市场调查报告书
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1463593
到 2030 年北美脊椎融合装置市场预测 - 区域分析 - 按产品类型、手术类型、疾病适应症和最终用户North America Spinal Fusion Devices Market Forecast to 2030 - Regional Analysis - By Product Type, Surgery Type, Disease Indications, and End User |
2022年北美脊椎融合装置市值为38.6893亿美元,预计2030年将达到60.7564亿美元;预计 2022 年至 20 30 年复合CAGR为 5.8%。
脊椎器材公司对脊椎技术的不断发展推动了北美脊椎融合器材市场的发展
脊椎器材公司广泛采用创新、分拆以及併购发展或策略。这些策略有助于标誌着北美脊椎融合装置市场在 2022 年实现指数级成长。
2022 年 8 月,凯鹏华盈设备实验室宣布使用其新型 KG2 Surge flow-thru 椎间系统成功完成了首次手术。 2022年7月19日,美国纽约布鲁克林医院中心实施单节经椎间孔腰椎椎间融合术(TLIF)手术。 Kleiner Device Labs 声称,新型 KG2 Surge flow-thru 椎间系统提供的骨移植材料量是传统脊椎手术方法的三倍。该公司还声称,他们的 KG2 Surge flow-thru 椎间系统是一种单一患者使用的骨移植输送工具,与 3D 列印的钛 I-Beam 融合植入物相结合。此外,KG2 Surge 流通式椎间系统将把多步骤、多器械透过练习减少到目前脊椎融合手术的单一插入过程。
2022 年 3 月,Zimmer Biomet Holdings, Inc. 宣布完全分拆 ZimVie。 ZimVie 将继续专注于脊椎和牙科市场的关键成长策略。该公司将开发产品,包括脊椎融合植入物、手术工具、骨移植、植入物、非融合替代品和数位护理技术。由于分拆,ZimVie 将作为在纳斯达克註册的独立实体运营,代码为「ZIMV」。因此,预计 ZimVie 将透过保持良好的市场份额来显着增强市场。
2022 年 10 月,Spineart 推出了新型微创脊椎手术 (MISS) 系统 PERLA TL MIS。该公司的 MISS 系统是一款全球通用的胸腰椎后路固定係统。 PERLA TL MIS 的推出预计将表明该公司致力于改变脊椎手术,使其最终用户受益:外科医生、患者和医院。此类产品的推出可能会在未来推动市场成长。
脊椎产业的发展趋势仍在继续,并见证了策略改进,推动了北美脊椎融合装置市场的成长。
2023年7月,Xtant Medical Holdings, Inc.宣布取得Surgalign Holdings, Inc.与脊椎固定及国内外生物製剂相关的部分资产负债。 Xtant Medical Holdings, Inc. 致力于开发脊椎植入系统,以促进复杂脊椎畸形退化过程中的脊椎融合。因此,脊椎设备公司在脊椎技术方面的发展正在促进市场的成长。
北美脊椎融合装置市场概况
DePuy Synthes、Stryker、Aurora Spine 和 Alevio Spine 是美国北美脊椎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成长。经美国食品药物管理局 (FDA) 批准的技术先进的脊椎融合装置在美国已被广泛采用。以下是 FDA 最近批准的脊椎融合装置清单:
2023 年 5 月,CTL Amedica 获得 FDA 510(k) 批准,允许 NITRO 椎间融合笼系统商业化,该系统专门由生物材料氮化硅融合而成。氮化硅材料与所有成像模式相容;它具有独特的抑菌特性并提供无伪影的成像。
2023 年 1 月,Alevio Spine 获得了 SI-Cure SI 关节融合系统附加适应症的 510 (K) 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 前路腰椎椎间融合器 (ALIF) 的 510K 许可。基于 DEXA 技术平台,3D 列印独立设备专为前侧和侧向腰椎椎间融合 (ALIF 和 LLIF) 手术而设计。
与年龄相关的磨损引发了美国老年族群中腰痛 (LBP) 的流行,进而刺激了对脊椎融合装置的需求。根据 2022 年国家卫生服务中心的数据,美国 LBP 的终生发生率为 60-90%,年发生率为 5%。消息来源也指出,每年有 14.3% 的新患者因腰痛就诊,约 1,300 万人因慢性腰痛就诊。
北美脊椎融合装置市场收入及 2030 年预测(百万美元)
北美脊椎融合设备市场细分
北美脊椎融合装置市场根据产品类型、手术类型、疾病适应症、最终用户和国家进行细分。
根据产品类型,北美脊椎融合装置市场分为胸腰椎装置、颈椎固定装置和椎间融合装置。 2022 年,胸腰椎器械领域占据最大份额。
依手术类型划分,北美脊椎融合装置市场分为开放式脊椎手术和微创脊椎手术。 2022 年,开放式脊椎手术领域占最大份额。
依疾病适应症,北美脊椎融合装置市场分为退化性椎间盘、创伤和骨折、复杂畸形等。 2022 年,退化性椎间盘细分市场占据最大份额。
就最终用户而言,北美脊椎融合装置市场分为医院、专科诊所等。 2022 年,医院领域占最大份额。
按国家/地区划分,北美脊椎融合装置市场分为美国、加拿大和墨西哥。 2022年,美国将主导北美脊椎融合装置市场。
ATEC Spine Inc、B. Braun SE、Centinel Spine LLC、DePuy Synthes Inc、Globus Medical Inc、Medtronic Plc、NuVasive Inc、Orthofix Medical Inc、Stryker Corp 和 ZimVie Inc 是北美脊椎融合领域的一些领先公司设备市场。
The North America spinal fusion devices market was valued at US$ 3,868.93 million in 2022 and is expected to reach US$ 6,075.64 million by 2030; it is estimated to grow at a CAGR of 5.8% from 2022 to 20 30.
Increasing Developments in Spinal Technology by Spine Device Companies Fuels the North America Spinal Fusion Devices Market
The spine device companies widely adopted innovation, spinoffs, and merger and acquisition developments or strategies. The strategies have helped mark an exponential growth of the North America spinal fusion devices market in 2022. Below are a few instances of developments made by the companies in 2022.
In August 2022, Kleiner Device Labs announced the completion of its first successful surgery using its new KG2 Surge flow-thru interbody system. On July 19, 2022, the single level transforaminal lumbar interbody fusion (TLIF) surgery was performed at the Brooklyn Hospital Center, New York, US. Kleiner Device Labs claims that the new KG2 Surge flow-thru interbody system provided the amount of bone-grafting material three times more than the traditional spinal surgery approaches. The company also claims that their KG2 Surge flow-thru interbody system is a single-patient-use bone graft delivery tool combined with a 3D-printed titanium I-Beam fusion implant. Further, the KG2 Surge flow-thru interbody system will reduce multi-step, multi-instrument pass practice to a single insertion process of current spinal fusion procedures.
In March 2022, Zimmer Biomet Holdings, Inc. announced a complete spinoff of ZimVie. ZimVie will continue to focus on key growth strategies for the spine and dental markets. The company will develop products, including spinal fusion implants, surgical tools, bone grafts, implants, non-fusion alternatives, and digital care technologies. Due to the spinoff, ZimVie will operate as an independent entity registered on the Nasdaq with the symbol 'ZIMV.' Thus, it is expected that ZimVie will significantly enhance the market by holding a good market share.
In October 2022, Spineart launched its new minimally invasive spine surgery (MISS) system, PERLA TL MIS. The company's MISS system is a thoracolumbar posterior fixation system available worldwide. The launch of PERLA TL MIS is anticipated to demonstrate the company's commitment to transforming spine surgery to benefit its end users: surgeons, patients, and hospitals. Such product launches are likely to drive market growth in the coming future.
The trend of developments in the spine industry has continued and witnessed strategic improvements that have fueled the growth of the North America spinal fusion devices market.
In July 2023, Xtant Medical Holdings, Inc. announced that it won certain assets and liabilities of Surgalign Holdings, Inc. related to spinal fixation and domestic and international biologics. Xtant Medical Holdings, Inc. is dedicated to developing spinal implant systems that facilitate spinal fusion in complex spinal deformity degenerative processes. Thus, such developments in spinal technology by spine device companies are catalyzing the market growth.
North America Spinal Fusion Devices Market Overview
DePuy Synthes, Stryker, Aurora Spine, and Alevio Spine are among the major players operating in the North America spinal fusion devices market in the US. Product developments and launches driven by these players favor the market growth. Technologically advanced spinal fusion devices approved by the Food and Drug Administration (FDA) are widely adopted in the US. Following is the list of spinal fusion devices recently approved by the FDA:
In May 2023, CTL Amedica received FDA 510(k) clearance for the commercialization of the NITRO Interbody Fusion Cage System, which is exclusively made by the fusion of biomaterial silicon nitride. Silicon nitride material is compatible with all imaging modalities; it exhibits unique bacteriostatic properties and provides artifact-free imaging.
In January 2023, Alevio Spine received 510 (K) clearance of additional indications for the SI-Cure SI Joint Fusion System. The expanded indication includes sacroiliac fusion for skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
In June 2022, the US FDA granted 510K clearance for Aurora Spine's DEXA SOLO-L anterior lumbar interbody fusion device (ALIF). Based on DEXA Technology Platform, a 3D printed standalone device was designed for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures.
Age-related wear-and-tear triggers the prevalence of lower back pain (LBP) among the geriatric population in the US, in turn, fuels the demand for spinal fusion devices. According to National Health Services in 2022, lifetime incidence of LBP in the US is reported to be 60-90%, with annual incidence of 5%. The source also states that 14.3% of new patients visit physicians each year because of LBP, and ~13 million people visit physician due to chronic LBP.
North America Spinal Fusion Devices Market Revenue and Forecast to 2030 (US$ Million)
North America Spinal Fusion Devices Market Segmentation
The North America spinal fusion devices market is segmented based on product type, surgery type, disease indications, end user, and country.
Based on product type, the North America spinal fusion devices market is segmented into thoracolumbar devices, cervical fixation devices, and interbody fusion devices. The thoracolumbar devices segment held the largest share in 2022.
By surgery type, the North America spinal fusion devices market is bifurcated into open spine surgery and minimally invasive spine surgery. The open spine surgery segment held the largest share in 2022.
By disease indications, the North America spinal fusion devices market is segmented into degenerative disc, trauma and fractures, complex deformity, and others. The degenerative disc segment held the largest share in 2022.
In terms of end users, the North America spinal fusion devices market is categorized into hospitals, specialty clinics, and others. The hospitals segment held the largest share in 2022.
Based on country, the North America spinal fusion devices market is segmented into the US, Canada, and Mexico. The US dominated the North America spinal fusion devices market in 2022.
ATEC Spine Inc, B. Braun SE, Centinel Spine LLC, DePuy Synthes Inc, Globus Medical Inc, Medtronic Plc, NuVasive Inc, Orthofix Medical Inc, Stryker Corp, and ZimVie Inc are some of the leading companies operating in the North America spinal fusion devices market.