Lyophilization Services Market

Lyophilization Services Market for Biopharmaceuticals 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

  • Lowest Price Guaranteed From USD 4,799

  • Companies Covered
    135

  • Pages
    225

  • View Count
    15752

Lyophilization Services Market Overview

The lyophilization services market is estimated to be worth $2.2 billion in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 6.8% during the forecast period. 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 dryer) 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 / freeze dryer 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 market growth during the forecast period.

This image highlights the context of Lyophilization Services Market report. In order to avail benefits, such as increased flexibility, lower costs and assistance in meeting the rising demands, drug developers are increasingly relying on contract manufacturing organizations (CMOs) for lyophilization of biopharmaceuticals This image provides list of Lyophilization Service Providers for Biopharmaceuticals. Presently, over 105 service providers claim to have the required expertise to offer lyophilization services for a variety of biotherapeutics, including proteins, antibodies, nucleic acids and cell / gene therapies This image highlights the geographical distribution of Lyophilization Services Providers for Biopharmaceuticals. The current market landscape is highly fragmented, featuring the presence of both new entrants and established players based in key geographical regions

Key Companies in Lyophilization Services Market

Examples of key companies engaged in lyophilization market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Baxter BioPharma Solutions, CordenPharma, Coriolis Pharma, Curia, Emergent BioSolutions, LSNE Contract Manufacturing, Lyophilization Technology, Northway Biotech, ProJect Pharmaceutics and Vetter Pharma. This lyophilization services market report includes an easily searchable excel database of all the companies providing lyophilization services for biopharmaceutical products, worldwide.

Recent Developments in Lyophilization Market:

Several recent developments have taken place in the field of lyophilization services market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In July 2023, Berkshire Sterile Manufacturing announced the expansion of its lyophilization capacity for their fully automated, isolator-based filling line to meet new demand. 
  • In April 2023, PharmaJet Partner Gennova Biopharmaceuticals seek emergency use authorization in India for the use of GEMCOVAC-OM, the First Needle-Free mRNA Vaccine Omicron Booster.

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” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the companies involved in offering lyophilization services for biopharmaceuticals. The market research report features an in-depth analysis of the key drivers and trends related to lyophilization services market . 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 lyophilization services market , 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 lyophilization services market, 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 dryer, atmospheric spray freeze dryer and vacuum foam drying.

One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for lyophilization services market for biopharmaceuticals in the forecast period. We have provided an informed estimate on the likely evolution of the market over the forecast period 2022-2035. The market 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.

This image presents current market landscape of Lyophilization Services Market for Biopharmaceuticals. Leveraging their expertise, stakeholders are offering lyophilization services at different scales of operation; further, vials emerged as the preferred choice of primary packaging system for storing biologics This image highlights competitive analysis of players engaged in the domain of Lyophilization Services Market. In order to successfully navigate the evolving regulatory landscape, service providers are expanding their portfolios to cater to customized requests of their clients This image highlights the partnership activity undertaken by players engaged in Lyophilization Services Market. The growing interest in this domain is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to lyophilization of biopharmaceuticals were inked in 2021

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following individuals:

  • Director of Business Development, and Vice President of Technical Support, Mid-sized Company, US
  • Regional Sales Director, Very Large Company, US
  • Former Director of CMO Business Development, BioDefense Division, Very Large Company, US
  • Head of CDMO Project Management, Small Company, Spain
  • Former Head of Business Development and Marketing, Mid-sized Company, US
  • Commercial DP (Depository Participant) Sales / Group Leader, Very Large Company, South Korea
  • Business Development Manager, Small Company, US
  • Manager, Very Large Company, US
  • Principal Scientist, Very Large Company, US
This image provides information about recent expansions undertaken by various lyophilization service providers for biopharmaceuticals. To keep pace with the growing demand, many companies have undertaken expansion initiatives, such as establishing new facilities or expanding their existing capabilities, to strengthen their service portfolio This image provides information on the current and future market trends and potential growth of Lyophilization Services Market for Biopharmaceuticals. The market is expected to grow at a steady rate till 2035; the projected opportunity is anticipated to be well distributed across various types of biologic lyophilized, primary packaging systems and geographical regions  

Frequently Asked Questions

Question 1: What is lyophilization?

Answer: Lyophilization (also known as freeze drying) technique, enables the production of stable dry biopharmaceutical formulations using low temperature dehydration process.

Question 2: How big is the lyophilization services market?

Answer: The lyophilization services market size is estimated to be worth $2.2 billion in 2022.

Question 3: What is the projected market growth of the lyophilization services market?

Answer: The lyophilization services market is expected to grow at compounded annual growth rate (CAGR) of 6.8% during the forecast period 2022 - 2035.

Question 4: Who are the leading players in the lyophilization market?

Answer: Examples of key companies engaged in lyophilization market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Baxter BioPharma Solutions, CordenPharma, Coriolis Pharma, Curia, Emergent BioSolutions, LSNE Contract Manufacturing, Lyophilization Technology, Northway Biotech, ProJect Pharmaceutics and Vetter Pharma.

Question 5: How many companies are currently engaged in the lyophilization services market?

Answer: Presently, more than 105 contract manufacturers claim to have the required capabilities to offer lyophilization services for biotherapeutics.

Question 6: Which type of biologic is most commonly lyophilized by the companies engaged in the lyophilization services market?

Answer: Presently, more than 40% of the companies engaged in the lyophilization services market offer services for protein molecules.

Question 7: What is the trend of outsourcing in the lyophilization services market?

Answer: Currently, over 50% of the lyophilization operations are being outsourced to third party service providers.

PRICING DETAILS

This license grants the right of use of the purchased report to a single recipient only (normally the person who buys the report). You may access the material on your computer, as and when required, for your own personal use. You may also print Read more about Single-User License

This license grants the right of use of the purchased report by the employees of a business unit at a particular site/office location. The report may be accessed on the computer of any employee within the business unit. You may also print multiple Read more about One Location Site License

This license grants the right of use of the purchased report by a department / team of individuals (up to 12) in a particular organization. The license does not limit the use to a particular site / office location. The report may be accessed on the computer Read more about Department License

This license entitles the buyer of the report to share, distribute the report (either full or in part) with other employees of the same firm/enterprise. The report may be accessed by any employee of the enterprise and there is no limit on the Read more about Enterprise License

Discounts available for multiple report purchases
Click here to send an email to Roots Analysis team. sales@rootsanalysis.com