The global market for orthobiologics, comprised primarily of bone replacement materials, reached almost $2 billion in 2009 and is growing at an overall rate of 7%. Medtronic leads in bone replacement with a 45% market share, but overall growth in orthobiologics may come from emerging segments, particular synthetic and stem-cell based technologies.
Article preview from Medtech Insight- April, 2010
Once considered the Holy Grail in bone replacement materials, 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 across 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. The product failed to receive a US Food & Drug Administration (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. Stryker reported about $50 million in sales of OP-1 in 2009.
BMPs under Attack
Medronic's INFUSE, on the other hand, generated approximately $776 million in sales in 2009, an increase of only 1% over the prior year. This slowdown in growth is largely attributed 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.
But Medtronic is not the only company with such woes. In March 2009, an FDA panel voted 6-1 against wider approval of Stryker's OP-1 for uninstrumented posterolateral fusions in the treatment of lumbar spondylolisthesis. The company presented 24-month clinical data and 36-month CT scans and reoperation rates; however, the panel cited biases and false positives in the study's design. To cap it all off, later in the year, executives from Stryker Biotech were indicted owing to allegations regarding illegal promotion of off-label use of OP-1, misbranding of devices, wire fraud, and submitting false reports to the FDA regarding the number of patients treated with OP-1 under the company's HDE.
Today, there is significant off-label usage of INFUSE, with estimates as high as 80%-90%. In July 2008, the FDA issued a warning highlighting a number of serious and life-threatening complications associated with use of BMP bone grafts in the cervical spine (eg, difficulty speaking and/or swallowing, and respiratory distress if swelling of the neck compresses the airway and nerves after an INFUSE implant). This has led to increased concerns about BMPs and has opened the door to competitive products that tout safety and savings as major advantages.
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