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市場調査レポート
商品コード
1374878
汎発性重症筋無力症治療の世界市場 - 2023年~2030年Global Generalized Myasthenia Gravis Treatment 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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汎発性重症筋無力症治療の世界市場 - 2023年~2030年 |
出版日: 2023年11月01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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重症筋無力症は、抗体を介する自己免疫疾患であり、神経筋接合部の機能に影響を及ぼし、眼筋、顔面筋、口輪筋、四肢筋、呼吸筋の変動性筋力低下を引き起こします。この疾患は、全世界で100万人あたり70~300人が罹患していると推定されています。重症筋無力症を放置しておくと、かなりの身体障害と病院への入院を繰り返すことになり、死亡率は約2%と評価されています。
重症筋無力症患者の多くは、コリンエステラーゼ阻害剤、コルチコステロイド、ステロイド温存免疫抑制剤(アザチオプリン、ミコフェノール酸モフェチルなど)などの典型的な治療を受けているが、約8.5~15%の患者は、臨床症状のコントロールが不十分であったり、副作用が不適切であったりするために、さまざまな程度の障害を抱えています。
症例の増加、製品認可の増加、研究活動からの好結果、合併・買収を含む市場開拓、製品導入、認知度の向上などが、予測期間における重症筋無力症治療薬市場の世界の成長を後押しすると予想されます。さらに、研究活動、投資、資金調達の増加も、予測期間における世界市場の成長に寄与すると期待されます。
明確な規制機関からの医薬品認可は、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、2023年6月、多国籍バイオ医薬品企業であるUCBは、抗アセチルコリン受容体(AchR)抗体または抗筋特異的チロシンキナーゼ(MuSK)抗体陽性の成人患者における全身型重症筋無力症(gMG)の治療を適応とするRYSTIGGO(rozanolixizumab-noli)の米国食品医薬品局(FDA)認可を取得しました。
この承認は、gMG2を対象とした重要な臨床第3相試験であるMycarinG試験に基づいています。この臨床第3相試験では、ロザノリキシズマブ・ノリの投与により、呼吸、会話、摂食、椅子からの立ち上がりなどの日常動作を含むgMG特有の結果が統計学的に顕著に改善することが示されました。
さらに、2023年3月、自己免疫疾患患者の生活向上に取り組む多国籍免疫企業であるアルジェンクス社は、AChR抗体陽性のgMG成人患者に対する従来療法への追加療法として、VYVGART(efgartigimod alfa-fcab)の英国医薬品・ヘルスケア製品規制庁(MHRA)認可を取得しました。
重症筋無力症に関する支援資金と認知度の向上も、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、2023年2月、筋ジストロフィー協会(MDA)は、5つの団体が10万9,065米ドルの助成金を受け入れることを宣言しました。この助成金は、神経筋障害を抱える人々がより長く自立した生活を送れるよう、受賞者と連携してMDAの主要な一般的アプローチやアドボカシー活動を推進・支援することを目的としています。
MDAの協会に対する献身的な姿勢のもと、地域社会はこの助成金を利用して、インパクトのある協力的なアドボカシー活動やイニシアチブを推進しています。この独創的なモデルの助成先には、All Wheels Up、Cure CMD、Cure Rare Disease、OPMD Association、タフツ医療センター(ジェームズ・チェンバース博士とそのチーム)などがあります。
さらに、ジョンソン・エンド・ジョンソンのヤンセンファーマシューティカルカンパニーズは、2022年2月、希少疾患の日と希少疾患とともに生きる2,500万~3,000万人のアメリカ人を認識し、慢性的な自己免疫性神経筋疾患である重症筋無力症(MG)に対する認識を高め、同疾患とともに生きる人々に支援を届けようとする全国的な運動、回復したiMaGineMyMGを開始しました。このキャンペーンの一環として、重症筋無力症に罹患している人々は、この稀な疾患との付き合い方を通して人々を支援し導くために計画された、新しくデザインされたオンライン支援ツールであるiMaGineMyMG.comにもアクセスできるようになる予定です。
薬物治療のコストが高いことが、予測期間中の世界市場の成長を妨げると予想されます。例えば、アストラゼネカのソリリス治療薬は割引前で年間65万米ドル以上かかり、米国では高コストの薬剤の一つです。ICER(Institute for Clinical and Economic Review)は重症筋無力症におけるこの薬剤のプロファイルを調査した結果、同機関はそのコストに関して厳しい懸念を抱いています。
さらに、研究によると、患者一人当たりの年間直接医療費の平均は760~2万8,780米ドル、入院一回当たりの医療費は2,550~16万4,730ドルと評価されました。病気の間接医療費は80ドルから3,550米ドルでした。費用は患者の特徴によって大きく異なり、免疫グロブリンの静脈注射や血漿交換、筋無力症救急、人工呼吸器補助、入院など、疾病の直接的な医療費の原動力となっています。
骨粗鬆症、高血糖、白内障、体重増加、高血圧、股関節の血管壊死などの長期的なステロイド効果などの重症筋無力症治療の合併症は、予測期間中の重症筋無力症治療の世界市場の成長を妨げると予想されます。さらに、この治療薬には悪寒、めまい、頭痛、体液貯留などの副作用があることも、予測期間中の世界市場成長の妨げになると予想されます。
Myasthenia gravis is an antibody-mediated autoimmune condition impacting the function of the neuromuscular junction, directing to the fluctuating weakness of ocular, facial, bulbar, limb, and respiratory muscles. The condition has an assessed preponderance of 70-300 per million individuals globally. Unchecked myasthenia gravis can lead to considerable disability and recurrent infirmary admissions, with an assessed mortality rate of approximately 2%.
Although a considerable number of individuals with myasthenia gravis advantage from typical therapies, including cholinesterase inhibitors, corticosteroids, and steroid-sparing immunosuppressants (e.g., azathioprine and mycophenolate mofetil), around 8.5-15% of individuals still hold differing extents of disability because of insufficiently controlled clinical manifestation or inappropriate side effects.
The growing cases, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, product introductions, growing awareness among other factors are expected to boost the global generalized myasthenia gravis treatment market growth in the forecast period. Further, increasing research activities, investments and fundings are also expected to contribute to the global market growth in the forecast period.
The drug authorizations from distinct regulatory bodies are expected to boost the global market growth during the forecast period. For instance, in June 2023, UCB, a multinational biopharmaceutical corporation, obtained the U.S. Food and Drug Administration (FDA) authorization for its RYSTIGGO (rozanolixizumab-noli) indicated for the treatment of generalized myasthenia gravis (gMG) in adult individuals who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
The authorization is established on the pivotal Phase 3 MycarinG investigation in gMG2, an extensive phase 3 investigation which showed treatment with rozanolixizumab-noli resulted in statistically noteworthy advancements in gMG-specific results, including day-to-day movements including breathing, speaking, ingesting, and being capable of rising from a chair.
Moreover, in March 2023, argenx, a multinational immunology corporation dedicated to enhancing the lives of individuals with intense autoimmune conditions, obtained the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorization for its VYVGART (efgartigimod alfa-fcab) as an add-on to traditional therapy for the treatment of adult patients with gMG that are AChR antibody positive.
The growing support funding and awareness about the myasthenia gravisare also expected to boost the global market growth during the forecast period. For instance, in February 2023, the Muscular Dystrophy Association (MDA) declared the five organizations accepting $109,065 in grant funding the grants are intended to advance and support MDA's key general approach and advocacy initiatives in coordination with awardees to allocate individuals living with neuromuscular disorders to live longer better independent lives.
In the temperament of MDA's dedication to the association, the community is using this funding agenda to promote impactful and cooperative advocacy schemes and initiatives. Grantees in this ingenious model include All Wheels Up, Cure CMD, Cure Rare Disease, OPMD Association, and Tufts Medical Center (Dr. James Chambers and team).
Further, in February 2022, in recognition of Rare Disease Day and the 25-30 million Americans living with rare conditions, the Janssen Pharmaceutical Companies of Johnson & Johnson launched the restored iMaGineMyMG, a nationwide movement that strived to raise awareness of myasthenia gravis (MG), a chronic autoimmune neuromuscular condition, and deliver aid to individuals living with the disorder. As part of the campaign, individuals impacted by MG are also expected to have access to iMaGineMyMG.com, a newly redesigned online aid planned to support and guide people throughout their journey with this rare condition.
The high cost of drug treatment is expected to hamper the global market growth during the forecast period. For instance, AstraZeneca's Soliris treatment costs over $650,000 annually before discounts, being one of the highly costly drugs in the U.S. After the Institute for Clinical and Economic Review (ICER) looked at the medicine's profile in Myasthenia gravis, the organization holds severe worries regarding its cost.
Moreover, according to studies, the mean per-patient yearly direct medical expense of illness was assessed at between $760 and $28,780, and the expense per hospitalization between $2550 and $164,730. The indirect expense of disease was assessed at $80 and $3550. Expenses differed extensively by patient features, and drivers of the immediate medical expense of disease-enclosed intravenous immunoglobulin and plasma exchange, myasthenic emergency, mechanical ventilatory aid, and hospitalizations.
The myasthenia gravis treatment complications such as long-term steroid effects like osteoporosis, hyperglycemia, cataracts, weight gain, hypertension, and avascular necrosis of the hip are expected to hamper the global myasthenia gravis treatment market growth during the forecast period. Moreover, the treatment has side effects such as chills, dizziness, headaches and fluid retention are also expected to hamper the global market growth during the forecast period.
The global generalized myasthenia gravis treatment market is segmented based on drug class, route of administration, distribution channel and region.
Owing to the increasing monoclonal antibody drug approvals and increasing number of approval request submissions the segment is expected to dominate the global market in the forecast period. For instance, in June 2023, the National Medical Products Administration (NMPA) of China accepted the Biologics License Application (BLA) of batoclimab (HBM9161) to treat generalized myasthenia gravis (gMG) from the Harbour Biomed, a multinational biopharmaceutical corporation committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology.
Moreover, in August 2023, Soliris (eculizumab) was authorized in Japan for extended usage to enclose the treatment of generalized myasthenia gravis (gMG) in pediatric individuals who are anti-acetylcholine receptor (AChR) antibody-positive and whose manifestations are hard to manage with elevated-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).
Owing to the increasing market developments in North America the region is expected to dominate the global market in the forecast period. For instance, in May 2023, Magenta Therapeutics, Inc. and Dianthus Therapeutics, Inc., a privately owned, clinical-stage biotechnology corporation committed to promoting the next generation of antibody complement therapeutics, formed a merger agreement to unite the corporations in an all-stock transaction.
The merged company is expected to focus on growing Dianthus' pipeline of next-generation complement inhibitors, including DNTH103 presently in a Phase 1 clinical trial. Upon fulfillment of the coalition, the United corporation is anticipated to function under the name Dianthus Therapeutics, Inc. In backing of the coalition, Dianthus has confirmed affirmations for a $70 million private investment.
Furthermore, the positive support from government organizations for clinical investigations to advance the disease treatment is also expected to boost the regional market growth during the forecast period. For instance, according to the NIH press release in June 2023, the proof from a small-scale clinical investigation supported by a small business grant from the National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health, and funded by Cartesian Therapeutics, Gaithersburg, Maryland, indicates that a variation of the advanced blood cancer immunotherapy comprehended as CAR-T could be adjusted for the treatment of myasthenia gravis, an autoimmune condition of the nervous system. The altered CAR-T therapy, short for chimeric antigen receptor T-cell, utilized by scientists presents the potential for a longer-lasting decline in myasthenia gravis signs and was well-tolerated without substantial adverse effects.
Conclusions from a recent patient analysis, related to understandings from earlier registered patients, suggest that COVID-19 infection can boost the commencement of myasthenia gravis (MG). The conclusions, published in the Journal of Neurology, hypothesize that SARS-CoV-2 disease may have initiated thymic inflammation, spearheading the initial presentation of muscle-like epitopes and T-cell dysregulation.
With over a dozen of these patient investigations reported to date, the investigators emphasized the significance of additional case sequences that examine the pathological timeline and immunological aspects of MG induced by COVID-19. Thus, it is expected that COVID-19 has increased the demand for myasthenia gravis treatment during the pandemic.
The major global players in the market include: AstraZeneca, Astellas Pharma, F. Hoffmann-La Roche Ltd., Grifols, S.A., Argenx SE, UCB, Harbour Biomed, Lepu Medical Technology (Beijing)Co., Ltd., ALEXION PHARMACEUTICALS, INC., and Immunovant, Inc. among others.
The global generalized myasthenia gravis treatment market report would provide approximately 61 tables, 60 figures and 186 Pages.
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