市場調査レポート
商品コード
1345404
副腎不全の世界市場-2023年~2030年Global Adrenal Insufficiency Market - 2023-2030 |
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副腎不全の世界市場-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: 約2営業日
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概要
世界の副腎不全市場は、2022年に3億6,770万米ドルに達し、2023~2030年の予測期間中にCAGR 10.5%で成長し、2030年には8億190万米ドルに達すると予測されています。
副腎不全には、原発性、二次性、三次性の3種類があります。原発性副腎不全は、しばしばアジソン病と呼ばれ、体内で特定のホルモンが十分に生産されない場合に起こる珍しい疾患です。アジソン病では、副腎から分泌されるコルチゾールの量が非常に少なく、また別のホルモンであるアルドステロンの量が過剰に少なくなることがよくあります。さまざまな種類の副腎不全には、さまざまな理由があります。副腎不全の原因として最も予想されるのは、副腎皮質ステロイドを長期間服用した後に突然中止したことです。
副腎不全は、ストレスに反応し、他の基本的な生命プロセスをサポートする身体の能力に影響を与える可能性があります。治療により、副腎不全の人の大部分は、通常の活動的な生活を送ることができます。アジソン病は先進国ではまれで、100万人あたり約100~140人が罹患しています。しかし、二次性副腎不全は非常に典型的で、100万人あたり150~280人に影響を与えます。二次性副腎不全と三次性副腎不全は通常一緒に分類されるため、三次性副腎不全単独の統計はありません。
研究活動の増加や、さまざまな治療法に対する明確な規制機関からの認可は、予測期間中の世界の副腎不全市場の成長を後押しする主な要因の1つです。さらに、多様な団体からの啓発活動や支援効果の高まりも、予測期間における世界の副腎不全市場の成長に寄与しています。
ダイナミクス
調査活動と製品認可の増加
研究活動と製品認可の増加は、予測期間中の世界の副腎不全市場の成長を後押しすると予想されます。例えば、2022年1月、食品医薬品局(FDA)は、成人および青年における急性副腎不全の治療薬としてATRS-1902にファストトラック指定を与えました。この指定は、副腎クリーゼに対するATRS-1902の第I相臨床試験の良好な結果に基づいて与えられます。
さらに2022年2月、Diurnal社は、徐放性ヒドロコルチゾンの欧州第2相臨床試験において、最初の患者が投与されたことを報告しました。アジソン病とも呼ばれる副腎不全(AI)の治療薬であるこの臨床試験は、欧州および英国全土で同社にとって大きな取引の可能性を象徴するものです。CHAMPAIN第2相試験は、副腎不全における徐放性ヒドロコルチゾンとプレナドレンの有効性、安全性、忍容性を評価するものです。
副腎不全の有病率の増加
副腎不全の有病率の増加も、予測期間における世界市場の成長に寄与すると予想されます。例えば、明確な研究によると、救急外来を受診したブドウ糖血症性低ナトリウム血症患者の2.7~3.8%に副腎不全が発見されておらず、専門治療室に入院した患者では15%に増加します。さらに、NIHによれば、先進国では約1億4,400万人がアジソン病に苦しんでいます。
さらに、2023年に発表された"Diagnosis and management of adrenal insufficiency"という論文によると、原発性副腎不全の割合は100万人あたり93~140人と評価されています。欧米では、自己免疫性副腎炎が原発性副腎不全患者の70%以上を占めています。二次性副腎不全は、原発性副腎不全と比較して典型的であり、100万人当たり150~280人の割合です。外因性グルココルチコイドの使用は、二次性副腎不全の最も典型的な原因であり、炎症性疾患や免疫介在性疾患のためにグルココルチコイドを投与している人が2.5%に達し、薬を突然中止するとステロイド欠乏症になりやすいことが指摘されています。
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低い成功確率は、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。
認識不足
有病率の低さから、副腎不全という疾患に対する認知度が低く、予測期間中、世界の副腎不全市場の成長が鈍化すると予想されます。例えば、NIHによると、アジソン病はまれです。その割合は、人口10万人当たり年間0.6人です。この疾患の影響を受ける人の数は、人口10万人当たり4人から11人です。
さらに、副腎不全の初期段階では、症状が徐々に現れるため、それを解釈することが困難であるため、発見が困難であることも、副腎不全疾患に対する認識のギャップを広げています。医療専門家は、カルテや徴候を後検査することがあります。その後の対策は、コルチゾール値が低すぎるかどうか気づくための血液検査であり、原因究明に役立ちます。
Global Adrenal Insufficiency Market reached US$ 367.7 million in 2022 and is expected to reach US$ 801.9 million by 2030, growing with a CAGR of 10.5% during the forecast period 2023-2030.
Adrenal insufficiency is of three types namely the primary, secondary, and tertiary. Primary adrenal insufficiency is often anointed as Addison's disease is an uncommon condition that transpires when the body doesn't produce sufficient amounts of specific hormones. In Addison's disorder, the adrenal glands produce very small quantities of cortisol and, frequently, excessively small quantities of another hormone, aldosterone. Distinct kinds of adrenal insufficiency hold diverse reasons. The highly expected reason for adrenal insufficiency overall is abruptly ceasing corticosteroids after taking them for a prolonged period.
Adrenal insufficiency can impact the body's capability to react to stress and support other fundamental life processes. With treatment, the majority of individuals with adrenal insufficiency can live a normal, active life. Addison's disease is rare in developed nations, it impacts approximately 100 to 140 per million individuals. However, secondary adrenal insufficiency is highly typical, impacting 150 to 280 individuals per million. Secondary and tertiary adrenal insufficiency are usually grouped jointly, so no statistics for tertiary adrenal insufficiency separately are available.
The increasing research activities and authorizations from distinct regulatory bodies for different treatments are among the primary factors boosting the global adrenal insufficiency market growth during the forecast period. Further, the growing awareness initiatives and support effects from diverse groups are also contributing to the global adrenal insufficiency market growth in the forecast period.
The increasing research activities and product authorizations are expected to boost the global adrenal insufficiency market growth during the forecast period. For instance, in January 2022, the Food and Drug Administration (FDA) awarded Fast Track designation to ATRS-1902 to treat acute adrenal insufficiency in adults and adolescents. The designation is awarded on the basis of favorable outcomes from a Phase I clinical investigation for ATRS-1902 for adrenal crisis.
Moreover, in February 2022, Diurnal reported that the foremost patient has been administered in its phase 2 European clinical investigation of modified-release hydrocortisone. Indicated for the treatment of individuals with adrenal insufficiency (AI), also comprehended as Addison's disorder, the trial even symbolizes a substantial trade possibility for the corporation across Europe and throughout the UK. The CHAMPAIN phase 2 investigation seeks to assess the effectiveness, safety, and tolerability of modified-release hydrocortisone versus Plenadren in adrenal insufficiency.
The growing prevalence of adrenal insufficiency cases is also expected to contribute to the global market growth in the forecast period. For instance, distinct studies have demonstrated that 2.7%-3.8% of emergency room visits of patients with euvolemic hyponatremia hold an undetected underlying adrenal insufficiency, and it increases up to 15% among those admitted to specialized care units. Moreover, according to NIH, around 144 million people in the developed world suffer from Addison's disease.
Further, according to an article titled "Diagnosis and management of adrenal insufficiency" published in 2023, the preponderance of primary adrenal insufficiency is assessed to be 93-140 per million. In the Western globe, autoimmune adrenalitis makes up over 70% of all patients with primary adrenal insufficiency. Secondary adrenal insufficiency is more typical compared to primary, with a preponderance rate of 150-280 per million. It has indicated that exogenous glucocorticoid usage is the most typical reason for secondary adrenal insufficiency having up to 2.5% of the people dosing them for inflammatory or immune-mediated disorders, making them vulnerable to steroid deficiency if the medicine is ceased abruptly.
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.
Owing to its low prevalence the lack of awareness about adrenal insufficiency condition is expected to slow the global adrenal insufficiency market growth during the forecast. For instance, according to the NIH, Addison's disease is infrequent. The preponderance is 0.6 per 100,000 of the population annually. The whole number of individuals impacted by this disorder at a given time varies from 4 to 11 per 100,000 of the population.
Further, the difficulty in detection is also pushing the gap in the awareness of adrenal insufficiency disorders as in its earlier phases, adrenal insufficiency is difficult to interpret since symptoms manifest gradually. The health care expert may presume post-examining the medical record and signs. The subsequent measure is blood testing to notice if the cortisol levels are too low and to help find the cause.
The global adrenal insufficiency market is segmented based on type, source, treatment, route of administration, distribution channel and region.
Congenital Adrenal Hyperplasia (CAH) is a term used to represent a bunch of genetically specified conditions of impaired steroidogenesis that result in varying lack of the end outcomes cortisol and/or aldosterone and their deleterious, including life-threatening, impacts on metabolism and electrolytes with concurrent diversion to the pile of androgens and their virilizing outcomes. The increasing research activities are expected to boost segment growth during the forecast period.
For instance, in February 2023, Biotech corporation HBM Alpha Therapeutics secured a seed round to extend its novel antibody therapies for the treatment of congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS), with the top nominee presently in the IND-enabling phase. Further, according to the clinical trials.gov presently five interventional studies with one phase 4, one phase 1, and the remaining three phases 3 are active investigation distinct therapeutic for the treatment of congenital adrenal hyperplasia.
The growing cases of adrenal insufficiency and increasing market developments in this region are estimated to boost the North America market growth in the forecast period. For instance, according to the rare disease organization, Addison's disorder impacts males and females in equal prevalence. Roughly 1 in 100,000 individuals in the United States suffer from Addison's disorder. The general preponderance is assessed to be between 40 and 60 individuals per million of the general population.
Further, the market developments in this region also contribute to the regional market growth. For instance, in June 2021, Eton Pharmaceuticals, Inc, the U.S. marketer of ALKINDI SPRINKLE, a therapy for adrenocortical insufficiency in pediatric individuals, completed the acquisition of U.S. and Canadian ownership to Crossject's ZENEO hydrocortisone needleless autoinjector, which is under development as a recovery therapy for adrenal crisis.
The pandemic disturbed the global healthcare system with disturbances in diagnosis, treatments, and research activities for rare conditions which negatively impacted the overall rare conditions market growth including adrenal insufficiency. However, as adrenal insufficiency was believed to be among the post-COVID-19 complications leading increase in diagnosis and treatment demands having a positive impact on the market growth.
For instance, according to the NIH, coronavirus disease 2019 (COVID-19) can impact numerous organs and systems, such as the endocrine system. Its manifestations can stay for months, resulting in post-COVID-19 disorders, among others. A small number of cases were reported to have central adrenal insufficiency (CAI) months post-recovery from COVID-19; however, its pathogenesis has not been completely explained.
The major global players in the market include: Acrotech Biopharma, Inc., Bausch Health, Canada Inc., AdvaCare Pharma, weefselpharma, Cipla Inc., Pfizer Inc, Wellona Pharma, Eugia US, Sandoz Inc., and Prevego Healthcare & Research Pvt Ltd. among others.
The global adrenal insufficiency market report would provide approximately 61 tables, 58 figures and 186 Pages.
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