Proven clinical efficiency key to success of nascent European bone graft substitutes market

Increased orthopaedic surgical procedures and an ageing baby boomer generation have been boosting the demand for bone grafts. Even as new applications and innovative products create exciting growth opportunities, the key challenge for bone graft substitutes suppliers is to produce material with clinical efficacy equivalent to, or surpassing, existing alternatives.

Traditionally, autografts (from the patient's own bone stock) or allografts (from a human donor) have been used by orthopaedic and trauma surgeons. Autografts, although considered the best option for curing musculoskeletal defects, incur high costs and have an increased probability of morbidity.

Consequently, there has been a demand for cheaper, effective options with decreased morbidity. Products currently available in the bone graft substitutes market reduce the time required in the operating theatre as well as a patient's rehabilitation time. However, to maximise product potential, manufacturers need to convince surgeons of the physiological similarity of the product to bone.

"To exploit full market potential in this area, the key is the development of a bone graft substitute material with clinical efficacy equal to, or better than, autograft bone," notes Dr. Nelesh Patel, Research Analyst from Frost & Sullivan. "Manufacturers are therefore, challenged to come up with materials that provide osteoconductive surfaces (which support bone growth) and osteoinductive surfaces (which induce bone formation)."

The bone graft substitutes market is currently the fastest growing sector of the orthopaedic field, especially for spinal applications. In 2003, the total European market for bone graft substitutes was valued at USD 39.5 million. Continued innovations are expected to push the market to USD 114.901 million in 2010.

Of the three major segments of the bone grafting substitutes market, synthetic bone graft substitutes and demineralised bone matrices (DBMs) have experienced significant growth in the past five years. These are likely, however, to be challenged by bone morphogenic proteins (BMP) products, which are expected to gain marketing approval across Europe in 2006-2007.

In this promising market, manufacturers face certain significant restraints. Apart from establishing the effectiveness of bone graft substitute materials, they must also convince and re-educate surgeons to adopt these new technologies. The market growth for substitutes could, in addition, be stalled by various factors such as the high costs of certain substitutes and the poor mechanical properties of DBM, synthetic substitutes and factor/cell based products.

Competitive and highly fragmented, the bone graft substitutes market is constantly witnessing product innovations and breakthroughs. Moving from offering a single product, companies are now offering an entire array of products under a single brand name.

"Traditionally, there was very little crossover between the product segments analysed, with most companies offering just one type of product," explains Dr. Patel. "This situation has changed as several of the major companies have developed products in other segments and offer a 'one stop shop' promoting a complete portfolio of bone graft substitute products - all under one brand."

With competition escalating, smaller companies must remain competitive in order to maintain their market share. With large companies seeking to widen product portfolios, there has been a trend towards mergers or acquisitions of smaller firms as demonstrated by the acquisition of Interpore Cross by Biomet Inc., and the creation of IsoTis OrthoBiologics from the merger between Swiss-Dutch biomedical company IsoTis S.A and US-based GenSci Orthobiologics.