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Worldwide Lyophilization Services for Biopharmaceuticals Industry Report to 2035 - Key Market Trends and Forecasts
Tuesday, May 24, 2022
DUBLIN, May 16, 2022 /PRNewswire/ -- The "Lyophilization Services Market for Biopharmaceuticals by Type of Biologic Lyophilized, Type of Primary Packaging System and Key Geographies, 2022-2035" report has been added to ResearchAndMarkets.com's offering.
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This report features an extensive study of companies engaged in offering lyophilization services for biopharmaceuticals. The study features an in-depth analysis of the key drivers and trends related to this domain.
Over the last decade, a steady rise has been observed in the annual number of approvals for various types of biologics (including monoclonal antibodies, cell therapies, recombinant proteins, vaccines and gene therapies). In addition, more than 8,000 biological therapeutics are currently being evaluated in clinical trials, being conducted across the globe. Evidently, biologics have emerged as one of the fastest growing segments in the pharmaceutical industry.
Driven by several advantages offered by biologics over small molecules (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is anticipated to witness continued and consistent growth over the next several years. However, there are a variety of challenges associated with such therapies.
For instance, biological drugs are inherently less stable as compared to small molecules and, therefore, more prone to physical and chemical degradation. In order to achieve longer and commercially viable shelf lives, players are actively adopting the lyophilization (also known as freeze-drying) technique; it enables the production of stable dry biopharmaceutical formulations. In this context, it is worth highlighting that around 50% of the currently approved biopharmaceuticals are injectables. Of these, about one third of the drug candidates are being lyophilized.
Setting up in-house lyophilization capabilities and operations is an expensive and time-consuming process, which requires specialized lyophilization equipment and expertise. Considering the high capital investment and technical / routine operations-related challenges associated with lyophilization of biopharmaceuticals, a growing number of biologic developers are outsourcing their lyophilization operations to qualified contract manufacturing organizations (CMOs) in order to leverage their capabilities and yield cost savings opportunities.
Presently, more than 105 contract manufacturers claim to have the required capabilities to offer lyophilization services for biotherapeutics. In addition, lyophilization service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance existing capabilities to meet the growing demand for biologics. Driven by the increasing preference for outsourcing, continuous growth of the biological therapeutics pipeline and a steady rise in drug approvals, the lyophilization services market for biopharmaceuticals is likely to witness steady growth in the foreseen future.
Amongst other elements, the report includes:
-- A detailed assessment of the current landscape of companies offering
lyophilization services for biopharmaceuticals, along with information
on their year of establishment, company size (in terms of employee
count), location of headquarters, scale of operation (preclinical,
clinical and commercial), regulatory certification / accreditation, type
of biologic lyophilized (proteins, antibodies, vaccines, nucleic acids,
cell / gene therapies, others and biologics (unspecified)), process of
lyophilization (bulk lyophilization and individual lyophilization), type
of primary packaging system (vials, pre-filled syringes, cartridges,
ampoules and others) and additional services offered by the firms
(lyophilization cycle development and lyophilization cycle
optimization).
-- An insightful benchmark analysis of various service providers segregated
into three peer groups based on location of their headquarters (North
America, Europe, and Asia Pacific and RoW). The companies were further
distributed across key geographies, based on their employee count, into
three categories, namely small (1-200 employees), mid-sized (201-500
employees) and large / very large (>500 employees), highlighting the top
players in this domain, based on their respective capabilities.
-- Elaborate profiles of prominent players offering lyophilization services
for biopharmaceuticals, based in North America, Europe and Asia Pacific.
Each profile features a brief overview of the company, details related
to lyophilization service offerings for biopharmaceuticals, dedicated
facilities, recent developments and an informed future outlook.
-- An analysis of the partnerships that have been inked by stakeholders
engaged in this domain, covering acquisitions, asset acquisitions,
product / technology development agreements, and other related
agreements. Further, the partnership activity in this domain has been
analyzed based on various parameters, such as year of partnership, most
active players (in terms of number of partnerships) and regional
distribution of the collaborations.
-- A detailed analysis of the recent expansions undertaken by various
lyophilization service providers for biopharmaceuticals, based on
several relevant parameters, such as year of expansion, type of
expansion (capacity expansions, facility expansions and new facility
addition), company size (small, mid-sized, large and very large
companies), location of headquarters, location of expanded facility,
most active players (in terms of number of recent expansions) and
geographical distribution.
-- A survey analysis presenting additional insights on lyophilization
services offered for biopharmaceuticals, apart from those mentioned on
the service provider's website. Inputs for this chapter were gathered
across key parameters, including type of biologic lyophilized, type of
primary packaging system, scale of operation, availability of
lyophilization cycle development / optimization capabilities and
location of dedicated manufacturing facility for lyophilization.
Additionally, through the questionnaire we obtained some insights on the
likely size of the current market for lyophilization services for
biopharmaceuticals.
-- A case study on lyophilization cycle development and optimization
services, highlighting the important parameters and techniques required
for these processes. Further, the chapter presents the list of players
that provide such services for biopharmaceuticals.
-- A case study on alternative approaches to the lyophilization process,
such as spray drying, spray freeze drying, atmospheric spray freeze
drying and vacuum foam drying.
-- One of the key objectives of the report was to estimate the existing
market size and identify potential growth opportunities for
lyophilization services market for biopharmaceuticals over the coming
decade. We have provided an informed estimate on the likely evolution of
the market over the period 2022-2035. The report features a detailed
forecast of the overall lyophilization services market for
biopharmaceuticals, wherein both the current and upcoming opportunity is
segmented across [A] type of biologic lyophilized (antibodies, cell and
gene therapies, vaccines and other biologics), [B] type of primary
packaging system (vials, syringes, cartridges, ampoules and others) and
[C] key geographies (North America, Europe, Asia Pacific, Middle East
and North Africa, Latin America and Rest of the world). In order to
account for future uncertainties and add robustness to our model, we
have provided three market forecast scenarios, namely conservative, base
and optimistic scenarios, representing different tracks of the
industry's growth.
Key Questions Answered
-- Who are the key players engaged in offering lyophilization services for
biopharmaceuticals?
-- What is the relative competitiveness of lyophilization service providers
for biopharmaceuticals?
-- What type of partnership models are commonly adopted by stakeholders in
this industry?
-- What are the different types of expansion initiatives being undertaken
by lyophilization service providers for biopharmaceuticals?
-- What are the key market trends and driving factors that are likely to
impact this market?
-- How is the current and future market opportunity likely to be
distributed across key segments?
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Lyophilization Service Providers for Biopharmaceuticals: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Scale of Operation
4.2.5. Analysis by Regulatory Certification / Accreditation
4.2.6. Analysis by Type of Biologic Lyophilized
4.2.7. Analysis by Process of Lyophilization
4.2.8. Analysis by Type of Primary Packaging System
4.2.9. Analysis by Additional Services Offered
5. BENCHMARK ANALYSIS
5.1. Chapter Overview
5.2. Methodology
5.3. Benchmark Analysis: Peer Groups
6. COMPANY PROFILES: LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS IN NORTH AMERICA
6.1. Chapter Overview
6.2. Baxter BioPharma Solutions
6.2.1. Company Overview
6.2.2. Lyophilization Service Offerings for Biopharmaceuticals
6.2.3. Dedicated Biopharmaceutical Lyophilization Facilities
6.2.4. Recent Developments and Future Outlook
6.3. Curia
6.3.1. Company Overview
6.3.2. Lyophilization Service Offerings for Biopharmaceuticals
6.3.3. Dedicated Biopharmaceutical Lyophilization Facilities
6.3.4. Recent Developments and Future Outlook
6.4. Emergent BioSolutions
6.4.1. Company Overview
6.4.2. Lyophilization Service Offerings for Biopharmaceuticals
6.4.3. Dedicated Biopharmaceutical Lyophilization Facilities
6.4.4. Recent Developments and Future Outlook
6.5. LSNE Contract Manufacturing
6.5.1. Company Overview
6.5.2. Lyophilization Service Offerings for Biopharmaceuticals
6.5.3. Dedicated Biopharmaceutical Lyophilization Facilities
6.5.4. Recent Developments and Future Outlook
6.6. Lyophilization Technology
6.6.1. Company Overview
6.6.2. Lyophilization Service Offerings for Biopharmaceuticals
6.6.3. Dedicated Biopharmaceutical Lyophilization Facilities
6.6.4. Recent Developments and Future Outlook
7. COMPANY PROFILES: LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS IN EUROPE
7.1. Chapter Overview
7.2. CordenPharma
7.2.1. Company Overview
7.2.2. Lyophilization Service Offerings for Biopharmaceuticals
7.2.3. Dedicated Biopharmaceutical Lyophilization Facilities
7.2.4. Recent Developments and Future Outlook
7.3. Coriolis Pharma
7.3.1. Company Overview
7.3.2. Lyophilization Service Offerings for Biopharmaceuticals
7.3.3. Dedicated Biopharmaceutical Lyophilization Facilities
7.3.4. Recent Developments and Future Outlook
7.4. Northway Biotech
7.4.1. Company Overview
7.4.2. Lyophilization Service Offerings for Biopharmaceuticals
7.4.3. Dedicated Biopharmaceutical Lyophilization Facilities
7.4.4. Recent Developments and Future Outlook
7.5. ProJect Pharmaceutics
7.5.1. Company Overview
7.5.2. Lyophilization Service Offerings for Biopharmaceuticals
7.5.3. Dedicated Biopharmaceutical Lyophilization Facilities
7.5.4. Recent Developments and Future Outlook
7.6. Vetter Pharma
7.6.1. Company Overview
7.6.2. Lyophilization Service Offerings for Biopharmaceuticals
7.6.3. Dedicated Biopharmaceutical Lyophilization Facilities
7.6.4. Recent Developments and Future Outlook
8. COMPANY PROFILES: LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS IN ASIA PACIFIC
8.1. Chapter Overview
8.2. BioZed Engineering
8.2.1. Company Overview
8.2.2. Lyophilization Service Offerings for Biopharmaceuticals
8.2.3. Dedicated Biopharmaceutical Lyophilization Facilities
8.2.4. Recent Developments and Future Outlook
8.3. CinnaGen
8.3.1. Company Overview
8.3.2. Lyophilization Service Offerings for Biopharmaceuticals
8.3.3. Dedicated Biopharmaceutical Lyophilization Facilities
8.3.4. Recent Developments and Future Outlook
8.4. MabPlex
8.4.1. Company Overview
8.4.2. Lyophilization Service Offerings for Biopharmaceuticals
8.4.3. Dedicated Biopharmaceutical Lyophilization Facilities
8.4.4. Recent Developments and Future Outlook
8.5. Samsung Biologics
8.5.1. Company Overview
8.5.2. Lyophilization Service Offerings for Biopharmaceuticals
8.5.3. Dedicated Biopharmaceutical Lyophilization Facilities
8.5.4. Recent Developments and Future Outlook
8.6. WuXi Biologics
8.6.1. Company Overview
8.6.2. Lyophilization Service Offerings for Biopharmaceuticals
8.6.3. Dedicated Biopharmaceutical Lyophilization Facilities
8.6.4. Recent Developments and Future Outlook
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Lyophilization Services for Biopharmaceuticals: List of Partnerships and Collaborations
10. RECENT EXPANSIONS
10.1. Chapter Overview
10.2. Lyophilization Services Market for Biopharmaceuticals: List of Recent Expansions
11. SURVEY ANALYSIS
11.1. Chapter Overview
11.2. Lyophilization Services Market for Biopharmaceuticals: List of Participating Companies
12. CASE STUDY I: LYOPHILIZATION CYCLE DEVELOPMENT AND OPTIMIZATION
12.1. Chapter Overview
12.2. Lyophilization Cycle Development
12.3. Lyophilization Cycle Optimization
12.4. Lyophilization Cycle Development and Optimization: List of Service Providers
13. CASE STUDY II: ALTERNATIVE APPROACHES TO LYOPHILIZATION
13.1. Chapter Overview
13.2. Alternative Approaches to Lyophilization
14. MARKET FORECAST AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Global Lyophilization Services Market for Biopharmaceuticals, 2022-2035
14.4. Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Biologic Lyophilized, 2022 and 2035
14.5. Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Primary Packaging System, 2022 and 2035
14.6. Lyophilization Services Market for Biopharmaceuticals: Distribution by Geography, 2022 and 2035
15. CONCLUDING REMARKS
16. EXECUTIVE INSIGHTS
17. APPENDIX 1: TABULATED DATA
18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION
For more information about this report visit https://www.researchandmarkets.com/r/bvt9f7
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Research and Markets
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