Lyophilization Equipment and Services Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, France, Japan - Size and Forecast 2024-2028

Lyophilization Equipment and Services Market Size 2024-2028

The  Lyophilization Equipment And Services Market size is estimated to grow by USD 2.65 billion at a CAGR of 7.92% between 2023 and 2028.  There have been several technological advances in lyophilization over the years and it has become more cost-effective, efficient, accurate, and convenient to use.  In addition, it is witnessing advances, such as modern computer/instrument control automation in viral loading. Moreover,  modern lyophilization equipment is featured with a separate drying chamber and an ice condenser to reduce cross-contamination. Refrigeration systems are properly sized and have become more reliable, and condensers are designed to handle high vapor loads effectively. Hence, such factors are positively impacting the market.

What will be the Size of the Lyophilization Equipment and Services Market During the Forecast Period?

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Market Segmentation

End-user Analysis

The pharmaceutical and biotechnology companies segment is estimated to witness significant growth during the forecast period. This segment mainly uses lyophilization technology to extend the shelf life of a wide range of biological products, including antibodies, proteins, peptides, coagulation factors, growth factors, cytokines, vaccines, nucleic acids, and antibody-drug conjugates. In addition, lyophilization plays a major role in the sterile manufacturing of injectable biopharmaceuticals as they are not as stable as aqueous formulations, making it difficult to preserve them for long durations.

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The pharmaceutical and biotechnology companies segment was the largest segment and was valued at USD 3.02 billion in 2018. Moreover, lyophilization enhances the storage stability of labile biopharmaceuticals. It enables the convenient and long-term preservation of biopharmaceuticals and their safe shipping. In addition,  lyophilization is the most common formulation strategy currently, and it is used in approximately one of every two biopharmaceutical products. Furthermore, the rapidly growing global biopharmaceutical market, the increasing research and development (R&D) of biopharmaceuticals, and the growing number of approvals for biologic products are fueling the demand for lyophilization equipment and services. Hence, such factors are fuelling the growth of this segment which in turn will drive the market growth during the forecast period.

Product Analysis

Tray-style freeze dryer

This segment comprises a large rectangular reservoir with shelves, and products can be placed in trays, vials, and other containers on these shelves. In addition, it is essentially used to lyophilize a variety of materials, such as pharmaceutical solutions, tissue extracts, and vaccines for long-term storage. Moreover, this segment is generally larger and more sophisticated than manifold freeze dryers. In addition, the main advantage of tray-style freeze dryers is that they allow products to be frozen in place and perform both primary and secondary freeze-drying, thus producing the driest possible end products. Hence, such factors are fuelling the growth of this segment which in turn will drive the market growth during the forecast period.

Manifold freeze dryer

Manifold freeze dryers comprise multiple containers, and the dried product is connected to a condenser by a sort of circular tube. In addition,  it is mainly used in laboratory settings when large amounts of materials need to be dried in a short period of time. Moreover, it is often used as the entry equipment for freeze-drying by researchers who look for an API or processing high-performance liquid chromatography (HPLC) fractions during the initial steps of freeze-drying. Manifold freeze dryers also have several advantages over tray-style freeze dryers. For instance, this segment allows the accommodation of several vessels for drying different products at the same time in vessels of different sizes, with a variety of closure systems. Hence, such factors are fuelling the growth of this segment which in turn will drive the market growth during the forecast period. Hence, such factors are fuelling the growth of this segment, which in turn will drive the market growth of Freeze Drying Equipment, Food Industry Freeze-drying Equipment, and Industrial Food Dryer during the forecast period.

Regional Analysis

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North America is estimated to contribute 36% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. One of the main countries that contributes to the lyophilization equipment and services market in North America is the US which is fuelled by the presence of various large-scale pharmaceutical and biotechnology companies. In addition, the number of biopharmaceutical and biosimilar product approvals has exponentially increased in North America in the last five years. Furthermore, there is an increase in the focus on the R&D of genes and other nucleic acid-based products in the US, such as antisense oligonucleotides (ASOs). Moreover. factors such as the advanced healthcare infrastructure of the region and the presence of CMOs with dedicated product lines for lyophilization operations. Hence, such factors are driving the market growth in North America during the forecast period.

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Key Lyophilization Equipment and Services Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

ATS Automation Tooling Systems Inc: The company offers lyophilization equipment and services such as the Lyoscan system.

• Azbil Corp.
• Baxter International Inc.
• Coriolis Pharma Research GmbH
• Cryotec.Fr
• GEA Group AG
• HOF Sonderanlagenbau GmbH
• Labconco Corp.
• LaboGene AS
• Lyophilization Technology Inc.
• Maquinaria Industrial Dara SL
• Martin Christ Gefriertrocknungsanlagen GmbH
• MechaTech Systems Ltd.
• Millrock Technology Inc.
• OPTIMA packaging group GmbH
• Shanghai Tofflon Science and Technology Co. Ltd.
• Thermo Fisher Scientific Inc.
• W. L. Gore and Associates Inc.
• Yamato Scientific Co. Ltd.
• IMA Industria Macchine Automatiche Spa

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Dynamics and Customer Landscape

Lyophilized products, including lyophilized drugs such as Remdesivir, are crucial in drug production for their enhanced stability and longer shelf life. Biotech manufacturing relies on lyophilization services and contract manufacturing to produce protein-based drugs, biologics, and recombinant proteins used in injectable therapeutics and biological therapeutics. These processes adhere to stringent regulatory guidelines governing aseptic packaging and ensuring safety profiles in clinical trials. The efficacy of monoclonal antibodies and gene therapies hinges on target specificity and small molecules designed for precise medical interventions. The biopharmaceutical industry continues to advance with innovations in preserved food and lyophilized products, meeting the evolving demands for effective treatments and therapies. As technology and research progress, these developments play a pivotal role in improving patient outcomes and addressing complex medical challenges globally.

Key Lyophilization Equipment and Services Market Drivers

One of the key factors driving the lyophilization equipment and services market growth is the advantages of lyophilization over conventional drying. There has been a significant presence of lyophilization or freeze-drying in the market for over three decades to stabilize various types of chemical components. In addition, it is increasingly being used by pharmaceutical and biotechnology sectors, owing to its potential advantages over conventional drying, which includes crystallization, filtration, and precipitation. 

Moreover, the main advantage of lyophilization over conventional drying is the preservation of the chemical and biological potency and homogeneity of the final products. In addition, it offers the ease of dispensing/metering before the final packaging and protection from solution effects and chemical degradation. Furthermore, it can also increase the speed and completeness of rehydration compared with dry powder fills. Hence, such factors are driving the market growth during the forecast period.

Significant Lyophilization Equipment and Services Market Trends

A key factor shaping the lyophilization equipment and services market growth is the rise in demand for controlled nucleation in lyophilization. The primary trend in the global market is controlled nucleation as nucleation behavior can affect the different steps in the lyophilization processes and product attributes.  In addition, the lack of control of the nucleation temperature can have an adverse effect on product uniformity and can lead to suboptimal lyophilization cycles.

Moreover, the variability in the nucleation temperature can be significantly decreased by controlled nucleation technology. In addition, the controlled nucleation enables uniform ice crystal formation within a vial and between the vials in the same batch at a minimum degree of supercooling. Hence, such factors are positively impacting the market. Therefore, it is expected to drive the market growth during the forecast period.

Major Lyophilization Equipment and Services Market Challenges

High costs associated with lyophilization are one of the key challenges hindering the lyophilization equipment and services market growth. There is an increasing adoption of lyophilization as it is currently an effective method to ensure the durability of many pharmaceutical products. However, it is considered a costly process due to the requirement for high capital investments in technology.

Moreover, the cost of lyophilization is significantly higher than that of conventional drying methods. In addition, it comprises the high costs of equipment purchase, power consumption, and sterilization. Furthermore, the cost of the equipment itself is in the range of USD2-USD3 million, regardless of the use of disposable or reusable stainless-steel trays. Hence, such factors are hindering the market growth during the forecast period.

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Key Lyophilization Equipment and Services Market Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Global Lyophilization Equipment and Services Market Customer Landscape

Segment Overview

The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments. 

• End-user Outlook
  • Pharmaceutical and biotechnology companies
  • Other healthcare service providers
• Product Outlook
  • Tray-style freeze dryer
  • Manifold freeze dryer
  • Rotary freeze dryer
• Geography Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of the World
    • Australia
    • Argentina
    • Brazil

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Market Analyst Overview

Rotary freeze dryers are essential in industrial-scale, pilot-scale, and laboratory-scale operations for freeze drying trays/shelves used in various applications, from food processing and packaging to medical applications such as injectables and cell therapies. These systems integrate loading and unloading systems, control and monitoring systems, and vacuum systems to ensure precise freeze drying of aqueous solutions and other formulations.

Moreover, for pharmaceuticals, lyophilization technique is pivotal, enabling the production of small-molecule drugs and large-molecule drugs with extended shelf lives and enhanced stability. The lyophilization services market supports commercially viable solutions by offering flexibility and cost savings opportunities through outsourcing activities to expert lyophilization service providers like Baxter BioPharma Solutions, CordenPharma, and Vetter Pharma. Lyophilization equipment and services are crucial in the preservation of doxorubicin, a chemotherapy drug, by ensuring its stability and efficacy through freeze-drying processes

Additionally, setup and maintenance costs, along with capital investment in CIP systems and alternative drying techniques such as spray drying and vacuum foam drying, impact pharmaceutical sales and technical operations. Cell/gene therapies and biological therapeutics benefit from these advanced technologies, enhancing disease condition management and drug developers' capabilities in the pharmaceutical industry. As the market evolves, capacity expansions and facility optimizations are crucial for meeting growing demand and ensuring quality in drug production and biotech manufacturing.

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What are the Key Data Covered in this Market Forecast Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2024 and 2028
• Precise estimation of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies

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