Se espera que el mercado de la terapia de reemplazo enzimático crezca de 9.673,39 millones de dólares en 2021 a 15.184,70 millones de dólares en 2028; se estima que crecerá a una tasa compuesta anual del 6,8 % entre 2022 y 2028.
La terapia de reemplazo enzimático (TRE) se realiza para tratar deficiencias enzimáticas congénitas mediante el uso de enzimas o proteínas con actividad enzimática. Las enzimas animales, humanas y recombinantes son algunas de las fuentes de enzimas necesarias para el tratamiento. La terapia se aplica generalmente en enfermedades de almacenamiento lisosomales y raras, incluidas la enfermedad de Pompe, la enfermedad de Fabry, la enfermedad de Gaucher, la enfermedad de Tay-Sachs y el síndrome de Hurler. El método de ERT más común son las infusiones intravenosas, en las que la enzima de reemplazo se administra directamente en el torrente sanguíneo mediante un goteo controlado de líquidos. El crecimiento del mercado mundial de terapias de reemplazo de enzimas se atribuye a la creciente prevalencia de enfermedades por almacenamiento lisosomal (LSD) y a la rápida aprobación regulatoria, junto con otros beneficios de comercialización para medicamentos con designación de medicamento huérfano. Sin embargo, la competencia feroz entre los actores del mercado obstaculiza el crecimiento del mercado.
El informe ofrece información y un análisis en profundidad del mercado global de terapia de reemplazo de enzimas, enfatizando varios parámetros que incluyen tendencias del mercado, avances tecnológicos, dinámica del mercado, y análisis del panorama competitivo de los principales actores del mercado mundial. También incluye el impacto de la pandemia de COVID-19 en el mercado de todas las regiones. Debido a la pandemia de COVID-19, muchas autoridades sanitarias se centraron en la atención relacionada con la pandemia. Además, muchos pacientes que requirieron terapia de reemplazo enzimático omitieron sus infusiones en marzo de 2020 debido a la insuficiencia de los servicios hospitalarios que se ocupan de la carga de los pacientes con COVID-19. Los pacientes que requirieron TRE afirmaron sentirse ansiosos durante los ingresos hospitalarios o con respecto al suministro de medicamentos. Además, los estudios revelaron que algunos pacientes tenían depresión y una mayor cantidad de ansiedad. Por lo tanto, las sesiones programadas de terapia de reemplazo enzimático (TRE) se interrumpieron durante la pandemia de COVID-19, lo que tuvo un impacto negativo en el mercado.
Información estratégica
Información basada en geografía
Por geografía, el mercado mundial de terapia de reemplazo enzimático está segmentado en América del Norte (EE. UU., Canadá y México), Europa (Francia, Alemania, Reino Unido, España, Italia y el resto de Europa), Asia Pacífico ( China, India, Japón, Australia, Corea del Sur y el resto de APAC), Medio Oriente y Asia. África (Arabia Saudita, Emiratos Árabes Unidos, Sudáfrica y el resto de los MEA) y Sur y África. América Central (Brasil, Argentina y el resto de América Central y del Sur).
regiones lucrativas para el mercado mundial de terapias de reemplazo enzimático
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Perspectivas del mercado
Prevalencia creciente de enfermedades por almacenamiento lisosomal (LSD)
Un lisosoma es un orgánulo celular rodeado de membrana que contiene enzimas digestivas. Un lisosoma es el centro celular clave para el catabolismo, el reciclaje y la señalización de macromoléculas. Cualquier defecto en estas funciones conduce a la acumulación o almacenamiento de macromoléculas en los lisosomas, lo que provoca daño celular. La principal causa de las enfermedades por almacenamiento lisosomal (LSD) son las mutaciones en los genes responsables de codificar una enzima lisosomal. Además, el LSD se caracteriza por ser un error innato del metabolismo que resulta en la ausencia o deficiencia de una enzima. Los bebés y los niños sufren más gravemente en comparación con los adultos, ya que los niños pueden heredar el gen defectuoso de uno o ambos padres. Sin embargo, desde la última década, el patrón ha ido cambiando y los LSD son más comunes en adultos
Además, los LSD son aproximadamente 70 enfermedades, incluidas la enfermedad de Gaucher, la enfermedad de Niemann-Pick, la enfermedad de Fabry, la enfermedad de Tay-Sachs. enfermedad, enfermedades mucopolisacaridosis (MPS) y enfermedad de Pompe. Estos trastornos son individualmente raros, pero en conjunto tienen una prevalencia significativa y afectan a 1 de cada 5.000 nacidos vivos. Muchos países realizaron encuestas para comprender el patrón de prevalencia, y la prevalencia general estaba aumentando. Por ejemplo, un estudio publicado en The Lancet Regional Health titulado "Prevalencia de trastornos por almacenamiento lisosomal en Australia de 2009 a 2020". El estudio reveló los siguientes resultados:
- La prevalencia en la población australiana es de 1,6 veces (1 por cada 4.800 nacidos vivos) , superior a la prevalencia notificada en 1996 (1 por cada 7700 nacidos vivos).
- La enfermedad de Fabry fue la más prevalente y representó el 34 % de todos los diagnósticos (hasta 2020). .
- Los LSD son más comunes en la edad adulta que en la infancia
De ahí la creciente prevalencia de los LSD y las limitadas terapias para curarlos. la enfermedad está impulsando el crecimiento del mercado mundial de terapias de reemplazo enzimático
Información basada en el tipo de enzimas
Según el tipo de enzima, el mercado global de terapias de reemplazo enzimático se segmenta en alglucosidasa alfa, agalsidasa beta, imiglucerasa, idursulfasa, galsulfasa, velaglucerasa alfa y otras enzimas. En 2021, el segmento de otras enzimas representó la mayor cuota de mercado. Se espera que el mismo segmento registre la CAGR más alta del mercado de 2022 a 2028.
Mercado global de terapia de reemplazo enzimático, por tipo de enzima: 2021 y 2028
Información basada en condiciones terapéuticas
Según las condiciones terapéuticas, el mercado global de terapia de reemplazo enzimático se segmenta en enfermedad de Gaucher, enfermedad de Fabry, enfermedad de Pompe, SCID, MPS y otras condiciones terapéuticas. El segmento de la enfermedad de Gaucher tuvo la mayor participación de mercado en 2021 y se espera que registre la CAGR más alta durante el período de pronóstico.
Ruta de información basada en la administración
Basado en la ruta de administración, el mercado mundial de terapia de reemplazo enzimático se bifurca en parenteral y oral. El segmento parenteral tuvo una mayor participación de mercado en 2021 y se anticipa que registre una CAGR más alta durante el período de pronóstico.
Información basada en el usuario final
Basada en el usuario final, la enzima global El mercado de terapias de reemplazo está segmentado en hospitales, centros de infusión y otros. El segmento de hospitales tuvo la mayor participación de mercado en 2021. Sin embargo, se espera que el segmento de centros de infusión registre la CAGR más alta durante el período de pronóstico.
Los actores del mercado global de terapia de reemplazo enzimático adoptan estrategias orgánicas, incluido el lanzamiento de productos y expansión, para expandir su presencia y cartera de productos en todo el mundo y satisfacer la creciente demanda. Algunos de los principales actores que contribuyen al mercado son Takeda Pharmaceutical Company Limited; Sanofi SA; AbbVie Inc.; BioMarin Pharmaceutical Inc.; Terapéutica Amicus; Alexion Pharmaceuticals, Inc. (AstraZeneca); Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.); Recordati SpA; Pfizer Inc.; y 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
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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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