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Lyophilization Equipment Market – By Product, By Scale of Operation, By Application, By Industry, Global Forecast, 2024 – 2032.

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Lyophilization Equipment Market Size

The global lyophilization equipment market size was valued at around USD 6.4 billion in 2023 and is estimated to grow at 8.7% CAGR from 2024 to 2032. Lyophilization equipment denotes devices used in the process of lyophilization which involves freeze drying. This equipment gets done by withdrawing moisture from perishable products such as drugs, biological as well as food material by first freezing it and then lowering the pressure around the frozen substance with the help of the lyophilization machine which allows the ice present to vaporize directly from a solid state to a gaseous form.
 

Lyophilization Equipment Market

The rising demand for lyophilized products is a key driver of market growth, fueled by the rising prevalence of chronic conditions are the major factors boosting the market growth. With increasing number of people suffering from conditions including diabetes and cardiovascular diseases, the expansion of the lyophilization equipment market seems to be on the rise. Cardiovascular diseases lead the NCDs and account for 17.9 million deaths every year, followed by 9.3 million cancer deaths, 4.1 million chronic respiratory diseases, and 2 million deaths as a result of diabetes-linked conditions such as kidney disease. The rising number of cases worldwide has increased the need for humid and heat resistant pharmaceuticals making the equipment more needed.
 

Moreover, the increasing global need for freeze dryers substantiates its significance in the biopharmaceutical sector, along with the growing emphasis on pharmaceutical and food industries coupled with the increasing manufacturer's focus on developing products with longer stability.
 

Lyophilization Equipment Market Trends

  • The ongoing profitability associated with lyophilization, coupled with vertical growth witnessed within this market, as well as technological advancements, there is a considerable forecasted demand to expand on the lyophilization equipment sector.
     
  •  Lyophilization is one of the methods used to remove water from the products in order to retain stability and allow for storage at room temperatures.
     
  •    Many innovations aiming at increasing scalability and quality have been made in this area, and they have transformation capabilities that enable firms to save on both processing periods and equipment expenses, hence enhancing overall efficacy.
     
  •   Lyoguard trays, a remarkable modern invention, play an important role in the handling of sensitive items during freeze-drying. They assist in optimizing the moisture removal conditions by facilitating equal temperature distribution which leads to uniform lyophilization in all the samples. The consistency is particularly important in the pharmaceutical and biopharmaceutical industries, where the integrity of the product must be preserved.
     
  •  In addition, GORE Lyoguard Freeze-Drying Trays are a more recent invention that make use of ePTFE membrane technology. This guarantees that liquid, or lyophilized active pharmaceutical ingredients (APIs) are sufficiently shielded during freeze-drying. The combination of lidding with advanced materials and newly designed trays enhances the trays' structure durability and its thermal conductivity and minimizes the risk of contamination.
     

Lyophilization Equipment Market Analysis

Lyophilization Equipment Market, By Product, 2021 – 2032 (USD Billion)

Based on product, the market is segmented into devices and consumables. The devices segment is bifurcated into tray-style freeze dryers, manifold freeze dryers, and rotary freeze dryers. Further, the consumables segment is segmented into lyoguard trays, manifolds and vial holders/adapters, vacuum pumps, product sensors and temperature probes, pouches, and other consumables. The devices segment dominated the market with the largest revenue of USD 3.4 billion in 2023 and is expected to grow at a significant CAGR over the forecast period.
 

  • A key advantage of lyophilization devices is their potential to largely increase the lifetime of products. Lyophilization allows the development of stable products for extended periods of time by preventing microbial growth and chemical reactions that depend on water, which is almost fully removed from materials during this process. This is particularly necessary for pharmaceuticals and biologics because a drug must be stable for it to be stored and used for an extended period of time without any degradation.

     
  • The devices enable sensitive materials that are at risk of structurally losing their potency or effectiveness to stay intact. Many biologically active materials such as proteins and vaccines are rendered unstable due to the use of heat or chemicals in routine drying techniques.
     
  • Freeze-drying does not involve excessive temperatures which would otherwise deteriorate the quality and bioactivity of the products. For instance, in the case of food, flavors, nutrients, and colors are increased in potency when employed alongside freeze-drying as opposed to other methods.
     
  • Aside from this, lyophilization devices help increase product safety by minimizing the water content as it's the main source for bacterial growth, thus lowering the risk of contamination. When moisture content is reduced to a minimum then the chances of microbial contamination are also reduced significantly, making the products safer. This is especially important when drugs and other pharmaceutical products are manufactured as sterility and control of contamination are key requirements by regulatory bodies and ensure patient safety.
     
 Lyophilization Equipment Market, By Scale of Operation (2023)

Based on scale of operation, the lyophilization equipment market is segmented into bench-top lyophilization equipment, pilot-scale lyophilization equipment, and industrial scale lyophilization equipment. The bench-top lyophilization equipment segment of the market, which held a 49.7% share in 2023, is poised for substantial growth in the coming years.
 

  • Pharmaceutical/biopharmaceutical industries require high-quality standards and as such bench-top lyophilizers are gaining traction as they increase quality control in the freeze-drying process duringthe lyophilization process.
     
  • Rising trends in personalized medicine also demand changeable solutions, which bench-top lyophilizers provide them by accommodating customized production processes.
     
  • Thus, aforementioned factors are propelling the market growth.
     

Based on application, the lyophilization equipment market is segmented into autoimmune diseases, respiratory diseases, gastrointestinal disorders, oncology, cardiovascular diseases, infectious diseases, metabolic disorders, and other applications. The autoimmune diseases segment is anticipated to reach USD 985.6 million by 2032, driven by the significant growth in the global healthcare landscape.
 

  • Some of the products which are highly sensitive such as monoclonal antibodies and proteins and many other biologics usually use lyophilization to prolong the shelf life and stability of the product. Lyophilization equipment comes in handy when one is developing and producing therapies for auto immune diseases since the immune system mistakes and assaults the body shafts requiring sensitive biologics.
     
  • The statistics provided by NIH MedicinePlus indicates that there are approximately eighty autoimmune diseases which combined affect over twenty three million people in the U.S. The growth in the number of biologic treatments for autoimmune diseases has increased the need for more advanced biologic therapies and this in turn calls for more lyophilization equipment to be manufactured to increase stability of the treatment.
     
  • The increase in the number of biologic drugs that the Food and Drug Administration approved in 2022 emphasizes how important lyophilization technology has become in formulating and producing more stable and harder to destroy biologics in the future which will accelerate the expansion of the biopharmaceutical industry. For instance, the US FDA reviewed and authorized thirty-seven biologic drugs in 2022 which was a big swings in comparison to the previous years.
     

Based on industry, the lyophilization equipment market is segmented into pharmaceutical, biotechnology, biomedical, food processing, and other industries. The pharmaceutical segment is anticipated to reach USD 2.7 billion by 2032, driven by the significant growth in the global healthcare landscape.
 

  • Lyophilization equipment technology works by removing moisture from pharmaceutical products utilizing a two-phase procedure where the product is first frozen, and then the ambient environment pressure is lowered which enables the ice to turn straight from solid to gaseous form. Lyophilization helps to maintain the stability and efficacy of many sensitive items, such as biologics, vaccines, and injectable medications, while also extending their shelf life.
     
  • There is a rising demand for advanced lyophilization devices due to the rise in development of biologic drugs that are typically sensitive to temperature and humidity and require advanced preservation techniques which makes effective lyophilization increasing out in the buzz within the pharmaceuticals sector.
     
  • The FDA and EMA are among the regulatory authorities that have laid out rules controlling the manufacture and storage of pharmaceutical products. This has led to a high increase in the demand for lyophilization equipment that provides a guaranteed standard particularly for aseptic and sterile processes.
     
  • In addition, novel developments of lyophilization techniques have captured the attention of drug manufacturers who wish to improve their manufacturing procedures. Loading systems, complex control and monitoring software, and the ability to view and interpret performance metrics are some of the improvements made within this area as well.
     
North America Lyophilization Equipment Market, 2021 – 2032 (USD Billion)

The North America lyophilization equipment market is forecasted to reach USD 4.4 billion by 2032. The U.S. dominated the North American market with the largest revenue of USD 1.9 billion in 2023.
 

  • The rising prevalence of chronic diseases such as diabetes, cancer and autoimmune diseases the demand for effective treatment has increased, for example, the center for disease control and prevention which shows around 30 million American citizen have diabetes as at year 2021 which also indicates the need for lyophilization which is needed for a number of therapies in order to retain efficacy and stability for such diseases.
     
  • The U.S. also have potentially active biopharma that has been gaining attraction for investment in biologics, vaccines and gene therapy. U.S. FDA indicates the number of biologics approved increased from 48 in 2019 to more than 53 in 2020 underlining an increasing market for lyophilization equipment used in increasing shelf life and stability of the product.
     
  • Therefore, the aforementioned factors are expected to significantly boost the growth of the segment over the forecast period.
     

The lyophilization equipment market in the UK is expected to experience significant and promising growth from 2024 to 2032.
 

  • The pharmaceutical and biotechnology industries in the UK have stringent rules and regulations that must be complied with and also high standards of quality ensuring a good potential market for lyophilization equipment. Authorities such as the Medicines and Healthcare Products Regulatory Agency (MHRA) guarantee that the entire pharmaceutical cycle, including the use of freeze dryers, is compliant with the stringent requirements of the core Aim of the country, thus ensuring a good position in the market for freeze dryer equipment.
     
  • There is a strong demand for advanced lyophilization equipment in the UK which is attributable to its well-established industry of biopharmaceuticals and life sciences.
     
  • The British pharmaceutical industry, its scientific research and development facilities, demand from ever new enhancements of medicines, biologics, vaccines and many others, all contribute to an ideal environment for lyophilization equipment producers The reason is simple, freeze drying is essential for the stabilization of heat sensitive biological products.
     

Japan lyophilization equipment market is anticipated to witness lucrative growth between 2024 and 2032.
 

  • Japan is famous for its precision engineering and well-developed manufacturing services. With a well-established industrial sector that specializes in fabricating specialized and niche types of machines, Japan is in a strong position to produce high end lyophilization equipment.
     
  • Japanese companies achieve competitiveness by forming synergy with international firms, which allows them to acquire new knowledge and enter new markets. These alliances may assist in enhancing the global competitiveness of Japanese lyophilization equipment. Saudi Arabia is also tightly integrated into the fast-growing Middle Eastern lukewarm market.
     

The lyophilization equipment market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.
 

  • Saudi Vision 2030, the Kingdom aims to restructure its economy by making investment in non-oil-related sectors such as healthcare, pharmaceutical, and biotechnological industries. In line with this, Saudi Arabia is promoting the development of its own pharmaceutical manufacturing industry, consequently creating additional markets for sophisticated lyophilization equipment.
     
  • The Israeli FDA, in response, has issued rules and regulations that encourage the safety and quality of medicine. It is necessary to comply with the rules and regulations set by the SFDA, hence such has created the need for cutting edge lyophilization equipment.
     

Lyophilization Equipment Market Share

The market for lyophilization equipment is regarded as fierce owing to competition from both larger international companies and small to medium size enterprises alike. Key to formulating a good strategy in the market is regular development of new technologies such as modernized energy efficient freeze dryers and new process control features. Key players in the industry play a pivotal role as they tend to facilitate major investments into research and development and drive the industry. Furthermore, market consolidation and expansion activities such as mergers, acquisitions and strategic partnerships are important in realigning to changing regulatory environments while focusing on processes and even sustainability and quality of the products still maintain the industry competitiveness.
 

Lyophilization Equipment Market Companies

Some of the eminent market participants operating in the lyophilization equipment industry include:

  • ATS Corporation
  • Azbil Corporation
  • Buchi
  • Cuddon
  • GEA Group Aktiengesellschaft
  • HOF Sonderanlagenbau
  • IlShin BioBase
  • Labconco Corporation
  • MechaTech Systems
  • Millrock Technology
  • Optima
  • W. L. Gore & Associates
  • ZIRBUS technology
     
  • GEA Group provides fully automated and energy efficient freeze-drying machines perfect for large scale pharmaceutical production with guaranteed high quality process performance.
     
  • Optima offers a wide range of advanced lyophilization systems which are capable of being integrated to filling and packaging lines which provides a complete solution for pharmaceutical and biotechnological needs.
     
  • Azbil Corporation is able to provide modern lyophilization equipment that is able to maintain the highest levels of quality and dependability through advanced temperature and pressure control.
     

Lyophilization Equipment Industry News:

  • In May 2024, Millrock Technology announced a strategic collaboration with LyoWave to incorporate LyoWave’s system into both existing and new freeze dryers, starting with the REVO Research and Development Freeze Dryer. This partnership enhanced Millrock’s offering by integrating advanced freeze-drying technology, further strengthening their position in delivering innovative solutions to the pharmaceutical and biotech sectors.
     
  • In June 2021, SP Industries, Inc. a subsidiary of ATS Corporation, launched the SP Hull LyoStar 4.0 R&D and process development freeze dryer, designed for faster operations in food and beverage and biopharmaceutical applications. This product launch further strengthened the company's portfolio.
     

The lyophilization equipment market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

Market, By Product

  • Devices
    • Tray-style freeze dryers
    • Manifold freeze dryers       
    • Rotary freeze dryers
  • Consumables
    • Lyoguard trays
    • Manifolds and vial holders/adapters
    • Vacuum pumps       
    • Product sensors and temperature probes
    • Pouches
      • Polyethylene terephthalate (PET)  
      • Polyethylene(PE)
      • Foil
    • Other consumables

Market, By Scale of Operation

  • Bench-top lyophilization equipment         
  • Pilot-scale lyophilization equipment         
  • Industrial scale lyophilization equipment

Market, By Application

  • Autoimmune diseases
  • Respiratory diseases
  • Gastrointestinal disorders
  • Oncology
  • Cardiovascular diseases
  • Infectious diseases  
  • Metabolic disorders  
  • Other applications    

Market, By Industry

  • Pharmaceutical
  • Biotechnology
  • Biomedical
  • Food processing
  • Other industries       

The above information is provided for the following regions and countries:

  • North America 
    • U.S.
    • Canada
  • Europe 
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Netherlands
  • Asia Pacific 
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America 
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa 
    • South Africa
    • Saudi Arabia
    • UAE

 

Authors: Mariam Faizullabhoy , Gauri Wani
Frequently Asked Question(FAQ) :
What is the size of the North America lyophilization equipment market?
North American lyophilization equipment industry is forecasted to reach USD 4.4 billion by 2032, with the U.S. leading the region with a revenue of USD 1.9 billion in 2023, driven by the high prevalence of chronic diseases requiring stable therapeutic solutions.
Who are some of the prominent players in the lyophilization equipment industry?
Why is the use of lyophilization devices rising?
How big is the lyophilization equipment market?
Lyophilization Equipment Market Scope
  • Lyophilization Equipment Market Size
  • Lyophilization Equipment Market Trends
  • Lyophilization Equipment Market Analysis
  • Lyophilization Equipment Market Share
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    Base Year: 2023

    Companies covered: 13

    Tables & Figures: 49

    Countries covered: 22

    Pages: 135

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