Although remarkable advances have been made in the prevention of the major transfusion-transmitted diseases, long intervals have transpired between the first recognition of transfusion risk and the implementation of a preventive strategy.
For hepatitis B virus, that interval was 30 years; for non-A non-B/hepatitis C virus, 15 years; and for human immunodeficiency virus, West Nile virus, Trypanosoma cruzi and bacteria, 3, 4, 5 and 18 years, respectively. In the existing reactive approach, there is a fundamental and inevitable delay before the government healthcare authorities can react; thus, infections are destined to occur.
The continued emergence or re-emergence of transfusion-transmitted infections calls for a new paradigm of pre-emptive pathogen reduction (PR) and pathogen inactivation (PI).
New analysis from Frost & Sullivan, European Blood Pathogen Inactivation Market, finds that the market generated revenues of about $238.5 in 2009 and estimates this to reach $521.5 million by 2013, as this is an early growth stage market with very good potential for growth. The following segments are covered in the research: platelets, plasma and red blood cells.
Platelets are highly susceptible to bacterial contamination and therefore cannot be stored for more than 5 days. If the bacterial count is too low to detect, it has to be repeatedly cultured and sub-cultured to verify the number of colony-forming units, by which time, even platelet units that might have initially been usable, become contaminated and expire.
“Therefore, in the case of platelets, PI makes good sense as it helps to extend the storage days from 5 to 7 days,” notes Frost & Sullivan Senior Research Analyst Rasika Ramachandran. “Having two extra days also helps blood centres to manage their inventory better and could mean the difference between having and not having platelet units for transfusion in an emergency situation.”
The European blood pathogen inactivation market is currently growing at a double-digit rate, which is significant even if it comes from a low base. This growth rate is projected to increase as more new products gain regulatory approval and enter the market.
Currently, there is no single PI method that is effective against all pathogens. This is a major drawback for the entire blood pathogen inactivation market, which leads to low uptake of PI techniques. In addition, it is impractical due to the labour intensiveness and cost issues, as currently, multiple inactivation techniques need to be applied to a unit of blood component.
“This is anticipated to be a key challenge in this market until one of two things happens,” states Ramachandran. “One, the significant cost reduction of existing methods or two, the discovery of a single all-encompassing pathogen inactivation technique, neither of which seem to be on the visible horizon.”
There are indications from industry participants that they are focusing on the issue of performing economic cost-benefit analyses. This will raise confidence among healthcare authorities in the adoption of blood PI techniques.
“Although the industry is currently focusing its resources towards clinical validation and gaining marketing approval in various regions in Europe, it is imperative that some resources be allocated towards performing cost-benefit analyses,” concludes Ramachandran.
Frost & Sullivan
