U.S. Orthopedic Biomaterials Market Slowed by Regulatory Setbacks

A recent report from Toronto, Canada-based Millennium Research Group (MRG), challenges presented by the U.S. Food and Drug Administration (FDA) have hindered revenue growth in a number of segments of the United States orthopedic biomaterial market.

According to the reports authors, this has been “particularly problematic” in the growth factor bone graft substitute product segment. The FDA rejected Wright Medical Technology’s Augment Bone Graft product in August, citing concerns with the patient population used during clinical trials. Although the FDA has agreed to establish a medical dispute resolution panel to advise the agency on contested issues regarding the product, the outlook for Augment remains unfavorable. Combined with ongoing negative publicity regarding off-label use of Medtronic’s Infuse bone graft product, the rejection of Augment will contribute to revenue declines in the growth factor segment through 2022.

Similarly, Anika Therapeutics’ Monovisc single-injection hyaluronic acid (HA) viscosupplementation product, which had been awaiting FDA approval since 2009, received a non-approval letter from the agency in December 2012. Although the company continues to work with the FDA, it is unlikely that Monovisc will receive approval by 2022.

Fewer products entering this segment will hinder market growth, analyts noted.

“The orthopedic stem cell segment also faces potential challenges from the FDA,” said MRG Senior Analyst Brady Baker. “Recently, there have been concerns regarding the valid classification of certain products in this segment, specifically, AlloSource’s AlloStem and Alphatec Spine’s PureGen. Alphatec voluntarily removed PureGen from the market in February 2013, in response to previous FDA inquiries regarding the composition of the product. Ongoing scrutiny of the segment, as well as the withdrawal of PureGen from the market, have had a negative impact on the growth of orthopedic stem cell revenues, which were lower than expected in 2013.”

Nonetheless, some bright spots remain.

Mesoblast’s NeoFuse and Cerapedics’ i-FACTOR are anticipated to enter the orthopedic stem cell and growth factor markets, respectively, in the next few years and should bolster growth. Zimmer’s Gel-One single-injection HA viscosupplementation product, launched early last year, has had “solid success so far,” analysts said. Combined with favorable demographics, product launches such as these will allow the U.S. orthopedic biomaterial market to continue to grow through 2022 to a value of approximately $4.5 billion.