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Lyophilization Services for Biopharmaceuticals, 2017-2027

Lyophilization Services for Biopharmaceuticals, 2017-2027

  • April 2017
  • 239 pages
  • ID: 4886788
  • Format: PDF
  • Roots Analysis Private Ltd.

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INTRODUCTION
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.


SCOPE OF THE REPORT
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. 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.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 80 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities, challenges and likely future trends. The opinions and insights presented in this study were also influenced by discussions conducted with experts in this field. These included contributions from Steven Nail (Principal Scientist, Baxter BioPharma Solutions), Adam Viverette (Lyophilization Manager, Patheon), Patrick DePalma (Director, CMO Business Development, BioDefense Division, Emergent BioSolutions) and John Shaw (Head of Business Development and Marketing, Vibalogics).



RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.



CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. This summary offers a high level view on the current state of the lyophilization services market for biopharmaceuticals and its likely evolution in the mid-long term.

Chapter 3 provides an introduction to the lyophilization approach. It includes a detailed discussion on the history / evolution of the lyophilization technology, the principle on which the process is based, the basic components of a lyophilizer, and highlights the advantages / disadvantages and applications of the lyophilization process.

Chapter 4 highlights the importance of lyophilization for biopharmaceuticals. It elaborates on the steps involved in the process of lyophilization, lyophilization cycle development and optimization, and the containment systems in which lyophilization services for biopharmaceuticals are carried out.

Chapter 5 includes a comprehensive market landscape of the companies that provide lyophilization services for biopharmaceuticals. It presents an analysis of the lyophilization service providers on the basis of their geographical location, types of biopharmaceuticals lyophilized (antibodies, ADCs, proteins, peptides, nucleic acids and vaccines), scale of operation (lab, clinical and commercial) and the containment systems (vials, bulk containers, syringes, cartridges and ampoules).

Chapter 6 provides detailed profiles of some of the lyophilization service providers for biopharmaceuticals based in North America. Each profile presents a brief overview of the company, its financial information, lyophilization capabilities and facilities, recent developments, and a comprehensive future outlook. The chapter also provides insights on the overall evolution of the North American lyophilization services market, specifically distributed on the basis of type of containment system.

Chapter 7 provides detailed profiles of some of the lyophilization service providers for biopharmaceuticals based in Europe. Each profile provides a brief overview of the company, its financial information, lyophilization capabilities and facilities, recent developments, and a comprehensive future outlook. The chapter also provides insights on the overall evolution of the European lyophilization services market, specifically distributed on the basis of type of containment system.

Chapter 8 provides brief profiles of some of the lyophilization service providers for biopharmaceuticals based in the Asia Pacific region. The chapter also provides insights on the overall evolution of the Asia Pacific lyophilization services market, specifically distributed on the basis of type of containment system.

Chapter 9 presents a comprehensive view on how the lyophilization services market for biopharmaceuticals is likely to evolve over the next ten years. We have segregated the financial opportunity on the basis of different regions (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) and the type of containment system (bulk containers, vials, syringes, ampoules and cartridges). All our predictions are backed by robust analysis of data procured from both secondary and primary sources. The analysis also presents insightful 2 X 2 matrices based on Market Share and Market Attractiveness derived from the current and likely future state of the market. Due to uncertainties surrounding some of the assumptions within our forecast model, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.

Chapter 10 provides a benchmark analysis of the companies that provide lyophilization services for biopharmaceuticals. The key parameters considered for this analysis include the scale of operation, number of biologics lyophilized and type of containment system used for the lyophilization of biologics. The analysis allows the companies to compare their existing capabilities within their peer group and identify opportunities to become more competitive in the industry.

Chapter 11 presents elaborate details on lyophilization cycle development and optimization services, highlighting the important parameters and techniques required for these processes and the list of players providing such services for biopharmaceuticals.

Chapter 12 features a case study on alternative methods to lyophilization such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying. It specifically elaborates on spray drying, covering information such as step-wise approach, applications of spray drying for biopharmaceuticals, key players providing such services and an informed comparison with lyophilization.

Chapter 13 presents insights from the survey conducted for this study. We invited over 80 stakeholders involved in providing lyophilization services for biopharmaceuticals. The participants, who were primarily Directors / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 14 summarizes the overall report. It presents a list of key takeaways and offers our independent opinion on the current market scenario and key trends that are likely to determine how the market is likely to evolve in the short and long term.

Chapter 15 is a collection of interview transcripts of our discussions with some of the key players in this industry. We have presented the details of our conversations with Steven Nail (Principal Scientist, Baxter BioPharma Solutions), Adam Viverette (Lyophilization Manager, Patheon), Patrick DePalma (Director, CMO Business Development, BioDefense Division, Emergent BioSolutions) and John Shaw (Head of Business Development and Marketing, Vibalogics).

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 17 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.


EXAMPLE HIGHLIGHTS
1. 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.
2. 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.
3. 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%).
4. 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.
5. 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.
6. 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.

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