The global blood screening market size was valued at USD 3.4 billion in 2023 and is projected to reach a value of USD 6.7 billion by 2032, registering a CAGR of 7.8% during the forecast period (2024-2032). Rising blood donations, an increase in the incidence of infectious diseases, and government activities all help to drive the blood screening market share.
Blood screening tests samples to discover and identify infectious infections, genetic problems, and other health issues. This screening is often performed on donated blood to guarantee its safety before it is used in transfusions or other medical procedures. Blood screening tests can identify pathogens such as viruses (e.g., HIV, hepatitis B, and C), bacteria, parasites, antibodies, and genetic markers linked to specific diseases.
The blood screening industry is predicted to grow significantly because of worldwide blood donations, awareness of transfusion-transmitted diseases, and demand for donated blood for medical purposes. Furthermore, the blood screening market prediction predicts that the global spike in blood donations will emerge as a key driver propelling the growth of the blood screening market share. Furthermore, growing awareness of transfusion-transmitted diseases has emerged as a primary driving force behind the blood screening industry's expansion.
However, the blood screening industry faces significant constraints in the form of regulatory barriers, limiting the global market opportunity. Furthermore, regular updates and changes in regulatory frameworks can create additional obstacles, forcing businesses to adapt quickly to remain compliant.
The growing prevalence of chronic diseases, surgical operations, and trauma cases has increased the global demand for blood transfusions. This increased demand needs stringent blood screening processes to ensure donated blood's safety and purity. According to the World Health Organization (WHO), noncommunicable diseases (NCDs) or chronic diseases are responsible for 17.9 million deaths each year, with cardiovascular disease being the primary cause, followed by malignancies, chronic respiratory diseases, and diabetes. These four types of diseases account for more than 80% of all premature NCD fatalities. As a result, there is an increasing need for blood transfusions to treat these illnesses, driving demand for safe and screened blood products.
Additionally, blood transfusions are frequently required during and after surgical interventions, such as major surgeries, organ transplants, and childbirth-related procedures. The growing number of surgical procedures conducted worldwide increases the demand for blood transfusions. Around 64 million surgical procedures in the United States, including tooth extraction and open heart surgery, are performed yearly. The most common operation in the United States is an appendectomy, which involves removing the appendix to treat acute appendicitis.
Furthermore, trauma cases caused by accidents, injuries, and natural catastrophes sometimes necessitate prompt medical attention, including blood transfusions to stabilize patients and refill lost blood volume. With the increasing number of traumatic injuries worldwide, particularly in cities and conflict zones, there is a growing demand for blood products for emergency medical care. According to the World Health Organization (WHO), injuries cause 4.4 million fatalities worldwide each year, accounting for approximately 8% of all deaths, with many requiring blood transfusions.
Moreover, as healthcare systems work to address the demands of various patient populations, comprehensive blood screening processes and technologies to ensure blood safety remain critical.
Regulatory bodies such as the FDA in the United States and the EMA in Europe have developed thorough blood screening criteria and standards to ensure the safety and quality of blood products. These laws address a wide range of topics related to blood screening, such as assay validation, quality control, and procedural documentation. Obtaining and maintaining regulatory compliance necessitates substantial financial and human resources. Blood screening facilities must budget for equipment purchases, employee training, quality control systems, and regulatory affairs operations. For example, according to a study published in the Journal of Clinical Microbiology, the cost of implementing nucleic acid testing (NAT) for HIV and hepatitis C virus (HCV) screening in blood donor screening laboratories ranged from USD 1.6 to USD 3.3 million per laboratory, depending on testing volume and infrastructure requirements.
Furthermore, the severe regulatory requirements for blood screening assays might create a barrier to entry for new market participants and novel technology. Companies seeking regulatory approval for new blood screening products must devote significant time and money to preclinical and clinical research, regulatory filings, and compliance efforts. As a result, smaller enterprises may need help to navigate the regulatory landscape and compete with more prominent manufacturers, limiting innovation and market diversity.
Rapid advances in blood screening technologies, such as nucleic acid testing (NAT), enzyme-linked immunosorbent assays (ELISAs), and next-generation sequencing (NGS), provide prospects for more accurate detection of infectious organisms and genetic markers in given blood. Automation, downsizing, and multiplexing advances allow for faster, more accurate, and high-throughput screening, increasing the efficiency of blood screening operations.
Similarly, NAT has transformed blood screening by allowing the direct detection of viral nucleic acids in donated blood samples, providing greater sensitivity and specificity than standard serological techniques. For example, NAT enables the detection of viral RNA or DNA in the early stages of infection, shortening the time between infection and detection. This method is commonly used to screen blood donations for HIV, hepatitis B and C viruses, and West Nile viruses. In Sweden, the cost of employing nucleic acid testing (NAT) to screen blood donors for HIV, Hepatitis B (HBV), and Hepatitis C (HCV) is projected to be SEK 101 million (USD 12.7 million) per averted viral transmission. The cost per QALY gained is SEK 22 million (USD 2.7 million).
Henceforth, NGS technologies allow for high-throughput sequencing of genetic material, making them valuable tools for blood screening applications such as virus detection, microbial identification, and blood group typing. NGS-based assays provide multiplexing capabilities, allowing for the simultaneous screening of numerous pathogens or genetic markers in a single test. For example, NGS may be used to accurately identify viral variations, detect new pathogens, and describe bloodborne illnesses.
| Study Period | 2020-2032 | CAGR | 7.8% |
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 3.4 billion |
| Forecast Year | 2032 | Forecast Year Market Size | USD 6.7 billion |
| Largest Market | North America | Fastest Growing Market | Asia Pacific |
The global blood screening market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.
North America is the most significant global blood screening market shareholder and is estimated to grow at a CAGR of 7.3% over the forecast period. The blood screening market in North America grew significantly throughout the forecast period. This region's dominance is due to increased blood donors, widespread use of blood screening procedures, and lower patient costs. Furthermore, the region's significant position in the global market is due to high public awareness regarding blood safety. For example, the American National Red Cross estimates that approximately 6.8 million people in the United States donate blood each year.
In addition, according to the American Cancer Society, the United States alone is expected to see approximately 1,918,030 new cancer cases and 609,360 cancer deaths in 2022. In the United States, 6.8 million people donate blood each year. These elements will contribute to the United States' sustained dominant position. Furthermore, the regulatory and reimbursement landscape is constantly developing to keep up with the rapid research speed in this field. Moreover, the FDA is creating new regulatory policies for NGS, which are expected to increase test innovation while ensuring that the data generated by these tests is accurate and reliable.
Asia-Pacific is anticipated to exhibit a CAGR of 7.6% over the forecast period. The Asia-Pacific market is expected to increase over the forecast period. Increasing investment by key companies in emerging regions, anticipated regulatory approvals, and improving patient affordability will likely fuel demand for blood screening in Asia Pacific throughout the forecast period. Furthermore, key Asian Pacific contributors include China, Japan, India, Singapore, and Australia. In 2020, India received an expected 12.7 million blood donations, compared to 15.5 million in China.
Additionally, India's market differs from other Asia Pacific countries, such as China and Japan, due to more flexible regulatory restrictions and the import of most equipment and materials from different countries. Its market is predicted to expand significantly due to growing expenditures by domestic and foreign businesses, which can help provide effective tests at cheaper rates. The well-distributed network of clinical laboratories and hospitals in India is accelerating the implementation of blood screening technology.
Europe holds a significant market share. Introducing new systems with advanced technologies in the European market is expected to boost demand for screening systems throughout the forecast period. For example, in December 2019, F. Hoffmann-La Roche introduced their cobas Zika test in Europe, which is used to screen blood donors.
Furthermore, in 2022, NAAT technology dominated the market due to a legislative necessity for mandatory NAAT screening for all blood donors. The Paul-Ehrlich-Institut, a German medical regulatory authority, mandates NAT testing for HCV and HIV for all blood donors.
Latin America, the Middle East and Africa have a lower market share due to vast, underpenetrated markets in these regions. As a result, a lower CAGR is predicted throughout the forecast period.
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The global blood screening market is segmented based on product type, technology, and end-user.
The market is further segmented by product type into Instruments, Reagents, and Kits.
The kits and reagent segment dominated the global market and is expected to continue during the forecast period. Reagents and kits are necessary consumables and biochemical substances used in blood screening tests to detect and identify specific analytes, pathogens, or biomarkers in blood samples. Enzymes, antibodies, probes, substrates, buffers, and other chemical substances are common reagents used in various screening procedures. Kits may include pre-packaged reagents, controls, calibrators, assay components, and instructions for use. They offer a straightforward and standardized method for performing specialized screening assays such as enzyme-linked immunosorbent assays (ELISAs), nucleic acid amplification tests (NAATs), and immunofluorescence assays (IFAs).
Additionally, reagents and kits ensure assay sensitivity, specificity, and reliability, allowing for accurate and repeatable results in blood screening laboratories. The segment's dominance is related to the cheaper cost and mobility of the kits and reagents, allowing efficient blood screening at small-scale and distant blood banks.
Instruments are the hardware and equipment required to perform various screening assays and processes. These instruments include a variety of technologies, such as automated analyzers, nucleic acid amplification systems, flow cytometers, and robotic liquid handling systems. Instruments are essential for sample processing, assay preparation, interpreting results, and data analysis. They are intended to maximize workflow efficiency, ensure assay accuracy and repeatability, and fulfill the throughput requirements of high-volume screening facilities. Instruments may include sophisticated technologies such as automation, robotics, and multiplexing to improve the performance and capacities of blood screening systems.
Based on technology, the market is fragmented into Molecular Tests and serology Tests.
Molecular tests dominated the global market. Molecular assays, also known as nucleic acid amplification tests (NAATs), look for specific nucleic acid sequences, such as DNA or RNA, associated with infectious pathogens in blood samples. These tests use techniques including polymerase chain reaction (PCR), real-time PCR, nucleic acid hybridization, and sequencing to amplify and detect target sequences with high sensitivity and specificity. Molecular tests commonly detect viral infections, such as HIV, hepatitis B and C, cytomegalovirus (CMV), and human papillomavirus. They are especially useful for early diagnosis, viral load monitoring, and screening of asymptomatic carriers, all of which help to enhance blood safety and transfusion results.
Moreover, the supremacy is due to the sensitivity of the nucleic acid amplification test (NAT) for detecting viral nucleic acids in blood samples. Furthermore, the NAT test is clinically successful for early detection of the HIV, HBV, and HCV viruses and is therefore gaining popularity in clinical laboratories around the world.
Serology tests, also known as immunoassays, identify antibodies or antigens the immune system produces in response to infection with specific microorganisms. These assays rely on antibody-antigen binding interactions to produce observable signals like colorimetry, fluorescence, or chemiluminescence. Serology tests are often used to screen for infectious diseases such as HIV, hepatitis, syphilis, and malaria. They identify antibodies produced in response to infection or antigens derived from the infectious agents.
The market can be bifurcated by application into Independent Clinical Laboratories and hospital-based Laboratories.
Hospital-based laboratories are expected to acquire market share as the frequency of blood transfusion procedures increases in these settings. Hospital-based laboratories are critical components of healthcare institutions, providing diagnostic testing services to inpatients, outpatients, and emergency room patients. These laboratories are often linked with hospitals, medical institutions, or healthcare systems and overseen by pathologists, laboratory directors, and other healthcare experts. To meet the clinical needs of physicians, specialists, and other healthcare providers, hospital laboratories provide a comprehensive range of blood screening tests, including regular, diagnostic, and specialized assays.
In addition, several hospitals worldwide are establishing various patient blood management systems to facilitate transfusion and screening processes, aiming to improve patient outcomes, lower costs, and conserve blood. As a result, such hospital activities are likely to boost the segment's growth over the projection period.
Independent clinical laboratories are private facilities that offer diagnostic testing services and operate independently of hospitals or healthcare institutions. These laboratories may provide healthcare practitioners, patients, and clients with various blood screening tests, such as molecular, serology, and other specialty assays. Independent clinical laboratories charge a fee for testing services and serve many customers, including doctors' offices, clinics, long-term care institutions, and occupational health centers.
