U.S. Biomaterials Market (By Product: Metallic, Natural, Ceramics; By Application: Cardiovascular, Ophthalmology, Wound Healing) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. biomaterials market size was estimated at USD 59.34 billion in 2023 and it is expected to surpass around USD 236.33 billion by 2033, poised to grow at a CAGR of 14.82% from 2024 to 2033.

Key Pointers

• By Product, the metallics segment held the largest revenue share of 41% in 2023.
• By Product, the natural biomaterials are poised to exhibit the fastest compound annual growth rate CAGR of 18.25% from 2024 to 2033
• By Application, the orthopedic procedures generated the maximum market share of 26% in 2023.
• By Application, the plastic surgery is projected to exhibit the fastest compound annual growth rate (CAGR) of 18.05% from 2024 to 2033.

U.S. Biomaterials Market Overview

The U.S. biomaterials market is a dynamic sector within the healthcare industry, encompassing a wide range of materials engineered for use in medical devices, implants, drug delivery systems, and tissue engineering applications. Biomaterials play a crucial role in advancing medical treatments and improving patient outcomes by providing biocompatible and functional materials that interact favorably with the human body.

U.S. Biomaterials Market Growth Factors

The U.S. biomaterials market is propelled by the technological advancements in material science and manufacturing processes continually drive innovation in biomaterials, enabling the development of novel materials with enhanced properties and functionalities. Additionally, the rising prevalence of chronic diseases, coupled with an aging population, creates a growing demand for biomaterials used in medical devices and implants for the treatment of orthopedic, cardiovascular, and other health conditions. Moreover, increasing investments in research and development, supported by government initiatives and private sector funding, foster the discovery of new biomaterials and applications, further fueling market expansion. Regulatory support for innovative medical technologies and the growing adoption of minimally invasive surgical procedures also contribute to the market's growth trajectory, providing opportunities for the development and commercialization of advanced biomaterial-based products.

U.S. Biomaterials Market Trends:

• Advancements in Material Science: Ongoing research and development efforts are driving innovations in biomaterials, leading to the creation of materials with improved biocompatibility, mechanical properties, and functionality.
• Rising Demand for Biodegradable Biomaterials: There is a growing preference for biodegradable and bioresorbable biomaterials, driven by sustainability concerns and the desire to reduce the need for implant removal procedures.
• Expansion of 3D Printing Technology: The adoption of 3D printing technology in biomaterials manufacturing is increasing, enabling the fabrication of complex and customized implants and medical devices with greater precision and efficiency.
• Focus on Regenerative Medicine: There is a shift towards the development of biomaterials for regenerative medicine applications, including tissue engineering and organ transplantation, aiming to restore damaged tissues and organs using biocompatible scaffolds and growth factors.
• Integration of Nanotechnology: Nanotechnology is being integrated into biomaterials research and development, allowing for the creation of nanoscale biomaterials with unique properties for targeted drug delivery, imaging, and diagnostic applications.

U.S. Biomaterials Market Challenges:

• Stringent Regulatory Requirements: The U.S. Biomaterials Market is subject to rigorous regulatory scrutiny by agencies such as the FDA, which imposes stringent requirements for the approval and commercialization of biomaterial-based medical devices and implants, leading to prolonged development timelines and increased costs.
• High Development Costs: Developing biomaterial-based products involves significant research, development, and testing costs, including preclinical and clinical trials, which can pose financial challenges for companies, particularly small and medium-sized enterprises (SMEs) with limited resources.
• Safety and Efficacy Concerns: Ensuring the safety and efficacy of biomaterial-based medical devices and implants over the long term is a major challenge, as concerns regarding biocompatibility, degradation rates, and immune responses need to be addressed to mitigate the risk of adverse reactions and device failure.
• Complexity of Biomaterials Science: Biomaterials science is inherently complex, involving the interdisciplinary integration of materials science, biology, chemistry, and engineering, which requires specialized expertise and resources to overcome technical challenges and optimize product performance.

Product Insights

Metallics currently dominate the market, commanding the largest revenue share of 41% in 2023. They are primarily utilized in dental and orthopedic applications, where their strength and durability are highly valued. Metals serve as the backbone of load-bearing implants, commonly employed in orthopedic surgeries for various purposes such as wire fixation, screw placement, and joint prostheses for hips, knees, and shoulders. Their inherent properties, including mechanical strength and resilience, make them indispensable in these applications. However, their use as biomaterials necessitates careful consideration of additional factors such as wear resistance, corrosion resistance, and biocompatibility.

Natural biomaterials are poised to exhibit the fastest compound annual growth rate (CAGR) of 18.25% from 2024 to 2033. Natural polymers offer distinct advantages over synthetic counterparts, particularly in terms of biocompatibility, biodegradability, and remodeling capabilities. These qualities make natural biomaterials highly suitable for tissue repair and organ replacement therapies, where they facilitate cell adhesion, proliferation, and differentiation upon implantation. With the current limitations in tissue and organ availability, the development of artificial substitutes is imperative. The anticipated rise in their clinical application and effectiveness in tissue remodeling processes is expected to be a key driver for market growth in this segment.

Application Insights

Orthopedic procedures dominated the market, holding the largest revenue share of 26% in 2023. A considerable portion of the population relies on various biomaterials in orthopedic treatments to address issues related to bone and joint degeneration. These biomaterials are typically classified into three generations based on their properties and functions. The first generation comprises bioinert materials such as metals, ceramics, and polymers. Moving to the second generation, we encounter bioactive and biodegradable ceramics, cements, metals, and polymers, which possess enhanced qualities promoting biological interaction. The third generation consists of biomaterials engineered to elicit specific molecular-level responses within the body. These advancements cater to diverse needs, including fractures, extensive resections, joint dysfunctions, spinal pathologies, and related conditions. Consequently, the demand for medical devices and biomaterials in orthopedic applications is expected to significantly increase in the foreseeable future.

Plastic surgery is projected to exhibit the fastest compound annual growth rate (CAGR) of 18.05% during the forecasted period. The utilization of biomaterials in plastic surgery has seen a notable increase due to the availability of various commercial products in recent years. These products encompass a range of items such as soft tissue fillers, bioengineered skins, acellular dermal matrices, materials for craniofacial surgery, and solutions for peripheral nerve repair. Plastic surgery encompasses both cosmetic and reconstructive procedures, with popular interventions including breast augmentation, rhinoplasty, and facelifts. Ensuring the development of safe and reliable products is paramount for advancing this critical surgical field. Biomaterials in plastic surgery continue to evolve, focusing on ongoing enhancements. In 2022, data from the American Society of Plastic Surgeons revealed a significant 19.0% increase in cosmetic surgeries compared to 2019, with 26.2 million surgical and minimally invasive cosmetic and reconstructive procedures performed in the United States. The growth of plastic surgery underscores its expanding demand and importance in modern healthcare practices.

U.S. Biomaterials Market Key Companies

• Medtronic plc
• Evonik Industries AG
• Carpenter Technology Corporation
• Berkeley Advanced Biomaterials
• Invibio Ltd.
• Zimmer Biomet Holdings, Inc.
• BASF SE
• Covalon Technologies Ltd.
• Stryker
• Johnson & Johnson
• Corbion
• Collagen Matrix, Inc.

Recent Developments

• In October 2023, Evonik unveiled VESTAKEEP iC4612 3DF and iC4620 3DF, groundbreaking carbon-fiber-reinforced PEEK filaments designed for 3D-printed medical implants. These filaments offer a unique blend of strength, flexibility, and adaptability, marking a significant step forward in personalized medical treatments.
• In September 2023, BASF SE launched a bio-based 2-octyl acrylate boasting a remarkable 73% 14C-traceable content, emphasizing its commitment to sustainability and reducing carbon footprint. Derived from castor oil, this monomer delivers enhanced performance for various applications like adhesives and coatings, with global registrations currently underway.
• In January 2023, Zimmer Biomet Holdings, Inc. revealed plans for the acquisition of Embody, Inc. for an initial USD 155 million, with the potential to rise to USD 275 million based on future milestones. This strategic move aims to bolster Zimmer Biomet's sports medicine portfolio, particularly in the realm of soft tissue healing solutions.

U.S. Biomaterials Market Segmentations:

By Product

• Metallic
• Natural
• Ceramics
• Polymers

By Application

• Cardiovascular
  • Sensors
  • Stents
  • Guidewires
  • Implantable Cardiac Defibrillators
  • Pacemakers
  • Vascular Grafts
  • Others
• Ophthalmology
  • Synthetic Corneas
  • Intraocular Lens
  • Contact Lens
  • Ocular Tissue Replacement
  • Others
• Dental
  • Tissue Regeneration Materials
  • Dental Implants
  • Bone Grafts & Substitutes
  • Dental Membranes
  • Others
• Orthopedic
  • Joint Replacement Biomaterials
  • Orthobiologics
  • Bioresorbable Tissue Fixation Products
  • Viscosupplementation
  • Spine Biomaterials
  • Others
• Wound Healing
  • Fracture Healing Device
  • Adhesion Barrier
  • Skin Substitutes
  • Internal Tissue Sealant
  • Surgical Hemostats
  • Others
• Tissue Engineering
• Plastic Surgery
  • Facial Wrinkle Treatment
  • Soft Tissue Fillers
  • Craniofacial Surgery
  • Bioengineered Skins
  • Peripheral Nerve Repair
  • Acellular Dermal Matrices
  • Others
• Neurology
  • Neural Stem Cell Encapsulation
  • Shunting Systems
  • Hydrogel Scaffold For CNS Repair
  • Cortical Neural Prosthetics
  • Others
• Others