市場調查報告書
商品編碼
1198463
脊髓刺激器市場——COVID-19 的增長、趨勢、影響和預測 (2023-2028)Spinal Cord Stimulation Devices Market - Growth, Trends, and Forecasts (2023 - 2028) |
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在預測期內 (2022-2027),脊髓刺激器市場預計將以 8.5% 的複合年增長率增長。
在 COVID-19 大流行期間,脊髓刺激器市場受到供應鏈問題的不利影響。 各種研究提供了有關 Covid 對脊髓刺激的影響的見解。 例如,2021 年 8 月,一項名為“COVID-19 大流行對英國等待脊髓刺激手術的患者的影響”的研究發表了。 根據多中心患者調查,脊髓刺激 (SCS) 是慢性頑固性神經性疼痛的推薦治療方法。 在 COVID-19 流行期間,擇期手術已無限期推遲,以提供處理緊急情況的能力,並避免將擇期手術患者暴露於 COVID-19。 因此,此類研究可以深入了解大流行對南海的負面影響。
脊柱疾病和慢性背痛的患病率上升以及醫療報銷的可用性等因素是市場增長的主要驅動力。 國家脊髓損傷統計中心 2021 年 6 月的一份報告估計,美國約有 296,000 人患有脊髓損傷。 在這一人群中,大約 78% 的脊髓損傷發生在男性,其餘 22% 發生在女性。 在這 34,683 名樣本中,最常見的脊髓損傷原因是車禍 (32%)、跌倒 (23.1%)、槍傷 (15.2%)、摩托車事故 (6.1%) 和潛水 (5.7%)。
同樣,2021 年 8 月,宣布了一項名為“脊髓損傷”的研究,指出全世界每年有 25 萬至 50 萬患者遭受脊髓損傷。 這些案件中的大多數是由於暴力和車禍等可預防的原因造成的。 它還指出,美國每年約有 17,000 例新的脊髓損傷 (SCI)。 同樣,腰痛也是市場增長因素之一。 例如,2021 年 11 月發表的一項題為“急性和慢性腰痛的干預措施”的研究。 2021 年修訂版”指出,腰痛 (LBP) 仍然是一種具有社會後果的肌肉骨骼疾病。 在世界範圍內,背痛非常普遍,是導致殘疾的主要原因。 因此,脊髓損傷和腰痛的增加可能會增加脊髓刺激器的消耗,從而增加市場增長。
對脊髓刺激器的需求正在增加。 例如,2022 年 2 月,世界醫療保健技術領導者之一美敦力公司報告了印度的第一個臨床程序,其 Intellis 脊髓刺激 (SCS) 平台。 它是世界上最小的 SCS 設備,用於治療某些類型的慢性頑固性疼痛。 在新興國家使用這種技術先進的產品可能會促進未來的市場增長。
報銷也是推動市場增長的因素之一。 例如,在 2021 年 12 月發表的題為“2022 年全國門診手術中心 (ASC) 的平均支付率”的報告中,帶有 Perc 導線的 SCS 植入物(插入或更換脊髓神經刺激器脈衝發生器或接收器,直接或電感耦合)贖回成本為 24,424 美元。 同樣,用於植入神經刺激器電極、板/槳和硬膜外的椎板切除術的費用為 17,146 美元。 因此,上述因素將增加未來市場的增長。
但是,與脊髓刺激器相關的風險可能會阻礙市場增長。
退行性椎間盤疾病 (DDD) 是指脊柱中一個或多個椎間盤因年齡增長而退化,導致背部和頸部疼痛。 流行程度的提高和產品批准等因素正在推動這一細分市場的增長。
關於椎間盤退變的各種研究已經發表。 例如,2022 年 2 月發表的一項題為“腰椎退行性椎間盤疾病”的研究表明,大多數椎間盤退變是無症狀的,因此很難真正了解患病率。 同一份文件還指出,椎間盤退變和椎間盤突出的定義並不統一,因此很難在多項研究中檢驗實際患病率。 對 20 項評估無症狀個體磁共振成像 (MRI) 研究的薈萃分析報告了各個層面的椎間盤異常。 20% 至 83% 的信號強度損失,10% 至 81% 的椎間盤突出,3% 至 63% 的椎間盤突出(0% 至 24% 的椎間盤突出),3% 至 56% 的椎間盤狹窄 %,環狀撕裂範圍為 6 % 至 56%。
同樣,2021 年 8 月發表的另一項名為“頸椎間盤退變”的研究表明,頸椎椎間盤退變與腰椎一樣,是一種與年齡相關的自然現象。。 同一份文件指出,無論患者的症狀如何,宮頸 DDD 的患病率都會隨著年齡的增長而增加。 四分之一的 40 歲以下患者有椎間盤退變或某一節段狹窄的證據。 這一證據見於同一人群中大約 60% 的 40 歲以上患者。 因此,DDD 的患病率很普遍,預計未來會增加。
臨床試驗是推動市場增長的另一個因素。 例如,2021 年 2 月,Mesoblast Limited 是治療炎症性疾病的同種異體細胞藥物的全球領導者之一,它宣布將治療因退行性椎間盤疾病 (DDD) 引起的慢性腰痛,這種疾病對阿片類藥物等可用療法無效。已從美國食品和藥物管理局 (FDA) 組織和高級治療辦公室 (OTAT) 收到關於 rexlemestrocel-L 在 CLBP 患者中的第 3 期計劃的反饋。 此類臨床試驗將增加市場創新,並有望在未來增長。 因此,由於上述因素,未來市場可能會增長。
市場研究的主要驅動因素是脊髓損傷 (SCI) 的增加、該地區的產品發布和研究。
各種研究提供了對北美地區脊髓損傷 (SCI) 流行病學的深入了解。 例如,在 2021 年,宣布了一項名為“制定加拿大脊髓損傷最佳實踐 (Can-SCIP) 指南”的研發工作。 根據方法和概述,可用的 SCI 特定臨床實踐指南 (CPG) 解決了特定的疾病、健康狀況或連續護理的一部分,但個人的護理之旅。它說它不能解決出現的每一個重要的臨床問題. 為了解決這一差距,SCI 專家組成的專家小組召集起來製定加拿大脊髓損傷最佳實踐 (Can-SCIP) 指南。 因此,標準指南可以提供更好的方法來改善治療結果,而高成功率可能會推動脊髓刺激器的採用。
產品發布也是該地區增長的一個因素。 2021 年 1 月,波士頓科學公司宣布其脊髓刺激器 (SCS) 系統產品組合 WaveWriter Alpha 限量上市。 由四個 MRI 條件、支持藍牙的可充電和不可充電植入式脈衝發生器 (IPG) 組成的統一產品組合提供了無與倫比的個性化服務,並且在 SCS 上首次推出了速效亞感知療法 (FAST),旨在提供深度、數分鐘內無感覺的疼痛緩解。 此類產品的推出將促進該地區的市場增長。
產品批准也是市場增長的一個因素。 例如,2021 年 7 月,美國食品藥品監督管理局 (FDA) 批准了 Senza 脊髓刺激 (SCS) 系統。 這是一種可植入、可充電的脊髓刺激系統,旨在治療難以控制的軀乾和四肢的長期(慢性)疼痛。
因此,上述因素有望推動未來的市場增長。
市場部分分散,由幾家大型企業組成。 從市場份額的角度來看,一些主要參與者目前主導著市場。 目前主導市場的公司包括 Abbott Laboratories, Inc.、Boston Scientific Corporation、Saluda Medical Pty Ltd.、Medtronic 和 NEVRO CORP 等公司。
The Spinal Cord Stimulation Devices Market is projected to register a CAGR of 8.5% during the forecast period (2022-2027).
During the COVID-19 pandemic, the spinal cord stimulation devices market was adversely affected due to supply chain issues. Various research studies have provided insight into the impact of Covid on spinal cord stimulations. For instance, in August 2021, a research study published titled "The Impact of the COVID-19 Pandemic on Patients Awaiting Spinal Cord Stimulation Surgery in the United Kingdom: A Multi-Center Patient Survey" stated that spinal cord stimulation (SCS) is a recommended treatment for chronic refractory neuropathic pain. During the COVID-19 pandemic, elective procedures have been postponed indefinitely both to provide capacity to deal with the emergency caseload and to avoid exposure of elective patients to COVID-19. Hence, such studies provide insight into the negative impact of the pandemic on SCS.
Factors such as the rising prevalence of spinal disorders and chronic lower back pains coupled with the availability of medical reimbursements are key factors for the growth of the market. According to the National Spinal Cord Injury Statistical Center June 2021 report, it is estimated that about 296,000 people in the United States are living with a spinal cord injury. Of this population, about 78% of spinal cord injury cases occur in males, while the remaining 22% occur in females. The most common causes of SCI in this sample of 34,683 include auto accidents (32%), falls (23.1%), gunshot wounds (15.2%), motorcycle accidents (6.1%), and Diving (5.7%).
Similarly, in August 2021, a research study published titled "Spinal Cord Injuries" stated that globally between 250,000 and 500,000 patients each year suffer a spinal cord injury. Most of these cases are due to preventable causes such as violence and motor vehicle accidents. The same source stated that in the United States, there are approximately 17,000 new cases of spinal cord injuries (SCI) each year. Similarly, lower back pains are another factor in the growth of the market. For instance, in November 2021, a research study published titled "Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021" stated that low back pain (LBP) remains a musculoskeletal condition with an adverse societal impact. Globally, LBP is highly prevalent and a leading cause of disability. Hence, increasing spinal cord injury and lower back pain would increase the consumption of spinal cord stimulation devices and will increase the market growth.
The demand for spinal cord stimulators is increasing. For instance, in February 2022, Medtronic plc, one of the global leaders in healthcare technology, reported the first clinical procedure in India with the Intellis spinal cord stimulation (SCS) platform. It is one of the world's smallest SCS devices for the management of certain types of chronic intractable pain. Such use of technologically advanced products in developing countries would increase market growth in the upcoming future.
Reimbursement is another factor in the growth of the market. For instance, in the December 2021 report published titled "2022 National Average Payment Rate for Ambulatory Surgery Center (ASC)," the reimbursement cost for SCS Implant with Perc Leads (Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling) is USD 24,424. Similarly, the cost for laminectomy for implantation of neurostimulator electrodes, plate/paddle, and epidural is USD 17,146. Thus, the abovementioned factors will increase market growth in the upcoming future.
However, the risk associated with spinal cord stimulation devices would hinder the market growth.
Degenerative disc disease (DDD) is a condition where one or more discs in the spine deteriorate due to age, which results in back or neck pain. Factors such as increasing prevalence and product approvals are driving the growth of this segment.
Various research studies have been published on degenerative disc diseases. For instance, in February 2022, a research study published titled "Lumbar Degenerative Disk Disease" stated that most intervertebral disc degenerations are asymptomatic, making a true understanding of the prevalence difficult. The same source stated that, due to the lack of uniformity in the definitions of disc degenerations and disc herniations, the actual prevalence of the disease is difficult to review across multiple studies. In a meta-analysis of 20 studies evaluating the magnetic resonance imaging (MRI) of asymptotic individuals, the reported disc abnormalities at any level were: 20% to 83% for a reduction in signal intensity, 10% to 81% for disc bulges, 3% to 63% for disc protrusion (versus 0% to 24% for disc extrusion), 3% to 56% for disc narrowing, and 6% to 56% with annular tears.
Similarly, another research published in August 2021, titled "Cervical Degenerative Disc Disease," stated that similar to the lumbar spine, cervical disc degeneration is a naturally occurring age-related phenomenon. The same source stated that the prevalence of cervical DDD increases with age regardless of the patient's symptomatology. A quarter of patients less than the age of 40 showed evidence of disk degeneration or narrowing at one level. This evidence was found in about 60% of patients in the same population who were greater than 40 years old. Hence, the prevalence of DDD is common and will increase in the upcoming future.
Clinical trials are another factor in the growth of the market. For instance, in February 2021, Mesoblast Limited, one of the global leaders in allogeneic cellular medicines for inflammatory diseases, received feedback from the United States Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) on the Phase III program of rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids. Such clinical trials increase the innovation in the market, which increases the growth of the market in the upcoming future. Hence, due to the abovementioned factors, the market is likely to grow in the future.
The key factors propelling the market studied are increasing spinal cord injuries (SCI), product launches, and research studies in the region.
Various research studies have provided insight into the epidemiology of spinal cord injury (SCI) in the North American region. For instance, in 2021, a research study published titled "Development of the Canadian Spinal Cord Injury Best Practice (Can-SCIP) Guideline: Methods and overview" stated that the available SCI-specific clinical practice guidelines (CPG) address specific impairments, health conditions, or a segment of the care continuum, however, fail to address all the important clinical questions arising throughout an individual's care journey. To address this gap, an interprofessional panel of experts in SCI convened to develop the Canadian Spinal Cord Injury Best Practice (Can-SCIP) Guideline. Hence, standard guidelines could provide better methods to increase the treatment outcomes, which would increase the adoption of spinal cord stimulation devices due to a higher success rate.
Product launches are another factor in the growth of the region. In January 2021, Boston Scientific reported a limited market release of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems. The unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable, and non-rechargeable implantable pulse generators (IPGs) provides uncompromised personalization, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST) is designed to deliver profound paresthesia-free pain relief in minutes. Such product launches would increase the market growth in the region.
Product approval is another factor in the growth of the market. For instance, in July 2021, Food and Drug Administration (FDA) approved Senza Spinal Cord Stimulation (SCS) System. It is an implanted, rechargeable spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage.
Hence, the abovementioned factors would increase market growth in the upcoming future.
The market is partially fragmented and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Abbott Laboratories, Inc., Boston Scientific Corporation, Saluda Medical Pty Ltd., Medtronic, and NEVRO CORP., among others.