酵素補充療法の市場規模、シェア、成長分析：製品別、治療法別、投与経路別、最終用途産業別、地域別 - 産業予測 2025年～2032年

酵素補充療法の世界市場規模は2023年に106億米ドルと評価され、2024年の111億米ドルから2032年には160億3,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは4.7％で成長する見通しです。

世界の酵素補充療法（ERT）市場は、主にゴーシェ病やファブリー病のような酵素欠乏症の罹患率の上昇によって大きな成長を遂げています。ERTは、患者に外因性酵素を投与することによって本質的な救済を提供し、それによって患者の生活の質を向上させる。市場拡大の主な促進要因としては、バイオテクノロジーの技術的進歩、医療費の高騰、診断能力の強化などが挙げられます。とはいえ、高額な治療費、特定の地域での利用制限、潜在的な副作用といった課題は依然として残っています。現在進行中の研究の進展に伴い、ERTの展望は、世界規模での手頃な価格と利用しやすさの向上に努めながら、患者の転帰を向上させることを目指し、変革の時を迎えています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

酵素補充療法市場規模：製品別& CAGR（2025-2032）

• 市場概要
• イミグルセラーゼ
• アガルシダーゼベータ
• アルグルコシダーゼアルファ
• タリグルセラーゼ
• ベラグルセラーゼアルファ
• ペガデマーゼ
• ラロニダーゼ
• パンクレリパーゼ
• イデュルスルファーゼ
• ガルスルファーゼ
• その他

酵素補充療法市場規模：治療法別 & CAGR（2025-2032）

• 市場概要
• ゴーシェ病
• ムコ多糖症
• 重症複合免疫不全症
• ポンペ病
• ファブリー病
• その他

酵素補充療法市場規模：投与経路別& CAGR（2025-2032）

• 市場概要
• 非経口
• 経口

酵素補充療法市場規模：最終用途産業別& CAGR（2025-2032）

• 市場概要
• 点滴センター
• 病院
• その他

酵素補充療法市場規模& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• BioMarin Pharmaceutical Inc.（United States）
• Sanofi S.A.（France）
• AbbVie Inc.（United States）
• Alexion Pharmaceuticals Inc.（United States）
• Allergan plc（Ireland）
• Horizon Pharma Public Limited Company（Ireland）
• Protalix BioTherapeutics（Israel）
• Amicus Therapeutics, Inc.（United States）
• Ultragenyx Pharmaceutical Inc.（United States）
• JCR Pharmaceuticals Co., Ltd.（Japan）
• Green Cross Corporation（South Korea）
• Chiesi Farmaceutici S.p.A.（Italy）
• Pfizer Inc.（United States）
• Takeda Pharmaceutical Company Limited（Japan）
• Sumitomo Pharma Co., Ltd.（Japan）

結論と推奨事項

Global Enzyme Replacement Therapy Market size was valued at USD 10.6 billion in 2023 and is poised to grow from USD 11.1 billion in 2024 to USD 16.03 billion by 2032, growing at a CAGR of 4.7% during the forecast period (2025-2032).

The global enzyme replacement therapy (ERT) market is experiencing significant growth, primarily fueled by the rising incidence of enzyme deficiency disorders like Gaucher and Fabry diseases. ERT provides essential relief by administering exogenous enzymes to patients, thereby enhancing their quality of life. Key drivers of market expansion include technological advancements in biotechnology, escalating healthcare expenditures, and enhanced diagnostic capabilities. Nevertheless, challenges such as high treatment costs, limited accessibility in certain regions, and potential side effects persist. As ongoing research unfolds, the ERT landscape is poised for transformation, aiming to enhance patient outcomes while striving for increased affordability and accessibility on a global scale.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Enzyme Replacement Therapy market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Enzyme Replacement Therapy Market Segments Analysis

Global Enzyme Replacement Therapy Market is segmented by Product, Therapeutic, Route of Administration, End-use Industry and region. Based on Product, the market is segmented into Imiglucerases, Agalsidase Beta, Alglucosidase Alfa, Taliglucerase, Velaglucerase Alfa, Pegademase, Laronidase, Pancreatic Enzymes, Idursulfase, Galsulfase and Others. Based on Therapeutic, the market is segmented into Gaucher Disease, MPS, SCID, Pompe Disease, Fabry Disease and Other. Based on Route of Administration, the market is segmented into Parenteral and Oral. Based on End-use Industry, the market is segmented into Infusion Centers, Hospitals and Other. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Enzyme Replacement Therapy Market

The global enzyme replacement therapy market is witnessing significant growth driven by the rising incidence of rare genetic disorders and heightened awareness regarding the efficacy of enzyme replacement therapy. As more patients become informed about the potential benefits of this treatment, there is a growing demand for effective management options for their medical conditions. This increased recognition of enzyme replacement therapy as a viable solution is fostering advancements in research and development, ultimately enhancing treatment availability and options. As a result, the market is expanding as healthcare professionals and patients alike pursue innovative therapies for better health outcomes.

Restraints in the Global Enzyme Replacement Therapy Market

The global enzyme replacement therapy market faces several constraints that impede its widespread adoption and accessibility. High treatment costs present a significant barrier for many patients, while the limited availability of these therapies in certain regions further restricts access. Additionally, potential side effects associated with enzyme replacement therapies can deter some patients from pursuing treatment. These challenges collectively impact the utilization of enzyme replacement therapies, creating a complex landscape that hinders their broader implementation and acceptance around the world, thus limiting the potential benefits for individuals suffering from conditions treatable by these therapies.

Market Trends of the Global Enzyme Replacement Therapy Market

The global enzyme replacement therapy (ERT) market is experiencing robust growth, fueled by heightened awareness and improved diagnostic capabilities for rare genetic disorders. Innovative biopharmaceutical technologies are leading to more effective and targeted ERT options, which in turn are improving patient adherence and treatment success rates. Additionally, supportive regulatory frameworks and a surge in R&D investment are propelling market development. Nonetheless, challenges such as high treatment costs and accessibility barriers in specific areas persist. The rise of personalized medicine and advancements in gene therapy are poised to reshape the ERT market, providing novel solutions for enhanced patient outcomes and addressing current limitations.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Enzyme Replacement Therapy Market Size by Product & CAGR (2025-2032)

• Market Overview
• Imiglucerases
• Agalsidase Beta
• Alglucosidase Alfa
• Taliglucerase
• Velaglucerase Alfa
• Pegademase
• Laronidase
• Pancreatic Enzymes
• Idursulfase
• Galsulfase
• Others

Global Enzyme Replacement Therapy Market Size by Therapeutic & CAGR (2025-2032)

• Market Overview
• Gaucher Disease
• MPS
• SCID
• Pompe Disease
• Fabry Disease
• Other

Global Enzyme Replacement Therapy Market Size by Route of Administration & CAGR (2025-2032)

• Market Overview
• Parenteral
• Oral

Global Enzyme Replacement Therapy Market Size by End-use Industry & CAGR (2025-2032)

• Market Overview
• Infusion Centers
• Hospitals
• Other

Global Enzyme Replacement Therapy Market Size & CAGR (2025-2032)

• North America (Product, Therapeutic, Route of Administration, End-use Industry)
  • US
  • Canada
• Europe (Product, Therapeutic, Route of Administration, End-use Industry)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product, Therapeutic, Route of Administration, End-use Industry)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product, Therapeutic, Route of Administration, End-use Industry)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product, Therapeutic, Route of Administration, End-use Industry)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• BioMarin Pharmaceutical Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sanofi S.A. (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AbbVie Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alexion Pharmaceuticals Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Allergan plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Horizon Pharma Public Limited Company (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Protalix BioTherapeutics (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amicus Therapeutics, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ultragenyx Pharmaceutical Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• JCR Pharmaceuticals Co., Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Green Cross Corporation (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Chiesi Farmaceutici S.p.A. (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Takeda Pharmaceutical Company Limited (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sumitomo Pharma Co., Ltd. (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations