• by Emil Salazar
  • February 21 2017


Challenged for Growth, Nucleic Acid Test Vendors Target New Threats to Global Blood Supply

Challenged for Growth, Nucleic Acid Test Vendors Target New Threats to Global Blood Supply

The market for nucleic acid tests (NAT) used in blood donation screening is constrained by stagnant or declining transfusion rates in the developed world. As reviewed in The World Market for Molecular Diagnostics, 7th Edition, blood transfusion rates in the United States declined from an estimated 40 transfusions per 1,000 population in 2011, to 35 per 1,000 in 2014, and 32 per 1,000 in 2016. Demand has fallen as a result of new practices in surgery, blood salvaging, and hospital blood management. Similar reforms in Europe and other developed healthcare systems have alleviated demand for blood transfusion. Achieving business growth in this market environment is challenging even for the largest IVD players. Competitive displacement, in the form of contract wins with blood organizations, is the most prominent strategy for growth, but is reliant upon vendors’ responsiveness to new transfusion transmitted infection (TTI) threats.

China has been the largest market opportunity for the limited number of players in the global NAT blood screening market. European, North American and Japanese blood banks and similar organizations are already established contract clients of market leaders Grifols and Roche Diagnostics. The addition of NAT screening for all donated blood in China was mandated by the national government by 2015, leading to recent tremendous market growth for NATs. Conversion and addition of NAT screening has been completed at Chinese provincial blood centers, but is far from complete among regional and county blood centers and plasma collection centers according to survey results from Kalorama Information’s Blood Testing Market in China.

Climate change and its effect on disease epidemiology, particularly for mosquito-borne diseases, could also factor into long-term market development for NAT blood screening in the United States. Market growth from added NAT screens for Zika and other infectious disease threats may ultimately prove marginal in the U.S. market, but lead vendors such as Grifols and Roche moved quickly to introduce Zika NAT assays to their platforms. In August 2016, the U.S. FDA recommended Zika virus screening of all donated blood and blood products in the United States in order to prevent transfusion-transmitted infections of the virus. Blood industry association and organizations in the United States – AABB, America’s Blood Centers and the American Red Cross – issued a joint statement in November 2016 criticizing the scope of the recommendation, lack of formal risk assessment for the recommended measures, and lack of consultation with stakeholders. Yet, AABB has reported that as of September 2016 Zika NAT screening was being performed in Puerto Rico, Florida (since July 2016), and 10 other southern states.

In the United States, FDA guidelines require the screening of all blood donations for West Nile Virus (WNV) in minipools of 6 or 16. The U.S. Centers for Disease Control & Prevention (CDC) reported a fatal WNV TTI in an August 2013 report. The case renewed calls from professionals for individual screening of every blood unit for West Nile, especially in Northern geographies where the disease is most prevalent. In Europe, travelers to areas with ongoing transmission of WNV may be deferred from donating blood for 28 days. However, lost blood supply from individuals turned away from donating blood combined with concerns regarding blood security have motivated European adoption of NAT screening for WNV. Some German blood centers began WNV screening during summer months in 2014 and 2015 and the practice is becoming increasingly routine in the country. Italian authorities have ramped up WNV surveillance and NAT screening following increased seasonal activity of the endemic pathogen.

Competitive bargaining between NAT vendors may negate the incremental value of Zika virus or WNV assays added to a contract, but assay development remains crucial to market share. The ever-evolving picture of TTIs and need to strengthen and secure blood supplies, particularly in the developing world, inject dynamism into an otherwise largely static molecular diagnostics segment. For market sizes, segmentation and further analysis of molecular blood screening and transplant diagnostics, Kalorama Information’s The World Market for Molecular Diagnostics, 7th Edition is a comprehensive resource.