Global Lyophilized Drugs Market is Estimated to Witness Growth Due to Increasing Demand for Longer Shelf Life & Convenience Offered
The global Lyophilized Drugs Market is estimated to be valued at USD 340.11 Bn in 2024, exhibiting a CAGR of 8.9% over the forecast period (2024-2031). The market is witnessing an increasing demand for lyophilized drugs owing to their longer shelf life and convenience in storage and transportation. With the growing pharmaceutical industry and rising healthcare expenditures worldwide, the need for stable long-term drug formulations is also increasing.
Market Dynamics:
The global lyophilized drugs market is primarily driven by the growing demand for drugs with longer shelf life and convenience in storage and administration. Lyophilization helps extend the shelf life of drugs significantly by removing water content from formulations through freeze-drying. This prevents the growth of microorganisms and allows drugs to be stored and transported easily without refrigeration. Another key driver is the rising incidence of chronic diseases worldwide which has fueled the demand for reliable long-term medications. According to forecasts, cardiovascular diseases, cancer, respiratory diseases, and diabetes will contribute significantly to the global disease burden in the coming years. This will generate greater requirements for lyophilized drugs in therapeutic areas like oncology, infectious diseases, and endocrinology.
Market Drivers:
Growing Demand for Alternative Forms of Drug Delivery is Driving Growth in the Lyophilized Drugs Market
One of the key drivers for the global lyophilized drugs market is the growing demand for alternative forms of drug delivery. Lyophilized drugs provide an easy-to-use and stable form of drug delivery compared to traditional options like injections. As patients increasingly seek more convenient drug delivery methods, lyophilized drugs that can be reconstituted and administered orally are becoming more popular. The ease of administration of lyophilized drugs helps improve patient compliance especially for chronic therapies that require long-term use. Various pharmaceutical companies are focusing on developing lyophilized drug formulations for conditions like cancer, infectious diseases, and autoimmune disorders to benefit from this growing demand.
Increasing Research into Therapeutics Areas is Expanding the Applications of Lyophilization
Another major driver is the increasing research into new disease areas and therapeutic categories where lyophilization can be applied. Traditionally, lyophilization was mainly used for injectable biologics and vaccines due to their instability. However, as novel drug delivery approaches are explored, lyophilization is finding new applications. For instance, manufacturers are investigating lyophilized formats for oral insoluble drugs and protein therapies to overcome challenges like poor solubility and chemical instability. Several clinical trials are also evaluating lyophilized drugs for conditions like congestive heart failure and Parkinson's disease. The expansion of research into novel areas will broaden the therapeutic scope for lyophilization and support the growth of the overall lyophilized drugs market.
Stringent Regulations on Stability Testing Pose Significant Compliance Burden
One key restraint for the lyophilized drugs market is the stringent regulations imposed on stability testing during product development and marketing. Regulatory agencies like the FDA have extensive guidelines on stability testing protocols, parameters to be evaluated, and data reporting for lyophilized drug products. Obtaining regulatory approval requires companies to commit to long-term and expensive real-time and accelerated stability studies throughout the shelf life of the product. Any failure to meet the prescribed stability specifications can delay market launch or lead to withdrawal. The high compliance costs and timelines associated with stability testing regulations increase the risk and resource investment required for manufacturers. This poses a hindrance, especially for small companies and those developing therapies for niche indications.
Complex Lyophilization Process Results in High Manufacturing Costs
Another challenge faced by market participants is the complexity of the lyophilization process which leads to high manufacturing costs. The lyophilization cycle involves careful control of various process parameters like temperature, pressure, and drying time to maintain drug stability and quality. Advanced equipment like freeze dryers for primary and secondary drying also have high capital and maintenance expenses. The complexity of optimizing the lyophilization cycle and need for validations significantly elevates production costs and minimum batch sizes. This increases the entry barrier for new entrants and prohibits the commercialization of niche therapies using the lyophilization technique. The high costs associated with lyophilized drug manufacturing acts as a deterrent, especially for developing countries and resource-constrained setting.
Growth of Biologics and Cell and Gene Therapies Open New Avenues
One major opportunity area for growth is the increasing commercialization of complex biologics and cell and gene therapies. Biologics have revolutionized the treatment of various chronic diseases but require specialized delivery and storage methods. Lyophilization provides an attractive formulation approach for these temperature-sensitive, high molecular weight biologics by transforming them into stable, low-volume drug products. Emerging therapies like gene therapies also rely on advanced formulation and delivery approaches like lyophilization to maintain efficacy and safety. As biologics and novel modalities gain market traction, lyophilized drug formulations tailored to their unique requirements will see rising adoption. This presents significant untapped market potential over the forecast period.
Lyophilized Injectables Poised to Disrupt Hospitals and Healthcare Delivery
Another key opportunity lies in the development of lyophilized injectable drugs, especially for emergency care and hospital settings. Traditionally, drugs administered via injection routes require reconstitution before use, leading to drug preparation/reconstitution time and errors in busy clinical settings. However, ready-to-use lyophilized injectables eliminate the need for reconstitution and can vastly streamline drug administration workflows. This improves efficiency, patient safety, and storage/distribution logistics for emergency drugs used in operating rooms and ambulances. The push for newer hospital practices like lyophilized injectables has potential to disrupt drug procurement channels and models of healthcare delivery itself.
Link - https://www.coherentmarketinsights.com/market-insight/lyophilized-drugs-market-2930
Key Development
- In January 2023, Berkshire Sterile Manufacturing (BSM)Biotechnology company based in Massachusetts, plans to double their lyophilization capacity by adding a second lyophilizer to their fully automated, isolator-based filling line. This expansion aims to meet increasing demand, allowing them to process up to 70,000 10R vials per run to better serve client needs and patient populations.
- In July 2020, Mylan N.V. has received regulatory approval from the Drug Controller General of India (DCGI) for its remdesivir lyophilized powder for injection, 100 mg/vial, for restricted emergency use in treating severe COVID-19 cases in India. Marketed under the brand name DESREM, it will be available starting July at , significantly cheaper than in developed countries.
- In September 2021, Lonza will invest in additional drug product manufacturing capabilities in Switzerland with a new aseptic flexible filling line at its Stein facility. This line will handle liquid and lyophilized vial filling, cartridges, and pre-filled syringes, accommodating various modalities including monoclonal antibodies and gene therapy products. It will feature state-of-the-art robotic and freeze-drying technology with a sustainable air-cooling system.
Key Players: Pfizer Inc., Novartis AG, Roche Holding AG, Johnson & Johnson, Sanofi S.A., Amgen Inc., AbbVie Inc., Merck & Co., Inc., Eli Lilly and Company, AstraZeneca PLC, Bristol Myers Squibb Company, GlaxoSmithKline plc, Gilead Sciences, Inc., Biogen Inc., Teva Pharmaceutical Industries Ltd., Mylan N.V., Celgene Corporation, Novo Nordisk A/S, Vertex Pharmaceuticals Incorporated, and Takeda Pharmaceutical Company Limited.
