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市場調査レポート
商品コード
955849
先端巨大症：市場分析、疫学、市場予測 (2030年)Acromegaly - Market Insights, Epidemiology, and Market Forecast-2030 |
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| 先端巨大症：市場分析、疫学、市場予測 (2030年) |
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出版日: 受注後作成
発行: DelveInsight Business Research LLP
ページ情報: 英文 200 Pages
納期: 約10営業日
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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。
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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。
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.
Study Period: 2017-2030
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.
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
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.
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
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
This section provides the total Acromegaly market size and; market size by therapies in the United States.
The total Acromegaly market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Acromegaly market size and market size by therapies in Japan are provided.
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.
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
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