Fibrin Sealants – An example of an expanding market opportunity

The concept of using clotting substances from human blood for wound management and to achieve haemostasis in bleeding parenchymatous organs can be traced to the early part of the 20th century when Bergel reported the haemostatic effect of fibrin. In 1916, Harvey reported the use of fibrin patches to stop bleeding from solid organs during general surgery. Some years later,

Young and Medawar, in 1940, reported an experimental nerve anastomosis by fibrin sealing. The “home-brew” nature of these products which failed to address the poor adhesive strength of fibrinogen meant that results were generally unacceptable. The use of fibrin sealants was given fresh impetus in 1975 when Matras and colleagues reported the successful use of autologous fibrin sealants in surgical practice.

The revenue generating potential for the use of surgical sealants is set for high growth. The perennial problem within healthcare of the “ageing population” brings with it the recorded and forecast increase in the number of surgical procedures across the surgical specialities. The recognised use of surgical sealants, adhesives and haemostats as necessary adjuncts to successful procedures forms the basis of solid assessments of market opportunity in this area. The utilisation of fibrin sealants in surgical procedures is increasing, as these products are found to be useful in combination with traditional methods such as suturing and stapling to achieve more efficient haemostasis.

The table below highlights the increase in the number of heart surgery procedures performed in the UK over the last four years. Considering that peri- and post-operative bleeding require immediate attention when these procedures are performed, the rate of increase in the number of procedures gives some basic indication of the upside potential for the surgical sealants markets.

Number of heart surgery procedures performed in the United Kingdom, 1998 – 2002

Source: Hospital episode Statistics, Dept of Health, UK

Additional market drivers are:

· Expanding knowledge of the biochemical and cellular mechanisms of tissue repair and incorporation of this knowledge into the design of next generation products
· Products facilitating opportunity for premium pricing returns within an environment where development and acceptance of newer drug-loaded products may be extremely favourable.
· Marketing message can increasingly point to use of sealants assisting in rapid rehabilitation of patients and reducing the need for repeat surgical procedures dealing with complications arising from the original procedure. Factoring in cost-benefit assessments can support the reimbursement approval process.
· Application of surgical sealants, through endoscopy for example, supports the drive for greater use of minimally invasive procedures.

This article does not allow an exhaustive review of the surgical sealants and haemostat market. Limiting the scope of the article to fibrin sealants, the following table highlights examples of the different fields of surgery where fibrin sealants find use:

Corporate activity – market directions.

The sealants market is attracting the attention of medical device and pharmaceutical companies. The main thrust of activity comes from the device sector but we anticipate that there is room for expanded collaboration between the two industry sectors as drug-loaded sealants are important advances and will be key drivers instrumental in expanding the use of sealants across different surgical procedures. As an example, investigating the role of fibrin sealants as drug delivery vehicles gives pharmaceutical manufacturers an opportunity to maximise sales of certain drugs. This is within a climate where thin late stage product pipelines necessitate investigation of all avenues where drug sales can be targeted. There is some evidence of research activity in this area. Consider purely as an example Patent Number:WO0072856, Publication date: 2000-12-07 entitled “Fibrin Sealants Providing Less Inflammatory Response and Methods Using Same” filed by Bristol-Myers Squibb which describes the development of fibrin sealants that act to downregulate nitric oxide formation which is believed to contribute to reducing the inflammatory response. The following table highlights principal corporate activity in the field and selects interesting product development activity.

Fibrin sealants are not now, nor have they ever been simple “patches” used in the control of surgical bleeding but are an ever more sophisticated and complex wound management tool having invaluable use in surgical procedures. As these products continue to be developed utilising the most recent knowledge on tissue repair mechanisms and become more biocompatible the possibility to continually offer premium priced sealants remains. The drug- loading and therefore drug-delivery properties are likely to see greater collaboration between device companies developing these products and, at the very least, mid-cap biotechnology companies with promising drug candidates that are compatible with fibrin sealants. From the pharmaceutical perspective this sector has the potential to become quite an important niche for certain drug companies that seek an extension of their product’s use and, by association, increased drug revenues.