Lyophilization Services for Biopharmaceuticals Market Research Report and Outlook by 2028

The market for lyophilization services in the biopharmaceutical sector is projected to expand from US$ 2,051.41 million in 2022 to US$ 3,586.55 million by 2028, reflecting a compound annual growth rate (CAGR) of 9.9% from 2023 to 2028.    

The growth of the lyophilization services for biopharmaceuticals market is primarily driven by the increasing demand for lyophilized products and the rapid expansion of contract manufacturing and lyophilization services globally. However, certain drawbacks associated with the lyophilization process may impede the market's growth.  

Increasing Demand for Lyophilized Products Fuels Market Expansion      

Lyophilization, commonly known as freeze-drying, is a technique that eliminates moisture from materials to enhance their stability and prolong shelf life. This process involves freezing the products under a high vacuum, making it particularly valuable in the pharmaceutical industry for producing high-quality and cost-effective products. Numerous new parenteral formulations, including those derived from biotechnology, in-vitro diagnostics, and anti-infectives, are created using lyophilization. Various antibiotics, such as certain cephalosporins, semi-synthetic penicillins, erythromycin salts, chloramphenicol, and doxycycline, are manufactured through this process. Lyophilization helps achieve low bioburden levels in antibiotic formulations, which is crucial for their efficacy. Additionally, other dosage forms like methylprednisolone sodium succinate and hydrocortisone sodium succinate, along with many biotechnology-derived products, are also lyophilized.

Moreover, the number of biopharmaceuticals being developed and produced has surged significantly in recent years. The US Food and Drug Administration (FDA) has approved over ten novel biologics annually in recent years. As reported by the FDA in February 2022, biologics now represent slightly more than 25% of all drugs approved by the FDA. Many of these products are unstable in aqueous formulations, posing challenges for long-term preservation. To ensure extended and commercially viable shelf lives, lyophilization is the preferred method for creating dry formulations of biopharmaceuticals. According to a report by Lubrizol Life Science in October 2019, more than 60% of biologics production would be unfeasible without lyophilization, and the demand for this technology is expected to rise due to the increasing development of biosimilars and novel biologics. This method is particularly advantageous for biologics that require precise dosages, especially when dealing with very small and highly concentrated doses, and is ideal for those sensitive to heat, oxygen, and humidity.

Despite being utilized for over fifty years in drug manufacturing due to its effectiveness in stabilizing and extending the shelf life of pharmaceutical products, the interest among biopharmaceutical manufacturers continues to grow, largely driven by the rising number of biological drug developments. Developers are increasingly adopting lyophilization to prolong the shelf life of both small and large-molecule drugs. The challenges associated with the stability of complex active pharmaceutical ingredients (APIs) and biologics have led to widespread adoption of lyophilization among pharmaceutical and biotech companies.

Furthermore, lyophilization has gained significance in the biotech sector, with numerous suppliers introducing lyo-ready or pre-lyophilized products into the market. Consequently, the demand for lyophilization services is experiencing rapid growth, further propelling the expansion of the lyophilization services for biopharmaceuticals market.

Market Segmentation of Lyophilization Services for Biopharmaceuticals      

The global lyophilization services for biopharmaceuticals market is categorized based on service type into commercial manufacturing, lyophilization cycle development, clinical manufacturing, and freeze-drying analytical services. In 2022, the commercial manufacturing segment held the largest market share, while the lyophilization cycle development segment is anticipated to exhibit the highest CAGR during the forecast period.

In terms of end users, the market is divided into pharmaceutical and biotechnology companies, research institutes, and others. The pharmaceutical and biotechnology companies segment dominated the market share in 2022, whereas the research institutes segment is projected to register the highest CAGR in the coming years.

Key organizations such as the World Health Organization (WHO), the Food and Drug Administration (FDA), the European Federation of Pharmaceutical Industry Associations, and the Pharmaceutical Research and Manufacturers of America are among the primary and secondary sources consulted in the preparation of the report on the lyophilization services for biopharmaceuticals market.