Since its 1995 launch, EXOGEN has been prescribed by more than 10,000 physicians and sold in 15 countries. The device uses low-intensity pulsed ultrasound waves to induce micromechanical stress in fractures, amplifying the body’s natural bone repair mechanism. Studies have linked EXOGEN to an 86 percent heal rate for stubborn fractures and a 38 percent quicker healing time for fresh fractures. Bioventus claims its technology is supported by 16 Level 1 studies, but a 2016 McMaster University clinical trial found the device to be ineffective.
Despite the study data disparity, EXOGEN has been a solid source of growth for Bioventus, accounting for roughly $100 million in annual worldwide sales. Part of its success can be attributed to the rising popularity of orthobiologics (a.k.a., regenerative cellular therapies), a category of biologically-based substances used to help orthopedic injuries heal more quickly. Orthobiologics are made from substances found naturally in the body, and they generally are used to improve the healing of fractures, injured muscles, tendons, and ligaments. The global orthobiologics market is forecast to grow 5.5 percent over the next seven years, driven by the world’s aging population, expanding waistlines, and increasing numbers of orthopedic conditions and musculoskeletal diseases. “Orthobiologics are revolutionizing orthopedic care,” Ignatios Papas, D.O., a non-surgical orthopedic physician in Tampa Bay, Fla., wrote in a blog last December. “Despite this, many patients don’t realize that these substances exist and can help them recover from orthopedic injuries, often without surgery.”
ODT’s January/February feature, “Nature’s Way,” explores the various trends and challenges driving the global orthobiologics market. Alla Danilkovitch, Ph.D., vice president of R&D at Smith+Nephew, was among the experts interviewed for the story. Dr. Danilkovitch’s full input is provided in the following Q&A.
Michael Barbella: Please discuss the current trends you see shaping the orthobiologics market.
Alla Danilkovitch: According to market reports, the major factors attributing to the growth of the orthobiologics include increased incidences of sports injury, road accidents, and osteoarthritis. By definition, orthobiologics are substances that orthopedic surgeons use to support the healing of injured bones and soft tissues. With aging and diseases such as diabetes, the regenerative potential of the body is significantly decreased. Surgical procedures alone are not sufficient, and orthobiologics as an adjunct to surgical procedures can lead to a significant improvement of the surgical outcomes.
Barbella: What factors are driving innovation in the orthobiologics market?
Danilkovitch: Our understanding of the structural and functional properties of native tissue, and mechanisms of healing of injured tissue is driving development of new innovative biomaterials and cellular therapies including stem cells. Bioengineering and 3D printing of human tissues are becoming a reality.
Barbella: What factors are impeding growth in the orthobiologics market? How can these challenges be overcome?
Danilkovitch: Limited scientific and clinical evidence showing benefits of orthobiologics for specific procedures/applications. Lack of level 1 studies, long-term evidence of efficacy and lack of consensus regarding when and how to apply orthobiologics. In addition to lack of compelling evidence, high cost is becoming a factor as well. Collaborating with leading orthopedic organizations (i.e., AAOS) is one approach to generate data. It is great to see they have announced a strategic investment in the field of biologics in November 2019.
Barbella: What new (orthobiologics) technologies are in the works?
Danilkovitch: Regenerative medicine technologies including tissue engineering, biologic drugs and combinations of biologic materials with devices are new technologies in development. The main goal is to address conditions and diseases with unmet medical needs and significantly improve outcome of surgical procedures and patient’s quality of life.
Barbella: Where does innovation come from in the orthobiologics market? How does Smith+Nephew stay innovative amid all the competition?
Danilkovitch: Academia continues to be the main source of innovation, including orthobiologics. Smith+Nephew is recognizing a critical role of orthobiologics and its synergy with devices and surgical procedures. Smith+Nephew collaborates with many leading research institutions around the world. In addition, recently, Smith+Nephew formed a Biologics and Regenerative Medicine R&D team dedicated to development of innovative orthobiologic products.
Barbella: How does the regulatory landscape for orthobiologics differ (if at all) from other sectors of the orthopedic market? (hips, knees,spine, etc.). How does this impact product innovation?
Danilkovitch: The regulatory landscape for orthobiologics is very complex in comparison to other markets. Orthobiologic products can fall in different regulatory classes: tissue allografts (so-called 361 HCT/Ps, when pre-market approval is not required), 510k or PMA devices, biologic drugs or combination products. Biologic drugs or their combinations with devices are known for high development cost and a long path to market. This is one of the factors negatively affecting product innovation. Currently, there are only a few examples of orthobiologic drugs on the market.
Barbella: What is the dominant orthobiologics application - spinal fusion, trauma repair, reconstructive surgery? What factors are driving growth in this particular application?
Danilkovitch: According to market reports the major market for orthobiologics is osteoarthritis (followed by spinal fusion procedures and soft tissue injuries). Osteoarthritis already is the most common cause of disability in adults. With the global increase in the number of geriatrics and obese people, osteoarthritis is expected to be the fastest growing application segment for orthobiologics.