정형외과용 생체재료 시장 보고서 : 동향, 예측 및 경쟁 분석(-2035년)

Orthopedic Biomaterial Market

The future of the global orthopedic biomaterial market looks promising with opportunities in the orthopedic implant, joint replacement/reconstruction, orthobiologic, viscosupplementation, and bio-resorbable tissue fixation markets. The global orthopedic biomaterial market is expected to reach an estimated $52 billion by 2035 from $23 billion in 2027 with a CAGR of 8.5% from 2027 to 2035. The major drivers for this market are the growing preference for advanced bioresorbable implants, the rising geriatric population prone to fractures, and the increasing prevalence of orthopedic musculoskeletal disorders.

• Lucintel forecasts that, within the material type category, ceramics & bioactive glass is expected to witness the highest growth over the forecast period due to the increasing demand for bioactive and regenerative biomaterials.
• Within the application category, orthopedic implant is expected to witness the highest growth over the forecast period due to the rising prevalence of orthopedic disorders globally.
• In terms of regions, APAC is expected to witness the highest growth over the forecast period due to the growing healthcare investments and increasing medical device adoption.

Emerging Trends in Orthopedic Biomaterial Market

Between 2024 and 2026, all the changes will happen with the use of safe allergenic materials, bio resorbable materials and materials with infection resistant capabilities in orthopedic biomaterials. Lucintel has mentioned material customization and digital manufacturing as integral parts of the trends shaping the focus of R&D spending in this area.

• Allergenic Metal Substitutes: First, there are metal alternatives for patients with sensitivity to nickel, cobalt and chromium. The approval of Zimmer Biomet's Persona Revision Solution Femur (Clearance March 2025) is the first of its kind as a metal alternative knee revision implant. This will continue to grow as orthopedic surgeons become more aware of the sensitivity to metal for revision candidates.
• Custom Bioresorbable Polymers: Next, device companies are offering tailored particle sizes and property changes in bioresorbable polymers as opposed to the standard, off the shelf materials. Now, Evonik's Darmstadt branch offers custom RESOMER powders by solvent-free micronization. This will encourage a movement toward bioresorbable implants.
• Infection Resistant Surface Changes: Now, with changes to surface coatings becoming more commonplace and less of a differentiator, Zimmer's iodine treated material for hip implants has received approval in Japan to be a breakthrough device in the U.S. The protection offered for post-operative infection, which is currently at a 1% to 2% rate, is enough clinically and cost wise to justify the use of this technology for implants in all categories.
• Digital Manufacturing Integration: Finally, with the Chinese regulatory system creating technical norms for 3D printed orthopedic devices that formally address what was an emerging technology, 3D printing will become the dominant technology for this application.
• Regional Manufacturing Diversification: Manufacturing incentives by the government in India and the development of domestic standards in China is resulting in biomaterials manufacturing moving away from Western concentrations.

The ability to diversify production regions and customize materials will continue to reshape the competitive landscape until 2030. Manufacturers that can formulate innovative materials and build localized supply chains will gain significant advantage over competition that is still reliant on the traditional titanium and cobalt-chromium products.

Recent Developments in the Orthopedic Biomaterial Market

In 2024 and 2025, there was an increase in consolidation and shrinking in the orthopedic biomaterials market. Large medical equipment companies purchased and sold companies. In addition, smaller medical equipment companies received funding. Lucintel predicted increased funding of biomaterials used for 3D-printed devices and surgical technology rather than basic medical implants.

• Competitive Advantages Gained Through Acquisitions: Enovis finalized its $1 billion purchase of LimaCorporate in January 2024. Additive manufacturing is considered a major factor in cup competition, but large purchases indicate it isn't an afterthought considering other options.
• Competitive Advantages Through Sales: Stryker sold its U.S. spine implant division to Viscogliosi Brothers in January 2024, and formed a new company, VB Spine. This enabled Stryker to concentrate on its core orthopedic reconstruction business. Large medical device companies gain competitive advantages by selling non-core business divisions.
• Expanding Services To New Medical Centers: Zimmer Biomet made its February 2025 purchase of Paragon 28 to strengthen its foot and ankle division and serve the growing market for outpatient medical services. This acquisition reflects the shift in many orthopedic services to outpatient medical clinics.
• New Technologies for Surgical Navigation: Smith+Nephew created the TESSA Spatial Surgery System in March 2025. This is pending FDA approval, and will integrate real-time surgical navigation with augmented reality technology for ACL reconstruction surgery. Navigation technology used to guide surgical implants is changing the way surgical biomaterials are evaluated.
• Early-stage Biomaterial Funding: In July 2024, the UK-based start-up 4D Medicine raised EUR 3.4 million to fund pre-clinical research and seek FDA approval for its orthopedic biomaterials.

Current trends illustrate large companies positioning themselves around the 3D printed and ASC technology, and divesting of non-key related assets. Meanwhile, early stage biomaterial companies are still receiving funding. The pace of acquisitions will continue to increase as companies manufacture devices that rely on specialised technology rather than commodities.

Strategic Growth Opportunities in the Orthopedic Biomaterial Market

With some implant manufacturers using materials beyond commodity titanium, new avenues for revenue are developing in regions of the market that have been traditionally overlooked. According to Lucintel, the most substantial potential between 2024 and 2026 will be found in allergy-friendly products, ambulatory surgery, and market localization in the emerging world.

• Allergy-friendly Products: Patients with metal-sensitivity present a largely unmet need, with the first FDA approval of the Persona Revision Solution Femur in March 2025 from Zimmer Biomet. By creating allergy-friendly product lines, manufacturers can create a monopoly for highly underserved patients who had no options for revision surgery.
• Expanding The Channel for Ambulatory Surgery: Procedures are increasingly being performed in clinics or other ambulatory surgery centers, rather than traditional hospitals. Zimmer's acquisition of Paragon 28, which occurred in February 2025, targets gaining market share at the foot and ankle surgery revenue channel. Biomaterial companies that design products and packaging to meet the needs of the ASC will gain market share as this shift of the site of surgery care continues.
• Bioresorbable Polymer Licensing: Specialty chemical companies have developed bioresorbable polymer technologies that are specifically built for next generation temporary implant devices, and are licensing those polymer technologies rather than manufacturing devices themselves.
• Infection Prevention Coating Technology: Antimicrobial coating technology, following the same path as Zimmer's iodine treated hip systems, provides a cross cutting revenue opportunity that spans trauma, hip, and knee implants.
• Emerging-market Localized Production: Recent developments in India and China create new opportunities for local production of biomaterials including the production of custom implants, as opposed to exporting fully assembled implants.

The production of biocompatible implant materials and the development of new allergy-safe materials, together with innovative packaging and coating technologies, will determine who establishes commercial dominance in this market. Fully integrating and owning these technologies maximizes the advantages over companies offering only standard materials in the form of titanium and cobalt-chromium implants.

Orthopedic Biomaterial Market Drivers and Challenges

Progress in materials science and the shift to an aging population drives growth in orthopedic biomaterials. Despite these trends, pressure from trade tariffs and more regulations makes expansion outside of the U.S. more difficult for the orthopedic industry. Lucintel defines the orthopedic biomaterials industry as a demographics-driven, manufacturing-driven market through 2030.

Drivers

• Older Patient Demand: High rates of joint replacements in the older population during 2024 and 2025 can be attributed to increased sedentary populations with higher levels of physical activity. These trends will continue to drive growth of joint replacements, even during periods of economic challenge.
• Robotic Assisted Surgery and Technology Integration: Autonomous and robotic assisted surgery integrated systems were installed in 25% of operating rooms by 2025. Stryker and Zimmer Biomet received FDA clearance to market their robotic shoulder systems in 2024. Greater surgical accuracy and consistency due to robotic surgery systems will help choose the implants systems for a hospital.
• Allergy-safe Materials: Development of implant systems is less obtrusive through the use of alternative materials to metals. These innovations provide options for patients that are allergic to metals and will sustain growth as patients become more informed about allergies related to implantation of metal devices.
• Shifting To Outpatient Surgery: A move to outpatient surgery centers, especially by Zimmer Biomet with the acquisition of Paragon 28 in 2025, signals a departure from current onsite surgical facilities. Packaging formats of biomaterials will be the deciding factor in obtaining new contracts.
• Regulatory Modernization: China's NMPA released 26 standards on advanced medical devices involving additive manufacturing and nanomaterials in March 2026 to provide further details on the advanced biomaterials approval process. Improved regulatory frameworks will help support the introduction of new advanced implant materials in the next few years.

Challenges

• Tariff Risk: Stryker anticipates tariffs will impact them by $200 million, and Zimmer Biomet will be impacted by $60 to $80 million, negatively affecting margins of imported components.
• Divergent Global Regulations: Regulations affecting novel biomaterials continue to be siloed in the U.S., China, and the EU, thus slowing parallel launches in the different markets.
• Lengthy and Expensive Research and Clinical Infrastructure: The requirement for extensive safety studies in biomaterials maintains lengthy and expensive development cycles in an industry with high barrier to entry.

New technology and a growing market will enable advanced procedures with an accompanying growing demand for innovative materials that will continue to fuel the industry, while the slow integration of new biomaterials across the globe due to tariffs and regulatory divergence will be offset with continued development. Companies who can sustain the tariffs and the costs associated with ongoing clinical work will be the market leaders over the next five years.

List of Orthopedic Biomaterial Market Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies orthopedic biomaterial market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the orthopedic biomaterial market companies profiled in this report include-

• Arthrex Inc.
• Berkeley Advanced Biomaterials
• CAM Bioceramics B.V.
• Collagen Matrix Inc.
• CoorsTek Inc.
• Exactech Inc.
• Globus Medical Inc.
• Koninklijke DSM N.V.
• Stryker Corporation
• Zimmer Biomet

Orthopedic Biomaterial Market by Segment

The study includes a forecast for the global orthopedic biomaterial market by material type, application, and region.

Orthopedic Biomaterial Market by Material Type [Value ($B) from 2019 to 2035]:

• Ceramics & Bioactive Glasses
• Polymers
• Calcium Phosphate Cement
• Metal
• Composites

Orthopedic Biomaterial Market by Application [Value ($B) from 2019 to 2035]:

• Orthopedic Implants
• Joint Replacement/Reconstruction
• Orthobiologics
• Viscosupplementation
• Bio-Resorbable Tissue Fixation

Orthopedic Biomaterial Market by Region [Value ($B) from 2019 to 2035]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Orthopedic Biomaterial Market

Orthopedic biomaterials are experiencing dramatic changes in the regulatory and manufacturing landscapes as advances in material science allow for allergic-safe and bioresorbable alternatives to titanium. Lucintel's recent report suggests that for regulatory clearances, the U.S. and China are leading the way, while Germany and India are focusing on manufacturing.

• United States: Zimmer Biomet received FDA clearance in March 2025 for the Persona Revision Solution Femur, which is the first metal-alternative knee revision implant for patients allergic to nickel, cobalt, and chromium. This all-clear opens a new market segment in knee revision implants for allergic-safe implants.
• China: In March 2026, the National Medical Products Administration released 26 new industry standards for medical devices. This includes new and updated standards for metal bone plates and additive manufacturing, as well as new nanotechnology standards. All of these new standards have constructed clear regulatory pathways for both domestic and foreign orthopedic biomaterials.
• Germany: Evonik announced in April 2024 an expansion of its RESOMER powder biomaterials at its Darmstadt plant by introducing technology for the production of micro powders under the compliancy of ISO 13485 and GMP. This strengthens Germany's position as the leading source of bioresorbable polymer for the implant industry.
• India: The Indian Production Linked Incentive program now supports the manufacturing of 36 medical devices, which includes orthopedic implants. There are established medical device parks under construction in Uttar Pradesh, Madhya Pradesh, and Tamil Nadu as of December 2025. Implants manufactured in India are priced at 10-30% less when compared to imported equivalents, and have increased affordability across India's hospitals.
• Japan: Regulatory approval for sale of its iodine-treated total hip replacement system by Zimmer Biomet to prevent post-surgical joint infections was gained in Japan in September 2025. This gives them the first infection prevention technology to market in a country that has made device review one of the longest and most rigorous processes.

Features of the Global Orthopedic Biomaterial Market

• Market Size Estimates: orthopedic biomaterial market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
• Segmentation Analysis: orthopedic biomaterial market size by material type, application, and region in terms of value ($B).
• Regional Analysis: orthopedic biomaterial market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different material types, applications, and regions for the orthopedic biomaterial market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the orthopedic biomaterial market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the orthopedic biomaterial market by material type (ceramics & bioactive glasses, polymers, calcium phosphate cement, metal, and composites), application (orthopedic implants, joint replacement/reconstruction, orthobiologics, viscosupplementation, and bio-resorbable tissue fixation), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 6 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.1 Macroeconomic Trends and Forecasts
• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Orthopedic Biomaterial Market by Material Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Material Type
• 4.3 Ceramics & Bioactive Glasses : Trends and Forecast (2019 to 2035)
• 4.4 Polymers : Trends and Forecast (2019 to 2035)
• 4.5 Calcium Phosphate Cement : Trends and Forecast (2019 to 2035)
• 4.6 Metal : Trends and Forecast (2019 to 2035)
• 4.7 Composites : Trends and Forecast (2019 to 2035)

5. Global Orthopedic Biomaterial Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Orthopedic Implants : Trends and Forecast (2019 to 2035)
• 5.4 Joint Replacement/Reconstruction : Trends and Forecast (2019 to 2035)
• 5.5 Orthobiologics : Trends and Forecast (2019 to 2035)
• 5.6 Viscosupplementation : Trends and Forecast (2019 to 2035)
• 5.7 Bio-Resorbable Tissue Fixation : Trends and Forecast (2019 to 2035)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Orthopedic Biomaterial Market by Region

7. North American Orthopedic Biomaterial Market

• 7.1 Overview
• 7.2 North American Orthopedic Biomaterial Market by Material Type
• 7.3 North American Orthopedic Biomaterial Market by Application
• 7.4 The United States Orthopedic Biomaterial Market
• 7.5 Canadian Orthopedic Biomaterial Market
• 7.6 Mexican Orthopedic Biomaterial Market

8. European Orthopedic Biomaterial Market

• 8.1 Overview
• 8.2 European Orthopedic Biomaterial Market by Material Type
• 8.3 European Orthopedic Biomaterial Market by Application
• 8.4 German Orthopedic Biomaterial Market
• 8.5 French Orthopedic Biomaterial Market
• 8.6 Italian Orthopedic Biomaterial Market
• 8.7 Spanish Orthopedic Biomaterial Market
• 8.8 The United Kingdom Orthopedic Biomaterial Market

9. APAC Orthopedic Biomaterial Market

• 9.1 Overview
• 9.2 APAC Orthopedic Biomaterial Market by Material Type
• 9.3 APAC Orthopedic Biomaterial Market by Application
• 9.4 Chinese Orthopedic Biomaterial Market
• 9.5 Indian Orthopedic Biomaterial Market
• 9.6 Japanese Orthopedic Biomaterial Market
• 9.7 South Korean Orthopedic Biomaterial Market
• 9.8 Indonesian Orthopedic Biomaterial Market

10. ROW Orthopedic Biomaterial Market

• 10.1 Overview
• 10.2 ROW Orthopedic Biomaterial Market by Material Type
• 10.3 ROW Orthopedic Biomaterial Market by Application
• 10.4 Middle Eastern Orthopedic Biomaterial Market
• 10.5 South American Orthopedic Biomaterial Market
• 10.6 African Orthopedic Biomaterial Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunity by Material Type
  • 12.2.2 Growth Opportunity by Application
  • 12.2.3 Growth Opportunity by Region
• 12.3 Emerging Trends in the Global Orthopedic Biomaterial Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis Overview
• 13.2 Arthrex Inc.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Berkeley Advanced Biomaterials
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 CAM Bioceramics B.V.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Collagen Matrix Inc.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 CoorsTek Inc.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Exactech Inc.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Globus Medical Inc.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 Koninklijke DSM N.V.
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Stryker Corporation
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Zimmer Biomet
  • Company Overview
  • Orthopedic Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us