Mercado de inyectables liofilizados: mapeo competitivo y perspectivas estratégicas para 2031

  • Report Code : TIPRE00004411
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 200
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Se prevé que el mercado de inyectables liofilizados alcance los 4.001,27 millones de dólares en 2028, frente a los 2.719,42 millones de dólares de 2021; se espera que crezca a una tasa compuesta anual del 5,8 % de 2022 a 2028.

Los factores clave que impulsan el mercado son la creciente demanda de servicios de fabricación de investigación por contrato y el aumento de las aprobaciones de productos farmacéuticos. y la creciente demanda de productos biológicos. Sin embargo, las retiradas de productos frenan el crecimiento del mercado.

Los inyectables liofilizados son medicamentos liofilizados que son estables durante el transporte. Se almacenan en viales de un solo uso, reconstitución en el lugar de atención y envases especiales durante un período más prolongado. En el momento del uso, se puede reconstituir la cantidad necesaria de medicamento con la ayuda de diluyentes. Los inyectables liofilizados también se denominan inyectables liofilizados, ya que se fabrican mediante el proceso de liofilización, una técnica que consiste en aislar un material sólido de un disolvente congelando y evaporando la solución al vacío. Las inyecciones liofilizadas a menudo se consideran la mejor alternativa a las formas farmacéuticas sólidas orales. En muchos estudios de casos, las inyecciones han beneficiado enormemente a los pacientes encamados. Las inyecciones liofilizadas también se recetan para lograr la máxima biodisponibilidad y estabilidad en pacientes que padecen varias enfermedades, ya que estos inyectables tienen una vida útil más larga que otras formas farmacéuticas.

Perspectivas estratégicas

regiones lucrativas para el mercado mundial de inyectables liofilizados

perspectivas del mercado

el aumento de las aprobaciones de productos farmacéuticos impulsa el mercado Crecimiento

Están surgiendo estudios en curso sobre la seguridad y eficacia de nuevos agentes terapéuticos liofilizados utilizados en pacientes adultos hospitalizados diagnosticados con COVID-19. Los fabricantes del mercado mundial de inyectables liofilizados están solicitando la aprobación de la FDA de EE. UU. para la autorización de uso de emergencia (EUA) de dichas innovaciones para tratar a pacientes que padecen síntomas graves de COVID-19.

 

Desde la pandemia de COVID-19, los actores del mercado mundial de inyectables liofilizados están aumentando sus esfuerzos para obtener la aprobación de las organizaciones reguladoras, como el Contralor General de Medicamentos de la India (DCGI), para su uso restringido de emergencia en la India. Las crecientes aprobaciones de productos farmacéuticos, como Remdesivir, eventualmente conducen a una gran demanda de inyectables liofilizados. A continuación se muestran algunos ejemplos de productos farmacéuticos aprobados por la FDA y otros organismos reguladores.

  • En febrero de 2020, Mylan obtuvo la aprobación regulatoria del DCGI para el polvo liofilizado de Remdesivir en la India para uso restringido de emergencia en COVID-19. pacientes.
  • En junio de 2020, Cipla lanzó Cipremi, Remdesivir liofilizado en polvo para inyección. Además, la FDA de EE. UU. emitió una Autorización de uso de emergencia (EUA) a Gilead Sciences Inc. para el uso de emergencia de Remdesivir para tratar a pacientes hospitalizados con COVID-19. Es el único tratamiento EUA aprobado por la FDA para pacientes adultos y pediátricos hospitalizados con infección por COVID-19 sospechada o confirmada por laboratorio. Así, en mayo, Gilead Sciences Inc. extendió una licencia voluntaria no exclusiva a Cipla para fabricar y comercializar la versión genérica de remedisvir de Cipla llamada CIPREMI.
  • En julio de 2020, Jubilant Life recibió la aprobación del medicamento. El Contralor General de la India (DCGI) fabricará y comercializará Remdesivir a 100 mg/vial (inyección liofilizada) para uso restringido de emergencia en la India para el tratamiento de la COVID-19 grave.
  • En agosto de 2020, Cosentyx en polvo liofilizado en un vial de un solo uso de Novartis AG recibió la aprobación de la UE. El fármaco aprobado fue muy productivo para mejorar rápidamente los síntomas de la piel y mejorar la calidad de vida del paciente que padece psoriasis. Por lo tanto, las crecientes aprobaciones en todo el mundo impulsan el crecimiento del mercado de inyectables liofilizados.

    Información basada en el tipo de embalaje

    El mercado global de inyectables liofilizados, según el tipo de embalaje, se segmenta en utilice viales, reconstitución en el lugar de atención y envases especiales. En 2021, el segmento de viales de un solo uso representó la mayor participación de mercado, mientras que se espera que el segmento de envases especiales registre la CAGR más alta del 6,7 % durante el período de pronóstico.

    < h3>Información basada en el tipo de administración

    Según el tipo de administración, el mercado global de inyectables liofilizados se segmenta en jeringas de diluyente precargadas, dispositivos de reconstitución patentados, dispositivos de un solo paso y dispositivos de varios pasos. El segmento de jeringas de diluyente precargadas tuvo la mayor participación de mercado en 2021 y se prevé que registre la tasa compuesta anual más alta del 6,3% durante el período de pronóstico.

    Información basada en indicaciones

    Según la indicación, el mercado mundial de inyectables liofilizados se segmenta en afecciones metabólicas y oncológicas, enfermedades infecciosas, enfermedades autoinmunes y otras indicaciones. El segmento de afecciones metabólicas y oncológicas tuvo la mayor participación de mercado en 2021 y se prevé que registre la CAGR más alta del 6,2 % durante el período de pronóstico.

    Información basada en el usuario final ;    

    Según el usuario final, el mercado mundial de inyectables liofilizados se segmenta en hospitales, centros quirúrgicos ambulatorios, clínicas especializadas y otros. El segmento de hospitales tuvo la mayor participación de mercado en 2021. Sin embargo, se estima que el segmento de clínicas especializadas registrará la CAGR más alta del mercado del 6,3% durante el período de pronóstico.

    Mercado global de inyectables liofilizados, por tipo de envase: 2021 y 2028

    Las empresas que operan en el mercado global de inyectables liofilizados adoptan la estrategia de innovación de productos para satisfacer las demandas cambiantes de los clientes en todo el mundo, lo que también les permite mantener su marca en el mercado mundial. Por ejemplo, en abril de 2022, Recipharm adquirió la terapia avanzada CDMO Arranta Bio y la viroterapia CDMO Vibalogics. La adquisición también permitió a Recipharm establecer una base sólida en EE. UU., con instalaciones en Boxborough, MA, y proporcionar una plataforma desde la cual desarrollar sus capacidades en nuevas modalidades biológicas.

    < h3>Mercado global de inyectables liofilizados: por geografía

    Geográficamente, el mercado mundial de inyectables liofilizados está segmentado en América del Norte (EE. UU., Canadá y México), Europa (Alemania, Reino Unido, Francia, Italia, España y el resto de Europa). , Asia Pacífico (China, India, Japón, Corea del Sur, Australia y el resto de APAC), Medio Oriente y Asia. África (Sudáfrica, Arabia Saudita, Emiratos Árabes Unidos y el resto de MEA) y América del Sur y Central (Brasil, Argentina y el resto de América del Sur y Central).

     

    Perfiles de la empresa

    • Baxter
    • Nipro
    • Curia Global, Inc.
    • Recipharm AB
    • Vetter Pharma
    • Jubilant HollisterStier LLC (Jubilant Pharma Limited)
    • Aristopharma Ltd.
    • CordenPharma International
    • Credence MedSystems, Inc.
    • SG Biopharm Pvt. Ltd. Ltd
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 lyophilized injectable market?

Lyophilized injectables are freeze-dried drugs that are more stable and can be transported and stored for a longer period. At the time of use, the required quantity of drugs can be reconstituted with the help of diluents. Lyophilized injectable are also termed as freeze-dried injectable as they are produced by the lyophilization process which is the technique of isolating a solid material from a solvent by freezing and evaporating the solution under vacuum. The lyophilized injectable market is segmented into type of packaging, type of delivery, indication, end user, and geography.

What are the driving factors for the lyophilized injectable market across the globe?

Increasing demand of contract research manufacturing services and rising approvals of pharmaceuticals are the most significant factors responsible for the overall market growth.

Which type of packaging segment held the largest market share in the lyophilized injectable market?

Based on type of packaging, single-use vials 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 type of delivery segment led the lyophilized injectable market?

Based on type of delivery, prefilled diluent syringes segment accounted for the largest share in 2021 in the worldwide market and is expected to continue to do so till the forecast period.

Which indication segment held the largest market share in the lyophilized injectable market?

The metabolic and oncology conditions segment dominated the indication segment in the global lyophilized injectable market and accounted for the largest market share of 46.05% in 2021.

Which end user segment led the lyophilized injectable market?

Based on end user, hospital 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.

Who are the key players in the lyophilized injectable market?

Baxter, Nipro, Curia Global, Inc., Recipharm AB, Vetter Pharma, Jubilant HollisterStier (Jubilant Pharma Limited), Aristopharma Ltd., CordenPharma International, Credence MedSystems, Inc., and S. G. Biopharm Pvt. Ltd. are among the leading companies operating in the lyophilized injectable market.

What is the regional market scenario of the lyophilized injectable market?

Global lyophilized injectable 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 lyophilized injectable market. The growth of the market in North America is expected due to the factors such as increasing demand for lyophilized injectable for safer packaging and prolonged shelf life, growing pharmaceutical production due to pandemic, and rising research and development in the healthcare industry. Further, the growing research & development activities owing to the investments by biotechnology, pharmaceutical, and biopharmaceutical companies and the rise in the research & applications of the lyophilized injectable drug in various fields are the key factors responsible for the Asia-Pacific regional growth for lyophilized injectable accounting for the fastest growth of the region during the coming years.

The List of Companies - Lyophilized Injectable Drugs Market

  1. Baxter
  2. Nipro
  3. Curia Global, Inc.
  4. Recipharm AB
  5. Vetter Pharma
  6. Jubilant HollisterStier LLC (Jubilant Pharma Limited)
  7. Aristopharma Ltd.
  8. CordenPharma International
  9. Credence MedSystems, Inc.
  10. S. G. Biopharm Pvt. Ltd

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.

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  • Validates and strengthens in-house secondary research findings
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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:

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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:

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  • 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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