Biopharmaceutical stabilization or lyophilisation or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid form to vapour form without passing through liquid state. The process consists of three separate, unique, and different phases; freezing, primary drying (sublimation), and secondary drying (desorption).

Lyophilization is an advanced technique and is useful in various pharmaceutical sectors. Some advantages of lyophilization are enhanced stability of powders, removal of water without excess heating of product, enhanced product stability in dry state, easy processing of liquid which ensures easy aseptic handling. Some of major disadvantages are higher handling and time and need for sterile diluents for reconstitution and high cost.

Global Lyophilization Services For Biopharmaceuticals Market – Drivers

Applications of biopharmaceutical stabilisation have impacted the pharmaceutical and bio-pharmaceutical market owing to the former’s stability characteristics and effective procedures. For instance, in 2015, Stirling, U.K – STERILE manufacturing specialist and symbiosis pharmaceutical service, unveiled a new bulk lyophilization (freeze drying) service. The Scotland-based contract manufacturing organisation (CMO) is supporting clients in the U.S., Europe, and Asia to assist with the manufacture of bulk intermediates and APIs by lyophilization. Moreover, in April 2018, Lyophilization Service of New England (LSNE) acquired an aseptic fill/finish manufacturing facility of PSC Biotech Pomona, U.S. This acquisition has helped the expansion of manufacturing capacity and services of the organization. Biopharmaceutical stabilisation (lyophilisation) used in pharmaceutical injectable products, vaccines, antibodies, and food products provide parallel growth to the lyophilisation services market which is involved in lyophilizing the products. Lyophilization service can protect the biological activity, extend the shelf life of drugs and increase the dosing precision for each product. These factors are expected to drive global biopharmaceutical stabilization market growth during the forecast period.

Global Lyophilization Services For Biopharmaceuticals Market – Impact of COVID-19

Service Providers in lyophilization service markets are expected to see witness an increase in demand , mostly for research and development of pandemic vaccines - or therapeutics. Many suppliers are have begun to addressing this increase in demand, and projected demand by accelerating their research activities . Manufacturers are expected to keep focusing on existing pipeline projects in addition to adding more pandemic- and infectious disease-related drugs and therapies related to pandemic and infectious disease in R&D. So Therefore, current pipelines are not expected to change in the near-term. The impact of COVID-19 on the global Lyophilization Services For Biopharmaceuticals Market has affected every market around the globe in a negative way. As the world is still struggling to recover from the COVID-19 situation it may take a long time in recovery of global biopharmaceutical stabilization market.

Global Lyophilization Services For Biopharmaceuticals Market – Restraints

Biopharmaceutical stabilization (Lyophilization) has few demerits as lyophilization includes heating of the product which can cause melt-back and collapse. Moreover, freezing of products is a process in lyophilisation where some microbes have the ability to sustain cold temperature which can cause contamination of products. Moreover, factors such as vapour choking and instability in form of freeze dried cakes is expected to restrain the market growth.

Global Lyophilization Services For Biopharmaceuticals Market – Regional Analysis

On the basis of region, the global Lyophilization Services For Biopharmaceuticals Market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is projected to dominate the global Lyophilization Services For Biopharmaceuticals Market and account for the largest share during forecast period owing to an increasing number of strategic mergers and acquisitions among players with regards to biopharmaceutical stabilization. For instance, in 2012, Anteco Pharma is a leader in lyophilization and freeze drying solutions for the specialty food, pharmaceutical industry, expanded its territory through a 25,000-square-foot addition to its manufacturing facility in Lodi, Wis, U.S This expansion is focused on manufacture of pharmaceutical and medical devices. Key players in the North America lyophilisation 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 Lyophilization Services For Biopharmaceuticals Market in North America.

Moreover, Key players in the Europe lyophilisation service market are GILYOS GmbH, Lyophilization Services of New England, Inc., and others. Europe is projected to witness sustainable growth in the global biopharmaceutical stabilisation (lyophilisation) service market during the forecast period. For instance, in February 2020, Lyophilization Services of New England (LSNE) Contract Manufacturing, a contract development and manufacturing organization, expanded its company through a 26,000 square foot addition to its existing seven commerce facilities in Bedford, New Hampshire campus, U.S. This expansion has further increased LSNE's commercial drug product manufacturing capacity. The addition will feature a high-speed six head Bausch+Ströbel aseptic vial filling line, Ziel isolator, and multiple large-scale commercial freeze-dryers with automated loading/unloading. These factors are propelling the growth of Lyophilization Services For Biopharmaceuticals Market in Europe.

Furthermore, the market in Asia Pacific particularly in India and China are expected to contribute significantly to the growth of the global lyophilization services market due to the growing number of contract manufacturing units. Countries such as India, China, and South Korea are two of the biggest countries operating in the market with high expectancy to dominate biopharmaceutical stabilization market in Asia pacific. For instance, in South Korea according to Korea Biomedical Review in 2020, Samsung Biologics said that it has signed a letter of intent for a contract manufacturing organization (CMO) deal worth 381 billion won (US$317.1 million) with a European client. The company said it would disclose its European client's name after Dec. 31, 2023, due to confidentiality reasons. Samsung Biologics plans to produce the client’s biopharmaceutical products at its third plant in Songdo, an international business zone in the western port city of Incheon, South Korea. Key players in Asia Pacific are Piramal Pharma Solutions Inc. and Dr Reddy's Laboratories. These factors are propelling the growth of the Lyophilization Services For Biopharmaceuticals Market in Asia Pacific.

Global Lyophilization Services For Biopharmaceuticals Market – Competitive Landscape

Key players operating in global Lyophilization Services For Biopharmaceuticals Market are CNS Pharmaceuticals, Jubilant HollisterStier LLC, Lyophilization Technology, Inc. (LTI), GILYOS GmbH, Lyophilization Services of New England, Inc., Piramal Pharma Solutions Inc., Symbiosis Pharmaceutical Services, Millrock Technology, Inc., Goodwin Biotechnology Inc., Celsus Laboratories Inc. and MME Group Inc.

Key Developments –

In 2015, Stirling, UK – STERILE manufacturing specialist and Symbiosis Pharmaceutical Service, unveiled a new bulk lyophilisation (freeze drying) service. The Scotland-based contract manufacturing organisation, is supporting clients in the U.S., Europe, and Asia to assist with the manufacture of bulk intermediates and APIs by lyophilisation.
In 2019, Lyophilization Services of New England (LSNE), a leading contract development and manufacturing organization (CDMO), announced the acquisition of a sterile injectables manufacturing facility located in León, Spain. The site, LSNE-León, will complement LSNE's existing full-service manufacturing capabilities and expand its presence into Europe.
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

Global Lyophilization Services For Biopharmaceuticals Market – Taxonomy

By Service

Cycle development
Aseptic filling

By Application

Antibiotic
Antibodies
Vaccines
Vitamins
Hormones

By End User

Pharmaceutical Companies
Research Laboratories
Others

By Region

North America
Latin America
Europe
Asia Pacific
Middle East
Africa

About Author

Abhijeet Kale is a results-driven management consultant with five years of specialized experience in the biotech and clinical diagnostics sectors. With a strong background in scientific research and business strategy, Abhijeet helps organizations identify potential revenue pockets, and in turn helping clients with market entry strategies. He assists clients in developing robust strategies for navigating FDA and EMA requirements.