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1542913

全球凍乾/冷凍乾燥設備市場 - 2024-2031

Global Lyophilization/Freeze Drying Equipment Market - 2024-2031

出版日期: 2024年08月26日 | 出版商:

DataM Intelligence | 英文 200 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

報告概述

2023年，全球冷凍乾燥/冷凍乾燥設備市場達到63.6億美元，預計2031年將達到120.6億美元，2024-2031年預測期間複合年成長率為8.6%。

冷凍乾燥或冷凍乾燥設備可去除樣品中的水或其他溶劑，使冰直接從固體變為蒸氣，而無需經過液相。冷凍乾燥的實現量多種多樣，從小型家用（冷凍乾燥食品）冷凍乾燥機到大型生產規模設備。實驗室冷凍乾燥機通常用於生物和環境學科的研究以及多種先進藥物的開發。

凍乾/冷凍乾燥設備市場動態

全球冷凍乾燥/冷凍乾燥設備市場的成長是由技術進步、對冷凍乾燥產品和保存食品的需求增加以及生命科學領域不斷增加的研發活動所推動的。

冷凍乾燥製程的優勢日益增強推動市場成長

製藥和生物技術行業不斷增加的研發活動推動了市場的發展。根據 2021 年 11 月發表在《國際藥劑學雜誌》上的文章，腸外生物藥品以透過各種填充技術製造的液體或固體產品進行銷售。在歐洲市場上，約 34% 的生物藥品以凍乾產品的形式銷售，透過凍乾脫水是製造固體生物藥品的黃金標準。冷凍乾燥的幾個優點已被認可。冷凍乾燥可以延長熱敏性和不穩定生物藥品的保存期限，並減少對冷鏈的需求。加工過程中的化學分解在極低的溫度下減少，後加工殘留水分含量 (RMC) 較低，保持產品穩定。

2022年7月，NJM推出了Dara Coolvacuum冷凍乾燥設備，適用於研發實驗室和商業填充-完成包裝線。該設備採用 Scada 軟體設計，符合 FDA 21 CFR 第 11 部分，以滿足 FDA GAMP5 和 GMP 法規。此外，2020年，Coolvavuum成為Dara Pharma Group的一部分，Dara已成為一家能夠為冷凍乾燥注射藥物提供交鑰匙解決方案的全球製造商。

與冷凍乾燥過程相關的缺點將阻礙市場的成長

然而，傳統的冷凍乾燥製程有一些缺點。處理時間可能從幾天到幾週不等，高昂的資本成本和能源消耗導致整個過程的效率降低。此外，靜態過程會增加在過程失敗的情況下整個批次被拒絕的風險。批量製程僅限於處理小體積的單位劑量，從而增加了對許多小瓶的需求。儘管目前採用良好生產規範 (cGMP)，但在此過程中的人為干預可能會增加污染風險。此外，還需要考慮與傳熱和傳質以及擴大製程規模有關的問題，這取決於乾燥機的設計、容器密閉、負載條件和產品配方。

COVID-19 影響分析

COVID-19 疫苗和 PCR 診斷試劑盒對於對抗這場流行病至關重要。與其儲存、運輸和使用相關的最大挑戰之一是需要冷藏或冷凍材料。冷凍乾燥或冷凍乾燥在開發均勻可靠的藥物化合物方面發揮關鍵作用。根據 Hudson Valley Lyomac 組織的說法，冷凍乾燥可以穩定藥物，並允許工業生產用於壓片或封裝的粉末。製藥客戶利用冷凍乾燥來生產保存期限長的產品，包括疫苗或其他注射藥物。 COVID-19 專門增加了對冷凍乾燥產品的需求，並增加了全球對冷凍乾燥設備的需求。

近年來，批量冷凍乾燥是大多數生物製藥產品的現代乾燥技術。多種替代乾燥技術擴大為固體生物製藥的生產提供了廣闊的前景，同時又不影響生物製藥產品的安全性、品質和功效。這些潛在的乾燥技術對生物製藥產業意義重大，因為它們不僅可以減少生產救命藥物的時間、能源消耗和相關成本，還有助於減輕 Covid-19 期間藥物供應的任何風險。

冷凍乾燥/冷凍乾燥設備市場細分分析

研究領域預計在預測期（2024-2031）將以最快的複合年成長率成長

研究領域佔據最大的市場佔有率。近年來，生物製藥在提高各種自體免疫疾病、癌症和遺傳性疾病患者的生活品質方面取得了突破。隨著生物製藥需求的不斷成長，在不影響產品安全、品質和功效的情況下降低製造成本至關重要。冷凍乾燥用於固體生物藥品的製造。

冷凍乾燥機具有冷凍乾燥等優點。脆弱、不穩定或熱敏感的藥物和生物製品可以在低溫下乾燥，而不會損壞其物理結構。冷凍乾燥產品可以快速、輕鬆地重構，這對於需要盡快施用的緊急疫苗和抗體來說尤其有價值。

根據 2022 年 8 月發表在《Advanced Drug Delivery Reviews》上的文章，如果特定生物化合物的液體穩定性不理想，那麼開發凍乾或冷凍產品將是配方設計師最有可能遵循的方案。例如，開發凍乾活病毒疫苗（LVV）。

此外，市場參與者正在設計用於研究目的的冷凍乾燥機。例如，VertMarkets Inc. 提供值得信賴的冷凍乾燥解決方案，旨在透過全面的設備系列滿足工業界和學術界研發設施日益成長的需求。

凍乾/冷凍乾燥設備市場地域佔有率

亞太地區佔據全球冷凍乾燥/冷凍乾燥設備市場最大市場佔有率

亞太地區在冷凍乾燥/冷凍乾燥設備市場上佔據主導地位，預計在預測期內將呈現類似的趨勢。市場的成長可歸因於生物技術產業研發投資的增加、對冷凍乾燥產品的需求增加、技術進步以及亞太地區的主要參與者。

生物技術產業研究資金的增加推動了市場的發展。例如，2022年7月，MaxHealth Biotechnology以7,400萬美元的B輪融資在亞太地區私人生物技術投資領域佔據主導地位。該組織將利用這筆資金擴大傳染病疫苗的開發，包括大流行性流感、季節性流感、狂犬病和冠狀病毒。

此外，食品業在該地區佔據主導地位。對即食食品的需求推動了亞太地區冷凍乾燥設備市場的發展。例如，2021年6月，可口可樂日本推出了凍乾大麥茶、咖啡塊和即溶綠茶。冷凍乾燥有助於將茶葉和咖啡豆的原始香氣和風味濃縮到立方體中，製成美味的沖泡品，非常適合包裝旅行或僅在家中享用，無需清洗。

凍乾/冷凍乾燥設備市場競爭格局

凍乾/冷凍乾燥設備市場是本地和全球公司的適度競爭的市場。為市場成長做出貢獻的一些主要參與者包括 Thermo Fisher Scientific Inc.、Millrock Technology Inc.、SP Scientific、Zirbus Technology GmbH、Azbil Telstar SL、LTE Scientific、Biopharma Process Systems Ltd.、GEA Group、Martin Christ GmbH 和Cuddon Freeze Dry 等。主要參與者正在採取多種成長策略，例如產品發布、收購和合作，為全球冷凍乾燥/冷凍乾燥設備市場的成長做出貢獻。

例如，

2020 年 3 月，泰事達開發了一款新型實驗室冷凍乾燥機 LyoQuest Arctic，使用天然氣運行，專為研發實驗室設計。它是一種桌上型、環保實驗室冷凍乾燥機。與使用 HFC 冷卻氣體的傳統冷凍乾燥機不同，Lyoquest Arctic 將 GWP 影響降低了 1,000 倍以上。

米爾洛克科技公司

概述：

Millrock Technology 是製藥、生物技術、診斷和生命科學應用領域先進冷凍乾燥機技術的創新者。它為生命科學提供製藥級 (c-GMP) 冷凍乾燥機或生產冷凍乾燥機。每台生產型冷凍乾燥機都是客製化設計和製造的，以滿足用戶的特定應用，並且具有成本效益。

產品組合：

QuantaS 蒸氣滅菌生產冷凍乾燥機：QuantaS 蒸氣滅菌生產冷凍乾燥機提供符合 21CFR 第 11 部分和蒸氣滅菌 (SIP) 要求的 cGMP 製藥冷凍乾燥機，以滿足生物製藥和製藥應用的要求。

全球凍乾/冷凍乾燥設備市場報告將提供約 40 多個市場資料表、45 多個圖表，頁數約為 200 頁。

Freeze drying or lyophilization equipment removes water or other solvents from the sample, allowing the ice to change directly from a solid to a vapor without passing through a liquid phase. Lyophilization is achieved in various volumes, from small at-home (to freeze-dry foods) freeze dryers to large, production-scale equipment. Laboratory freeze dryers are generally used for research in biological and environmental disciplines and in developing multiple advanced medicines.

Lyophilization/Freeze Drying Equipment Market Dynamics

The growth of the global lyophilization/freeze drying equipment market is driven by technological advancements, increasing demand for lyophilized products and preserved food and rising research and development activities in life sciences.

An increasing advantage of freeze drying process drives the market growth

The increasing number of research and development activities in the pharmaceutical and biotechnology industries drives the market. As per the article published in the International Journal of Pharmaceutics in November 2021, Parenteral biopharmaceuticals are marketed as liquid or solid products manufactured by various fill finish technologies. With about 34 % of biopharmaceuticals marketed as freeze-dried products in the European market, dehydration via freeze-drying is the gold standard for manufacturing solid biopharmaceuticals. Several advantages of Freeze-drying have been recognized. Freeze-drying allows improved shelf-life of heat-sensitive and labile biopharmaceuticals and reduces the requirement for a cold chain. Chemical decomposition is reduced at very low temperatures during the process, with low residual moisture content (RMC) post-processing, keeping the product stable.

In July 2022, NJM launched Dara coolavacuum freeze-drying equipment, suitable for research and development laboratory and commercial fill-finish packaging lines. This equipment is designed with Scada software for FDA 21 CFR part 11 compliance to meet FDA GAMP5 and GMP regulations. Also, In 2020, Coolvavuum became part of the Dara Pharma Group, and Dara has become a global manufacturer capable of offering turn-key solutions for freeze-dried injectable drugs.

The drawbacks related to freeze drying process will hamper the growth of the market

However, several drawbacks are associated with the conventional freeze-drying process. Processing times could vary from days to weeks, with high capital costs and energy consumption leading to reduced efficiency in the overall process. Also, a static process increases the risk of rejection of the entire batch in case of process failure. A batch process is limited to processing small volumes of unit doses, increasing the requirement for many vials. Human intervention during the process can increase the risk of contamination despite current Good Manufacturing Practices (cGMP). In addition, concerns related to heat and mass transfer and scaling up the process, which depend on the dryer design, container closure, load condition and product formulation.

COVID-19 Impact Analysis

Vaccines and PCR diagnostic kits for COVID-19 are crucial for fighting the pandemic. One of the largest challenges associated with their storage, transport and use is the requirement for refrigeration or freezing of the material. Lyophilization, or freeze-drying, recreates a key role to play in developing pharmaceutical compounds that are both uniform and reliable. According to Hudson Valley Lyomac organization, freeze-drying stabilizes medicines and allows the industrial production of powders for tableting or encapsulating. Pharmaceutical customers utilize freeze-drying to create products with long shelf life, including vaccines or other injected medications. COVID-19 exclusively increases the demand for lyophilization products and increases the demand for freeze-drying equipment worldwide.

Recently, batch freeze-drying is a modern drying technology for the most biopharmaceutical products. Multiple alternative drying technologies have increasingly offered promising prospects for manufacturing solid biopharmaceuticals without compromising biopharmaceutical products' safety, quality and efficacy. These potential drying technologies are significant to the biopharmaceutical industry as they will not only reduce time, energy consumption and associated costs with the manufacturing of life-saving drugs but also help mitigate any risks with the supply of drugs during Covid-19.

Lyophilization/Freeze Drying Equipment Market Segmentation Analysis

The research segment is expected to grow at the fastest CAGR during the forecast period (2024-2031)

The research segment accounts for the largest market share. In recent years, biopharmaceuticals have been a breakthrough in enhancing the quality of lives of patients with various autoimmune, cancers, and genetic disorders. With the rising demand for biopharmaceuticals, the need to reduce manufacturing costs is essential without compromising product safety, quality, and efficacy. Freeze-drying is used in the manufacturing of solid biopharmaceuticals.

Freeze dryers provide the advantages such as With freeze drying. Delicate, unstable or heat-sensitive drugs and biologicals can be dried at low temperatures without damaging their physical structure. Freeze-dried products can be reconstituted quickly and easily, which is particularly valuable in the case of emergency vaccines and antibodies, which need to be administered as quickly as possible.

As per the article published in Advanced Drug Delivery Reviews in August 2022, if the liquid stability of a specific biological compound is not desirable, the development of a freeze-dried or frozen product will be the most likely scenario to be followed by formulators. For instance, developing freeze-dried live virus vaccines (LVV).

In addition, the market players are designing freeze dryers for research purposes. For instance, VertMarkets Inc. provides trusted, freeze-drying solutions designed to meet the increasing demands of R&D facilities in industry and academia with a comprehensive equipment range.

Lyophilization/Freeze Drying Equipment Market Geographical Share

Asia Pacific region holds the largest market share of the global lyophilization/freeze drying equipment market

The Asia Pacific dominates the lyophilization/freeze-drying equipment market and is expected to show a similar trend over the forecast period. The market's growth can be attributed to increasing investment in research and development in biotech industries, increasing demand for freeze-dried products, technological advancement, and key players in the Asia Pacific region.

The rising funding for research in biotechnological industries drives the market. For instance, in July 2022, MaxHealth Biotechnology reigned supreme in the Asia-Pacific region's private biotech investment sphere with a $74 million Series B round. The organization will utilize this funding to expand the development of vaccines for infectious diseases, including pandemic influenza, seasonal influenza, rabies and coronavirus.

In addition, the food sector is dominating in the region. The demand for ready-to-use food drives the market for freeze-drying equipment in the Asia Pacific region. For instance, in June 2021, Coca-Cola Japan launched freeze-dried barley tea, coffee cubes, and green tea for instant brews. Freeze drying helps concentrate the original aroma and flavor of tea leaves and coffee beans into the cube for a flavorful brew perfect for packing for excursions or only enjoying at residence with less washing.

Lyophilization/Freeze Drying Equipment Market Competitive Landscape

The lyophilization/freeze-drying equipment market is a moderately competitive presence of local and global companies. Some of the key players which are contributing to the growth of the market are Thermo Fisher Scientific Inc., Millrock Technology Inc., SP Scientific, Zirbus Technology GmbH, Azbil Telstar SL, LTE Scientific, Biopharma Process Systems Ltd., GEA Group, Martin Christ GmbH, and Cuddon Freeze Dry, among others. The major players are adopting several growth strategies, such as product launches, acquisitions, and collaborations, contributing to the growth of the global lyophilization/freeze-drying equipment market.

For instance,

In March 2020, Telstar developed a novel laboratory freeze dryer, LyoQuest Arctic operating with natural gases, particularly designed for research and development laboratories. It is a bench-top, environmentally friendly lab freeze-dryer. Unlike conventional freeze dryers operating HFC cooling gases, the Lyoquest Arctic decreases the GWP impact more than 1,000-fold.

Millrock Technology, Inc.

Overview:

Millrock Technology is an innovator in advanced freeze-dryer technology for pharmaceutical, biotechnology, diagnostics, and life science applications. It offers a pharmaceutical quality (c-GMP) freeze dryer or a production freeze dryer for the life sciences. Each production freeze dryer is custom designed and manufactured to meet the user's specific application and is cost-effective.

Product Portfolio:

QuantaS Steam Sterilizable Production Freeze Dryer: The QuantaS Steam Sterilizable Production Freeze Dryer supplies cGMP pharmaceutical freeze dryers with 21CFR part 11 and steam sterilization (SIP) for requesting applications in bio-pharmaceutical and pharmaceutical applications.

The global lyophilization/freeze drying equipment market report would provide access to approximately 40+ market data tables, 45+ figures, and in the range of 200 (approximate) pages.

1. Market Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

4.1. Market Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rising demand for lyophilized Types
  - 4.1.1.2. Technological Advancements in lyophilization technique
- 4.1.2. Restraints:
- 4.1.3. Lack of skilled workforce
- 4.1.4. Opportunity
- 4.1.5. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Forces Analysis
5.2. Supply Chain Analysis
5.3. Regulatory Analysis

6. COVID-19 Analysis

6.1. Analysis of Covid-19 on the Market
- 6.1.1. Before COVID-19 Market Scenario
- 6.1.2. Present COVID-19 Market Scenario
- 6.1.3. After COVID-19 or Future Scenario
6.2. Pricing Dynamics Amid Covid-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturer's Strategic Initiatives
6.6. Conclusion

7. By Type

7.1. Introduction
- 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 7.1.2. Market Attractiveness Index, By Type
7.2. Refrigeration System*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
7.3. Vacuum System
7.4. Controlling and Monitoring Systems
7.5. Product Chamber or Manifold
7.6. Clean-In-Place (CIP) Systems
7.7. Drying Chambers
7.8. Loading and Unloading Systems
7.9. Other Equipment

8. By Technology

8.1. Introduction
- 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 8.1.2. Market Attractiveness Index, By Technology
8.2. Tray style Freeze Dryers*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
8.3. Manifold Freeze Dryer
8.4. Rotatory Freeze Dryers

9. By Scale of Operation

9.1. Introduction
- 9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 9.1.2. Market Attractiveness Index, By Scale of Operation
9.2. Lab-Scale Freeze Dryers*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
9.3. Pilot-Scale Freeze Dryers
9.4. Industrial-Scale Freeze Dryers

10. By Application

10.1. Introduction
- 10.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 10.1.2. Market Attractiveness Index, By Application
10.2. Nutraceuticals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
10.3. Drug Development
10.4. Medical Diagnostics
10.5. Research
10.6. Others

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 11.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 11.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 11.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 11.2.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. The U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 11.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 11.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 11.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 11.3.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. U.K.
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 11.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 11.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 11.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 11.4.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 11.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 11.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 11.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 11.5.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 11.5.7.1. China
  - 11.5.7.2. India
  - 11.5.7.3. Japan
  - 11.5.7.4. Australia
  - 11.5.7.5. Rest of Asia Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Type
- 11.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
- 11.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Scale of Operation
- 11.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application

12. Competitive Landscape

12.1. Key Developments and Strategies
12.2. Company Share Analysis
12.3. Product Benchmarking

13. Company Profiles

13.1. Thermo Fisher Scientific Inc.*
- 13.1.1. Company Overview
- 13.1.2. Type Portfolio and Description
- 13.1.3. Key Highlights
- 13.1.4. Financial Overview
13.2. Millrock Technology Inc.
13.3. SP Scientific
13.4. Zirbus Technology GmbH
13.5. Azbil Telstar SL
13.6. LTE Scientific
13.7. Biopharma Process Systems Ltd.
13.8. GEA Group
13.9. Martin Christ GmbH
13.10. Cuddon Freeze Dry (*LIST NOT EXHAUSTIVE)

14. DataM Intelligence

14.1. Appendix
14.2. About Us and Services
14.3. Contact Us

02-2729-4219

+886-2-2729-4219

License/價格

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