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市場調查報告書
商品編碼
1138387

全球酵素替代療法市場2022-2029

Global Enzyme Replacement Therapy Market - 2022-2029
出版日期: | 出版商: DataM Intelligence | 英文 180 Pages | 商品交期: 約2個工作天內

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簡介目錄

市場動態

罕見病患病率上升推動市場增長

根據 2021 年孤兒藥法案公佈的數據，罕見病是指在美國影響不到 200,000 人的疾病和病症，已知的罕見病約有 7,000 種，總共約有十分之一的人（約 30百萬人）據說患有一種罕見的疾病。最常見的溶酵素體貯積病包括 Fabry、Pompe、Gaucher、各種形式的 MPS 和 SCID。這些類型的罕見疾病很少發生。例如，據 Orphanet 稱，預計戈謝病將影響超過 100,000 人中的 1 人。罕見病發病率低是醫藥行業罕見病增長受限的關鍵因素之一。

政府針對罕見病的舉措也在推動市場增長。各國政府正大力推動罕見病研發，以應對全球罕見病日益流行的問題。英國政府已啟動一項擴大罕見病診斷和治療的戰略。在此框架下，政府計劃改善該國超過 350 萬罕見病患者的生活。這將加快診斷速度，同時提高對罕見病的認識、治療和護理。因此，在政府的大力支持下，預計在預測期內對酵素替代療法的需求將會增加。

但是，由於替代療法的廣泛採用，預計熟練醫護人員的短缺將成為預測期內市場增長的限制因素。

內容

第一章研究方法與範圍

  • 調查方法
  • 調查目的和範圍

第 2 章市場定義和概述

第 3 章執行摘要

  • 第 3 章:按酵素類型劃分的市場細分
  • 按指標劃分的市場細分
  • 按管理途徑劃分的市場細分
  • 最終用戶的市場細分
  • 按地區劃分的市場細分

第 4 章市場動態

  • 市場影響因素
    • 驅動程序
      • 罕見病的高額醫療保健支出
      • 罕見病患病率上升
    • 限制因素
      • 缺乏熟練的專業人員
    • 商機
    • 影響分析

第五章行業分析

  • 波特五力分析
  • 供應鏈分析
  • 價值鏈分析
  • PEST 分析
  • 定價分析
  • 監管分析
  • 保險報銷分析
  • 未滿足的需求
  • 專利趨勢

第 6 章 COVID-19 分析

  • COVID-19 的市場分析
    • COVID-19 之前的市場情景
    • COVID-19 的當前市場情景
    • COVID-19 後或未來情景
  • COVID-19 期間的價格動態
  • 供需範圍
  • 大流行期間與市場相關的政府舉措
  • 製造商的戰略舉措
  • 總結

第 7 章:按酵素類型分類

  • 葡萄糖甘酵素 ALPHA
  • 伊米甘酵素
  • Tari 葡萄糖酵素 Alpha
  • 貝拉葡萄糖酵素 ALPHA

第8章按功效和作用

  • 戈謝病
  • 法布裡病
  • 龐貝病
  • 投擲者綜合症
  • 其他

第 9 章給藥途徑

  • 口語
  • 注入

第 10 章，最終用戶

  • 醫院和診所
  • 居家護理
  • 其他

第 11 章按地區劃分

  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 意大利
    • 西班牙
    • 其他歐洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳大利亞
    • 其他亞太地區
  • 中東和非洲

第 12 章競爭格局

  • 競爭場景
  • 市場情況/份額分析
  • 併購分析

第 13 章公司簡介

  • AbbVie PLC
    • 公司概況
    • 產品組合和描述
    • 主要亮點
    • 財務摘要
  • 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

簡介目錄
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