Freeze-Drying/Lyophilization Market Is Projected to Expand At A CAGR Of 8.5% Between 2024 And 2032

21 Mar 2023

The global freeze-drying market is anticipated to expand at a CAGR of 8.5% between 2024 and 2032. Increasing demand for food preservation, rapid growth in contract manufacturing and lyophilization services worldwide, rising demand for lyophilized products (especially for the production of new biologic drugs and injectable formulations), and technological advancements in lyophilization methods are the major factors driving the growth of this market. On the other hand, the increasing use of alternative drying techniques in the pharmaceutical and biotechnology industries and failure to meet cGMP regulatory guidelines established by regulatory bodies (resulting in recalls of lyophilized products) are expected to restrain the growth of this market during the forecast period.

Various foods, including fruits and vegetables, meat, fish, herbs and culinary flavorings, ice creams, and coffee, are preserved using lyophilization equipment. By adding water, freeze-dried meals can be reconstituted without refrigeration or chemical preservation quickly and easily. Another important advantage of freeze-drying food is its ability to produce clean, full, nutrient-rich food ingredients with a very long shelf life (making food products versatile and accessible). Astronauts and military personnel increasingly utilize freeze-dried foods due to the limitations of conventional drying procedures. High temperatures, for instance, can cause chemical or physical changes in food products, and their overall quality is lower than that of freeze-dried items. In view of these advantages, the global use of freeze-drying as a food preservation technique is increasing.

Lyophilization is an expensive process with high operational costs, high energy consumption, high capital costs, and a lengthy processing time. Due to the capital-intensive nature of lyophilization systems, businesses in the food, pharmaceutical, and biotechnology industries are focusing on alternative drying techniques to reduce the overall cost of their products without compromising quality. Spray drying has been recognized as the most effective alternative to freeze-drying. It is a one-step method for drying chemicals with increased scalability and reduced equipment, facility, and utility costs. Moreover, spray drying's drying cycle time is significantly shorter than lyophilization's, which reduces companies' operational costs. Precipitation, vacuum-microwave dehydration, vacuum foam drying, use of glycerol, and atmospheric freeze-drying are other alternatives to lyophilization. The advent of these low-cost alternative methods impedes industry growth. However, lyophilization is the only method that can provide stable, physiologically active products with a long shelf life.

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One of the major contributors to the expansion of the freeze-drying market in the healthcare industry is the market for biologics. Biosimilars are projected to contribute to the rise of the biotechnology sector in the coming decade. Several significant biologics are expected to lose patent protection in the coming years. A growing number of biosimilars are being developed and introduced to the market as a cost-effective alternative to biologic medications for chronic conditions. Expanding R&D and the development of biosimilars will drive the market for the lyophilization of biologics and biopharmaceutical products. More than thirty percent of FDA-approved parenteral medications were lyophilized in recent years. Soon, more than half of all injectable drugs will require lyophilization, which will raise the demand for lyophilization solutions in the pharmaceutical business.

Frequently, an adequate level of moisture removal is not achieved during the lyophilization process; products are contaminated due to the presence of excess moisture, which may represent considerable dangers to patients who receive these products. In addition, the removal of excess moisture might result in the loss of structural integrity and biological activity in the product. To prevent contamination of food and pharmaceutical products, it is crucial to exactly attain the required moisture level. Due to the difficulties of achieving these desired moisture levels, manufacturers have a considerable challenge in accomplishing them.

Based on the type of product, the lyophilization equipment market is divided into tray-style freeze dryers, manifold freeze dryers, and shell (rotary) freeze dryers. At 70% of the market in 2023, tray-style freeze dryers retained the largest market share. This section is also anticipated to grow at the fastest rate during the forecast period, 8.5% per year. This market's expansion is primarily attributable to the rising demand for contract manufacturing and contract lyophilization services in the pharmaceutical industry, the increasing commercialization of labile pharmaceuticals, and the rising demand for freeze-dried food products. Moreover, tray-style freeze dryers are larger than manifold and rotary freeze dryers, enabling them to dry vast numbers of products.

In 2023, industrial freeze dryers led the market and accounted for 35% of the global revenue share. Due to industrial freeze dryers, the food processing and dairy industries can preserve extremely delicate products that cannot be dried via evaporation. These enormous devices are capable of storing vast quantities of food for consistent dehydration.

Freeze drying is necessary for conserving, storing, and prolonging the shelf life of sensitive biological samples in the laboratory. Freeze drying is used to remove water from fragile biological products without affecting their chemical structure in the laboratory. This facilitates easy storage and reconstitution with water or solvents. Freeze-drying is a method of low-temperature dehydration. Throughout the bulk of processes, materials are stored at a temperature below zero. Freeze-drying has consequently less of an impact on the natural properties of the food, preserving its biological activity, vitamins, flavor, taste, and appearance. They can be swiftly and easily reconstituted by adding water or other solvents.

Due to their portability, versatility, and ease of use, it is predicted that the mobile freeze-dryer product segment will increase at a CAGR of 11.0% throughout the projection period. Freeze-drying is a method for prolonging the shelf life of perishable items by removing their water content. Freeze-drying is required for frozen water to directly transform into vapor in a material.

Based on the scale of operation, the freeze-drying market is segmented into industrial-scale lyophilization equipment, pilot-scale lyophilization equipment, and laboratory-scale lyophilization equipment. In 2023, the industrial-scale lyophilization equipment category maintained a 65 percent market share. This market segment holds a large proportion due to the superior quality provided by industrial-scale lyophilization equipment. In addition, industrial-scale lyophilization equipment can be adapted to match the requirements of a particular procedure.

In 2023, the food processing application dominated the market and accounted for 35.0% of the global revenue share. During freeze-drying, the food retains its original size and shape with minimal cell damage. As a result, shrinkage is minimized or altogether avoided, allowing the food to be stored in practically immaculate condition for a longer period of time, which will improve the product's demand in food processing applications.

The majority of the increase in surgical procedures is attributable to the aging population, the incidence of cancer, and the prevalence of chronic diseases. Due to the use of freeze-dried platelet-rich plasma (PRP) in surgical procedures, which retains PRP's efficacy and bioactivity for a longer period of time, the number of surgical procedures will increase, hence driving up the need for freeze-drying equipment. Due to the substantial usage of freeze-drying equipment to preserve biologicals such as enzymes, proteins, viruses & bacteria, and penicillin, demand for freeze-drying equipment in the pharmaceuticals industry is projected to expand at an 11.0% CAGR over the projection period. Freeze-drying can be used to dry pharmaceuticals and biologics that are fragile, unstable, or heat-sensitive without causing structural damage. In the event of emergency vaccinations and prompt injection of antibodies, freeze-dried products are simply and quickly transportable, creating market demand.

According to the Alliance for Regenerative Medicine, companies specializing in cell and gene treatments raised more than USD 23.1 billion in funding globally in 2021, an increase of about 16% over the previous year's total of USD 19.8 billion. Additionally, the government is aggressively supporting the biotechnology industry by modernizing the regulatory environment, enhancing approval and reimbursement processes, and standardizing clinical trials. During freeze-drying, the removal of aqueous and solvent solutions from biologics reduces degradation and maintains the proteins necessary for their drug delivery mechanism, hence promoting market expansion.

On the basis of accessories, the lyophilization equipment market is divided into vacuum systems, loading and unloading systems, clean-in-place (CIP) systems, drying chambers, controlling and monitoring systems, freeze-drying trays and shelves, manifolds, and other accessories. In 2023, loading & unloading systems held the greatest market share at 26.6%; this segment is also expected to increase at the quickest CAGR of 10.0% during the projected period. This segment's significant growth can be attributed to technological advancements in lyophilization equipment, reduced cycle times, greater productivity, and cGMP-compliant aseptic environments.

APAC Remains the Global Leader In 2023, Asia-Pacific held a 35% share of the market and is projected to grow at the highest CAGR over the forecast period, 10.5%. The significant part of the Asia-Pacific regional segment can be attributed to the increasing number of investments in this region, the rise in R&D spending, and the geographic growth of lyophilization equipment companies in this region. In addition, the presence of prominent competitors in the lyophilization market in the APAC region and the expansion of leading pharmaceutical companies' manufacturing facilities in this region is expected to boost the market growth in this region throughout the forecast period.

The worldwide market is highly competitive and concentrated, dominated by major corporations. In addition, businesses are investing extensively in research and development to produce innovative solutions and gain a competitive advantage. In February 2023, for instance, food maker Pol's won GEA its third contract to build and supply RAY freeze-drying equipment at the company's 4,000 square meter vegetable and fruit freeze-drying facility in Ermenek, Karaman, Turkey. This will increase the annual production of freeze-dried items from 200 tonnes to 300 tonnes. Some of the key market players are GEA Group (Germany), Azbil Corporation (Japan), Shanghai Tofflon Science Technology Co., Ltd. (China), IMA S.p.A. (Italy), SP Industries, Inc. (United States), HOF Enterprise Group (Germany), LabconcoCorporation (United States), Martin Christ Gefriertrocknungsanlagen GmbH (Germany), Millrock Technology, Inc. (United States), OPTIMA and others.

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