United States Biosurgery Market Overview, 2031

Key Insights
• The United States biosurgery market represents the largest and most sophisticated national market for surgical biomaterials globally. Valued at approximately USD 6.86 billion in 2025, the U.S. market accounts for an estimated 87.61% of the North American biosurgery market and serves as the primary revenue driver for virtually every major global biosurgery manufacturer. The market encompasses a broad range of biologically derived and bio-compatible materials including hemostatic agents, surgical sealants and adhesives, bone-graft substitutes, adhesion barriers, soft-tissue attachments, and staple-line reinforcement products that assist in surgical procedures by controlling bleeding, sealing tissues, promoting regeneration, and preventing postoperative complications.
• The U.S. biosurgery market is distinguished by its depth of clinical adoption, robust reimbursement infrastructure, high healthcare expenditure, and the presence of the world's most advanced surgical ecosystem. With tens of millions of surgical procedures performed annually across inpatient hospitals, ambulatory surgical centers (ASCs), and specialty clinics, the demand for biosurgical products is both broad-based and deeply integrated into standard surgical practice. The market is shaped by a complex interplay of demographic trends, disease burden, technological innovation, regulatory frameworks, and evolving healthcare delivery models that are redefining how and where surgical care is delivered.
• Hemostatic agents represent the major product category within the U.S. biosurgery market, driven by their ubiquitous application across all surgical specialties from routine general surgery to complex cardiovascular and trauma procedures. The widespread use of anticoagulant therapies in the aging U.S. population has further intensified demand for advanced bleeding control solutions.Bone-graft substitutes constitute a major market pillar, with revenue driven by the high volume of spinal fusion procedures, joint replacements, and orthopedic trauma surgeries performed annually in the U.S. The aging population and rising obesity rates continue to fuel demand for musculoskeletal interventions.
• The regulatory environment, centered on the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), plays a decisive role in shaping market dynamics. FDA clearances and approvals determine product availability, while CMS reimbursement policies directly influence adoption rates across hospital and ambulatory settings.The U.S. market is experiencing a structural shift toward ambulatory surgical centers (ASCs) and outpatient settings, driven by cost-containment pressures, technological advancements enabling less invasive procedures, and CMS payment policies that increasingly favor lower-cost care sites. This shift is reshaping product portfolios and distribution strategies for biosurgery manufacturers.

Market Outlook
• According to the Bonafide research report, "USA Biosurgery market Outlook, 2031,” published by Bonafide Research, the U.S. Biosurgery Market is anticipated to add to more than 9248 Million by 2031. supported by favorable demographic trends, ongoing technological innovation, and expanding surgical volumes across both inpatient and outpatient settings. The market's growth trajectory is intrinsically linked to the broader U.S. healthcare landscape, including Medicare reimbursement policies, hospital capital investment cycles, and the pace of adoption of minimally invasive surgical technologies.
• The aging U.S. population represents the most significant long-term demand driver. In the U.S., over a million total joint arthroplasties are performed annually, including more than 540,000 total hip arthroplasties and over 1 million total knee arthroplasties. Additionally, more than 400,000 spinal fusion procedures are performed each year, including over 340,000 interbody fusions. As the cohort of Americans aged 65 and older continues to expand, the incidence of degenerative joint diseases, spinal disorders, cardiovascular conditions, and cancers all of which require surgical intervention will rise correspondingly, driving sustained demand for biosurgical products across all major product categories.
• Technological innovation in biomaterials and surgical delivery systems is expanding the addressable market. The FDA has granted approval for ETHICON™ OMNEX™ Surgical Sealant, the first synthetic sealant designed to achieve adjunctive hemostasis in vascular reconstructions by mechanically sealing areas of leakage. Johnson & Johnson MedTech also received FDA approval for its ETHIZIA hemostatic sealing patch designed for challenging surgical bleeding control. These next-generation products with faster action times, enhanced wet-tissue adhesion, and bioactive capabilities are creating new clinical applications and premium-pricing opportunities.
• The shift toward value-based care is simultaneously creating both opportunities and challenges. The ASC market in the U.S. is projected at $45.6 billion in late 2025, with ASC Data's Q4 2025 Insights Report tracking 10,494 ASCs across the nation. As of Q2 2025, there are 12,294 total ASCs operating nationwide, including 6,504 Medicare-certified facilities. While hospitals and ASCs face pressure to reduce costs, the use of biosurgical products that reduce complication rates, shorten hospital stays, and prevent readmissions aligns with value-based incentives, supporting continued adoption of premium products with demonstrated clinical and economic benefits.

Market Dynamics
Driver: High and Growing Surgical Volumes Across All Specialties
The United States performs tens of millions of surgical procedures annually, spanning inpatient hospital settings, ambulatory surgical centers, and outpatient clinics. This immense surgical volume creates a persistent and expanding demand for biosurgical products across all major categories. Joint replacement remains the biggest money-making segment in orthopedics, with worldwide sales in 2025 of nearly $24 billion. The breadth and depth of surgical activity in the U.S. ensure that biosurgical products particularly hemostatic agents and sealants are utilized in virtually every operating room, making the U.S. market the foundational revenue base for global biosurgery manufacturers. The continued expansion of surgical capacity, driven by new hospital construction, ASC development, and workforce growth, further reinforces this demand driver. Procedure volumes at ASCs are forecast to climb 21% during the 2025–2035 window, and the number of spine procedures performed in the U.S. has reached more than 259,869 since 2015, according to the 2025 American Spine Registry.
Challenge: Pricing Pressure and Cost-Containment Initiatives
Despite the market's size and sophistication, biosurgery manufacturers face persistent pricing pressure from hospital procurement organizations, group purchasing organizations (GPOs), and government payers. The Centers for Medicare & Medicaid Services (CMS) has implemented various cost-containment measures, including payment adjustments for outpatient and ASC settings. For CY 2025, CMS increased payment rates under the Hospital Outpatient Prospective Payment System (OPPS) and the ASC Payment System by 2.9%. However, CMS finalized updates to the ASC covered procedures list by adding 21 medical and dental surgical procedures to the list. The financial pressures on surgical practices, combined with decreasing federal reimbursement for surgical work, create a challenging environment for both surgeons and device manufacturers. Manufacturers must continually demonstrate the clinical and economic value of their products to justify premium pricing in an increasingly cost-conscious healthcare system. Additionally, small hospitals and ambulatory surgical centers may find it challenging to consistently adopt advanced biosurgical solutions due to limited financial resources.
Trend: Accelerating Shift to Ambulatory Surgical Centers and Outpatient Settings
The U.S. biosurgery market is undergoing a fundamental structural transformation as surgical care continues its long-term migration from inpatient hospitals to ambulatory surgical centers (ASCs) and outpatient settings. CMS released the calendar year 2025 final rule for Medicare's hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system (CMS-1809-FC) on November 1, 2024. This shift is driven by multiple factors: technological advances enabling more complex procedures to be performed safely in outpatient settings, patient preference for convenience and lower out-of-pocket costs, and payer initiatives to reduce healthcare expenditure by steering care to lower-cost sites. Of note for ambulatory surgery centers, new data revealed how spinal surgeries increased nearly 8% annually from 2021 through 2024. From 2018 through 2024, nearly 900,000 outpatient spinal procedures were performed in ASCs in the United States. The migration of surgical procedures from hospitals to ambulatory surgery centers continues to accelerate, with colonoscopy and esophagogastroduodenoscopy among the top procedures moving out of hospitals and into ASCs. For biosurgery manufacturers, this trend requires adaptation of product portfolios developing formulations and delivery systems optimized for the fast-paced, high-throughput ASC environment and adjustment of commercial strategies to target the growing ASC customer base.

Policies
• The FDA regulates biosurgical products through 510(k) premarket notification, Premarket Approval (PMA), and De Novo pathways. In 2025, the FDA cleared FIBERGRAFT™ BG Putty GPS bone-graft substitute (K253147), demonstrating ongoing regulatory support for product innovation in this space.
• The CMS plays a pivotal role through its payment policies. The CY 2025 final rule for OPPS and ASC payment systems (CMS-1809-FC) outlines Medicare payment rates for hospital outpatient and ASC services, directly influencing the financial viability of biosurgical product utilization.
• The FDA's approval of expanded indications continues to broaden the addressable market. TISSEEL fibrin sealant is indicated as an adjunct to hemostasis and to prevent leakage from colonic anastomoses, enabling manufacturers to capture additional clinical applications and revenue streams.
• Regulatory oversight of hemostatic products includes regulation of fibrin sealants, thrombin, and other adjuncts to hemostasis. The FDA maintains a comprehensive regulatory framework ensuring rigorous safety and efficacy standards before products reach the U.S. market.
• FDA oversight of surgical sealants includes polymerizing sealants classified as Class III requiring Premarket Approval (PMA) due to significant risks associated with internal use. BD's Progel™ is the only sealant FDA approved and clinically proven to seal air leaks in thoracic surgery.
• Recent FDA approvals for bone graft substitutes have expanded treatment options. The FDA cleared magnesium-based bone graft substitutes from Bone Solutions for pediatric use in patients 6 years and older, designed to treat bone voids or defects resulting from trauma, tumors or cysts.
• The FDA's accelerated 510(k) pathways for absorbable biological materials have facilitated market access for innovative biosurgical products, reducing time-to-market and supporting continued investment in next-generation biomaterials.

Segment Analysis
United States Biosurgery Market By Product • Hemostatic Agents represent the major market segment, reflecting their essential role across all surgical disciplines. These products including topical hemostats, flowable matrices, fibrin sealants, and thrombin-based agents are utilized in virtually every surgical procedure to control intraoperative bleeding. The widespread use of anticoagulant therapies in the aging U.S. population has intensified demand for advanced hemostatic solutions.
• Bone-Graft Substitutes constitute a major market segment, driven by the high volume of spinal fusion procedures, joint replacements, and orthopedic trauma surgeries. These products include demineralized bone matrix (DBM), synthetic bone grafts, and biologic grafts incorporating growth factors. The FDA's clearance of novel bone-graft substitutes demonstrates ongoing innovation in this category.
• Surgical Sealants and Adhesives represent a dynamic and rapidly evolving product category, driven by increasing adoption of minimally invasive and robotic surgical techniques. These products including fibrin sealants, synthetic polymer-based sealants, and protein-based adhesives are used to seal tissue surfaces, prevent fluid and air leaks, and reinforce surgical anastomoses.
• Staple-Line Reinforcement products are utilized in gastrointestinal, bariatric, and thoracic procedures to strengthen tissue interfaces along surgical staple lines, reducing the risk of bleeding and leakage. The rising prevalence of obesity in the U.S. population has driven significant growth in bariatric surgery volumes, directly benefiting this product category.
• Soft-Tissue Attachments encompass products used to reinforce, repair, or secure soft tissues, including surgical meshes, biologic scaffolds, and tissue grafts. These products are utilized in hernia repair, pelvic floor reconstruction, breast reconstruction, and various other soft-tissue procedures, supported by high procedure volumes and favorable demographics.
• Adhesion Barriers represent a clinically important product category used to prevent postoperative adhesion formation in abdominal, pelvic, and gynecological surgeries. While the shift toward minimally invasive surgery has reduced adhesion formation incidence, the category continues to benefit from ongoing product innovation and clinical evidence supporting adhesion prevention.



United States Biosurgery Market By Application • Orthopedic Surgery is the largest application area for biosurgical products in the U.S., driven by the high volume of spinal fusion procedures, total joint replacements, and orthopedic trauma surgeries. Bone-graft substitutes are the primary biosurgical products utilized, supplemented by hemostatic agents and soft-tissue attachments.
• General Surgery encompasses abdominal, gastrointestinal, and soft-tissue procedures including bariatric surgery, colorectal surgery, and hernia repair. Biosurgical products utilized include hemostatic agents, surgical sealants, staple-line reinforcement products, and adhesion barriers, ensuring consistent demand across all product categories.
• Neurological Surgery utilizes biosurgical products particularly hemostatic agents and dural sealants to manage bleeding and prevent cerebrospinal fluid leaks in cranial and spinal procedures. The FDA has issued warnings regarding shortages of neurosurgical sponges, highlighting the critical importance of these products.
• Cardiovascular Surgery represents a high-value application area for biosurgical products, including vascular sealants, hemostatic agents, and soft-tissue attachments. TISSEEL and COSEAL are indicated for use in cardiovascular surgeries, and the high prevalence of cardiovascular disease supports sustained demand.
• Reconstructive Surgery involves the use of biosurgical products to restore, repair, or reconstruct damaged or surgically altered tissues. Applications include soft-tissue repair, tissue reinforcement, wound reconstruction, and restoration of anatomical structures following injury, disease, or surgery.
• Gynecological Surgery includes biosurgical applications in procedures involving the female reproductive system. Products are used for hemostasis, tissue sealing, adhesion prevention, tissue repair, and reinforcement in hysterectomies and other gynecological interventions.
• Urological Surgery covers biosurgical applications in procedures involving the urinary tract and male reproductive system. Products are used for bleeding control, tissue sealing, reinforcement, repair, and prevention of postoperative complications.
• Thoracic and Other Surgeries represent a growing application area, driven by increasing adoption of video-assisted thoracoscopic surgery (VATS) and the rising lung cancer burden. Progel™ Pleural Air Leak Sealant is FDA approved for sealing air leaks in thoracic surgery.

United States Biosurgery Market By Source/Origin • Biologic products derived from human, animal, or microbial sources have traditionally dominated the U.S. market due to their superior biocompatibility and natural healing properties. These products include demineralized bone matrix, fibrin sealants, collagen hemostats, allografts, and xenografts, supported by strong reimbursement and surgeon preference.
• Synthetic and Semi-Synthetic products are gaining share rapidly due to cost-effectiveness, consistent quality, lower immunogenicity risks, and longer shelf life. These products include synthetic bone substitutes, PEG-based sealants, synthetic meshes, and polysaccharide hemostats. FDA clearances for synthetic bone graft substitutes demonstrate growing acceptance.

United States Biosurgery Market By End-User • Hospitals remain the largest end-user segment for biosurgical products in the U.S., accounting for the majority of revenue. Hospitals utilize more than 70% of biosurgery products compared to ambulatory surgical centers and specialty clinics. The concentration of complex surgical procedures and availability of specialized surgical teams make hospitals the primary setting for biosurgical product utilization.
• Ambulatory Surgical Centers (ASCs) represent the fastest-growing end-user segment, reflecting the broader healthcare industry shift toward outpatient and same-day discharge models. As of Q2 2025, there are 12,294 total ASCs operating nationwide, including 6,504 Medicare-certified facilities. Procedure volumes at ASCs are forecast to climb 21% during the 2025–2035 window.
• Clinics represent a smaller but growing end-user segment, with specialty clinics performing eligible surgical or minimally invasive procedures utilizing biosurgical products for tissue repair, bleeding control, and sealing. The expansion of outpatient care networks in urban and semi-urban areas supports clinic-based procedure growth.

United States Biosurgery Market Economics

• The U.S. biosurgery market operates within a complex economic environment characterized by high healthcare expenditure, sophisticated procurement systems, and evolving reimbursement mechanisms. Understanding the economic drivers of the market is essential for manufacturers seeking to optimize their commercial strategies.
• Pricing and Reimbursement: Biosurgical products in the U.S. command premium prices compared to other global markets, reflecting the country's high healthcare expenditure and willingness to pay for advanced technologies. Observed public price anchors for noninvasive surgical wound closure range from $12.50 (3M Steri-Strip, 50-unit box) to $250 (Baxter TISSEEL fibrin sealant kit). However, manufacturers face increasing pricing pressure from hospital procurement organizations, Group Purchasing Organizations (GPOs), and government payers. CMS reimbursement policies play a decisive role in determining product adoption, as hospitals and surgeons are more likely to utilize products that are separately reimbursed or that contribute to favorable episode-of-care economics. For CY 2025, CMS increased payment rates under the Hospital Outpatient Prospective Payment System (OPPS) and the ASC Payment System by 2.9%. CMS finalized updates to the ASC covered procedures list by adding 21 medical and dental surgical procedures.
• Procurement and Supply Chain: Biosurgical products are procured through a combination of GPO contracts, hospital system-level agreements, and individual surgeon preference. The consolidation of hospital systems and the increasing influence of GPOs have intensified pricing competition, particularly for commoditized products such as standard hemostatic agents. Manufacturers must navigate complex procurement processes, demonstrating both clinical value and economic benefit to secure favorable contract positions. The U.S. supply chain for biosurgical products is sophisticated and well-developed, with major manufacturers maintaining extensive distribution networks to ensure timely product availability across the country's thousands of hospitals, ASCs, and clinics.
• Manufacturing and Investment: Major biosurgery manufacturers maintain significant manufacturing operations within the United States, benefiting from the country's skilled workforce, advanced manufacturing infrastructure, and favorable intellectual property protections. Investment in U.S. manufacturing capacity is supported by the country's large and stable market, which provides a reliable revenue base to justify capital expenditure. Recent years have seen continued investment in manufacturing automation, quality systems, and capacity expansion to meet growing demand.


Considered in this report
• Historic Year: 2020
• Base year: 2025
• Estimated year: 2026
• Forecast year: 2031

Aspects covered in this report
• Biosurgery Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product
• Bone-Graft Substitutes
• Hemostatic Agents
• Surgical Sealants & Adhesives
• Adhesion Barriers
• Soft-Tissue Attachments
• Staple-Line Reinforcement

By Application:
• Orthopedic Surgery
• General Surgery
• Neurological Surgery
• Cardiovascular Surgery
• Reconstructive Surgery
• Gynecological Surgery
• Urological Surgery
• Other surgeries (Thoracic surgeries & more)

By Source/Origin
• Biologic
• Synthetic / Semi-synthetic

By End-user:
• Hospitals
• Ambulatory Surgical Centers
• Clinics
• Others"