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Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Biologic Lyophilized (Antibodies, Cell and Gene Therapies, Vaccines and Other Biologics), Type of Primary Packaging System (Vials, Syringes, Cartridges, Ampoules and Others) and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World) – Industry Trends and Global Forecasts, 2022-2035

April 2022 | 225 pages | ID: L40889AAD44EEN
Roots Analysis

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The lyophilization services market is expected to reach USD 2.2 billion in 2022 anticipated to grow at a CAGR of 6.8% during the forecast period 2022-2035.

Over the past decade, there has been a consistent upward trend in the approvals of various biologics, encompassing monoclonal antibodies, cell therapies, recombinant proteins, vaccines, and gene therapies. This sector has emerged as one of the fastest-growing segments within the pharmaceutical industry, attributed to the distinct advantages these therapies offer, including high efficacy, targeted action, and favorable safety profiles. Forecasts suggest that the biopharmaceutical market will sustain its expansion in the forthcoming years.

However, biologic drugs present unique challenges. They exhibit lesser stability in comparison to small molecules and are more susceptible to physical and chemical degradation. To enhance their shelf life and ensure stability, the adoption of lyophilization, commonly known as freeze-drying, has become prevalent. This technique facilitates the production of stable, dry biopharmaceutical formulations. Approximately half of the presently approved biopharmaceuticals are injectables, and around one-third of these are suitable candidates for lyophilization.

Establishing in-house lyophilization capabilities is a costly and time-intensive endeavor, requiring specialized equipment and expertise. Consequently, a growing number of biologic developers are opting to outsource their lyophilization operations to specialized contract manufacturing organizations (CMOs). This approach allows them to leverage the capabilities of these organizations while also realizing cost-saving opportunities. Currently, more than 105 contract manufacturers claim to possess the requisite expertise to provide lyophilization services for biotherapeutics. Furthermore, these service providers are forging strategic alliances to bolster their position in the industry and augment their capabilities to meet the increasing demand for biologics. The preference for outsourcing, combined with the continual expansion of the biological therapeutics pipeline and the steady increase in drug approvals, indicates that the lyophilization services market for biopharmaceuticals is poised for consistent growth in the forecasted period.

Report Coverage
  • Overview of lyophilization for biopharmaceuticals, detailing the process, historical evolution, advantages, and disadvantages. It highlights the steps, lyophilizer components, packaging systems, and cycle development.
  • Market landscape, analyzing 105 companies providing lyophilization services. It focuses on parameters like establishment year, company size, location, operation scale, certification, types of biologics, lyophilization process, packaging systems, and additional services.
  • Service providers in North America, Europe, Asia Pacific, and RoW based on employee count, facilities, biologics lyophilized, process, and packaging systems. It plots top stakeholders on a capability’s spider web.
  • Detailed profiles of key companies providing lyophilization services in North America, Europe, and Asia Pacific. Each profile covers service offerings, facilities, recent developments, and future outlook.
  • Details on collaborations in the lyophilization domain from 2018 to 2021, focusing on partnership types, active players, and regional distribution.
  • Analyzes recent expansions by service providers, considering expansion types, company size, headquarters, locations, and active players.
  • Details on insights from a survey conducted among senior stakeholders in lyophilization services, focusing on biologics, packaging, scale, capabilities, and market potential.
  • Detailed market forecast till 2035 based on biologic types, packaging systems, and key geographies, using a top-down approach supported by primary research data.
Key Market Companies
  • Baxter BioPharma Solutions
  • Curia
  • Emergent BioSolutions
  • LSNE Contract Manufacturing
  • Lyophilization Technology
  • CordenPharma
  • Coriolis Pharma
  • Northway Biotech
  • ProJect Pharmaceutics
  • Vetter Pharma
  • BioZed Engineering
  • CinnaGen
  • MabPlex
  • Samsung Biologics
  • WuXi Biologics
1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Lyophilization
  3.2.1. Historical Evolution
  3.2.2. Underlying Principles
  3.2.3. Advantages and Disadvantages
3.3. Lyophilization of Biopharmaceuticals
  3.3.1. Need for Lyophilization of Biopharmaceuticals
  3.3.2. Lyophilization Process
    3.3.2.1. Formulation and Filling
    3.3.2.2. Freezing
    3.3.2.3. Primary Drying
    3.3.2.4. Secondary Drying
3.4. Lyophilizer and its Key Components
3.5. Primary Packaging Systems Used for Lyophilization of Biopharmaceuticals
3.6. Lyophilization Cycle Development and Optimization
3.7. Concluding Remarks

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
  5.3.1. Benchmark Analysis: North America (Peer Group I)
  5.3.2. Benchmark Analysis: North America (Peer Group II)
  5.3.3. Benchmark Analysis: North America (Peer Group III)
  5.3.4. Benchmark Analysis: Europe (Peer Group IV)
  5.3.5. Benchmark Analysis: Europe (Peer Group V)
  5.3.6. Benchmark Analysis: Europe (Peer Group VI)
  5.3.7. Benchmark Analysis: Asia Pacific and Rest of the World (Peer Group VII)
  5.3.8. Benchmark Analysis: Asia Pacific and Rest of the World (Peer Group VIII)

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
  9.3.1. Analysis by Year of Partnership
  9.3.2. Analysis by Type of Partnership
  9.3.3. Analysis by Year and Type of Partnership
  9.3.4. Most Active Players: Analysis by Number of Partnerships
  9.3.5. Analysis by Geography
    9.3.5.1. Intercontinental and Intracontinental Deals
    9.3.5.2. International and Local Deals

10. RECENT EXPANSIONS

10.1. Chapter Overview
10.2. Lyophilization Services Market for Biopharmaceuticals: List of Recent Expansions
  10.2.1. Analysis by Year of Expansion
  10.2.2. Analysis by Type of Expansion
  10.2.3. Analysis by Year and Type of Expansion
  10.2.4. Analysis by Company Size and Location of Headquarters
  10.2.5. Analysis by Location of Expanded Facility
  10.2.6. Active Players: Analysis by Number of Recent Expansions
  10.2.7. Analysis by Geography

11. SURVEY ANALYSIS

11.1. Chapter Overview
11.2. Lyophilization Services Market for Biopharmaceuticals: List of Participating Companies
  11.2.1. Analysis by Seniority Level of Respondents
  11.2.2 Analysis by Type of Biologic Lyophilized
  11.2.3. Analysis by Type of Primary Packaging System
  11.2.4. Analysis by Scale of Operation
  11.2.5. Analysis by Additional Services Offered
  11.2.6. Analysis by Location of Lyophilization Facility
  11.2.7. Analysis by Share of Lyophilization Operations Outsourced
  11.2.8. Analysis by Likely Market Size
  11.2.9. Analysis of Likely Market Share by Type of Biologic Lyophilized
  11.2.10. Analysis of Likely Market Share by Geography

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
  12.4.1. Analysis by Company Size
  12.4.2. Analysis by Location of Headquarters
  12.4.3. Analysis by Type of Service Offered
  12.4.4 Lyophilization Cycle Development and Optimization Service Providers: Company Snapshots

13. CASE STUDY II: ALTERNATIVE APPROACHES TO LYOPHILIZATION

13.1. Chapter Overview
13.2. Alternative Approaches to Lyophilization
  13.2.1. Spray Drying
    13.2.1.1. Spray Drying Process
    13.2.1.2. Applications of Spray Drying
    13.2.1.3. Spray Drying of Biopharmaceuticals
    13.2.1.4. Spray Drying Service Providers for Biopharmaceuticals
    13.2.1.5. Comparison of Lyophilization and Spray Drying
  13.2.2. Spray Freeze Drying
  13.2.3. Atmospheric Spray Freeze Drying
  13.2.4. Vacuum Foam Drying

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
  14.4.1. Lyophilization Services Market for Antibodies, 2022-2035
  14.4.2. Lyophilization Services Market for Cell and Gene Therapies, 2022-2035
  14.4.3. Lyophilization Services Market for Vaccines, 2022-2035
  14.4.4. Lyophilization Services Market for Other Biologics, 2022-2035
14.5. Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Primary Packaging System, 2022 and 2035
  14.5.1. Lyophilization Services Market for Biopharmaceuticals for Vials, 2022-2035
  14.5.2. Lyophilization Services Market for Biopharmaceuticals for Syringes, 2022-2035
  14.5.3. Lyophilization Services Market for Biopharmaceuticals for Cartridges, 2022-2035
  14.5.4. Lyophilization Services Market for Biopharmaceuticals for Ampoules, 2022-2035
  14.5.5. Lyophilization Services Market for Biopharmaceuticals for Other Primary Packaging Systems, 2022-2035
14.6. Lyophilization Services Market for Biopharmaceuticals: Distribution by Geography, 2022 and 2035
  14.6.1. Lyophilization Services Market for Biopharmaceuticals in North America, 2022-2035
  14.6.2. Lyophilization Services Market for Biopharmaceuticals in Europe, 2022-2035
  14.6.3. Lyophilization Services Market for Biopharmaceuticals in Asia Pacific, 2022-2035
  14.6.4. Lyophilization Services Market for Biopharmaceuticals in Middle East and North Africa, 2022-2035
  14.6.5. Lyophilization Services Market for Biopharmaceuticals in Latin America, 2022-2035
  14.6.6. Lyophilization Services Market for Biopharmaceuticals in Rest of the World, 2022-2035

15. CONCLUDING REMARKS

16. EXECUTIVE INSIGHTS

16.1. Chapter Overview
16.2. Pharmaceutical International
  16.2.1. Company Snapshot
  16.2.2. Interview Transcript: Brian Sasaki, Director of Business Development and Thomas Ingallinera, Vice President of Technical Support
16.3. Curia
  16.3.1. Company Snapshot
  16.3.2. Interview Transcript: Doreen Coull, Regional Sales Director
16.4. Emergent BioSolutions
  16.4.1. Company Snapshot
  16.4.2. Interview Transcript: Patrick DePalma, Former Director, CMO Business Development, BioDefense Division
16.5. Liof Pharma
  16.5.1. Company Snapshot
  16.5.2. Interview Transcript: Rocio Gonzalez Rodriguez, Head of CDMO Project Management
16.6. Vibalogics
  16.6.1. Company Snapshot
  16.6.2. Interview Transcript: John Shaw, Former Head of Business Development and Marketing
16.7. Samsung Biologics
  16.7.1. Company Snapshot
  16.7.2. Interview Transcript: Sophia Kim, Commercial DP (Depository Participant) Sales / Group Leader
16.8. Bioserv
  16.8.1. Company Snapshot
  16.8.2. Interview Transcript: Marianna Tcherpakov, Business Development Manager
16.9. Symbiosis Pharmaceutical Services
  16.9.1. Company Snapshot
  16.9.2. Interview Transcript: Adam Inche, Marketing Manager
16.10. Patheon
  16.10.1. Company Snapshot
  16.10.2. Interview Transcript: Adam Viverette, Manager of Lyophilization Operations
16.11. Baxter BioPharma Solutions
  16.11.1. Company Snapshot
  16.11.2. Interview Transcript: Steven Nail, Principal Scientist

17. APPENDIX 1: TABULATED DATA

18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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