脊柱固定装置市场 - COVID-19 的增长、趋势、影响和预测 (2023-2028)

在 2022 年至 2027 年的预测期内，脊柱固定装置市场的复合年增长率预计为 6.25%。

COVID-19 大流行继续改变着各个市场的增长，并产生了不同的直接影响。 最初，COVID-19 爆发导致医院和诊所无法在全球范围内提供脊柱融合服务。 例如，2021 年 12 月在 PubMed 上发表的一项题为“COVID-19 大流行和选择性脊柱手术的取消——患者会发生什么”的研究发现，重新分配资源来照顾 COVID-19 患者可能会导致 COVID-19 患者说-19 大流行导致择期手术停止。 择期手术开始后，相当多的患者继续推迟手术，其中许多人仍在等待重新安排时间，这可能会延长不适和残疾时间。 该研究得出的结论是，超过三分之一因 COVID-19 而取消的择期脊柱手术在恢復手术八个月后没有进行。 在大流行期间，预计此类事件将对脊柱固定装置的需求产生负面影响。

此外，由于出生率下降和预期寿命增加，世界人口正在迅速老龄化。 人口老龄化趋势意味着越来越需要管理与年龄相关的脊柱疾病。 根据世界卫生组织 2021 年 5 月的数据，到 2030 年，地球上将有六分之一的人超过 60 岁。 预计 60 岁及以上的人口数量将从 2020 年的 10 亿增长到 2050 年的 14 亿。 到 2050 年，世界 60 岁以上人口将翻一番，达到 21 亿。 从 2020 年到 2050 年，80 岁及以上的人口数量预计将增加两倍，达到 4.26 亿。 长期接触这些生理变化和危险因素会增加脊柱疾病的发病率，需要手术干预。 因此，研究市场很可能主要受到人口老龄化和脊柱疾病增加的推动。

此外，根据 2022 年 5 月发表的一项名为“脊髓损伤”的研究，全世界每年有 25 万至 50 万人遭受脊髓损伤。 大多数是由于暴力和交通事故等可预防的因素造成的。 美国每年报告大约 17,000 例新的脊髓损伤 (SCI) 病例，估计有 282,000 人患有 SCI。 大多数因运动损伤而发展为 SCI 的人是男性。 16 至 30 岁年龄段的人患 SCI 的风险最大。 因此，脊髓损伤的高发率将推动未来几年对脊柱固定装置的需求。 此外，由于微创手术的多项优势，人们越来越喜欢微创手术，这也推动了整个市场的增长。

主要市场参与者不断推出的产品预计将在预测期内提振市场。 例如，2021 年 12 月，Spinewave 报告立即推出了采用 TiCell 3D 先进表面技术的 Defender 前路颈椎板和 Strongold C 3D 钛椎体间装置。 Defender 前路颈椎板是用于前路颈椎融合的钛板和螺钉系统。 预计与脊柱固定装置相关的严格法规将在预测期内抑制脊柱固定装置市场的增长。

脊柱固定器市场趋势

脊柱固定器械预计在预测期内实现健康增长

腰椎融合术是一项复杂的手术，需要使用放置在要融合的椎骨之间的螺钉。 然后在螺钉周围进行骨移植。 该手术中使用的螺钉由钛製成，通常会在您的余生中固定到位。 这些手术比简单的椎板切除术或椎间盘切除术具有更高的风险。 恢復期比平时长，手术时间4-8小时不等。

根据 2021 年 12 月发表的一项题为“在老年大鼠体内脊柱融合模型中建立新型脊柱椎间盘切除术”的研究，融合手术是脊柱最常见的外科手术之一。 美国每年进行大约 400,000 例脊柱融合手术，估计费用为 320 亿美元。 因此，增加腰椎融合术的使用预计将增加对腰椎融合器械的需求并推动该领域的增长。

微创腰椎融合术领域取得重大进展。 2020 年 6 月，4WEB Medical 公司获得美国食品和药物管理局（FDA）的 510(k) 许可，可以销售其独立的前路腰椎椎间融合装置。 此外，经腰椎椎间融合术（TLIF）和后路腰椎椎间融合术（PLIF）等微创手术的高采用率似乎也有助于市场扩张。 因此，所有上述因素预计将在预测期内推动该部门的增长。

北美有望占据脊柱固定器械市场的最大份额

在北美地区，预计美国将占据最大的市场份额。 美国目前在脊柱外科设备市场占据主导地位，随着遭受背痛和其他脊柱相关疾病困扰的美国人人数逐年增加，这种主导地位预计将在未来几年持续下去。 根据 2020 年国家脊髓损伤统计中心的数据，美国脊髓损伤 (SCI) 的年发病率约为每百万人 54 例，而该国目前的人口规模为 3.29 亿，新增约 17,810 例每年都有案例。这意味着你已经开发了 SCI 因此，脊髓损伤负担的增加预计将推动对脊柱固定装置的需求并促进市场增长。

美国是世界上受 COVID-19 影响最严重的国家。 根据发表在《英国外科杂誌》上的题为“因 COVID-19 大流行导致选择性手术取消：为手术恢復计划提供信息的全球预测模型”的研究，2020 年 5 月标誌着 COVID-19 导致医院服务中断的高峰期以2020年的12週计算，全球约有2840万例择期手术被取消或推迟。 最初，对脊柱手术产品的需求下降对整个市场的增长产生了负面影响。

此外，一些市场参与者也参与实施战略计划，从而促进市场的增长。 例如，2021 年 6 月，Spectrum Spine 收购了用于脊髓外伤的高度独特和专有的表面技术 BIOBraille，并开始使用该设备进行操作。 此外，2020 年 9 月，Spineology Inc .获得了食品和药物管理局对其专有的 Spinology 椎间融合系统“OptiMesh 可扩展椎间融合系统”的批准。 2021 年 2 月，Empirical Spine Inc. 报告了 LimiFlex 的 PMA 申请启动，该申请为患有腰椎管狭窄症的退行性脊椎病患者减轻了压力。 因此，所有上述因素预计将在预测期内推动市场增长。

其他福利。

• Excel 格式的市场预测 (ME) 表
• 三个月的分析师支持

内容

第一章介绍

• 研究假设和市场定义
• 调查范围

第二章研究方法论

第 3 章执行摘要

第四章市场动态

• 市场概览
• 市场驱动力
  • 老年人口增加
  • 脊柱疾病的发病率和患病率不断上升
  • 越来越喜欢微创手术
• 市场製约因素
  • 与脊柱器械相关的严格规定
• 行业吸引力 - 波特五力分析
  • 买方/消费者议价能力
  • 供应商的议价能力
  • 新进入者的威胁
  • 替代品的威胁
  • 竞争公司之间的敌对关係

第 5 章市场细分（基于价值的市场规模：百万美元）

• 按类型
  • 颈椎固定装置
  • 胸椎固定装置
  • 腰椎固定装置
• 按手术类型
  • 开放式脊柱手术
  • 微创脊柱手术
• 按地区
  • 北美
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 其他欧洲地区
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 澳大利亚
    • 韩国
    • 其他亚太地区
  • 中东
    • 海湾合作委员会
    • 南非
    • 其他中东地区
  • 南美洲地区
    • 巴西
    • 阿根廷
    • 其他南美洲

第六章竞争格局

• 公司简介
  • Johnson and Johnson
  • Globus Medical Inc.
  • Medtronic PLC
  • Zimmer Biomet Holdings Inc.
  • B Braun Melsungen AG
  • Stryker Corporation
  • NuVasive
  • Integra LifeSciences
  • Alphatec Holdings Inc.
  • Orthofix Holdings Inc.
  • RTI Surgical Inc.
  • Stryker Corporation
  • Matrix Meditec Pvt Ltd
  • SpineEX

第7章 市场机会今后动向

The spinal fusion devices market is projected to register a CAGR of 6.25% during the forecast period, 2022-2027.

The COVID-19 pandemic has been continuing to transform the growth of various markets, and the immediate impact of the outbreak is varied. Initially, the COVID-19 outbreak, worldwide, has been inhibiting hospitals and clinics from providing spine fusion services. For instance, a research study titled "COVID-19 pandemic and elective spinal surgery cancelations - what happens to the patients?" published in PubMed, in December 2021, stated that due to the reallocation of resources to the care of COVID-19 patients, the COVID-19 pandemic resulted in a suspension of elective procedures. Following the start of elective surgeries, a considerable number of patients continued to postpone surgery, with many still waiting to be rescheduled, potentially prolonging their discomfort and impairment of function. The study concluded that over one-third of the elective spine procedures that were canceled due to COVID-19 had not been performed in the eight months since the procedures were resumed. During the pandemic phase, such events are expected to have a negative impact on the demand for spinal fusion devices.

Moreover, the global population is aging rapidly due to the reduced birth rates and increasing life expectancy. The demographic trend toward an aging population represents an increasing need for the management of old age-associated spine disorders. According to the World Health Organization in May 2021, by 2030, 1 out of every 6 people on the planet will be 60 years old or older. The number of people aged 60 and up is expected to rise from 1 billion in 2020 to 1.4 billion by 2050. By 2050, the global population of people aged 60 and above will get double to reach 2.1 billion. Between 2020 and 2050, the number of people aged 80 and above is expected to triple, reaching 426 million.​ These physiological changes and prolonged exposure to risk factors increase the incidence rates of spine disorders, which may require surgical intervention. Hence, the market studied may be majorly driven by the aging population rise and growing spine disorders.

Moreover, as per the study titled "Spinal Cord Injuries" published in May 2022, every year, between 250,000 and 500,000 people worldwide suffer a spinal cord injury. The majority of these cases are the result of preventable factors such as violence and car accidents. Each year, approximately 17,000 new cases of spinal cord injury (SCI) are reported in the United States, with an estimated 282,000 people living with SCI. The majority of patients with SCI caused by a sports injury are men. The age group from 16 to 30 years old has the highest risk of SCI. Thus, the high incidence of spinal cord injuries surges the demand for spinal fusion devices over the coming years. Furthermore, the increasing preference for minimally invasive surgeries due to several benefits is propelling the overall market growth.

Increasing product launches by the key market players are anticipated to boost the market over the forecast period. For instance, in December 2021, Spine Wave reported the immediate launch of both the Defender Anterior Cervical Plate and the Stronghold C 3D Titanium Interbody Device featuring TiCell 3D advanced surface technology. The Defender Anterior Cervical Plate is a titanium plate and screw system that provides fixation for anterior cervical fusion procedures. The stringent regulation associated with spinal devices is expected to restrain the growth of the spinal fusion devices market over the forecast period.

Spinal Fusion Devices Market Trends

Lumbar Fusion Devices are Expected to Witness Healthy Growth Over the Forecast Period

Lumbar fusion is a complex operation that requires the use of screws placed between the vertebrae to be fused. The bone graft is then placed around these screws. The screws that are used during this operation are made of titanium and are usually placed for a lifetime. These operations involve higher risks than simple laminectomies or discectomies. The recovery period is typically longer after this procedure, and operating time can be anywhere between four to eight hours.

According to the study titled "Establishment of a Novel Method for Spinal Discectomy Surgery in Elderly Rats in an In Vivo Spinal Fusion Model" published in December 2021, fusion surgery is one of the most common surgical procedures for the spine. Annually, approximately 400,000 spinal fusions are performed in the United States, with estimated costs of USD 32 billion. Thus, increasing the use of lumbar fusion surgery is anticipated to rise in demand for lumber fusion devices thereby boosting the segment growth.

There have been significant advancements in the field of minimally invasive lumbar fusions. In June 2020, the company 4WEB Medical received the 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device. The high adoption rates of minimally invasive procedures, such as transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are contributing to the market expansion. Thus, all aforementioned factors are anticipated to drive the segment growth over the forecast period.

North America Region is Expected to Hold Largest Share in the Spinal Fusion Devices Market

Within North America, the United States is expected to have the largest market share. The United States currently dominates the market for spinal surgery devices, and this dominance is expected to continue in the coming years as the number of Americans suffering from lower back pain and other spine-related disorders rises year after year. According to the National Spinal Cord Injury Statistical Center 2020, the annual incidence of spinal cord injury (SCI) in the United States is roughly 54 cases per one million people, or approximately 17,810 new SCI cases each year, given the country's current population size of 329 million people. Thus, the growing burden of spinal cord injury is anticipated to drive the demand for spinal fusion devices thereby boosting the market growth.

The United States is the most COVID-19-affected country in the world. According to the study titled " Elective surgery cancellations due to the COVID-19 pandemic: global predictive modeling to inform surgical recovery plans" published in the British Journal of Surgery, in May 2020, based on 12 weeks of peak disruption to hospital services due to COVID-19, around 28.4 million elective surgeries worldwide were canceled or postponed 2020. Initially, there is a decline in demand for spine surgery products which has negatively impacted the overall market growth.

Furthermore, several market players are also engaged in the implementation of strategic initiatives, thereby contributing to market growth. For instance, in June 2021, Spectrum Spine, acquired a highly unique and proprietary surface technology BIOBraille for spinal trauma and has begun operations with the device. Additionally, In September 2020, the company Spineology Inc. received the Food and Drug Administration Approval of its proprietary Spineology Interbody Fusion System called OptiMesh Expandable Interbody Fusion System. In February 2021, the company Empirical Spine Inc. reported the initiation of the PMA submission process for LimiFlex with decompression for patients affected by degenerative spondylolisthesis with lumbar spinal stenosis. Thus, all aforementioned factors are anticipated to drive the market growth over the forecast period.

Spinal Fusion Devices Market Competitor Analysis

The market studied is moderately competitive and consists of local and international players across various major countries. Some of the companies are implementing strategies, such as collaboration and acquisition, to gain market share. In the future, it is expected that a few small to mid-sized companies may enter the market and hold a substantial share. Some of the key players in the market are Johnson and Johnson, Medtronic Plc, Zimmer Biomet, NuVasive Inc., and Gloobus Medical Inc. among others.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Growing Geriatric Population
  • 4.2.2 Rising Incidences and Prevalence of Spinal Problems
  • 4.2.3 Increasing Preference for Minimally Invasive Surgeries
• 4.3 Market Restraints
  • 4.3.1 Stringent Regulation Associated with Spinal Devices
• 4.4 Industry Attractiveness - Porter's Five Forces Analysis
  • 4.4.1 Bargaining Power of Buyers/Consumers
  • 4.4.2 Bargaining Power of Suppliers
  • 4.4.3 Threat of New Entrants
  • 4.4.4 Threat of Substitute Products
  • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD Million)

• 5.1 By Type
  • 5.1.1 Cervical Fusion Device
  • 5.1.2 Thoracic Fusion Device
  • 5.1.3 Lumbar Fusion Device
• 5.2 By Type of Surgery
  • 5.2.1 Open Spine Surgery
  • 5.2.2 Minimally Invasive Spine Surgery
• 5.3 Geography
  • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
  • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
  • 5.3.3 Asia Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia Pacific
  • 5.3.4 Middle East
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle East
  • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Johnson and Johnson
  • 6.1.2 Globus Medical Inc.
  • 6.1.3 Medtronic PLC
  • 6.1.4 Zimmer Biomet Holdings Inc.
  • 6.1.5 B Braun Melsungen AG
  • 6.1.6 Stryker Corporation
  • 6.1.7 NuVasive
  • 6.1.8 Integra LifeSciences
  • 6.1.9 Alphatec Holdings Inc.
  • 6.1.10 Orthofix Holdings Inc.
  • 6.1.11 RTI Surgical Inc.
  • 6.1.12 Stryker Corporation
  • 6.1.13 Matrix Meditec Pvt Ltd
  • 6.1.14 SpineEX

7 MARKET OPPORTUNITIES AND FUTURE TRENDS