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US Blood Transfusion Diagnostics Market

ID: MRFR/LS/17162-HCR
100 Pages
Garvit Vyas
October 2025

US Blood Transfusion Diagnostics Market Research Report By Product Type (Infectious Disease Testing, Blood Grouping Tests, Compatibility Testing, Nucleic Acid Testing), By Technique (Enzyme-Linked Immunosorbent Assay, Polymerase Chain Reaction, Chemiluminescent Immunoassay, Microbiological Techniques), By End User (Hospitals, Blood Banks, Diagnostic Laboratories, Academic Institutions) and By Application (Transfusion Medicine, Organ Transplantation, Clinical Research) - Forecast to 2035

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US Blood Transfusion Diagnostics Market Summary

As per MRFR analysis, the US blood transfusion-diagnostics market size was estimated at 2295.16 USD Million in 2024. The US blood transfusion-diagnostics market is projected to grow from 2430.34 USD Million in 2025 to 4308.57 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 5.89% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US blood transfusion-diagnostics market is poised for growth driven by technological advancements and increasing demand for blood products.

  • Technological advancements are enhancing the accuracy and efficiency of blood diagnostics.
  • The regulatory compliance landscape is evolving, necessitating adherence to stricter quality standards.
  • The demand for blood products is rising, particularly in the largest segment of transfusion diagnostics.
  • Key market drivers include the rising prevalence of blood disorders and growing awareness of blood safety.

Market Size & Forecast

2024 Market Size 2295.16 (USD Million)
2035 Market Size 4308.57 (USD Million)

Major Players

Roche Diagnostics (CH), Abbott Laboratories (US), Grifols (ES), Terumo Corporation (JP), Baxter International (US), Ortho Clinical Diagnostics (US), Bio-Rad Laboratories (US), Hologic (US)

US Blood Transfusion Diagnostics Market Trends

The blood transfusion-diagnostics market is currently experiencing notable advancements. These advancements are driven by technological innovations and an increasing demand for safe blood transfusions. Enhanced diagnostic tools are being developed to improve the accuracy and efficiency of blood typing and cross-matching processes. These innovations are crucial in ensuring patient safety and minimizing the risk of transfusion-related complications. Furthermore, regulatory bodies are actively promoting stringent guidelines to ensure the quality and safety of blood products, which is likely to bolster confidence among healthcare providers and patients alike. In addition, the rising prevalence of chronic diseases and the aging population are contributing to a heightened need for blood transfusions. This trend is prompting healthcare facilities to invest in advanced diagnostic solutions that can streamline operations and enhance patient outcomes. The integration of automation and artificial intelligence in blood transfusion diagnostics is also gaining traction, as it offers the potential to reduce human error and improve turnaround times. Overall, the blood transfusion-diagnostics market appears poised for growth, driven by these multifaceted factors that emphasize safety, efficiency, and technological advancement.

Technological Advancements

The blood transfusion-diagnostics market is witnessing rapid technological advancements that enhance the accuracy and speed of blood testing. Innovations such as automated systems and advanced software solutions are streamlining processes, thereby reducing the likelihood of human error. These developments are crucial for ensuring patient safety and improving overall healthcare outcomes.

Regulatory Compliance

Regulatory bodies are increasingly emphasizing compliance with stringent safety standards in the blood transfusion-diagnostics market. This focus on regulation is driving healthcare facilities to adopt more rigorous testing protocols and quality assurance measures. As a result, the market is likely to see a rise in demand for diagnostic tools that meet these enhanced regulatory requirements.

Increased Demand for Blood Products

The growing prevalence of chronic diseases and an aging population are contributing to an increased demand for blood products. This trend is prompting healthcare providers to seek more efficient diagnostic solutions to manage blood transfusions effectively. Consequently, the blood transfusion-diagnostics market is expected to expand as facilities invest in technologies that support this rising need.

US Blood Transfusion Diagnostics Market Drivers

Growing Awareness of Blood Safety

There is a heightened awareness regarding blood safety and the risks associated with transfusions, which significantly impacts the blood transfusion-diagnostics market. Educational campaigns and initiatives by health organizations emphasize the importance of rigorous testing and screening of blood products. This awareness drives healthcare providers to adopt more comprehensive diagnostic measures to ensure the safety of transfusions. As a result, the market is expected to see an increase in demand for diagnostic tools that can detect infectious diseases and other potential risks in blood products, thereby enhancing patient safety and trust in transfusion practices.

Rising Prevalence of Blood Disorders

The increasing incidence of blood disorders such as anemia, hemophilia, and thalassemia is a crucial driver for the blood transfusion-diagnostics market. As more individuals are diagnosed with these conditions, the demand for accurate diagnostic tools and blood products rises. According to recent data, approximately 3 million Americans are affected by anemia alone, necessitating regular blood transfusions and monitoring. This trend indicates a growing need for advanced diagnostic solutions that can ensure safe and effective blood transfusions. The blood transfusion-diagnostics market is likely to expand. This expansion is due to healthcare providers seeking to improve patient outcomes through better diagnostic capabilities.

Regulatory Changes and Quality Standards

Regulatory changes and the establishment of stringent quality standards are shaping the blood transfusion-diagnostics market. Agencies such as the FDA enforce regulations that require rigorous testing and validation of blood products and diagnostic tools. Compliance with these regulations is essential for manufacturers and healthcare providers, as it ensures the safety and efficacy of blood transfusions. The ongoing evolution of these regulations may lead to increased investments in research and development of new diagnostic technologies. Consequently, the blood transfusion-diagnostics market is likely to experience growth as stakeholders adapt to these regulatory demands and strive to meet high-quality standards.

Technological Innovations in Diagnostics

Technological advancements in diagnostic tools are transforming the blood transfusion-diagnostics market. Innovations such as automated blood typing systems, molecular diagnostics, and point-of-care testing devices enhance the accuracy and speed of blood testing. For instance, the introduction of next-generation sequencing technologies allows for more precise identification of blood group antigens, which is critical for safe transfusions. The market is projected to grow as these technologies become more integrated into clinical practice, potentially increasing efficiency and reducing the risk of transfusion-related complications. As a result, healthcare facilities are likely to invest in these advanced diagnostic solutions.

Aging Population and Increased Surgical Procedures

The aging population in the United States is contributing to a higher demand for surgical procedures, which in turn drives the blood transfusion-diagnostics market. Older adults are more likely to undergo surgeries that require blood transfusions, such as orthopedic and cardiac procedures. As the population aged 65 and older continues to grow, the need for effective blood management and diagnostic solutions becomes increasingly critical. This demographic shift suggests that healthcare systems will need to enhance their blood transfusion protocols and diagnostic capabilities to accommodate the rising number of surgical interventions, thereby expanding the market.

Market Segment Insights

By Product Type: Infectious Disease Testing (Largest) vs. Blood Grouping Tests (Fastest-Growing)

The US blood transfusion-diagnostics market is characterized by a robust distribution of market share across various product types. Infectious Disease Testing holds the largest share, driven by stringent regulations and increasing incidences of transfusion-transmitted infections. Blood Grouping Tests, while smaller in share, have shown rapid adoption, particularly with advancements in technology enhancing accuracy and reducing turnaround times. Growth trends in this segment are being fueled by technological innovations and an increasing demand for safe blood transfusion practices. The emergence of new testing methodologies and the rising awareness of transfusion safety are key drivers. Compatibility Testing and Nucleic Acid Testing are also gaining traction, reflecting the industry's response to evolving healthcare needs and the urgency for precise diagnostics.

Testing: Infectious Disease (Dominant) vs. Blood Grouping (Emerging)

Infectious Disease Testing is the dominant segment, primarily because it addresses critical safety issues within blood transfusions, ensuring the detection of pathogens. This segment is heavily regulated to minimize risks associated with transfusion-transmitted infections. On the other hand, Blood Grouping Tests are emerging as a vital part of pre-transfusion screening, leveraging recent advancements in blood grouping technologies that enhance efficiency and reliability. While Infectious Disease Testing is pivotal for public safety, Blood Grouping Tests are rapidly evolving, incorporating automation and more accurate techniques to accommodate the growing demand for transfusions in a diverse patient population.

By Technique: Enzyme-Linked Immunosorbent Assay (Largest) vs. Polymerase Chain Reaction (Fastest-Growing)

The US blood transfusion-diagnostics market exhibits a diverse distribution of techniques, with Enzyme-Linked Immunosorbent Assay (ELISA) capturing the largest share due to its reliability and established usage in various applications. Polymerase Chain Reaction (PCR), while smaller in market share, is rapidly gaining traction owing to its high sensitivity and specificity for detecting pathogens, making it almost indispensable in modern diagnostics. Growth trends are being driven by advancements in technology, increasing demand for accurate and rapid diagnostics, and a rising prevalence of chronic diseases that necessitate frequent blood testing and transfusion practices. Moreover, the ongoing need for safety and precision in blood transfusions is pushing healthcare providers to adopt more innovative diagnostic techniques, particularly PCR, which is considered the fastest-growing method in this space.

Technique: ELISA (Dominant) vs. PCR (Emerging)

Enzyme-Linked Immunosorbent Assay (ELISA) stands as the dominant technique in the segment due to its high throughput, cost-effectiveness, and versatility in detecting a wide range of antigens and antibodies. Commonly used for screening blood donors and various diseases, it has a robust market presence. Conversely, Polymerase Chain Reaction (PCR) is emerging as a critical technique owing to its ability to amplify DNA, thus providing precise detection of infectious agents. This method's quick turnaround time and accuracy significantly enhance diagnostic capabilities in transfusion diagnostics. The differentiation between these techniques highlights the shift towards more advanced and rapid testing methodologies, with PCR positioned to capture greater market share in the coming years.

By End User: Hospitals (Largest) vs. Blood Banks (Fastest-Growing)

In the US blood transfusion-diagnostics market, hospitals constitute the largest segment, driven by the high volume of blood transfusions performed daily. Blood banks follow closely, serving as critical hubs for blood collection and distribution, reflecting significant market share but slightly lesser compared to hospitals. Diagnostic laboratories and academic institutions hold smaller shares, primarily supporting research and specialized testing needs within the healthcare ecosystem. The growth trends within this segment indicate a robust demand for blood transfusion services and diagnostic solutions, largely influenced by an increase in surgical procedures and emergency care requirements. Additionally, the expansion of blood banks as the fastest-growing segment is attributed to initiatives for enhancing blood donation and advancements in storage technologies, enhancing operational efficiency and patient care quality in the US blood transfusion-diagnostics market.

Hospitals (Dominant) vs. Blood Banks (Emerging)

Hospitals represent the dominant force in the US blood transfusion-diagnostics market due to their integral role in patient care, conducting numerous transfusions across various departments including emergency and surgical units. Their extensive network and resources place them at the forefront of service delivery in this sector. Conversely, blood banks, while emerging, are increasingly recognized for their vital function in blood collection, testing, and distribution. They are adapting to technological advancements and increasing demand for blood products, thus carving a prominent niche within the market. Both segments are crucial for ensuring seamless availability and safety of blood supplies, underscoring their interdependent roles in the healthcare landscape.

By Application: Transfusion Medicine (Largest) vs. Organ Transplantation (Fastest-Growing)

The US blood transfusion-diagnostics market exhibits a diverse distribution among its application segments, with Transfusion Medicine holding the largest market share. This segment plays a crucial role in routine and emergency transfusion practices, making it indispensable. Organ Transplantation, while possessing a smaller market share, is experiencing rapid growth due to increasing organ donation rates and advances in transplant procedures, indicating a shift in focus within the healthcare system. Growth trends in the US blood transfusion-diagnostics market highlight a growing demand for advanced diagnostic solutions, particularly in the Organ Transplantation segment. Factors such as an aging population, rising prevalence of chronic diseases, and technological advancements in transfusion technology are the primary drivers of this growth. Moreover, ongoing research in the field of transfusion medicine is paving the way for innovative products, further stimulating market expansion in the near future.

Transfusion Medicine (Dominant) vs. Clinical Research (Emerging)

Transfusion Medicine is established as the dominant segment within the US blood transfusion-diagnostics market, characterized by its extensive use in hospitals and emergency care settings. It focuses on ensuring the safe and efficient transfusion of blood products, with stringent regulatory standards governing the process. Conversely, Clinical Research is considered an emerging segment, focused on exploring novel therapies and technologies related to blood transfusion and diagnostics. As pharmaceutical and biotech companies continue to invest in research, this segment is witnessing growth driven by the need for innovative diagnostic solutions and therapies, which ultimately complements the advancements seen in Transfusion Medicine.

Get more detailed insights about US Blood Transfusion Diagnostics Market

Key Players and Competitive Insights

The blood transfusion-diagnostics market is characterized by a dynamic competitive landscape. This landscape is driven by technological advancements, regulatory changes, and an increasing demand for safe blood products. Key players such as Abbott Laboratories (US), Roche Diagnostics (CH), and Grifols (ES) are strategically positioned to leverage innovation and partnerships to enhance their market presence. Abbott Laboratories (US) focuses on expanding its diagnostic portfolio through strategic acquisitions and collaborations, while Roche Diagnostics (CH) emphasizes research and development to introduce cutting-edge solutions. Grifols (ES) is actively pursuing global expansion, particularly in emerging markets, to capitalize on the growing need for transfusion diagnostics.

The market structure appears moderately fragmented, with several players vying for market share. Companies are increasingly localizing manufacturing and optimizing supply chains to enhance efficiency and reduce costs. This competitive structure allows for a diverse range of products and services, catering to various customer needs while fostering innovation across the sector.

In October 2025, Abbott Laboratories (US) announced the launch of a new rapid blood screening test designed to detect infectious diseases in blood donations. This strategic move is significant as it not only enhances the safety of blood transfusions but also positions Abbott as a leader in the diagnostic space, potentially increasing its market share. The introduction of such innovative solutions is likely to set new standards in the industry, compelling competitors to elevate their offerings.

In September 2025, Roche Diagnostics (CH) unveiled a digital platform aimed at streamlining blood transfusion processes through enhanced data analytics. This initiative underscores Roche's commitment to digital transformation, which is increasingly vital in the diagnostics market. By integrating advanced analytics, Roche aims to improve operational efficiencies and patient outcomes, thereby reinforcing its competitive edge.

In August 2025, Grifols (ES) entered into a partnership with a leading biotechnology firm to develop next-generation blood screening technologies. This collaboration is pivotal as it not only expands Grifols' technological capabilities but also enhances its product offerings in the transfusion diagnostics market. Such strategic alliances are becoming essential for companies seeking to innovate and maintain relevance in a rapidly evolving landscape.

As of November 2025, current trends in the blood transfusion-diagnostics market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in diagnostic processes. Strategic alliances are increasingly shaping the competitive landscape, enabling companies to pool resources and expertise. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability, as companies strive to meet the growing demands of the healthcare sector.

Key Companies in the US Blood Transfusion Diagnostics Market market include

Industry Developments

In recent months, the US Blood Transfusion Diagnostics Market has seen significant developments among key players. Siemens Healthineers continues to innovate with their high-performance analyzers, enhancing transfusion compatibility testing. Mayo Clinic Laboratories is advancing in genetic testing to ensure safe transfusions, while Roche Diagnostics is rolling out new assays to improve screening processes. 

Notably, Cerus Corporation has expanded its user base for the INTERCEPT Blood System, which is gaining traction for pathogen inactivation protocols. In terms of mergers and acquisitions, Abbott Laboratories announced their acquisition of St. Jude Medical in January 2017, aiming to bolster capabilities in cardiac and vascular devices, directly impacting diagnostic segments. The growth of this sector has been robust, with estimated market valuations exceeding USD 3 billion as of 2023, driven by increasing demand for safer blood transfusions and technological innovations. 

Moreover, the ongoing focus on regulatory compliance and safety standards by organizations such as the Food and Drug Administration is shaping the industry's landscape. Over the past two years, the adoption of automated systems and AI-based diagnostics has gained momentum, reflecting a shift towards efficiency and accuracy in blood transfusion practices in the US.

Future Outlook

US Blood Transfusion Diagnostics Market Future Outlook

The Blood Transfusion Diagnostics Market is projected to grow at a 5.89% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for blood products, and regulatory support.

New opportunities lie in:

  • Development of AI-driven blood screening technologies
  • Expansion of mobile blood collection units
  • Integration of blockchain for blood traceability

By 2035, the market is expected to achieve robust growth, driven by innovation and strategic investments.

Market Segmentation

US Blood Transfusion Diagnostics Market End User Outlook

  • Hospitals
  • Blood Banks
  • Diagnostic Laboratories
  • Academic Institutions

US Blood Transfusion Diagnostics Market Technique Outlook

  • Enzyme-Linked Immunosorbent Assay
  • Polymerase Chain Reaction
  • Chemiluminescent Immunoassay
  • Microbiological Techniques

US Blood Transfusion Diagnostics Market Application Outlook

  • Transfusion Medicine
  • Organ Transplantation
  • Clinical Research

US Blood Transfusion Diagnostics Market Product Type Outlook

  • Infectious Disease Testing
  • Blood Grouping Tests
  • Compatibility Testing
  • Nucleic Acid Testing

Report Scope

MARKET SIZE 2024 2295.16(USD Million)
MARKET SIZE 2025 2430.34(USD Million)
MARKET SIZE 2035 4308.57(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 5.89% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Roche Diagnostics (CH), Abbott Laboratories (US), Grifols (ES), Terumo Corporation (JP), Baxter International (US), Ortho Clinical Diagnostics (US), Bio-Rad Laboratories (US), Hologic (US)
Segments Covered Product Type, Technique, End User, Application
Key Market Opportunities Integration of advanced molecular diagnostics enhances safety and efficiency in the blood transfusion-diagnostics market.
Key Market Dynamics Technological advancements and regulatory changes drive innovation in blood transfusion-diagnostics, enhancing safety and efficiency.
Countries Covered US

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FAQs

What is the expected market size of the US Blood Transfusion Diagnostics Market in 2024?

The US Blood Transfusion Diagnostics Market is expected to be valued at 1.1 billion USD in 2024.

What is the projected market size for the US Blood Transfusion Diagnostics Market by 2035?

By 2035, the US Blood Transfusion Diagnostics Market is projected to reach 1.65 billion USD.

What is the anticipated compound annual growth rate (CAGR) for the US Blood Transfusion Diagnostics Market from 2025 to 2035?

The anticipated CAGR for the US Blood Transfusion Diagnostics Market from 2025 to 2035 is 3.754%.

Which product type will dominate the US Blood Transfusion Diagnostics Market in 2024?

Infectious Disease Testing is expected to dominate the US Blood Transfusion Diagnostics Market, valued at 0.44 billion USD in 2024.

What market value is expected for Blood Grouping Tests in 2035?

Blood Grouping Tests are expected to be valued at approximately 0.4985 billion USD by 2035.

What is the projected market size for Compatibility Testing in 2024?

Compatibility Testing is projected to have a market size of 0.22 billion USD in 2024.

Who are the key players in the US Blood Transfusion Diagnostics Market?

Key players in this market include Siemens Healthineers, Mayo Clinic Laboratories, Cerus Corporation, and Roche Diagnostics.

What market growth can be expected for Nucleic Acid Testing by 2035?

Nucleic Acid Testing is expected to grow to a market size of 0.1455 billion USD by 2035.

What factors are driving growth in the US Blood Transfusion Diagnostics Market?

Growth is driven by advancements in technology and increasing healthcare demands for safe blood transfusions.

How is the market affected by current global trends?

Current global trends can impact the US Blood Transfusion Diagnostics Market by influencing demand and distribution processes.

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