INTRODUCTION 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).

New York, April 27, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Lyophilization Services Market for Biopharmaceuticals by Type of Biologic Lyophilized, Type of Primary Packaging System and Key Geographies : Industry Trends and Global Forecasts, 2022-2035" - https://www.reportlinker.com/p06272145/?utm_source=GNW 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 dry stable 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. SCOPE OF THE REPORT The “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” 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. 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. The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following individuals: Brian Sasaki (Director of Business Development) and Thomas Ingallinera (Vice President of Technical Support), Pharmaceutical International Doreen Coull (Regional Sales Director, Curia) Patrick DePalma (Former Director of CMO Business Development, BioDefense Division, Emergent BioSolutions) Rocio Gonzalez Rodriguez (Head of CDMO Project Management, Liof Pharma) John Shaw (Former Head of Business Development and Marketing, Vibalogics) Sophia Kim (Commercial DP (Depository Participant) Sales / Group Leader, Samsung Biologics) Marianna Tcherpakov (Business Development Manager, Bioserv) Adam Inche (Marketing Manager, Symbiosis Pharmaceutical Services) Adam Viverette (Lyophilization Manager, Patheon) Steven Nail (Principal Scientist, Baxter BioPharma Solutions) RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in this domain (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 will 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 All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified. 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? CHAPTER OUTLINES Chapter 2 is an executive summary of the key insights captured in our report. It offers a high-level view of the current state of lyophilization services market for biopharmaceuticals and its likely evolution in the short term, mid-term and long term. Chapter 3 provides a general overview of the lyophilization process, its historical evolution, underlying principle, as well as associated advantages and disadvantages. The chapter also lays emphasis on lyophilization of biopharmaceuticals, along with various steps involved in the process. Furthermore, it features an elaborate discussion on the lyophilizer, its components and the primary packaging systems used for storage of the lyophilized formulations. It also presents information on lyophilization cycle development and optimization. Chapter 4 features a detailed review of the current market landscape of around 105 companies offering lyophilization services for biopharmaceuticals. Additionally, it features an in-depth analysis of service providers, based on a number of relevant parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters. The chapter also covers details about 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). Chapter 5 presents an insightful benchmark analysis of the lyophilization service providers for biopharmaceuticals, located in North America, Europe, and Asia Pacific and RoW. The companies are further segmented based on their employee count, into three categories, namely small (1-200 employees), mid-sized (201-500 employees) and large / very large (>500 employees) across the key geographies. The analysis compares the service providers on the basis of various parameters, such as number of facilities, scale of operation, number of biologics lyophilized, process of lyophilization and number of primary packaging systems. In the chapter, the top stakeholders in each geography have been plotted on a spider web for their respective capabilities. Chapter 6 features detailed profiles of the prominent companies that offer lyophilization services for biopharmaceuticals in North America. Each company 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. Chapter 7 features detailed profiles of the prominent companies that offer lyophilization services for biopharmaceuticals in Europe. Each company profile features a brief overview of the company, details related to its lyophilization service offerings for biopharmaceuticals, dedicated facilities, recent developments and an informed future outlook. Chapter 8 features detailed profiles of the prominent companies that offer lyophilization services for biopharmaceuticals in Asia Pacific. Each company profile features a brief overview of the company, details related to its lyophilization service offerings for biopharmaceuticals, dedicated facilities, recent developments and an informed future outlook. Chapter 9 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst stakeholders in this domain, in the period 2018 – 2021. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership model (acquisitions, asset acquisitions, product / technology development agreements and others), most active player(s) (in terms of number of partnerships inked) and regional distribution of the collaborations. Chapter 10 presents 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 additions), 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. Chapter 11 presents insights from the survey conducted for this study. We approached senior stakeholders from various companies involved in providing lyophilization services for biopharmaceuticals. The questionnaire primarily focused on 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. This helped us develop a deeper understanding on the nature of their services and the associated commercial potential. Additionally, we obtained some insights on the likely size of the current market of lyophilization services for biopharmaceuticals. Chapter 12 presents a comprehensive market forecast analysis, highlighting the future potential of the market till 2035. We have segregated the current and upcoming opportunity based on [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). It is worth mentioning that we adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research. Chapter 13 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 offering such services for biopharmaceuticals. Chapter 14 features a case study on alternative methods to the lyophilization process, such as spray drying, spray freeze drying, atmospheric spray freeze drying and vacuum foam drying. It specifically elaborates 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 15 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters. Chapter 16 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interview held with Brian Sasaki (Director of Business Development) and Thomas Ingallinera (Vice President of Technical Support), Pharmaceutical International, Doreen Coull (Regional Sales Director, Curia), Patrick DePalma (Former Director of CMO Business Development, BioDefense Division, Emergent BioSolutions), Rocio Gonzalez Rodriguez (Head of CDMO Project Management, Liof Pharma), John Shaw (Former Head of Business Development and Marketing, Vibalogics), Sophia Kim (Commercial DP (Depository Participant) Sales / Group Leader, Samsung Biologics), Marianna Tcherpakov (Business Development Manager, Bioserv), Adam Inche (Marketing Manager, Symbiosis Pharmaceutical Services), Adam Viverette (Lyophilization Manager, Patheon) and Steven Nail (Principal Scientist, Baxter BioPharma Solutions). Chapter 17 is an appendix, which provides tabulated data and numbers for all the figures provided in the report. Chapter 18 is an appendix, which contains the list of companies and organizations mentioned in the report. Read the full report: https://www.reportlinker.com/p06272145/?utm_source=GNW About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

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