Lyophilization Services for Biopharmaceuticals Market is segmented By Service Type (Product & Cycle Development, Clinical Manufacturing, Commercial Manufacturing, Freeze Drying Analytical Services), By Application (Antibiotic, Antibodies, Vaccines, Vitamins, Hormones), By End-User (Pharmaceutical & Biotechnology Companies, Research Institutes, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Market Overview
The Lyophilization Services for Biopharmaceuticals Market is estimated to reach at a high CAGR during the forecast period (2024-2031).
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.
Market Summary
| Metrics | Details |
| Market CAGR | High |
| Segments Covered | By Service Type, By Application, By End-User, and By Region |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
| Fastest Growing Region | Asia Pacific |
| Largest Market Share | North America |
For more details on this report - Request for Sample
Market Dynamics
The global lyophilization services for biopharmaceuticals market growth is driven by the rising focus on enhanced manufacturing practices are increasing the demand for lyophilization services, rising demand for lyophilized products, and rapid growth in contract manufacturing and lyophilization services worldwide.
Rapid growth in contract manufacturing and lyophilization services worldwide is expected to drive market growth
The need to prolong the shelf-life of antibiotics and protein-based drug formulations is a key trend boosting the prospect in the lyophilization services for the biopharmaceuticals market. Notably, there is a persistent need to keep the biological activity of vaccines intact and the shelf-life as high as possible. The growing uptake of these in third-world countries increases the need. Contract manufacturing organizations have also expanded their array of lyophilization services for biopharmaceuticals. This has also expanded the outlook of the lyophilization services for the biopharmaceuticals market.
In addition, technological advancements in cGMP lyophilizers have led them to assess cutting-edge lyophilizers at a cost-effective rate. The uptake in the lyophilization services for the biopharmaceuticals market has been underpinned by the rapid pace of the rising demand for biological therapies for disease therapeutics in developed and developing regions. Over the past few years, the need to improve the shelf-life and efficacy of biologics has increased in emerging markets for the biopharmaceutical industry. The drive stems from the need for novel formulations for biologics in developed countries. This has propelled the demand for lyophilization services on a contract basis. Automation in lyophilization has bolstered the demands for topical and injectable ophthalmics services over the past recent years.
Few challenges associated with the lyophilization process is likely to hamper the market growth
However, the market is likely to hinder due to the challenges associated with the lyophilization process, such as leakage during filling; the lyophilization process requires placing material in reusable containers, which require rigorous cleaning before the next batch is added. But, despite new technologies, equipment and instrumentation, such as condensers that can handle high-vapour loads, lyophilization remains time-consuming and, as such, a costly process for developing APIs and medical polymers. Hence, these factors are likely to restrain the market growth.
COVID-19 Impact Analysis
With the outbreak of COVID-19, the healthcare sector is adopting new technology that can help hospitals overcome the current pandemic and future medical emergencies. Owing to the growing adoption of new tools and technologies, the global Lyophilization Services for Biopharmaceuticals market is projected to grow substantially during the coming years. COVID-19 has become a global pandemic and consumed more than a million lives. This has stimulated healthcare companies are developing innovative tools and technologies that can help doctors and medical officers to overcome present and future medical emergencies. For instance, In February 2021, Rentschler Biopharma; Germany-based contract development and manufacturing organization (CDMO) announced to start commercial manufacture, formulation, and downstream processing of CVnCoV COVID-19 candidate vaccine by CureVac. Similarly, Bayer also announced to manufacture 160 million doses of CVnCoV in 2022. Owing to this, the global Lyophilization Services for Biopharmaceuticals market is projected to grow exponentially in the coming years.
Market Segment Analysis
The freeze-drying analytical services segment is expected to hold the largest share in this market segment
Lyophilization services preserve various food products, such as fruits and vegetables, meat, fish, herbs and food flavorings, ice creams, and coffee. Freeze-dried foods do not need to be refrigerated or preserved with chemicals and can be reconstituted quickly and easily by adding water. Another major advantage of freeze-drying services is their ability to produce clean, whole, and nutritious food ingredients with a highly prolonged shelf life (making food products versatile and accessible).
The use of freeze-dried foods is increasing for astronauts and military personnel, as conventional drying methods have major disadvantages. For instance, high temperatures can cause chemical or physical changes in food products, and their overall quality is not on par with freeze-dried food products. Considering these advantages, the use of freeze-drying analytical services as a food preservation technique is increasing across the globe.
Market Geographical Share
North America region holds the largest market share of global lyophilization services for the biopharmaceuticals market
North America is projected to dominate the global lyophilization services for biopharmaceuticals market and accounts for the largest share during the forecast period owing to an increasing number of strategic mergers and acquisitions among players regarding biopharmaceutical stabilization. For instance, in recent times, many players have leveraged the potential of partnership to expand their new fill and finish equipment for sterile processing packaging. A case in point is West Pharmaceutical Services, Inc., a company that says it pioneers in injectable drug administration solutions, entering into a partnership with SCHOTT. The agreement will combine the Ready Pack system of the former with the glass vials platform of the later, notably its high-quality RTU glass vials. Numerous such players are aiming to meet the customization needs through partnerships. Key players in the North American lyophilization service markets are Anteco Pharma LLC, Axcellerate Pharma LLC, Berkshire Sterile Manufacturing, Inc., Jubilant HollisterStier LLC, Lyophilization Technology, Inc. (LTI). These factors are propelling the growth of the lyophilization services for the biopharmaceuticals market in North America.
Market Competitive Landscape
The global lyophilization services for the biopharmaceuticals market is highly competitive with the presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include ATTWILL Medical Solutions; Axcellerate Pharma LLC.; AB BioTechnologies, Inc.; Berkshire Sterile Manufacturing, Inc.; Emergent BioSolutions; LSNE Contract Manufacturing; Lyophilization Technology, Inc.; Jubilant HollisterStier LLC; Biofortuna Ltd; and GILYOS GmbH. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, In February 2020, Grand River Aseptic Manufacturing (GRAM), a contract development and manufacturing organization, completed its US$60 million expansion project and recently took occupancy with the opening of its large-scale fill/finish facility with this expansion.
Key Companies to Watch
Biofortuna Ltd
Overview: Biofortuna is a specialist contract development and manufacturing organisation providing Genomic services, custom development and manufacturing support. Its service portfolio includes custom development, laboratory services, freeze-drying (lyophilisation), contract manufacturing and dispensing and kitting.
Product Portfolio: It provides products like SSPGo HLA typing Freeze-Drying- SSPGo is the ONLY single step ‘off the shelf’ SSP solution. The world’s first freeze-dried (lyophilised) HLA SSP delivers unique simplicity, accuracy and ease of use.
Key Developments: In June 2020, Biofortuna has provided assay development and manufacturing support to QuantuMDx Group Limited to assist in the manufacturing scale-up, regulatory approval and launch of their rapid, sensitive SARS-CoV-2 test.
