Lyophilization Services for Biopharmaceuticals Market, 2027

(MENAFNEditorial) Dublin, Jan. 11, 2018 (GLOBE NEWSWIRE) -- The report has been added to Research and Markets' offering.

The Lyophilization Services for Biopharmaceuticals, 2017-2027' report provides an extensive study on the current market landscape of lyophilization services for biopharmaceuticals. The study presents an in-depth analysis of a diverse set of companies that provide such services across different regions worldwide. In fact, we identified close to 90 companies that are actively involved in providing lyophilization services for biopharmaceuticals.

The number of biopharmaceuticals being developed and manufactured has increased significantly in recent years. This is evident from the fact that over 10 novel biologics have been approved annually by FDA over the last three years; this represents around 30% of the total novel drugs approved during this time period.

Currently, more than 50% of the drugs in clinical pipeline comprise of biologics. It is worth highlighting that most of these products are not stable as aqueous formulations, making it difficult to preserve them for longer durations. In order to achieve longer and commercially viable shelf lives, lyophilization has emerged as the preferred choice for making dry biopharmaceutical formulations. The method proves to be beneficial for biologics with stability issues or when providing exact dosage is challenging (for instance, very small and highly concentrated doses). In addition, it is suitable for biologics that are sensitive to heat, oxygen and/or humidity.

The lyophilization process requires specialized equipment, expertise and care. Contract manufacturing organizations (CMOs) that provide such services have specialized facilities and dedicated lines for lyophilization operations. A number of biopharmaceutical companies are outsourcing their lyophilization operations to CMOs to leverage their expertise and capabilities. It is well-known that setting up in-house lyophilization capabilities and operations is an expensive and time-consuming process. In order to decrease the overall cost of the product and yield cost savings, we expect that drug developers will continue to outsource such operations to CMOs. Key drivers, both in the short-mid term and long term, not only include the increasing demand for biological therapies but also the expected entry of a number of biosimilars and the technological advancements that are steadily resulting in improved productivity for clients.

In addition to other elements, the report covers the following:

• The current state of the market with respect to key players along with information on location of facilities, the type of biopharmaceuticals lyophilized (antibodies, proteins, peptides, vaccines, nucleic acids and ADCs), scale of operation (lab, clinical and commercial) and the containment systems (vials, bulk containers, syringes, ampoules and cartridges) utilized for lyophilization operations.
• Elaborate profiles of established/emerging players that primarily have expertise in providing broader lyophilization services and/or are focused on providing lyophilization services for emerging containment systems such as syringes; each profile provides a company overview, financial information, details on lyophilization capabilities and facilities, recent developments and an informed future outlook.
• Most active regions in terms of lyophilization services for biologics; the report contains schematic representations of world maps that clearly indicate the location of active lyophilization service hubs.
• Benchmark analysis allowing companies to compare their existing capabilities within respective peer groups and identify ways to become more competitive in the industry.
• Competitive landscape of companies providing lyophilization cycle development and/or optimization services for biopharmaceuticals.
• A case study on alternative approaches to lyophilization such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying.

The study features a detailed analysis of the existing size and potential future growth opportunities (2017-2027) in the lyophilization services market for biopharmaceuticals. We have provided insights on the likely regional evolution of the market covering North America, Europe (UK, France, Italy, Spain, Germany and rest of Europe), Asia Pacific (Japan, China, India and South Korea) and rest of the world. In addition, we have provided the likely evolution and a market attractiveness analysis on the basis of the type of containment system (bulk containers, vials, syringes, ampoules and cartridges). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have presented three different forecast scenarios, depicting conservative, base and optimistic tracks of the market's evolution.

Key Topics Covered:

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION TO LYOPHILIZATION
3.1. Chapter Overview
3.2. Lyophilization: Historical Background
3.3. Lyophilization: Underlying Principle
3.4. Lyophilization: Equipment
3.5. Lyophilization: Advantages and Disadvantages
3.6. Lyophilization: Applications
3.6.1. Pharmaceutical and Biotechnology Industry
3.6.2. Food Industry
3.6.3. Microbiology
3.6.4. Chemical Industry
3.6.5. Dairy Industry
3.6.6. Nutraceutical Industry
3.6.7. Floral Lyophilization
3.6.8. Other Applications

4. LYOPHILIZATION OF BIOPHARMACEUTICALS
4.1. Chapter Overview
4.2. Need for Lyophilization of Biopharmaceuticals
4.3. Lyophilization Process for Biopharmaceuticals
4.3.1. Formulation and Filling
4.3.2. Freezing
4.3.3. Primary Drying
4.3.4. Secondary Drying
4.4. Lyophilization Cycle Development and Optimization
4.5. Containment Systems Used for the Lyophilization of Biopharmaceuticals

5. COMPETITIVE LANDSCAPE
5.1. Chapter Overview
5.2. Lyophilization Service Providers for Biopharmaceuticals: Overall Landscape
5.3. Lyophilization Service Providers for Biopharmaceuticals: Analysis by Type of Biopharmaceuticals Lyophilized
5.4. Lyophilization Service Provides for Biopharmaceuticals: Analysis by Scale of Operation
5.5. Lyophilization Service Providers for Biopharmaceuticals: Analysis by Containment Systems

6. LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS: NORTH AMERICA
6.1. Chapter Overview
6.2. Anteco Pharma
6.2.1. Company Overview
6.2.2. Lyophilization Capabilities and Facilities
6.2.3. Recent Developments
6.2.4. Future Outlook
6.3. Axcellerate Pharma
6.3.1. Company Overview
6.3.2. Lyophilization Capabilities and Facilities
6.3.3. Recent Developments
6.3.4. Future Outlook
6.4. Berkshire Sterile Manufacturing
6.4.1. Company Overview
6.4.2. Lyophilization Capabilities and Facilities
6.4.3. Recent Developments
6.4.4. Future Outlook
6.5. Emergent BioSolutions
6.5.1. Company Overview
6.5.2. Financial Performance
6.5.3. Lyophilization Facilities and Capabilities
6.5.4. Recent Developments
6.5.5. Future Outlook
6.6. LSNE Contract Manufacturing
6.6.1. Company Overview
6.6.2. Lyophilization Capabilities and Facilities
6.6.3. Recent Developments
6.6.4. Future Outlook
6.7. Lyophilization Technology
6.7.1. Company Overview
6.7.2. Lyophilization Capabilities and Facilities
6.7.3. Recent Developments
6.7.4. Future Outlook
6.8. Quality BioResources
6.8.1. Company Overview
6.8.2. Lyophilization Capabilities and Facilities
6.8.3. Future Outlook
6.9. North America: Lyophilization Services Market for Biopharmaceuticals, 2017-2027 (USD Million)
6.9.1. North America Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Containment System (USD Million)

7. LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS: EUROPE
7.1. Chapter Overview
7.2. Amatsigroup
7.2.1. Company Overview
7.2.2. Financial Performance
7.2.3. Lyophilization Capabilities and Facilities
7.2.4. Recent Developments
7.2.5. Future Outlook
7.3. Biopharma Technology
7.3.1. Company Overview
7.3.2. Lyophilization Capabilities and Facilities
7.3.3. Recent Developments
7.3.4. Future Outlook
7.4. Boehringer Ingelheim BioXcellence
7.4.1. Company Overview
7.4.2. Financial Performance
7.4.3. Lyophilization Capabilities and Facilities
7.4.4. Recent Developments
7.4.5. Future Outlook
7.5. LYOCONTRACT
7.5.1. Company Overview
7.5.2. Lyophilization Capabilities and Facilities
7.5.3. Recent Developments
7.5.4. Future Outlook
7.6. Lyofal
7.6.1. Company Overview
7.6.2. Lyophilization Facilities and Capabilities
7.6.3. Recent Developments
7.6.4. Future Outlook
7.7. Vetter Pharma
7.7.1. Company Overview
7.7.2. Lyophilization Capabilities and Facilities
7.7.3. Recent Developments
7.7.4. Future Outlook
7.8. Europe: Lyophilization Services Market for Biopharmaceuticals, 2017-2027 (USD Million)
7.8.1. Europe Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Containment System (USD Million)

8. LYOPHILIZATION SERVICE PROVIDERS FOR BIOPHARMACEUTICALS: ASIA PACIFIC
8.1. Chapter Overview
8.2. BioZed Engineering
8.3. Bovogen Biologics
8.4. CinnaGen
8.5. Mycenax Biotech
8.6. Piramal Pharma Solutions
8.7. Samsung Biologics
8.8. Siam Bioscience
8.9. WuXi AppTec
8.10. Asia Pacific: Lyophilization Services Market for Biopharmaceuticals, 2017-2027 (USD Million)
8.10.1. Asia Pacific Lyophilization Services Market for Biopharmaceuticals: Distribution by Type of Containment System (USD Million)

9. MARKET SIZING AND FORECAST
9.1. Chapter Overview
9.2. Forecast Methodology
9.3. Lyophilization Services Market for Biopharmaceuticals, 2017-2027 (USD Million)
9.4. Lyophilization Services Market for Biopharmaceuticals, 2017-2027: Distribution by Region (USD Million)
9.4.1. Lyophilization Services Market for Biopharmaceuticals: North America (USD Million)
9.4.2. Lyophilization Services Market for Biopharmaceuticals: Europe (USD Million)
9.4.3. Lyophilization Services Market for Biopharmaceuticals: Asia Pacific and Rest of the World (USD Million)
9.5. Lyophilization Services Market for Biopharmaceuticals, 2017-2027: Distribution by Type of Containment System (USD Million)
9.5.1. Lyophilization Services Market for Biopharmaceuticals: Market Attractiveness Analysis by Type of Containment System

10. BENCHMARK ANALYSIS
10.1. Chapter Overview
10.2. Benchmark Analysis: Methodology
10.3. Benchmark Analysis: Peer Groups
10.3.1. Benchmark Analysis: North America, Peer Group I
10.3.2. Benchmark Analysis: North America, Peer Group II
10.3.3. Benchmark Analysis: North America, Peer Group III
10.3.4. Benchmark Analysis: Europe, Peer Group IV
10.3.5. Benchmark Analysis: Europe, Peer Group V
10.3.6. Benchmark Analysis: Europe, Peer Group VI
10.3.7. Benchmark Analysis: Asia Pacific, Peer Group VII
10.3.8. Benchmark Analysis: Asia Pacific, Peer Group VIII

11. LYOPHILIZATION CYCLE DEVELOPMENT AND OPTIMIZATION
11.1. Chapter Overview
11.2. Lyophilization Cycle Development
11.3. Lyophilization Cycle Optimization
11.4. Lyophilization Cycle Development and Optimization: Service Providers
11.4.1. Lyophilization Cycle Development and Optimization Service Providers: Analysis by Type of Services
11.4.2. Lyophilization Cycle Development and Optimization Service Providers: Analysis by Company Size
11.4.3. Lyophilization Cycle Development and Optimization Service Providers: Analysis by Geography
11.5. Lyophilization Cycle Development and Optimization Service Providers: Company Snapshots

12. ALTERNATIVE APPROACHES TO LYOPHILIZATION
12.1. Chapter Overview
12.2. Spray Drying
12.2.1. Spray Drying: Process
12.2.2. Spray Drying: Applications
12.2.3. Spray Drying of Biopharmaceuticals
12.2.4. Spray Drying Service Providers for Biopharmaceuticals
12.2.5. Comparison: Lyophilization and Spray Drying
12.3. Spray Freeze Drying
12.4. Atmospheric Spray Freeze Drying
12.5. Vacuum Foam Drying

13. SURVEY ANALYSIS
13.1. Chapter Overview
13.2. Seniority Level of Respondents
13.3. Type of Biopharmaceuticals Lyophilized
13.4. Type of Containment System
13.5. Scale of Operation
13.6. Lyophilization Cycle Development and Optimization
13.7. Location of Lyophilization Facility
13.8. Likely Market Size

14. CONCLUSION
14.1. In Light of High Costs Associated with Establishing In-house Lyophilization Capabilities, Outsourcing has Emerged as a Convenient Alternative
14.2. Cycle Development and Optimization are Among the Key Lyophilization Processes; a Number of Players Specializing in These Services Have Entered the Market Expanding the Value Chain
14.3. Although Alternative Methods have Gained Attention in Recent Times, Lyophilization will Continue to Play a Pivotal Role
14.4. Fueled by the Growing Pipeline of Biopharmaceuticals, the Market is Likely to Witness Continuous Growth in the Coming Decade

15. INTERVIEW TRANSCRIPTS
15.1. Chapter Overview
15.2. Steven Nail, Principal Scientist, Baxter BioPharma Solutions
15.3. Adam Viverette, Lyophilization Manager, Patheon
15.4. Patrick DePalma, Director, CMO Business Development BioDefense Division, Emergent BioSolutions
15.5. John Shaw, Head of Business Development and Marketing, Vibalogics

APPENDIX 1: TABULATED DATA

APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION

Companies Mentioned

• AB BioTechnologies
• Affinity Biologicals
• Affinity Life Sciences
• Ajinomoto
• Albany Molecular Research (AMRI)
• Alcami
• Althea
• Amatsigroup
• Anteco Pharma
• Apexigen
• Aptevo Therapeutics
• AusiaBio
• Avrio Biopharmaceuticals
• Axcellerate Pharma
• Axys-Network
• BSP Pharmaceuticals
• Baccinex
• Baxter BioPharma Solutions
• Bayer Healthcare
• Berkshire Sterile Manufacturing (BSM)
• BioConnection
• BioReliance
• BioTechLogic
• BioTechnique
• BioZed Engineering
• Biocon
• Biopharma Technology
• Bioserv Corporation
• Biotechpharma
• Biovian
• Boehringer Ingelheim BioXcellence
• Bovogen Biologicals
• Bryllan
• Burrard Pharmaceuticals
• CARBOGEN AMCIS
• CEPiA
• CMC Biologics
• Camurus
• Canada Peptide
• Capua BioServices
• Catalent
• Cenexi
• CinnaGen
• Clarity BioSolutions
• Cobra Biologics
• Coldstream Laboratories
• Cook Pharmica
• Corden Pharma
• Coriolis Pharma
• CuriRx
• Dalton Pharma Services
• DavosPharma
• EUCODIS Bioscience
• Emergent BioSolutions
• Engineered Biopharmaceuticals
• Eurogentec
• FUJIFILM Diosynth Biotechnologies
• Famar Health Care Services
• Fedegari Group
• Formurex
• Fresenius Kabi Product Partnering
• Frontage Labs
• GILYOS (GIeseler LYOphilization Solutions)
• GP Pharm
• Gipharma
• GlaxoSmithKline (GSK)
• Goodwin Biotechnology
• Grand River Aseptic Manufacturing (GRAM)
• HALIX
• HTD Biosystems
• Hart Biologicals
• Hovione
• Hycult Biotech
• IDIFARMA
• IDT Biologika
• Infectious Disease Research Institute (IDRI)
• Integrity Bio
• Jubilant HollisterStier
• Jubilant Pharma
• KABS Pharmaceutical Services
• KBI Biopharma
• Kamat Pharmatech
• Kemwell Biopharma
• LEUKOCARE
• LSNE Contract Manufacturing
• LYOCONTRACT
• Legacy BioDesign
• Lonza
• Lyofal
• Lyophilization Technology
• MabPlex
• Markt Technologies
• MassDevelopment
• Medicago
• Micro-sphere
• Miltenyi Biotec
• Mycenax Biotech
• NanoTools
• National Institute of Allergy and Infectious Diseases (NIAID)
• Nitto Avecia Pharma Services
• Nova Laboratories
• OctoPlus
• Oncotec Pharma Produktion
• OsoBio
• PREMAS Biotech
• PYRAMID Laboratories
• PaizaBio
• Particle Sciences
• Patheon
• Pfizer CentreOne
• Pharmagen
• Pharmatek
• Pierre Fabre
• Piramal Pharma Solutions
• Praxair
• Praxis Pharmaceutical
• ProJect Pharmaceutics
• Quality BioResources
• Recipharm
• Rentschler
• SGS Group
• SP Scientific
• SYNERLAB Group
• Samsung Biologics
• Sanofi
• Siam Bioscience
• Singota Solutions
• StemProtein
• Symbiosis Pharmaceutical Services
• SynCo Bio Partners
• Syngene
• The Native Antigen Company (NAC)
• Therapure Biomanufacturing
• Tofflon
• Universal Stabilization Technologies
• Upperton
• Vectura
• Vetter Pharma
• Vibalogics
• VxP Pharma
• Wolfe Laboratories
• WuXi AppTec

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