Worldwide Lyophilization Services for Biopharmaceuticals Industry Report to 2035 - Key Market Trends and Forecasts

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.

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

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets