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정형외과 업계 전략(2025-2030년) : 고관절, 슬관절, 척추, 외상, 견관절, 사지, 오소바이오로직스, 주요 기업 200사의 개요( 제4판)

Orthopedic Industry Strategic Report 2025-2030: Hip, Knee, Spine, Trauma, Shoulder, Extremities, Orthobiologics & Profile of 200 key players, 4th Edition

발행일: | 리서치사: 구분자 AVICENNE | 페이지 정보: 영문 400+ Pages, 550 Exhibits & Profiles | 배송안내 : 1-2일 (영업일 기준)

    
    
    



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개요:

본 보고서에서는 550억 달러 규모의 정형외과 최종 사용자 시장의 90% 이상을 차지하는 200개 정형외과 관련 기업을 분석하고 있습니다. 주요 내용으로는 지역별 정형외과 시장 및 시장 전망, 경쟁 환경 및 세그먼트별 기업 순위, 정형외과 분야의 혁신 및 신기술(로보틱스, REACH 규정 및 코발트-크롬(Co-Cr)에 미치는 영향, 오르토바이오로직스, 일회용 기구, 미국의 외래 수술 센터), 미국 관세의 영향, 주요 정형외과 기업의 재고 수준 및 수익성에 대한 상세한 분석이 포함됩니다.

주요 기업 200개사 프로필:

  • 상위 6개 기업
  • 북미 기업 70개사
  • 유럽 기업 75개사
  • 아시아 및 중남미 기업 50개사

목차

경영진 요약

정형외과 시장 개요: 시장 및 동향, 경쟁 환경 및 기업 전략, 시장 촉진 요인 및 억제 요인, 정형외과 기업의 주요 성공 요인

개요: 혁신·신제품, 로봇공학·3D 프린팅, 인플레이션·코로나19·환율의 영향

시장 기회: 신제품 출시(NPI)를 통한 시장 점유율 확대, EBITDA 마진 수준, 장기적인 시장 예측 가능성, 지불 주체의 지불 능력, 높은 진입 장벽, 활발한 M&A

제1장 정형외과 환경

  • 정형외과 거시 환경: 정치, 경제, 사회·문화, 기술, 환경, 법규
  • 위험: 규제 부담, 평균 판매 가격의 정체·하락, 정형외과 최종 사용자 시장을 위한 기구·CNC 공작 기계에 대한 막대한 설비 투자
  • 정형외과 업계의 주요 동향: 대규모 인수합병, 리콜, 사업 매각, 신규 진입 기업
  • 지난 20년간의 제품 회수 사례
  • 시장 촉진 요인
  • 시장 촉진 요인

제2장 정형외과·척추 시장 및 전망: 지역별

  • 고관절·무릎 관절 제품의 가격 전망: 미국, 호주, 일본, 유럽
  • 정형외과 제품의 촉진 요인 및 억제 요인
  • 전 세계 임플란트 시장: 지역별 시장 규모 - 무릎 관절, 고관절, 척추, 미국, 유럽, 기타
  • 전 세계 임플란트 시장: 지역별 시장 규모 - 외상, 어깨, 사지, 미국, 유럽, 기타
  • 고관절·무릎 관절 시장: 지역별 - 미국, 유럽, 일본, 호주, 한국, 기타
  • 인구 1만 명당 고관절·무릎 관절 수술 비율 및 연평균 성장률(CAGR) - 지역별
  • 척추·외상 시장: 지역별
  • 척추 수술: 고정술 (외상, 변형, 퇴행성), 비고정술 (동적 척추 치료), 척추체 성형술·후만 교정술 어깨·사지 시장: 지역별 - 미국, 유럽, 일본, 호주, 한국, 기타 지역
  • 정형외과 제품의 수명 주기: 고관절, 무릎관절, 척추, 외상, 사지의 성장 전망
  • 전 세계 정형외과 시장 및 전망: 고관절, 무릎 관절, 척추, 외상, 어깨, 사지, 정형외과 생체재료, 기타

    제3장 산업 전략: 경쟁 구도·기업 순위·분포

    • 대기업과 경쟁하는 3가지 유형의 챌린저: 유형 1 (국내 리더), 유형 2 (국내 기업), 유형 3 (지역 벤더)
    • 고관절·무릎 관절·어깨 관절 분야의 도전자 기업 성장: Corin, Medacta, Enovis, FX Solutions의 매출액
    • 척추·정형외과 생물학적 제제 분야의 도전자 기업들이 대기업으로부터 시장 점유율을 확보하고 주요 기업으로 부상: Globus, Alphatec Spine, Depuy ‘Spine & other’, Bonesupport의 매출액
    • 챌린저 기업의 지속적인 시장 점유율 확대와 COVID-19의 영향을 받은 2020년의 예외: 고관절, 무릎 관절, 척추, 외상, 정형외과 전체에서의 시장 점유율 급감
    • 대기업과 도전자 기업의 비교: 이익률을 유지한 대기업과 성장을 이룬 도전자 기업, 각사의 시장 점유율 및 정형외과·척추 관련 매출액 성장
    • 2019-2024년 기업 동향: 대기업 중에서는 Stryker만이 2019년 이후 연평균 6.5% 성장, Globus와 NuVasive의 통합, 기타 대기업의 저성장 또는 감소, 챌린저 기업 전체의 완만한 성장과 다수의 기업이 두 자릿수 성장
    • 챌린저 기업이 대기업보다 높은 성장률을 보이는 이유
    • 고도로 집중된 고관절 임플란트 시장과 4대 기업: 순위 및 시장 분산
    • 고도로 집중된 무릎 관절 임플란트 시장과 4대 기업: 순위 및 시장 분산
    • 고도로 집중된 척추 임플란트 시장과 4대 기업: 순위 및 시장 분산
    • 고도로 집중된 외상용 임플란트 시장: 순위 및 시장 분산
    • 고도로 집중된 어깨 관절 임플란트 시장: 순위 및 시장 분산
    • 중간 수준의 집중도를 보이는 사지 임플란트 시장과 주요 4개 기업: 순위 및 시장 분산
    • 중간 정도로 집중된 오르토바이오로직스 시장과 주요 4개사: 순위 및 시장 분산

    제4장 정형외과 분야의 혁신과 신기술

    • 파괴적 혁신의 역사: 세라믹, 고관절용 듀얼 모빌리티 컵, 쇼트 스템, 전방 접근 수술, 고관절용 3D 프린팅, 시멘트리스 제품, 로보틱스, 무릎 관절용 특수 세라믹 부품, 어깨 관절용 리버스형 임플란트, 인공 추간판, 척추용 3D 프린팅 케이지
    • 시장 촉진 요인: 파괴적 혁신이 적고 위험 회피 성향이 강한 정형외과 시장, 소규모 기업에서 비롯된 혁신과 다수의 점진적 혁신
    • Alphatec Spine: 신제품이 매출의 82%를 차지
    • Smith & Nephew: 연간 평균 신제품 출시 수
    • Smith & Nephew와 Alphatec Spine의 혁신 수준 비교

    정형외과용 로봇

    3D 프린팅

    REACH와 Co-Cr에 미치는 영향

    오르토바이오로직스

    인플레이션의 영향

    관세의 영향

    일회용

    외래 수술 센터(ASC): 미국

제5장 기업 프로필

  • 주요 6개 기업
  • 매출액 1억-10억 달러 규모의 기업
  • 매출액 4,000만-1억 달러 규모의 기업
  • 매출액 2,000만-4,000만 달러 규모의 기업
  • 매출액 1,000만-2,000만 달러 기업
  • 결론·요약
  • 부록
KSA 26.08.27

Overview:

The report analyzes 200 orthopedic companies that account for more than 90% of the 55 BUS$ in the orthopedic end-user market: Orthopedic market by region & forecasts. Competitive landscape & players’ ranking per segment. Innovations & new technologies in orthopedics: Robotics, REACH & impact on Co-Cr, orthobiologics, single-use instruments, Ambulatory Surgery Center – ASC in the USA. Impact of U.S. Tariffs. Detailed Analysis of Inventory Levels and Profitability at Major Orthopedic Companies.

Player profiles: 200:

  • 6 Majors
  • 70 North America companies
  • 75 European
  • 50 Asian and Latin America players.

Table of Contents

Aims of the study, Methodology, Hip, knee, shoulder, spine, trauma, extremities, bone substitutes & orthopedic and spine cement segmentation, Synopsis, Executive summary

Executive summary

Summary of the orthopedic market: Market & trends, Competitive Landscape & Player strategies, Drivers & limiters, Key Success Factors for an orthopedic player

Synopsis: Innovation & new products, Robotics & 3D printing, Impact of inflation, Covid & FX rate

Opportunities: gaining market share through NPIs, level of Ebitda margin , long market visibility, solvency of payers, high barriers to entry & very active M&A

1. Orthopedic environment

  • Orthopedics Macro environment: Political, Economic, Social / Culture, Technology, Environment, Legal & Regulatory
  • Risks: regulatory burden, ASP almost frozen or declining, significant capex for instruments & CNC machines for orthopedic end-user market
  • Milestones in the orthopedic industry: major acquisitions, recalls, divestments, new-comers
  • Product withdrawal cases over the past 20 years, 2000-2020
  • Market drivers: population growth, population over 65 years, health expenses, obesity, product mix impact
  • Market drivers: demographic & economic: Global population growth 1950-2050 and people over 65
  • Market drivers: health expenses & obesity rates, USA, France & UK, 1980-2025
  • Market drivers: innovation and new products are the differentiating factors on the orthopedic market: innovative, advanced and mature products
  • Market drivers: innovative surgeons, follower surgeons and conservative surgeons
  • Market limiters: regulatory & certification, details, impact on the market
  • Market limiter: reimbursement, a worldwide pricing regulation detailed for the USA, Germany, UK, Sweden, Italy, Belgium, Switzerland and France - Date of
  • launch, Classification system and targets
  • Market limiter: MDR (Medical Device Regulation): impact in Europe for implants and for instruments
  • Market limiter: MDR: New deadline for Class III products fixed in December 2027
  • Market limiter: Hip ASP erosion 2012-2024 in developed countries, USA, Australia, Japan & Europe
  • Market limiter: Knee ASP erosion 2012-2024 in developed countries, USA, Australia, Japan & Europe

2. Orthopedic & spine market by region & forecasts

  • Forecast Price for hip & knee 2024-2030: USA, Australia, Japan, Europe
  • Drivers & limiters for Orthopedic products: matrix summarizing (volume, price) x (driver, argument, past impact & future impact)
  • Worldwide implants market in 2024 in value by region (US$Bn): knee, hip & spine - USA, Europe & ROW
  • Worldwide implants market in 2024 in value by region (US$Bn): trauma, shoulder & extremities - USA, Europe & ROW
  • Hip & Knee by region (US$Bn): USA, Europe, Japan, Australia, South Korea & ROW
  • Hip & knee ratio for 10,000 inhabitants, USA, Europe, South Korea, Australia, Japan, China & ROW. Growth by area for hip & knee CAGR 2024-2030
  • Spine & trauma by region in 2024 (US$Bn): USA, Europe, South Korea, Australia, Japan - Rest Of the World
  • Spine procedures: fusion (trauma, deformation, degenerative), non-fusion (spine dynamic) & vertebroplasty-kyphoplasty
  • Shoulder & Extremities by region (US$Bn): USA, Europe, Japan, Australia, South Korea & ROW
  • The life cycle of orthopedic products: growth forecasts by 2024-2030 for hip, knee, spine, trauma & extremities
  • Worldwide orthopedic market in 2024 and forecasts 2024-2030 for hip, knee, spine, trauma, shoulder, extremities, orthobiologics and other

3. Player strategies: competitive landscape, players’ ranking & dispersion

  • Three types of Challengers compete with the Majors: Challengers type 1 (country leader) / Challengers type 2 (country player) / Challengers type 3 (local vendors)
  • Hip, knee & shoulder challengers growth: Corin, Medacta, Enovis and FX Solutions revenues
  • Spine & Orthobiologics challengers are grabbing market share from the Majors and emerging as top players: Globus, Alphatec Spine, Depuy “Spine & other”
  • and Bonesupport revenues
  • Challengers have continuously gained market share except in 2020 due to Covid impact: challengers market shares collapsed for hip, knee, spine, trauma &
  • total ortho
  • Table of Contents: Orthopedic industry strategic report 2025-2030: Hip, Knee, Spine, Trauma, Shoulder, Extremities & Orthobiologics - Profile of 200 key players
  • Published June 2026 - 4th Edition
  • Challengers have continuously gained market share except in 2020 due to Covid impact: challengers market shares evolution from 2018 to 2025 for hip, knee,
  • spine, trauma & total ortho
  • Majors vs. Challengers: Majors saved their margins while Challengers got the growth, position of each players in terms of market shares and ortho & spine
  • revenues growth from 2019 to 2025
  • 2019-2024: Stryker is the only Major that has been growing at 6.5% per year since 2019. Globus merged with Nuvasive. The other Majors experienced slower
  • growth or decline. Taken together, the challengers experienced moderate growth, but many of them have achieved double-digit growth.
  • Reasons why Challengers are growing faster than Majors
  • The hip implant market is highly concentrated, with the 4 majors : ranking & dispersion: Top 4 / Top 5-10 / Other
  • The knee implant market is highly concentrated, with the 4 majors : ranking & dispersion : Top 4 / Top 5-10 / Other
  • The spine implant market is highly concentrated, with the 4 majors : ranking & dispersion : Top 4 / Top 5-10 / Other
  • The Trauma implant market is highly concentrated, with the 4 majors : ranking & dispersion: Top 5 / Top 6-10 / Other
  • The shoulder implant market is highly concentrated, with the 4 majors : ranking & dispersion : Top 5 / Top 6-10 / Other
  • The extremities implant market is moderately concentrated, the 4 leaders : ranking & dispersion : Top 4 / Top 5-10 / Other
  • The Orthobiologics market is moderately concentrated, the 4 leaders : ranking & dispersion : Top 4 / Top 5-10 / Other

4. Innovations & new technologies in orthopedics

  • History of disruptive innovations: ceramics, hip dual mobility cup, short stem, anterior approach surgery, 3D printing for hips, cementless products, robotics,
  • specific ceramic parts for the knee, reversed for shoulder, disk, 3D printing cages for spine
  • Market drivers: orthopedics is generally risk-averse with few disruptive innovations, often coming from small players, but many small incremental
  • innovations.
  • For Alphatec Spine 82% of revenues are driven by New Products
  • Smith & Nephew: average new products launched per year
  • Innovation level comparison between Smith & Nephew and Alphatec Spine

Orthopedic robotics

  • Orthopedic robotic market: MAKO from Stryker, ROSA from Zimmer Biomet, Navio of Smith & Nephew, Mazor from Medtronic and Velys from Depuy robotic
  • systems Omni robotic from OMNIlife science, Apollo from Corin, Tinavi…
  • Navigation Vs robotic assisted surgery comparison: tools description, features, end-user price, easy to use, pro & cons
  • Stryker with Mako’s acquisition boosted the orthopedic robotic market and have a huge impact on instruments market
  • Orthopedic robotics surgeries: Stryker open the mass market, Smith & Nephew, Zimmer Biomet, Depuy and many others have followed
  • New generations of Mako for shoulder and spine surgery launched & Stryker Mako installed base machines 2017-2025 for hip & knee
  • New generations of Rosa for shoulder surgery launched & Zimmer Biomet Rosa installed base machines 2017-2025 for hip & knee
  • New generations of Cori pre-operative planning and modelling which allows image-free and image-based planning launched in 2024 & Smith & Nephew
  • Navio & Cori installed base machines 2020-2025 for hip & knee
  • New generations of Velys for spine surgery launched i& Depuy Synthes Velys installed base machines 2021-2025 for hip & knee
  • Robotic orthopedic system benchmark: there are several families of orthopedic robots, handheld or with a robotic arm. Mako, Rosa and Velys have chosen
  • the robotic arm, while Cori is handheld. Another variant is the need for a CT Scan or not (Imageless); only Mako uses a CT Scan. Finally, the use of cutting
  • guides is eliminated for Mako and Velys, who operate direct cuts by the robot, while Cori uses several cutting guides and Rosa only for tibial cuts.
  • Mako, Rosa, Velys and Cori benchmark by operating cost and acquisition cost
  • Product benchmarking: Mako is the robot with the most extensive clinical track record, but the acquisition cost is high.
  • Australia was always a pioneer in the use of innovations in orthopedics. Germany and Japan will be the fastest-growing markets. In France, the robotized
  • knee ratio lags far behind. Australian, Japanese, German, Italian, UK and French knee surgeries performed with robotics (in K units) 2020-2030
  • Robotic-assisted surgeries outside the US: Between 2025 and 2030, the number of robotic knee operations outside the USA forecasts. Germany and the UK
  • will lead the way in Europe in terms of volume. Outside US knee surgeries performed with robotics (in K units) 2020-2030: Australia, Japan, Germany, Italy,
  • UK, France, Rest of Europe & Rest of the World

3D Printing

  • 3D Printing in Orthopedics: Zimmer opened up this market with Trabecular Tantalum then Lima (Enovis) & Adler, Italian-based companies, started mass
  • market sales
  • Story of Zimmer and Trabecular Tantalum 1997-2025
  • Zimmer Trabecular metal product portfolio: Patellar knee implant, femoral et tibial cone augments, acetabular revision system, acetabular cup, reversed
  • shoulder system, shoulder glenoid part, knee tibial plate, primary hip stem
  • Metal 3D Printing: technologies and major players, EOS, Arcam, SLM Solutions, Concept Laser, other players by raw materials used and technologies
  • Number of Arcam EBM installed base for orthopedic industry at Enovis 2007-2025 and % of hip cups and shoulder glenoid made by 3D printing machines
  • Number of EBM installed base at AK MEDICAL & Implantcast
  • Illustrative build-up speed and resolution of selected Metal 3D Printing systems: EBM Vs Selective Laser Melting (SLM) comparison between maximum build
  • up speed in cm3/h and resolution
  • Smith & Nephew uses 3D Printing: 20 EOS M290 for metal and 3 for plastic to produce hip cup & customized cutting blocks to manufacture customized
  • cutting blocks and hip revision cup
  • Table of Contents: Orthopedic industry strategic report 2025-2030: Hip, Knee, Spine, Trauma, Shoulder, Extremities & Orthobiologics - Profile of 200 key players
  • Published June 2026 - 4th Edition
  • Stryker has announced massive investments in 3D Printing, In 2016, a US$400 Million plan to build a 3D printing manufacturing facility in Cork, Ireland was
  • released. Today, many of Stryker's products are made by 3D printing
  • Current Stryker products made by 3D Printing: knee tibial plate, patellar knee implant, knee augment, cages, other
  • Depuy Spine uses 3D Printing for prototyping complex surgical tools and announced investments in 3D printing
  • DePuy Synthes has acquired 3D printing technology from Tissue Regeneration Systems
  • DePuy Synthes Launched 3D Printed Titanium Facial Reconstruction Implants in US
  • XILLOC for Cranio-Maxillofacial applications using PEEK and titanium alloys
  • 3D printing machine suppliers for orthopedics, installed : EOS, ARCAM, CONCEPT LASER, SLM Solutions, 3D Systems and their customers. Number of installed
  • base machines per machine manufacturer
  • Addressable market should increase with lower 3D Printing cost: cost and complexity curve linked with addressable market
  • 3D Printing is attractive for reconstructive implants to accelerate and improve osteo-integration.
  • Number of implants produced using 3D Printing: Stryker , Zimmer Biomet, Enovis, Advita, Adler Ortho, etc.
  • FDA clearance for medical devices using 3D Printing in USA
  • 3D Printing has reached the mass market for a few key products: hip cups, tibial knee, spine cages, shoulder glenoid and several trauma have switched to 3D
  • Printing
  • 3D Printing today has a slight impact on the forging, casting & machining of implants. Our research shows that Stryker and challengers are most advanced in
  • the use of 3D printing, particularly for hip cups, tibial knee plates and spinal cages. % of implants produced using 3D printing worldwide:
  • 3D printing cages are gaining in market share over Peek and Titanium cages.
  • 3D Printing and impact on the forging, casting & machining of hip cups
  • Hip: manufacturing process and raw materials, 3D printing is not a threat to the forging of hip stems
  • Knee: manufacturing process and raw materials: 3D printing is not a threat to the forging of tibial plates
  • Cages for spine surgeries in the five main European countries
  • Is 3D Printing the right option for the implant Contract Manufacturing business? Analysis of different products & players for reconstructive implants, standard
  • cages, special cages and customized implants - Benefits / Drivers & Limiters for each products
  • Is 3D Printing the right option for the instruments Contract Manufacturing business? Analysis of different products & players for customized cutting guides
  • and complex instruments: Lincotek 3D Printing activity details
  • Most large contract manufacturers are investing in 3D printing and, after an initial learning curve, are moving into the scale-up phase.
  • The most manufactured orthopedic products by 3D Printing
  • Standard manufacturing process Vs 3D Printing process: cost comparison for hip cup, knee tibial, spine cages and shoulder glenoid
  • Trend of the installed bases of the main machine suppliers: the number of 3D Printing machines used in orthopedics 2015-2025
  • 3D Printing In-house & Contract Manufacturing market 2015-2030 by hip cup, knee tibial plate, shoulder glenoid, spine cage, other parts: in value

REACH & impact on Co-Cr

  • EU Regulation 2017/745 says that a CMR substance
  • Cobalt-Chrome is used today in 6 major orthopedic products: femoral knee, dual mobility liner, hip and shoulder heads, bipolar cups and tibial knee plates.
  • The use of Co-Cr varies depending on the geographical area. REACH regulation: ban on Co-Cr for implants?
  • REACH regulation: no ban on Co-Cr for implants is expected,, Co-Cr implants have to be CMR-labeled, which will not have a major impact on Co-Cr use. Co-Cr
  • will continue to be used for implants that have been manufactured for several decades and have a very long track-record. Only new hip product development
  • projects will be affected. Co-Cr hip implants will be flat or slightly down.
  • Co-Cr has been used for decades for friction parts in implants
  • Oxinium Hip & Knee is a breakthrough bearing solution comparable to ceramic bearings.
  • Anti-allergic solutions against nickel, cobalt, etc. have been developed for several decades

Orthobiologics

  • Use of antibiotics for orthopedic cements: need for cements with new antibiotics
  • Cement price / mix: mix effect offsetting small price erosion that is common in the orthopedic industry
  • Synthetic or natural bone substitutes, allografts, growth factors, Demineralized Bone Matrix (DBM), xenografts, autografts segmentation
  • Main bone grafts on the market: injectables and antibiotics are the main drivers: injectable & non-injectable

Inflation impact

  • Impact of inflation on the end-user market and on contract manufacturing: Majors OEMs & Majors CMOs quotes
  • FX rate variation
  • Impact of exchange rate fluctuations on the major orthopedic companies

Tariffs impact

  • Impact of Tariffs on OEMs and CMOs
  • Table of Contents: Orthopedic industry strategic report 2025-2030: Hip, Knee, Spine, Trauma, Shoulder, Extremities & Orthobiologics - Profile of 200 key players
  • Published June 2026 - 4th Edition

Single use

  • Single-use trend: the introduction of single-use starts with the less expensive cutting tools: drills, taps, burrs, pins, sawblades, rasps & acetabular reamers
  • Single use in the USA & Europe: trauma and extremities are the largest consumers of single-use cutting tools and disposable kits - % of single use USA and
  • Europe 2018-2026
  • Cutting tools: 3D printing's contribution is to lighten and reduce the number of parts and generate cost savings

Ambulatory Surgery Center - ASC in the USA

  • Ambulatory Surgery Center - ASC in the USA, expected to skyrocket for hip, knee, spine and trauma non-complex surgeries!

5. Player profiles:

  • 6 Majors
  • Players: US$100M -> US$1B
  • Players: US$40M -> US$100M
  • Players: US$20M -> US$40M
  • Players: US$10M -> US$20M
  • Conclusions, Executive summary
  • Appendices
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