Blood Screening Market Size, Share & Trends Analysis Report By Product (Reagent, Instrument), By Technology (NAT, ELISA, CLIA & EIA, NGS, Western Blotting), By Region, And Segment Forecasts, 2020 - 2024

Report Overview

The global blood screening market size was valued at USD 1.6 billion in 2015 and is projected to grow at a CAGR of 10.2% over the forecast period. Blood screening is a process in which donated blood is screened for various infectious diseases such as HBV, HCV, HIV1, and HIV2. High growth of this market is attributed to rising blood donations, increase in the incidence of infectious diseases, and government initiatives. 

Initiatives by the various organizations and governments increase awareness about donation and screening before transfusion. According to the WHO, approximately 108 million blood donations are collected every year across the globe. About 50% of these blood donations collected from high-income countries which is home to less than 20% of the total population. Hence, rising awareness coupled with the high demand for safe blood create opportunities in emerging countries.

Furthermore, in 2010, the rate of screening for hepatitis B, hepatitis C, and HIV viruses increased as compared to previous years with almost 100% in most of the countries. To motivate volunteers, the WHO established a goal to provide safe blood access to the entire world by 2020. Such initiatives increase voluntary donations and are likely to propel the market during the forecast period.

Australia Red Cross launched two new initiatives to enhance voluntary donation on 14^th June 2016, which is a world blood donor day. The first initiative is an SMS alert and second is a toolkit that reduces the anxiety of the first-time donor and, thereby, increases voluntary donation in the country.

Blood Screening Market Trends

Growing incidence of cancer, cardiovascular, neurological, genetic, and other disorders is expected to fuel the market growth. According to the Globocan report, worldwide, an estimated 19.2 million new cancer cases were estimated in 2020 and this number is projected to reach 24.5 million by 2030. Unhealthy dietary habits, obesity, high tobacco & alcohol consumption, and sedentary lifestyle are factors expected to increase the incidence of chronic diseases. Thus, the rising incidence of chronic diseases is expected to drive the blood screening market.

Rising number of new product approvals and technological advancements are expected to boost the market growth. For instance, in February 2021, Health Canada approved GenDx’s two NGS products, NGSgo-AmpX v2 and NGSgo-MX6-1, for individual HLA gene amplification and combining six HLA genes for multiplexed amplification, respectively. Moreover, innovations in the market are rising and companies are focusing on the development of novel screening tests based on biomarker technology. For instance, in April 2021, CardiNor, a Norway-based firm received funding of USD 1.4 million for the development of a biomarker-based ELISA test for cardiovascular disease detection. The development is aimed at making the routine diagnosis of the patients easier.

According to WHO, life expectancy is now exceeding 80 years in most developed economies owing to early diagnosis of diseases, availability of advanced healthcare facilities, and rising spending on healthcare. Based on the U.S. National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Database, 38% of women and 43% of men are estimated to develop cancer during their lifetime. Nearly two-thirds of all new cancer cases are diagnosed in people aged 65 years and above, showing that aging can make people more vulnerable to cancer. Blood screening can play an important role in early diagnosis as it has a tremendous impact on the management of cancer, infectious diseases, and cardiovascular diseases.  Thus, the growing demand for blood screening for the early detection of chronic diseases is projected to drive market growth.

Several market players are focusing on mergers & acquisitions to strengthen their market position. This strategy enables companies to increase capabilities, expand product portfolios, and improve competencies, which will boost market growth during the forecast period. For instance, in January 2021, Thermo Fisher Scientific, Inc. announced the acquisition of Mesa Biotech, Inc.—a diagnostic company for USD 450 million to expand its product portfolio. Similarly, in April 2021, GenMark Diagnostics, Inc. acquired by F. Hoffmann-La Roche Ltd. GenMark Diagnostics, Inc. has patented technologies, such as ePlex and eSensor XT-8 which can be utilized in the screening of bloodstream infections.  

High prices associated with blood screening is among the primary factor impeding this market growth. Lack of substitute products is another reason for high prices. This problem is further compounded by the significant variations in prices for different applications of each blood screening product. Lower and middle-income countries are affected more due to less out-of-pocket expenditure and improper reimbursement scenarios. According to WHO, about 50% of healthcare financing in low-income countries comes from out-of-pocket payments, compared to the ~14% in high-income countries and ~30% in middle-income countries. 

The stringent regulatory scenario is expected to slow down the market growth. The regulatory atmosphere is becoming complex, and the FDA is more careful as dependency on blood screening for making severe medical decisions is rising. The FDA also conducts a post-market investigation of IVD products to ensure parity between performance and claims. For instance, in October 2021, Magellan Diagnostics recalled its LeadCare II, LeadCare Ultra Blood Lead, and LeadCare Plus Tests due to threat of invalid low results. Hence, the stringency of regulations associated with the approval process for blood screening is limiting the market growth.

Product Insights

Reagent dominated in 2015 and is expected to maintain its dominance over the forecast period. Higher accuracy and specificity in detecting presence and type of various elements in a small sample would drive the market.

In addition, reagents are cost-effective for customers and give a high return on investment to the vendors. High cost and reusable nature of instruments restraint the growth of instrument segment in the blood screening market during the forecast period 2016 - 2024.

Instrument accounted for a significant share in the market due to introduction of devices in the market after their marketing approval. For instance, in October 2017, the FDA approved Roche’s Cobas Zika donor screening test for Zika virus. This will prevent the spread of Zika virus in the U.S. through blood donations.

Technology Insights

Nucleic acid amplification test (NAT) is expected to grow at the fastest rate owing to its high sensitivity and specificity for viral nucleic acid. The test detects nucleic acid earlier than other screening methods and, thus, narrows the window period of HBV, HCV, and HIV infections.

NAT was introduced in developed countries initially in the 1990s and early 2000. About 33 countries in the world implemented NAT for HIV and around 27 countries for hepatitis B virus till 2014. The methods that fall under this segment are polymerase chain reaction, ligase chain reaction, and transcription-mediated amplification.

In October 2016, Roche received the U.S.FDA approval for their next generation cobas MPX donor screening test to prevent the spread of viruses through blood transfusion. Cobas MPX assay is a NAT for the detection of five viruses HIV-1 Group O, HIV-1 Group M, HIV-2, HBV, and HCV, from a single sample.

ELISA accounted the second largest share of the market. The growth of this technology is attributed to continuous development to increase its specificity, low cost as compared to NAT, and increasing prevalence of infectious diseases in the Asia Pacific region. There are various ELISA generations available in the market.

Regional Insights

In 2021, North America accounted for the largest revenue share. The presence of key industry players, increased adoption of the blood screening process, stringent FDA regulations for transfusion, and greater patient affordability are responsible for maintaining its position during the forecast period.  Asia Pacific is the fastest-growing region due to increasing awareness among people about blood donation, rising patient affordability, and growing focus of key industry players on emerging countries in the region. China, Japan, India, Singapore, and Australia are major contributing countries in the Asia Pacific region.

The U.S. leads the blood screening market due to the local presence of leading players such as Roche Diagnostics, Abbott, and Danaher. One of the reasons for their continued dominance is the presence of well-established R&D infrastructure and favorable reimbursement policies. Furthermore, according to the American Cancer Society, in 2022, around 1,918,030 new cases of cancer and about 609,360 cancer deaths are anticipated in the U.S. alone. These factors are expected to contribute to the continued dominance of the U.S. In addition, the regulatory and reimbursement landscape is continuously evolving to adapt to the fast-paced research progress in this sector. Moreover, the FDA is developing new regulatory strategies regarding NGS, which is anticipated to boost innovation in tests, while ensuring that the data produced by these tests are accurate and reliable.

India’s market is a different scenario compared to the other Asia Pacific countries, such as China and Japan, owing to more relaxed regulatory guidelines and the import of most equipment & materials from other countries. Its market is expected to witness significant growth owing to increased investments by private and foreign entities, which can help provide effective tests at lower costs. The well-distributed network of clinical laboratories and hospitals in India is leading to faster adoption of blood screening techniques.

In India, testing for infectious diseases has led to increasing demand for blood screening. Major infectious diseases, such as sexually transmitted diseases, HIV/AIDS, ventilator-acquired pneumonia, tuberculosis, and hospital-acquired infections, serve as key drivers for the market. Although blood screening is costlier and affordable only to the middle and mainly upper-tier economic group, rapid economic development is expected to increase the purchasing capacity of people. This factor, along with the demand for better diagnosis and preventive medicine, renders a promising outlook for India’s blood screening market.

Key Companies & Market Share Insights

Some of the key players in the industry include Becton Dickinson and Company, Thermo Fisher Scientific., Ortho-Clinical Diagnostics, Inc., Grifols, Danaher Corporation (Beckman Coulter), Abbott Laboratories; Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd.; and Siemens AG

Development of new products and partnership or collaborations for the development and commercialization of products are the key strategies adopted by the companies to capture the market. For instance, Grifols received CE mark for the Procleix HEV assay, which uses NAT to detect hepatitis E virus. The test was developed in partnership with Hologic, Inc. Hence, collaboration for commercialization and development is likely to propel the industry during the forecast period.

Blood Screening Market Report Scope

Segments covered in the report

This report forecasts revenue growth and provides an analysis of the industry trends in each of the sub-segments from 2013 to 2024. For the purpose of this study, Grand View Research has segmented the global blood screening market report based on technology, product, and region:

• Blood Screening Technology Outlook (Revenue, USD Million; 2013 - 2024)

  • Nucleic Acid Amplification Test (NAT)

  • ELISA

  • Chemiluminescence Immunoassay (CLIA) and Enzyme Immunoassay (EIA)

  • Next-Generation Sequencing (NGS)

  • Western Blotting

• Blood Screening Product Outlook (Revenue, USD Million; 2013 - 2024)

  • Reagent

  • Instrument

• Blood Screening Regional Outlook (Revenue, USD Million; 2013 - 2024)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • MEA

    • South Africa