The hemostats market stands at the threshold of remarkable expansion, propelled by a dynamic interplay of innovative product formulations and escalating surgical demands across various medical fields. As healthcare systems worldwide grapple with an increasing volume of complex procedures, the need for effective bleeding control solutions is more critical than ever.
Chicago, Jan. 20, 2026 (GLOBE NEWSWIRE) — According to recent data from Astute Analytica, the global hemostats market was valued at US$ 2,884.13 million in 2024 and is projected to hit the market valuation of US$ 4,839.68 million by 2033 at a CAGR of 5.92% during the forecast period 2025–2033.
The global landscape is witnessing a notable increase in surgical interventions, fueled primarily by the rising prevalence of chronic conditions such as arthritis and cardiovascular diseases, alongside a sustained volume of trauma cases. These health challenges are driving more patients to undergo major surgeries, which inherently come with critical bleeding management needs. According to the World Health Organization, approximately 330 million major operations were performed worldwide in 2023, marking a significant rise of 9 million procedures compared to 2021. This upward trend underscores an expanding surgical workload and intensifies the demand for reliable, efficient hemostatic solutions.
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Each surgical procedure carries an inherent obligation to control bleeding effectively to ensure patient safety, reduce complications, and improve outcomes. As the volume of operations grows, clinicians are increasingly turning to topical and adjunctive hemostatic agents that can accelerate bleeding control and minimize operating times. These products not only help maintain surgical momentum but also reduce overall procedure duration, which is critical in complex cases where time is of the essence.
Rise of Hybrid Collagen-Chitosan Hemostats: Shaping the Future of Surgical Bleeding Control
Scientific and clinical preferences in the hemostats market are decisively shifting toward hybrid collagen-chitosan formulations, signaling a transformative shift in competitive dynamics. These composites combine the natural hemostatic properties of collagen with the antimicrobial and biocompatible benefits of chitosan, resulting in advanced matrices that enhance clot formation and tissue healing.
Between January 2023 and March 2024, Europe’s EUDAMED database recorded 11 new CE Mark approvals for collagen-chitosan composite hemostats, significantly outpacing the mere three approvals for oxidized cellulose products during the same period. This regulatory momentum illustrates strong market confidence in the efficacy and safety profiles of hybrid materials. Meanwhile, in the United States, the FDA cleared six hybrid hemostats within the same timeframe, with half of these receiving the prestigious Breakthrough Device designation.
Supporting this trend, ongoing clinical research is robust and expansive. ClinicalTrials.gov currently lists 14 active multicenter studies investigating collagen-chitosan matrices. These trials collectively enroll approximately 4,720 patients undergoing cardiothoracic, hepatic, and bariatric surgeries—procedures where effective hemostasis can significantly impact patient outcomes.
Topical Hemostats: The Cornerstone of Surgical Bleeding Control
The topical category reigns supreme in the hemostats market, commanding an impressive 85.46% market share thanks to its unmatched versatility and ease of use. These products integrate seamlessly into virtually every surgical workflow, whether open or minimally invasive, without requiring any additional hardware or complex setup. This simplicity makes topical hemostats the go-to solution for surgeons seeking rapid, effective bleeding control during critical moments.
According to data from the American College of Surgeons, 92% of level-1 trauma rooms now stock oxidized cellulose or gelatin sponges readily available on the Mayo stand. This widespread availability ensures that these hemostats are at the fingertips of surgical teams across an estimated 5.4 million emergent procedures annually in the United States alone. Their straightforward “tear-apply-compress” technique is a game changer—it reduces average application time to just 24 seconds, a full 41 seconds faster than more complex spray sealants.
Regulatory momentum further underscores the category’s dominance. Since 2020, the U.S. Food and Drug Administration (FDA) has cleared 36 distinct topical hemostat SKUs, each offering broad anatomical labeling that spans from liver resections to delicate plastic flap surgeries. This extensive product portfolio provides healthcare providers with a diverse range of options tailored to specific clinical needs.
Regulatory Shifts: Balancing Stricter Standards with Accelerated Pathways in Hemostat Approvals
Regulatory agencies worldwide are tightening evidentiary standards for hemostatic products, demanding more robust clinical data to ensure safety and efficacy. At the same time, they are laying the groundwork for accelerated clearances when clear clinical needs are demonstrated, creating a dual landscape of heightened scrutiny paired with streamlined pathways. In the United States, the Food and Drug Administration (FDA) approved eight new topical hemostatic products through the 510(k) clearance process in 2023. Notably, three of these products benefited from the FDA’s Safer Technologies Program (STeP), which is designed to expedite review for innovative devices with evident clinical advantages.
In contrast, Europe’s regulatory environment presents a more challenging scenario under the Medical Device Regulation (MDR). Capacity constraints among notified bodies have led to substantial delays in device recertification processes. For example, oxidized cellulose sheets that previously secured recertification within 90 days now face wait times approaching 340 days. These extended queues create bottlenecks that slow product availability and complicate supply chain planning across European markets.
This divergence between the U.S. and Europe forces global strategists in the hemostats market to adopt nuanced regulatory and commercial approaches. Companies must carefully stagger product launches to align with regional approval timelines and build inventory buffers to mitigate supply disruptions. Balancing these differing regulatory landscapes requires agility and foresight, as manufacturers strive to meet evolving compliance demands while capitalizing on opportunities for accelerated access in priority markets.
Matrices and Gels: The Rising Stars of Hemostat Formulations
Matrices and gels are leading the charge in hemostat formulation revenue, commanding a significant 34.26% market share in 2024. Their popularity stems from an ideal blend of practical handling and superior anatomical adaptability, combining the ease-of-use typically associated with topical agents and the fluid coverage advantages of liquid formulations. This unique combination makes them particularly suited to complex surgical fields where bleeding arises from irregular cavities or delicate, friable tissues such as parenchyma.
Clinical data highlights the growing preference for these flowable matrices in demanding procedures. According to Premier Inc., 48% of hepatic resections and a remarkable 61% of complex spine surgeries employed flowable matrix hemostats in 2024. This contrasts sharply with powdered formulations, which were used in only 19% of such cases. Surgeons clearly favor materials that can conform precisely to challenging anatomical structures—such as undermined bone surfaces or interlaminar gaps—where traditional powders often fall short.
Innovative research at the Mayo Clinic is shedding light on the rheological properties that make matrices and gels so effective. Based on their experimental work with chitosan-gelatin blends, they found that the yield stress is 16 pascals, an optimal balance that allows the material to stay firmly affixed to vertical bone surfaces while remaining sufficiently flexible to be easily extruded through narrow 10-Fr applicators used in arthroscopic procedures.
North America’s Hemostat Market: A Powerhouse Fueled by Surgical Volume and Innovation
North America commands roughly 40% of the global hemostat market revenue, with about 80% of this share originating from the United States alone. The country’s dominance is underscored by staggering surgical activity; according to the American Hospital Association, the U.S. recorded just under 210 million surgical encounters in 2024—surpassing the combined totals of the next three largest regions.
Data from Premier Inc.’s national utilization dashboard reveals that U.S. hospitals consumed 68 million units of topical or flowable hemostats between January and August 2024, already surpassing the total usage for the entire year of 2021. This sharp increase highlights an accelerating shift toward advanced hemostatic agents in clinical practice. Regulatory momentum is also propelling market growth; the U.S. Food and Drug Administration (FDA) has cleared 14 adjunctive hemostatic products since January 2023 alone.
Reimbursement policies add another powerful dimension to this market’s expansion. The introduction of HCPCS code A4672, which reimburses mechanically activated flowable hemostats at USD 114 per 10 mL, has created an immediate revenue opportunity for healthcare providers. Approximately 960 accredited ambulatory surgery centers adopted this code during first-quarter audits, benefiting from improved margins and incentivizing broader adoption of next-generation hemostats.
Top Players in the Hemostats Market
- B.Braun Melsungen AG
- Baxter International Inc.
- Becton Dickinson and Co.
- Gelita Medical GmbH
- Hemostatis LLC
- Integra Life Sciences Holding Corp.
- Johnson and Johnson
- Medtronic PLC
- Pfizer Inc.
- Stryker Corp.
- Teleflex Inc.
- Other Prominent Players
Market Segmentation Overview:
By Type
- Topical Hemostats
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- Mechanical Hemostats
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- ORC Based
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- Gelatin Based
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- Collagen Based
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- Polysaccharide-Based Topical Hemostats
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- Active Hemostats
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- Flowable Hemostats
- Topical Thrombin-Based Topical Hemostats
- Others
By Formulation
- Sheet and Pad Hemostats
- Sponge Hemostats
- Powder Hemostats
- Matrix and Gel Hemostats
- Others
By Application
- Orthopedic Surgery
- General Surgery
- Neurological Surgery
- Cardiovascular Surgery
- Reconstructive Surgery
- Gynecological Surgery
- Others
By End User
- Hospitals
- Ambulatory Surgical Centers
- Home Care
- Others
By Distribution Channel
- Online
- Offline
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- Direct
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- Distributor
By Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- South America
For more information about this report visit: https://www.astuteanalytica.com/industry-report/hemostats-market
About Astute Analytica
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CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@astuteanalytica.com Website: https://www.astuteanalytica.com/
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