U.S. Blood Transfusion Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Product (Instruments and Reagents & Kits), By Application (Blood Screening, Blood Group Typing) and By End-user (Hospital-based Laboratories and Independent Laboratories & Blood Banks), 2022-2029

The U.S. blood transfusion diagnostics market size was valued at USD 1.91 billion in 2021 and is projected to grow from USD 2.20 billion in 2022 to USD 3.58 billion by 2029, at a CAGR of 7.2% during the forecast period. The global market exhibited a decline of -6.5% in 2020 as compared to 2019. The global COVID-19 pandemic has been unprecedented and staggering, with blood transfusion diagnostics experiencing lower-than-anticipated demand in the U.S. compared to pre-pandemic levels.

Blood transfusion diagnostics refer to the tests performed on blood or blood components prior to the transfusion process. These tests are referred to as pre-transfusion tests such as blood group typing and blood screening which are imperative as they help in avoiding adverse reactions or prevent the transmission of any infection. They also aid healthcare professionals in finding compatibility between the donor's and the recipient’s blood types. Furthermore, there is increased adoption of these products in blood banks where several tests are performed or store donated blood units and later conduct a safe transfusion process. Thus, these factors have also accelerated the demand as these diagnostics refer to tests, which are mandatory for the blood transfusion process in the country.

Over the recent years, growth in the number of blood transfusions due to a number of factors has been witnessed. This is due to the surge in the launches of new products to cater to the needs of patients requiring regular blood transfusions. Furthermore, due to the increasing number of blood donations in the country, blood group typing and screening procedures are performed more frequently, which will help the market to record strong growth in the forecast period. The awareness regarding blood transfusion diagnostics procedures among the population and the growing demand for blood and blood components are expected to contribute positively to the transfusion diagnostics market growth in the forecast period.  

COVID-19 IMPACT

Global Market Witnessed a Negative Impact due to Decline in Blood Transfusion Procedures

The impact of COVID-19 on the U.S. healthcare system differed as the impact varied from market to market. Preventative steps such as lockdowns imposed by the regulatory bodies to curb the spread of the virus led to the decline of the blood transfusion diagnostics market.

The decline in the number of patients visiting healthcare institutions led to a considerable drop in the number of blood transfusion diagnostic procedures as it refers to tests performed as a prerequisite for surgical and transplantation procedures. Furthermore, a decline in the number of blood donations led to a limited number of blood group typing and screening procedures. Thus, both of these factors led to the decline of the market.

• For instance, in January 2022, the American Red Cross Society mentioned that it was responsible for the provision of 40.0% of the blood units used in the U.S. However, post the pandemic, there was a shortage of blood donations which led to a decline of 10.0% in the total number of people donating blood. Furthermore, owing to the shortage, the organization had to limit the distribution of blood to hospitals.

Major companies with significant product applications and portfolios for transfusion diagnostics also reported a decline in their revenue as the demand for their products declined during the pandemic. Disruption in their manufacturing and supply chain operations also leads to a decline in their revenue.

• For example, Bio-Rad Laboratories, Inc. witnessed a decline of 7.6% in its clinical diagnostics segments during FY 2020 compared to the same period in 2019. The company’s transfusion diagnostics portfolio falls under its clinical diagnostics segment.

In 2021, after the COVID-19 restrictions were lifted, the market witnessed growth as healthcare activities returned to their normal pace. Furthermore, the rise in organ transplants, a key procedure that requires blood transfusions, also increased, which contributed to the market growth. 

• For instance, the data provided by the United Network of Organ Sharing (UNOS) states that a total of 41,354 organ transplant surgeries were performed in 2021 in the U.S., leading to an increase of 5.9% as compared to 2020.

Therefore, key players also reported an increase in their revenue as compared to the previous year due to the increase in the number of blood transfusion diagnostics procedures in 2021.

• For example, Abbott witnessed an increase of 14.6% in the revenue generated by their core laboratories segment in 2021 as compared to the previous year. The company’s transfusion diagnostics portfolio falls under its core laboratories segment.

LATEST TRENDS

Adoption of Automated Blood Group Typing Technologies to Drive Market Growth

The increasing focus of major players toward launching automated blood group typing technologies can be considered one of the major trends in the market. Automated technologies improve the diagnostic transfusion process by reducing the turnaround time without compromising safety and maintaining the standard. The automated platforms have proven to be pivotal for the detection of transfusion-transmitted infections (TTIs) in an individual’s blood sample eliminating human error during the transfusion process.

The technology is said to significantly improve the diagnostic transfusion process by enhancing its speed and maintaining standardization along with safety. Automated blood group typing solutions provide several benefits such as efficiency, cost-effectiveness, and few errors compared to manual typing systems. Furthermore, automated blood group typing solutions do not require multiple healthcare personnel, which can lead to cross-trained and less experienced medical professionals in transfusion service.

• In July 2022, Rhinostics announced the launch of an automated sample collection technology with the launch of a patent-pending VERIstic collection device that focuses on a small volume of blood collection.

Therefore, the launch of such advanced technologies is expected to fuel market growth in the forecast period.  

DRIVING FACTORS

Rising Demand for Blood and Blood Components to Accelerate Market Growth 

The growing prevalence of blood-related disorders, such as hemophilia, leukemia, and thrombocytopenia, and the rapid increase in chronic diseases amongst the general population have been responsible for the increased demand for transfusion of blood and blood components.

• For example, according to the data published by the Leukemia & Lymphoma Society, it was estimated that around 376,508 people in the U.S. were living with or in remission from leukemia in 2020.

Furthermore, rising cases of blood disorders amongst geriatric patients suffering from blood disorders also lead to an increase in the demand for blood transfusion diagnostics. Similarly, growth in the number of patients suffering from anemia has also led to an upsurge in demand for blood transfusion diagnostics procedures in the country. This, along with the increasing number of surgical procedures due to the rising number of trauma cases and road accidents, further augments the demand for blood transfusion procedures. Therefore, the above factors are contributing to the increasing demand for these diagnostics and are thus fueling the growth of the market in the forecast period.

Increase in Number of Blood Donations to Propel Market Growth

The country witnessed a rise in the number of blood donations over a decade. The surge in the adoption of blood group typing and blood screening procedures during these blood donation procedures has fueled the growth of the market.

The COVID-19 pandemic drastically led to a decrease in the number of blood donations during that time period. However, the growing demand for blood in the country for several surgical and medical applications will eventually lead to an increase in the number of donations.

• For instance, in September 2021, the American Red Cross mentioned that sickle cell disease affects 90,000 to 100,000 people in the U.S., and these patients require blood transfusion throughout their lives, therefore increasing the need for blood donations. 

Similarly, several government initiatives in regard to voluntary blood donations are also anticipated to accelerate the growth in the number of donations in the forecast period.

• For instance, in August 2022, the U.S. Department of Health and Human Services (HHS) announced a new campaign to increase blood and plasma donations known as “Giving=Living.”

Hence, the growth in the number of blood donations in the country will lead to the increasing adoption of these products in several facilities, including hospitals and blood donation centers thereby, leading to market growth in the forecast period of 2022-2029.

RESTRAINING FACTORS

Adverse Reactions Associated with Blood Transfusion Processes May Hinder Market Growth Prospects

Blood transfusions may sometimes cause side effects, including allergic reactions, blood-borne infections, and fever or acute hemolytic reactions. These side effects associated with transfusion procedures may negatively affect the growth of the market in the forecast period.

• For example, according to a report published in eClinicalMedicine in May 2020, a study was conducted in the U.S. to assess transfusion reactions in pediatric and adolescent young adults in hematology and immune effector cell patients.

Another adverse reaction an individual faces during a transfusion process is an acute immune hemolytic reaction. It is a rare reaction but is considered serious and is caused when a patient’s blood does not match with the donor. The reaction is caused when the transfused red blood cells are destroyed by the patient’s immune system, causing hemolysis.

• According to the American Red Cross, blood-borne infections from blood transfusions are rare; however, there are slight chances for them to occur.

Such side effects associated with blood transfusion procedures may negatively impact its adoption amongst patients opting for it. This may hinder the U.S. blood transfusion diagnostics market growth.  

SEGMENTATION

By Product Analysis

Significant Product Launches in Reagents & Kits Lead to the Segment’s Dominance

On the basis of product, the market is bifurcated into reagents & kits and instruments. The reagents & kits segment holds a dominant share of the market. The segment dominates the blood transfusion diagnostics market as these products are used more often compared to the instruments. Furthermore, initiatives by key companies to launch new products in this segment also lead to its dominance.

• For instance, in July 2022, Immucor, Inc. announced that they received FDA approval for a blood grouping reagent, nti-Jka (Monoclonal), Anti-Jkb (Monoclonal) Gamma-clone, Anti-S, Anti-s and Anti-Fya (IgG)

The instruments segment holds a comparatively lower U.S. blood transfusion diagnostics market share as the cost associated with these products are much higher. Furthermore, the instruments have a longer shelf life, and thus the replacement rate is lower as compared to reagents & kits. Moreover, a single instrument can be used for multiple purposes, which leads to slower adoption of these products.

• For instance, in July 2020, Beckman Coulter, Inc. received FDA approval for its PK7400 Automated Microplated System along with the instrument’s reagents.

By Application Analysis

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Blood Screening Segment to Grow at a Moderately Faster Pace due to the Prevalence of Transfusion-Transmissible Infections

Based on application, the market is segmented into blood group typing and blood screening. The blood screening segment is expected to record a comparatively higher CAGR over the forecast period. This is due to the growing prevalence of transfusion-transmissible infections along with the presence of a vast product portfolio to cater to the growing number of blood screening procedures.

• For instance, in May 2020, Grifols, S.A. announced that the U.S. FDA approved Procleix Panther System featuring ART to be used with the U.S. licensed products: Procleix Ultrio Elite Assay, Procleix WNV Assay, Procleix Zika Virus Assay, and the Procleix Babesia Assay.

The blood group typing segment is estimated to grow at a comparatively lower CAGR in the forecast period. However, the growing demand for pre-transfusion blood group typing tests to check for the compatibility of the donor and the recipient blood type will lead to the segment’s growth in the forecast period.

By End-user Analysis

Strong Patient Volumes in Blood Banks & Independent Laboratories Ensured Segment’s Dominance in 2021

Based on end-user, the market is divided into independent laboratories & blood banks and hospital-based laboratories. The independent laboratories & blood banks segment is likely to account for the highest market share during the forecast period. This segment's dominance is owing to the growing number of labs and stand-alone clinical laboratories. Furthermore, partnerships amongst labs and government organizations such as the American Red Cross are also expected to fuel the growth of the segment in the forecast period.

• For instance, according to the Blood Centers of America (BCA), over 60 independent community blood collection centers collect and distribute 50% of the country’s blood supply.

The presence of a large number of hospitals with laboratories having advanced instruments to perform blood transfusions in the U.S. resulted in the growth of the hospital-based laboratories segment.

• For instance, according to the statistics published by the American Hospital Association, in 2022, the total number of hospitals in the U.S. were estimated to be 6,093.

KEY INDUSTRY PLAYERS

Strong Product Portfolio and Significant Regulatory Approvals to Enable Grifols, S.A. and F. Hoffmann-La Roche Ltd. Led to Market Dominance in 2021

In terms of the competitive landscape, the market reflects the presence of established companies. Grifols, S.A. dominated the U.S. market in 2021. The company's apex position is attributed to the presence of versatile blood transfusion diagnostics products in the U.S.

• For instance, in March 2021, Grifols, S.A. installed the DG Reader Net semi-automated analyzer to facilitate pre-transfusion blood type compatibility testing in North America.

Other prominent companies with a considerable presence in the market include F. Hoffmann-La Roche Ltd and QuidelOrtho Corporation. Multiple regulatory approvals received by these companies have contributed to the dominance of these companies' market share.

• In September 2020, F. Hoffmann-La Roche Ltd. announced that they received FDA approval for the cobas HIV-1/HIV-2 qualitative test to be used in their fully automated cobas 6800/8800 systems.

Such major factors are expected to further enable these companies to strengthen their market presence. Other players, such as Bio-Rad Laboratories, Abbott, Quotient Limited, Beckman Coulter, Inc., and Immucor, Inc., with their strong distribution network and diverse product portfolio are steadily increasing their presence in the market.

LIST OF KEY COMPANIES PROFILED:

• QUOTIENT LIMITED (Switzerland)


• Grifols, S.A. (Spain)


• Immucor, Inc. (U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)


• Merck KGaA (Germany)


• Beckman Coulter, Inc. (Danaher) (U.S.)


• QuidelOrtho Corporation (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Abbott (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• June 2022: Alba Bioscience Limited (QUOTIENT LIMITED) announced that they received the USFDA approval for ORTHO Sera and ALBAclone blood grouping reagents.


• June 2022: Ortho-Clinical Diagnostics, Inc. announced that they received the 510(k) approval from the USFDA to launch ORTHO Optix Reader for blood group typing solutions.


• January 2021: Grifols, S.A. received approval from the USFDA for the launch of DG Gel Card Blood Grouping Reagent Combination Kit for blood group typing prior to transfusion.


• February 2021: F. Hoffmann-La Roche Ltd announced that they received the USFDA approval for cobas MPX to be used as a multiplex HIV, HCV, and NBV nucleic acid test in human serum and plasma.


• October 2020: Calibre Scientific acquired Lorne Laboratories, which manufactures diagnostic test kits and blood grouping reagents for medical procedures.

REPORT COVERAGE

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The U.S. blood transfusion diagnostics market research report provides a detailed analysis and factors driving the market. It focuses on key aspects such as an overview of technological advancements, prevalence of key bleeding disorders, and blood donation statistics. Additionally, the report includes an insight regarding blood donations and blood group type, distribution of blood group type in the population, blood transfusion statistics, new product launches, key industry developments, such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation