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According to our new market research study titled “Lyophilization Service for Biopharmaceuticals Market – Global Analysis and Forecast – by Service Type, and End User” the global lyophilization service for biopharmaceutical market is expected to reach US$ 1,456.74 million by 2027 from US$ 702.06 million in 2019; it is estimated to grow at a CAGR of 9.7% from 2020 to 2027. The report highlights the trends prevalent in the global lyophilization service for biopharmaceuticals market, and the drivers and deterrents pertaining to its growth.

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.

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Lyophilization Services for Biopharmaceuticals Market Competitive Landscape and Key Development

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 growth of the 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. On the other hand, the demerits associated with lyophilization process such as leakage during filling, are the major factors hindering the market growth.

Rapid Growth in Contract Manufacturing

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.

Lyophilization Services for Biopharmaceuticals Market: Segmental Overview

Based on service type, the lyophilization services for biopharmaceuticals market is segmented into product and cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. The commercial manufacturing segment held the largest share of the market in 2019. Increasing development and manufacturing of biopharmaceutical products has increased the demand of commercial lyophilization manufacturing services. As per the FDA, more than 10 novel biologics are approved annually. Lyophilization service is growing rapidly owing to the increasing demand for injectable solutions, proteins, peptides, and vaccines. However, for drug manufacturers to set up in-house lyophilization capabilities are an expensive and time-consuming process, which requires specialized equipment and expertise. In order to reduce the overall cost of the product, biopharmaceutical companies continue to outsource commercial manufacturing services from contract manufacturing organizations (CMOs). Moreover, at commercial scale, several problems may occur that can affect therapeutic capabilities of the product. Various industrial players offer commercial manufacturing services to overcome these issues, further driving the growth of the market. For instance, Piramal Pharma Solutions manufactures, supplies, and distributes commercial formulations from its facilities in the UK and India. They offer scalability services for commercial level manufacturing of a wide range of pharmaceutical products.

Based on end user, the lyophilization services for biopharmaceuticals market is segmented into pharmaceutical and biotechnology companies, research institutes, and other end users. The pharmaceutical and biotechnology companies segment held the largest share of the market in 2019. At present, the global biopharmaceutical portfolio reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise in treatment methods for various orphan diseases. These trends have given rise to biopharmaceutical products with limited production runs, specific manufacturing requirements, and genotype-specific products. This fundamental shift in the overall product mix and a focus on improving the efficiency and effectiveness of production is spurring an evolution in the technologies and processes that is required to support advanced biopharmaceutical manufacturing. However, the research institutes segment is anticipated to witness a significant growth rate during the forecast period.

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