Expanded indications for bone morphogenetic proteins and new alternatives to those first-generation bone growth factors have the potential to grow the $2 billion market for bone replacement materials.
Bioactive Technologies For Bone Replacement
Article preview from Start Up - May, 2010
Bone morphogenetic proteins have dominated the field of bone replacement materials for more than eight years, but penetration is starting to slow down for a number of reasons, including FDA crackdowns on off-label use.
Companies see an opportunity for competitive advantage in gaining new and specific labeling claims for BMP products. Many companies have circumvented patent fences surrounding BMPs with new families of growth factors that work on bone. Offering advantages over BMP, these have the potential to expand the market.
Although BMPs will dominate the bone replacement market for some time to come, synthetics and cell-based products represent the fastest growing segments of the orthobiologics category. Here, companies undertaking comparative effectiveneßs studies hope to obtain regulatory and marketing advantages.
A high level of licensing and acquisition activity in the orthobiologics industry points start-ups to a clear exit.
Once considered the Holy Grail in bone repair, Medtronic Inc.'s Spinal and Biologics Division's INFUSE Bone Graft, the first bone growth factor approved for use in the US, raised the bar in terms of clinical efficacy and has dominated the market for bone replacement materials since its approval in 2002. This recombinant bone morphogenetic protein (rhBMP)-2 has the ability to induce bone growth acroßs a repair site resulting in predictable healing and was PMA approved for use in conjunction with Medtronic's LT-CAGE for treating degenerative disc disease of the lumbar spine. Delivered on a bovine collagen sponge placed within an interbody fusion cage, INFUSE achieved rapid adoption after its release, primarily because it obviated the need to harvest an iliac crest bone graft from a secondary operative site, which is the major source of postoperative pain following spinal fusion. In 2004, INFUSE received a second PMA approval for repair of open long-bone fractures of the tibia. The company has completed an additional Investigational Device Exemption (IDE) study for posterolateral fusions and has another one for cervical fusion underway.
Today, INFUSE remains the only BMP that is PMA approved in the US. Its sole competitor, Stryker Corp.'s OP-1 (rhBMP-7), is approved under a Humanitarian Device Exemption (HDE) with separate HDEs for revision posterolateral spinal fusion and recalcitrant long-bone nonunions where autograft is not feasible and alternative treatments have failed. An HDE restricts usage to 4,000 patients a year. But the product failed to receive an FDA advisory panel PMA approval recommendation last year for use in posterolateral lumbar spine fusion procedures, with the panel citing concerns about potential immunologic effects and problems with the company's clinical study design.BMPs Under Attack
Stryker reported about $50 million in sales of OP-1 in 2009, while
Medtronic's INFUSE generated approximately $776 million in sales in
2009. However, Medtronic's large sales number represented an increase
of only 1% over the prior year. This slowdown in growth is largely
attributable to a series of adverse events that have significantly
hampered the product's use, including a public health notice from the
FDA regarding off-label use in the cervical spine, a previously
disclosed government investigation, negative newspaper reports, and a
whistleblower lawsuit filed against a number of spine surgeons and
distributors of INFUSE.
- Sharon O'Reilly
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