Lyophilization. Not easily pronounced, may be essential for biopharmaceutical products. In simple terms, it’s the scientific process of freeze-drying used to remove moisture and preserve stability of sensitive drugs. According to FDA lyophilization is defined1 as “a process that removes water from a product after it is frozen and placed under a vacuum, allowing the ice to turn directly into vapor (sublimation) without going through a liquid phase. This low-temperature dehydration process preserves the product's stability and extends its shelf life by transforming a liquid into a dry, solid form.”
According to Research and Markets2 “the global freeze-drying/lyophilization (equipment) market grew from $7.1 billion in 2024 to $7.9 billion in 2025. Demonstrating healthy expansion, the sector is projected to sustain a CAGR of 10.8%, ultimately reaching an estimated $16.2 billion by 2032.”
Benefits of Lyophilization
- Improved stability and purity
- Longer product shelf life
- Long term storage and shipping savings
While lyophilization can be a complicated process, it has become a regular practice in many industries, including medical (pharmaceutical, biotechnology) and agriculture. Lyophilization offers several advantages, from improved drug product stability and purity to increased shelf life and reduced costs. For example, lyophilized powders can be easily stored at room temperatures or in 4°C refrigerators, reducing the need for expensive -80°C freezers.
In addition to an increased shelf life, lyophilized drug products have reduced weight and volume. This helps to reduce shipping costs and the environmental impact of other bulky storage systems. Costs are also reduced due because lyophilized drug products do not need the expensive shipping procedures designed to maintain sample stability, such as dry ice.
Because lyophilization does not need heat for the dehydration process, It provides a suitable and safe method for long-term storage of pharmaceutical products while preserving the critical characteristics of product.
Examples of lyophilized product types
- Antibiotics: Certain antibiotics degrade quickly when in solution, they are often lyophilized to improve stability and solubility.
- Biologics: Monoclonal Antibodies, peptides and proteins are easily prompt to degradation and molecular changes in liquid form, many are usually lyophilized to better preserve their biological activity.
- Enzymes: Similar to antibodies, enzymes can be lyophilized to ensure long-term stability.
- Hormones: Large, protein-based molecules are lyophilized to improve shelf life while maintaining efficacy.
- Vaccines: Some biological components in vaccines are highly sensitive to heat. Because vaccines often need to remain stable during storage and transport, especially in remote locations, they are frequently lyophilized to preserve their potency and extend shelf life.
Industry trends
According to the LyoHUB 2025 Annual report3:
- Twenty-seven lyophilized drugs were approved by the US FDA in 2024 submitted by a total of 22 pharmaceutical companies.
- Among these approvals, oncology emerged as the dominant category by indication, accounting for 40% of the total approved drugs. Infectious diseases represented the second largest category, comprising 18% of the approvals and Immune system approvals account for 15%. The remaining categories—including diagnostic, surgical, pulmonary, metabolic, renal, and neurology rounded out the approvals.
- Of the approvals in 2024, 23% were biologics, 12% were NDA, and 65% were generic.
- In the past 10 years, as many as 50 approvals have been registered annually for lyophilized products.
- Since 1954, 674 lyophilized products have been approved by FDA with a substantial growth in the past 10 years. While this can be traced to advancements in lyophilization technology, it’s also a nod to the number of novel, temperature labile drug molecules, such as biologics, reaching the market.
What should you look for in a lyophilization CDMO?
When it comes to partnering with a CDMO for your lyophilization needs, you need capacity, redundancy, and expertise. That’s where Pyramid Pharma Services comes in.
- In our industry “getting the slot” is half the battle or more. Partnering with a CDMO to ensure they have capacity when you need it is critical to meeting your timelines and financial commitments.
- Not often talked about, but unpredicted downtime is a real risk. Pyramid has redundant systems ready to kick in should the need arise, thus mitigating potential timeline risks for the sponsor.
- Expertise and experience. Pyramid Pharma Services has been providing lyophilization services to the biopharma industry for more than 25 years. Tap into their expertise for product development and commercialization needs.
- US-based (a bonus benefit). With tariff uncertainties and a move to reshoring in the US, turn to a CDMO that is based in the US and reduce geopolitical risks.
Lyophilization FAQs
- Are lyophilized products on the rise?
Yes, absolutely. The number of lyophilized drug products continues to grow across the pharmaceutical and biotech industry.
- Do multiple product types benefit from lyophilization process?
Yes, a wide category of molecules, from small peptides to complex biologics and vaccines, can be effectively lyophilized, extending their stability profile.
- Should lyophilization be part of your product development or commercialization strategy?
Yes, most definitely be considered early in the development of your product. Lyophilization can enhance product stability, extend shelf life, and improve overall supply chain.
Sources:
1 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/lyophilization-parenteral-793#
2 https://www.researchandmarkets.com/report/freeze-drying
3 (2025), "LyoHUB 2025 Annual Report," https://pharmahub.org/resources/lyoreport2025