Se prevé que el mercado de subcontratación de llenado y acabado farmacéutico alcance los 4.010,51 millones de dólares en 2028, desde los 2.657,04 millones de dólares de 2021; se espera que registre una tasa compuesta anual del 6,1% de 2021 a 2028.
Se espera la creciente demanda de las industrias farmacéutica y biofarmacéutica para satisfacer la demanda de llenado/acabado de brechas. para impulsar el crecimiento del mercado. Según el Centro para la Evaluación e Investigación de Medicamentos (CDER) de la Administración de Alimentos y Medicamentos de EE. UU. (FDA), los productos biológicos representaron entre el 20% y el 29% de las aprobaciones de nuevas entidades moleculares (NME) en 2020. En 2019, las moléculas pequeñas representaron el 79 % de todas las aprobaciones de NME, lo que representa 38 de las 48 NME aprobadas por la FDA, y los productos biológicos representaron 10 de las 48 NME aprobadas o el 21 % de todas las aprobaciones de NME. En 2018, las moléculas pequeñas representaron el 71 % de las aprobaciones de las NME y los productos biológicos el 29 % de las aprobaciones de las NME. Las empresas con capacidades internas a veces carecen de la capacidad para fabricar nuevos productos. Este factor apoya el crecimiento del mercado. Las capacidades especializadas, como la liofilización, el llenado de jeringas y cartuchos precargados, o terapias novedosas, requieren técnicas de fabricación únicas que las empresas de tecnología biotecnológica consideran beneficiosa subcontratar a organizaciones de fabricación por contrato, ya que son rentables. Las empresas con capacidad interna de llenado y acabado aséptico subcontratan en promedio el 39% de sus necesidades de llenado y acabado.
Es probable que América del Norte continúe su dominio en el mercado de subcontratación de llenado y acabado de productos farmacéuticos durante 2021-2028. Estados Unidos tiene la mayor participación del mercado en América del Norte y se espera que continúe esta tendencia durante el período previsto. Los avances en automatización, como la robótica, han sido una de las áreas de progreso para las operaciones de llenado y acabado en EE. UU. Esto reduce en gran medida el riesgo de contaminación y contribuye así al crecimiento regional. La integración general de la cadena de suministro que reduce las interacciones humanas está impulsando el crecimiento del mercado de subcontratación de llenado y acabado de productos farmacéuticos. Por ejemplo, ABL adoptó la automatización en sus operaciones de llenado/acabado en 2017. La compañía completó una expansión de las operaciones de llenado/acabado aséptico en sus instalaciones de biofabricación GMP en Rockville, MD. La empresa instaló un sistema de llenado de viales totalmente automatizado. Se espera que estos factores contribuyan al crecimiento del mercado general de subcontratación de llenado y acabado farmacéutico.
Perspectivas estratégicas
regiones lucrativas para el mercado de subcontratación de llenado y acabado farmacéutico
Perspectivas del mercado
Aumento de la demanda de productos biológicos
Se espera que la creciente cartera de medicamentos biológicos y la creciente preferencia por este tipo de intervenciones terapéuticas impulsen la demanda de llenado y subcontratación farmacéutica durante el período previsto. Aproximadamente el 60% de los servicios de llenado y acabado implican el envasado a escala clínica y comercial de vacunas anti-COVID-19. La ampliación de las instalaciones es uno de los factores críticos que las empresas biofarmacéuticas están considerando durante la pandemia. Las empresas biofarmacéuticas se enfrentan a problemas como los cambios y las restricciones presupuestarias antes mencionados. Se requiere subcontratación para superar estos problemas y satisfacer las demandas de los productos biológicos. Se espera que la subcontratación de productos biofarmacéuticos de las organizaciones de fabricación por contrato impulse la industria de subcontratación de llenado y acabado de productos farmacéuticos durante los próximos siete años. Aproximadamente el 90% de la capacidad instalada de llenado/acabado pertenece a participantes del mercado con capacidades de producción a escala comercial. Más del 85% de la capacidad de llenado y acabado disponible pertenece a grandes empresas.
Información basada en el estado de los productos terminados
Según el estado de los productos terminados, el mercado de subcontratación de llenado y acabado farmacéutico se segmenta en sólidos, semi -sólidos y líquidos. El segmento de líquidos capturó la mayor participación en 2021 y se espera que continúe una tendencia similar durante el período previsto. Se espera que la creciente demanda de jeringas y viales precargados en las industrias de jeringas de plástico impulse la demanda de subcontratación de llenado y acabado de productos farmacéuticos. La demanda de aplicaciones de viales en liofilización está impulsando el crecimiento del mercado de servicios de llenado y acabado. Además, el creciente número de nuevos participantes en la fabricación mundial de productos biológicos da como resultado un aumento de las actividades de subcontratación. Se prevé que este factor ayude al mercado mundial de subcontratación de llenado y acabado de productos farmacéuticos.
Mercado de subcontratación de llenado y acabado farmacéutico, por estado de los productos terminados: 2021 y 2028
Según el contenido, el mercado de subcontratación de llenado y acabado farmacéutico se segmenta en sustancias orgánicas aisladas de microorganismos, sustancias orgánicas aislados de animales y sustancias inorgánicas. El segmento de sustancias orgánicas aisladas de microorganismos tiene una cuota de mercado considerable y se prevé que continúe una tendencia similar durante el período de previsión. Los avances en la subcontratación de llenado y acabado farmacéutico han permitido implementar con éxito la reducción de los riesgos de contaminación en la cadena de suministro. Esta integración de extremo a extremo ha ayudado con éxito a la demanda de sustancias orgánicas aisladas de microorganismos, contribuyendo así a la demanda de subcontratación de llenado y acabado farmacéutico.
Las empresas que operan en el mercado de subcontratación de llenado y acabado farmacéutico adoptan la estrategia de innovación de productos para satisfacer las cambiantes demandas de los clientes en todo el mundo, lo que también les permite mantener su marca. en el mercado mundial.
Mercado de subcontratación de llenado y acabado farmacéutico
El mercado global de subcontratación de llenado y acabado de productos farmacéuticos está segmentado en función de el estado de los productos terminados y el contenido. Según el estado de los productos terminados, el mercado se clasifica en líquidos, sólidos y semisólidos. Por contenido, el mercado se segmenta en sustancias orgánicas aisladas de microorganismos, sustancias orgánicas aisladas de animales y sustancias inorgánicas. Según las regiones, el mercado mundial de subcontratación de llenado y acabado farmacéutico está segmentado en América del Norte, Europa, Asia Pacífico, América del Sur y Central, y Oriente Medio y África. El mercado de América del Norte está segmentado en Estados Unidos, Canadá y México. El mercado europeo está segmentado en Francia, Alemania, Italia, España, Reino Unido y resto de Europa. Asia Pacífico está segmentada en China, Japón, Corea del Sur, India, Australia y el resto de Asia Pacífico. Medio Oriente y África está segmentado en Sudáfrica, Arabia Saudita, Emiratos Árabes Unidos y el resto de Medio Oriente y África. América del Sur y Central se bifurca en Brasil, Argentina y el resto de América del Sur y Central.
Las empresas que operan en el mercado son Abbott, TEVA PHARMACEUTICAL INDUSTRIES LTD, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries Ltd, Piramal Enterprises Ltd., MabPlex International Ltd, WOCKHARDT, Cytovance Biologics, Thermo Fisher Scientific Inc. (Patheon NV), Boehringer Ingelheim International GmbH, entre otros.
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
Biopharmaceutical companies and pharmaceutical companies outsource a portion of the products from the contract outsourcing companies to meet the unmet demand of the companies. This process is termed as the pharmaceutical fill and finish outsourcing.
Rising investment in biopharmaceutical sectors and growing demand for biologics is expected to drive the market
Based on content, organic substances isolated from microorganisms took the forefront lead in the worldwide market by accounting largest share in 2020 and is expected to continue a similar trend over the forecast period.
The liquid segment accounted for the largest share in 2021 and is expected to continue during the forecast period.
Companies operating in the market are Abbott, TEVA PHARMACEUTICAL INDUSTRIES LTD, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries Ltd, Piramal Enterprises Ltd., MabPlex International Ltd, WOCKHARDT, Cytovance Biologics, Thermo Fisher Scientific Inc. (Patheon N.V), Boehringer Ingelheim International GmbH amongst others.
Global pharmaceutical fill and finish outsourcing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the pharmaceutical fill and finish outsourcing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Automation advancements such as robotics have been one of the areas of progress for the US fill/finish operations. This primarily reduces the contamination risk to a great extent, thus aiding the regional growth. The overall integration of the supply chain that reduces human interactions is driving the pharmaceutical fill and finish outsourcing market growth.
The List of Companies - Pharmaceutical Fill and Finish Outsourcing Market
- Abbott
- Teva Pharmaceutical Industries Ltd
- Dr. Reddy's Laboratories
- Sun Pharmaceutical Industries Ltd
- Piramal Enterprises Ltd
- MabPlex International Ltd
- Wockhardt
- Cytovance Biologics
- Thermo Fisher Scientific Inc. (Patheon N.V.)
- Boehringer Ingelheim International GmbH
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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