Regulatory Challenges Are Increasingly Limiting Product Availability and Revenues in the US Market for Orthopedic Biomaterials

Market Growth in Many Segments Will Be Lower Than Previously Anticipated as a Result of Stringent Regulations, According to Millennium Research Group

Dec 12, 2013, 08:00 ET from Millennium Research Group

TORONTO, Dec. 12, 2013 /PRNewswire/ -- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, challenges presented by the Food and Drug Administration (FDA) have hindered revenue growth in a number of segments of the United States orthopedic biomaterial market.


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 2013, 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, 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 nonapproval 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 somewhat hinder market growth.

"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 in early 2013, has had solid success so far. Combined with favorable demographics, product launches such as these will allow the US orthopedic biomaterial market to continue to grow through 2022 to a value of approximately $4.5 billion.

Millennium Research Group's US Markets for Orthopedic Biomaterials 2014 report includes unit, procedure, average selling price and revenue information, along with market drivers and limiters and a competitive landscape for bone graft substitutes, HA viscosupplementation, machined bone interbody devices and cell concentration systems in the United States.

About Millennium Research Group
Millennium Research Group (, a Decision Resources Group company (, is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.

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SOURCE Millennium Research Group