Medtronic, Genzyme Lead US Orthopedic Biomaterials Market Due to High R&D Costs Limiting Competition

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According to a new series of reports on the U.S. market for orthopedic biomaterials by iData Research, orthopedic growth factors have a relatively high average selling price (ASP) since their introduction to the market due to the high costs of recombinant growth factor technologies. The high research and development (R&D) costs associated with the growth factor segment provide a barrier to entry against potential competitors.

Currently there are only two growth factor products in the United States. Since they’re both used in different indications, there is a lack of direct competition, allowing companies such as Medtronic to charge a premium for the Spine indication and recover the large initial costs associated with R&D. The commoditized nature in some parts of the market, such as the allograft and demineralized bone matrix (DBM) segments, which is due to the lack of product differentiation, has limited growth.

“The market is being driven by more competitors venturing outside their traditional space to tap into the high growth segments where they can charge a premium,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “These segments may include the cell therapy and cellular allograft segments, both of which have relatively high ASP.”

Tapping into new markets entails partnering with a company by taking on the costs associated with regulation and market approval, in exchange for exclusive market rights. The goal is to penetrate the high growing segments and build or strengthen networks before the segment matures. This is especially the case for competitors in segments that are in decline, such as competitors in the five-injection hyaluronic acid treatment. The two leading competitors within that particular segment have retained their overall market shares through either creating a new product or partnering with an external market competitor in a new segment.

One of the biggest market limiters in the U.S. orthopedic biomaterials market is the cost of getting a product to market. In addition to development costs associated with R&D, a company must gain proper FDA approval. Moreover, most orthopedic biomaterials are categorized as devices and are required to apply for pre-market approval. This highly regulated market produces a barrier to entry, and products that are used in other markets outside the U.S. cannot be sold until they are formally approved.

Medtronic is the leading competitor in the U.S. orthopedic biomaterials market. This is due to their market share in the spine indication segment, which is the largest indication in terms of both procedures and market value. The company’s leading bone graft substitute product is their DBM Grafton®. Their line of machined bone allograft products includes the Tangent® machined bone system and other dowels and wedges.

Genzyme is the second leading competitor in the U.S. orthopedic biomaterials market due to a leading share in the hyaluronic acid viscosupplementation market. Synvisc® was Genzyme’s first three-injection cycle product on the market; however, its market share increased significantly by way of Synvisc-One® single-injection product sales since this product received approval in 2009. Additional competitors in the US orthopedic biomaterials market includes DePuy Synthes, Anika Therapeutics, Zimmer Biomet, Ferring Pharmaceuticals, Stryker, Bioventus, NuVasive, RTI Surgical, Seaspine, Arthrex, Wright Medical, Fidia Pharmaceuticals, MTF, Orthofix, Harvest Technologies, AlloSource, Vericel, Baxter, Xtant, Arteriocyte, Exactech, LifeNet Health, Biocomposites, Alphatec Spine, Globus Medical, Celling Biosciences, K2M and Cytomedix among others.

For Further Information
More on the orthopedic biomaterials market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Orthopedic Biomaterials. This report covers the following market segments: orthopedic bone graft substitutes, orthopedic growth factors, orthopedic stem cell therapy, orthopedic hyaluronic acid viscosupplementations, orthopedic cartilage repairs, and spinal machined bone allografts.

The iData series on the market for orthopedic biomaterials covers the U.S., Japan, South Korea, Australia, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic biomaterials device market data or procedure data, register online or email us at for an U.S. Market Report Suite for Orthopedic Biomaterials brochure and synopsis.

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