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

Advanced Biomaterial Market

The future of the global advanced biomaterial market looks promising with opportunities in the hospitals & clinic, ambulatory surgical center, research & academic institute, pharmaceutical & biotechnology company, and medical device manufacturer markets. The global advanced biomaterial market is expected to reach an estimated $495 billion by 2035 from $248 billion in 2027 with a CAGR of 8.0% from 2027 to 2035. The major drivers for this market are the growing investment in tissue engineering applications, the rising prevalence of chronic orthopedic diseases, and the increasing demand for advanced medical implants.

• Lucintel forecasts that, within the material type category, polymeric biomaterial is expected to witness the highest growth over the forecast period due to the high biocompatibility and versatility in medical implants.
• Within the end use category, hospitals & clinic is expected to witness the highest growth over the forecast period due to the increasing volume of surgical procedures performed.
• In terms of regions, North America will remain the largest region over the forecast period due to the well-established healthcare infrastructure and high spending on medical research.

Emerging Trends in Advanced Biomaterial Market

Biomaterials combining bioresorbability with precision at the cellular level and digital fabrication were introduced from roughly 2024 to 2026. Per Lucintel's latest data, these innovations will influence what qualifies as competitive biomaterial products.

Adoption of Bioresorbable Materials: Institutions are shifting to materials that play the intended role in the body and then biodegrade to eliminate the need for a second surgery. An example of this is the use of bioresorbable polymers in orthopedic pins, sutures, and systems for controlled release of therapeutics, which will reach an estimated market value of 2,563 million dollars by 2025. Over the next few years, bioresorbable materials will replace permanent implants in both orthopedic and cardiovascular devices.

• 3D Bioprinting and Additive Manufacturing: Cell-specific responses to implant design in tissue regeneration are being addressed through cell-specific regeneration scaffolds that can be manufactured in a personalized manner using additive manufacturing. This manufacturing method can fabricate structures that combine solid and porous material components in a single implant. As 3D-printed biomaterial scaffolds become more widely used, traditional, mass-produced implants will be displaced.
• Recombinant Protein Platforms: Collagen derived from non-animal sources is replacing traditional sources of animal collagen, thus eliminating the potential for the implant to elicit an undesired immune response and providing the end user with more consistency and control over the sourcing. The use of bioengineered materials will continue to be the preferred option of both regulators and consumers.
• AI-Accelerated Material Discovery: Inventive design and modeling of novel biomaterials can reward companies that employ artificial intelligence (AI) strategically and efficiently. AI-integrated design cycles decrease costs and repetition time and shorten the time for biomaterial products to transition from research to a clinical setting. AI-guided design can also shorten the time and costs for research and development (R&D) related to biomaterials.
• Regulatory Modernization for Innovation: Multiple global regulatory agencies are beginning to think about biomaterials in new and broader contexts. New regulatory approaches and frameworks will shorten the time needed to bring to market novel biomaterials. The current lack of formal regulatory frameworks stifles new biomaterial innovations.

AI and biomaterials will inevitably change the field of biomaterials engineering in the next few years. In a field of emerging recombinant technologies, players that add AI to recombinant technologies and don't offer additive manufacturing will most likely lose market share to competitors.

Recent Developments in the Advanced Biomaterial Market

Deal-making and regulatory approvals tied to advanced biomaterials began to accelerate in 2024-2026 as firms rushed to secure differentiated scaffold technologies and cross-border market access. Based on recent research published by Lucintel, the transaction velocity marks a departure from the industry's tradition of incremental, single-product approvals.

• Transaction for Scaffold Technology: Toray Industries acquired a Japanese biomedical scaffolds startup in October 2025, to expand its fiber and scaffold solutions for the neural tissue regeneration business. Toray's acquisition is the first in a series of acquisitions and partnerships that materials conglomerates are likely to make as the complexity of scaffold technologies grows.
• Market Entry Based on Regulatory Approval: Regenity Biosciences received NMPA approval for its Matrixflex collagen dental membrane in China and is targeting the dental implant market which is projected to be worth $586 million by 2029. Regenity Biosciences is one of the first biomaterial companies to tap into a new and growing market in China by securing several cross-border regulatory approvals.
• Exclusive Distribution Agreement: Evonik signed an agreement with IMCD to make IMCD Evonik's exclusive distributor of RESOMER bioresorbable polymers for medical devices in Europe. Materials suppliers can focus on research and development to extend their markets and penetrate new regions if they form the right distribution partnerships.
• AI Integration of Production Systems: Kyocera expanded its bioactive ceramic factory in Kagoshima, Japan, in January 2026, to offer AI-embedded plasma spray processing of hydroxyapatite to produce implants for orthopedic and dental applications. AI integration in manufacturing will improve the level of customization possible while also limiting variation in the production outcomes.
• 4D Medicine, a spin-out from Birmingham and Warwick universities, received $4.4 million in Series A Funding in early July to further develop their 4Degra bioresorbable biomaterial in preparation of submitting the material for clearance to the FDA for use in 3D printed implants and soft tissue scaffolds. Funding of spin out companies focused on biomaterials from universities demonstrates to venture capitalists the potential of funding projects that can commercialize existing regenerative medicine research.

Current efforts from biomaterial companies to position themselves for either acquisition or overseas partnerships and enhance their manufacturing capabilities through Artificial Intelligence demonstrate that companies working in regenerative medicine and related fields will be able to consistently shift their positioning over the coming years.

Strategic Growth Opportunities in the Advanced Biomaterial Market

The next five years will afford significant opportunities for biomaterial manufacturers beyond conventional implants thanks to new applications in bioelectronics, veterinary medicine, and advanced wound care. According to Lucintel's market assessment, these emerging biomaterials will push biomaterial manufacturers into higher margin, application-specific product development.

• Flexible Neural Probes/Bioresorbable Electrodes: With China's NMPA facilitating the standardization of brain-computer interface flexible electrodes, technologies in bioresorbable neural probes and bioelectronics are advancing at a rapid pace. As neural technologies move into the arena of clinical devices, biomaterials designed to ensure long-term biocompatibility with neural tissue offer a high value challenge to a limited number of suppliers.
• Advanced Wound Care: The incorporation of bioelectronic stimulation in biomaterial-based dressings results in the controlled release of therapeutics coupled with electric-field-directed cell migration, thereby hastening the healing of chronic wounds. With chronic wounds increasing with an aging population, this segment provides recurrent, steady demand compared to one-time implant-based procedures.
• Aesthetic and Dermatology Applications: The use of biomaterials in the post-procedure healing of energy-based aesthetic procedures represents a separate market from traditional surgical implants fast growing with the increasing demand for minimally invasive aesthetic procedures.
• Bioresorbable Diagnostic Electronics: Technologies in bioresorbable diagnostic and therapeutic electronics provide temporary post-surgical biomaterials and controlled drug delivery systems intervened by surgical extraction. This merging of electronics and bioresorbable and biostimulatory materials has been a valuable new market for suppliers of integrated sensing, delivery, and therapy.
• Veterinary and Animal Health Applications: The use case for veterinary surgery for biomaterial scaffolds and bioresorbable implants developed for human orthopedic and wound healing applications is an extension to the currently existing parallel commercial market. Suppliers are able to recoup their investment on research and development without financing further human clinical trials for surgery.

Growth along these 5 paths focuses on applications integrating biomaterials with either electronics, aesthetics, or other species medicine, as opposed to focusing solely on orthopedic implants. Companies able to combine bioelectronics, diagnostics, and therapeutics will ultimately satisfy the demand that companies focused on orthopedic implants cannot.

Advanced Biomaterial Market Drivers and Challenges

The growing, but stabilizing, demand for biomaterials is predicted to continue as aging populations and increasing investments in regenerative medicine push for more innovative solutions, counterbalanced by long, multi-pronged regulatory approval processes and biocompatibility concerns. According to Lucintel's new market research, the disparity between the medical community's need and the regulatory community's demands will drive most biomaterials manufacturers' spending through 2026.

Drivers

• The Aging Population: Increasing volumes of surgical procedures driven by the aging population will continue to create a demand for medical implants in the U.S. biomaterials market, which Lucintel estimates will be valued at $23.45 billion by 2024. The aging of global populations will continue to stimulate the demand for biomaterials in the orthopedic, cardiovascular, and dental sectors throughout the next ten years.
• Reforms in Regulation: There is a trend toward shortening regulatory approval time frames in the U.S., with the average review time for biomaterial-based medical devices dropping from 18 to 12 months (a 33% improvement), with some 3D-printed spinal implants made from novel titanium alloys seeing a 40% reduction in approval time. With such trends, it can be expected that the next generation of biomaterials will come to market even more rapidly.
• 3D Bioprinting: There was an estimated 420,000+ customized implants produced in the 3D bioprinting sector in 2024, with 65% of those implants made from biomaterials. The technology will continue to displace standard implants in favor of customized, personalized implants in orthopedics and dentistry.
• Increasing The Number of Minimally Invasive Procedures: An estimated 15 million minimally invasive surgical procedures were conducted globally in 2024. These procedures require the use of biocompatible implant materials that can be delivered via laparoscopic or robotic surgical systems. The increase in robotic surgical systems will continue to drive the use of flexible, lightweight biomaterials that can be used to design and produce implants for these surgical systems.
• Expanded Insurance Reimbursement: Insurance coverage for procedures involving biomaterials has increased reimbursement allowances by 27% in the last three years, eliminating a significant financial burden for the patient. The expansion will help convert clinical innovations to marketable volumes more rapidly than in previous years.

Challenges

• Longer Regulatory Processes: New biomaterials can take five to seven years to secure approval within regulated markets due to the large number (2,000) of biomaterial-based devices that have been either delayed or denied in 2023 and 2024.
• Biocompatibility and Adverse Events: Approximately 8% of implant recipients experience material adverse events. During 2024, the FDA's MAUDE database reported a 15% increase over the previous year and contained 12,346 biomaterial-related events.
• High Production Costs: High production costs associated with advanced biomaterials, coupled with complex purification and sterile manufacturing processes, greatly impact scalability, especially for smaller innovators who file only 23% of new patents while representing 68% of market players.

At the end of the day, the company that is able to leverage these factors will dominate the market, while the rest will fail to keep up. Companies that combine efficient regulatory processes with biocompatibility and safer biomaterials manufacturing, and manage the risks of adverse events, will dominate the market in this decade.

List of Advanced 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 advanced biomaterial market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the advanced biomaterial market companies profiled in this report include-

• Medtronic plc
• Dentsply Sirona Inc.
• Johnson & Johnson
• Invibio Ltd.
• Stryker Corporation
• GELITA AG
• CoorsTek Inc.
• Evonik Industries AG
• CeramTec GmbH
• BASF SE

Advanced Biomaterial Market by Segment

The study includes a forecast for the global advanced biomaterial market by material type, technology, application, end use, and region.

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

• Metallic Biomaterials
• Polymeric Biomaterials
• Ceramic Biomaterials
• Natural Biomaterials
• Composite Biomaterials

Advanced Biomaterial Market by Technology [Value ($B) from 2019 to 2035]:

• 3D Printing & Bioprinting
• Surface Modification Technologies
• Nanotechnology-Based Biomaterials
• Electrospinning Techniques

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

• Orthopedic Applications
• Cardiovascular Applications
• Dental Applications
• Ophthalmology
• Neurology
• Plastic & Reconstructive Surgery
• Tissue Engineering & Regenerative Medicine
• Wound Healing

Advanced Biomaterial Market by End Use [Value ($B) from 2019 to 2035]:

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Research & Academic Institutes
• Pharmaceutical & Biotechnology Companies
• Medical Device Manufacturers

Advanced 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 Advanced Biomaterial Market

From 2024 to 2026, the development of regenerative medicine and the manufacture of bioresorbable implants gained momentum when a framework for regulation was developed and the manufacturing capacity for most major economies was achieved. According to Lucintel, this combination of clinical and industrial sectors is reshaping global biomaterial supply chains.

• United States: Stryker released its Citrefix Suture Anchor System, which incorporates Citregen, a bioresorbable biomaterial designed to substitute native bone, in December 2025 and further developed its Titanium In-Growth Technology for bone regeneration. The innovation of biomaterials maintains U.S. orthopedic device manufacturers on the edge of bioresorbable implant technology.
• China: On November 4, 2025, the Medical Device Good Manufacturing Practice of the National Medical Products Administration was fully revised and now includes 15 chapters and 132 articles with an emphasis on the incorporation of more standards of innovative biomaterials, including additive manufacturing and genetically modified materials. Regulatory reform in the biomaterial approval process in China, to align it close to ISO 13485 and FDA regulations, encourages both domestic and foreign device manufacturers to enter the market.
• Germany: Evonik reached a significant milestone for its VECOLLAN platform in 2025, providing a clinically viable grade recombinant non-animal derived collagen-like protein. Evonik further established its application facility for medical devices in Shanghai and formed a strong partnership in the collagen-based biomaterial area. VECOLLAN, along with additional protein innovation, led Evonik to enhancing its global supply of biomaterials.
• India: Clinical-stage biotech company Pandorum Technologies in Bengaluru raised money in Series B funding in November 2025. This supports India's growing tissue engineering ecosystem as biomaterials developed in India shift from academia to the commercial stage.
• Japan: In August 2025, the Sumitomo Pharma subsidiary S-RACMO announced a ¥15 billion plan to create a fourth regenerative medicine and cell therapy manufacturing site, with the support of Japan's Ministry of Economy, Trade and Industry's subsidy program for regenerative medicine manufacturing equipment. This plan will strengthen the domestic capacity for contract manufacturing of cell and gene therapies serving both the domestic and foreign markets for biomaterial dependent regenerative therapeuses.

Features of the Global Advanced Biomaterial Market

• Market Size Estimates: advanced biomaterial market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
• Segmentation Analysis: advanced biomaterial market size by various segments, such as by material type, technologies, application, end use, and region in terms of value ($B).
• Regional Analysis: advanced biomaterial market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different material types, technology, applications, end uses, and regions for the advanced biomaterial market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the advanced 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 advanced biomaterial market by material type (metallic biomaterials, polymeric biomaterials, ceramic biomaterials, natural biomaterials, and composite biomaterials), technology (3D printing & bioprinting, surface modification technologies, nanotechnology-based biomaterials, and electrospinning techniques), application (orthopedic applications, cardiovascular applications, dental applications, ophthalmology, neurology, plastic & reconstructive surgery, tissue engineering & regenerative medicine, and wound healing), end use (hospitals & clinics, ambulatory surgical centers, research & academic institutes, pharmaceutical & biotechnology companies, and medical device manufacturers), 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 Advanced Biomaterial Market by Material Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Material Type
• 4.3 Metallic Biomaterials : Trends and Forecast (2019 to 2035)
• 4.4 Polymeric Biomaterials : Trends and Forecast (2019 to 2035)
• 4.5 Ceramic Biomaterials : Trends and Forecast (2019 to 2035)
• 4.6 Natural Biomaterials : Trends and Forecast (2019 to 2035)
• 4.7 Composite Biomaterials : Trends and Forecast (2019 to 2035)

5. Global Advanced Biomaterial Market by Technology

• 5.1 Overview
• 5.2 Attractiveness Analysis by Technology
• 5.3 3D Printing & Bioprinting : Trends and Forecast (2019 to 2035)
• 5.4 Surface Modification Technologies : Trends and Forecast (2019 to 2035)
• 5.5 Nanotechnology-Based Biomaterials : Trends and Forecast (2019 to 2035)
• 5.6 Electrospinning Techniques : Trends and Forecast (2019 to 2035)

6. Global Advanced Biomaterial Market by Application

• 6.1 Overview
• 6.2 Attractiveness Analysis by Application
• 6.3 Orthopedic Applications : Trends and Forecast (2019 to 2035)
• 6.4 Cardiovascular Applications : Trends and Forecast (2019 to 2035)
• 6.5 Dental Applications : Trends and Forecast (2019 to 2035)
• 6.6 Ophthalmology : Trends and Forecast (2019 to 2035)
• 6.7 Neurology : Trends and Forecast (2019 to 2035)
• 6.8 Plastic & Reconstructive Surgery : Trends and Forecast (2019 to 2035)
• 6.9 Tissue Engineering & Regenerative Medicine : Trends and Forecast (2019 to 2035)
• 6.10 Wound Healing : Trends and Forecast (2019 to 2035)

7. Global Advanced Biomaterial Market by End Use

• 7.1 Overview
• 7.2 Attractiveness Analysis by End Use
• 7.3 Hospitals & Clinics : Trends and Forecast (2019 to 2035)
• 7.4 Ambulatory Surgical Centers : Trends and Forecast (2019 to 2035)
• 7.5 Research & Academic Institutes : Trends and Forecast (2019 to 2035)
• 7.6 Pharmaceutical & Biotechnology Companies : Trends and Forecast (2019 to 2035)
• 7.7 Medical Device Manufacturers : Trends and Forecast (2019 to 2035)

8. Regional Analysis

• 8.1 Overview
• 8.2 Global Advanced Biomaterial Market by Region

9. North American Advanced Biomaterial Market

• 9.1 Overview
• 9.2 North American Advanced Biomaterial Market by Material Type
• 9.3 North American Advanced Biomaterial Market by End Use
• 9.4 The United States Advanced Biomaterial Market
• 9.5 Canadian Advanced Biomaterial Market
• 9.6 Mexican Advanced Biomaterial Market

10. European Advanced Biomaterial Market

• 10.1 Overview
• 10.2 European Advanced Biomaterial Market by Material Type
• 10.3 European Advanced Biomaterial Market by End Use
• 10.4 German Advanced Biomaterial Market
• 10.5 French Advanced Biomaterial Market
• 10.6 Italian Advanced Biomaterial Market
• 10.7 Spanish Advanced Biomaterial Market
• 10.8 The United Kingdom Advanced Biomaterial Market

11. APAC Advanced Biomaterial Market

• 11.1 Overview
• 11.2 APAC Advanced Biomaterial Market by Material Type
• 11.3 APAC Advanced Biomaterial Market by End Use
• 11.4 Chinese Advanced Biomaterial Market
• 11.5 Indian Advanced Biomaterial Market
• 11.6 Japanese Advanced Biomaterial Market
• 11.7 South Korean Advanced Biomaterial Market
• 11.8 Indonesian Advanced Biomaterial Market

12. ROW Advanced Biomaterial Market

• 12.1 Overview
• 12.2 ROW Advanced Biomaterial Market by Material Type
• 12.3 ROW Advanced Biomaterial Market by End Use
• 12.4 Middle Eastern Advanced Biomaterial Market
• 12.5 South American Advanced Biomaterial Market
• 12.6 African Advanced Biomaterial Market

13. Competitor Analysis

• 13.1 Product Portfolio Analysis
• 13.2 Operational Integration
• 13.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 13.4 Market Share Analysis

14. Opportunities & Strategic Analysis

• 14.1 Value Chain Analysis
• 14.2 Growth Opportunity Analysis
  • 14.2.1 Growth Opportunity by Material Type
  • 14.2.2 Growth Opportunity by Technology
  • 14.2.3 Growth Opportunity by Application
  • 14.2.4 Growth Opportunity by End Use
  • 14.2.5 Growth Opportunity by Region
• 14.3 Emerging Trends in the Global Advanced Biomaterial Market
• 14.4 Strategic Analysis
  • 14.4.1 New Product Development
  • 14.4.2 Certification and Licensing
  • 14.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

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

• 15.1 Competitive Analysis Overview
• 15.2 Medtronic plc
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.3 Dentsply Sirona Inc.
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.4 Johnson & Johnson
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.5 Invibio Ltd.
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.6 Stryker Corporation
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.7 GELITA AG
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.8 CoorsTek Inc.
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.9 Evonik Industries AG
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.10 CeramTec GmbH
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 15.11 BASF SE
  • Company Overview
  • Advanced Biomaterial Market Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

16. Appendix

• 16.1 List of Figures
• 16.2 List of Tables
• 16.3 Research Methodology
• 16.4 Disclaimer
• 16.5 Copyright
• 16.6 Abbreviations and Technical Units
• 16.7 About Us
• 16.8 Contact Us