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市場調査レポート
商品コード
1345449
腰椎椎間板変性症の世界市場-2023年~2030年Global Lumbar Degenerative Disc Disease Market - 2023-2030 |
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カスタマイズ可能
適宜更新あり
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腰椎椎間板変性症の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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概要
腰椎椎間板変性症の世界市場は、2022年に121億米ドルに達し、2023-2030年の予測期間中にCAGR 7.4%で成長し、2030年には213億米ドルに達すると予測されています。
脊椎の各椎体の間には、椎間板として理解される、支持、柔軟性、わずかな荷重分担を提供する線維軟骨ベースの構造のパッドがあります。この丸い椎間板の正常なアーキテクチャが乱れると、椎間板ヘルニアや内部の髄核の突出につながり、おそらく脊髄や神経根に負担が広がり、放散痛や典型的な脱力感の原因となります。
椎間板ヘルニアの90%以上はL4-L5またはL5-S1の椎間板腔で発生し、L4、L5、またはS1の神経根を圧迫します。この圧迫により、後脚や足背への神経根症が誘発されます。椎間板変性症は、椎骨と椎骨の間にある椎間板の老化に関連した病態で、その結果、クッション性が失われ、断片化し、ヘルニアが生じます。近年、椎間板変性疾患を治療するための再生医療アプローチが注目されています。
脊椎損傷の増加、FDAの認可、合併・買収を含む市場開拓、製品のイントロダクション、認知度の高まりなどが、予測期間における腰椎椎間板変性症の世界市場の成長を後押しすると予想されます。さらに、老人人口の増加や研究活動も、予測期間における世界市場の成長に貢献すると期待されています。
ダイナミクス
製品認可の増加
明確な規制当局からの製品認可の増加は、予測期間中の世界市場の成長を後押しすると予想されます。例えば、炎症性疾患に対する同種細胞医薬の多国籍リーダーであるメソブラスト社は、2023年2月、椎間板変性に関連する慢性腰痛症(CLBP)の治療を適応症とし、ヒアルロン酸(HA)と混合して腰椎椎間板に注入するデリバリー剤として使用されるrexlemestrocel-Lについて、米国食品医薬品局(FDA)の組織・先端療法局(OTAT)再生医療先端療法(RMAT)の指定を取得しました。
さらに、2023年2月、ディスクジェニックス社は、腰椎椎間板変性症を有する患者を治療するための注射用椎間板細胞療法について、FDAの再生医療進行性治療の指定を取得しました。注射可能椎間板細胞療法(IDCT)は、腰椎椎間板変性症患者の椎間板容積を改善し、腰痛を改善し、痛み止めの使用を減らす見込みがあります。
椎間板変性症患者の増加
椎間板変性疾患の症例の増加は、予測期間中の世界市場の成長を後押しすると予想されます。40歳以上の成人の約40%は少なくとも1つの椎間板が変性しており、80歳までには80%以上が変性しています。椎間板の減少は、肌のシワや白髪と同様、老化の標準的な要素と考えられています。例えば、国連が2022年に発表したデータによると、世界の人口に占める65歳以上の高齢者の割合は、2022年の10%から2050年には16%に増加すると予測されています。老年人口の増加に伴い、脊髄障害の数も増加すると予想されます。
さらに、米国国立生物工学情報センター(NCBI)によると、世界全体で年間2億6,600万人(3.63%)が脊椎椎間板変性症や腰痛症に罹患していることが判明しています。また、社会・保健・家族問題委員会によると、欧州評議会加盟国には、脊髄損傷(対麻痺と四肢麻痺)を患う患者が推定33万人おり、毎年1万1千人近くが新たに発症しています。これらの傷害の約半数は交通事故によるもので、若年で発症します。
医薬品開発の厳しいプロセスと高コスト
医薬品開発と商業化のための長く厳しい手続きと成功確率の低さは、予測期間中の世界市場の発展の妨げになると予想されます。例えば、臨床調査の最も明白な目的は、食品医薬品局(FDA)の認可を得るために安全性と有効性を確立することです。FDAは、許容される臨床投資と公正な結果を構成するものに関して、設計者に勧告を行う。特に、十分な(安全性や有効性に関する追加データをより多く提供することを意味する)、より迅速な臨床試験を実施することにより、医薬品開発アプローチを強化することは、医薬品開発におけるイノベーションを促進することができます。
新薬の商業化に向けてFDAの承認を得ようとする製薬企業は、創薬・コンセプト、前臨床研究、臨床研究、FDA審査、FDA市販後安全性監視の5段階のプロセスを満たす必要があり、医薬品の開発・商業化を困難にしています。さらに、新薬開発のための多額の支出も、予測期間における世界市場の成長を妨げると予想されます。例えば、新薬開発に予想される費用は、資金や市場承認に失敗した医薬品の費用を含めて、10億米ドル未満から20億米ドル以上と評価されています。
他の代替治療オプションの可用性
個人における椎間板変性症に対する他の治療オプションが利用可能であることも、薬物治療の需要を低下させます。例えば、理学療法は患者の背骨の最適なフィットネスを達成・維持し、不快感を和らげるのに有効です。理学療法の一般的な目標は、既存の痛みの徴候を軽減し、安定性と機能を強化し、症状の再発を低下させることに重点を置いて、脊柱に関連する問題を改善するための効率的な体制アプローチを特定し、個人に指導することです。
理学療法は、他の従来の治療法の有無にかかわらず、通常、脊椎の痛みを治すことができます。これは、首や背中に問題を抱える人のうち、最終的に脊椎の手術を受ける人が1パーセントにも満たないことからも明らかです。さらに、前方腰椎椎弓切除・固定術、前方腰椎椎体間固定術(ALIF)、後方腰椎固定術(PLF)などの外科手術も、椎間板変性症患者の選択肢の一つであり、予測期間中の世界市場の成長を鈍化させています。
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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