酶替代疗法市场基于(关键地区、市场参与者、规模和份额)- 到 2031 年的预测

  • Report Code : TIPRE00008474
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 226
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酶替代疗法市场预计将从2021年的96.7339亿美元增长到2028年的151.847亿美元;预计2022年至2028年复合年增长率为6.8%。

酶替代疗法(ERT)是通过使用酶或具有酶活性的蛋白质来治疗先天性酶缺乏症。动物、人类和重组工程酶是治疗所需酶的几种来源。该疗法通常应用于罕见的溶酶体贮积病,包括庞贝病、法布里病、戈谢病、泰-萨克斯病和胡勒综合征。最常见的 ERT 方法是静脉输注,其中通过受控的液体滴注将替代酶直接注入血液中。全球酶替代疗法市场的增长归因于溶酶体贮积病 (LSD) 患病率的上升以及孤儿药指定药物的快速监管批准以及其他营销优势。然而,市场参与者之间的激烈竞争阻碍了市场的增长。

该报告对全球酶替代疗法市场进行了见解和深入分析,强调了包括市场趋势、技术进步、市场动态、以及全球领先市场参与者的竞争格局分析。它还包括 COVID-19 大流行对所有地区市场的影响。由于 COVID-19 大流行,许多卫生当局将重点放在与大流行相关的护理上。此外,由于医院服务不足以应对 COVID-19 患者的负担,许多需要酶替代治疗的患者在 2020 年 3 月错过了输液。需要 ERT 的患者声称在住院期间或对药物供应感到焦虑。此外,研究还显示,一些患者患有抑郁症和焦虑感增加。因此,预定的酶替代疗法 (ERT) 在 COVID-19 大流行期间被打乱,从而对市场产生了负面影响。

战略见解

基于地理的见解

按地域划分,全球酶替代疗法市场分为北美(美国、加拿大和墨西哥)、欧洲(法国、德国、英国、西班牙、意大利和欧洲其他地区)、亚太地区(中国、印度、日本、澳大利亚、韩国和亚太地区其他地区)、中东和非洲非洲(沙特阿拉伯、阿联酋、南非和中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。

全球酶替代疗法市场利润丰厚的地区

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市场洞察

溶酶体贮积病 (LSD) 患病率上升

溶酶体是一种膜结合细胞器,含有消化酶。溶酶体是大分子分解代谢、回收和信号传导的关键细胞中心。这些功能的任何缺陷都会导致大分子在溶酶体中积累或储存,从而导致细胞损伤。溶酶体贮积病 (LSD) 的主要原因是负责编码溶酶体酶的基因突变。此外,LSD 的特征是一种先天代谢错误,导致酶的缺失或缺乏。与成人相比,婴儿和儿童遭受的痛苦更严重,因为儿童可以从父母一方或双方遗传有缺陷的基因。然而,近十年来,这种模式正在发生变化,LSD在成人中更为常见

此外,LSD大约有70种疾病,包括戈谢病、尼曼-匹克病、法布里病、泰-萨克斯病病、粘多糖贮积症(MPS)疾病和庞贝病。这些疾病单独来看很少见,但总的来说却非常普遍,影响五千分之一的活产儿。许多国家进行了调查以了解患病率模式,总体患病率正在上升。例如,《柳叶刀地区健康》杂志上发表的一项题为“2009 年至 2020 年澳大利亚溶酶体贮积症患病率”的研究。该研究揭示了以下结果:

  • 澳大利亚人口中的患病率是其 1.6 倍(每 4,800 名活产婴儿中就有 1 人) ,高于 1996 年报告的患病率(每 7,700 名活产婴儿 1 例)。
  • 法布里病最为常见,占所有诊断的 34%(截至 2020 年) .
  • LSD 在成年期比儿童期更常见

因此,LSD 患病率不断上升,且治愈方法有限该疾病正在推动全球酶替代疗法市场的增长

基于酶类型的见解

根据酶类型,全球酶替代疗法市场分为阿葡萄糖苷酶 alfa、阿加糖酶β、伊米苷酶、艾杜磺酶、半乳糖酶、维拉苷酶α和其他酶。 2021年,其他酶细分市场占据最大的市场份额。预计从 2022 年到 2028 年,同一细分市场将实现最高的复合年增长率。

全球酶替代疗法市场(按酶类型) 2021年和2028年

基于治疗条件的见解

根据治疗条件,全球酶替代疗法市场分为戈谢病、法布里病、庞贝氏病、SCID、MPS和其他治疗条件。戈谢病细分市场在 2021 年占据最大的市场份额,预计在预测期内复合年增长率最高。

基于管理的洞察路线

基于管理方面,全球酶替代疗法市场分为肠胃外和口服。注射剂细分市场在 2021 年占据了更大的市场份额,预计在预测期内将实现更高的复合年增长率。

基于最终用户的见解

基于最终用户,全球酶替代疗法市场分为医院、输液中心等。医院细分市场在 2021 年占据最大的市场份额。然而,输液中心细分市场预计在预测期内复合年增长率最高。

全球酶替代疗法市场参与者采取有机策略,包括产品推出和扩张,以扩大其在全球的足迹和产品组合,并满足不断增长的需求。对市场做出贡献的几个主要参与者包括武田药品工业株式会社 (Takeda Pharmaceutical Company Limited);赛诺菲公司;艾伯维公司; BioMarin 制药公司;之友治疗公司;亚力兄制药公司(阿斯利康);杨森制药(强生服务公司); Recordati SpA;辉瑞公司;和 CHIESI Farmaceutici SpA

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What is meant by the enzyme replacement therapy market?

Enzyme replacement therapy (ERT) is a treatment that replaces enzymes that are not present or are deficient in the body. This is usually done by giving the patient an intravenous (IV) infusion or oral solution in which the enzyme is present. ERT is available for various lysosomal storage diseases which include Fabry’s disease, Gaucher’s disease, Pompe’s disease, MPS, and others. The ERT only increases the concentration of the enzymes which is lacking in the patient body and it does not correct any underlying genetic defect. ERT has also been used to treat patients with severe combined immunodeficiency (SCID) resulting from an adenosine deaminase deficiency (ADA-SCID).

What are the driving factors for the enzyme replacement therapy market across the globe?

Rising prevalence of lysosomal storage diseases (LSDS) and rapid regulatory approval with other benefits for drug with orphan drug designation are the most significant factors responsible for the overall market growth.

Which enzyme type segment led the enzyme replacement therapy market?

Based on enzyme type, other enzymes segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period. Other enzymes include taliglucerase, laronidase, agalsidase alfa, eliglustat, cipaglucosidase alfa, miglustat, elosulfase alfa, elapegademase, velmanase alfa, pancreatic enzymes, pegademase, sebelipase alfa, cerliponase alfa, among others.

Which therapeutic conditions segment held the largest market share in the enzyme replacement therapy market?

Based on therapeutic conditions, Gaucher's disease segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which route of administration segment led the enzyme replacement therapy market?

Based on route of administration, parenteral route of administration segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which end user segment held the largest market share in the enzyme replacement therapy market?

The hospitals segment dominated the global enzyme replacement therapy market and accounted for the largest market share of 49.00% in 2021.

Who are the key players in the enzyme replacement therapy market?

Takeda Pharmaceutical Company Limited, Sanofi, AbbVie Inc., BioMarin Pharmaceutical Inc., Amicus Therapeutics, Alexion Pharmaceuticals, Inc.(AstraZeneca), Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.), Recordati S.p.A., Pfizer Inc., and CHIESI Farmaceutici S.p.A. are among the leading companies operating in the enzyme replacement therapy market

What is the regional market scenario of the enzyme replacement therapy market?

Global enzyme replacement therapy market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for enzyme replacement therapy market. A rise in the prevalence of lysosomal storage diseases such as Gaucher’s, Pompe’s, and Fabry’s diseases, increasing regulatory approval, favorable regulatory support by the government, and the availability of various ERT products will drive enzyme replacement therapy market growth in North America. However, the growing government funding for rare disease treatment, increasing clinical trials, an increasing number of product approvals, and expanding partnerships among key players are the key factors responsible for the Asia-Pacific regional growth of the enzyme replacement therapy market accounting fastest growth in the region during the coming years.

The List of Companies - Enzyme Replacement Therapy Market

  1. Sanofi
  2. BioMarin Pharmaceutical Inc.
  3. Takeda Pharmaceutical Company Limited
  4. AbbVie Inc.        
  5. Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.)
  6. Alexion Pharmaceuticals, Inc (AstraZeneca)
  7. Amicus Therapeutics
  8. Recordati S.p.A.
  9. CHIESI Farmaceutici S.p.A.
  10. Pfizer Inc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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