[Rapporto di ricerca] Si prevede che il mercato dei servizi di liofilizzazione per i prodotti biofarmaceutici crescerà da 2.051,41 milioni di dollari nel 2022 a 3.586,55 milioni di dollari entro il 2028; si stima registrerà un CAGR del 9,9% dal 2023 al 2028.
La crescita del mercato dei servizi di liofilizzazione per i prodotti biofarmaceutici è attribuita alla crescente domanda di prodotti liofilizzati e alla rapida crescita dei servizi di produzione a contratto e di liofilizzazione in tutto il mondo .
Il mercato dei servizi di liofilizzazione per prodotti biofarmaceutici è segmentato in base al tipo di servizio, all'utente finale e alla regione. Il rapporto offre approfondimenti e analisi approfondite del mercato, sottolineando parametri quali le tendenze del mercato dei servizi di liofilizzazione per i prodotti biofarmaceutici, i progressi tecnologici, le dinamiche del mercato e l’analisi del panorama competitivo dei principali attori del mercato.
Servizi di liofilizzazione per il mercato biofarmaceutico - Approfondimenti strategici
Servizi globali di liofilizzazione per il mercato biofarmaceutico -
Servizi di liofilizzazione per il mercato biofarmaceutico - Approfondimenti di mercato
Il rapido aumento della produzione a contratto e dei servizi di liofilizzazione guida la crescita del mercato dei servizi di liofilizzazione per i prodotti biofarmaceutici
Il mercato dei prodotti biofarmaceutici continua ad espandersi in tutto il mondo, il che può rappresentare il principale motore di crescita per l’industria farmaceutica. La produzione biofarmaceutica parenterale si è ampliata di recente con l'approvazione di ulteriori prodotti biologici terapeutici. Le aziende biotecnologiche esternalizzano i propri prodotti da organizzazioni di produzione a contratto (CMO) per soddisfare le loro esigenze di riempimento e finitura e ridurre il rischio di contaminazione microbica. Le aziende biofarmaceutiche dipendono dalle organizzazioni di produzione a contratto (CMO) per fornire capacità e capacità secondo necessità; in alcuni casi, i CMO forniscono gran parte della produzione di un'azienda.
La creazione di capacità e operazioni di liofilizzazione interne richiede attrezzature e competenze specializzate, il che è un processo costoso e richiede tempo. Tuttavia, l’outsourcing è più economico e aumenta l’efficienza dei processi produttivi. Inoltre, consente alle aziende biotecnologiche di reindirizzare le risorse verso altre aree. Pertanto, gli sviluppatori di farmaci e le aziende biofarmaceutiche esternalizzano tali operazioni ai CMO per risparmiare sulla produzione complessiva e sui costi di resa. Alcuni anni fa, l’industria delle OCM era un mercato di servizi di nicchia, che offriva capacità produttiva aggiuntiva o servizi specifici alle aziende biotecnologiche. Oggi molte aziende biotecnologiche esternalizzano vari servizi, dallo sviluppo di farmaci in fase iniziale alla produzione su scala commerciale. Mentre l’industria della biotecnologia si sta spostando dalla produzione su larga scala a terapie di nicchia e mirate (medicina personalizzata), la domanda di capacità operative flessibili, scale di produzione e operazioni con più prodotti è in aumento. A causa di tutti questi fattori, la propensione verso i CMO è in crescita. Uno di questi CMO che fornisce strutture specializzate e linee dedicate per le operazioni di liofilizzazione è Jubilant HollisterStier Contract Manufacturing & Servizi. L'OCM offre riempimento/finitura sterile della Fase I attraverso un iniettabile sterile commerciale e una suite completa di servizi di liofilizzazione. Per tenere il passo con la crescente domanda dei suoi servizi, Jubilant sta installando un nuovo liofilizzatore da 385 piedi quadrati. Pertanto, la crescente capacità e disponibilità dei CMO biofarmaceutici alimenta la crescita del mercato dei servizi di liofilizzazione per i prodotti biofarmaceutici.
Mercato globale dei servizi di liofilizzazione per i prodotti biofarmaceutici, per tipo di servizio: 2022 vs 2028
Servizi di liofilizzazione per il mercato dei prodotti biofarmaceutici - Approfondimenti basati sul tipo di servizio
In base al tipo di servizio, il mercato globale dei servizi di liofilizzazione per prodotti biofarmaceutici è segmentato in produzione commerciale, sviluppo di cicli di liofilizzazione, produzione clinica e servizi analitici di liofilizzazione. Il segmento della produzione commerciale ha detenuto la quota di mercato maggiore nel 2022. Si prevede che il segmento di sviluppo del ciclo di liofilizzazione registrerà il CAGR più elevato durante il periodo di previsione.
Servizi di liofilizzazione per il mercato dei prodotti biofarmaceutici: In base ad approfondimenti basati sull'utente finale
In base all'utente finale, il mercato globale dei servizi di liofilizzazione per prodotti biofarmaceutici è segmentato in aziende farmaceutiche e biotecnologiche, istituti di ricerca e altri. Il segmento delle aziende farmaceutiche e biotecnologiche ha detenuto la quota di mercato maggiore nel 2022. Si prevede che il segmento degli istituti di ricerca registrerà il CAGR più elevato durante il periodo di previsione.
Le aziende nel mercato dei servizi di liofilizzazione per prodotti biofarmaceutici adottano prodotti inorganici e strategie organiche come fusioni e acquisizioni. Di seguito sono elencati alcuni recenti sviluppi chiave del mercato:
- Nel novembre 2022, LTI ha annunciato il suo impegno nello sviluppo, nell'ingegneria di processo e nella preparazione di materiale clinico per il candidato vaccino contro la tubercolosi ID93 / GLA-SE . Il vaccino contro la tubercolosi ha raggiunto con successo la sperimentazione clinica di Fase 2. Questo studio rappresenta il primo rapporto sul successo della liofilizzazione di un candidato vaccino a subunità termostabile contenente un adiuvante a base di emulsione.
- Nel maggio 2022, Jubilant HollisterStier LLC ha stipulato un accordo di cooperazione per 149,6 milioni di dollari con l'Esercito Contracting Comando, in coordinamento con l'Ufficio esecutivo del programma congiunto per la difesa chimica, biologica, radiologica e nucleare (JPEOCBRND) per conto dell'Autorità per la ricerca e lo sviluppo avanzato biomedico (BARDA), all'interno del Dipartimento della salute e dei servizi umani degli Stati Uniti.
- Nell'ottobre 2021, PCI Pharma Services (PCI) ha annunciato di aver firmato un accordo definitivo per l'acquisizione di Lyophilization Services di New England, Inc. (LSNE), una delle principali organizzazioni di sviluppo e produzione a contratto (CDMO) con sede a Bedford , New Hampshire, dalla società globale di private equity Permira. L'acquisizione aggiunge cinque stabilimenti approvati dalla FDA negli Stati Uniti (New Hampshire, Wisconsin) e in Europa (Spagna), con un sesto in attesa di approvazione nei prossimi mesi. Inoltre, tre ulteriori strutture sono in fase di sviluppo. Queste strutture rafforzeranno la loro rete globale di 30 sedi.
- Nel luglio 2021, Albany Molecular Research, Inc. (AMRI) ha annunciato che cambierà il proprio nome in Curia, a partire dal 12 luglio 2021. Il nuovo nome rafforza il posizionamento strategico dell'azienda come CDMO globale end-to-end, applicando le sue competenze scientifiche e le sue ampie capacità dalla ricerca e sviluppo (R&D) alla produzione commerciale per consentire ai suoi clienti farmaceutici e biotecnologici di promuovere nuovi importanti prodotti che migliorano vive.
Profili aziendali - Servizi di liofilizzazione per il mercato dei prodotti biofarmaceutici
- ATTWILL Medical Solutions
- Axcellerate Pharma LLC
- Labyrinth Biopharma LLC
- Berkshire Sterile Manufacturing
- PCI Pharma Services
- Curia Global Inc
- Emergent BioSolutions Inc
- Jubilant HollisterStier LLC
- Biofortuna
- Lyophilization Technology Inc.
- SYNERLAB GROUP
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
Companies operating in the market are ATTWILL Medical Solutions; Axcellerate Pharma LLC; Labyrinth Biopharma LLC; Berkshire Sterile Manufacturing; PCI Pharma Services; Curia Global Inc; Emergent BioSolutions Inc.; Jubilant HollisterStier LLC; Biofortuna; Lyophilization Technology Inc.; and SYNERLAB GROUP.
Lyophilization is a process of isolating a solid substance from a solution. It is also known as freeze-drying is a process. The process is carried by freezing the solution and evaporating under vacuum. It helps in optimizing lyophilization cycle times and improves stability for critically complexes of injectable during the parenteral product development.
Global lyophilization services for biopharmaceuticals market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the lyophilization services for biopharmaceuticals market during 2023–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period.
The growth of market is likely to grow due to factors such as rising demand for lyophilized products and rapid growth in contract manufacturing and lyophilization services across the world are expected to boost the growth of the global lyophilization service for biopharmaceuticals market. However, the market is likely to get impacted by the demerits associated with lyophilization process during the forecast period.
Based on service type, the global lyophilization services for biopharmaceuticals market is divided into commercial manufacturing, lyophilization cycle development, clinical manufacturing, and freeze-drying analytical services. The commercial manufacturing segment held the largest share of the market in 2022. The lyophilization cycle development segment is expected to grow at the highest CAGR during the forecast period.
Based on end user, the global lyophilization services for biopharmaceuticals market is divided into pharmaceutical and biotechnology companies, research institutes, and others. The pharmaceutical and biotechnology companies segment held the largest share of the market in 2022. The research institutes segment is expected to grow at the highest CAGR during the forecast period.
The List of Companies - Lyophilization Services for Biopharmaceuticals Market
- ATTWILL Medical Solutions
- Axcellerate Pharma LLC
- Labyrinth Biopharma LLC
- Berkshire Sterile Manufacturing
- PCI Pharma Services
- Curia Global Inc
- Emergent BioSolutions Inc
- Jubilant HollisterStier LLC
- Biofortuna
- Lyophilization Technology Inc.
- SYNERLAB GROUP
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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