October 05, 2010 08:08 ET

Global Orthobiologics Market Worth Nearly US$3.1 Billion in 2009

ROCKVILLE, MD--(Marketwire - October 5, 2010) - has announced the addition of Espicom Healthcare Intelligence's new report "The Global Market for Orthobiological Products" to their collection of Biotechnology market reports. For more information, visit

The global orthobiologics market was worth nearly US$3.1 billion in 2009 and experienced 7.3% growth compared with 2008 levels. However, safety concerns in some product areas, compounded by the pressure of the economic downturn, could create fundamental changes to the success of technologies and companies active in the area.

BMP product sales have suffered from a July 2008 US Public Health Notification regarding complications associated with their use in the cervical spine. The off-label use of BMP products has also led to negative publicity regarding the products, as well as legal proceedings brought against the market leader, Medtronic. Stryker, the only other company with an FDA-approved growth factor, has also experienced setbacks with its products.

According to the report, in March 2009, the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel voted not to recommend broad-based marketing approval for the use of Stryker's OP-1 for spinal fusion. In contrast, Medtronic is currently pursuing FDA approval for a new, higher-concentration BMP product, AMPLIFY. If approved, AMPLIFY could regenerate Medtronic's flagging BMP operations. In July 2010, the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel gave a positive recommendation of AMPLIFY.

Synthetic bone graft substitutes have benefited from increased demand as a result of their lower cost compared with competing products, ease-of-use, ready availability and ease of storage, according to Espicom. This led to an 18% increase in sales volumes during 2009.

In addition, cell-based products, including autologous cartilage repair therapies, blood separation systems and bone marrow concentration systems, experienced 20% growth in 2009. However, the report found that this market is still in its infancy and was worth just US$180 million during the year. Growth for cell-based products is being driven by their clinical effectiveness, increased surgeon acceptance, and new product innovation in this sector.

Human-derived products such as allograft and DBM each saw around 5% growth in 2009, to US$790 and US$575 million, respectively. While there continues to be increased demand, growth is somewhat hampered by a lack of availability, particularly in the case of allograft products.

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