Blood Grouping Reagents Market Analysis

Blood Grouping Reagents Market Overview:

Global Blood Grouping Reagents Market size is projected to be worth USD 0.0020 billion by 2032, registering a CAGR of 7.6% during the forecast period (2023 - 2032), The market was valued at USD 1,578.78 million in 2020.

Blood grouping reagents are solutions that can be used to identify ABO, Rhesus, Kell and MNS blood groups. These classifications of human blood are based on the presence or absence of antigens on the surface of red blood cells. The reagents can affect the agglutination (clumping) on the test red blood cells which transfer antigen. No clumping of the test red blood cells can specify the absence of a certain antigen.

The blood grouping reagents market has been segmented into products, technique, test type, end user, and region. The market is driven by factors such as growing prevalence of chronic disorders and increasing spending in medical research. However, concern pertaining to efficiency and proficiency of test kits hinder the growth of this market.

COVID-19 Analysis

The emergence of coronavirus negatively impacted various sectors across the globe. The healthcare sector was also negatively impacted owing to production restrictions, cessation of clinical trials, and R&D activities. However, the increasing number of COVID-19 patients require blood grouping reagent products on a large scale for diagnostic applications. The increasing number of assay techniques to confirm the presence or absence of coronavirus among patients is creating huge demand across the globe. The sudden surge in diagnostic tests created pressure among the market players to produce blood grouping reagent products. In addition, the rising number of molecular assay tests and RT-PCR tests for confirmation of disease is driving the demand for blood grouping reagent products.

Market Dynamics

• 
  Increasing prevalence of chronic disorders
  
  
  • The increasing prevalence of chronic disorders is propelling the demand for effective treatment. Chronic diseases such as anemia, hemophilia, lymphoma, diabetes, and leukemia, along with the ongoing COVID-19 pandemic, account for a substantial burden. The Center for Disease Control (CDC) in 2019 states that six in ten adults suffer from chronic disease while four in ten suffer from more than two chronic diseases. The data demonstrates the rising burden in terms of diseases and their effective management.
  
  
  • Moreover, according to the WHO, anemia affects more than 1.62 billion people across the globe, nearly 24.8% of the global population. Additionally, women of reproductive age are also affected with anemia due to iron deficiency. The women aging 15-49 are prevalent to anemia. The WHO reported that in 2019, 29.9% of the women aged 15-49 years agonized from anemia. Additionally, in 2019, 39.8% of children aged 6-59 months were affected by anemia.
  
  
  
  


• Increasing spending in medical research

Market Restraints

• 
  Concern pertaining to the efficiency and accuracy of test kits
  • The blood grouping reagent test kits demand rose during the COVID-19 outbreak. The increasing usage of blood typing kits, RT-PCR kits, and serology test kits surge the sales of the market players. However, many complaints were registered about the inaccurate test results of the rapid test kits during the pandemic era. The immediate need for the test kits on a large scale might have compromised the quality of the product. In addition, the government authority ordered to perform serological tests on the defined hotspots with a population highly exposed to the coronavirus.
  
  

Market Opportunities

• 
  Emergence of automated blood grouping devices
  
  
  • The increasing number of blood grouping diagnostics and the rising population has created the demand for automated blood grouping devices. The fully automated systems can perform a large number of tests in a single input, further increasing productivity and efficiency within the stipulated timeline. These devices are programmed to carry out consistent test procedures with high accuracy while preventing contamination across the samples.
  
  
  • Moreover, the market players are offering fully automated blood typing devices with remote access features for enhanced monitoring and result validation. In addition, this equipment has specific features of tube size and diameter recognition, integrated quality control program, random position for samples, real-time information about the reagent and sample status, and high-definition color results, among others.
  
  
  
  

Value Chain Analysis

The global blood grouping reagents market is showing significant growth owing to the increasing hereditary disorders, high exposure to chemical toxins, and radioactive materials. The value chain analysis for the market comprises four major components, research & development and product designing, manufacturing, distribution & sales, and post-sales review.

Segment Overview

By Product

• Consumables

Blood grouping reagents include several consumables, including Anti-A, Anti-B, Anti-AB, Anti-D, Anti-D (PK 1), Anti-D (PK 2), control reagents, and phenotyping reagents as Anti-C, Anti-E, Anti-c, Anti-e, Anti-K. Companies such as Merck KGaA, Bio-Rad Laboratories Inc, Novacyt SA, Beckman Coulter, Inc., Grifols SA, Immucor, Inc., among others, offer a wide range of consumables supporting the market demand.

• Instruments

The blood grouping instrument is used to determine blood type by performing ABO grouping, Rh typing, antibody screening, and cross matching tests. These instruments are utilized to analyze the blood groups and offer several benefits over tests performed manually by technicians, such as a reduction in human errors. For instance, the IH-500 system by Bio-Rad Laboratories Inc. (US) incorporates a 6-axis robot transport arm and offers a high level of automation and minimizes user operations.

By Technique

• PCR-based and Microarray Technique

The increasing pace of development in molecular biological techniques has directly affected mass testing and diagnostic applications, including blood screening. Polymerase chain reaction (PCR) and microarray techniques have been successfully applied to blood grouping. PCR-based assays can be used to predict the antigen type of donor RBCs for transfusion and antibody identification reagent panels.

• Assay-Based Techniques

An assay-based technique is an analytic procedure used for blood grouping. Solid-phase assays such as ELISA and bead-based technology, including the Luminex method, are used for blood grouping. Solid-phase assays use reagent antigens or antibodies affixed to a surface (usually a microplate).  Several automated analyzers use solid-phase assays for blood grouping. For instance, Abcam Plc (UK), provides Human ABO ELISA Kit (Histo-Blood Group ABO System Transferase).

• Massively Parallel Sequencing Techniques

Massively parallel sequencing techniques provide a comprehensive blood-group variant profile. However, this technique is dependent on labor-intensive data analysis by experts in blood-group genomics—a lack of trained workforce restraints the growth of this technique.

• Serology

Serology is an analytic technique used for the diagnostic identification of antibodies in the serum that involves typing for antigens found on the surface of blood cells. However, this technique has certain limitations and cannot respond to the growing demand for blood products type for a large number of antigens. The serology segment is further be sub-segmented into gel technique, erythrocytes magnetized technology (EMT), solid-phase red-cell adherence (SPRCA), glass slide, glass tube, cassette/kits, and others.

• Other Techniques

The other techniques are expected to register a CAGR of 7.39%.

By Test Type

• Blood Group and Phenotype

The phenotype of RBCs refers to determining the type of antigens present on the RBC. The 'type and screen' determines both the ABO-Rh of the patient and screens for the presence of the most commonly found unexpected antibodies. It is performed on all patients requiring transfusions. However, an extended antigen phenotype may also be performed.

• Antibody Screening

The antibody screening is done to check whether an antibody to a red cell antigen has been produced. Antibody screening is performed to detect antibodies in patients requiring blood transfusion, pregnant women, patients with suspected transfusion reactions, and blood and plasma donors.

• Cross-matching Tests

Crossmatching tests are among the most important serological tests and are performed before a blood transfusion to ensure that the donor blood is compatible. It involves adding the recipient's plasma to the donor blood cells and observing for agglutination reactions.

• Antibody Identification

Antibody identification involves analysis for the presence or absence of a particular antibody (qualitative) or the amount of antibody present (quantitative). The antibody identification testing is done for several applications, including documenting exposure to an infectious or foreign agent, evaluating immune status against a particular microorganism, diagnosing an autoimmune condition, diagnosing the reason for a transfusion reaction or a rejection of a transplanted organ, diagnosing an allergy, and monitoring the course of an infection or autoimmune process.

• Coombs Tests

A Coombs test, also known as antiglobulin test, is either of two blood tests used in immunohematology. They are the direct and indirect Coombs tests. A direct Coombs test is performed to detect if antibodies are bound to red blood cells inside the person's body, which is abnormal and can occur in conditions like autoimmune hemolytic anemia, hemolytic disease of the newborn and transfusion reactions. The indirect Coombs test is used to screen for antibodies that could cause transfusion reactions and identify certain blood group antigens.

• Antigen Typing

Antigen typing is performed if patients are found with clinically significant autoantibodies. The procedure is performed for the corresponding antigens to confirm if the antibodies are alloantibodies or autoantibodies. Also, if such a patient requires blood transfusion, all donor units to be crossmatched are antigen typed.

By End User

• Hospitals

A person usually visits a clinic or hospital to find out their blood type. In clinics and hospitals, a doctor or nurse draws a blood sample and sends it to a lab for testing. Hospital-based laboratories are attached to the hospital, and the laboratory staff are employed by the hospital. These laboratories perform laboratory testing for inpatients and outpatients.

• Blood Banks

Blood banking tasks primarily include collecting, processing, testing, storing, and distributing whole blood and blood products. According to the American National Red Cross, about 6.8 million people in the US donate blood each year. A certain set of standard tests are done in the lab once blood is donated, including ABO grouping and Rh typing.

• Clinical Laboratories

Clinical laboratories are independent organizations or companies that test the product and material according to the requirements. The testing carried out by independent laboratories is known as "third-party" testing. These clinical laboratories offer advanced testing services and potentially provide a cost-saving alternative to hospitals and clinics lacking the infrastructure.

Regional Analysis

GLOBAL BLOOD GROUPING REAGENTS MARKET SHARE (%), BY Region, 2020Source: MRFR analysis

North America

North America dominated the global blood grouping market due to the presence of major manufacturers, increasing prevalence of chronic diseases leading to the high demand for blood transfusion and organ transplant

The key factors such as presence of major manufacturers, increasing prevalence of chronic diseases leading to the high demand for blood transfusion and organ transplant, technological advancements in the clinical segment, and increasing awareness among the population are expected to drive market growth. The key manufacturers are anticipated to launch new products, collaborate for optimization of the cash flow channel, and partially outsource the production process. Moreover, increasing investments in research and collaborative approach to improve the technology for blood grouping in the region is anticipated to increase the market size over the forecast period.

Asia-Pacific

Asia-Pacific presents lucrative opportunities for players operating in the blood grouping reagents market

The blood grouping reagents market in Asia-Pacific is expected to be the fastest-growing regional market. Key factors that influence the markets growth include the growing incidence of traumatic injuries from accidents and trauma in the region. Increasing demand for blood banking services, government initiatives and increasing public awareness about blood donation are driving the markets growth in this region. Globally, road accidents are the tenth leading cause of death. India accounted for about 500,000 road accidents in 2019, one of the highest in the world, in which about 150,000 people die and another 300,000 became crippled. In 2018, India had 467,044 reported road accidents, an increase of 0.5% from 464,910 in 2017, according to the road ministry's data. Moreover, in 2018, 63,194 traffic accident fatalities were recorded by China's National Bureau of Statistics. Many road accidents causing traumatic injuries are anticipated to increase the demand for blood grouping reagents in the region.

Competitive Landscape

The global blood grouping reagents market is expected to grow significantly in the coming years due to the increasing chronic diseases across the globe. The global blood grouping reagents market is characterized by the presence of several global, regional, and local vendors. The market is highly competitive, with all the players trying to gain maximum market share. Frequent changes in government policies, intense competition, and FDA regulations are the key factors that impact global market growth. The vendors compete based on cost, product quality, reliability, and aftermarket services. It is crucial for the players to offer cost-efficient and high-quality blood grouping reagents products to succeed in an intensely competitive market environment.

List of companies with HQ

• Merck KGaA (Germany)


• Bio-Rad Laboratories, Inc (US)


• Novacyt Group (France)


• Beckman Coulter, Inc (US)


• Haemokinesis Pty Ltd (Australia)


• MTC Med. Produkte GmbH (Germany)


• DAY medical SA (Switzerland),


• Rapid Labs Ltd (UK),


• Ortho Clinical Diagnostics (US)


• Diagast SAS (France)


• Yuvraj Biobiz Incubator India Pvt (India)


• Tulip Diagnostics (India)


• Aikang (China)

Recent Developments

• In July 2020, Merck KGaA invested 18 million euros in new life science laboratory in Switzerland. The laboratory facility is to be built in Buchs (Switzerland) to support the growth of the company in the reference materials.


• In April 2018, Quotient Limited received FDA approval for U.S. commercialization of seven new blood bank reagents.


• In December 2017, Beckman Coulter, Inc. expanded its development & manufacturing facility based in Lismeehan, County Clare (Ireland). At this facility, the company develops and manufactures reagents used in clinical chemistry, hematology, and immunochemistry product.

Report Overview

The study covers the existing short-term and long-term market effects. It helps decision-makers to draught short-term and long-term business plans by region. The report covers major regions in North North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's five forces, value chain, and impact of COVID-19 on the market.

Study Objectives

• To provide a comprehensive analysis of the global blood grouping reagents market and its sub-segments, thereby providing a detailed structure of the industry


• To provide detailed insights into factors driving and restraining the growth of the global blood grouping reagents market


• To estimate the market size of the blood grouping reagents market where 2018 to 2019 would be the historical period, 2020 shall be the base year, and 2021 to 2027 will be forecast period for the study


• To provide strategic profiling of key companies (manufacturers and distributors) present across the countries, and comprehensively analyze their competitiveness/competitive landscape in this market


• To provide a value chain analysis for the blood grouping reagents market.

Market Segmentation:

Global Blood Grouping Reagents Market, By Product

• Consumables


• Instruments
  
  
  • Fully automated
  
  
  • Semi-automated
  
  
  
  

Global Blood Grouping Reagents Market, By Technique

• PCR-based and Microarray Technique


• Assay-Based Techniques


• Massively Parallel Sequencing Techniques


• Serology
  
  
  • Gel Technique
  
  
  • Erythrocytes Magnetised Technology (EMT)
  
  
  • Solid-Phase Red-Cell Adherence (SPRCA)
  
  
  • Glass Slide and Tubes
  
  
  • Cassette/Kit
  
  
  • Others
  
  
  
  


• Other Techniques

Global Blood Grouping Reagents Market, By Test Type

• Blood Group and Phenotype


• Antibody Screening


• Cross-matching Tests


• Antibody Identification


• Coombs Tests


• Antigen Typing

Global Blood Grouping Reagents Market, By End User

• Hospitals


• Blood Banks


• Clinical Laboratories

Global Blood Grouping Reagents Market, By Region

• North America
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America