Lyophilization involves freeze drying of products. In pharmaceutical industries this process is widely used to increase the self-life of antibiotics, vaccines, and protein based drugs. Biopharmaceutical companies are using lyophilization services to keep APIs and drugs sterile. Focus towards enhanced manufacturing practices is increasing the demand for lyophilization services. The growing importance of lyophilization services in biopharmaceuticals market is attributed to the factors such as rising demand for lyophilized products and rapid growth in contract manufacturing and lyophilization services across the world. However, the market is likely to get impacted by the demerits associated with lyophilization process such as leakage during filling, during the forecast period.
Based on service type, the lyophilization service for biopharmaceuticals market is segmented into product and cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. In terms of service type, the commercial manufacturing segment held the highest share of the lyophilization services for biopharmaceuticals market in 2019; however, the product and cycle development segment is anticipated to witness a significant growth rate during the forecast period. The growth of the market is attributed to the advantages offered by the lyophilization process such as increased shelf life for both small and large molecule drugs, stabilizing formulation by commercially validated method, and reduces cost for complex logistics such as rigorous cold-chain custody validation regimes and constant documentable refrigeration at the dispensary level.
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ATTWILL Medical Solutions; Axcellerate Pharma LLC.; AB BioTechnologies, Inc.; Berkshire Sterile Manufacturing, Inc.; Emergent BioSolutions; LSNE Contract Manufacturing; Albany Molecular Research (AMRI); Lyophilization Technology, Inc.; Jubilant HollisterStier LLC; Biofortuna Ltd; and Synerlab Group are some of the prominent players operating in the lyophilization services for biopharmaceuticals market. The market players are focused on organic strategies to sustain their position in the market. For instance, in June 2020, Berkshire Sterile Manufacturing (BSM) has secured US$ 16.5 million financing from Berkshire Bank and Lee Bank to expand its operations in Lee. This financing will be used to add manufacturing capabilities including an additional state-of-the-art robotic line for producing sterile drug products such as vials, syringes, and cartridges.
The market for biopharmaceuticals continues to expand worldwide, and they have been the primary growth driver for the pharmaceutical industry. Biopharmaceuticals will continue to provide a significant growth for the pharmaceutical market during the next five years. Biopharmaceutical parenteral manufacturing has expanded in recent years as more therapeutic biologics have been approved for the market. Biotechnology companies continue to outsource to contract manufacturing organizations (CMOs) as a way to meet their fill-and-finish needs and reduce risk. Biopharmaceutical companies are depended on contract manufacturing organizations (CMOs) to provide capacity and capabilities as per need; in some cases, CMOS provide a great deal of company’s production.
For drug developers to set up in-house lyophilization capabilities and operations, specialized equipment and expertise are required, which is an expensive and time-consuming process. To decrease the overall cost of the product and yield cost savings, biopharmaceutical companies continue to outsource such operations to contract manufacturing organizations (CMOs). Outsourcing is cheaper and increases the efficiency of manufacturing processes. Additionally, it allows biotechnology companies to redirect resources to other areas.
The report segments the global lyophilization services for biopharmaceuticals market as follows:
By Service Type
- Product and Cycle Development
- Clinical Manufacturing
- Commercial Manufacturing
- Freeze Drying
By End User
- Pharmaceutical and Biotechnology Companies
- Research Institutes
- North America
- Asia Pacific (APAC)
- South Korea
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- South and Central America (SCAM)
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