脊柱融合装置市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPMD00002296
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 208
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【研究报告】脊柱融合装置市场规模预计将从2022年的827,631万美元增长到2030年达到12,993.25百万美元,预计2022年至2030年复合年增长率为5.8%。< br>市场洞察和分析师观点:
由于胆结石病例增加,脊柱融合装置病例数量增加,脊柱融合装置市场规模正在快速增长。此外,糖尿病病例的增加也推动了市场的增长。
此外,公司针对市场开发的战略举措正在推动市场的增长。 2022 年 9 月,GE Healthcare 宣布美国 FDA 510(k) 批准其用于 3D 和 PROPELLER 成像序列的突破性 AIR Recon DL。这些新功能将 AIR Recon DL 的优势扩展到几乎所有磁共振成像 (MRI) 临床程序,涵盖所有解剖结构,并实现更好的图像质量、更短的扫描时间和增强的患者体验。因此,满足客户需求的革命性技术的显着增长可能会在预测期内给市场带来新的趋势。
机遇与挑战:
脊柱融合手术成本更高;许多患者放弃了接受脊柱手术的决定。此外,在许多情况下,脊柱植入物的费用不包括在健康保险计划内,从而限制了手术数量。例如,像美国这样的国家物价昂贵;根据2022年2月发布的医疗保健蓝皮书数据,腰椎融合术费用排名前五位的城市为:丹佛:86,182美元,加利福尼亚州圣何塞:78,809美元,旧金山:78,809美元,印第安纳波利斯:78,809美元。 77,269 美元,西雅图:74,499 美元。与此同时,在孟菲斯、田纳西州和圣安东尼奥等城市,腰椎融合术的最低费用约为 48,000 美元。
另一方面,医疗旅游业使得能够以更便宜的成本提供脊柱融合手术。发展中地区国家大力发展医疗旅游,拥有先进技术,能够以更便宜的价格提供世界一流的医疗服务。 Lyfboat 技术列兵。 2023 年 7 月发布的数据表明,印度、泰国、土耳其、阿联酋和埃及等国家被认为最能提供 8,000 美元至 16,000 美元之间的脊柱侧弯手术。 Lyfboat Technologies Pvt 公布的数据还显示,埃及脊柱融合手术的费用为 10,897 美元,阿联酋约为 8,200 美元。同样,在土耳其,脊柱融合手术的费用为 15,000 美元,而在印度则接近 8000 美元至 12,000 美元。此外,印度的胸廓成形术费用在 2,500 美元至 4,000 美元之间。
以更便宜的费用提供关键手术会增加前往这些国家接受治疗的患者流量。此外,先进医疗技术的可用性和政府为增加医疗旅游业提供的资金的增加导致对先进外科植入物的需求不断增加。此外,发展中国家不断进步的医疗保健基础设施可能会持续增加对先进医疗设备的需求,从而增加脊柱融合设备市场的增长机会。
脊柱融合设备的监管要求不同于其他植入设备。脊柱融合装置的法规定期更新,以保持产品质量,从而提高患者的生活质量。 2023 年 3 月,美国食品和药物管理局 (FDA) 更新了医疗器械、骨科器械、椎间融合手术中使用的脊柱球体分类(最终规则)最终监管影响分析。根据 FDA 的分析,脊柱装置被归类为 III 类。这些设备需要单独提交上市前批准申请。此外,FDA 发现一般和特殊控制措施不足以确保设备的有效性和安全性。因此,期望企业必须提供完整的产品描述和产品效率和安全性分析,以避免产品材料、尺寸规格和临床条件意图的混淆。
同样,发展中国家的法规正在更新监管要求用于脊柱融合装置。 2021年11月,澳大利亚政府卫生和老年护理治疗用品管理局(TGA)修订了脊柱植入式医疗器械的监管框架。 TGA 旨在支持赞助商和制造商了解新的监管要求,以了解并遵守更新的要求。 TGA对制造商提出了四项主要要求,其中包括需要在ARTG条目中提供有关IIb类脊柱融合装置的具体信息; TGA对器械纳入申请的强制性审核评估,包括临床证据评估;证明设备分类适当程序的合格评定文件,以及制造商对与每个设备相关的质量管理体系和技术文件的详尽评估。因此,法规对制造商的严格将导致更多的经济投资,而召回风险可能会导致损失。因此,对脊柱融合装置的严格监管是阻碍市场增长的因素之一。
战略见解
报告细分和范围:
脊柱融合装置市场份额按产品类型、手术划分类型、疾病适应症和最终用户。脊柱融合装置市场按产品类型分为胸腰椎装置、颈椎固定装置和椎间融合装置。脊柱融合装置市场按手术类型分为开放性脊柱手术和微创脊柱手术。脊柱融合装置市场按疾病适应症分为退行性椎间盘、创伤和骨折、复杂畸形等。脊柱融合装置市场按最终用户划分为医院、专科诊所等。根据地理位置,市场分为北美(美国、加拿大和墨西哥)、欧洲(英国、德国、法国、意大利、西班牙和欧洲其他地区)、亚太地区(中国、日本、印度、韩国、澳大利亚和亚太其他地区)、中东和非洲(阿联酋、沙特阿拉伯、南非以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和其他地区)南美洲和中美洲)。
细分分析:
根据手术类型,脊柱融合装置市场分为开放脊柱手术和微创脊柱手术。 2022年,开放式脊柱手术领域通过手术占据了更大的市场份额。由于越来越多地采用微创脊柱手术方法,预计微创脊柱手术领域在 2022 年至 2030 年期间将以更高的复合年增长率增长。开放式手术被认为是标准手术,因为它们可以完全暴露解剖结构。建议进行开放性脊柱手术来治疗脊柱侧弯、椎间盘严重退变、脊柱不稳定或这些问题的组合等疾病。如果病情严重且复杂,则广泛首选开放手术;它提供了更多的解剖暴露,使手术变得容易,并且周围结构的可见度更高。然而,开放式脊柱手术存在多种风险。风险包括失血过多和恢复时间较长。
在许多情况下,开放性脊柱手术类型可能会逆转脊柱疾病的症状。并发症还可能导致感染、伤口愈合不良、血栓以及周围静脉或神经损伤。
微创脊柱手术类型 (MISS) 比传统的开放式脊柱手术类型获得了显着关注。 MISS 需要较小的切口;因此,说服患者接受 MISS 更容易。其他优点,例如避免周围肌肉损伤、出血少、疼痛少、恢复快和住院时间短等,增加了 MISS 的采用。目前,MISS 被认为是脊柱融合的常见手术。 MISS 的广泛采用包括通过限制风险、改变报销模式和患者偏好来治疗老年人和重症患者的脊柱问题。此外,MISS 的转变通过结合强大的软件引入了新的术中成像技术。成像技术和软件的结合允许外科医生进行实时导航,以补充他们对脊柱 3 维 (3D) 解剖结构的理解。因此,MISS 的转型正在导致该细分市场增长最快,最终推动市场增长。根据 2022 年 7 月发表的题为“微创脊柱手术类型:概述”的文章,美国每年 120 万例脊柱手术中,约有 75% 是通过 MISS 技术进行的。同样,2022 年 1 月发表的一篇文章《脊柱内窥镜检查:证据、技术、全球趋势和未来预测》指出,96.7% 的亚洲外科医生进行了 MISS。因此,考虑到 MISS 手术数量的增加,预计未来几年市场将显着增长。
脊柱融合装置市场,按手术类型 - 2022 年和 2030 年
脊柱融合装置市场,按产品类型划分,分为胸腰椎装置、颈椎固定装置、椎间融合装置。 2022年,按产品类型划分,胸腰椎器械细分市场占据最大市场份额。由于椎间融合装置的不断发展,预计椎间融合装置市场在 2022 年至 2030 年期间将以显着的复合年增长率增长。脊柱融合器市场按疾病适应症分为退行性椎间盘、创伤和骨折、复杂畸形等。 2022年,退行性椎间盘细分市场按疾病适应症占据最大市场份额,并且由于更容易患退行性疾病的老年人口不断增加,预计在2022年至2030年期间将以显着的复合年增长率增长。脊柱融合装置市场按最终用户划分为医院、专科诊所等。到 2022 年,医院细分市场将占据最大的市场份额,预计未来几年将以最快的速度增长。
区域分析:
根据地理位置,脊柱融合装置市场分为北美、欧洲、亚太地区、中东和非洲以及南美洲和中美洲。北美是市场增长的最大贡献者,亚太地区是增长最快的地区。北美的脊柱融合装置市场分为美国、加拿大和墨西哥。 2022年,美国在该地区占据最大市场份额,预计在预测期内将继续保持主导地位。 DePuy Synthes、Stryker、Aurora Spine 和 Alevio Spine 是美国脊柱融合装置市场的主要参与者。这些参与者推动的产品开发和发布有利于市场增长。经美国食品和药物管理局 (FDA) 批准的技术先进的脊柱融合装置在美国得到广泛采用。以下是最近获得 FDA 批准的脊柱融合装置列表:
2023 年 5 月,CTL Amedica 获得 FDA 510(k) 批准 NITRO 椎间融合笼系统商业化,该系统完全由生物材料融合制成氮化硅。氮化硅材料与所有成像模式兼容;它具有独特的抑菌特性,并提供无伪影成像。 2023 年 1 月,Alevio Spine 获得了 510 (K) 的 SI-Cure SI 关节融合系统附加适应症许可。扩大的适应症包括为骨骼成熟的患者进行骶髂融合,作为腰椎或胸腰椎融合的一部分进行骶骨盆固定。 2022年6月,美国 FDA 批准了 Aurora Spine 的 DEXA SOLO-L 前路腰椎间融合装置 (ALIF) 510K 许可。基于 DEXA 技术平台,3D 打印独立设备专为前侧和侧向腰椎椎间融合术 (ALIF & LLIF) 手术而设计。与年龄相关的磨损引发了老年人群中腰痛 (LBP) 的患病率反过来,美国刺激了对脊柱融合装置的需求。根据 2022 年国家卫生服务中心的数据,美国 LBP 的终生发病率为 60-90%,年发病率为 5%。消息来源还指出,每年有 14.3% 的新患者因 LBP 就诊,约 1300 万人因慢性 LBP 就医。
行业发展和未来机遇:
行业内主要参与者的各种举措脊柱融合设备市场如下:
2023 年 2 月,著名的肌肉骨骼解决方案提供商 Globus Medical Inc 和脊柱技术创新先驱 NUVASIVE 同意以全股票交易方式合并。此次交易汇集了两家拥有共同创新愿景的知名肌肉骨骼技术公司,不懈追求未满足的临床需求,以改善患者护理。 2022 年 11 月,Centinel Spine LLC 宣布首次植入其 prodisc C SK 颈椎间盘置换术(TDR)产品。 prodisc C SK 系统是即将发布的三款新产品中的第二款。 2022 年 3 月,DePuy Synthes Inc 收购了 CUPTIMIZE Hip-Spine Analysis,为外科医生提供了一种易于使用的工具,以更好地理解和解决异常的影响一些需要全髋关节置换术(THA)的患者的脊柱和骨盆之间的活动能力。 CUPTIMIZE 髋关节脊柱分析提高了 VELYS 髋关节导航的手术规划能力,VELYS 髋关节导航是 DePuy Synthes 的 VELYS 数字手术互联技术平台之一。竞争格局和主要公司:
脊柱融合设备市场上的一些知名参与者包括美敦力 (Medtronic) PLC、Johnson & Johnson Services Inc、B.Braun SE、Stryker Corp、ATEC Spine Inc、Globus Medical Inc、NuVasive Inc、ZimVie Inc、Centinel Spine LLC 和 Orthofix Medical Inc。这些公司专注于新产品发布和地域扩张,以满足全球不断增长的消费者需求,并增加其专业产品组合的产品范围。他们的全球业务使他们能够为大量客户提供服务,从而扩大他们的市场份额。
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
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Frequently Asked Questions


What is the regional market scenario of the spinal fusion devices market?

Global spinal fusion devices market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the spinal fusion devices market during 2022–2030. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period.

Which product type segment led spinal fusion devices market?

The spinal fusion devices market, by product type, is bifurcated into thoracolumbar devices, cervical fixation devices, and interbody fusion devices. In 2022, the thoracolumbar devices segment held the largest share of the market by product type. And interbody fusion devices segment is estimated to grow at a significant CAGR during 2022-2030.

What are the driving factors for the spinal fusion devices market across the globe?

The factors driving the market include the increasing developments in the spinal technology by spine device companies and increasing numbers of spinal fusion procedures.

What is meant by the spinal fusion devices market?

Spinal fusion is surgery to connect two or more bones in any part of the spine. Connecting them prevents movement between them. Preventing movement helps to prevent pain. During spinal fusion, a surgeon places bone or a bonelike material in the space between two spinal bones. Metal plates, screws or rods might hold the bones together. They then can fuse and heal as one bone.

Which surgery type segment held the largest revenue (US$ Mn) in the spinal fusion devices market?

The spinal fusion devices market, by surgery type, is bifurcated into open spine surgery and minimally invasive spine surgery. In 2022, the open spine surgery segment held the largest share of the market by surgery. And minimally invasive spine surgery segment is estimated to grow at a significant CAGR during 2022-2030.

Who are the key players in the spinal fusion devices market?

Companies operating in the market are Medtronic PLC, Johnson & Johnson Services Inc, B.Braun SE, Stryker Corp, ATEC Spine Inc, Globus Medical Inc, NuVasive Inc, ZimVie Inc, Centinel Spine LLC, and Orthofix Medical Inc.

The List of Companies - Spinal Fusion Devices Market

  1. DePuy Synthes Inc.
  2. Stryker Corp
  3. B. Braun SE
  4. ATEC Spine Inc.
  5. Globus Medical Inc.
  6. NuVasive Inc.
  7. ZimVie Inc.
  8. Medtronic Plc
  9. Centinel Spine LLC
  10. Orthofix Medical Inc.

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