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表紙：ファブリー病治療の世界市場-2023年～2030年
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1297784

ファブリー病治療の世界市場-2023年～2030年

Global Fabry Disease Treatment Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 195 Pages | 納期: 約2営業日

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ファブリー病治療の世界市場-2023年～2030年
出版日: 2023年06月15日
発行: DataM Intelligence
ページ情報: 英文 195 Pages
納期: 約2営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
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  • 概要
  • 目次
概要

市場概要

ファブリー病治療の世界市場規模は2022年に18億7,670万米ドルに達し、2030年には32億8,720万米ドルに達するなど、有利な成長が予測されています。世界のファブリー病治療市場は、予測期間中（2023-2030年）にCAGR 7.4%を示すと予測されます。主な市場動向は、精密医療と個別化治療への注目の高まりです。

例えば、個別化医療とは、患者の遺伝子や分子構造に合わせた治療法で、予後を改善し、患者に合わない治療法から患者を遠ざけるのに役立つと期待されています。これは、患者の経験、集団の健康、コスト削減を改善するというトリプル・エイムに沿ったものです。

ファブリー病は、α-ガラクトシダーゼA（AGA）と呼ばれる酵素の欠損や機能不全を特徴とする稀な遺伝性疾患です。この酵素は、グロボトリアオシルセラミド（GL-3）またはグロボトリアオシルスフィンゴシン（Lyso-GL-3）と呼ばれる脂肪物質を分解する役割を担っています。様々な組織や臓器にGL-3やLyso-GL-3が蓄積すると、重篤な症状や合併症を引き起こす可能性があります。

ファブリー病治療市場は、認知度や診断の向上、シャペロン療法や酵素補充療法などの新規治療に対する需要の増加、治療選択肢の進歩、研究開発活動の活発化、技術の進歩などの要因によって牽引されています。

例えば、2023年3月、ChiesiグループのChiesi Global Rare Diseasesとバイオ医薬品会社のProtalix BioTherapeuticsは、欧州医薬品庁（EMA）のヒト用医薬品委員会（CHMP）がPRX-102の販売承認を推奨する肯定的意見を採択したと発表しました。PRX-102はペグニガルシダーゼ・アルファとして知られ、成人ファブリー病患者を対象とした最初で唯一のペグ化酵素製剤です。

市場力学

新規治療に対する需要の増加

新規治療薬に対する需要の増加は、ファブリー病治療薬市場のシェアを押し上げる大きな要因となっています。ファブリー病患者により良い結果をもたらす、より効果的で革新的な治療オプションに対するニーズが高まっています。酵素補充療法（ERT）などの現行療法に伴う限界や課題が、代替アプローチへの需要を生み出しています。

シャペロン療法や基質減少療法などの新しい治療法の開発は、この分野に大きな関心と興奮をもたらしています。これらの治療法は、従来のERTと比較して、有効性の向上、利便性、治療負担の軽減などの潜在的な利点を提供します。これらの治療法は、ERTに最適な反応を示さない患者や、ERTへのアクセスやERTを受けることに制限のある患者に、新たな治療選択肢を提供します。

高い治療費と限られた治療選択肢

高額な治療費と限られた治療選択肢は、ファブリー病治療市場の成長を阻害する可能性があります。これらの要因は患者とヘルスケアシステムの双方に影響を与える可能性があります。

酵素補充療法（ERT）やその他の新しい治療法などのファブリー病治療には高額な費用がかかります。特に医療保険が限られている地域や償還政策が不十分な地域では、高額な治療費は患者にとって経済的な障壁となる可能性があります。治療薬の購入しやすさは、治療へのアクセスや市場への浸透に大きく影響する可能性があります。

ファブリー病治療には進歩が見られるもの、より一般的な疾患と比較すると、治療の選択肢は依然として限られています。この限られた選択肢は、患者の特定の疾患プロファイルや治療嗜好に最も適した治療法へのアクセスを制限する可能性があります。また、市場の競争が制限され、価格や技術革新に影響を与える可能性もあります。

COVID-19影響分析

COVID-19の大流行は、ファブリー病治療薬市場を含むヘルスケア業界に多大な影響を与えました。パンデミックの経済的影響はヘルスケアシステム、支払者、患者に影響を与えました。ヘルスケアの予算は逼迫し、ERTのような高価な治療への資金援助が困難になる可能性があっています。

患者は、失業、収入の減少、保険の適用範囲の変更などにより経済的困難に直面し、ファブリー病の治療費を支払うことや必要な医療サービスを受けることが困難になったかもしれないです。

パンデミックは進行中の研究活動や臨床試験にも影響を与えました。患者募集の制限、施設の閉鎖、COVID-19研究の優先順位付けなどにより、多くの臨床試験が一時的に中止されたり、遅延したりしました。このため、新しい治療法の開発や評価が遅れたり、ファブリー病患者に対する治験治療へのアクセスが制限されたりした可能性があります。

ロシア・ウクライナ紛争分析

ロシア・ウクライナ紛争はファブリー病治療薬市場に大きな影響を与えています。紛争による混乱は、酵素補充療法（ERT）を含む医薬品の生産、流通、入手に影響を与える可能性があります。また、専門クリニックや診断施設、医療従事者へのアクセスなど、ヘルスケアサービスの提供にも支障をきたす可能性があります。

紛争はファブリー病治療に関する研究開発活動に支障をきたす可能性があります。影響を受けた地域の機関や企業が関与する臨床試験、共同研究、研究プロジェクトは、遅延や中断に直面する可能性があります。その結果、新たな治療法の開発や既存の治療法の評価が遅れ、ファブリー病治療市場全体の進展に影響を及ぼす可能性があります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 新規治療薬に対する需要の増加
      • 研究開発活動の活発化
    • 抑制要因
      • 治療費の高騰
      • 治療の選択肢が限られている
    • 機会
      • 治療オプションの進歩
    • 影響分析

第5章 産業分析

  • ポーターの5フォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析

第6章 COVID-19分析

第7章 医薬品別

  • アガルシダーゼベータ（ファブラザイム／リプラガル）
  • ミガラスタット（ガラフォールド）
  • その他

第8章 治療法別

  • 酵素補充療法（ERT）
  • シャペロン治療
  • 基質低減療法（SRT）
  • その他

第9章 投与経路別

  • 経口
  • 非経口
  • その他

第10章 流通チャネル別

  • 病院薬局
  • 小売薬局
  • オンライン薬局
  • その他

第11章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • オーストラリア
    • その他アジア太平洋地域
  • 中東・アフリカ

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • Sanofi S.A.
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展
  • Takeda Pharmaceutical Company Ltd
  • Teva Pharmaceutical Industries Ltd.
  • Amicus Therapeutics Inc.
  • Amgen Inc.
  • Bristol-Myers Squibb Company
  • Neuraltus Pharmaceuticals Inc.
  • Novartis AG
  • Pfizer Inc.
  • Idorsia Pharmaceuticals Ltd.

第14章 付録

目次
Product Code: PH2867

Market Overview

The Global Fabry Disease Treatment Market size reached US$ 1,876.7 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 3,287.2 million by 2030. The global Fabry disease treatment market is expected to exhibit a CAGR of 7.4% during the forecast period (2023-2030). The key market trend is the increasing focus on precision medicine and personalized therapies.

For instance, Personalized medicine, therapies tailored to patients' genetic and molecular makeup, is expected to improve outcomes and help direct patients away from therapies that don't work for them. It is aligned with the Triple Aim of improving patient experience, population health, and cost reduction.

Fabry disease is a rare genetic disorder characterized by the deficiency or malfunction of an enzyme called alpha-galactosidase A (AGA). This enzyme is responsible for breaking down a fatty substance called globotriaosylceramide (GL-3) or globotriaosylsphingosine (Lyso-GL-3). The accumulation of GL-3 or Lyso-GL-3 in various tissues and organs can lead to severe symptoms and complications.

The Fabry disease treatment market is driven by factors such as increasing awareness and diagnosis, increasing demand for novel therapies such as chaperone therapies and enzyme replacement therapies, advancements in treatment options, increasing R&D activities, and technological advancements.

For instance, in March 2023, Chiesi Global Rare Diseases, a part of the Chiesi Group and Protalix BioTherapeutics, a biopharmaceutical company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for PRX-102. The therapy also known as pegunigalsidase alfa, is the first and only pegylated enzyme for the treatment of adult patients with Fabry disease

Market Dynamics

Increasing Demand For Novel Therapies

The increasing demand for novel therapies is indeed a major factor driving the market share in the Fabry disease treatment market. There is a growing need for more effective and innovative treatment options that can provide better outcomes for patients with Fabry disease. The limitations and challenges associated with current therapies, such as enzyme replacement therapy (ERT), have created a demand for alternative approaches.

The development of novel therapies, such as chaperone therapies and substrate reduction therapies, has generated significant interest and excitement in the field. These therapies offer potential advantages such as improved efficacy, convenience, and reduced treatment burden compared to traditional ERT. They provide additional treatment options for patients who may not respond optimally to ERT or have limitations in accessing or receiving ERT.

High Cost of the Treatment and Limited Treatment Options

The high cost of treatment and limited treatment options can present challenges and potentially hamper the growth of the Fabry disease treatment market. These factors can impact both patients and healthcare systems.

Fabry disease treatments, such as enzyme replacement therapy (ERT) and other emerging therapies, can be costly. The high cost of these treatments can create financial barriers for patients, particularly in regions with limited healthcare coverage or inadequate reimbursement policies. The affordability of therapies can significantly influence access to treatment and market penetration.

While there have been advancements in Fabry disease treatment, the availability of treatment options remains limited compared to more prevalent conditions. This limited choice can restrict patient access to therapies that are most suitable for their specific disease profile or treatment preferences. It can also limit competition in the market, potentially affecting affordability and innovation.

COVID-19 Impact Analysis

The COVID-19 pandemic has had a profound impact on the healthcare industry, including the Fabry disease treatment market. The economic consequences of the pandemic have affected healthcare systems, payers, and patients. Healthcare budgets may have been strained, leading to potential challenges in funding expensive treatments like ERT.

Patients may have faced financial hardships due to job loss, reduced incomes, or changes in insurance coverage, making it difficult to afford Fabry disease treatments or access necessary healthcare services.

The pandemic had an impact on ongoing research activities and clinical trials. Many trials were temporarily halted or experienced delays due to restrictions on patient recruitment, site closures, and prioritization of COVID-19 research. This may have slowed down the development and evaluation of new treatments or limited access to investigational therapies for Fabry disease patients.

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict has had a significant impact on the Fabry disease treatment market. The disruptions caused by a conflict could affect the production, distribution, and availability of medications, including enzyme replacement therapy (ERT). It may also disrupt the delivery of healthcare services, such as access to specialized clinics, diagnostic facilities, or healthcare professionals.

The conflict may disrupt research and development activities related to Fabry disease treatments. Clinical trials, collaborations, and research projects involving institutions or companies in the affected regions may face delays or interruptions. This can slow down the development of new therapies or the evaluation of existing treatments, affecting the overall advancement of the Fabry disease treatment market.

Segment Analysis

The global Fabry disease treatment market is segmented based on drugs, treatment, route of administration, distribution channel, and region.

Based on Treatment, the Enzyme Replacement Therapy (ERT) Segment is Expected to Dominate the Market Share

The market for enzyme replacement therapy (ERT) holds the 65.2% of the global Fabry disease treatment market share in 2022. Currently, there are two approved ERT products for Fabry disease: agalsidase alfa (Replagal) and agalsidase beta (Fabrazyme). These products have been in the market for several years and have established a significant market presence. The availability of approved ERT options provides healthcare professionals and patients with a reliable and recognized treatment approach.

In May 2023, Protalix BioTherapeutics, a biopharmaceutical company, and Chiesi Group, a specialty pharmaceutical company developed a drug called Elfabrio is approved by FDA for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.

Geographical Analysis

North America Holds the Largest Market Share Due to the Increasing Adoption of Novel Therapies and the Presence of a Strong Healthcare Infrastructure

North America holds the 43.2% market share for the Fabry disease treatment market in 2022 due to the increasing adoption of novel therapies and the presence of strong healthcare infrastructure in the region.

North America has been at the forefront of adopting and integrating novel therapies for Fabry disease treatment. The region has a robust research and development ecosystem, which facilitates the discovery and development of innovative treatment options. The introduction of alternative therapies, such as chaperone therapies and substrate reduction therapies, has gained traction in North America, providing additional treatment choices for patients.

Competitive Landscape

The major global players in the market include: Sanofi S.A, Takeda Pharmaceutical Company Ltd, Teva Pharmaceutical Industries Ltd., Amicus Therapeutics Inc., Amgen Inc., Bristol-Myers Squibb Company, Neuraltus Pharmaceuticals Inc., Novartis AG, Pfizer Inc., and Idorsia Pharmaceuticals Ltd.

Why Purchase the Report?

  • To visualize the global Fabry disease treatment market segmentation based on drugs, treatment, route of administration, distribution channel, and region, as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of Fabry disease treatment market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as Excel consisting of key products of all the major players.

The global Fabry disease treatment market report would provide approximately 54 tables, 46 figures, and 195 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Drugs
  • 3.2. Snippet by Treatment
  • 3.3. Snippet by Route of Administration
  • 3.4. Snippet by Distribution Channel
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Demand for Novel Therapies
      • 4.1.1.2. Increasing R&D Activities
    • 4.1.2. Restraints
      • 4.1.2.1. High Cost of the Treatment
      • 4.1.2.2. Limited treatment options
    • 4.1.3. Opportunity
      • 4.1.3.1. Advancements in Treatment Options
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's 5 Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID-19
    • 6.1.2. Scenario During COVID-19
    • 6.1.3. Scenario Post COVID-19
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During the Pandemic
  • 6.5. Manufacturer's Strategic Initiatives
  • 6.6. Conclusion

7. By Drugs

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 7.1.2. Market Attractiveness Index, By Drugs
  • 7.2. Agalsidase Beta (Fabrazyme/Replagal)*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Migalastat (Galafold)
  • 7.4. Others

8. By Treatment

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 8.1.2. Market Attractiveness Index, By Treatment
  • 8.2. Enzyme Replacement Therapy (ERT)*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Chaperone Treatment
  • 8.4. Substrate Reduction Therapy (SRT)
  • 8.5. Others

9. By Route of Administration

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 9.1.2. Market Attractiveness Index, By Route of Administration
  • 9.2. Oral*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Parenteral
  • 9.4. Others

10. By Distribution Channel

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 10.1.2. Market Attractiveness Index, By Distribution Channel
  • 10.2. Hospital Pharmacies*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Retail Pharmacies
  • 10.4. Online Pharmacies
  • 10.5. Others

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.7.1. The U.S.
      • 11.2.7.2. Canada
      • 11.2.7.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.7.1. Germany
      • 11.3.7.2. The UK
      • 11.3.7.3. France
      • 11.3.7.4. Italy
      • 11.3.7.5. Spain
      • 11.3.7.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan
      • 11.5.7.4. Australia
      • 11.5.7.5. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drugs
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Sanofi S.A.*
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Takeda Pharmaceutical Company Ltd
  • 13.3. Teva Pharmaceutical Industries Ltd.
  • 13.4. Amicus Therapeutics Inc.
  • 13.5. Amgen Inc.
  • 13.6. Bristol-Myers Squibb Company
  • 13.7. Neuraltus Pharmaceuticals Inc.
  • 13.8. Novartis AG
  • 13.9. Pfizer Inc.
  • 13.10. Idorsia Pharmaceuticals Ltd.

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us