The lyophilization equipment and services market is poised to grow at a CAGR of 8.5% during the forecast period.
The impact of COVID-19 in its initial phase was profound owing to restrictions on drug production in pharmaceutical and biotech manufacturing sites, which hampered market growth. The demand for lyophilized drugs and emergency use authorization (EUA) for certain lyophilized drugs compensated for the market growth in the later stages of the pandemic. For instance, in May 2020, Cipla launched remdesivir under its brand name CIPREMI (remdesivir lyophilized powder for injection, 100 mg). Gilead Sciences Inc. received a EUA from the US FDA to use remdesivir for COVID-19 patients who were hospitalized. The market has been recovering well over the last two years since the drug manufacturing restrictions were lifted. The growing demand and approvals for lyophilized drugs are ultimately propelling the use of lyophilization equipment and services and are hence expected to propel the market during the forecast period.
The key drivers augmenting the market are the rising demand for lyophilized products in the pharmaceutical industry and technological advancements in lyophilization methods.
In the past few years, the number of biopharmaceuticals being developed and manufactured has increased significantly. Moreover, the rising demand for aseptic packaging and preservation, as well as the increase in the production of protein-based drugs, is expected to boost the demand for freeze-drying. Thus, pharmaceutical manufacturers and equipment suppliers are moving toward an array of advanced process analytical technologies (PAT) to help optimize their freeze-drying operations. In the case of biologics, the formulation and storage in aqueous solutions result in instability. Lyophilization can help improve their long-term stability. The process of lyophilization is a complex, multistep process that requires a sound understanding of both the product and the process-related attributes to ensure higher operational efficiency and consistency in producing acceptable final products. As most pharmaceutical products could not be commercially viable without lyophilization, their usage is inevitable.
Furthermore, growth in the number of commercially available vaccines and injectables for various disease conditions and rising demand for contract manufacturing and outsourcing activities in the biopharmaceutical industry are also anticipated to emphasize the growth of the global lyophilization equipment and services market in the near future.
The advancements in technology and increasing product approvals, along with partnerships and collaborations by key players, are helping in the market's growth. For instance, in September 2021, DARA Pharma Group and MOTUS signed a technology transfer agreement to manufacture loading systems for freeze dryers. Moreover, in December 2021, PCI Pharma Services (PCI), a CDMO, reported the closing of the earlier-notified acquisition of Lyophilization Services of New England, Inc., a CDMO based in Bedford, New Hampshire. This addition is a critical step for PCI, as LSNE will extend PCI’s range of services as a global CDMO, creating its expertise in the clinical trial supply, specialty manufacturing, and pharmaceutical packaging. PCI can now offer integrated large and small-molecule solutions for its clinical and commercial consumers, including global manufacturing capabilities in high potency, complex formulations, sterile fill-finish, and lyophilization, an important manufacturing process commonly used with injectable and biologic therapies. Such partnerships are projected to boost market growth during the forecast period.
Therefore, owing to the aforementioned factors, it is anticipated that the studied market will witness growth over the analysis period. However, the high setup and maintenance costs of freeze-drying equipment and the increasing utilization of alternative drying techniques in the pharmaceutical and biotechnology industries are likely to impede the market growth.
The use of lyophilization is crucial for both pharmaceutical and biopharmaceutical manufacturing. For instance, according to an article published in the Pharmaceutics Journal in July 2021, freeze drying, also known as lyophilization, is the most employed process for producing pharmaceutical products that are unstable and thermosensitive in an aqueous medium in order to ensure stability and long-term storage in the dried state. Given the advantages, the demand for lyophilization equipment and services by pharmaceutical and biotech companies is estimated to rise during the analysis period.
The pharmaceutical and biotech companies are engaged in the manufacturing of lyophilized medication owing to the increased demand for lyophilized drugs, which is ultimately leading to a surge in approvals and the launch of the lyophilized medication. For instance, in October 2021, Dr. Reddy’s Laboratories Ltd. launched carmustine for injection, USP, after approval by the US FDA. The lyophilized powder marketed as carmustine for injection USP comes in a package with a single-dose vial having 100 mg of the medication and 3 mL of sterile diluent. The launches of lyophilized drugs are anticipated to boost the utility of lyophilization equipment and thereby propel the segment's growth during the forecast period.
Also, in May 2022, Optima Pharma Division inaugurated a comprehensive scientific process engineering (CSPE) center in Germany. The company responded to customer requests and expanded the successful CSPE process for fast and safe production start-up of the integrated filling lines with isolators and freeze dryers. The inauguration of the CSPE center is associated with the use of lyophilization equipment, which will add to market growth.
Therefore, the above-mentioned facts indicate the growth of the segment over the forecast period. Moreover, the rising research and development expenditure by pharmaceutical companies is estimated to boost the market's growth during the analysis period.
According to EFPIA data for the pharmaceutical industry for 2022, North America accounted for 49.1% of world pharmaceutical sales in 2021, compared with 23.4% in Europe. A huge percentage of pharmaceutical sales, including lyophilized drugs, indicated the high utility of lyophilization equipment and services, contributing to the market growth of the region.
Furthermore, the advancements in technology and increasing product approvals, along with partnerships and collaborations by key players, are helping in the market's growth. For instance, in April 2022, NJM launched Dara Pharma Group's Coolvacuum freeze-drying equipment in the United States and Canada at the Interphex booth. The Coolvacuum product line includes a variety of lyophilization solutions, from small, standalone freeze dryers for research and development labs to large, fully integrated systems for commercial fill-finish packaging lines. Such launches illustrate the demand for lyophilization equipment and services that are required for manufacturing medications and food processing.
Thus, owing to all the above-mentioned factors, the market is expected to witness high growth in the region during the forecast period.
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The impact of COVID-19 in its initial phase was profound owing to restrictions on drug production in pharmaceutical and biotech manufacturing sites, which hampered market growth. The demand for lyophilized drugs and emergency use authorization (EUA) for certain lyophilized drugs compensated for the market growth in the later stages of the pandemic. For instance, in May 2020, Cipla launched remdesivir under its brand name CIPREMI (remdesivir lyophilized powder for injection, 100 mg). Gilead Sciences Inc. received a EUA from the US FDA to use remdesivir for COVID-19 patients who were hospitalized. The market has been recovering well over the last two years since the drug manufacturing restrictions were lifted. The growing demand and approvals for lyophilized drugs are ultimately propelling the use of lyophilization equipment and services and are hence expected to propel the market during the forecast period.
The key drivers augmenting the market are the rising demand for lyophilized products in the pharmaceutical industry and technological advancements in lyophilization methods.
In the past few years, the number of biopharmaceuticals being developed and manufactured has increased significantly. Moreover, the rising demand for aseptic packaging and preservation, as well as the increase in the production of protein-based drugs, is expected to boost the demand for freeze-drying. Thus, pharmaceutical manufacturers and equipment suppliers are moving toward an array of advanced process analytical technologies (PAT) to help optimize their freeze-drying operations. In the case of biologics, the formulation and storage in aqueous solutions result in instability. Lyophilization can help improve their long-term stability. The process of lyophilization is a complex, multistep process that requires a sound understanding of both the product and the process-related attributes to ensure higher operational efficiency and consistency in producing acceptable final products. As most pharmaceutical products could not be commercially viable without lyophilization, their usage is inevitable.
Furthermore, growth in the number of commercially available vaccines and injectables for various disease conditions and rising demand for contract manufacturing and outsourcing activities in the biopharmaceutical industry are also anticipated to emphasize the growth of the global lyophilization equipment and services market in the near future.
The advancements in technology and increasing product approvals, along with partnerships and collaborations by key players, are helping in the market's growth. For instance, in September 2021, DARA Pharma Group and MOTUS signed a technology transfer agreement to manufacture loading systems for freeze dryers. Moreover, in December 2021, PCI Pharma Services (PCI), a CDMO, reported the closing of the earlier-notified acquisition of Lyophilization Services of New England, Inc., a CDMO based in Bedford, New Hampshire. This addition is a critical step for PCI, as LSNE will extend PCI’s range of services as a global CDMO, creating its expertise in the clinical trial supply, specialty manufacturing, and pharmaceutical packaging. PCI can now offer integrated large and small-molecule solutions for its clinical and commercial consumers, including global manufacturing capabilities in high potency, complex formulations, sterile fill-finish, and lyophilization, an important manufacturing process commonly used with injectable and biologic therapies. Such partnerships are projected to boost market growth during the forecast period.
Therefore, owing to the aforementioned factors, it is anticipated that the studied market will witness growth over the analysis period. However, the high setup and maintenance costs of freeze-drying equipment and the increasing utilization of alternative drying techniques in the pharmaceutical and biotechnology industries are likely to impede the market growth.
Lyophilization Equipment & Services Market Trends
Pharmaceutical and Biotech Manufacturing Segment is Expected to Witness Growth Over the Forecast Period
Lyophilization transforms a drug product from a liquid to a stable solid by eliminating water or other solvents. Pharmaceutical and biotech manufacturing companies are increasingly interested in the lyophilization technique as it extends the shelf life of both small and large-molecule drugs.The use of lyophilization is crucial for both pharmaceutical and biopharmaceutical manufacturing. For instance, according to an article published in the Pharmaceutics Journal in July 2021, freeze drying, also known as lyophilization, is the most employed process for producing pharmaceutical products that are unstable and thermosensitive in an aqueous medium in order to ensure stability and long-term storage in the dried state. Given the advantages, the demand for lyophilization equipment and services by pharmaceutical and biotech companies is estimated to rise during the analysis period.
The pharmaceutical and biotech companies are engaged in the manufacturing of lyophilized medication owing to the increased demand for lyophilized drugs, which is ultimately leading to a surge in approvals and the launch of the lyophilized medication. For instance, in October 2021, Dr. Reddy’s Laboratories Ltd. launched carmustine for injection, USP, after approval by the US FDA. The lyophilized powder marketed as carmustine for injection USP comes in a package with a single-dose vial having 100 mg of the medication and 3 mL of sterile diluent. The launches of lyophilized drugs are anticipated to boost the utility of lyophilization equipment and thereby propel the segment's growth during the forecast period.
Also, in May 2022, Optima Pharma Division inaugurated a comprehensive scientific process engineering (CSPE) center in Germany. The company responded to customer requests and expanded the successful CSPE process for fast and safe production start-up of the integrated filling lines with isolators and freeze dryers. The inauguration of the CSPE center is associated with the use of lyophilization equipment, which will add to market growth.
Therefore, the above-mentioned facts indicate the growth of the segment over the forecast period. Moreover, the rising research and development expenditure by pharmaceutical companies is estimated to boost the market's growth during the analysis period.
North America is Expected to Dominate the Lyophilization Equipment and Services Market Over the Forecast Period
North America is expected to dominate the market owing to factors such as rising research and development activities, the rising approval of biological products, and the strong presence of industry players in the region.According to EFPIA data for the pharmaceutical industry for 2022, North America accounted for 49.1% of world pharmaceutical sales in 2021, compared with 23.4% in Europe. A huge percentage of pharmaceutical sales, including lyophilized drugs, indicated the high utility of lyophilization equipment and services, contributing to the market growth of the region.
Furthermore, the advancements in technology and increasing product approvals, along with partnerships and collaborations by key players, are helping in the market's growth. For instance, in April 2022, NJM launched Dara Pharma Group's Coolvacuum freeze-drying equipment in the United States and Canada at the Interphex booth. The Coolvacuum product line includes a variety of lyophilization solutions, from small, standalone freeze dryers for research and development labs to large, fully integrated systems for commercial fill-finish packaging lines. Such launches illustrate the demand for lyophilization equipment and services that are required for manufacturing medications and food processing.
Thus, owing to all the above-mentioned factors, the market is expected to witness high growth in the region during the forecast period.
Lyophilization Equipment & Services Market Competitor Analysis
The lyophilization equipment and services market is fragmented in nature due to the presence of many companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies that hold market shares and are well known. Some key market players are Azbil Corporation (Telstar), GEA Group Aktiengesellschaft, Labconco Corporation, Martin Christ Gefriertrocknungsanlagen GmbH, Millrock Technology Inc., Optima Packaging Group GmbH, SP Industries, HOF Sonderanlagenbau GmbH, Tofflon Science and Technology Co. Ltd., Scala Scientific, and ZIRBUS Technology GmbH, among others.Additional benefits of purchasing the report:
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Azbil Corporation (Telstar)
- GEA Group
- Labconco
- Martin Christ Gefriertrocknungsanlagen GmbH
- Millrock Technology Inc
- Optima Packaging Group GmbH
- SP Industries
- Tofflon Science and Technology Co. Ltd
- ZIRBUS technology GmbH
- HOF Sonderanlagenbau GmbH
- Scala Scientific
Methodology
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