LYOPHILIZED DRUGS MARKET ANALYSIS

Market Concentration and Competitive Landscape

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Growing need for temperature-controlled manufacturing process

The global pharmaceutical industry has seen growing demand for drugs that need temperature-controlled manufacturing processes. Many biologic drugs and vaccines require strict temperature control during manufacturing as well as storage and distribution to maintain their efficacy and safety. Lyophilization or freeze drying has emerged as a critical process to meet this demand. Lyophilization involves freezing the drug product and then reducing the pressure to allow the frozen water in it to sublimate or transition from solid to gas. This process removes water from the product but retains its overall structure. It allows for the drugs to maintain stability without refrigeration for longer durations of time. This makes lyophilized drugs easier to distribute in regions with limited cold chain infrastructure as well as store and transport in developing countries with warmer climates. The COVID-19 pandemic has underscored the need for vaccines and biologics that have longer shelf lives and do not require constant refrigeration. According to the World Health Organization, as of September 2022, over 12 billion doses of COVID-19 vaccines had been administered globally. Ensuring efficacy of these doses during storage and distribution in diverse geographic locations worldwide was challenging. Lyophilization provided answers by producing stable vaccines like Pfizer and Moderna's MRNA shots which maintain quality unrefrigerated for months. This significantly boosted uptake in places lacking cold storage.