酵素補充療法市場 - 2031年の成長予測、統計および事実

  • Report Code : TIPRE00008474
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 226
Buy Now

酵素補充療法市場は、2021 年の 96 億 7,339 万米ドルから 2028 年までに 151 億 8,470 万米ドルに成長すると予想されています。 2022 年から 2028 年にかけて 6.8% の CAGR で成長すると推定されています。

酵素補充療法 (ERT) は、酵素または酵素活性を持つタンパク質を使用して先天性酵素欠損症を治療するために行われます。動物、ヒト、および遺伝子組み換え酵素は、治療に必要な酵素の数少ない供給源です。この治療法は一般に、ポンペ病、ファブリー病、ゴーシェ病、テイ・サックス病、ハーラー症候群などの稀なリソソーム性蓄積症に適用されます。最も一般的な ERT 方法は IV 注入です。この方法では、制御された液体の点滴によって補充酵素が血流に直接投与されます。世界的な酵素補充療法市場の成長は、リソソーム蓄積症 (LSD) の有病率の上昇と、希少疾病用医薬品に指定された医薬品のその他のマーケティング上の利点を伴う迅速な規制当局の承認によるものです。しかし、市場プレーヤー間の熾烈な競争は市場の成長を妨げています。

このレポートは、市場動向、技術の進歩、市場力学、世界の主要市場プレーヤーの競争状況分析。これには、すべての地域の市場に対する新型コロナウイルス感染症のパンデミックの影響も含まれています。新型コロナウイルス感染症のパンデミックにより、多くの保健当局はパンデミック関連のケアに焦点を当てました。さらに、2020年3月には、新型コロナウイルス感染症患者の負担に対処する病院サービスが不十分だったため、酵素補充療法を必要とする多くの患者が点滴を受けられなかった。 ERT を必要とする患者は、入院中または薬剤供給に関して不安を感じていると主張した。また、一部の患者はうつ病を患い、不安が増大していることも研究で明らかになりました。したがって、予定されていた酵素補充療法 (ERT) セッションは、新型コロナウイルス感染症のパンデミック中に中断され、市場に悪影響を及ぼしました。

戦略的洞察

地理ベースの洞察

世界の酵素補充療法市場は地理的に、北米 (米国、カナダ、メキシコ)、欧州 (フランス、ドイツ、英国、スペイン、イタリア、その他の欧州)、アジア太平洋 (中国、インド、日本、オーストラリア、韓国、およびその他のアジア太平洋地域)、中東、およびその他の地域アフリカ (サウジアラビア、UAE、南アフリカ、およびその他の MEA)、および南および南アフリカ中央アメリカ (ブラジル、アルゼンチン、その他の南米および中米)。

世界の酵素補充療法市場にとって有利な地域

< /p>

市場洞察

リソソーム蓄積症 (LSD) の有病率の上昇

リソソームは、消化酵素を含む膜結合細胞小器官です。リソソームは、高分子の異化、リサイクル、シグナル伝達の重要な細胞ハブです。これらの機能に欠陥があると、リソソーム内に高分子が蓄積または貯蔵され、細胞損傷が引き起こされます。リソソーム蓄積症(LSD)の主な原因は、リソソーム酵素のコード化に関与する遺伝子の変異です。さらに、LSD は、酵素の欠如または欠乏を引き起こす先天的な代謝異常として特徴付けられます。子供は両親の一方または両方から欠陥遺伝子を受け継ぐ可能性があるため、乳児と子供は成人に比べてより深刻な苦しみを伴います。しかし、過去 10 年以来、そのパターンは変化しており、LSD は成人でより一般的です。

さらに、LSD はゴーシェ病、ニーマンピック病、ファブリー病、テイサックス病を含む約 70 の病気です。ムコ多糖症(MPS)疾患、ポンペ病などがあります。これらの疾患は、個別にはまれですが、全体としては非常に蔓延しており、出生 5,000 人に 1 人が罹患しています。多くの国が有病パターンを理解するために調査を実施し、全体的な有病率は上昇しています。たとえば、『The Lancet Regional Health』に掲載された「2009年から2020年までのオーストラリアにおけるリソソーム蓄積障害の蔓延」というタイトルの研究。この研究により、次の結果が明らかになりました。

  • オーストラリアの人口における有病率は 1.6 倍 (出生 4,800 人に 1 人)
  • ファブリー病が最も蔓延しており、全診断の 34% を占めました(2020 年まで)。 .
  • LSD は小児期よりも成人期に多く見られます

したがって、LSD の有病率は上昇しており、治療法は限られています。この病気は世界の酵素補充療法市場の成長を牽引しています

酵素の種類に基づく洞察

酵素の種類に基づいて、世界の酵素補充療法市場はアルグルコシダーゼ アルファ、アガルシダーゼに分類されます。ベータ、イミグルセラーゼ、イドゥルスルファーゼ、ガルスルファーゼ、ベラグルセラーゼ アルファ、およびその他の酵素。 2021 年には、その他の酵素セグメントが最大の市場シェアを占めました。同じセグメントは、2022 年から 2028 年にかけて市場で最高の CAGR を記録すると予想されています。

酵素の種類別の世界の酵素補充療法市場 – 2021 年と 2028 年

治療条件に基づく洞察

世界の酵素補充療法市場は、治療条件に基づいて、ゴーシェ病、ファブリー病、ポンペ病、SCID、MPS、および他の治療状態。ゴーシェ病セグメントは 2021 年に最大の市場シェアを保持しており、予測期間中に最高の CAGR を記録すると予想されます。

投与経路ベースの洞察

投与経路に基づく酵素補充療法の世界市場は非経口と経口に分かれています。非経口セグメントは 2021 年に大きな市場シェアを保持しており、予測期間中により高い CAGR を記録すると予想されます。

エンドユーザーベースの洞察

エンドユーザーに基づいた、世界的な酵素補充療法市場は病院、点滴センターなどに分割されています。 2021 年には病院セグメントが最大の市場シェアを占めました。しかし、輸液センターセグメントは、予測期間中に最高の CAGR を記録すると予想されます。

世界の酵素補充療法市場のプレーヤーは、製品発売を含む有機的な戦略を採用しています。世界中でその拠点と製品ポートフォリオを拡大し、増大する需要に対応するための拡大です。市場に貢献している主要企業としては、武田薬品工業株式会社が挙げられます。サノフィSA;アッヴィ株式会社;バイオマリン製薬株式会社;アミカス・セラピューティクス。 Alexion Pharmaceuticals, Inc. (アストラゼネカ);ヤンセン ファーマシューティカルズ (ジョンソン・アンド・ジョンソン・サービス社); Recordati SpA;ファイザー株式会社;および 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

This text is related
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.

Your data will never be shared with third parties, however, we may send you information from time to time about our products that may be of interest to you. By submitting your details, you agree to be contacted by us. You may contact us at any time to opt-out.

Related Reports