At 10.3% CAGR, the North America Lyophilization Services for Biopharmaceuticals Market is projected to be worth US$ 1,587.77 million by 2028, says Business Market Insights

According to Business Market Insights research, the North America lyophilization services for biopharmaceuticals market was valued at US$ 974.05 million in 2023 and is expected to reach US$ 1,587.77 million by 2028, registering a CAGR of 10.3% from 2023 to 2028. Rising demand for lyophilized products and rapid growth in contract manufacturing and lyophilization services across the region are the critical factors attributed to the North America lyophilization services for biopharmaceuticals market expansion.        

The biopharmaceuticals market continues to expand across the world, which can be the primary growth driver for the pharmaceutical industry. Biopharmaceutical parenteral manufacturing has expanded recently as more therapeutic biologics have been approved. Biotechnology companies outsource from contract manufacturing organizations (CMOs) to meet their fill-and-finish needs and reduce the risk of microbial contamination. Biopharma companies are dependent on contract manufacturing organizations (CMOs) to provide capacity and capabilities as needed; in some cases, CMOs provide a great deal of a company’s production.

Setting up in-house lyophilization capabilities and operations requires specialized equipment and expertise, which is an expensive and time-consuming. However, outsourcing is cheaper and increases the efficiency of manufacturing processes. Additionally, it allows biotechnology companies to redirect resources to other areas. Thus, drug developers and biopharmaceutical companies outsource such operations to CMOs to save overall production and yield cost. A few years ago, the CMO industry was a niche service market, offering additional manufacturing capacity or specific services to biotechnology companies. Now, many biotechnology companies outsource various services, from early-stage drug development to commercial-scale manufacturing. As the biotechnology industry is shifting from large-scale production to niche and targeted therapies (personalized medicine), the demand for flexible operational capabilities, production scales, and multiple-product operations is rising. Owing to all these factors, the inclination toward CMOs is growing. One such CMO that provides specialized facilities and dedicated lines for lyophilization operations is Jubilant HollisterStier Contract Manufacturing & Services. The CMO offers sterile fill/finish of Phase I through a commercial sterile injectable and a full suite of lyophilization services. To keep up with the growing demand for its services, Jubilant is installing a new 385-square-foot lyophilizer. Thus, the rising capability and availability of biopharma CMOs fuel the North America lyophilization services for biopharmaceuticals market growth.

On the contrary, demerits associated with lyophilization process hampers the North America lyophilization services for biopharmaceuticals market.  

Based on service type, the North America lyophilization services for biopharmaceuticals market is segmented into lyophilization cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. The commercial manufacturing segment held 29.13% share of North America lyophilization services for biopharmaceuticals market in 2023, amassing US$ 283.74 million. It is projected to garner US$ 436.09 million by 2028 to expand at 9.0% CAGR during 2023–2028. 

Based on end user, the North America lyophilization services for biopharmaceuticals market is segmented into pharmaceutical & biotechnology companies, research institutes, and other. The pharmaceutical & biotechnology companies segment held 76.07% share of North America lyophilization services for biopharmaceuticals market in 2023, amassing US$ 740.96 million. It is projected to garner US$ 1,218.70 million by 2028 to expand at 10.5% CAGR during 2023–2028.

Based on country, the North America lyophilization services for biopharmaceuticals market  has been categorized into the US, Canada, and Mexico. Our regional analysis states that the US captured 79.30% share of North America lyophilization services for biopharmaceuticals market in 2023. It was assessed at US$ 772.44 million in 2023 and is likely to hit US$ 1,282.76 million by 2028, exhibiting a CAGR of 10.7% during the forecast period.      

Key players dominating the North America lyophilization services for biopharmaceuticals market are ATTWILL Medical Solutions; Axcellerate Pharma LLC; Berkshire Sterile Manufacturing; Curia Global Inc; Emergent BioSolutions Inc; Jubilant HollisterStier LLC.; Labyrinth BioPharma LLC; Lyophilization Technology, Inc.; and PCI Pharma Services, among others.   

•  In May 2022, Jubilant HollisterStier LLC has entered into a cooperative agreement for US$149.6 million with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEOCBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services.

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