[Rapport de recherche]Le marché des pharmacies de préparation stérile devrait atteindre 6 198,59 millions de dollars US d'ici 2028, contre 3 968,70 millions de dollars US en 2021 ; il devrait croître à un TCAC de 6,6 % de 2021 à 2028.
Des facteurs tels que l'augmentation de l'adoption des médicaments personnalisés et les avantages associés à la préparation stérile sur site stimulent la croissance du marché . Cependant, les rappels de produits et les exigences réglementaires strictes entravent la croissance du marché. D'autre part, le développement de centres de préparation centralisés ou régionaux pour les formulations personnalisées créerait des opportunités lucratives de croissance du marché au cours de la période de prévision.
L'Amérique du Nord devrait continuer à dominer le marché des pharmacies de préparation stérile pendant 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. Cela est principalement attribué à la hausse des dépenses pharmaceutiques et à l'infrastructure de soins de santé bien établie. Par exemple, la Food and Drug Administration (FDA) a désigné 503B (Pour les dossiers, 503B est appelé un établissement d'externalisation et est parfois appelé pharmacies 503B et sont strictement surveillés par la FDA qui établit un nouveau niveau de soins aux patients et sécurité). En outre, près de 75 % des hôpitaux aux États-Unis sous-traitent les préparations stériles à des établissements 503B pour assurer la stabilité, faire face aux pénuries de médicaments, obtenir une forme prête à l'emploi du médicament et prolonger la durée de conservation. En outre, la population gériatrique croissante et l'adoption croissante de formulations personnalisées par rapport aux produits commerciaux devraient stimuler la croissance du marché américain des pharmacies de préparation stérile dans les années à venir.
Aperçus stratégiques
Régions lucratives pour le marché des pharmacies de préparation stérile
Aperçus du marché
Avantages de la sur- La préparation stérile sur site stimule la croissance du marché
La préparation et la stérilisation sur site peuvent s'avérer vitales dans le cas d'une solution intraveineuse destinée à être personnalisée selon les besoins du patient. La fabrication sur site permet à l'ingrédient pharmaceutique actif (IPA) d'être introduit chez des sujets humains au cours des premières phases du développement clinique précoce des médicaments. La préparation extemporanée stérile offre une option flexible au développement coûteux et prolongé de produits expérimentaux parentéraux conçus selon les normes de bonne fabrication (BPF). En règle générale, les API administrés par voie parentérale pour les études cliniques sont fabriqués dans des conditions GMP. Cela réduit potentiellement le temps nécessaire à la production d'un produit fini nécessaire à un dosage spécifique.
De plus, la préparation et la filtration d'une formulation dans une solution intraveineuse stérile sont réalisées avec succès grâce à une étroite collaboration avec le sponsor pharmaceutique et les pharmaciens du site clinique, où les tests de stérilité peuvent être effectués efficacement.
La préparation stérile sur site a attiré une attention considérable sur le marché mondial et est l'un des facteurs les plus influents responsables de la croissance du marché. Cela est dû au fait que les pharmaciens de préparation stérile se concentrent davantage sur les dernières activités de recherche, les techniques innovantes, les règles de contrôle de la qualité et l'obtention des meilleurs ingrédients pour répondre aux besoins des patients. Par exemple, la National Association of Boards of Pharmacy (NABP) a annoncé avoir reçu un financement de la Food and Drug Administration (FDA) pour développer un système de partage de données afin d'améliorer la surveillance des pharmacies de préparation stérile. Ce nouveau système devrait faciliter la collecte, la gestion et le partage des informations relatives à la préparation stérile aux États-Unis. Le projet vise également à réduire le risque de blessure, en favorisant les patients dont les produits pharmaceutiques ont été mal préparés.
Informations basées sur les produits
En fonction des produits, le marché des pharmacies de préparation stérile est bifurqué en médicaments injectables et en perfusions. Le segment des médicaments injectables représenterait une part de marché plus importante au cours de la période 2021-2028. Les médicaments injectables font partie des préparations stériles hautement préférées en raison de leur mode d'action plus rapide. Pour éviter tout effet indésirable sur les patients, les médicaments injectables composés (définis comme des médicaments qui sont dilués, mélangés, reconstitués et préparés dans un cabinet) sont composés dans un environnement où des mesures de protection appropriées sont maintenues contre la propagation de la maladie et les composants des composés médicaments qui ont la force et la composition appropriées. Les acteurs du marché adoptent des stratégies de croissance organique et inorganique pour la croissance du marché. Par exemple, en septembre 2019, QuVa Pharma, Inc. a déclaré une augmentation considérable de sa capacité de préparations injectables stériles composées.
Taille et prévisions du marché des pharmacies de préparation stérile, par produit - 2021 et 2028
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Voie des informations basées sur l'administration
En fonction de la voie d'administration, le marché des pharmacies de préparation stérile est segmenté en intraveineux, intramusculaire et sous-cutané. Le segment intraveineux détenait la plus grande part du marché en 2020 et devrait maintenir sa domination au cours de la période de prévision. Cependant, on estime que le segment intramusculaire enregistre le TCAC le plus élevé du marché au cours de la période de prévision. La voie intramusculaire (IM) d'administration de médicaments est la voie la plus courante pour l'injection parentérale. De nombreux antibiotiques, sédatifs préopératoires et narcotiques sont administrés par voie intramusculaire. Par exemple, en février 2021, Biogen a annoncé que la Food and Drug Administration (FDA) des États-Unis avait approuvé une nouvelle injection intramusculaire (IM) pour "Plegridy (peginterféron bêta-1a) responsable du traitement de la sclérose en plaques (SEP).
Les entreprises opérant sur le marché des pharmacies de préparation stérile 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 conserver leur marque sur le marché mondial.
Basé sur le produit , le marché des pharmacies de préparation stérile est divisé en injectables et en perfusions.
Selon la voie d'administration, le marché des pharmacies de préparation stérile est segmenté en intraveineux, intramusculaire et sous-cutané
Pharmacies de préparation stérile Taille du marché - par zone géographique
- Amérique du Nord
- États-Unis
- Canada
- Mexique
- Europe
- France
- Allemagne
- Italie
- Royaume-Uni
- Espagne
< li>Reste de l'Europe
- Chine
- Inde
- Corée du Sud< /li>
- Japon
- Australie
- Reste de l'APAC
- Afrique du Sud
- Arabie saoudite
- EAU
- Reste de la MEA
- Brésil
- Argentine
- Reste de SCAM
Profils des entreprises
- Fagron, Inc.
- Triangle Compounding Pharmacy
- B. Braun Melsungen AG
- PharMedium Healthcare Holdings, Inc.
- Fresenius Kabi AG
- Pharmacie spécialisée Avella
- Pharmacie Pencol Compounding
- Pavilion Compounding Pharmacy LLC
- Pace Pharmacy
- SandsRx
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
Global sterile compounding pharmacies 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 sterile compounding pharmacies market. The US is estimated to hold the largest share in the sterile compounding pharmacies market during the forecast period. The presence of top players and favorable regulations related to product approvals coupled with commercializing new products are the contributing factors for the regional growth. Additionally, the increasing number of R&D activities is the key factor responsible for the Asia-Pacific regional growth for sterile compounding pharmacies accounting fastest growth of the region during the coming years.
Fagron, Inc., Triangle Compounding Pharmacy, B. Braun Melsungen AG, PharMedium Healthcare Holdings, Inc., Fresenious Kabi AG, Avella Specialty Pharmacy, Pencol Compounding Pharmacy, Pavilion Compounding Pharmacy, LLC., Pace Pharmacy, and SandsRx are among the leading companies operating in the global sterile compounding pharmacies market
The intravenous segment dominated the global sterile compounding pharmacies market and accounted for the largest revenue of 2,954.51 Mn in 2021.
Sterile compounding pharmacies involve creating a medication in an environment free from viruses, bacteria, or any other potentially infectious microorganisms. Such a type of compounding is intended for medications that will be administered either through an IV or an injection.
Rising uptake of personalized medicines and the benefits of on-sterile compounding are the most significant factors responsible for the overall market growth.
Based on product type, injectable drugs took the forefront lead in the worldwide market by accounting largest share in 2020 and is expected to continue to do so till the forecast period.
The List of Companies - sterile compounding pharmacies market
- Fagron, Inc.
- Triangle Compounding Pharmacy
- B. Braun Melsungen AG
- PharMedium Healthcare Holdings, Inc.
- Fresenious Kabi AG
- Avella Specialty Pharmacy
- Pencol Compounding Pharmacy
- Pavilion Compounding Pharmacy, LLC.
- Pace Pharmacy
- SandsRx
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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