효소대체요법 시장은 2021년 96억 7,339만 달러에서 2028년 151억 8,470만 달러로 성장할 것으로 예상된다. 2022년부터 2028년까지 연평균 성장률(CAGR) 6.8%로 성장할 것으로 추정됩니다.
효소대체요법(ERT)은 효소 활성을 갖는 효소나 단백질을 이용하여 선천성 효소 결핍증을 치료하는 치료법입니다. 동물, 인간 및 재조합 공학 효소는 치료에 필요한 몇 가지 효소 공급원입니다. 이 치료법은 일반적으로 폼페병, 파브리병, 고셔병, 테이삭스병, 헐러 증후군 등 희귀 리소좀 축적 질환에 적용됩니다. 가장 일반적인 ERT 방법은 IV 주입으로, 이 방법에서는 대체 효소를 조절된 수액 주입을 통해 혈류에 직접 투여합니다. 글로벌 효소 대체 요법 시장의 성장은 리소좀 축적 질환(LSD)의 유병률 증가와 희귀 의약품 지정 의약품에 대한 기타 마케팅 혜택과 함께 신속한 규제 승인에 기인합니다. 그러나 시장 참가자들 간의 치열한 경쟁은 시장 성장을 방해합니다.
이 보고서는 글로벌 효소 대체 요법 시장에 대한 통찰력과 심층 분석을 제공하며 시장 동향, 기술 발전, 시장 역학, 글로벌 선두 시장 플레이어의 경쟁 구도 분석. 또한 모든 지역의 시장에 대한 COVID-19 전염병의 영향도 포함됩니다. 코로나19 팬데믹으로 인해 많은 보건당국이 팬데믹 관련 진료에 집중하고 있습니다. 더욱이 2020년 3월에는 코로나19 환자의 부담을 감당하기 위한 병원 서비스의 미흡으로 인해 효소대체요법이 필요한 많은 환자들이 주사를 놓쳤습니다. ERT가 필요한 환자들은 병원 입원 중이나 약물 공급과 관련하여 불안감을 느낀다고 주장했습니다. 또한 연구에 따르면 일부 환자는 우울증을 앓고 불안이 증가한 것으로 나타났습니다. 따라서 예정된 효소 대체 요법(ERT) 세션이 코로나19 팬데믹 기간 동안 중단되어 시장에 부정적인 영향을 미쳤습니다.
전략적 통찰력
지리 기반 통찰력
지역별로 전 세계 효소 대체 요법 시장은 북미(미국, 캐나다, 멕시코), 유럽(프랑스, 독일, 영국, 스페인, 이탈리아 및 기타 유럽 지역), 아시아 태평양( 중국, 인도, 일본, 호주, 한국 및 기타 APAC 지역), 중동 및 아프리카(사우디아라비아, UAE, 남아프리카공화국 및 나머지 MEA 지역), 남부 & 중앙 아메리카(브라질, 아르헨티나, 나머지 중남미).
글로벌 효소 대체 요법 시장의 수익성이 높은 지역
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시장 통찰력
리소좀축적질환(LSD)의 확산 증가
리소좀은 소화 효소를 포함하는 막으로 둘러싸인 세포 소기관입니다. 리소좀은 고분자 이화작용, 재활용 및 신호 전달을 위한 핵심 세포 허브입니다. 이러한 기능에 결함이 있으면 리소좀에 거대분자가 축적되거나 저장되어 세포가 손상됩니다. 리소좀 축적 질환(LSD)의 주요 원인은 리소좀 효소를 암호화하는 유전자의 돌연변이입니다. 또한, LSD는 효소의 부재 또는 결핍을 초래하는 선천적 대사 오류로 특징지어집니다. 유아와 어린이는 부모 중 한 명 또는 두 명 모두로부터 결함이 있는 유전자를 물려받을 수 있기 때문에 성인에 비해 더 심각한 고통을 받습니다. 그러나 지난 10년 동안 패턴이 바뀌어 LSD는 성인에게 더 흔하게 발생합니다
게다가 LSD는 고셔병, 니만픽병, 파브리병, 테이삭스병 등 약 70여종의 질병입니다. 질환, 뮤코다당증(MPS) 질환, 폼페병 등이 있습니다. 이러한 장애는 개별적으로는 드물지만 집단적으로는 상당히 널리 퍼져 있으며 출생 5,000명 중 1명에게 영향을 미칩니다. 많은 국가에서 유병률 패턴을 이해하기 위해 설문조사를 실시했으며, 전반적인 유병률은 증가하고 있었습니다. 예를 들어, The Lancet Regional Health에 발표된 "2009년부터 2020년까지 호주의 리소좀 축적 장애 유병률"이라는 제목의 연구입니다. 연구 결과는 다음과 같습니다:
- 호주 인구의 유병률은 1.6배(출생 4,800명당 1명)입니다. , 이는 1996년에 보고된 유병률(7,700명 출생당 1명)보다 높은 수치입니다.
- 파브리병은 가장 널리 퍼져 있으며 전체 진단의 34%를 차지합니다(2020년까지). .
- LSD는 아동기보다 성인기에 더 흔합니다.
따라서 LSD의 유병률이 증가하고 치료 요법이 제한되고 있습니다. 이 질병은 전 세계 효소 대체 요법 시장의 성장을 주도하고 있습니다.
효소 유형 기반 통찰력
효소 유형을 기준으로 전 세계 효소 대체 요법 시장은 알글루코시다제 알파, 아갈시다제로 분류됩니다. 베타, 이미글루세라제, idursulfase, 갈설파제, 벨라글루세라제 알파 및 기타 효소. 2021년에는 기타 효소 부문이 가장 큰 시장 점유율을 차지했습니다. 동일한 부문은 2022년부터 2028년까지 시장에서 가장 높은 CAGR을 기록할 것으로 예상됩니다.
효소 유형별 글로벌 효소 대체 요법 시장 – 2021년 및 2028년
치료 조건 기반 통찰력
치료 조건을 기반으로 전 세계 효소 대체 요법 시장은 고셔병, 파브리병, 폼페병, SCID, MPS 및 다른 치료 조건. 고셔병 부문은 2021년 가장 큰 시장 점유율을 차지했으며 예측 기간 동안 가장 높은 CAGR을 기록할 것으로 예상됩니다.
관리 기반 통찰력 경로
경로 기준 투여를 시작으로 전 세계 효소대체요법 시장은 비경구용과 경구용으로 양분됩니다. 비경구 부문은 2021년에 더 큰 시장 점유율을 차지했으며 예측 기간 동안 더 높은 CAGR을 기록할 것으로 예상됩니다.
최종 사용자 기반 통찰력
글로벌 효소인 최종 사용자를 기반으로 합니다. 대체 요법 시장은 병원, 주입 센터 등으로 분류됩니다. 병원 부문은 2021년 가장 큰 시장 점유율을 차지했습니다. 그러나 주입 센터 부문은 예측 기간 동안 가장 높은 CAGR을 기록할 것으로 예상됩니다.
글로벌 효소 대체 요법 시장 플레이어는 제품 출시를 포함한 유기적 전략을 채택합니다. 전 세계적으로 입지와 제품 포트폴리오를 확장하고 증가하는 수요를 충족하기 위한 확장입니다. 시장에 기여하는 몇몇 주요 업체로는 Takeda Pharmaceutical Company Limited가 있습니다. 사노피 SA; 애브비 주식회사; BioMarin Pharmaceutical Inc.; 아미쿠스 테라퓨틱스(Amicus Therapeutics); Alexion Pharmaceuticals, Inc.(AstraZeneca); Janssen Pharmaceuticals(Johnson & Johnson Services, Inc.); Recordati SpA; 화이자 주식회사; 및 CHIESI Farmaceutici SpA
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
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).
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.
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.
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.
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.
The hospitals segment dominated the global enzyme replacement therapy market and accounted for the largest market share of 49.00% in 2021.
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
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
- Sanofi
- BioMarin Pharmaceutical Inc.
- Takeda Pharmaceutical Company Limited
- AbbVie Inc.
- Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.)
- Alexion Pharmaceuticals, Inc (AstraZeneca)
- Amicus Therapeutics
- Recordati S.p.A.
- CHIESI Farmaceutici S.p.A.
- Pfizer Inc.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- 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.
- 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:
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.
- 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.
- 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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