The pharmaceutical and biotechnology industries are increasingly turning to alternative drying techniques. Aside from ensuring product quality and safety, freeze-drying also improves shelf-life. Lyophilization also helps improve the storage and transportation of pharmaceutical injectables. In addition to improving shelf-life, it can also improve transport and storage of pharmaceutical injectables in their original powdered forms. The demand for lyophilization equipment is expected to increase with the development of novel drugs. Major pharmaceutical companies are focusing on increasing their product manufacturing capacity, which is fuelling the demand for lyophilization. Further, the increasing demand for higher stability and shelf life will drive the market
Global Biopharmaceutical Stabilization (Lyophilization) Service 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.
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Global Biopharmaceutical Stabilization (Lyophilization) Service Market – Impact of COVID-19
Service Providers in lyophilization service markets are expected to witness an increase in demand, mostly for research and development of pandemic vaccines – or therapeutics. Many suppliers are have begun addressing this increase in demand, and expected demand by accelerating their research activities. Producers are 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, current pipelines are not expected to change in the near-term. The impact of COVID-19 on the global biopharmaceutical stabilization (lyophilization) service 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 Biopharmaceutical Stabilization (Lyophilization) Service Market – Restraints
Biopharmaceutical stabilization (Lyophilization) has few demerits as lyophilization includes heating of the product which can cause melt-back and collapse. Additionally, 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 projected to restrain the market growth.
Global Biopharmaceutical Stabilization (Lyophilization) Service Market – Regional Analysis
On the basis of region, the global biopharmaceutical stabilization (lyophilization) service market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America is expected to lead the global biopharmaceutical stabilization (lyophilization) service market and account for the largest share over the forecast period due to a growing 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 biopharmaceutical stabilization (Lyophilization) service 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 biopharmaceutical stabilization (Lyophilization) service market in Europe.
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Furthermore, the market in Asia Pacific particularly in India and China are projected to contribute significantly to the growth of the global lyophilization services market due to the increasing 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 biopharmaceutical stabilization (Lyophilization) service market in Asia Pacific.
Global Biopharmaceutical Stabilization (Lyophilization) Service Market – Competitive Landscape
Key players operating in global biopharmaceutical stabilization (Lyophilization) service 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 Biopharmaceutical Stabilization (Lyophilization) Service 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
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Table of Content
Chapter 1 Industry Overview
1.1 Definition
1.2 Assumptions
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Lyophilization Services for Biopharmaceuticals Market Size Analysis from 2021 to 2028
1.6 COVID-19 Outbreak: Lyophilization Services for Biopharmaceuticals Market Industry Impact
Chapter 2 Lyophilization Services for Biopharmaceuticals Market Competition by Types, Applications, and Top Regions and Countries
2.1 Lyophilization Services for Biopharmaceuticals Market (Volume and Value) by Type
2.3 Lyophilization Services for Biopharmaceuticals Market (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Lyophilization Services for Biopharmaceuticals Market Sales, Consumption, Export, Import by Regions
Chapter 5 North America Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 6 East Asia Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 7 Europe Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 8 South Asia Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 9 Southeast Asia Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 10 Middle East Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 11 Africa Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 12 Oceania Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 13 South America Lyophilization Services for Biopharmaceuticals Market Analysis
Chapter 14 Company Profiles and Key Figures in Lyophilization Services for Biopharmaceuticals Market Business
Chapter 15 Lyophilization Services for Biopharmaceuticals Market Forecast (2021-2028)
Chapter 16 Conclusions
Research Methodology….
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