Although the USD 90 million European tissue sealants market is in the growth phase, the rate of growth is projected to be gradual due to sluggish technological advancements, the slow pace of collecting clinical evidence and unclear product demarcations. Moreover, while around 35 per cent of all internal surgical procedures offer the potential for sealants' use, their deployment has been limited to only a few procedures.
Expanded licence indications, accelerated technological progress and more rapid clinical data collection are, therefore, being seen as critical to leveraging opportunities in an, as yet, virtually untapped market.
Still at an embryonic stage, market capitalisation is relatively low at around 36 per cent. Over 2005-2011, the market is poised to grow at an annual rate of 17.3 per cent to reach USD 276 million.
"Though at the moment, products such as surgical adhesives have a higher market size, owing to their early entry into the market, in the years to come, they are expected to fall behind because they are niche products and their line of application is also very limited," notes Frost & Sullivan Research Analyst, Aarati Ajay. "This could be a major driver for the tissue sealants market, as they have a wider application spectrum."
Here, comprehensive clinical data is likely to be key to supporting the use of tissue sealants in new indications. Clinical data is also expected to be crucial in assuaging safety concerns about potential viral transmission in traditional, plasma based, 'home brews' and promote more frequent usage of commercial tissue sealants.
Cardiac surgery, pulmonary surgery and vascular surgery exhibit the highest number of tissue sealant applications (licensed indications). Rising awareness is also pushing the use of tissue sealants in hepatic surgery. Orthopaedic indications are being investigated even as demand for sealants for burn applications is set to increase.
The availability of pharmacoeconomic data is, moreover, set to convince medical practitioners about the superiority, versatility and cost advantages offered by tissue sealants over competing alternatives. Data confirming the technological superiority of tissue sealant products is poised to help justify higher outlays incurred.
In addition, establishing their comparative benefits over other closure devices such as synthetic glues and adhesives is set to help overcome the problem of substitution caused by unclear demarcation between various wound care products. Awareness programmes educating end users on the differences, potential and economic advantages of tissue sealants over competing products will be crucial to maximising uptake.
In 2004, the well-established pooled fibrin sealants segment is forecast to account for 80 per cent of the overall European tissue sealants market trailed by synthetic sealants with 17 per cent and autologous fibrin sealants with the remainder.
Rising acceptance from the medical community, aggressive marketing and their increasing use in preference to pooled fibrin sealants, are poised to underpin a robust compound annual growth rate of 74 per cent between 2005 and 2011 for autologous fibrin sealants. Strong growth potential is also forecast for the yet to be introduced recombinant human tissue sealants.
High manufacturing expenses together with high infrastructure and R&D outlays have resulted in costly products. "Technological upgrades and working with research organisations involved in the development of new technologies, could reduce manufacturing costs and boost adoption levels," advises Ms. Ajay. "Creating newer markets by increasing the indications would also effect increased volumes, thereby reducing costs."
Currently, Germany is the largest revenue contributor to the European tissue sealants market, primarily due to the well-established presence of large companies such as Baxter. In Italy and Spain as well, the presence of leading market competitors has served to promote usage of tissue sealants. The United Kingdom has recently entered the tissue sealants market with majors such as Baxter, Omrix and Aventis getting their licences only over the past 2-3 years.