LYOPHILIZED DRUGS MARKET ANALYSIS

Lyophilized Drugs Market Size and Trends

The global lyophilized drugs market is estimated to be valued at USD 340.11 Bn in 2024 and is expected to reach USD 618.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 8.9% from 2024 to 2031.

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The market for lyophilized drugs is expected to witness a positive growth trend over the forecast period. Factors such as rising prevalence of chronic diseases, growing geriatric population, and increasing demand for long-term stable drugs are expected to drive the demand for lyophilized drugs during this period. This technique is widely used for the manufacturing of parenteral pharmaceuticals and biopharmaceuticals as it removes moisture completely from the product which helps in long term stability. With growing need for long term stable drug formulations for conditions such as cancer, infectious diseases, etc., the lyophilized drugs market is anticipated to grow significantly from 2024 to 2031.

Increasing adoption of lyophilization in pharmaceuticals companies

The adoption of lyophilization as a technique for drug formulation is growing rapidly among pharmaceutical companies globally. Lyophilization, also known as freeze-drying, allows for longer shelf life and more stable storage of drugs without refrigeration. This has immense benefit for drugs that need to be transported or stored in difficult geographic and climatic conditions where maintaining cold chains is a challenge. The process removes water from the frozen form of the drug product, resulting in a highly porous cake that can be reconstituted on addition of water. More pharmaceutical firms are opting for lyophilization as it helps extend the life of drugs from 2-3 years to 5 or more years. This reduces loss due to drugs expiring before use. It also ensures drugs maintain their potency even when stored at room temperature for longer durations. For example, lyophilization is extensively used for formulation of life-saving vaccines that need to be administered in remote regions with limited cold storage facilities. According to UNICEF supply data, lyophilized vaccines like those for hepatitis, rabies, and yellow fever comprised over 60% of global public health vaccine stockpile in 2021. This shows the preference for longer shelf life vaccines that lyophilization offers. The anticipated growth in biologics and monoclonal antibody drugs in the coming years will further drive the lyophilization usage. As biologics require sensitive cold chain management for stability, lyophilization alleviates such needs and eases global distribution of these drugs. It is projected that over 500 new biologic drugs will be commercialized between 2020 and 2025.

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.