Rising Demand for Lyophilized Products Drives Lyophilization Services for Biopharmaceuticals Market Growth
According to our new research study on “Lyophilization Services for Biopharmaceuticals Market –Global Analysis and Forecast – by Service Type and End User,” the market is expected to reach US$ 3,586.55 million by 2028 from US$ 2,051.41 million in 2022; it is estimated to record a CAGR of 9.9% from 2023 to 2028. The report highlights the trends prevalent in the global lyophilization services for biopharmaceuticals market, and the drivers and deterrents pertaining to lyophilization services for biopharmaceuticals market growth. The market growth is mainly attributed to factors such as rising demand for lyophilized products and rapidly growing contract manufacturing and lyophilization services. However, the demerits associated with lyophilization process such as leakage during filling hinder the lyophilization services for biopharmaceuticals market growth.
Lyophilization is a freeze drying method that removes water from the material to extend its stability and shelf life. The products processed under lyophilization are frozen under high vacuum that is majorly used for application in pharmaceutical industries to manufacture high quality and affordable products. Many new parenteral products, including biotechnology-derived products, in-vitro diagnostics, and anti-infectives, are manufactured as lyophilized products. Many antibiotics such as some cephalosporins, semi-synthetic penicillin, erythromycin salts, chloramphenicol, and doxycycline are made by the lyophilization process. Low bioburden is expected when batching antibiotics formulations, which can be attained using lyophilization. Similarly, a few other dosage forms such as methylprednisolone sodium succinate, hydrocortisone sodium succinate, and many biotechnology-derived products are lyophilized.
Additionally, the number of biopharmaceuticals being developed and manufactured has increased considerably in recent years. Over ten novel biologics have been approved annually by the US Food and Drug Administration (FDA) in the last few years. According to the data published by FDA in February 2022, biologics continue to account for slightly more than 25% of all drugs accepted by the FDA. Most of these products are not stable as aqueous formulations, making it challenging to preserve them for longer durations. To achieve longer and commercially viable shelf lives, lyophilization is preferred for making dry biopharmaceutical formulations. According to the data published by Lubrizol Life Science, in October 2019, over 60% of biologics production in the market would not be possible without lyophilization, and market demand for lyophilization technology will increase due to the growing biosimilars and novel biologics development. The method proves to be beneficial when there is a stability issue while providing exact biologics dosage (for instance, very small and highly concentrated doses). Furthermore, it is suitable for biologics that are sensitive to heat, oxygen, and humidity.
Although lyophilization has been used for more than half a century in the drug product manufacturing industry owing to its ability to stabilize and extend the shelf life of pharmaceutical products, thus interest of biopharmaceutical manufacturers continues to grow, mainly due to the increasing number of biological drug developments. Drug developers are focusing on adopting lyophilization as it can extend the shelf life of small and large-molecule drugs. The prevalence of formulation stability challenges for complex APIs and biologics has resulted in the adoption of lyophilization among most pharmaceutical and biotech manufacturers.
Further, lyophilization become important in the biotech industry, as several suppliers are introducing lyo-ready or pre-lyophilized products to the marketplace. As a result, the demand for lyophilization services is growing rapidly, which is driving the lyophilization services for biopharmaceuticals market growth.
ATTWILL Medical Solutions, Axcellerate Pharma LLC, Labyrinth Biopharma LLC, Berkshire Sterile Manufacturing, PCI Pharma Services, Curia Global Inc, Emergent BioSolutions Inc., Jubilant HollisterStier LLC, Biofortuna, Lyophilization Technology Inc., and SYNERLAB GROUP are among the prominent players operating in the lyophilization services for biopharmaceuticals market. These players are focused on organic and inorganic growth strategies to sustain their position in the lyophilization services for biopharmaceuticals market. In October 2021, PCI Pharma Services (PCI) announced that they have signed a definitive agreement to acquire Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization (CDMO) headquartered in Bedford, New Hampshire, from global private equity firm Permira. The acquisition adds five FDA-approved facilities in the U.S. (New Hampshire, Wisconsin) and Europe (Spain), with a sixth expecting approval over the coming months, and three additional facilities under development, to strengthen their global 30-site network..
The report segments the global lyophilization services for biopharmaceuticals market as follows:
Based on service type, the lyophilization services for biopharmaceuticals market is segmented into lyophilization cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. By end user, the lyophilization services for biopharmaceuticals market is segmented into pharmaceutical & biotechnology companies, research institutes, and others. By geography, the Lyophilization Services for Biopharmaceuticals market is segmented into North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, and the Rest of APAC), the Middle East & Africa (Saudi Arabia, the UAE, South Africa, and the Rest of MEA), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).
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