개요
퇴행성 요추 디스크질환(Lumbar Degenerative Disc Disease) 시장은 2022년에 121억 달러에서, 2023-2030년 예측 기간 동안 CAGR 7.4%로 성장하여 2030년에는 213억 달러에 이를 것으로 예측됩니다.
척추의 모든 척추체 사이에는 추간판으로 이해되는 지지력과 유연성, 약간의 하중 분담을 제공하는 섬유연골 기반 구조의 패드가 있습니다. 이러한 둥근 디스크의 정상적인 구조에 장애가 생기면 디스크 탈출증이나 내부 수핵의 돌출로 이어질 수 있으며, 척수나 신경근으로 긴장이 퍼져 방사통과 전형적인 약화 부위를 유발할 수 있습니다.
추간판 탈출증의 90% 이상이 L4-L5 또는 L5-S1 디스크 공간에서 발생하며, 이는 L4, L5 또는 S1 신경근에 충돌합니다. 이러한 압박은 다리 뒤쪽과 등쪽 발로 방사통 병증을 유발합니다. 퇴행성 디스크 장애는 척추뼈 사이의 디스크가 노화로 인해 쿠션 손실, 파편화 및 탈출을 일으키는 질환입니다. 최근 몇 년 동안 퇴행성 디스크 질환을 치료하기 위한 재생 의학 접근법이 더욱 주목받고 있습니다.
척추 부상 증가, FDA 승인, 합병, 인수, 제품 소개를 포함한 시장 개발, 기타 요인 중 인지도 증가는 예측 기간 동안 글로벌 요추 퇴행성 디스크 질환 시장 성장을 촉진 할 것으로 예상됩니다. 또한 노인 인구 및 연구 활동의 증가 사례도 예측 기간 동안 글로벌 시장 성장에 기여할 것으로 예상됩니다.
역학
제품 허가 증가
다양한 규제 당국의 제품 승인이 증가함에 따라 예측 기간 동안 글로벌 시장 성장이 촉진 될 것으로 예상됩니다. 예를 들어, 2023년 2월, 염증성 질환에 대한 동종 세포 의약품의 다국적 리더 인 Mesoblast Limited는 디스크 퇴행과 관련된 만성 요통(CLBP) 치료에 대한 미국 식품의약국(FDA)의 조직 및 첨단 요법국(OTAT) 재생 의학 첨단 요법 (RMAT)지정을 획득하여 요추 디스크에 주사하기위한 전달 제로서 히알루 론산 (HA)과 혼합하여 렉스 레 메스트로 셀-L을 사용하도록 지정했습니다.
또한, 2023년 2월, DiscGenics Inc는 퇴행성 요추 디스크질환을 앓고 있는 환자를 치료하기 위한 주사용 추간판 세포 요법에 대한 FDA의 재생 의학 진행 치료의 지정을 받았습니다. 주사가능한 추간판 세포요법(IDCT)은 요추 추간판 변성 환자의 추간판 부피를 개선하고 요통을 개선하며 통증의 사용을 줄일 것으로 예상
추간판 변성증 환자 증가
추간판 변성 질환의 증례 증가는 예측 기간 동안 시장 성장을 뒷받침할 것으로 예상됩니다. 40세 이상 성인의 약 40%는 적어도 하나의 추간판이 변성하고 있으며, 80세까지는 80% 이상이 변성하고 있습니다. 추간판의 감소는 피부 주름과 백발과 마찬가지로 노화의 표준 요소로 간주됩니다. 예를 들어 유엔이 2022년에 발표한 데이터에 따르면 세계의 인구에서 차지하는 65세 이상의 노인 비율은 2022년 10%에서 2050년 16%로 증가할 것으로 예측됩니다. 노년 인구가 증가함에 따라 척수 장애의 수가 증가할 것으로 예상됩니다.
또한 미국 국립생물공학정보센터(NCBI)에 따르면 세계적으로 연간 2억 6,600만 명(3.63%)이 척추 추간판 변성증 및 요통증을 앓고 있는 것으로 나타났습니다. 또한 사회·보건·가족문제위원회에 따르면 유럽평의회 회원국에는 척수손상(대마비와 사지마비)을 앓고 있는 환자가 추정 33만명 있어 매년 1만1천명 가까이 새롭게 발병 중입니다. 이러한 부상의 약 절반은 교통 사고로 인한 것으로, 청소년에서 발생합니다.
의약품 개발의 까다로운 프로세스와 높은 비용
의약품 개발 및 상업화를 위한 길고 엄격한 절차와 성공 확률의 낮음은 예측 기간 동안 시장 발전을 방해할 것으로 예상됩니다. 예를 들어, 임상 연구의 가장 명백한 목적은 식품의약국(FDA)의 허가를 얻기 위해 안전과 효능을 확립하는 것입니다. FDA는 허용되는 임상 투자와 공정한 결과를 구성하는 것에 대해 설계자에게 권고를 합니다. 특히, 충분한(안전성 및 효능에 대한 추가 데이터를 더 많이 제공함을 의미함), 보다 신속한 임상시험을 실시함으로써 의약품 개발 접근법을 강화하는 것은 의약품 개발에서 혁신을 촉진 수 있습니다.
신약의 상업화를 위해 FDA의 승인을 얻고자 하는 제약기업은 창약·컨셉, 전임상 연구, 임상 연구, FDA 심사, FDA 시판 후 안전성 감시의 5단계의 프로세스를 충족할 필요가 있습니다, 의약품의 개발·상업화를 곤란하게 하고 있습니다. 또한, 신약 개발을 위한 많은 지출은 예측 기간 동안 시장 성장을 방해할 것으로 예상됩니다. 예를 들어 신약 개발에 예상되는 비용은 자금 및 시장 승인에 실패한 의약품 비용을 포함하여 10억 달러 미만에서 20억 달러 이상으로 평가됩니다.
기타 대체 치료 옵션의 가용성
개인의 추간판 변성에 대한 다른 치료 옵션을 사용할 수 있다는 것은 약물 치료에 대한 수요를 감소시킵니다. 예를 들어, 물리치료는 환자의 척추의 최적의 피트니스를 달성하고 유지하고 불쾌감을 완화하는 데 효과적입니다. 물리치료의 일반적인 목표는 기존 통증의 징후를 줄이고 안정성과 기능을 강화하며 증상의 재발을 낮추는 데 중점을 두고 척추와 관련된 문제를 개선하는 효율성 적인 체제 접근법을 확인하고 개인에게 지도하는 것입니다.
물리치료는 다른 전통적인 치료의 유무에 관계없이 일반적으로 척추의 통증을 치료할 수 있습니다. 이는 목과 등에 문제가 있는 사람 중에서 궁극적으로 척추 수술을 받는 사람이 1퍼센트 미만이기 때문에 분명합니다. 또한, 전방요추추궁절제·고정술, 전방요추체간 고정술(ALIF), 후방요추 고정술(PLF) 등 수술도 추간판 변성증 환자의 선택의 하나이며, 예측 기간 중 시장 성장을 둔화시키고 있습니다.
Global Lumbar Degenerative Disc Disease Market reached US$ 12.1 billion in 2022 and is expected to reach US$ 21.3 billion by 2030, growing with a CAGR of 7.4% during the forecast period 2023-2030.
Between every vertebral body of the spine are pads of fibrocartilage-based structures that deliver support, flexibility, and little load-sharing, comprehended as the intervertebral discs. A disturbance of the normal architecture of these round discs can lead to a disc herniation or a protrusion of the inner nucleus pulposus, perhaps spreading strain to the spinal cord or nerve root and resulting in radiating pain and typical locations of weakness.
Little more than 90% of herniated discs arise at the L4-L5 or the L5-S1 disc space, which will impinge on the L4, L5, or S1 nerve root. This compression elicits radiculopathy into the posterior leg and dorsal foot. Degenerative disc disorder is an aging-related condition of the discs between the vertebrae resulting in cushioning loss, fragmentation, and herniation. In recent years the Regenerative medicine approaches for treating degenerative disc disease have drawn more attention in recent years.
The growing spinal injuries, FDA authorizations, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global lumbar degenerative disc disease market growth in the forecast period. Further, the growing cases of geriatric population and research activities are also expected to contribute to the global market growth in the forecast period.
The increasing product authorization from distinct regulatory authorities is expected to boost the global market growth during the forecast period. For instance, in February 2023, Mesoblast Limited, a multinational leader in allogeneic cellular medicines for inflammatory conditions, obtained the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) Regenerative Medicine Advanced Therapy (RMAT) designation for its rexlemestrocel-L indicated for the treatment of chronic low back pain (CLBP) related with disc degeneration, in mixture with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.
Moreover, in February 2023, DiscGenics Inc. obtained the FDA regenerative medicine progressive therapy designation for its injectable disc cell therapy to treat individuals with symptomatic lumbar degenerative disc disorder. Injectable disc cell therapy (IDCT) has the prospect of improving disc volume, enhancing low back pain, and reducing pain medication use in individuals with lumbar degenerative disc disease.
The growing cases of degenerative disc disease are expected to boost the global market growth during the forecast period. Approximately 40% of adults above the age of 40 have at least one degenerated vertebral disc and by the age of 80, over 80% of them do. Disc decline is considered a standard element of aging, such as skin wrinkles and gray hair. For instance, according to the data published by the UN in 2022, it is assessed that the percentage of the global inhabitants of individuals aged 65 years and above is projected to increase from 10 percent in 2022 to 16 percent in 2050. With the growing geriatric population, it is anticipated that the number of spinal cord disorders will grow.
Moreover, according to the National Center for Biotechnology Information (NCBI), a whole of 266 million individuals (3.63%) globally were detected with Degenerative Spinal Disc and LBP yearly. Again, according to the Social, Health, and Family Affairs Committee, there are an estimated 330,000 individuals living with spinal cord injury (paraplegia and tetraplegia) in the associate states of the Council of Europe, with almost 11,000 new patients annually. About half of these injuries are the consequence of road accidents and arise at a young age.
The long and stringent procedure for drug development and commercialization with low success probability is expected to hamper the global market growth during the forecast period. For instance, the most evident purpose of clinical investigation is to establish safeness and effectiveness to achieve Food and Drug Administration (FDA) clearance. FDA delivers recommendations to designers regarding what constitutes permitted clinical investments and fair results. Enhancing the drug development approach, particularly by conducting sufficient (meaning delivering more additional data on safeness or effectiveness) and more quick clinical investigations, can encourage innovation in medical product development.
A pharmaceutical corporation pursuing FDA authorization to commercialize a new pharmaceutical drug is required to meet a five-step process: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring, making it difficult to develop and commercialize the drug product. Further, the large expenditure for new drug development is also expected to hamper the global market growth in the forecast period. For instance, the anticipated cost to develop a new drug including funds expenses and expenses on drugs that fail to achieve market approval has been assessed to vary from less than $1 billion to over $2 billion.
The availability of other treatment options for Degenerative Disc Disease in individuals also lowers the demand for drug treatment. For instance, physical therapy can benefit in attaining and sustaining optimal fitness of a patient's backbone and relieving discomfort. The general goal of physical therapy is to specify and instruct individuals on efficient regime approaches to enhance spine-related issues with a focus on reducing existing pain signs, enhancing stability and function, and lowering the recurrence of symptoms.
Physical therapy, with or without other conventional treatments, can usually cure spinal pain, as evidenced by the fact that rarer than one percent of individuals with neck or back problems eventually go on to have spinal surgery. Further, surgical procedures such as Anterior Lumbar Corpectomy and Fusion Surgery, Anterior Lumbar Interbody Fusion (ALIF) Surgery, and Posterior Lumbar Fusion (PLF) among others is also a choice for patients for Degenerative Disc Disease slowing the global market growth during the forecast period.
The global lumbar degenerative disc disease market is segmented based on treatment type, route of administration, end-user and region.
Owing to The increasing research activities in biologics treatment are expected to boost the segment market growth dominating the global market during the forecast period. For instance, in January 2023, DiscGenics, Inc., a clinical-stage biopharmaceutical corporation concentrated on developing regenerative cell-based treatments that relieve pain and repair function in patients with degenerative disorders of the spine, reported favorable two-year clinical information from its first-in-human clinical investigation of IDCT (rebonuputemcel), an allogeneic discogenic progenitor cell therapy for lumbar degenerative disc disorder (DDD).
Moreover, in March 2023, an injection that reduces lower back discomfort by assisting injured spinal discs seems to bear sustained advantages, new clinical investigation reports revealed. The majority of patients who received an injection of viable disc allograft supplementation (VIA-Disc) a blend of bone marrow cells and ground-up spinal disc tissue from donors obtained back pain comfort that lasted at least three years. Approximately 60% of patients had a 50% or better progress in their pain three years post-treatment, outcomes indicated, while over 70% retained a greater than 20-point progress in movement and function.
The increasing number of spinal cord injury cases in North America is expected to boost regional market growth, dominating the global market throughout the forecast period. For instance, according to the National Spinal Cord Injury Statistical Center in 2022, approximately 30% of individuals with spinal cord injury (SCI) were re-hospitalized one or more times in any given year following injury, and out of those re-hospitalized, the duration of hospital visit averages around 18 days and the estimated number of people with spinal cord injury living in the United States in 2021 was approximately 299,000 individuals, with a degree from 253,000 to 378,000. The indirect expenses of SCI averaged USD 82,329 every year in the United States in 2021. Further, the 2021 American Community Survey assessed there were 55,892,014 individuals aged 65 and above in the U.S. out of a total inhabitant of 331,893,745, accounting for 16.8%.
Further, the increasing research funding sustains the regional market growth in the forecast period. For instance, in February 2023, Investigators at Cedars-Sinai obtained $2 million in funding from the California Institute for Regenerative Medicine (CIRM) to design a new cell therapy that aids in enhancing the quality of life for individuals with worsened discs and chronic lower back discomfort.
In February 2022, Russia unreasonably attacked Ukraine. The bloody conflict in Ukraine has seen several attacks on healthcare institutions, including hospitals and clinics. Since the inception of the war in Ukraine, the healthcare system in some regions has been devastated. As per records, a total of 103 assaults have been documented, including 89 attacks on healthcare institutions and about 13 attacks on healthcare transportation.
When Russia invaded Ukraine, hospitals had to suspend all elective surgeries, including cancer surgery thus, slowing the regional market growth. However, the absence of key market players from this region has not affected the global market in any major way, yet the impact on export of raw Route of Administrations from the war-influenced region has a minimal impact on the global market.
During the COVID-19 pandemic, elective and routine examinations and operations were postponed or discontinued because of redirecting aids to additional emergent therapy for extremely sick individuals and to avert the spread and contraction of COVID-19. Further, the workforce was pulled narrow, and healthcare structures witnessed growing turnover rates for full-time and agreement workers, which pushed the system and decreased the capacity to deliver clinical assistance.
Since more beds in wards and intensive care units were assigned to COVID-19 patients, considerable surgical divisions registered a reduction in the number of patient visits. The imposition of lockdown as a strategy to flatten the curve of COVID-19 patients also stalled the management of these patients. However, currently majority of healthcare departments have recovered and gained the number of patient vesting's to a standard value.
The major global players in the market include: Sorrento Therapeutics, SpineThera, Eliem Therapeutics, Scilex Holding, Sinfonia Biotherapeutics, Seikagaku Corporation, Kolon life Science, Vita Sciences, Aurobindo Pharma, and Neurotech among others.
The global lumbar degenerative disc disease market report would provide approximately 61 tables, 58 figures and 186 Pages.
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