Demand for a biologic alternative
The orthobiologic market has experienced tremendous growth in the past decade, a trend that will continue in light of the aging, yet highly active U.S. population. This highlights the growing need and demand for highly effective, reliable graft material, but at a cost that will fit within the changing healthcare model.
A $2 billion market
The worldwide broad orthobiologics market is estimated at nearly $2 billion in sales in 2009, with the bone graft subset encompassing nearly 1 million procedures and generating $1.5 billion in revenue. Traditionally comprised of allograft donated from cadavers and simple synthetic scaffolds, the recent advent of first generation biologics has fueled significant growth in the past few years. The current trend of double digit growth rates is forecasted to continue over the next several years as the markets for orthobiologics expands and new, safer and more effective biologic products are introduced.
Accounts for ~75% of all bone graft usage
The vast majority of bone graft procedures are performed by neuro and orthopedic surgeons in spine fusion procedures. Surgeons may treat a severe degeneration of the disc material in the spine (DDD) and spondylolisthesis, or what is commonly referred to as a “slipped disc”, by removing the damaged disc, placing bone graft in its place and allowing new bone to bridge the two vertebra. This eliminates the unwanted motion in this area of the spine that is causing severe pain, numbness and tingling of the arms or legs. Nearly 500,000 spine fusions were performed in the U.S. alone in 2009 with over 200,000 specifically in the low back or lumbar spine. While a simple, single-level interbody fusion may use one unit of bone graft, some procedures require two grafts, while severe and complex spine procedures will require multiple levels of fusion and multiple units of graft material. Spinal fusion alone may account for 75% of all bone grafts used in the U.S.
Foot and Ankle Fusions
A smaller, yet potential growth market for synthetic bone grafting is extremity procedures such as foot/ankle fusions. While ankle fusion is estimated at less than 15,000 procedures annually in the U.S., many more mid-foot, deformity, and fracture surgeries may require some level of enhanced bone graft. Others have estimated the foot/ankle bone graft market at 100,000 procedures per year, performed by podiatric, orthopedic and osteopathic surgeons. As in spine fusion, the goal of an ankle fusion is to eliminate unwanted motion in the joints of the foot to alleviate the pain and disability associated with a diseased or injured ankle joint.
The use of bone grafts is common in orthopedic trauma surgery to repair major injury to bone and soft tissue. Injuries are typically the result of accidents, such as falls, car and motorcycle crashes or violence. The trauma surgeon relies on a combination of metallic plates, screws and rods to brace the broken bones, while incorporating a bone graft to fill any defects or bone lost in the injury. Long bone fractures of the arm and leg are at risk of a non-union, or the bones not fully healing. This is a major concern to trauma surgeons as it proves one of the most challenging and difficult indications to treat. It is estimated that over 1 million internal fixation orthopedic trauma procedures were performed in the U.S. in 2009.
Joint replacement of the hip or knee is a common and highly successful procedure to replace worn or damaged bones and cartilage of the joints. While these surgeries and the use of associated metal implants have evolved to a near routine procedure, occasionally these implants may require removal, a process known as revision surgery. In these cases, a significant amount of bone may be lost in the revision, requiring bone grafting material to replace the lost bone and insure proper implant fit within the joint. Like all bone grafting requirements in surgery, surgeons may choose from the typical list of available graft materials and their associated shortcomings.
Growing need for biologic solutions in sports medicine
Beyond the hard tissue orthobiologics markets, the field of soft tissue grafting is large and growing. There is significant clinical need for soft tissue reinforcement grafts in sports medicine injuries such as rotator cuff (shoulder), Achilles tendon (ankle) and ligament and cartilage in the knee. These injuries have been notoriously difficult to treat, and typically result in poor tissue regeneration, resulting in chronic instability and re-injury. As a result, biologic solutions that can effectively reinforce the surgical repair, then promote long term tissue regeneration, hold tremendous promise in the treatment of difficult to treat conditions.