Rising Need for Enhanced Shelf-life and Stability of Medicinal Products to Boost Prospects of Lyophilization
Lyophilization is a freeze-drying (dehydration) process, typically used to preserve a perishable material or make the material logistically convenient. It enables extended shelf-life, often as long as 2-4 years and facilitates transportation of products stored at room temperature. Lyophilization is extensively employed by the pharmaceuticals industry to maintain stability of complex drug formulations that are not stable in liquid form. Lyophilization also enhances the stability of dry powder as well as products in a dry state. Consistently rising need for the enhanced shelf-life of vaccines, injectables, and several other drug products is fuelling the demand for lyophilization worldwide, thereby pushing the sales of lyophilization equipment. Growing applications in large-scale manufacturing, widespread use in food engineering/packaging, and pharmaceuticals production to improve product longevity will stimulate growth potential of the global lyophilization equipment market.
Growth of Biopharma and Biotechnology Industries Fuel Demand for Lyophilization Equipment
Lyophilization has been in significant use in the pharma industry, for bulk pharmaceutical/biopharmaceutical ingredients, monoclonal antibodies, protein, peptide, collagen, oligonucleotide, and enzymes. The recent industry statistics suggest that nearly 16% of the top 100 pharmaceutical drugs and around 35% of biologic drugs are lyophilized. More than 30% of the FDA-approved parenteral medicines are lyophilized and soon ~50% of injectable drugs require lyophilization. Moreover, there is robust double-digit growth in contract manufacturing organisations (CMOs) involved in biopharma segment. In recent times, substantial growth has been registered in demand for oligonucleotides and peptides, which degrade in liquid form and thus require lyophilization equipment to enhance their stability and shelf-life. Other verticals of biotechnology industry, viz. industrial biotech, food biotech, agricultural biotech, and environmental biotech are witnessing a steady growth trail, which also points to the subsequent demand growth in the lyophilization equipment market in future.
Technological Advancements Play out as a Key Lever for Long-term Market Growth
A modern lyophilizer consists of a separated ice condenser and drying chamber to reduce cross- contamination. Modern lyophilization equipment enable simultaneous defrosting and loading to standardise the process flow. Further sophistication with controls and monitors provides enhanced process optimization. Automation with interlocks and safety alarms, vacuum pumps, and refrigeration systems will further boost the market lyophilization equipment. However, certain limitations are needed to be addressed immediately. Termination of an unoptimised lyophilization is time-, energy-, and cost-intensive. Freeze dryer is a ~US$ 2-3 Mn investment, which makes it the most expensive operating unit in the production process. In 2019, SP Scientific launched LyoS 2.0 – a line-of-sight enabled lyophilizer control system able to control platforms from development to production units. Thus, increasing R&D in the development of novel drugs will fast-track demand for lyophilization equipment.
Lyophilized Vaccines Witness Fostering Demand amid COVID-19 Pandemic
As per experts, demand for lyophilization for monoclonal antibody therapies (mAbs), antibody-drug conjugates (ADCs) for COVID-19, and some of the raw materials used in COVID-19 vaccines is seeing a strong upsurge during the coronavirus outbreak. Existing vaccines require ultra-cold storage facilities for storage and transportation. Lyophilized vaccines thus offer advantages as they only require standard refrigeration. In April 2021, Pfizer started a clinical trial evaluating a lyophilized formulation, targeting adults (18-55 years) in the US. Russia is also exploring possibilities of primarily freeze-dried Sputnik V vaccine production. Also, with unprecedented high demand for bulk lyophilization, the COVID-19 pandemic pinpointed deficiencies with vial-based lyophilization; ~80% of the market lyophilizes in vials.
Tray Freeze Dryers Preferred During Large-scale Manufacturing
On the basis of technology, the market is segmented into tray-style freeze dryers, pilot-scale freeze dryers, and laboratory-scale freeze dryers. The tray-style freeze dryers continue to capture a major chunk of the global lyophilization equipment market valuation on the back of their wider areas of applications in the pharmaceuticals industry, and food technology sector. They also offer a higher degree of product lyophilization. Soaring demand of frozen food is expected to increase the demand for tray-style freeze dryers. On the basis of the scale of operation, the lyophilization equipment market is segmented into industrial-scale, pilot-scale, and laboratory-scale freeze dryers. Products like Freeze dryer scitek, and Sterile steam production freeze dryer Mill rock are widely used in large-scale production. Smal-scale production utilizes benchtop pro freeze dryer, freezemobile freeze dryer, and vaccum concentrator.
Key Players Ramp up Production Capacities to Meet Surging Demand
Argonaut Manufacturing Services, a molecular diagnostics and biopharma CMO, is expanding its current Good Manufacturing Practices (cGMP) facilities in the Greater San Diego area of Carlsbad, CA. LSNE Contract Manufacturing, a leading contract development and manufacturing organisation (CDMO) also expanded its vial filling and lyophilization capacity with the addition of a new automated aseptic fill line during early 2021. Some of the key companies in the global lyophilization equipment market are Azbil Corporation, Industria Macchine Automatiche S.P.A, SP Industries, Inc., GEA Group, Tofflon Science and Technology Co. Ltd., Martin Christ Gefriertrocknungsanlagen GmbH, Labconco Corporation, Hof Enterprise Group, Millrock Technology Inc., Telstar, Labconco, Scala Scientific, and Optima Packaging Group GmbH.