Orthobiologics Market Analysis, Size, Trends | Global | 2019-2025 | MedSuite

  • Year: 2019
  • Scope: 2015-2025
  • Region: China, Europe, India, Japan, South Korea, United States
  • Pages: 1823
  • Published Date: 12/2/2018
  • Type: MedSuite

Industry Trends

A particular trend in the U.S. orthobiologics market is competitors that are seeking to penetrate high growth segments outside their traditional space by distributing existing products manufactured by other companies, rather than creating their own. This often involves partnering with a company by taking on the costs associated with regulation and market approval, in exchange for exclusive market rights.

Several products within orthopedic biomaterials have much more market potential than others, but are also very expensive for manufacturers to develop and produce. This subsequently leads to
premium pricing to cover fixed and research and development (R&D) costs. This is the case for growth factor and cellular allograft competitors in the U.S. orthopedic biomaterials market. For
example, the R&D cost required to develop growth factor products is a major entry barrier against potential competitors. There are now three growth factor products in the United States. Since
they are all used for different indications, there is a lack of direct competition, allowing companies to charge a premium for their products. Despite high prices, the growth factor and cellular allograft segments have huge potential to expand as companies continue to research these products. Conversely, the commoditized nature in some parts of the market, such as the allograft and
possibly DBM segments, have limited growth.

The largest limiter in the U.S. orthobiologics markets is pricing pressure on nearly all products. Stakeholders that influence prices include consumers, physicians, hospitals, and
insurance providers. Many insurance providers are reluctant to cover such high costs for premium products, causing consumers to seek more inexpensive alternatives. This, in turn, affects how
likely physicians are to use them for procedures.

Constraints on reimbursements will continue to limit the European orthopedic biomaterials market. Presently, only a few premium products under the umbrella of pharmaceuticals are
reimbursed by the government or healthcare organizations in the European region. In addition to not being as well-received as reimbursed products, the lack of reimbursement drives pricing down, hinders innovation and discourages new entrants.

orthopedic biologics market value chart segmented by product type for the United States - report by iData Research

Report Regional Coverage

Throughout this research series, iData has covered several countries in great detail. Each country may be purchased as a stand-alone report, tailoring the data to your needs. The covered countries are:

  • United States
  • Europe (15 countries including: Germany, France, U.K., Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Denmark, Finland, Norway and Sweden) Austria, Switzerland and Portugal)
  • Japan
  • India
  • China
  • South Korea


The Only Medical Device Market Research With:

Procedure Volume Data & Trends
Unit Sales Growth Analysis
Average Selling Prices
Competitor Shares by Segment & Country
 SKU-Level Research Methods
 The Lowest Acquisition Cost

Highly Detailed Segmentation

While this report suite contains all data, each of the markets are also available as stand alone MedCore reports. This allows you to get access to only the market research that you need. You can view all these included reports and segmentation here:

  • Procedure Numbers for Orthobiologics – MedPro
  • Orthopedic Bone Graft Substitute Market – MedCore
  • Orthopedic Growth Factor Market – MedCore
  • Cellular Allograft Market – MedCore
  • Orthopedic Cell Therapy Market – MedCore
  • Hyaluronic Acid Viscosupplementation Market – MedCore
  • Orthopedic Cartilage Repair Market – MedCore
  • Spinal Machined Bone Allograft Market – MedCore

Buying all of these reports together in this suite package will provide you with substantial discounts from the separate prices. Request Pricing to Learn More

Full Segmentation Map for the United States Region

part one of iData Research's orthobiologics market segmentation map for the United States

part two of iData Research's orthobiologics market segmentation map for the United States

part three of iData Research's orthobiologics market segmentation map for the United States

Data Types Included

  • Unit Sales, Average Selling Prices, Market Value & Growth Trends
  • Procedure Volume Analysis
  • Forecasts Until 2025, and Historical Data to 2015
  • Market Drivers & Limiters for Each Segment
  • Competitive Analysis with Market Shares for Each Segment
  • Recent Mergers & Acquisitions
  • Disease Overviews and Demographic Information
  • Company Profiles, Product Portfolios and SWOT for Top Competitors

Orthobiologics Market Share Insights

The competitive landscape among orthobiologics companies varies dramatically across different regions. For example, Medtronic and DePuy Synthes are battling for the leading market share in the United States market, with Zimmer Biomet and Sanofi trailing behind. Fidia actually has a minimal market share in the United States, in the single-digits, but significantly leads the European market.

Medtronic has the largest share in the United States bone graft substitute segment and has their dominating product, INFUSE™ in the growth factor market. This company’s growth has been recovering since the negative media attention and lawsuits regarding off-label usage of its growth factor bone morphogenetic protein (BMP) product, INFUSE®, which accounts for a significant portion of the company’s revenue in biologic therapy.

Fidia is the leading competitor in the total European orthopedic biomaterials market. However, the company is only present in the hyaluronic acid market. Extensive research of hyaluronic acid has solidified Fidia Farmaceutici S.p.A.’s leading position in the lucrative HA market. Fidia has increased their market share over the past few years, and a considerable amount of this expansion is due to Fidia’s expansion into the German market.

Throughout this series of research, iData analyzed over 130 companies to estimate market size, trends, and market shares of leading competitors. Below is a list of all companies analyzed throughout this study.


All Companies Analyzed in this Study

  • Ajanta Pharma
  • Aju Pharm
  • Alkem Laboratories
  • Allgens Medical
  • AlloSource
  • Alphatec Spine
  • Anika Therapeutics
  • Arteriocyte/Isto
  • Arthrex
  • Aziyo
  • Basic Healthcare
  • Baxter
  • Berkely Advanced Biomaterials
  • Bharat Biotech
  • Biocomposites
  • Bioiberica
  • Bioimplant Technologies
  • Biolu Biomaterials
  • Biomantle
  • Bioventus
  • Bloomage Freda Biopharm
  • BonAlive
  • Bonesupport
  • Cadila Pharmaceutical
  • Cambridge Medical
  • Celling Biosciences
  • Cellumed
  • Cerapedics
  • Cesca Therapeutics
  • CG Bio
  • Chugai Pharmaceuticals
  • CO.DON
  • Collagen Matrix
  • Community Tissue Services
  • Croma-Pharma
  • Curasan
  • Cytomedix
  • Daewoong
  • Datsing Bio-tech
  • DCI Donor Servicers
  • DePuy Synthes
  • Doctor Reddy’s Laboratory
  • Documedica
  • Dong Kwang
  • DongKook
  • Doo Song International
  • Etex
  • Exactech
  • Ferring Pharmaceuticals
  • Fidia Pharmaceuticals
  • Finceramica
  • FocusChem
  • Geistlich
  • Genzyme
  • Gland Pharma
  • Globus Medical
  • GS Medical
  • Guona Keiji
  • Hammi Pharm
  • Hangzhou Gallop
  • HansBiomed
  • Harbin Gloria Pharmaceutical
  • Harvest Technologies
  • Hoya Technosurgical
  • IFGL Bio Ceramic
  • Intas Pharmaceutical
  • Integra LifeSciences
  • Isto
  • Japan Medicalnext
  • Jinxingda Company (Tianjin)
  • JunYoung Medical
  • K2M
  • Kaken Pharmaceuticals
  • Kinedex Healthcare
  • Kunming Baker Norton
  • Kuraray
  • Kuros Biosciences
  • Kyocera Medical
  • Laboratoire Genevrier
  • LCA Pharma
  • LG Life Science
  • LifeNet Health
  • M. M. Surgical
  • Maruho
  • Meda Pharmaceuticals
  • Medtronic
  • Meji Seika Pharma
  • Mitsubishi Materials
  • Mizuho
  • Musculoskeletal Transplant Foundation (MTF)
  • Narang Medical Limited
  • Novabone
  • NuTech Spine/LifeLink Tissue Bank
  • NuVasive
  • Olympus Terumo
  • Orotech
  • Orthofix
  • OrthogenRX
  • Osiris Therapeutics
  • Osteolink Biomaterials
  • Osteomed
  • OStetic
  • Pacific Pharma
  • Plasmaconcept AG
  • Ranbaxy
  • Recordati
  • Regenexx
  • RTI Surgical
  • Saehan Pharma
  • Sanofi
  • SeaSpine
  • Seikagaku
  • Shanghai Anjiu Biotechnology
  • Shanghai HaoHai
  • Shanghai Jingfeng Pharmaceutical
  • Shanghai Rebone Biomaterials
  • Shanxi OsteoRad Biomaterials
  • Shin Poong
  • Spinal Elements
  • Stella Pharmaceuticals
  • Stryker
  • Sun Pharma Limited
  • Taisho
  • Tedec-Meiji
  • Tetec
  • TiGenix
  • TRB Chemedica
  • Unimed
  • Vericel
  • Virchow Biotech
  • Vivex
  • Wright Medical
  • Xin Kang Chen
  • Xtant
  • Yunkanghengye Company
  • Zimmer Biomet
  • Zydus Cadila

Orthobiologics Statistics and Procedure Trends

Procedures using orthobiologics are expected to continue to grow at a rapid rate. Procedures in the U.S. total nearly 4.5 million annually and are expected to surpass 7 million procedures by 2025. This growth is largely due to market developments relating to stem cells. Cellular allograft procedures are expected to grow the fastest by far. Orthopedic cartilage repair is the slowest-growing segment in terms of procedures, as the high prices are a barrier for many patients.

Procedures using bone graft substitutes in the Europe will continue to grow moderately over the forecast period. The most common type of material for bone graft substitutes is synthetic bone grafts. Because the use of autograft bone requires two incisions, and thus an increase in operation time, alternative graft options are often more preferable. Moreover, the process of demineralization can make grafts more osteoinductive in exchange for osteoconductivity when compared to allografts, but the high ASP, as well as stringent regulation in the EU and other European countries, have made demineralized bone matrix (DBM) the least common BGS material.

Latest Market Developments

December 2018 – Meda Pharmaceuticals sells manufacturing facility in the U.S. to ADM

November 2018 – Stryker acquires K2M

August 2018 – Wright Medical acquires Cartiva

FREE Sample Report

One of the the most accurate methods of market research in the medical device industry is to analyze the procedure volumes and trends. Through this study on orthopedic biomaterials, iData Research has performed an analysis on the following procedure segments in order to increase the accuracy of our market sizing, and provide you with the volume of procedures over a 10 year range. While the below market segmentation map is representative of the United States, procedure volume data is also provided for the other regions within this complete series.

Procedure Volume Analysis Segments in the United States

Orthobiologics procedure analysis segmentation map part 1 Orthobiologics procedure analysis segmentation map part 2

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Step 5: Research Analysis: Establishing Baseline Estimates Following the completion of the primary research phase, the collected information must be synthesized into an accurate view of the market status. The most important question is the current state of the market.

Step 6: Market Forecast and Analysis iData Research uses a proprietary method to combine statistical data and opinions of industry experts to forecast future market values.

Step 7: Identify Strategic Opportunities iData analysts identify in broad terms why some companies are gaining or losing share within a given market segment.

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