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The Global Market for
OrthobiologicProducts

Evaluate the challenges, opportunities and companies in this advanced medical sector

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.

Growth is currently being driven by the increased awareness and adoption of orthobiologics, technological advancements and higher numbers of orthopaedic-related procedures being undertaken globally. Demographic factors such as the ageing population are the main driver of the higher number of orthopaedic procedures being undertaken. As well as leading to more orthopaedic procedures, the ageing population also means orthopaedic patients often have poor bone stock or osteoporosis. This in turn means more patients are requiring a bone graft substitute as they are unsuitable for autograft.

Other growth drivers include the rising numbers of obese patients with increasing levels of osteoarthritis and the resulting need for cartilage repair procedures. In addition, increasing numbers of patients have diabetes, which can lead to slower natural bone and soft tissue healing, and a greater number of people are participating in sports, leading to higher numbers of trauma and sport-related injuries.

Safety concerns about bone morphogenetic protein (BMP)...
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. 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.

...has refocused interest on other technologies
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. 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, 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.

Medtronic acquires Osteotech – an ever changing competitive landscape
As this report went to press, Medtronic announced it had agreed to acquire Osteotech, a leading competitor. While consolidating Medtronic’s domination of the market, this development marks the latest corporate move to secure market share. Increasing interest from multi-nationals can be seen. For example, Baxter International made its formal entry into the biologics market by acquiring ApaTech, a UK-based company that has developed and markets innovative synthetic bone substitutes.

Providing…

• Sales forecasts for key orthobiologic sectors

• Market share for leading companies

• A review of the complex regulatory requirement in the US and EU

• Evaluation of key orthobiologic applications areas

• Detailed examination of product offerings by company for each sector

Covering all major areas including…

• Allograft
• Demineralised bone matrix
• Synthetic bone grafts
• Soft tissue implants
• Growth factors
• Autologous platelet separation products
• Autologous bone marrow concentration products
• Autologous chondrocyte transplantation
• Stem cell therapy

At-a-glance competitive comparisons for major and emerging companies