing
• Investigation of Immune Hemolysis

Blood Typing is the most dominant application. It is the most fundamental and high-volume test in immunohematology, performed on every blood donor and every potential transfusion recipient as the first and most critical step in ensuring compatibility. Its universal requirement solidifies its dominant market position.

Antibody Screening and Perinatal Testing represent the fastest-growing application segments. The increasing focus on identifying clinically significant antibodies to prevent delayed transfusion reactions, coupled with a greater emphasis on monitoring expectant mothers to prevent Hemolytic Disease of the Fetus and Newborn (HDFN), is driving significant growth and R&D in these more complex screening applications.

Segmentation by End-User:

• Hospitals
• Blood Banks (Independent & National Centers)
• Diagnostic Laboratories
• Research Institutes

Hospitals are the most dominant end-user segment, holding the largest market share (over 54%). This is because hospitals are the primary site of both blood consumption (due to surgeries, trauma, and patient treatment) and immediate-need testing. Most large hospitals maintain their own blood banks or transfusion service laboratories, making them the largest purchasers of both analyzers and reagents.

Diagnostic Laboratories are the fastest-growing end-user segment. The trend of healthcare consolidation is leading to the rise of large, centralized, and independent diagnostic laboratories. These facilities leverage economies of scale to invest in ultra-high-throughput automated systems, attracting outsourced testing from smaller clinics and hospitals, which fuels their rapid expansion.

Immunohematology Market Segmentation: Regional Analysis:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa

Most Dominant Region: North America dominates the global market, commanding the largest revenue share of 40.2% in 2024. This leadership is attributed to the region's advanced healthcare infrastructure, high adoption rate of sophisticated automated and molecular technologies, significant healthcare expenditure, and the presence of several key market players and research institutions.

Fastest-Growing Region: The Asia-Pacific region is the fastest-growing market. This rapid expansion is driven by massive government and private investments in healthcare infrastructure in countries like China and India, a growing awareness of blood transfusion safety, the establishment of new blood banks, and the strategic expansion of major international companies into these largely untapped markets.

Immunohematology Market COVID-19 Impact Analysis:

The COVID-19 pandemic introduced a complex duality to the immunohematology market. Initially, the market faced significant headwinds from widespread lockdowns, which led to a sharp decline in blood donations and the cancellation of elective surgeries, reducing test volumes. However, the crisis simultaneously underscored the critical importance of a robust diagnostic infrastructure. Furthermore, the virus spurred intense research into its immunohematologic effects, such as cytokine storms and coagulopathy, reinforcing the value of advanced hematological analysis.

Latest Market News (2024):

• June 2024: Grifols, a dominant player, successfully completed the divestment of its stake in Shanghai RAAS (SRAAS) for approximately USD 1.8 billion (€1.6 billion). This strategic move significantly bolstered its balance sheet and liquidity, allowing for greater focus on its core diagnostic and plasma businesses.
• April 2024: The new 13th edition of the "Standards for Immunohematology Reference Laboratories," established by AABB, was implemented on April 1, 2024. This update introduces revised standards for laboratory processes, quality control, and personnel, influencing reagent and equipment validation protocols industry-wide.
• February 2024: QuidelOrtho Corporation announced it had received FDA 510(k) clearance for its VITROS® Syphilis TPA assay. This automated test, running on its high-throughput VITROS® systems, expands the infectious disease screening menu often bundled with blood bank operations, strengthening its integrated lab portfolio.

Latest Trends and Developments:

The current innovation wave is focused on integrating "smart" technologies. This includes the development of artificial intelligence (AI) and machine-learning algorithms to improve the accuracy of digital image analysis for agglutination reactions, potentially reducing indeterminate results. There is also a major push for advanced phenotyping, using both automated serology and molecular methods, to build comprehensive rare-donor databases. Finally, the development of multiplexed bead-based assays is trending, allowing labs to screen for multiple antibodies simultaneously in a single, efficient test.

Key Players in the Market:

1. Grifols, S.A.
2. QuidelOrtho Corporation
3. Bio-Rad Laboratories, Inc.
4. Abbott Laboratories
5. Thermo Fisher Scientific, Inc.
6. Beckman Coulter, Inc. (Danaher)
7. Siemens Healthcare GmbH
8. Immucor, Inc.
9. BD (Becton, Dickinson and Company)
10. Hologic, Inc.