The lyophilization services market is expected to reach USD 2.2 billion in 2022 anticipated to grow at a CAGR of 6.8% during the forecast period 2022-2035.

Over the past decade, there has been a consistent upward trend in the approvals of various biologics, encompassing monoclonal antibodies, cell therapies, recombinant proteins, vaccines, and gene therapies. This sector has emerged as one of the fastest-growing segments within the pharmaceutical industry, attributed to the distinct advantages these therapies offer, including high efficacy, targeted action, and favorable safety profiles. Forecasts suggest that the biopharmaceutical market will sustain its expansion in the forthcoming years.
However, biologic drugs present unique challenges. They exhibit lesser stability in comparison to small molecules and are more susceptible to physical and chemical degradation. To enhance their shelf life and ensure stability, the adoption of lyophilization, commonly known as freeze-drying, has become prevalent. This technique facilitates the production of stable, dry biopharmaceutical formulations. Approximately half of the presently approved biopharmaceuticals are injectables, and around one-third of these are suitable candidates for lyophilization.
Establishing in-house lyophilization capabilities is a costly and time-intensive endeavor, requiring specialized equipment and expertise. Consequently, a growing number of biologic developers are opting to outsource their lyophilization operations to specialized contract manufacturing organizations (CMOs). This approach allows them to leverage the capabilities of these organizations while also realizing cost-saving opportunities. Currently, more than 105 contract manufacturers claim to possess the requisite expertise to provide lyophilization services for biotherapeutics. Furthermore, these service providers are forging strategic alliances to bolster their position in the industry and augment their capabilities to meet the increasing demand for biologics. The preference for outsourcing, combined with the continual expansion of the biological therapeutics pipeline and the steady increase in drug approvals, indicates that the lyophilization services market for biopharmaceuticals is poised for consistent growth in the forecasted period.

Report Coverage
? Overview of lyophilization for biopharmaceuticals, detailing the process, historical evolution, advantages, and disadvantages. It highlights the steps, lyophilizer components, packaging systems, and cycle development.
? Market landscape, analyzing 105 companies providing lyophilization services. It focuses on parameters like establishment year, company size, location, operation scale, certification, types of biologics, lyophilization process, packaging systems, and additional services.
? Service providers in North America, Europe, Asia Pacific, and RoW based on employee count, facilities, biologics lyophilized, process, and packaging systems. It plots top stakeholders on a capability’s spider web.
? Detailed profiles of key companies providing lyophilization services in North America, Europe, and Asia Pacific. Each profile covers service offerings, facilities, recent developments, and future outlook.
? Details on collaborations in the lyophilization domain from 2018 to 2021, focusing on partnership types, active players, and regional distribution.
? Analyzes recent expansions by service providers, considering expansion types, company size, headquarters, locations, and active players.
? Details on insights from a survey conducted among senior stakeholders in lyophilization services, focusing on biologics, packaging, scale, capabilities, and market potential.
? Detailed market forecast till 2035 based on biologic types, packaging systems, and key geographies, using a top-down approach supported by primary research data.

Key Market Companies
? Baxter BioPharma Solutions
? Curia
? Emergent BioSolutions
? LSNE Contract Manufacturing
? Lyophilization Technology
? CordenPharma
? Coriolis Pharma
? Northway Biotech
? ProJect Pharmaceutics
? Vetter Pharma
? BioZed Engineering
? CinnaGen
? MabPlex
? Samsung Biologics
? WuXi Biologics