先端巨大症：市場分析、疫学、市場予測 (2030年)

世界の主要7ヶ国における先端巨大症 (ACM) の市場規模は、2017年には9億5696万米ドルに達しました。また、2017～2030年のCAGRは5.73%と予測されています。米国一国だけで5億1776万米ドルもの市場規模を有しています。現在最も優勢な治療薬にはSSA (ソマトスタチン類縁体) やドーパミン作動薬、GHR (成長ホルモン受容体) 拮抗薬などがあり、市場規模は各々7億3677万米ドル、1億8629万米ドル、3390万米ドルとなっています。

当レポートでは、世界の主要7カ国 - 米国、欧州主要5ヶ国 (EU5：フランス・ドイツ・イタリア・スペイン・英国)、日本 - における先端巨大症 (ACM) の疫学的動向と今後の市場見通しについて分析し、疾患の概要や市場の基本構造、現在の治療法とアンメットニーズ、有病者数の動向見通し、上市済み／治験中の治療薬のプロファイル、世界全体／各国の市場規模 (2017～2030年)、主な市場促進・抑制要因、といった情報を取りまとめてお届けいたします。

目次

第1章 主な考察

第2章 エグゼクティブサマリー

第3章 先端巨大症：市場概要

• 全体的な市場シェア構造 (2017年)
• 全体的な市場シェア構造 (2030年)

第4章 先端巨大症 (ACM)：疾患概要

• イントロダクション
• 兆候と症状
• 下垂体腺腫の分類
• 先端巨大症の臨床症状
• 病因
• 病態生理
• 先端巨大症の遺伝的基盤
• 病因
• 診断基準・ガイドライン

第5章 症例報告

• 大腸癌を呈する先端巨大症の患者：症例シリーズ
• 症例報告：持続性先端巨大症-ランレオチドによる効果的な治療と、ペグビソマントの毎週注射
• 妊娠中の先端巨大症の管理：症例報告と文献レビュー
• 高齢の先端巨大症患者の症例報告

第5章 疫学と患者人口

• 主な分析結果
• 分析手法
• 先端巨大症 (ACM) の有病者総数 (主要7ヶ国の場合)
• 先端巨大症 (ACM) の受診済み患者数 (主要7ヶ国の場合)

第7章 米国の疫学的動向

• 先端巨大症の有病者総数
• 先端巨大症の受診済み患者数
• 受診済み患者数：感染源別
• 受診済み患者数：先端巨大症の種類別

第8章 欧州主要5ヶ国 (EU5) の疫学的動向

• ドイツ
• フランス
• イタリア
• スペイン
• 英国

第9章 日本の疫学的動向

第10章 治療

• 先端巨大症 (ACM) のバイオマーカー
• 治療ガイドライン：国別

第11章 アンメットニーズ

第12章 市販薬

• Somatuline Depot (酢酸ランレオチド)：Ipsen Biopharmaceuticals
  • 薬物の説明
  • 作用機序
  • 規制のマイルストーン
  • 長所と短所
  • 臨床開発
  • 治験情報
  • 安全性と有効性
  • 製品のプロファイル
• Somavert (ペグビソマント)：Pharmacia & Upjohn/Pfizer
• Sandostatin LAR Depot：Novartis Pharmaceuticals
  • 長所と短所
• Signifor LAR (パシレオチド)：Novartis Pharmaceuticals

第13章 主要なクロス競合

第14章 新たな治療薬

• IONIS-GHR-LRx：Ionis Pharmaceuticals
  • 製品説明
  • その他の発達活動
  • 臨床開発
  • 治験情報
  • 製品のプロファイル
• Mycapssa (オクトレオチドカプセル)：Chiasma Pharma
  • 安全性と有効性
  • 長所と短所
• ATL1103：アンチセンス治療薬
• CAM2029：Camurus
• GT-02037 (G-SRIF)：GlyTech
  • 臨床試験情報
• ベルドレオチド (COR-005、DG3173)：Strongbridge Biopharma
• パルツソチン (CRN00808)：Crinetics Pharmaceuticals
• MTD201：Midatech
  • その他の開発活動
  • 治験情報
• Lanreotide PRF：Ipsen

第15章 先端巨大症：主要7ヶ国の市場分析

• 主な調査結果
• 先端巨大症の市場規模：主要7ヶ国
• 先端巨大症の市場規模：主要7ヶ国、治療薬別

第16章 市場展望：米国

• 米国の市場規模
  • 先端巨大症の全体的な市場規模
  • 市場規模：治療薬別

第17章 欧州5ヶ国：市場展望

• ドイツの市場規模
• フランスの市場規模
• イタリアの市場規模
• スペインの市場規模
• 英国の市場規模

第18章 日本：市場展望

第19章 市場促進要因

第20章 市場阻害要因

第21章 業界の有識者 (KOL) の見解

第22章 SWOT分析

第23章 医療費償還と市場アクセス

第24章 付録

第25章 DelveInsightのサービス内容

第26章 免責事項

第27章 DelveInsightについて

List of Tables

• Table 1 Summary of Acromegaly, Market, Epidemiology and Key Events (2017-2030)
• Table 2 The 2017 WHO Pathological Classification of Pituitary adenomas
• Table 3 Mutated genes associated with acromegaly/gigantism
• Table 4 Genes that contribute to the molecular pathogenesis of GH-secreting adenomas
• Table 5 Total Prevalent Cases of Acromegaly in the 7MM (2017-2030)
• Table 6 Total Diagnosed Prevalent Cases of Acromegaly in the 7MM (2017-2030)
• Table 7 Total Prevalent Cases of Acromegaly in the US (2017-2030)
• Table 8 Diagnosed Cases of Acromegaly in the US (2017-2030)
• Table 9 Origin Specific Diagnosed Prevalent Cases of Acromegaly in the US (2017-2030)
• Table 10 Total Prevalent Cases of Acromegaly in Germany (2017-2030)
• Table 11 Diagnosed Cases of Acromegaly in Germany (2017-2030)
• Table 12 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Germany (2017-2030)
• Table 13 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Germany (2017-2030)
• Table 14 Total Prevalent Cases of Acromegaly in France (2017-2030)
• Table 15 Diagnosed Cases of Acromegaly in France (2017-2030)
• Table 16 Origin Specific Diagnosed Prevalent Cases of Acromegaly in France (2017-2030)
• Table 17 Diagnosed Cases of Acromegaly Based on Type of Adenomas in France (2017-2030)
• Table 18 Total Prevalent Cases of Acromegaly in Italy (2017-2030)
• Table 19 Diagnosed Cases of Acromegaly in Italy (2017-2030)
• Table 20 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Italy (2017-2030)
• Table 21 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Italy (2017-2030)
• Table 22 Total Prevalent Cases of Acromegaly in Spain (2017-2030)
• Table 23 Diagnosed Cases of Acromegaly in Spain (2017-2030)
• Table 24 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Spain (2017-2030)
• Table 25 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Spain (2017-2030)
• Table 26 Total Prevalent Cases of Acromegaly in the UK (2017-2030)
• Table 27 Diagnosed Cases of Acromegaly in the UK (2017-2030)
• Table 28 Origin Specific Diagnosed Prevalent Cases of Acromegaly in the UK (2017-2030)
• Table 29 Diagnosed Cases of Acromegaly Based on Type of Adenomas in the UK (2017-2030)
• Table 30 Total Prevalent Cases of Acromegaly in Japan (2017-2030)
• Table 31 Diagnosed Cases of Acromegaly in Japan (2017-2030)
• Table 32 Origin Based Diagnosed Prevalent Cases of Acromegaly in Japan (2017-2030)
• Table 33 Diagnosed Cases of Acromegaly Based on Types of Adenomas in Japan (2017-2030)
• Table 34 Somatuline Depot (lanreotide acetate), Clinical Trial Description, 2020
• Table 35 Somavert (pegvisomant), Clinical Trial Description, 2020
• Table 36 Sandostatin LAR Depot, Clinical Trial Description, 2020
• Table 37 Signifor LAR (pasireotide), Clinical Trial Description, 2020
• Table 38 Emerging Drug Analysis
• Table 39 Emerging Drug Analysis (Continued)
• Table 40 IONIS-GHR-LRx, Clinical Trial Description, 2020
• Table 41 Octreotide capsules, Clinical Trial Description, 2020
• Table 42 ATL1103, Clinical Trial Description, 2020
• Table 43 CAM2029, Clinical Trial Description, 2020
• Table 44 GT-02037, Clinical Trial Description, 2020
• Table 45 DG3173, Clinical Trial Description, 2020
• Table 46 Paltusotine (CRN00808), Clinical Trial Description, 2020
• Table 47 MTD201,Clinical Trial Description, 2020
• Table 48 Lanreotide PRF, Clinical Trial Description, 2020
• Table 49 Seven Major Market Size of Acromegaly in USD Million (2017-2030)
• Table 50 Seven Major Market Size of Acromegaly by therapies in USD Million (2017-2030)
• Table 51 Market Size of Acromegaly in the United States, USD Million (2017-2030)
• Table 52 United States Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 53 Market Size of Acromegaly in Germany, USD Million (2017-2030)
• Table 54 Germany Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 55 Market Size of Acromegaly in France, USD Million (2017-2030)
• Table 56 France Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 57 Market Size of Acromegaly in Italy, USD Million (2017-2030)
• Table 58 Italy Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 59 Market Size of Acromegaly in Spain, USD Million (2017-2030)
• Table 60 Spain Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 61 Market Size of Acromegaly in the United Kingdom, USD Million (2017-2030)
• Table 62 United Kingdom Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Table 63 Market Size of Acromegaly in Japan, USD Million (2017-2030)
• Table 64 Japan Market Size of Acromegaly by Therapies in USD Million (2017-2030)

List of Figures

• Figure 1 Change in facial features in Acromegaly
• Figure 2 Clinical Manifestations of Acromegaly
• Figure 3 Clinical Features of Acromegaly
• Figure 4 Etiology of Acromegaly
• Figure 5 Pathophysiology of Acromegaly
• Figure 6 Molecular Pathogenesis of Acromegaly
• Figure 7 Normal and disrupted the GHRH-GH-IGF1 axis and molecular targets for therapy
• Figure 8 Diagnostic Algorithm of Acromegaly
• Figure 9 Total Prevalent Cases of Acromegaly in the 7MM (2017-2030)
• Figure 10 Total Diagnosed Cases of Acromegaly in the 7MM (2017-2030)
• Figure 11 Total Prevalent cases of Acromegaly in the US (2017-2030)
• Figure 12 Diagnosed Cases of Acromegaly in the US (2017-2030)
• Figure 13 Origin Specific Diagnosed Prevalent Cases of Acromegaly in the US (2017-2030)
• Figure 14 Total Prevalent cases of Acromegaly in Germany (2017-2030)
• Figure 15 Diagnosed Cases of Acromegaly in Germany (2017-2030)
• Figure 16 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Germany (2017-2030)
• Figure 17 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Germany (2017-2030)
• Figure 18 Total Prevalent cases of Acromegaly in France (2017-2030)
• Figure 19 Diagnosed Cases of Acromegaly in France (2017-2030)
• Figure 20 Origin Specific Diagnosed Prevalent Cases of Acromegaly in France (2017-2030)
• Figure 21 Diagnosed Cases of Acromegaly Based on Type of Adenomas in France (2017-2030)
• Figure 22 Total Prevalent cases of Acromegaly in Italy (2017-2030)
• Figure 23 Diagnosed Cases of Acromegaly in Italy (2017-2030)
• Figure 24 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Italy (2017-2030)
• Figure 25 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Italy (2017-2030)
• Figure 26 Total Prevalent cases of Acromegaly in Spain (2017-2030)
• Figure 27 Diagnosed Cases of Acromegaly in Spain (2017-2030)
• Figure 28 Origin Specific Diagnosed Prevalent Cases of Acromegaly in Spain (2017-2030)
• Figure 29 Diagnosed Cases of Acromegaly Based on Type of Adenomas in Spain (2017-2030)
• Figure 30 Total Prevalent cases of Acromegaly in the UK (2017-2030)
• Figure 31 Diagnosed Cases of Acromegaly in the UK (2017-2030)
• Figure 32 Origin Specific Diagnosed Prevalent Cases of Acromegaly in the UK (2017-2030)
• Figure 33 Diagnosed Cases of Acromegaly Based on Type of Adenomas in the UK (2017-2030)
• Figure 34 Total Prevalent cases of Acromegaly in Japan (2017-2030)
• Figure 35 Diagnosed Cases of Acromegaly in Japan (2017-2030)
• Figure 36 Origin Based Diagnosed Prevalent Cases of Acromegaly in Japan (2017-2030)
• Figure 37 Diagnosed Cases of Acromegaly Based on Types of Adenomas in Japan (2017-2030)
• Figure 38 Treatment therapies for Acromegaly
• Figure 39 Treatment Algorithm
• Figure 40 Unmet needs for Acromegaly
• Figure 41 Seven Major Market Size of Acromegaly in USD Million (2017-2030)
• Figure 42 Seven Major Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 43 Market Size of Acromegaly in the United States, USD Million (2017-2030)
• Figure 44 United States Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 45 Market Size of Acromegaly in Germany, USD Million (2017-2030)
• Figure 46 Germany Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 47 Market Size of Acromegaly in France, USD Million (2017-2030)
• Figure 48 France Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 49 Market Size of Acromegaly in Italy, USD Million (2017-2030)
• Figure 50 Italy Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 51 Market Size of Acromegaly in Spain, USD Million (2017-2030)
• Figure 52 Spain Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 53 Market Size of Acromegaly in the United Kingdom, USD Million (2017-2030)
• Figure 54 United Kingdom Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 55 Market Size of Acromegaly in Japan, USD Million (2017-2030)
• Figure 56 Japan Market Size of Acromegaly by Therapies in USD Million (2017-2030)
• Figure 57 Market Drivers
• Figure 58 Market Barriers
• Figure 59 United States KOL Views
• Figure 60 Europe KOL Views
• Figure 61 SWOT analysis of acromegaly

DelveInsight's 'Acromegaly-Market Insights, Epidemiology, and Market Forecast-2030' report deliver an in-depth understanding of the Acromegaly, historical and forecasted epidemiology as well as the Acromegaly market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Acromegaly market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Acromegaly market size from 2017 to 2030. The Report also covers current Acromegaly treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2017-2030

Acromegaly Disease Understanding and Treatment Algorithm

Acromegaly Overview

Acromegaly is a hormonal disorder that results from the availability of excessive growth hormone (GH) in the body, which is produced by the pituitary gland (a small gland in the brain). In acromegaly, the pituitary produces an immoderate amount of GH, which is resulted from benign or non-cancerous tumors on the pituitary. These benign tumors are called Adenomas. Pituitary Adenomas are classified by WHO classification by the combination of two main histopathological features: the hormone content of the tumor cells, as assessed by immunohistochemical stains (IHC) and ultrastructural features of the tumor cells.

One of the most common signs of Acromegaly is enlarged hands and feet. Because Acromegaly tends to progress slowly, early signs may not be readily apparent for several years.

Acromegaly Diagnosis

The diagnosis of Acromegaly requires demonstration of dysregulated and enhanced GH secretion as well as elevated IGF1 levels, reflective of peripheral tissue exposure to tonically elevated GH concentrations. In Acromegaly, basal GH secretion is tonically elevated with relatively blunted bursts. Accordingly, a random GH value of fewer than 0.04 μg/l effectively excludes the diagnosis of Acromegaly. Importantly, an elevated randomly obtained GH measurement may not necessarily imply excessive integrated GH secretion. Net GH secretion is attenuated after the age of 60 (when 24-h GH secretion is less than 50% of that in younger subjects) and by elevated BMI.

Continued in the report

Acromegaly Treatment

Various targets for treatment have been used in the past but the current consensus is to aim for growth hormone level of less than 1 µg/l after an oral glucose tolerance test and a normal IGF-1 level for age and sex. There is also a general agreement that a basal growth hormone level below 2.5 µg/l is an acceptable target to consider the patient as cured.

The treatment options include surgery, medications and radiotherapy. The medication most commonly used in the treatment of Acromegaly are somatostatin analogs (SSAs), dopamine agonists (DA) and growth hormone antagonists. Dopamine agonists are mainly effective in tumors with positive growth hormone plus prolactin immunostaining. Dopamine agonists such as bromocriptine and cabergoline have been used with limited effect in the treatment of Acromegaly. Somatostatin analogs are administered as a parental formulation that suppresses GH secretion by binding to somatostatin receptors, of which there are five subtypes (SST), on somatotrope adenoma cells. Octreotide (Sandostatin) was the first medical treatment for Acromegaly that was effective in a large proportion of patients. Growth hormone antagonists such as Pegvisomant acts in the periphery by to GH receptors and preventing their dimerization; this blocks GH signal transduction and inhibits GH activity, including IGF-I production.

Acromegaly Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Acromegaly, Total Diagnosed Prevalent Cases of Acromegaly, Origin Specific Cases of Acromegaly, and Diagnosed Cases of Acromegaly Based on Type of Adenomas scenario of Acromegaly in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030.

Key Findings

• As per DelveInsight analysis, the prevalent cases in the 7MM were 64,508 in 2017.
• The diagnosed patient pool in the 7MM comprised 49,814 patients in 2017.
• In the case of the United States, the prevalent population was estimated to be 28,671 cases in 2017.
• In the US, the diagnosed cases of Acromegaly based on types of Adenomas were 18,349 of macroadenomas and 4,587 of microadenomas in 2017.
• In the Origin based segmentation of Acromegaly in 2017, 21,790 cases were originated at the Pituitary Tumor and the remaining 1,147 Acromegaly cases were from Non-Pituitary Tumor, in the US
• In the EU5, the highest prevalent cases were reported to be in Germany followed by the United Kingdom and France whereas the lowest prevalence rates were reported in Spain from 2017 through 2030
• Japan was reported to have 10,690 prevalent cases in 2017.

Acromegaly Epidemiology

The epidemiology segment also provides the Acromegaly epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Acromegaly Drug Chapters

The drug chapter segment of the Acromegaly report encloses the detailed analysis of Acromegaly marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Acromegaly clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

Acromegaly Marketed Drugs

Somatuline Depot (lanreotide acetate): Ipsen Biopharmaceuticals

Somatuline Depot (lanreotide) Injection is approved for the long-term treatment of Acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. It is also approved for neuroendocrine tumors along with carcinoid syndrome. It contains the drug substance lanreotide acetate, a synthetic octapeptide with biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Somatuline Depot is available as sterile, ready-to-use, single-use prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Somatuline is marketed as Somatuline Depot within the United States and as Somatuline Autogel in other countries where it has marketing authorization, including the various EU Member States.

Products detail in the report

Somavert (Pegvisomant): Pharmacia & Upjohn/Pfizer

Somavert (pegvisomant) is an injection developed by Pharmacia & Upjohn for the treatment of Acromegaly. It is an analog of human growth hormone (GH) that has been structurally altered to act as a GH receptor antagonist. Pegvisomant is a protein of recombinant DNA origin containing 191 amino acid residues to which many polyethylene glycol (PEG) polymers are covalently bound (predominantly 4 to 6 PEG/protein molecule). Pegvisomant is synthesized by a specific strain of Escherichia coli bacteria that has been genetically modified by the addition of a plasmid that carries a gene for GH receptor antagonist. Biological potency is determined using a cell proliferation bioassay. Somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.

Products detail in the report

Sandostatin LAR Depot: Novartis Pharmaceuticals

Sandostatin LAR Depot is an approved product by Novartis Pharmaceuticals in the form of injectable suspension. Octreotide is the acetate salt of a cyclic octapeptide. The drug is a cyclic octapeptide prepared as a clear sterile solution of the octreotide acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (SC) or intravenous (IV) injection. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Sandostatin LAR Depot is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. Sandostatin LAR is a somatostatin analog indicated for the treatment of Acromegaly, Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors and Profuse watery diarrhea associated with VIP-secreting tumors.

Products detail in the report

List to be continued in the report

Acromegaly Emerging Drugs

IONIS-GHR-LRx: Ionis Pharmaceuticals

IONIS-GHR-LRx is a Ligand-Conjugated Antisense (LICA) drug designed to reduce the production of the growth hormone receptor, or GHr, to decrease the circulating level of insulin-like growth factor-1 or IGF-1. IGF-1 is a hormone primarily produced in the liver that plays an important role in childhood growth and has anabolic effects in adults. When produced in excess, IGF-1 results in Acromegaly. It is being developed to be administered via the subcutaneous route.

Ionis Pharmaceuticals has already completed a Phase I, double-blind, placebo-controlled, dose-escalation study of IONIS-GHR-LRx in healthy volunteers. In this study, IONIS-GHR-LRx demonstrated a favorable safety and tolerability profile. There were no reports of deaths, serious adverse events or adverse events that led to study discontinuation. This investigative drug candidate is in two Phase II clinical studies in Patients with acromegaly being treated with long-acting somatostatin receptor ligands (SRL).

Products detail in the report

Mycapssa (Octreotide Capsules): Chiasma Pharma

Mycapssa (Octreotide Capsules) is an investigational drug being developed by Chiasma Pharma for the maintenance treatment of Acromegaly. Chiasma had submitted an NDA in 2015 for Octreotide capsules. Octreotide capsules have been granted orphan designation in the US and the European Union for the potential treatment of acromegaly. Octreotide capsules were developed using Chiasma's proprietary Transient Permeability Enhancer (TPE) technology platform designed to facilitate gastrointestinal absorption of the unmodified drug into the bloodstream safely. The company completed an international Phase III trial of octreotide capsules. The NDA of the resubmission was accepted by the US FDA in January 2020 and the FDA assigned a Prescription Drug User-Fee Act (PDUFA) target action date of June 26, 2020. The company is also anticipating the top-line data from the MPOWERED (for EU approval) trial in the fourth quarter of 2020.

Products detail in the report

ATL1103: Antisense Therapeutics

ATL1103 (Atesidorsen) is a second-generation antisense drug being developed by Antisense Therapeutics. It is designed to block growth hormone receptor (GHr) expression thereby reducing levels of the hormone-insulin-like growth factor-I (IGF-I) in the blood and is a potential treatment for diseases associated with excessive growth hormone action. The Company had already conducted a Phase II trial of ATL1103 with the trial has met its primary efficacy endpoint by showing a statistically significant average reduction in serum IGF-1 (sIGF-1) levels. It is being developed to be administered via the subcutaneous route.

The Company conducted a successful Phase II trial of ATL1103 with the trial met its primary efficacy endpoint by showing a statistically significant average reduction in sIGF-1 levels. The Company has also completed a high dose study of ATL1103 in adult patients with acromegaly in Australia.

In August 2019, the Company provided a market update on the status of the EAP confirming that to date the Company had been unable to obtain myTomorrows' clearance for the importation of ATL1103 drug product. It is required to be approved to use in clinical trials in the EU. The Company stated that it would not apply further resources to the early access process for acromegaly.

Products detail in the report

List to be continued in the report

Acromegaly Market Outlook

United States contributes to the major share of the Acromegaly market as compared to other countries, such as EU5 (Italy, Spain, United Kingdom, France, and Germany) and Japan. The high prevalence of Acromegaly in the United States is a major factor in stimulating market growth.

The current treatment method for acromegaly is focused on preventing the tumor compression of surrounding tissues by excising the diseases causing areas, and on reducing GH and IGF-1 levels to normal. Although, the primary treatment method for acromegaly is transsphenoidal surgery all the patients are not eligible for surgery. The cure rate of surgery is about 80% for microadenomas and 40-50% for macroadenomas. Those patients who are not eligible for surgery and those for whom surgery was failed to correct GH/IGF-1 hypersecretion, medical treatment with somatostatin analogs (SSAs), dopamine agonists (DA), growth hormone antagonists and/or radiotherapy can be used.

The approved therapies for the treatment acromegaly include Somatuline Depot (lanreotide acetate) injection, Somavert (pegvisomant), Sandostatin LAR Depot, and Signifor LAR (pasireotide).

According to DelveInsight, Acromegaly 7MM is expected to change in the study period 2017-2030.

Key Findings

• The therapeutic market of Acromegaly in the 7MM was USD 956.96 million in 2017 which is expected to increase with a CAGR of 5.73% for the study period 2017-2030
• The therapeutic market of Acromegaly in the United States was USD 517.76 million in the year 2017.
• The main therapeutic goal of the Acromegaly treatment market is to lower the risk of death by reducing the complication rate (progression rate) by safe treatment and controlling growth hormones.
• The therapeutic market of Acromegaly is dominated by SSAs, Dopamine Agonists and GHR Antagonists. The total market of these therapies was USD 736.77 million of SSAs, USD 186.29 million of GHR and USD 33.90 million of Dopamine Agonists in the year 2017 in the 7MM.
• Among the EU-5, Germany has the highest market size followed by the United Kingdom and France.

The United States Market Outlook

This section provides the total Acromegaly market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Acromegaly market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Acromegaly market size and market size by therapies in Japan are provided.

Acromegaly Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Acromegaly market or expected to get launched in the market during the study period 2017-2030. The analysis covers Acromegaly market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Acromegaly Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for Acromegaly emerging therapies.

Reimbursement Scenario in Acromegaly

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Acromegaly market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report:

• The report covers the descriptive overview of Acromegaly, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Acromegaly epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Acromegaly is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Acromegaly market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Acromegaly market.

Report Highlights:

• The robust pipeline with novel MOA and oral ROA, increasing prevalence, effectiveness of drugs as both mono and combination therapy will positively drive the Acromegaly market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Acromegaly R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Acromegaly. Launch of emerging therapies will significantly impact the Acromegaly market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Acromegaly Report Insights

• Patient Population
• Therapeutic Approaches
• Acromegaly Pipeline Analysis
• Acromegaly Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Acromegaly Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Acromegaly Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Acromegaly Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions:

Market Insights:

• What was the Acromegaly market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Acromegaly total market size as well as market size by therapies across the 7MM during the forecast period (2020-2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Acromegaly market size during the forecast period (2020-2030)?
• At what CAGR, the Acromegaly market is expected to grow at the 7MM level during the forecast period (2020-2030)?
• What would be the Acromegaly market outlook across the 7MM during the forecast period (2020-2030)?
• What would be the Acromegaly market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Acromegaly?
• What is the historical Acromegaly patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Acromegaly at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Acromegaly?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Acromegaly during the forecast period (2020-2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020-2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Acromegaly along with the approved therapy?
• What are the current treatment guidelines for the treatment of Acromegaly in the US and Europe?
• What are the Acromegaly marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Acromegaly?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Acromegaly?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acromegaly therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Acromegaly and their status?
• What are the key designations that have been granted for the emerging therapies for Acromegaly?
• What are the 7MM historical and forecasted market of Acromegaly?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the Acromegaly.
• To understand the future market competition in the Acromegaly market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Acromegaly in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Acromegaly market.
• To understand the future market competition in the Acromegaly market.

Table of Contents

1. Key Insights

2. Executive Summary

3. Acromegaly Market Overview at a Glance

• 3.1. Market (%) Distribution of Acromegaly in 2017
• 3.2. Market (%) Distribution of Acromegaly in 2030

4. Acromegaly (ACM): Disease Overview

• 4.1. Introduction
• 4.2. Signs and Symptoms
• 4.3. Classification of Pituitary Adenomas
• 4.4. Clinical Manifestations of Acromegaly
• 4.5. Etiology
• 4.6. Pathophysiology
• 4.7. Genetic Bases of Acromegaly
• 4.8. Pathogenesis
• 4.9. Diagnosis
  • 4.9.1. Diagnosis Guidelines
  • 4.9.2. Endocrine Society Clinical Practice Guideline-United Kingdom
  • 4.9.3. American Association of Clinical Endocrinologists (AACE) - USA

5. Case Reports

• 5.1. Patients with Acromegaly Presenting with Colon Cancer: A Case Series
• 5.2. Case Report: Persistent Acromegaly - Effective Therapy with Lanreotide and Weekly Pegvisomant Injections
• 5.3. Management of acromegaly in pregnancy: Case report and literature review
• 5.4. A Case Report of an Elderly Patient with Acromegaly

6. Epidemiology and Patient Population

• 6.1. Key Findings
• 6.2. Methodology
• 6.3. Total Prevalent Cases of Acromegaly in the 7MM
• 6.4. Total Diagnosed Cases of Acromegaly in the 7MM

7. United States Epidemiology

• 7.1. Total Prevalent Cases of Acromegaly in the United States
• 7.2. Diagnosed Cases of Acromegaly in the United States
• 7.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in the United States
• 7.4. Diagnosed Cases of Acromegaly Based on Types of Adenomas in the US

8. EU5 Epidemiology

• 8.1. Germany
  • 8.1.1. Total Prevalent Cases of Acromegaly in Germany
  • 8.1.2. Diagnosed Cases of Acromegaly in Germany
  • 8.1.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in Germany
  • 8.1.4. Diagnosed Cases of Acromegaly Based on Type of Adenomas in Germany
• 8.2. France
  • 8.2.1. Total Prevalent Cases of Acromegaly in France
  • 8.2.2. Diagnosed Cases of Acromegaly in France
  • 8.2.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in France
  • 8.2.4. Diagnosed Cases of Acromegaly Based on Type of Adenomas in France
• 8.3. Italy
  • 8.3.1. Total Prevalent Cases of Acromegaly in Italy
  • 8.3.2. Diagnosed Cases of Acromegaly in Italy
  • 8.3.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in Italy
  • 8.3.4. Diagnosed Cases of Acromegaly Based on Type of Adenomas in Italy
• 8.4. Spain
  • 8.4.1. Total Prevalent Cases of Acromegaly in Spain
  • 8.4.2. Diagnosed Cases of Acromegaly in Spain
  • 8.4.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in Spain
  • 8.4.4. Diagnosed Cases of Acromegaly Based on Type of Adenomas in Spain
• 8.5. United Kingdom
  • 8.5.1. Total Prevalent Cases of Acromegaly in the United Kingdom
  • 8.5.2. Diagnosed Cases of Acromegaly in the United Kingdom
  • 8.5.3. Origin Specific Diagnosed Prevalent Cases of Acromegaly in the United Kingdom
  • 8.5.4. Diagnosed Cases of Acromegaly Based on Type of Adenomas in the United Kingdom

9. Japan Epidemiology

• 9.1. Total Prevalent Cases of Acromegaly in Japan
• 9.2. Diagnosed Cases of Acromegaly in Japan
• 9.3. Origin-Based Diagnosed Prevalent Cases of Acromegaly in Japan
• 9.4. Diagnosed Cases of Acromegaly Based on Types of Adenomas in Japan

10. Treatment

• 10.1. Biomarkers of Acromegaly
• 10.2. Treatment Guidelines
  • 10.2.1. American Association of Clinical Endocrinologists (AACE) - U.S.A.
  • 10.2.2. Endocrine Society Clinical Practice Guideline-United Kingdom

11. Unmet Needs

12. Marketed Drug

• 12.1. Somatuline Depot (lanreotide acetate): Ipsen Biopharmaceuticals
  • 12.1.1. Drug Description
  • 12.1.2. Mechanism of Action
  • 12.1.3. Regulatory Milestones
  • 12.1.4. Advantages and Disadvantages
  • 12.1.5. Clinical Development
  • 12.1.6. Clinical Trials Information
  • 12.1.7. Safety and Efficacy
  • 12.1.8. Product Profile
• 12.2. Somavert (Pegvisomant): Pharmacia & Upjohn/Pfizer
  • 12.2.1. Drug Description
  • 12.2.2. Mechanism of Action
  • 12.2.3. Regulatory Milestones
  • 12.2.4. Clinical Development
  • 12.2.5. Clinical Trials Information
  • 12.2.6. Safety and Efficacy
  • 12.2.7. Advantages and Disadvantages
  • 12.2.8. Product Profile
• 12.3. Sandostatin LAR Depot: Novartis Pharmaceuticals
  • 12.3.1. Drug Description
  • 12.3.2. Mechanism of Action
  • 12.3.3. Regulatory Milestones
  • 12.3.4. Clinical Development
  • 12.3.5. Clinical Trials Information
  • 12.3.6. Safety and Efficacy
  • 12.3.7. Advantages & Disadvantages
  • 12.3.8. Product Profile
• 12.4. Signifor LAR (pasireotide): Novartis Pharmaceuticals
  • 12.4.1. Drug Description
  • 12.4.2. Mechanism of Action
  • 12.4.3. Regulatory Milestones
  • 12.4.4. Advantages & Disadvantages
  • 12.4.5. Clinical Development
  • 12.4.6. Clinical Trials Information
  • 12.4.7. Safety and Efficacy
  • 12.4.8. Product Profile

13. Key Cross Competition

14. Emerging Drugs

• 14.1. IONIS-GHR-LRx: Ionis Pharmaceuticals
  • 14.1.1. Product Description
  • 14.1.2. Other Developmental Activities
  • 14.1.3. Clinical Development
  • 14.1.4. Clinical Trials Information
  • 14.1.5. Product Profile
• 14.2. Mycapssa (Octreotide Capsules): Chiasma Pharma
  • 14.2.1. Product Description
  • 14.2.2. Other Developmental Activities
  • 14.2.3. Clinical Development
  • 14.2.4. Clinical Trials Information
  • 14.2.5. Safety and Efficacy
  • 14.2.6. Advantages and Disadvantages
  • 14.2.7. Product Profile
• 14.3. ATL1103: Antisense Therapeutics
  • 14.3.1. Product Description
  • 14.3.2. Other Developmental Activities
  • 14.3.3. Clinical Development
  • 14.3.4. Clinical Trials Information
  • 14.3.5. Safety and Efficacy
  • 14.3.6. Product Profile
• 14.4. CAM2029: Camurus
  • 14.4.1. Product Description
  • 14.4.2. Other Developmental Activities
  • 14.4.3. Clinical Development
  • 14.4.4. Clinical Trials Information
  • 14.4.5. Safety and Efficacy
  • 14.4.6. Advantages and Disadvantages
  • 14.4.7. Product Profile
• 14.5. GT-02037 (G-SRIF): GlyTech
  • 14.5.1. Product Description
  • 14.5.2. Other Developmental Activities
  • 14.5.3. Clinical Development
  • 14.5.4. Clinical Trials Informations
  • 14.5.5. Product Profile
• 14.6. Veldoreotide (COR-005, DG3173): Strongbridge Biopharma
  • 14.6.1. Product Description
  • 14.6.2. Other Developmental Activities
  • 14.6.3. Clinical Development
  • 14.6.4. Clinical Trials Information
  • 14.6.5. Safety and Efficacy
  • 14.6.6. Advantages and Disadvantages
  • 14.6.7. Product Profile
• 14.7. Paltusotine (CRN00808): Crinetics Pharmaceuticals
  • 14.7.1. Product Description
  • 14.7.2. Other Developmental Activities
  • 14.7.3. Clinical Development
  • 14.7.4. Clinical Trials Information
  • 14.7.5. Safety and Efficacy
  • 14.7.6. Advantages and Disadvantages
  • 14.7.7. Product Profile
• 14.8. MTD201: Midatech
  • 14.8.1. Product Description
  • 14.8.2. Other Development Activities
  • 14.8.3. Clinical Development
  • 14.8.4. Clinical Trial information
  • 14.8.5. Safety and Efficacy
  • 14.8.6. Advantages and Disadvantages
  • 14.8.7. Product Profile
• 14.9. Lanreotide PRF: Ipsen
  • 14.9.1. Product Description
  • 14.9.2. Clinical Development
  • 14.9.3. Clinical Trial information
  • 14.9.4. Safety and Efficacy
  • 14.9.5. Advantages and Disadvantages
  • 14.9.6. Product Profile

15. Acromegaly: Seven Major Market Analysis

• 15.1. Key Findings
• 15.2. Market Size of Acromegaly in the 7MM
• 15.3. Market Size of Acromegaly in the 7MM by Therapies

16. Market Outlook: The United States

• 16.1. The United States Market Size
  • 16.1.1. Total Market size of Acromegaly
  • 16.1.2. Market Size by Therapies

17. EU5: Market Outlook

• 17.1. Germany Market Size
  • 17.1.1. Total Market Size of Acromegaly
  • 17.1.2. Market Size by Therapies
• 17.2. France Market Size
  • 17.2.1. Total Market Size of Acromegaly
  • 17.2.2. Market Size by Therapies
• 17.3. Italy Market Size
  • 17.3.1. Total Market size of Acromegaly
  • 17.3.2. Market Size by Therapies
• 17.4. Spain Market Size
  • 17.4.1. Total Market size of Acromegaly
  • 17.4.2. Market Size by Therapies
• 17.5. The United Kingdom Market Size
  • 17.5.1. Total Market size of Acromegaly
  • 17.5.2. Market Size by Therapies

18. Japan: Market Outlook

• 18.1. Japan Market Size
• 18.2. Total Market size of Acromegaly
• 18.3. Market Size by Therapies

19. Market Drivers

20. Market Barriers

21. KOL Views

22. SWOT Analysis

23. Reimbursement and market access

24. Appendix

• 24.1. Report Methodology

25. DelveInsight Capabilities

26. Disclaimer

27. About DelveInsight