지혈제 시장은 전 세계 외과수술의 속도와 밀접하게 연관되어 있으며, 이는 수술시 효과적인 출혈 조절에 대한 수요 증가를 반영하고 있습니다. 2024년 시장 규모는 약 28억 8,413만 달러로, 앞으로도 안정적으로 성장하며, 2033년까지 48억 3,968만 달러에 달할 것으로 예측됩니다.이 성장률은 2025-2033년 CAGR 5.92%입니다. 이러한 확장의 주요 촉진요인 중 하나는 복강경 수술이나 로봇 수술과 같은 최소침습 수술 기법의 채택이 증가하고 있다는 점입니다.
지역별로는 북미가 의료 인프라가 잘 구축되어 있고 수술 건수가 많은 북미가 지혈제 소비량에서 시장을 주도하고 있습니다. 그러나 아시아태평양은 특히 중국이나 인도와 같이 인구가 많은 국가에서 정부 지원 외상 네트워크에 대한 막대한 투자와 복강경 수술의 급증에 힘입어 빠르게 자리를 잡아가고 있습니다. 이러한 성장은 아시아태평양의 수술 증가와 의료 접근성 확대를 활용하고자 하는 지혈제 제조업체들에게 중요한 성장 동력으로 부상하고 있으며, 시장 역학의 변화를 시사하고 있습니다.
지혈제 시장은 Johnson & Johnson, Baxter International, Pfizer Inc., B. Braun SE, Becton, Dickinson and Company(BD) 등의 주요 기업이 촉진하고 있습니다. 이들 업계 선두주자들은 강력한 세계 입지를 자랑하며, 활발한 연구개발, 전략적 제휴, 지속적인 제품 혁신을 통해 시장 지위 향상에 전념하고 있습니다.
박스터 인터내셔널은 차세대 지혈 솔루션 개발에 전념하는 50명의 과학자들로 구성된 Applied Hemostasis laboratory를 통해 이러한 혁신 주도적 접근 방식을 구현하고 있습니다. 2023년에만 42건의 특허를 출원했으며, 전단감점젤라틴, 동결보호 트롬빈 복합제 등 첨단 소재에 집중하고 있습니다. 이러한 혁신은 지혈제의 효과와 용도의 다양성을 향상시키고 최신 수술의 미묘한 요구를 충족시키기 위한 것입니다.
한편, BD는 인수를 통해 전략적으로 포트폴리오를 확장하고 있으며, 티슈메드(Tissuemed)를 2억 1,400만 달러에 인수한 것이 그 예입니다. 이번 인수로 BD는 Tissuemed의 초박형 폴리에틸렌 글리콜 패치 기술을 활용할 수 있게 되어 제품의 폭을 넓히고 보다 전문적이고 효과적인 지혈제를 시장에 제공할 수 있게 되었습니다. 이러한 움직임은 혁신적인 제품에 대한 집중적인 투자를 통해 그 입지를 강화하겠다는 BD의 의지를 보여줍니다.
주요 성장 촉진요인
최소침습수술(MIS)의 급증은 지혈제 시장 확대를 견인하는 가장 강력한 요인으로 부각되고 있습니다. International Society for Minimally Invasive Surgery에 따르면 2024년 전 세계에서 약 1억 8천만 건의 복강경 수술, 로봇 수술, 내시경 수술이 시행될 것으로 예측됩니다. 이는 2022년 대비 약 1,100만 건이 증가한 것으로, 다양한 수술 분야에서 MIS 기술 도입이 가속화되고 있음을 보여줍니다.
지혈제는 현재 최소침습수술 3건 중 1건 꼴로 사용되고 있으며, 2024년에는 약 3,600만 쌍이 사용될 것으로 예측됩니다. 이러한 광범위한 통합은 지혈제가 안전하고 효율적인 MIS 수술을 가능하게 하는 데 중요한 역할을 하고 있음을 강조합니다. 저침습적 기술의 지속적인 확장으로 지혈제 제품에 대한 수요가 지속적으로 증가하면서 지혈제 시장의 혁신과 성장이 더욱 가속화될 것으로 예측됩니다.
새로운 기회의 동향
콜라겐과 키토산 하이브리드 지혈제에 대한 과학적 관심이 점점 더 높아지고 있으며, 이러한 추세는 지혈제 시장의 경쟁 역학에 큰 변화를 가져오고 있습니다. 이 하이브리드 제제는 콜라겐의 유익한 특성과 키토산의 고유한 특성을 결합하여 지혈 성능 향상과 조직 적합성 향상을 가져옵니다. 2023년 1월부터 2024년 3월까지 유럽 의료기기 데이터베이스(European Database on Medical Devices, EUDAMED)는 콜라겐-키토산 복합 제품에 대해 11건의 신규 CE 마크 승인을 기록했으며, 같은 기간 중 산화셀룰로오스 기반 지혈제는 단 3건만 승인된 것과는 대조적입니다. 대조적입니다.
세계의 지혈제 시장에 대해 조사분석했으며, 각 부문 시장 규모와 예측, 시장 역학과 동향, 기업 개요 등을 제공하고 있습니다.
The hemostats market is closely tied to the pace of surgical activity worldwide, reflecting the growing demand for effective bleeding control in an expanding range of procedures. In 2024, the market is valued at approximately US$ 2,884.13 million and is forecasted to grow steadily, reaching an estimated valuation of US$ 4,839.68 million by 2033. This growth corresponds to a compound annual growth rate (CAGR) of 5.92% between 2025 and 2033. One of the key drivers behind this expansion is the increasing adoption of minimally invasive surgical techniques, such as laparoscopic and robotic surgeries.
Regionally, North America continues to dominate the hemostats market in terms of procedural consumption, benefiting from a well-established healthcare infrastructure and high surgical volumes. However, the Asia-Pacific region is rapidly gaining ground, propelled by significant investments in government-funded trauma networks and a surge in laparoscopic surgeries, especially in populous countries like China and India. This growth signals a shift in market dynamics as Asia-Pacific emerges as a vital growth engine for hemostatic product manufacturers seeking to capitalize on increasing surgical activities and expanding healthcare access in the region.
The hemostats market is led by several prominent companies, including Johnson & Johnson, Baxter International, Pfizer Inc., B. Braun SE, and Becton, Dickinson and Company (BD). These industry giants boast a strong global footprint and remain deeply committed to advancing their market positions through vigorous research and development efforts, strategic partnerships, and continuous product innovation.
Baxter International exemplifies this innovation-driven approach with its Applied Hemostasis laboratory, staffed by a team of 50 scientists dedicated to developing next-generation hemostatic solutions. In 2023 alone, this lab filed 42 patent families, focusing on advanced materials such as shear-thinning gelatin and lyoprotected thrombin combinations. These innovations aim to improve the efficacy and application versatility of hemostats, addressing the nuanced needs of modern surgical procedures.
Meanwhile, BD has strategically expanded its portfolio through acquisitions, exemplified by its purchase of Tissuemed for $214 million. This acquisition granted BD access to Tissuemed's ultra-thin polyethylene glycol patch technology, enhancing its product breadth and enabling it to offer more specialized and effective hemostatic options to the market. Such moves demonstrate BD's commitment to strengthening its position through targeted investments in innovative products.
Core Growth Drivers
The rapid growth in minimally invasive surgery (MIS) volumes stands out as the most powerful driver fueling expansion in the hemostats market. According to the International Society for Minimally Invasive Surgery, approximately 108 million laparoscopic, robotic, and endoscopic procedures are expected to be performed globally in 2024. This represents an increase of about 11 million cases compared to 2022, highlighting the accelerating adoption of MIS techniques across a wide range of surgical specialties.
Hemostatic agents are now deployed in roughly one out of every three minimally invasive surgeries, translating to nearly 36 million units utilized in 2024 alone. This widespread integration underscores the vital role hemostats play in enabling safe and efficient MIS procedures. The continued expansion of minimally invasive techniques is expected to sustain strong demand for hemostatic products, further driving innovation and growth within the market
Emerging Opportunity Trends
Scientific interest is increasingly shifting toward hybrid collagen-chitosan hemostats, a trend that is significantly reshaping the competitive dynamics within the hemostats market. These hybrid formulations combine the beneficial properties of collagen with the unique features of chitosan, offering enhanced hemostatic performance and improved tissue compatibility. Between January 2023 and March 2024, the European Database on Medical Devices (EUDAMED) recorded 11 new CE Mark approvals for collagen-chitosan composite products, a stark contrast to the mere three approvals granted for oxidized cellulose-based hemostats during the same period.
In the United States, the Food and Drug Administration (FDA) cleared six collagen-chitosan hybrid hemostats within the same timeframe. Notably, half of these products received Breakthrough Device designation, underscoring their innovative nature and clinical promise. These designations were largely based on rapid clot formation benchmarks demonstrated through preclinical testing, where bleeding times were reduced to under 20 seconds in porcine liver models.
Barriers to Optimization
Rising raw-material prices are significantly impacting profitability within the bovine-collagen-based biosurgicals segment, posing a substantial challenge to the hemostats market in 2024. According to data from the U.S. Department of Agriculture, the cost of medical-grade bovine tendon collagen surged to $19.40 per kilogram in April 2024, up sharply from $13.00 per kilogram in 2022. Although the amount of purified collagen used in each absorbable patch averages just 1.9 grams, this increase translates to a material cost of approximately $0.037 per unit.
Baxter's most recent 10-K filing highlights the financial strain caused by these raw material price hikes, reporting a $94 million year-over-year increase in biomaterial expenditures, driven predominantly by rising bovine collagen costs. This surge has compressed gross margins by roughly $6 per device, a notable figure that directly affects profitability. To counterbalance these increased costs, manufacturers have implemented price adjustments at the SKU level, with hospital group purchasing organization (GPO) catalogs reflecting average price hikes of around $9 per unit.
By Type, the topical category occupies a dominant position in the hemostats market, commanding over 85.46% of the total market share. This prominence is largely attributed to the versatility and convenience that topical hemostatic agents offer across a broad spectrum of surgical workflows. Unlike some hemostatic products that require specialized equipment or ancillary hardware, topical agents can be applied directly to the bleeding site with minimal preparation, making them highly compatible with both open surgeries and minimally invasive procedures.
By formulation, matrices and gels dominate the hemostats market in terms of formulation revenue, accounting for 34.26% of the total market share. Their popularity stems from their unique ability to combine the ease of handling typically associated with topical agents with the flexibility and adaptability of liquids. This hybrid quality makes them particularly well-suited for controlling bleeding in complex surgical fields where blood loss often originates from irregular cavities or delicate, friable parenchymal tissue.
Based on application, orthopedic surgery represents a significant segment of the hemostats market, capturing more than 30.26% of the total market share based on application. This prominence is largely due to the nature of orthopedic procedures, which tend to generate some of the heaviest routine blood loss among elective surgical specialties. As a result, orthopedic theaters are among the most intensive users of hemostatic products, relying heavily on these adjuncts to manage bleeding effectively during complex joint, spine, and trauma fixation surgeries.
By End Users, hospitals hold a commanding position in the hemostats market, capturing over 56.20% of the total market share. This dominance is primarily due to their responsibility for managing the highest acuity cases, which require a broad range of surgical consumables, including hemostatic products. Hospitals also exercise significant control over procurement formularies, enabling them to standardize and streamline the acquisition of essential items to meet the demands of complex surgical procedures.
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