In early March, we interviewed former Bioventus CEO Anthony P. Bihl III on the state of the orthobiologics market and his vision for the future of Bioventus. Since then, COVID-19 has spread globally and Mr. Bihl announced his retirement, effective April 30. We believe that his perspective on the growth opportunities and headwinds in biologics remains relevant, specifically the strength of the soft tissue repair/replacement and regenerative medicine markets and the hurdles for reimbursement.
Mr. Bihl joined Bioventus in December 2013. Ken Reali, who previously held the titles of President and CEO at Clinical Innovations and Baxano Surgical, was recently named as Bioventus’ new CEO.
How would you describe today’s orthobiologics market?
Mr. Bihl: Continuing from 2019 trends, orthobiologics remains a heterogeneous market inclusive of historically large yet slower growth segments like bone replacement ($2.1 billion, 3% to 5% growth) and joint fluid replacement ($1 billion, 1% growth), along with smaller segments like soft tissue repair/replacement and regenerative medicine that are experiencing higher growth.
What will be the high-growth segments of orthobiologics in the next two to three years? Why?
Mr. Bihl: Technologies that can keep pace with the increasing demands of patients to maintain active lifestyles. Some people are more active later in life; others are less active and may have a challenge for healing. Both types of people can benefit from less invasive technologies and those that can keep them going longer. We see strong growth in segments that support this, such as joint fluid therapy and bone replacement. Within the larger segment of joint fluid replacement, single-injection hyaluronic acid products (HAs) continue to grow rapidly and have overtaken the 3-injection segment as the market-leading category.
More broadly speaking, regenerative medicine appears to be an area of focus and high growth in the mid-term as more and more companies target alternative treatments for prevalent disease states like osteoarthritis. In particular, the fastest growing segments with CAGRs over 10% are amniotic injectables, expanded autologous cell and synthetic cartilage implants, PRP and soft tissue augmentation.
What headwinds do you expect the market to face?
Mr. Bihl: The joint fluid replacement market is a crowded space of competitors facing heavy pricing pressure, in particular for the 3- and 5-injection segments. The dynamic nature of competitors keeping and/or securing reimbursement status from commercial payors will also impact growth of this segment. In general, uncertainty of FDA re-classification for the HA class.
Despite a growing body of basic science research and clinical evidence that looks promising, regulatory scrutiny and obtainment of reimbursement will continue to be hurdles for newer orthobiologic products within the higher growth segments of regenerative medicine. FDA has stated their intentions of trying to simplify and expedite the approval process going forward, while also maintaining a high standard of scrutiny to protect public safety from risks of unapproved products.
What are the primary differences between the U.S. vs. OUS orthobiologic markets?
Mr. Bihl: The regulatory environment and reimbursement landscape are perhaps the two biggest differences. The flow of products from manufacturer to customers and patients can also vary greatly by market, requiring companies to adopt different approaches to distribution by geography. Use of allograft-derived products can vary depending on access and governmental regulations. The OUS orthobiologic market tends to be more crowded with a wider range of competitive players. Pricing pressures and reimbursement, or lack thereof, can heavily dictate which therapies are utilized in a given market.
What personally excites you about orthobiologics and the opportunities ahead for Bioventus?
Mr. Bihl: Orthobiologics are in a unique position to address the unmet needs that remain prevalent despite advancements in traditional orthopedic products that focus on mechanical modes of action, and bring the potential for true disease modifying therapies. Likewise, Bioventus remains in a unique position to deliver on its mission of partnering with the healthcare community to help people resume and enjoy active lives through our dedicated focus on orthobiologics, portfolio of clinically differentiated products and commitment to advancing the field in a meaningful, responsible fashion.
What’s Next for Bioventus?
The following are among the company’s objectives, according to Mr. Bihl.
- Acceleration of leadership within the HA market with continued focus on the most complete portfolio of 1-, 3- and 5-injection products, including DUROLANE, a single-injection product with the longest reported half-life and more Level I studies than any other single-injection product.
- Continued market leadership within the Bone Growth Stimulation market with the celebration of EXOGEN’s 25th anniversary and an updated label that now prominently features indications for using EXOGEN as an adjunctive non-invasive treatment of established nonunions in important usage scenarios, where fracture management protocol may have limited consideration previously.
- Following the announcement in 2019 regarding its partnership with MTF Biologics, Bioventus will continue product development and clinical evidence generation for its next generation placental tissue product to treat knee osteoarthritis.
- Expansion and innovation of its bone graft substitute solutions as well as the delivery of further clinical evidence that supports its position as a viable alternative to the gold standard of iliac crest bone graft.