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酵素補充療法の世界市場-2022-2029

Global Enzyme Replacement Therapy Market - 2022-2029
出版日: | 発行: DataM Intelligence | ページ情報: 英文 180 Pages | 納期: 約2営業日

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酵素補充療法の世界市場-2022-2029
出版日: 2022年10月18日
発行: DataM Intelligence
ページ情報: 英文 180 Pages
納期: 約2営業日
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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

市場力学

希少疾患の有病率上昇が市場成長の原動力

2021年に発表された希少医薬品法のデータによると、希少疾患とは、米国で20万人未満に影響を与える疾患や状態を指し、約7000の希少疾患が知られており、米国では合わせて約10人に1人（約3000万人）が希少疾患を有しているとされています。最もよく見られるライソゾーム貯蔵病には、ファブリー病、ポンペ病、ゴーシェ病、様々な形態のMPS、SCID病などがあります。このようなタイプの希少疾患は、低い頻度で発生します。例えば、Orphanetによると、ゴーシェ病は10万人強に1人の割合で有病すると予想されています。希少疾患の発生頻度が低いことが、製薬業界において希少疾患の成長が限定的であることの重要な側面の1つです。

また、希少疾患に対する政府の取り組みも市場の成長を後押ししています。各国政府は、世界中で増加する希少疾患の有病率に対処するため、希少疾患の研究開発の推進に大きく注力しています。英国政府は、希少疾患の診断と治療を拡大するための戦略を打ち出しています。この枠組みに従って、政府は国内の350万人以上の希少疾患患者の生活を向上させることを計画しています。これにより、診断が迅速化され、同時に希少疾病に対する認識、治療、ケアも向上することになるでしょう。したがって、このような政府の支援的な取り組みにより、酵素補充療法の需要は予測期間中に増加すると考えられます。

しかし、代替療法が広く普及しているため、熟練した医療従事者が不足していることが、予測期間中の市場成長を制限する要因になると予想されます。

目次

第1章 調査手法と調査範囲

  • 調査手法
  • 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

  • 第3章： 酵素タイプ別市場内訳
  • 適応症別市場内訳
  • 投与経路別市場内訳
  • エンドユーザー別市場内訳
  • 地域別市場内訳

第4章 市場力学

  • 市場影響要因
    • 促進要因
      • 希少疾患に対する高いヘルスケア支出
      • 希少疾病の有病率の上昇
    • 抑制要因
      • 熟練した専門家の不足
    • ビジネスチャンス
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • バリューチェーン分析
  • PEST分析
  • プライシング分析
  • 法規制分析
  • 保険償還分析
  • アンメットニーズ
  • 特許動向

第6章 COVID-19の分析

  • COVID-19の市場分析
    • COVID-19以前の市場シナリオ
    • COVID-19の現在の市場シナリオ
    • COVID-19の後、あるいは将来のシナリオ
  • COVID-19の中での価格ダイナミクス
  • 需要-供給スペクトラム
  • パンデミック時の市場に関連する政府の取り組み
  • メーカーの戦略的な取り組み
  • まとめ

第7章 酵素タイプ別

  • アルグルセラーゼ・アルファ
  • イミグルセラーゼ
  • タリグルセラーゼアルファ
  • ベラグルセラーゼアルファ

第8章 効能・効果別

  • ゴーシェ病
  • ファブリー病
  • ポンペ病
  • ハーラー症候群
  • その他

第9章 投与経路別

  • 経口
  • 注射剤

第10章 エンドユーザー別

  • 病院・診療所
  • 在宅医療
  • 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
    • その他の南米地域
  • アジア太平洋地域
    • 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・アフリカ地域

第12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A（合併・買収）分析

第13章 企業プロファイル

  • AbbVie PLC
    • 企業概要
    • 製品ポートフォリオと説明
    • 主なハイライト
    • 財務概要
  • Alexion Pharmaceuticals Inc.
  • Allergan plc
  • BioMarin Pharmaceutical Inc.
  • Horizon Pharma Public Limited Company
  • Protalix Biotherapeutics
  • Recordati Rare Diseases
  • Johnson & Johnson Services Inc.
  • Sanofi SA
  • Shire PLC（List Not Exhaustive）

第14章 重要考察

第15章 DataM

目次
Product Code: DMHCIT3075

Market Overview

Enzyme Replacement Therapy Market was valued at USD XX million in 2021. It is forecasted to reach USD XX million by 2029, growing at a CAGR of 5.1 % during the forecast period (2022-2029).

Enzyme Replacement Therapy (ERT) is the treatment involved for rare diseases. According to Global genes.org, around 80.0% of rare diseases are categorized under genetic origin. There are more than 7,000 different types of rare diseases discovered globally. Around 50.0% of the people globally affected by rare diseases are infants and children. The FDA-approved drugs are not available for 95.0% of rare diseases, per the Kakkis Every life Foundations. ERT replenishes an enzyme that is not present in the body. ERT is available for diseases such as Gaucher disease, Fabry disease, mucopolysaccharidosis, Pompe disease, and lysosomal acid lipase deficiency. An increase in healthcare spending and the rising prevalence of rare diseases globally are among the key factors driving the enzyme replacement therapy market. Moreover, the growth in the demand for enzyme replacement therapy to improve the treatment of rare diseases is expected to drive the market during the forecast period.

Market Dynamics: Rising prevalence of rare diseases drives market growth.

According to the data published in 2021 by the Orphan drug Act, a rare disease is a disease or condition that impacts less than 200,000 people in the U.S. There are about 7000 known rare diseases, and collectively about 1 in 10 people (or 30 million people) in the United States have a rare disease. The most commonly occurring lysosomal storage diseases include Fabry, Pompe, Gaucher, various forms of MPS, and SCID diseases. Such type of rare diseases occurs in low frequencies. For instance, Gaucher's disease is expected to be prevalent in 1 in over 100,000 individuals, according to Orphanet. The low prevalence of rare diseases is one of the key aspects of its limited growth in the pharmaceutical industry.

Also, Government initiatives for rare diseases drive market growth. Governments are significantly focussing on driving R&D in rare diseases to address the rising prevalence of rare diseases across the globe. The Government of the U.K. has set out a strategy to escalate the diagnosis and treatment of rare diseases. As per the framework, the government has planned to improve the lives of over 3.5 million people with rare diseases in the country. This would speed up the diagnosis and will simultaneously increase the awareness, treatment, and care for rare diseases. Therefore, with such supportive government initiatives, the demand for enzyme replacement therapy will increase during the forecast period.

However, the wide availability of alternative treatment solutions lack of skilled healthcare professionals is a factors expected to restrict the market growth during the forecast period.

Market Segmentation: Agalsidase Alfa segment accounted for the highest share in global enzyme replacement therapy market.

Agalsidase Alfa segment led the overall market with a share in 2022 and is likely to register the fastest CAGR during the forecast period. It is a recombinant formulation of human a-galactosidase (AGAL) that is especially being used for the treatment of Fabry disease. This enzyme is manufactured by Shire, a subsidiary of Takeda Pharmaceutical, with the brand name Replagal.

Based on the indication type, the enzyme replacement therapy market has been classified into Gaucher disease, Fabry disease, Pompe disease, and hurler syndrome. Gaucher disease segment dominated the global enzyme replacement therapy market in 2022. It is attributed to the high incidence of Gaucher disease across the globe. It is expected to occur in one of 50,000 to 10,000 individuals. According to Clinicaltrials.gov, more than 60 studies are undergoing for Gaucher's disease, primarily funded by pharmaceutical companies. Considering such wide scope analyzed for Gaucher disease, the market for enzyme replacement therapy will increase during the forecast period.

Geographical Penetration: North America is the dominating region during the forecast period.

North America dominates the global enzyme replacement therapy market with the largest share in terms of value and volume globally, followed by Europe. The US dominated the North America enzyme replacement therapy market in 2019. The adoption of advanced technologies, and well-developed healthcare infrastructure, are certain factors that will enhance the market growth in the region during the forecast period.

Asia Pacific is expected to project a considerable CAGR in the market during the forecast period. The expansion of healthcare giants in rapidly emerging markets, such as China, India, and others, drives the market growth. These multinational companies are significantly investing in the healthcare sector in the Asia Pacific region.

Competitive Landscape:

The enzyme replacement therapy market is highly competitive, owing to the large presence of enzyme replacement therapy brands. The key enzyme replacement therapy players include AbbVie PLC, Alexion Pharmaceuticals Inc., Allergan plc, BioMarin Pharmaceutical Inc., Horizon Pharma Public Limited Company, Protalix Biotherapeutics, Recordati Rare Diseases, Johnson & Johnson Services Inc., Sanofi SA, Shire PLC. The crucial players are adopting new product launches and expansion strategies for global growth in the enzyme replacement therapy market. In January 2021, Horizon Therapeutics plc acquired Viela Bio, Inc. to significantly expand the development pipeline and grow the rare disease medicine portfolio. This acquisition Strengthens current R&D capability by adding a team with early-stage research, translational and clinical development capabilities along with deep scientific knowledge in autoimmune and severe inflammatory diseases. In June 2022, Recordati Rare Diseases announces positive data from phase III Linc 4, Phase III Linc 3, and Illustrate ISTURISA studies presented at ENDO 2022 meeting in Atlanta, Georgia. This drug is well tolerated in most patients without any side effects.

COVID-19 Impact: Positive impact on the global enzyme replacement therapy market.

The people dealing with the Fabry disease are at a major risk for the development of rare diseases. The impact of COVID-19 on patients dealing with Fabry disease and undergoing enzyme replacement therapy is still unknown. However, the new diagnosis rate has reduced to some extent; the market is mainly driven by the people that were previously diagnosed with the disease. Therefore, considerable growth can be projected in the enzyme replacement therapy market in 2020.

Table of Contents

1. Methodology and Scope

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

2. Market Definition and Overview

3. Executive Summary

  • 3.1. Market Snippet by Enzyme Type
  • 3.2. Market Snippet by Indication Type
  • 3.3. Market Snippet by Route of Administration
  • 3.4. Market Snippet by End-Users
  • 3.5. Market Snippet by Region

4. Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. High healthcare spending on rare diseases
      • 4.1.1.2. Rising prevalence of rare diseases
    • 4.1.2. Restraints:
      • 4.1.2.1. Lack of skilled professional
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Value Chain Analysis
  • 5.4. PEST Analysis
  • 5.5. Pricing Analysis
  • 5.6. Regulatory Analysis
  • 5.7. Reimbursement Analysis
  • 5.8. Unmet Needs
  • 5.9. Patent Trends

6. COVID-19 Analysis

  • 6.1. Analysis of Covid-19 on the Market
    • 6.1.1. Before COVID-19 Market Scenario
    • 6.1.2. Present COVID-19 Market Scenario
    • 6.1.3. After COVID-19 or Future Scenario
  • 6.2. Pricing Dynamics Amid Covid-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Enzyme Type

  • 7.1. Introduction
  • 7.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Enzyme Type Segment
  • 7.3. Market Attractiveness Index, By Enzyme Type Segment
    • 7.3.1. Alglucerase alfa*
      • 7.3.1.1. Introduction
      • 7.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 7.3.2. Imiglucerase
    • 7.3.3. Taliglucerase alfa
    • 7.3.4. Velaglucerase alfa

8. By Indication Type

  • 8.1. Introduction
  • 8.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type Segment
  • 8.3. Market Attractiveness Index, By Indication Type Segment
    • 8.3.1. Gaucher Disease*
      • 8.3.1.1. Introduction
      • 8.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 8.3.2. Fabry Disease
    • 8.3.3. Pompe Disease
    • 8.3.4. Hurler Syndrome
    • 8.3.5. Others

9. By Route of Administration

  • 9.1. Introduction
  • 9.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.3. Market Attractiveness Index, By Route of Administration
    • 9.3.1. Oral*
      • 9.3.1.1. Introduction
      • 9.3.1.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
    • 9.3.2. Injectable

10. By End-Users

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 10.1.2. Market Attractiveness Index, By End-Users
  • 10.2. Hospitals & Clinics*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis, and Y-o-Y Growth Analysis (%)
  • 10.3. Homecare
  • 10.4. Others

11. By Region

  • 11.1. Introduction
  • 11.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Region
  • 11.3. Market Attractiveness Index, By Region
  • 11.4. North 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 Enzyme Type
    • 11.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type
    • 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 End-Users
    • 11.4.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. U.S.
      • 11.4.7.2. Canada
      • 11.4.7.3. Mexico
  • 11.5. Europe
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Enzyme Type
    • 11.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type
    • 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 End-Users
    • 11.5.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. Germany
      • 11.5.7.2. U.K.
      • 11.5.7.3. France
      • 11.5.7.4. Italy
      • 11.5.7.5. Spain
      • 11.5.7.6. Rest of Europe
  • 11.6. South America
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Enzyme Type
    • 11.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type
    • 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 End-Users
    • 11.6.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.6.7.1. Brazil
      • 11.6.7.2. Argentina
      • 11.6.7.3. Rest of South America
  • 11.7. Asia Pacific
    • 11.7.1. Introduction
    • 11.7.2. Key Region-Specific Dynamics
    • 11.7.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Enzyme Type
    • 11.7.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type
    • 11.7.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.7.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.7.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 11.7.7.1. China
      • 11.7.7.2. India
      • 11.7.7.3. Japan
      • 11.7.7.4. Australia
      • 11.7.7.5. Rest of Asia Pacific
  • 11.8. Middle East and Africa
    • 11.8.1. Introduction
    • 11.8.2. Key Region-Specific Dynamics
    • 11.8.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Enzyme Type
    • 11.8.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Indication Type
    • 11.8.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.8.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-Users
    • 11.8.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country

12. Competitive Landscape

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

13. Company Profiles

  • 13.1. AbbVie PLC*
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Key Highlights
    • 13.1.4. Financial Overview
  • 13.2. Alexion Pharmaceuticals Inc.
  • 13.3. Allergan plc
  • 13.4. BioMarin Pharmaceutical Inc.
  • 13.5. Horizon Pharma Public Limited Company
  • 13.6. Protalix Biotherapeutics
  • 13.7. Recordati Rare Diseases
  • 13.8. Johnson & Johnson Services Inc.
  • 13.9. Sanofi SA
  • 13.10. Shire PLC (List Not Exhaustive)

14. Premium Insights

15. DataM Intelligence

  • 15.1. Appendix
  • 15.2. About Us and Services
  • 15.3. Contact Us