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ºÏ¹ÌÀÇ Ã´Ãß °íÁ¤ ±â±â : ½ÃÀå ¿¹Ãø(2030³â) - ºÎ¹®º° ºÐ¼® - Á¦Ç°, ¼ö¼ú À¯Çü, ÀûÀÀ Áúȯ, ÃÖÁ¾ »ç¿ëÀÚº°North America Spinal Fusion Devices Market Forecast to 2030 - Regional Analysis - By Product Type, Surgery Type, Disease Indications, and End User |
ºÏ¹Ì ôÃß °íÁ¤ ±â±â(Spinal Fusion Devices) ½ÃÀåÀº 2022³â¿¡ 38¾ï 6,893¸¸ ´Þ·¯·Î Æò°¡µÇ¾ú°í, 2030³â¿¡´Â 60¾ï 7,564¸¸ ´Þ·¯¿¡ À̸¦ °ÍÀ¸·Î ¿¹ÃøµÇ¾úÀ¸¸ç, 2022-2030³âÀÇ CAGRÀº 5.8%¸¦ ³ªÅ¸³¾ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù.
ôÃß °íÁ¤ ±â±â ±â¾÷¿¡ ÀÇÇÑ Ã´Ãß±â¼úÀÇ ½ÅÈï±¹ ½ÃÀå °³Ã´ÀÌ ºÏ¹ÌÀÇ Ã´Ãß°íÁ¤±â±â ½ÃÀåÀ» Ȱ¼ºÈ
ôÃß °íÁ¤ ±â±â ±â¾÷Àº ±â¼ú Çõ½Å, ½ºÇÉ¿ÀÇÁ, M&A µî °³¹ß¡¤Àü·«À» ³Î¸® äÅÃÇϰí ÀÖ½À´Ï´Ù. ÀÌ·¯ÇÑ Àü·«À» ÅëÇØ ºÏ¹Ì ôÃß °íÁ¤ ±â±â ½ÃÀåÀº 2022³â¿¡ ºñ¾àÀûÀÎ ¼ºÀåÀ» ÀÌ·ê °ÍÀ¸·Î ¿¹»óµË´Ï´Ù. ´ÙÀ½Àº 2022³â¿¡ °¢ ȸ»ç°¡ ½Ç½ÃÇÑ °³¹ßÀÇ ¿¹ÀÔ´Ï´Ù.
2022³â 8¿ù, Kleiner Device Labs´Â »õ·Î¿î KG2 ¼Áö ÇÃ·Î¿ì ½º·ç ÀÎÅ͹ٵð ½Ã½ºÅÛÀ» »ç¿ëÇÑ ÃÖÃÊÀÇ ¼ö¼ú ¼º°øÀ» ¹ßÇ¥Çß½À´Ï´Ù. 2022³â 7¿ù 19ÀÏ, ¹Ì±¹ ´º¿åÀÇ ºê·çŬ¸° º´¿ø ¼¾ÅÍ¿¡¼ 1·¹º§ÀÇ °æÃßü ¿äÃßü°£ °íÁ¤¼ú(TLIF)ÀÌ ½Ç½ÃµÇ¾ú½À´Ï´Ù. Kleiner Device Labs´Â »õ·Î¿î KG2 ¼Áö ÇÃ·Î¿ì ½º·ç ÀÎÅÍ ¹Ùµð ½Ã½ºÅÛÀÌ ÀüÅëÀûÀΠôÃß ¼ö¼ú Á¢±Ù¹ý¿¡ ºñÇØ 3¹èÀÇ »À ÀÌ½Ä Àç·á¸¦ Á¦°øÇÒ ¼ö ÀÖ´Ù°íÇÕ´Ï´Ù. ÀÌ È¸»ç´Â ¶ÇÇÑ KG2 ¼Áö ÇÃ·Î¿ì ½º·ç ÀÎÅÍ ¹Ùµð ½Ã½ºÅÛÀÌ 3D ÇÁ¸°ÆÃ ƼŸ´½ i-Beam À¶ÇÕ ÀÓÇöõÆ®¿Í °áÇÕ µÈ ȯÀÚ 1 ÀÎ¿ë »À ÀÌ½Ä Àü´Þ µµ±¸ÀÔ´Ï´Ù. ¶ÇÇÑ KG2 ¼Áö ÇÃ·Î¿ì ½º·ç ÀÎÅÍ ¹Ùµð ½Ã½ºÅÛÀº ÇöÀçÀÇ Ã´Ãß °íÁ¤¼úÀÇ ´Ù´Ü°è, ´ÙÁ߱ⱸ Åë°ú¸¦ ´ÜÀÏ »ðÀÔ ´Ü°è·Î ÁÙÀÔ´Ï´Ù.
2022³â 3¿ù, Zimmer Biomet Holdings, Inc´Â JimbyÀÇ ¿ÏÀü ºÐ¸® µ¶¸³À» ¹ßÇ¥Çß½À´Ï´Ù. ZimVie´Â ôÃß¿Í Ä¡°ú ½ÃÀåÀÇ ÁÖ¿ä ¼ºÀå Àü·«¿¡ °è¼Ó ÁÖ·ÂÇϰí ÀÖ½À´Ï´Ù. ÀÌ È¸»ç´Â ôÃß °íÁ¤ ÀÓÇöõÆ®, ¼ö¼ú µµ±¸, »À ÀÌ½ÄÆí, ÀÓÇöõÆ®, ºñ °íÁ¤ ´ëüǰ, µðÁöÅÐ ÄÉ¾î ±â¼ú µî Á¦Ç°À» °³¹ßÇÕ´Ï´Ù. ºÐ»çȸ¦ ÅëÇØ ZimVie´Â ³ª½º´Ú¿¡ 'ZIMV'ÀÇ »ó¡À¸·Î µî·ÏµÈ µ¶¸³ ±â¾÷À¸·Î ¿î¿µµË´Ï´Ù. µû¶ó¼ ZimVie´Â ÁÁÀº ½ÃÀå Á¡À¯À²À» À¯ÁöÇÔÀ¸·Î½á ½ÃÀåÀ» Å©°Ô °ÈÇÒ °ÍÀ¸·Î ±â´ëµË´Ï´Ù.
2022³â 10¿ù, Spineart´Â »õ·Î¿î ÃÖ¼Ò Ä§½À ôÃß ¼ö¼ú(MISS) ½Ã½ºÅÛ 'PERLA TL MIS'¸¦ Ãâ½ÃÇß½À´Ï´Ù. ÀÌ È¸»çÀÇ MISS ½Ã½ºÅÛÀº ¼¼°è¿¡¼ »ç¿ëÇÒ ¼ö ÀÖ´Â Èä¿äÃß ÈÄ¹æ °íÁ¤ ½Ã½ºÅÛÀÔ´Ï´Ù. PERLA TL MISÀÇ Ãâ½Ã´Â ÃÖÁ¾ »ç¿ëÀÚ(¿Ü°úÀÇ»ç, ȯÀÚ, º´¿ø)¿¡ ÀÌÀÍÀ» Áִ ôÃß ¿Ü°ú ¼ö¼úÀÇ º¯È¿¡ ´ëÇÑ È¸»çÀÇ Çå½ÅÀ» º¸¿©ÁÙ °ÍÀ¸·Î ±â´ëµË´Ï´Ù. ÀÌ·¯ÇÑ Á¦Ç°ÀÇ Ãâ½Ã´Â ÇâÈÄ ½ÃÀå ¼ºÀåÀ» °ßÀÎÇÒ °ÍÀ¸·Î ¿¹»óµË´Ï´Ù.
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2023³â 7¿ù, Xtant Medical Holdings, Inc.´Â ôÃß °íÁ¤ ¹× ±¹³»¿Ü »ý¹° Á¦Á¦¿¡ ´ëÇÑ Surgalign Holdings, Inc.ÀÇ Æ¯Á¤ ÀÚ»ê°ú ºÎ並 ȹµæÇß´Ù°í ¹ßÇ¥Çß½À´Ï´Ù. Xtant Medical Holdings, Inc.´Â º¹ÀâÇÑ Ã´Ãß º¯ÇüÀÇ ÅðÇà °úÁ¤¿¡¼ ôÃß °íÁ¤À» ÃËÁøÇϴ ôÃß ÀÓÇöõÆ® ½Ã½ºÅÛÀÇ °³¹ß¿¡ Àü³äÇϰí ÀÖ½À´Ï´Ù. ÀÌ¿Í °°ÀÌ Ã´Ã߱ⱸ Á¦Á¶¾÷ü¿¡ ÀÇÇÑ Ã´Ãß ±â¼úÀÇ ÀÌ·¯ÇÑ ½ÃÀå °³Ã´ÀÌ ½ÃÀå ¼ºÀåÀ» °¡¼ÓÇϰí ÀÖ½À´Ï´Ù.
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2023³â 5¿ù, CTL Amedica´Â »ýü Àç·áÀÎ ÁúȱԼÒÀÇ À¶ÇÕ¿¡ ÀÇÇØ¼¸¸ Á¦Á¶µÇ´Â NITRO Interbody Fusion Cage SystemÀÇ »óǰȿ¡ ´ëÇØ FDA 510(k) Àΰ¡¸¦ ÃëµæÇß½À´Ï´Ù. ½Ç¸®ÄÜ Áúȹ° Àç·á´Â ¸ðµç À̹ÌÁö ¾ç½Ä°ú ȣȯµÇ¸ç °íÀ¯ÀÇ Á¤±Õ Ư¼ºÀ» ³ªÅ¸³»¸ç ¾ÆÆ¼ÆÑÆ®°¡ ¾ø´Â À̹ÌÁö¸¦ ¼³¸íÇÕ´Ï´Ù.
2023³â 1¿ù, Alevio SpineÀº SI-Cure SI Joint Fusion SystemÀÇ ÀûÀÀ Ãß°¡ 510(K) Ŭ¸®¾î·±½º¸¦ ȹµæÇß½À´Ï´Ù. ÀûÀÀ È®´ë¿¡´Â ¿äÃß ¶Ç´Â Èä ¿äÃß °íÁ¤¼úÀÇ ÀϺημ õÀå °üÀý °íÁ¤¼úÀ» ¹Þ´Â °ñ°Ý ¼º¼÷ ȯÀÚ¿¡ ´ëÇÑ ÃµÀå °üÀý °íÁ¤¼úÀÌ Æ÷ÇԵ˴ϴÙ.
2022³â 6¿ù, ¹Ì±¹ FDA´Â Aurora SpineÀÇ DEXA SOLO-L Àü¹æ ¿äÃß Ã´Ãß°£ °íÁ¤ ±â±â(ALIF)ÀÇ 510K ÀÎÁõÀ» ¹Þ¾Ò½À´Ï´Ù. DEXA ±â¼ú ¹× Ç÷§ÆûÀ» ±â¹ÝÀ¸·Î 3D ÀμâµÈ µ¶¸³Çü ±â±â°¡ Àü¹æ ¹× Ãø¹æ ¿äÃß Ã´Ãß°£ °íÁ¤¼ú(ALIF &LLIF)¿ëÀ¸·Î ¼³°èµÇ¾ú½À´Ï´Ù.
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ATEC Spine Inc, B. Braun SE, Centinel Spine LLC, DePuy Synthes Inc, Globus Medical Inc, Medtronic Plc, NuVasive Inc, Orthofix Medical Inc, Stryker Corp, ZimVie Inc µîÀÌ ºÏ¹Ì ôÃß °íÁ¤ ±â±â ½ÃÀå¿¡¼ »ç¾÷À» Àü°³ÇÏ´Â ÁÖ¿ä ±â¾÷ÀÔ´Ï´Ù.
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.