脊柱固定裝置市場 - COVID-19 的增長、趨勢、影響和預測 (2023-2028)

在 2022 年至 2027 年的預測期內，脊柱固定裝置市場的複合年增長率預計為 6.25%。

COVID-19 大流行繼續改變著各個市場的增長，並產生了不同的直接影響。 最初，COVID-19 爆發導致醫院和診所無法在全球範圍內提供脊柱融合服務。 例如，2021 年 12 月在 PubMed 上發表的一項題為“COVID-19 大流行和選擇性脊柱手術的取消——患者會發生什麼”的研究發現，重新分配資源來照顧 COVID-19 患者可能會導致 COVID-19 患者說-19 大流行導致擇期手術停止。 擇期手術開始後，相當多的患者繼續推遲手術，其中許多人仍在等待重新安排時間，這可能會延長不適和殘疾時間。 該研究得出的結論是，超過三分之一因 COVID-19 而取消的擇期脊柱手術在恢復手術八個月後沒有進行。 在大流行期間，預計此類事件將對脊柱固定裝置的需求產生負面影響。

此外，由於出生率下降和預期壽命增加，世界人口正在迅速老齡化。 人口老齡化趨勢意味著越來越需要管理與年齡相關的脊柱疾病。 根據世界衛生組織 2021 年 5 月的數據，到 2030 年，地球上將有六分之一的人超過 60 歲。 預計 60 歲及以上的人口數量將從 2020 年的 10 億增長到 2050 年的 14 億。 到 2050 年，世界 60 歲以上人口將翻一番，達到 21 億。 從 2020 年到 2050 年，80 歲及以上的人口數量預計將增加兩倍，達到 4.26 億。 長期接觸這些生理變化和危險因素會增加脊柱疾病的發病率，需要手術干預。 因此，研究市場很可能主要受到人口老齡化和脊柱疾病增加的推動。

此外，根據 2022 年 5 月發表的一項名為“脊髓損傷”的研究，全世界每年有 25 萬至 50 萬人遭受脊髓損傷。 大多數是由於暴力和交通事故等可預防的因素造成的。 美國每年報告大約 17,000 例新的脊髓損傷 (SCI) 病例，估計有 282,000 人患有 SCI。 大多數因運動損傷而發展為 SCI 的人是男性。 16 至 30 歲年齡段的人患 SCI 的風險最大。 因此，脊髓損傷的高發率將推動未來幾年對脊柱固定裝置的需求。 此外，由於微創手術的多項優勢，人們越來越喜歡微創手術，這也推動了整個市場的增長。

主要市場參與者不斷推出的產品預計將在預測期內提振市場。 例如，2021 年 12 月，Spinewave 報告立即推出了採用 TiCell 3D 先進表面技術的 Defender 前路頸椎板和 Strongold C 3D 鈦椎體間裝置。 Defender 前路頸椎板是用於前路頸椎融合的鈦板和螺釘系統。 預計與脊柱固定裝置相關的嚴格法規將在預測期內抑制脊柱固定裝置市場的增長。

脊柱固定器市場趨勢

脊柱固定器械預計在預測期內實現健康增長

腰椎融合術是一項複雜的手術，需要使用放置在要融合的椎骨之間的螺釘。 然後在螺釘周圍進行骨移植。 該手術中使用的螺釘由鈦製成，通常會在您的餘生中固定到位。 這些手術比簡單的椎板切除術或椎間盤切除術具有更高的風險。 恢復期比平時長，手術時間4-8小時不等。

根據 2021 年 12 月發表的一項題為“在老年大鼠體內脊柱融合模型中建立新型脊柱椎間盤切除術”的研究，融合手術是脊柱最常見的外科手術之一。 美國每年進行大約 400,000 例脊柱融合手術，估計費用為 320 億美元。 因此，增加腰椎融合術的使用預計將增加對腰椎融合器械的需求並推動該領域的增長。

微創腰椎融合術領域取得重大進展。 2020 年 6 月，4WEB Medical 公司獲得美國食品和藥物管理局（FDA）的 510(k) 許可，可以銷售其獨立的前路腰椎椎間融合裝置。 此外，經腰椎椎間融合術（TLIF）和後路腰椎椎間融合術（PLIF）等微創手術的高采用率似乎也有助於市場擴張。 因此，所有上述因素預計將在預測期內推動該部門的增長。

北美有望佔據脊柱固定器械市場的最大份額

在北美地區，預計美國將佔據最大的市場份額。 美國目前在脊柱外科設備市場佔據主導地位，隨著遭受背痛和其他脊柱相關疾病困擾的美國人人數逐年增加，這種主導地位預計將在未來幾年持續下去。 根據 2020 年國家脊髓損傷統計中心的數據，美國脊髓損傷 (SCI) 的年發病率約為每百萬人 54 例，而該國目前的人口規模為 3.29 億，新增約 17,810 例每年都有案例。這意味著你已經開發了 SCI 因此，脊髓損傷負擔的增加預計將推動對脊柱固定裝置的需求並促進市場增長。

美國是世界上受 COVID-19 影響最嚴重的國家。 根據發表在《英國外科雜誌》上的題為“因 COVID-19 大流行導致選擇性手術取消：為手術恢復計劃提供信息的全球預測模型”的研究，2020 年 5 月標誌著 COVID-19 導致醫院服務中斷的高峰期以2020年的12週計算，全球約有2840萬例擇期手術被取消或推遲。 最初，對脊柱手術產品的需求下降對整個市場的增長產生了負面影響。

此外，一些市場參與者也參與實施戰略計劃，從而促進市場的增長。 例如，2021 年 6 月，Spectrum Spine 收購了用於脊髓外傷的高度獨特和專有的表面技術 BIOBraille，並開始使用該設備進行操作。 此外，2020 年 9 月，Spineology Inc .獲得了食品和藥物管理局對其專有的 Spinology 椎間融合系統“OptiMesh 可擴展椎間融合系統”的批准。 2021 年 2 月，Empirical Spine Inc. 報告了 LimiFlex 的 PMA 申請啟動，該申請為患有腰椎管狹窄症的退行性脊椎病患者減輕了壓力。 因此，所有上述因素預計將在預測期內推動市場增長。

其他福利。

• Excel 格式的市場預測 (ME) 表
• 三個月的分析師支持

內容

第一章介紹

• 研究假設和市場定義
• 調查範圍

第二章研究方法論

第 3 章執行摘要

第四章市場動態

• 市場概覽
• 市場驅動力
  • 老年人口增加
  • 脊柱疾病的發病率和患病率不斷上升
  • 越來越喜歡微創手術
• 市場製約因素
  • 與脊柱器械相關的嚴格規定
• 行業吸引力 - 波特五力分析
  • 買方/消費者議價能力
  • 供應商的議價能力
  • 新進入者的威脅
  • 替代品的威脅
  • 競爭公司之間的敵對關係

第 5 章市場細分（基於價值的市場規模：百萬美元）

• 按類型
  • 頸椎固定裝置
  • 胸椎固定裝置
  • 腰椎固定裝置
• 按手術類型
  • 開放式脊柱手術
  • 微創脊柱手術
• 按地區
  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 意大利
    • 西班牙
    • 其他歐洲地區
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 澳大利亞
    • 韓國
    • 其他亞太地區
  • 中東
    • 海灣合作委員會
    • 南非
    • 其他中東地區
  • 南美洲地區
    • 巴西
    • 阿根廷
    • 其他南美洲

第六章競爭格局

• 公司簡介
  • 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 市場機會今後動向

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