Market Overview

Biomaterials include any material products, either natural or synthetic, that interact with the human body for medical purposes. A large fraction of biomaterials are intended for therapeutic purposes, such as tissue implants or drug delivery systems. While the tissue engineering market sub-set has seen limited clinical approvals due to complex regulatory needs, increased focus in precision medicine has renewed interest in the biomaterials market. With highly modular systems, biomaterials are poised for expanded growth in patient-specific treatments. 

The biomaterials market has broad applications in tissue engineering, drug delivery, and regenerative medicine. The market is projected to grow from $14.5 billion in 2023 to $50.5 billion in 2034 with a CAGR of 12.3%.1 Market drivers include the rising aging population, the increasing incidence of chronic disease, enhanced manufacturing methods, and the increasing investment in novel and personalized drug delivery systems. 

Market Segmentation

By Application

1. Orthopedics: Accounts for the largest market share, with metallic biomaterials in joint applications motivating market size. Advanced orthopedic implants, including tissue engineered orthopedic tissues, such as bone, tendon, and cartilage demonstrate continued preclinical advancement with notable clinical trials in knee articular surface lesions, maxillary sinus augmentation, and cranial reconstruction.2

2. Cardiology: Top products include pacemakers and synthetic blood vessels. With increasing prevalence of cardiovascular diseases, this sub-segment has potential for continued growth. Both natural and synthetic materials are used for cardiac applications with tissue engineered therapies often incorporating stem cells for regeneration.3 

3. Ophthalmology: Applications primarily focus on corneal implants and other vision-restoring devices. With novel devices being developed for intravitreal injection of sustained-release implants, several biomaterial-based drug-device conjugates have been successfully progressing through the clinical trial pipeline.4 

• 1 Smart Biomaterials Market Forecast to 2034. Transparency Market Research, globalnewswire.com (2025)

• 2 Biomaterials Search Results, clinicaltrials.gov (2025)

• 3 Biomaterials Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030), mordorintelligence.com (2025)

• 4 Ham et al. Novel Drug Delivery Methods and Approaches for the Treatment of Retinal Diseases, Asia-pacific Journal of Ophthalmalogy (2023) 

4. Dentistry: An increasing prevalence of dental implants and cosmetic dentistry has motivated continued growth of this market subsegment. While this sub-segment can be further stratified by implantology, prosthodontics, orthodontics, and other applications, the implantology segment dominates in the biomaterials space.5 

5. Wound healing: Advanced biomaterial-based wound dressings have established a clear pipeline for bringing wound healing products to market. Within skin being the first tissue engineered product to reach patient care, there are currently 12 acellular products and 39 cellular products commercially available.6 While academic research continues to seek solutions to improve overall wound healing, this sub-segment may experience less growth as compared to larger more opportunistic areas. 

6. Plastic surgery: Demonstrates the highest CAGR from 2024 to 2030 with increased prevalence of cosmetic surgeries and the need for reconstructive surgeries. Companies such as LifeSprout are developing products such as dermal fillers that integrate with the body’s native tissues, resulting in superior safety and biocompatibility than current filler products. 

7. Neurology: Applicable to both peripheral and central nerve injuries and central nervous system disorders, such as neurodegenerative diseases. Academic research in this segment includes injectable hydrogels for repairing damaged tissues, scaffolds for neuroregeneration, and sustained drug delivery devices. Clinical trials include those for spinal cord injury, ischemic stroke, and multiple sclerosis.7 

By Material

1. Metals: The largest segment of the market, estimated at 40%, including steel, titanium, and other alloys that are prioritized for their high strength and ductility, particularly in orthopedic applications.8 However, metals exhibit low biocompatibility and corrosion and may be difficult to manufacture tissue forms. 

2. Ceramics: Includes calcium phosphate, carbon, and glass.9 Ceramic materials have high biocompatibility, strong mechanical properties, and are resistant to corrosion, however, they can be difficult to reproduce and may face difficulties in processing and fabrication. 

3. Polymers: Includes PLGA, polycaprolactone, and nylon.10 Polymers are easy to produce, yet suffer from low mechanical resistance and fast degradation. 

4. Natural Materials: Includes hyaluronic acid, collagen, and fibrin and is often prioritized for its high biocompatibility and bioactivity. Although generally biocompatible, animal-based materials, such as porcine collagen, which can be derived from animal waste, can exhibit biocompatibility issues with human hosts. 

• 5 Dental Biomaterials Market by Type, marketsandmarkets.com (2018)

• 6 Vig et al. Advances in Skin Regeneration Using Tissue Engineering, Int J Mol Sci (2017) 

• 7 Paj et al. Insights into Advances and Applications of Biomaterials for Nerve Tissue Injuries and Neurodegenerative Disorders, Macromol Biosci (2024)

• 8 Biomaterials Market, rootsanalysis.com (2024)

• 9 Saenz et al. Ceramic Biomaterials: An Introductory Overview, Journal of Materials Education (1999)

• 10 Biomaterials Market: Growth, Size, Share, and Trends, marketsandmarkets.com (2024)

By Geography:

1. North America: Dominates the market (15.5% estimated CAGR from 2019-2031) with large R&D investment into biomaterial technologies in both academia and industry.11 In addition to overall market drivers, established players motivate continued growth in the North American market. 

2. Europe: With an estimated CAGR of 15.1% from 2019-2031, Europe demonstrates continued expansion of biomaterials with increased academic research and conferences in the region. 

3. Asia-Pacific: While initial adoption remains low in the APAC region, South Korea’s active market suggests growth potential in the region. General investment from APAC countries into preclinical research may also contribute to the continued growth in the region.

4. ROW: Latin America and the Middle East contain several biomaterials start-ups and are experiencing similar market drivers, yet maintain the lowest market share, potentially due to slower overall market growth. 

Customer Demographics

Patient Populations:

1. Standard surgical procedures: Common surgical procedures such as knee replacement and cardiac pacing are the most common use cases for biomaterials. Any patient procedure requiring integration of a material with the body falls into this patient category. 

2. Critical-sized injuries: Defined by their inability to fully heal and restore the native environment, critical-sized injuries motivate the field of tissue engineering. Aiming to regenerate lost tissue, tissue engineered therapies for critical-sized defects have shown promise in orthopedic, dental, and wound healing applications. Patients suffering from these injuries, often caused by cancer resection, congenital defects, or traumatic injury are often relegated to unfavorable outcomes with limited overall tissue reconstruction with current treatments. 

3. Localized drug delivery: Due to off-target effects and overall systemic toxicity for many therapeutic compounds, there exists a need for local delivery to target tissues. With innovative biomaterials including targeted lipid nanoparticles, local and sustained delivery can be achieved using minimally invasive delivery techniques. Patients can benefit from intravenous injection or oral delivery methods that still ensure limited systemic toxicity and patient safety. 

Buyers, Payers, and Other Stakeholders:

1. Hospital Systems and Clinics: Hospital purchasing groups, clinical departments, specialized committees facilitate purchasing for large hospital systems. Improvements either to hospital efficiency or overall costs are weighed heavily in addition to patient outcomes. Biomaterial pricing strategies and impacts on physician workflow are important for effective marketing to these purchasing groups. 

• 11 Biomaterials Market Size, Share & Trends Analysis Report By Product, By Application, and By Region, straitsresearch.com (2023)

• 12 HCPCS Level II Coding Reference Guide. Zimmer Biomet (2023)

2. Insurance Companies: With insurance companies likely covering the costs of a significant fraction of any one biomaterial-based therapy, realistic pricing strategies are crucial for insurance pre-authorization and subsequent coverage. With existing reimbursement codes such as C1776 Artificial Joint and L8699 Prosthetic Implant, novel products can more easily be associated with predicate devices with existing codes to more easily facilitate commercialization and integration into current workflows.12 Further, with improved patient outcomes potentially resulting in reduced readmission rates and further treatment, overall insurance costs should decrease with effective biomaterial-based therapies. 

3. Surgeons and Providers: Within all segments of the biomaterials market, there remains a clear unmet need to improve current biomaterial-based therapies. Physicians among all of these segments desire to improve patient outcomes, however, it is critical to identify clear pain points for both patients and physicians when developing biomaterial-based therapies. By solving key bottlenecks faced by providers such as drug-delivery issues and a lack of native tissue restoration, these therapies can revolutionize current treatment modalities. 

Growth Drivers & Trends

1. Growing aging population: According to the US Census in 2020, 1 in 6 people in the United States were 65 and older, demonstrating a 38.6% increase since 2010.13 Larger aging populations require increased investment in medical treatments, especially those related to longevity. For example, joint replacements are most common in older adults, with over 4 million hip and knee replacement procedures performed from 2012 to 2023.14 While treatment options for hip replacements have significantly improved, 10% of these surgeries require revision surgery, providing an opportunity for improved biomaterials that facilitate successful healing.X15

2. Rising incidence of chronic disease: The CDC estimates that at least 129 million Americans have at least one chronic disease with expected population increases in projected years.16,17 Biomaterial products have potential applications in a wide range of chronic diseases with potential for improved treatments and patient outcomes. Academic research into biomaterial-based therapies for diseases, such as Type I diabetes, demonstrate potential for novel methods to deliver insulin-generating cells without external disease management.18 With continued preclinical and clinical success, the results of these investigations have potential to impact large patient populations. 

• 13 Caplan. 2020 Census: 1 in 6 People in the United States Were 65 and Over, census.gov (2023)

• 14 American Joint Replacement Registry Surpasses 4 Million Captured Hip and Knee Arthroplasty Procedures, aaos.org (2024)

• 15 Mahomed et al. Rates and Outcomes of Primary and Revision Total Hip Replacement in the United States Medicare Population, The Journal of Bone and Joint Surgery (2003)

• 16 Benavidez et al. Chronic Disease Prevalence in the US: Sociodemographic and Geographic Variations by Zip Code Tabulation Area, Preventing Chronic Disease, CDC (2024)

• 17 Ansah et al. Projecting the chronic disease burden among the adult population in the United States using a multi-state population model, Frontiers in Public Health (2023)

• 18 Tang et al. Designing biomaterials for the treatment of autoimmune diseases. Applied Materials Today (2024)

3. Enhanced manufacturing methods: Techniques such as 3D bioprinting have emerged as novel methods to generate tissue structures, specifically for application in the field of tissue engineering.19 By combining natural materials, embedded cells, and other biomolecules, 3D tissue structures can be easily manufactured with GMP principles. While no bioprinted products are currently FDA approved, several clinical trials are in progress, including one that focuses on 3D bioprinting of the trachea for patients with thyroid or respiratory diseases.20 

4. Personalized drug delivery systems and precision medicine: Patient-specific medicine has potential to revolutionize current treatments by improving therapeutic efficacy and reducing side effects by incorporating autologous or patient -specific factors. For example, cell-laden biomaterial therapeutics often incorporate exogenous cells to restore stem-cell populations and regenerate tissue. By incorporating autologous stem cells into biomaterial-based therapies, overall implant immunogenicity is reduced and implanted cells are more readily effective for subsequent tissue regeneration. 

5. Expansion of cell therapies: With the continued success of cell-based therapies in immuno-oncology, including CAR T-cell therapy and stem cell transplantation, the regulatory avenues for additional cell-based therapies in other applications are becoming increasingly defined. Further, in combination with biomaterial-based therapies, much of the concerns associated with implanted exogenous cells are being alleviated. According to BioInformant, 43 cell and gene therapies have been approved in the US with seven approved in 2024 alone.21

Challenges & Barriers

1. Stringent regulatory environment: While basic biomaterials are considered medical devices, any drug-, biologic-, or cell-laden biomaterial is deemed a combination device and must be reviewed by the NIH Office of Combination Products and assigned to an FDA center (by an Request for Designation) based on the primary mode of action of the product.22 In addition to the RFD process, combination devices require testing of individual components independently and combined. While this expanded process has potential to delay approval times, combination devices are often considered for expedited approval which can remedy this concern. 

2. Biocompatibility and long term performance: Given the fact that biomaterial devices are primarily designated for long term tissue integration, biocompatibility and safety is paramount. Biocompatibility assessments primarily focus on safety and potential for adverse reactions. Prior to FDA approval, products must be evaluated for systemic toxicity and pharmacokinetic and pharmacodynamic properties. For example, product degradation and degradation byproducts must be evaluated to ensure continued patient safety. Thus, given the extended lifetime of the product, these evaluations may slow the approval process and result in product improvements and redesign to ensure compliance. 

• 19 Zhang et al. 3D Bioprinting: A Novel Avenue for Manufacturing Tissues and Organs, Engineering (2019)

• 20 Patient-Customized Bioprinting Technology for Practical Regeneration of the Respiratory Tract (Trachea), clinicaltrials.gov (2023)

• 21 Hildreth. List of U.S. FDA Approved Cell and Gene Therapy Products, bioinformant.com (2025)

• 22 Frequently Asked Questions About Combination Products, fda.gov (2022)

Competitive Landscape

The biomaterials market is vastly under-saturated. Although key players control a large portion of the biomaterials market for standard procedures such as orthopedic joint reconstructions and cardiac pacing, small, up-and-coming players have potential to break into the market and capture niche applications that require improvements to current treatment methods. 

1. Key Pharma Players: Evonik Industries, Medtronic, DSM-Firmenich, and Stryker are key players, each with a >$10 billion dollar enterprise value. Their offerings span biomaterials market segments, however, Stryker is the primary player in the orthopedics segment, providing a large portion of all joint reconstruction products.23  

2. University Spin-outs: Includes companies that have licensed IP from universities to facilitate product commercialization. Some examples include Dimension Inx, Sana Biotechnology, inSoma Bio, and Resilience.

3. Other Startups and Incubator Programs: Outside of academia, start-ups may be built out of industry incubator programs or spun out from parent companies. Some independent start-ups include BoneReg, Gbrain, Agave Biosensors, Titanium Textiles, and Cellulora. These companies are all in revenue generating stages with ground breaking solutions for orthopedic, neurologic, or soft tissue applications. 

Investment Opportunities

1. Recent regulatory approvals set precedent: With increases in regulatory approvals in the biomaterials market, companies developing products with clear predicate devices and drugs now have clearer pathways to regulatory approval. Investment into these companies has potential faster timelines to revenue generating stages. However, regardless of predicate devices, technology evaluation remains important to ensure a successful regulatory pathway. 

2. Medical device designations expedite approvals: Breakthrough Device Designation can assist in a faster review process. Thus, devices that are fulfilling large unmet needs can be expedited to market faster. For example, Syntellix AG's MAGNEZIX CS 3.2 magnesium alloy screw has received such a designation due to its ability to degrade over time, eliminating the need for future removal. 

3. Expanded therapeutic applications offer first-in-class potential: With additional application areas continuing to grow in the biomaterials market, there exists potential for first-in-class products. For example, neurodegenerative diseases, such as Alzheimer's, impact a large population of adults each year, however, treatment options are largely palliative. Ongoing academic research is investigating potential biomaterial-based treatments, which if successful could capture a large share of the market and change patient lives. 

SWOT Analysis

Strengths 

1. Demonstrated efficacy in select applications: Current marketed products with widespread success pave the way for new products with further improved outcomes. 

• 23 Regenerative Medicines: Bone and Joint Applications, bccresearch.com (2023)

2. Clear market needs and patient populations: Several application areas have limited treatment options as of late with large patient populations that have potential to benefit from new therapies. 

Weaknesses 

1. Limited long term efficacy data: Recent treatments have yet to be evaluated for long term efficacy due to time constraints. Future evaluations will determine if products live up to their treatment timeline promises. 

2. Novel materials may require advanced evaluation: While advanced manufacturing techniques allow the development of new material combinations, new materials without predicate comparisons may require extended evaluations to ensure safety. 

Opportunities 

1. Novel application areas: Additional diseases foci and other market subsegments have potential for rapid expansion by using other more developed application areas as precedent. 

2. Potential for expedited regulatory process: Breakthrough device designation and select combination devices can be considered to expedited approval. 

Threats

1. High price points: Pricing must be optimized to allow buyers to consider biomaterial-based therapies as a valid opportunity that also benefits patients. 

2. Individual product failure may threaten future product successes: As previously seen with gene therapy treatments, any clear danger to patient wellbeing will dramatically impact all subsequent treatments within that focus area, regardless of relevance to the original product. It is critical that patient safety is the highest priority to maintain a positive outlook for biomaterial-based treatment. 

3. Manufacturing challenges: Following demonstration of healing efficacy, good manufacturing practices and platform scale up are necessary for commercialization. Clear pathways to commercialized scale are important to facilitate effective product launch and patient treatment. 

Key takeaways

1. Widespread applications for biomaterial-based therapies.

2. Potential for significant patient impact in first-in-class areas. 

3. Current product success in the regulatory process helps to set precedent for future candidates.

4. Continued academic advancement motivates market growth by enhancing novel treatment and manufacturing methods. 

Recommendations

1. Ensure safety and long term efficacy data is well investigated to mitigate future product issues. 

2. Early consideration of regulatory plans can help develop clear pathways to market. 

3. Partnerships with established pharma players may benefit small company development of novel products, particularly in the orthopedics space.