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 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.
- Over 80 companies, with a diverse array of offerings and scale of operations, are providing lyophilization services for biopharmaceuticals. Majority (more than 80%) of these companies are based in North America and Europe. A number of players have also emerged in Asia Pacific; examples include (in alphabetical order) Bovogen Biologicals, Kemwell Biopharma, Mycenax Biotech, Pharmagen, Piramal Pharma Solutions, Samsung Biologics, Siam Bioscience and WuXi AppTec.
- It is worth highlighting that, while majority of the companies provide a broader suite of services, there are several companies that solely/primarily focus on providing lyophilization services. These include (in alphabetical order) Anteco Pharma, Biopharma Technology, LSNE Contract Manufacturing, Lyofal, LYOCONTRACT, Lyophilization Technology and Quality BioResources.
- The companies are providing lyophilization services for a wide range of biopharmaceuticals, including antibodies, proteins, peptides, vaccines, nucleic acids and ADCs. As expected, a larger proportion of companies (- 70%) provides services for antibodies and proteins followed by peptides (- 50%) and vaccines (- 45%).
- Development and optimization of the lyophilization cycle are crucial methods for generating a lyophilized formulation of the product. During our research, we identified over 70 players specializing in providing such services. North America is home to majority of these companies (approximately 47%); this is followed by the EU, where approximately 40% of the companies are based.
- Methods, such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying, have emerged as potential alternatives to lyophilization for the production of dry formulations of biologics. Specifically, spray drying has gained relatively more popularity in recent years. RAPLIXA®, a blend of spray-dried thrombin and fibrinogen, was the first spray dried novel biologic to receive USFDA approval in April 2015. In fact, we identified 16 players, including (in alphabetical order) Biopharma Technology, IDIFARMA, Lonza, Micro-Sphere, Nova Laboratories and Upperton, which provide spray drying services for biopharmaceuticals.
- The increasing focus on biological therapies is the key factor that is likely to drive the lyophilization services market in coming years. Additionally, technological advances in the field and the entry of a number of biosimilars in the near future are likely to provide the necessary impetus. We expect the lyophilization services market for biopharmaceuticals to grow at an annualized growth of 9.5% between 2017 and 2027. North America and Europe, the current hubs, are likely to continue to dominate the market in the next decade.
Key Topics Covered:
2. Executive Summary
3. Introduction To Lyophilization
4. Lyophilization Of Biopharmaceuticals
5. Competitive Landscape
6. Lyophilization Service Providers For Biopharmaceuticals: North America
7. Lyophilization Service Providers For Biopharmaceuticals: Europe
8. Lyophilization Service Providers For Biopharmaceuticals: Asia Pacific
9. Market Sizing And Forecast
10. Benchmark Analysis
11. Lyophilization Cycle Development And Optimization
12. Alternative Approaches To Lyophilization
13. Survey Analysis
15. Interview Transcripts
Appendix 1: Tabulated Data
Appendix 2: List Of Companies And Organization
- AB BioTechnologies - Albany Molecular Research (AMRI) - Alcami - Althea - Amatsigroup - BioTechLogic - BioTechnique - Engineered Biopharmaceuticals - Eurogentec - FUJIFILM Diosynth Biotechnologies - Famar Health Care Services - Fedegari Group - IDT Biologika - 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 - Vibalogics - VxP Pharma - Wolfe Laboratories - WuXi AppTec
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