Le marché de l'externalisation du remplissage et de la finition pharmaceutique devrait atteindre 4 010,51 millions de dollars US d'ici 2028, contre 2 657,04 millions de dollars US en 2021 ; il devrait enregistrer un TCAC de 6,1 % de 2021 à 2028.
La demande croissante des industries pharmaceutiques et biopharmaceutiques pour répondre à la demande d'espace de remplissage/finition devrait stimuler la croissance du marché. Selon le Center for Drug Evaluation and Research (CDER) de la Food and Drug Administration (FDA) des États-Unis, les produits biologiques ont représenté 20 à 29 % des approbations de nouvelles entités moléculaires (NME) en 2020. En 2019, de petites les molécules représentaient 79 % de toutes les approbations NME, représentant 38 des 48 NME approuvées par la FDA et les produits biologiques représentaient 10 des 48 NME approuvées ou 21 % de toutes les approbations NME. En 2018, les petites molécules représentaient 71 % des approbations NME et les produits biologiques 29 % des approbations NME. Capacités internes Les entreprises n'ont parfois pas la capacité de fabriquer de nouveaux produits. Ce facteur soutient la croissance du marché. Des capacités spécialisées, telles que la lyophilisation, le remplissage de seringues et de cartouches préremplies ou de nouvelles thérapies, nécessitent des techniques de fabrication uniques que les entreprises de technologie biotechnologique trouvent avantageux d'externaliser auprès d'organisations de fabrication sous contrat, car elles sont rentables. Les entreprises disposant d'une capacité interne de remplissage et de finition aseptique sous-traitent en moyenne 39 % de leurs besoins en matière de remplissage et de finition.
L'Amérique du Nord devrait continuer à dominer le marché de l'externalisation du remplissage et de la finition pharmaceutiques au cours de la période 2021-2028. Les États-Unis détiennent la plus grande part du marché en Amérique du Nord et devraient poursuivre cette tendance au cours de la période de prévision. Les progrès de l'automatisation tels que la robotique ont été l'un des domaines de progrès pour les opérations de remplissage/finition aux États-Unis. Cela réduit principalement le risque de contamination dans une large mesure, contribuant ainsi à la croissance régionale. L'intégration globale de la chaîne d'approvisionnement qui réduit les interactions humaines est le moteur de la croissance du marché de l'externalisation du remplissage et de la finition pharmaceutique. Par exemple, ABL a adopté l'automatisation dans ses opérations de remplissage/finition en 2017. La société a achevé une expansion des opérations de remplissage/finition aseptique dans son usine de biofabrication GMP à Rockville, MD. L'entreprise a installé un système de remplissage de flacons entièrement automatisé. Ces facteurs devraient contribuer à la croissance du marché global de l'externalisation du remplissage et de la finition pharmaceutiques.
Perspectives stratégiques
Régions lucratives pour le marché de l'externalisation du remplissage et de la finition pharmaceutique
Perspectives du marché
Augmentation de la demande de produits biologiques
La filière croissante de médicaments biologiques et la préférence croissante pour de telles interventions thérapeutiques devraient stimuler la demande d'externalisation du remplissage et de la finition pharmaceutiques au cours de la période de prévision . Environ 60 % des services de remplissage/finition impliquent le conditionnement à l'échelle clinique et commerciale des vaccins anti-COVID-19. L'expansion des installations est l'un des facteurs critiques que les sociétés biopharmaceutiques envisagent pendant la pandémie. Les entreprises biopharmaceutiques sont confrontées à des problèmes tels que les changements susmentionnés et les contraintes budgétaires. L'externalisation est nécessaire pour surmonter ces problèmes et répondre aux exigences des produits biologiques. L'externalisation des produits biopharmaceutiques des organisations de fabrication sous contrat devrait stimuler l'industrie de l'externalisation du remplissage et de la finition pharmaceutique au cours des sept prochaines années. Environ 90 % de la capacité de remplissage/finition installée appartient à des acteurs du marché disposant de capacités de production à l'échelle commerciale. Plus de 85 % de la capacité de remplissage et de finition disponible appartient à de grandes entreprises.
Informations basées sur l'état des produits finis
Sur la base de l'état des produits finis, le marché de l'externalisation du remplissage et de la finition pharmaceutique est segmenté en solides, semi-solides et liquides. Le segment liquide a capturé la plus grande part en 2021 et devrait poursuivre une tendance similaire au cours de la période de prévision. La demande croissante de seringues préremplies et de flacons dans les industries des seringues en plastique devrait stimuler la demande d'externalisation du remplissage et de la finition pharmaceutiques. La demande d'applications de flacons dans la lyophilisation alimente la croissance du marché des services de remplissage et de finition. En outre, le nombre croissant de nouveaux entrants dans la fabrication mondiale de produits biologiques entraîne une augmentation des activités d'externalisation. Un tel facteur devrait aider le marché mondial de l'externalisation du remplissage et de la finition pharmaceutique.
Marché de l'externalisation du remplissage et de la finition pharmaceutiques, par état des produits finis - 2021 et 2028
Sur la base du contenu, le marché de l'externalisation du remplissage et de la finition pharmaceutiques est segmenté en substances organiques isolées de micro-organismes, en substances organiques isolées d'animaux et en substances inorganiques. Le segment des substances organiques isolées à partir de micro-organismes détient une part de marché considérable et devrait poursuivre une tendance similaire au cours de la période de prévision. Les progrès de l'externalisation du remplissage et de la finition pharmaceutique ont permis une mise en uvre réussie de la réduction des risques de contamination dans la chaîne d'approvisionnement. Une telle intégration de bout en bout a aidé avec succès la demande de substances organiques isolées des micro-organismes, aidant ainsi la demande d'externalisation du remplissage et de la finition pharmaceutique.
Les entreprises opérant sur le marché de l'externalisation du remplissage et de la finition pharmaceutique adoptent la stratégie d'innovation de produits pour répondre à l'évolution des demandes des clients à travers le monde, ce qui leur permet également de maintenir leur marque sur le marché mondial.
Marché de l'externalisation du remplissage et de la finition pharmaceutique
Le marché mondial de l'externalisation du remplissage et de la finition pharmaceutique est segmenté en fonction de l'état des produits finis et de leur contenu. Sur la base de l'état des produits finis, le marché est classé en liquides, solides et semi-solides. Par contenu, le marché est segmenté en substances organiques isolées de micro-organismes, substances organiques isolées d'animaux et substances inorganiques. Sur la base des régions, le marché mondial de l'externalisation du remplissage et de la finition pharmaceutiques est segmenté en Amérique du Nord, en Europe, en Asie-Pacifique, en Amérique du Sud et centrale, au Moyen-Orient et en Afrique. Le marché nord-américain est segmenté entre les États-Unis, le Canada et le Mexique. Le marché européen est segmenté en France, Allemagne, Italie, Espagne, Royaume-Uni et reste de l'Europe. L'Asie-Pacifique est segmentée en Chine, au Japon, en Corée du Sud, en Inde, en Australie et dans le reste de l'Asie-Pacifique. Le Moyen-Orient et l'Afrique sont segmentés en Afrique du Sud, en Arabie saoudite, aux Émirats arabes unis et dans le reste du Moyen-Orient et de l'Afrique. L'Amérique du Sud et centrale est divisée en Brésil, Argentine et reste de l'Amérique du Sud et centrale.
Les entreprises opérant sur le marché sont 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 autres.
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.
Related Reports
Dec 2021
Aquatic Veterinary Market
Size and Forecast (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type (Diagnostics and Treatments), Species (Fish, Crustaceans, Mollusca, and Others), Disease Source (Bacteria, Viruses, Parasites, and Others), Route of Administration (Water Medication, Medicated Feed, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Dec 2021
Sickle Cell Disease Treatment Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis By Treatment (Generic Drugs and Originators), Route of Administration (Oral and Parenteral), and Distribution Channel (Direct Tender, Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, and Others)
Dec 2021
Malaria and Sickle Cell Disease Treatment Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Treatment [Malaria and Sickle Cell Disease (SCD)], Route of Administration (Oral and Parenteral), and Distribution Channel (Direct Tender, Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, and Others)
Dec 2021
Pharmaceutical Contract Sales Organizations Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Services (Commercial Services and Non-Commercial Services), Modules (Syndicated Modules and Dedicated Modules), Therapeutic Area (Cardiovascular Disorders, Oncology, Metabolic Disorders, Neurology, Orthopedic Diseases, Infectious Diseases, and Others), End User (Biopharmaceutical Companies and Pharmaceutical Companies), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Dec 2021
Breast Cancer Therapeutics Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Drug Therapy [Targeted Drug Therapy (Abemaciclib, Ado-Trastuzumab Emtansine, Palbociclib, Trastuzumab, and Other Target Drug Therapies), Hormonal Drug Therapy (Selective Estrogen Receptor Modulators, Aromatase Inhibitors, and Selective Estrogen Receptor Downregulators), Chemotherapy, and Immunotherapy/Biological Therapy], Breast Cancer Type (Hormone Receptor, HER2+, and Triple-Negative Breast Cancer), Distribution Channel (Hospital Pharmacies, Drug Stores and Retail Pharmacies, and Online Pharmacies), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Dec 2021
Radioactive Tracer Market
Size and Forecast to 2030 - Global Analysis by Tracer Type [Technetium-99m & Tc-97m, Iodine-131, Iron-59, Lutetium-171, Rubidium (Rb-82) Chloride & Ammonia (N-13), Scandium-46, Seaborgium-269, Hassium-269, Gallium Citrate Ga 67, Prostate-Specific Membrane Antigen (PSMA) (Ga-68), FDDNP (F-18) & FDOPA (F-18), Phosphorus-32 & Chromium-51, Thallium-201, F-18 FDG, F-18 FAPI, Ga-68 FAPI, F-18 PSMA, DOTATOC/DOTANOC/DOTATATE (Ga-68), and Others], Test Type (PET, SPECT, and Others), Application (Oncology, Pulmonary, Neurology, Cardiology, and Others) End User (Hospitals & Clinics, Diagnostic Centers, Academic & Research Institutes, And Others), and Geography
Dec 2021
Glioma Treatment Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Disease (Astrocytoma, Oligoastrocytoma, and Oligodendroglioma), Treatment Type (Surgery, Chemotherapy, Radiation Therapy, and Others), Grade (Low Grade and High Grade), End User (Hospital & Clinics and Ambulatory Surgical Center), and Geography
Dec 2021
Hyperpigmentation Disorder Treatment Market
Size and Forecast (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Treatment Type (Cosmeceutical, Light or Laser Therapy, Microdermabrasion, Chemical Peels, Cryotherapy, and Others), Condition (Melasma, Solar Lentigines, Post-Inflammatory Hyperpigmentation, and Others), End User (Hospitals, Dermatology Centers, and Others), and Geography (North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa)