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시장보고서
상품코드
2149231
생체 외과용 의료기기 시장 규모, 점유율, 성장, 세계 산업 분석, 지역별 인사이트 및 예측(2026-2034년)Biosurgery Devices Market Size, Share, Growth and Global Industry Analysis, Regional Insights and Forecast to 2026-2034 |
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세계 생체 외과용 의료기기 시장 규모는 2025년에 115억 1,000만 달러로 평가되며, 2026년 121억 8,000만 달러에서 2034년에는 199억 9,000만 달러로 성장하여, 2026년부터 2034년까지 연평균 성장률(CAGR) 6.4%를 기록할 것으로 예측됩니다. 북미는 수술 건수 증가, 고령화, 선진적인 의료 인프라, 그리고 혁신적인 바이오 외과 기술의 도입에 힘입어 2025년에는 45.7%의 점유율로 세계 시장을 선도했습니다.
바이오 외과용 의료기기에는 지혈제, 외과용 실란트 및 접착제, 골이식 대체재, 유착 방지 제품, 그리고 수술 중 및 수술 후에 사용되는 기타 제품이 포함됩니다. 이러한 의료기기는 출혈 억제, 상처 봉합, 조직 복구 및 수술 결과 개선에 도움이 됩니다. 수술 건수의 증가, 회복 기간 단축에 대한 수요, 기술 발전, 그리고 신제품 출시 증가가 시장 확대를 뒷받침하고 있습니다.
연도별 시장 규모 및 시장 가치
시장의 정의 및 범위
생체 외과용 기기 시장은 지혈, 조직 밀봉, 상처 봉합, 조직 복원, 유착 방지 및 골 재생에 사용되는 제품을 대상으로 합니다. 이 시장은 제품 유형, 소재, 용도 및 최종사용자별로 세분화되어 있으며, 정형외과, 심혈관, 신경, 산부인과 및 기타 외과 수술 분야에서 폭넓게 활용되고 있습니다.
시장 역학
시장 촉진요인 : 전 세계적으로 수술 건수가 증가하고 있는 것이 주요 촉진요인입니다. 암, 심혈관질환, 외상, 비만 및 정형외과 질환에 대한 수술 건수가 증가함에 따라 지혈제, 실란트, 조직 복원 제품 및 기타 생체의학 수술 솔루션에 대한 수요가 높아지고 있습니다. 수술 결과 개선과 회복 기간 단축이 중요시되고 있는 점도 도입을 더욱 촉진하고 있습니다.
시장 제약요인 : 엄격한 규제 요건으로 인해 제품 승인 및 시장 진입이 지연될 가능성이 있습니다. 바이오 외과 제품은 혈액, 조직 또는 장기와 직접 접촉하기 때문에 많은 경우 광범위한 안전성 시험 및 임상시험이 필요합니다. 이러한 요건은 특히 중소 규모 제조업체의 경우 개발 비용 증가로 이어질 수 있습니다.
시장 기회 : 최소침습 수술 및 당일 퇴원 수술에 대한 선호도가 높아짐에 따라, 복강경 수술, 로봇 수술, 내시경 수술용으로 설계된 바이오 수술 제품에 새로운 기회가 창출되고 있습니다. 신속한 봉합 및 지혈을 실현하는 제품은 수술 시간 단축과 환자의 조기 퇴원을 가능하게 합니다.
시장 동향 : 흡수성이 있고 생체 친화성이 높은 소재의 사용이 증가하고 있는 것이 중요한 트렌드입니다. 장기적인 잔류물을 줄이고 인체 조직과의 적합성을 향상시키기 위해 새로운 지혈제, 실란트, 패치 및 이식 재료가 개발되고 있습니다.
시장의 과제 : 보관 및 취급에 관한 요건이 도입을 저해하는 경우가 있습니다. 일부 실란트, 패치, 지혈 제품은 냉장 보관, 조제, 혼합, 활성화 또는 특정 시간 내 사용이 필요하며, 바쁜 수술 현장에서는 업무 흐름을 복잡하게 만들 수 있습니다.
The global biosurgery devices market size was valued at USD 11.51 billion in 2025 and is projected to grow from USD 12.18 billion in 2026 to USD 19.99 billion by 2034, exhibiting a CAGR of 6.4% from 2026 to 2034. North America dominated the global market with a 45.7% share in 2025, supported by increasing surgical procedures, an aging population, advanced healthcare infrastructure, and adoption of innovative biosurgery technologies.
Biosurgery devices include hemostatic agents, surgical sealants and adhesives, bone graft substitutes, adhesion prevention products, and other products used during and after surgical procedures. These devices help control bleeding, close wounds, repair tissues, and improve surgical outcomes. Growing surgical volumes, faster recovery requirements, technological advancements, and increasing product launches are supporting market expansion.
Market Size and Value by Year
Market Definition and Scope
The biosurgery devices market covers products used for hemostasis, tissue sealing, wound closure, tissue repair, adhesion prevention, and bone regeneration. The market is segmented by product type, material, application, and end-user, with applications across orthopedic, cardiovascular, neurological, gynecological, and other surgical procedures.
Market Dynamics
Market Drivers: The increasing number of surgical procedures globally is a major driver. Growing procedures for cancer, cardiovascular diseases, trauma, obesity, and orthopedic conditions are increasing demand for hemostats, sealants, tissue repair products, and other biosurgery solutions. The emphasis on improved surgical outcomes and faster recovery is further supporting adoption.
Market Restraints: Strict regulatory requirements can delay product approvals and market entry. Biosurgery products often require extensive safety testing and clinical studies because they interact directly with blood, tissues, or organs. These requirements can increase development costs, particularly for smaller manufacturers.
Market Opportunities: The growing preference for minimally invasive and day-care surgeries is creating opportunities for biosurgery products designed for laparoscopic, robotic, and endoscopic procedures. Products that provide rapid sealing and hemostasis can support shorter procedures and faster patient discharge.
Market Trends: Increasing use of absorbable and tissue-friendly materials is an important trend. New hemostats, sealants, patches, and graft materials are being developed to reduce long-term residue and improve compatibility with human tissue.
Market Challenges: Storage and handling requirements can restrict adoption. Some sealants, patches, and hemostatic products require refrigeration, preparation, mixing, activation, or use within specific time windows, which can complicate workflows in busy surgical settings.
By Product Type: Hemostatic agents held the largest market share in 2025 because they are widely used across general, orthopedic, cardiac, spine, cancer, and trauma surgeries. Surgical sealants and adhesives are projected to grow at a 7.1% CAGR.
By Material: Biological materials dominated the market in 2025 due to their biocompatibility, absorbability, and lower risk of adverse reactions. This segment is expected to hold a 65.3% share in 2026. Synthetic materials are projected to grow at a 6.8% CAGR.
By Application: Orthopedic surgery dominated the market in 2025 and is expected to hold a 35.8% share in 2026, supported by the high prevalence of musculoskeletal conditions and continued technological development. Cardiovascular surgery is projected to grow at a 7.1% CAGR.
By End-User: Hospitals and clinics accounted for the largest share in 2025 and are expected to hold a 64.2% share in 2026. Academic and research institutes are projected to grow at a 6.5% CAGR.
North America: North America remained the leading region, reaching USD 5.26 billion in 2025. The U.S. market is estimated to reach USD 5.24 billion in 2026, supported by increasing procedure volumes and technological advancements.
Europe: Europe is projected to grow at a 5.4% CAGR and reach USD 3.40 billion in 2026. Germany, the U.K., and France are major markets, with respective 2026 values of USD 0.76 billion, USD 0.55 billion, and USD 0.45 billion.
Asia Pacific: Asia Pacific is expected to reach USD 2.36 billion in 2026, while China and India are estimated at USD 0.78 billion and USD 0.52 billion, respectively.
Latin America and Middle East & Africa: Latin America is projected to reach USD 0.50 billion in 2026, while the GCC is expected to reach USD 0.13 billion.
Competitive Landscape
Major companies include Johnson & Johnson Services Inc., Baxter International, Medtronic, BD, Integra LifeSciences, Zimmer Biomet, Stryker, CSL Behring, B. Braun Melsungen AG, and 3M. Competition is driven by product innovation, regulatory approvals, strategic partnerships, acquisitions, collaborations, and expansion into emerging markets.
Recent developments include Cerapedics receiving FDA approval for PearlMatrix P-15 Peptide enhanced bone graft in June 2025, Axogen launching Avive+ tissue matrix in June 2024, and Olympus launching EndoClot hemostatic agents in Europe in April 2023.
Report Coverage
The report covers biosurgery devices market size and forecast, product types, materials, applications, end-users, regional markets, market drivers, restraints, opportunities, trends, challenges, competitive landscape, product launches, approvals, partnerships, acquisitions, and major industry developments.
Conclusion
The global biosurgery devices market is expanding alongside the rising number of surgical procedures and increasing demand for effective bleeding control, wound closure, tissue repair, and faster recovery. The market is valued at USD 11.51 billion in 2025, projected to reach USD 12.18 billion in 2026, and expected to reach USD 19.99 billion by 2034. North America remains the largest regional market, while minimally invasive procedures, absorbable materials, biological products, and continued product innovation are creating further opportunities. Increasing adoption of advanced surgical technologies is expected to support market development through 2034.
Segmentation By Product Type
By Material
By Application
By End-user
By Region