European market for bone morphogenic proteins in spine fusion

Dec 20 2004

High growth is forecast for novel technologies used either as adjuncts or as alternatives to current surgical procedures for the fusion of spinal vertebrae. Bone morphogenic proteins (BMP) - a new and innovative class of natural growth factors - represent amongst the most exciting of these niches. Still pending marketing approval for use in spinal surgery across Europe, BMP promises to offer an improvement on existing spinal fusion techniques.

The increased incidence of degenerative diseases of the lower back is expected to be a key growth driver in the BMP market. As more people opt for surgical procedures to alleviate back pain caused by degenerative diseases, demand for spinal fusion products is set to soar. BMP is expected to profit from this trend, once it has been granted marketing authorisation - anticipated to occur between 2006 and 2007.

In both pre-clinical studies on animals and clinical studies on humans, BMPs appeared to improve fusion rates compared with the autograft 'gold standard' bone-grafting techniques. The prospect of substantially reducing instances of patient mortality associated with autogenous bone grafting is expected to boost BMP's application in spinal fusion.

"Getting rid of the bone graft harvest is an exciting concept, and could possibly help spinal specialists overcome their relative lack of knowledge about this technology since considerable interest is being generated among spinal specialists, medical researchers and within the medical industry concerning osteogenic products including BMPs," remarks Frost & Sullivan Programme Manager, Ms Tanya Pullen.

"There could, however, be a temptation to 'push the envelope' when it comes to indications and applications. With this new opportunity, also comes the responsibility and challenge of appropriate patient selection," adds Ms. Pullen.

While BMPs offer significant clinical advantages over traditional autologous bone and commercial bone graft substitute materials, high costs could constrain their uptake even following marketing authorisation. Issues relating to biocompatibility and safety concerns over excessive bone growth could further curb market expansion.

Supported by an increase in the number of randomised controlled clinical trials required to gain marketing authorisation, sales revenues stood at an estimated USD 582,500 in 2003. Growing at an impressive compound annual growth rate of 61.0 per cent, the market for BMPs in spine fusion is set to reach USD 16.3 million in 2010. The lumbar spine is projected to be the most popular application area for growth factors in spinal surgery in the future.

As the wider commercial use of growth factors in orthopaedics becomes imminent, dosage and carrier matrix issues are likely to remain major challenges. Moreover, while the two products to be first launched in the recombinant BMP arena, OP-1 and InductOs, consist of a single BMP, the most effective treatment is likely to comprise a cocktail of multiple BMPs.

"There consequently exists an opportunity for researchers and developers to collaborate on the development and commercialisation of one of these cocktail growth-factor products," notes Ms. Pullen.

Germany is projected to continue as the largest market in Europe for BMPs, expanding from its current share of 23.6 per cent to an estimated 32.0 per cent share of the overall market in 2010. This notable increase is set to result from the anticipated granting of marketing authorisation throughout Europe and the principle spinal centres in Germany adopting the new technologies.

The French market is forecast to retain its status as the second largest regional market over the long term, accounting for an estimated 27.5 per cent share of the market in 2010 followed by the United Kingdom and Italy.