2022年至2031年,美国椎弓根螺钉市场将以6.79%的复合年增长率增长,达到6.1085亿美元

Publication Month : Oct 2023

  • Report Code : TIPRE00030071
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 81
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【研究报告】美国椎弓根螺钉市场规模预计将从2022年的3.6128亿美元增长到2030年的6.1085亿美元;预计 2022 年至 2030 年复合年增长率为 6.79%。

 

分析师的预测观点

美国椎弓根螺钉市场分析解释了市场驱动因素,例如人口老龄化对脊柱疾病的易感性以及使用椎弓根螺钉系统的脊柱手术数量的增加。此外,市场参与者之间的产品发布、扩展、协作和伙伴关系以及在螺钉放置过程中使用机器人进行导航预计将在 2022 年至 2030 年期间引入市场新趋势。从产品类型来看,多轴椎弓根螺钉系统细分市场在2022年占据最大份额。从应用来看,胸腰椎骨折细分市场占据最大份额,占据市场主导地位。按手术类型细分,开放手术细分市场可能在预测期内占据美国椎弓根螺钉市场的相当大份额。根据最终用户,医院细分市场预计将在 2022 年至 2030 年占据美国椎弓根螺钉市场的最大份额。

椎弓根螺钉是螺纹钛或不锈钢植入物,通过位于脊柱骨后部的椎弓根进行紧固。椎弓根螺钉有助于在脊柱融合手术期间将杆和/或板固定到脊柱节段。螺钉充当锚点,通常位于通过短杆连接的 2 或 3 个连续脊柱节段处。

市场洞察

人口老龄化对脊柱疾病的易感性

 

老年人更容易患脊柱疾病,如椎间盘退行性疾病、骨关节炎、脊柱侧凸、脊柱肿瘤和椎管狭窄。与衰老相关的脊柱自然磨损会导致多种脊柱疾病。此外,由于多种虚弱、合并症、营养状况下降以及术后并发症的可能性较高,这一人群给脊柱外科医生带来了独特的挑战。根据世界卫生组织(WHO)2022年10月发布的数据,到2050年,约80%的老年人口将生活在低收入和中等收入国家。此外,预计人口老龄化速度将加快比过去报告的速度快得多。椎弓根螺钉广泛用于矫正椎体骨折、椎体畸形、脊柱创伤、脊柱肿瘤等的外科手术中。因此,由于老年人口的增加(容易患各种脊柱疾病),椎弓根螺钉系统受到越来越多的关注。下图描绘了70岁以下(A组)和70岁及以上(B组)两组老年人口的累积发病率(%)。 A组后路融合术后椎体骨折病例高于B组。椎弓根螺钉在矫正椎体骨折、椎体畸形、脊柱创伤、脊柱肿瘤等手术过程中广泛使用。根据美国人口普查局2023年报告过去几十年来,美国老年人口迅速增长。 2010年—2020年,65岁及以上人口出现自1880年—1890年十年以来最大、最快的增长;到 2020 年,这一人口达到 5580 万,占总人口的 16.8%。这一增长主要归因于 1946 年至 1964 年出生的婴儿潮一代的老龄化。

图 1:有椎骨骨折风险的患者数量

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来源:Nakahashi 等人。 BMC肌肉骨骼疾病,2019

椎弓根螺钉固定术后椎体骨折是老龄化人群中相对常见的并发症。椎体骨折和脊柱疾病的手术治疗通常需要椎弓根螺钉固定。例如,脊柱侧弯的手术治疗包括中性元件减压和融合以重新调整脊柱节段椎弓根螺钉系统。

未来趋势

在螺钉放置过程中使用机器人进行导航

近年来,椎弓根螺钉市场见证了机器人导航的出现,特别是在微创脊柱手术 (MISS) 中,由于机器人技术有助于螺钉轨迹规划、尺寸和实际位置,因此提高了椎弓根螺钉放置的准确性。 - 手术期间的时间可视化。在与腰椎椎间融合相关的手术中,机器人技术的应用已经超出了椎弓根螺钉的置入范围。根据 2020 年《骨与关节外科杂志》上发表的一篇文章,机器人设备有助于为解剖结构困难的患者放置椎弓根螺钉,从而提高手术的准确性、可行性和效率。美国 FDA 已批准使用机器人技术来分析椎弓根螺钉置入的理想轨迹。这些机器人设备作为半主动手术辅助工具,使外科医生能够扩大治疗患者的能力。

  • 2022 年,北京 TINAVI Medical Technologies 推出了 TiRobot,这是一种作为新技术开发的骨科机器人,用于辅助微创、经皮椎弓根螺钉置入。该技术准确且安全,可减少术中失血量、缩短手术时间、提高固定精度,并降低老龄化人群的手术风险。
  • 2021 年 5 月,CUREXO Corp.(一家医疗公司)机器人专业公司,获得美国 FDA 开发 CUVIS-Spine 脊柱手术机器人的许可。它是新一代脊柱手术机器人,通过高精度机械臂引导椎弓根螺钉的插入并根据手术计划发挥作用,基于实时OTS传感器的无线单步导航,赋予精确、安全、更快的操作。 CUVIS-Spine 还最大限度地减少了拍摄,减少了患者和医务人员的辐射暴露。
  • 2022 年 5 月,脊柱矫正手术中使用的医疗设备开发和创新先驱 Altus Spine 推出,宣布摩纳哥 HA 椎弓根螺钉系统获得 FDA 510 (K) 批准。该系统包括薄型结构和插入装置,具有旨在增强固定的优化表面。该表面由钙和磷制成,可增强椎弓根螺钉与周围骨骼的固定。

战略见解

报告细分和范围

 

< strong>基于产品类型的洞察

根据产品类型,美国椎弓根螺钉市场分为多轴椎弓根螺钉系统、单轴椎弓根螺钉系统和其他椎弓根螺钉系统。多轴椎弓根螺钉系统细分市场在 2022 年占据最大的市场份额,预计在 2022 年至 2030 年期间将实现显着的复合年增长率。多轴椎弓根螺钉系统用于脊柱手术,旨在稳定和固定脊柱。螺钉固定在椎弓根上,椎弓根是椎体上的小骨突出物。这种类型的螺钉可以在多个方向上移动,使外科医生在椎弓根放置过程中具有更大的灵活性。近年来,微创手术已成为使用后路椎弓根螺钉固定的脊柱手术的首选方法。

提供多轴椎弓根螺钉系统的公司

公司

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多轴椎弓根螺钉系统

奥希恩医疗

VERTAUX –带帽多轴椎弓根螺钉

Stryker

< p>夏3

B. 布劳恩

S4 脊柱系统(单轴和多轴)

Zimmer Biomet

重要脊柱固定系统

来源:公司网站和 Insight Partners 分析

脊柱手术数量不断增加,技术不断进步;多轴椎弓根螺钉系统加上微创手术数量的增加预计将促进该产品类型市场的增长。

基于应用的见解

根据应用,全球美国椎弓根螺钉市场分为胸腰椎骨折、脊柱肿瘤、脊柱融合失败、脊柱侧凸、和脊柱炎。胸腰椎骨折领域在 2022 年占据最大的市场份额,预计 2022 年至 2030 年复合年增长率最高。胸腰椎骨折可显着影响生活质量,导致神经功能缺损、畸形和疼痛。据2020年骨科杂志发表的文章显示,脊柱骨折占每人口32.8/10万,其中胸腰椎骨折约占脊柱骨折的90%。此外,这些骨折中近20%是由于轴压引起的爆裂骨折。胸腰椎骨折大多发生在T11和L2之间,是应力集中区。

椎弓根螺钉多用于矫正胸腰椎爆裂性骨折,被认为是后路手术中脊柱内固定的金标准。常用的椎弓根螺钉系统包括4个钉子和2个杆。已经使用椎弓根螺钉进行了大量的生化研究。尽管椎弓根螺钉固定已被证明在矫正脊柱骨折方面具有优势,但骨质疏松症患者仍然存在螺钉松动的缺点,导致矫正手术失败。

基于手术类型的见解

就手术类型而言,美国椎弓根螺钉市场分为开放手术和微创手术侵入性手术。开放手术细分市场将在 2022 年占据更大的市场份额,预计微创手术细分市场将在 2022 年至 2030 年实现更高的复合年增长率。

由于技术先进的机器人和图像引导 (IG) 手术的应用不断增加,微创手术 (MIS) 受到了关注。在预测期内,MIS 市场的增长速度预计是开放手术市场的六倍。这些手术对周围肌肉的损伤较小,出血较少,疼痛最小,恢复较快,住院时间较短。目前,MIS 被认为是脊柱融合的常见手术。

美国主要椎弓根螺钉市场参与者正致力于扩大其产品组合支持微创手术的产品类型。 2021年9月,Alphatec Holdings, Inc.推出了InVictus OsseoScrew脊柱固定系统,这是一种可扩张的椎弓根螺钉系统。因此,随着外科医生和患者对 MIS 的日益偏好,以及脊髓退行性疾病的迅速流行,美国椎弓根螺钉市场将在预测期内加快步伐。

  ;

基于最终用户的见解

按最终用户划分,市场分为医院、门诊手术中心和专科诊所。医院细分市场在 2022 年占据最大市场份额,预计 2022 年至 2030 年美国椎弓根螺钉市场复合年增长率最高。

美国椎弓根螺钉市场,按产品类型划分 – 2022年和2030年

国家分析

美国椎弓根螺钉的增长归因于人口老龄化史无前例地转向容易患脊柱疾病的人口以及使用椎弓根螺钉系统的脊柱手术数量不断增加。然而,与椎弓根螺钉固定相关的监管障碍和挑战阻碍了市场的增长。

美国椎弓根螺钉的主要市场参与者包括 DePuy Synthes、Stryker 和 Intelivation Technologies。这些公司致力于产品类型的开发和推出,以保持市场竞争力。在美国,技术先进的椎弓根螺钉被广泛应用于各种微创和开放手术。

以下是椎弓根螺钉生态系统中各公司所进行的主要开发:

  • 2023年5月,Intelivation Technologies推出了新型微创椎弓根螺钉系统。Golden Isles 是一种经皮系统,可提高外科医生的手术灵活性和可视化,从而最大限度地减少患者的软组织损伤。
  • 2022 年 3 月,SurGenTec(一家总部位于美国的私营公司,专门从事脊柱和骨科技术,其独立脊柱固定植入物 ION Screw 获得美国 FDA 批准。
  • 2022 年 2 月,OsteoCentric Spine, LLC 宣布计划进军椎弓根螺钉固定市场。与 Altus Spine 执行自有品牌协议。该安排使 OsteoCentric 能够将现有的 FDA 批准的系统与其 UnifiMI 机械集成技术平台集成。
  • 2020 年 10 月,Stryker 宣布其 Mesa 椎弓根螺钉(于 2006 年推出)的数量达到全球植入 100 万例。该系统在 2020 年北美脊柱学会 (NASS) 年会上进行了专题介绍。

腰椎骨折、脊柱畸形和脊柱肿瘤病例数量增加美国人口和椎弓根螺钉技术进步有利于椎弓根螺钉市场。腰椎骨折是最常见的脊柱骨折,损伤复杂,致残率高,给患者带来严重的心理和经济压力。

  • DePuy Synthes Inc           
  • Zimmer Biomet Holdings Inc         
  • Globus Medical Inc           
  • B.Braun SE           
  • 史赛克公司         
  • 美敦力公司          
  • Surgalign Holdings Inc       
  • NuVasive Inc          
  • Orthofix Medical Inc
  • Alphatec Holdings Inc
  • Alphatec Holdings Inc    
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What are the driving factors for the US pedicle screws market?

The key factor that is driving the pedicle screws market growth include increased adoption of these devices in treating degenerative spinal disorders, and the rising number of life-saving surgeries.

What is meant by the pedicle screws market?

Pedicle screws are used sometimes in a spinal fusion to add extra support and strength to the fusion while it heals. Pedicle screws are placed above and below the vertebrae that were fused. A rod is used to connect the screws which prevents movement and allows the bone graft to heal. After the fusion is completely healed, the screws and rods can be removed. Removal isn't necessary unless they cause the patient discomfort.

Which offering segment led US pedicle screws market?

The pedicle screws market, by product type, is fragmented into polyaxial pedicle screw system, monoaxial pedicle screw system, and other pedicle screw systems. The polyaxial pedicle screw system segment held the largest market share in 2022 and services segment is anticipated to register the highest CAGR during the forecast period.

Which end user segment held the largest revenue (US$ Mn) in the US pedicle screws market?

The US pedicle screws market, by end user, is fragmented into hospitals, ambulatory surgical centers, and specialty clinics. The hospitals segment held the largest market share in 2022 and ambulatory surgical center anticipated to register the highest CAGR during the forecast period.

Who are the key players in the US pedicle screws market?

US pedicle screws market comprises top players such as Johnson & Johnson (Depuy Synthes), Zimmer Biomet, Globus Medical, Inc., B. Braun Melsungen AG, Orthofix International N.V., Stryker, Medtronic PLC, RTI Surgical, Inc and NuVasive.

The List of Companies - US Pedicle Screw Market

  1. DePuy Synthes Inc
  2. Zimmer Biomet Holdings Inc
  3. Globus Medical Inc
  4. Hill-Rom Holdings Inc
  5. Stryker Corp
  6. B. Braun SE
  7. Medtronic Plc
  8. Surgalign Holdings Inc.
  9. NuVasive Inc
  10. Orthofix Medical Inc
  11. Alphatec Holdings Inc

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

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Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

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Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

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Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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