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市场调查报告书

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1542913

全球冻干/冷冻干燥设备市场 - 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个工作天内

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简介目录

报告概述

2023年，全球冷冻干燥/冷冻干燥设备市场达到63.6亿美元，预计2031年将达到120.6亿美元，2024-2031年预测期间复合年增长率为8.6%。

冷冻干燥或冷冻干燥设备可去除样品中的水或其他溶剂，使冰直接从固体变为蒸气，而无需经过液相。冷冻干燥的实现量多种多样，从小型家用（冷冻干燥食品）冷冻干燥机到大型生产规模设备。实验室冷冻干燥机通常用于生物和环境学科的研究以及多种先进药物的开发。

冻干/冷冻干燥设备市场动态

全球冷冻干燥/冷冻干燥设备市场的成长是由技术进步、对冷冻干燥产品和保存食品的需求增加以及生命科学领域不断增加的研发活动所推动的。

冷冻干燥製程的优势日益增强推动市场成长

製药和生物技术行业不断增加的研发活动推动了市场的发展。根据 2021 年 11 月发表在《国际药剂学杂誌》上的文章，肠外生物药品以透过各种填充技术製造的液体或固体产品进行销售。在欧洲市场上，约 34% 的生物药品以冻干产品的形式销售，透过冻干脱水是製造固体生物药品的黄金标准。冷冻干燥的几个优点已被认可。冷冻干燥可以延长热敏性和不稳定生物药品的保质期，并减少对冷链的需求。加工过程中的化学分解在极低的温度下减少，后加工残留水分含量 (RMC) 较低，保持产品稳定。

2022年7月，NJM推出了Dara Coolvacuum冷冻干燥设备，适用于研发实验室和商业填充-完成包装线。该设备采用 Scada 软体设计，符合 FDA 21 CFR 第 11 部分，以满足 FDA GAMP5 和 GMP 法规。此外，2020年，Coolvavuum成为Dara Pharma Group的一部分，Dara已成为一家能够为冷冻干燥注射药物提供交钥匙解决方案的全球製造商。

与冷冻干燥过程相关的缺点将阻碍市场的成长

然而，传统的冷冻干燥製程有一些缺点。处理时间可能从几天到几週不等，高昂的资本成本和能源消耗导致整个过程的效率降低。此外，静态过程会增加在过程失败的情况下整个批次被拒绝的风险。批量製程仅限于处理小体积的单位剂量，从而增加了对许多小瓶的需求。儘管目前采用良好生产规范 (cGMP)，但在此过程中的人为干预可能会增加污染风险。此外，还需要考虑与传热和传质以及扩大製程规模有关的问题，这取决于干燥机的设计、容器密闭、负载条件和产品配方。

COVID-19 影响分析

COVID-19 疫苗和 PCR 诊断试剂盒对于对抗这场流行病至关重要。与其储存、运输和使用相关的最大挑战之一是需要冷藏或冷冻材料。冷冻干燥或冷冻干燥在开发均匀可靠的药物化合物方面发挥关键作用。根据 Hudson Valley Lyomac 组织的说法，冷冻干燥可以稳定药物，并允许工业生产用于压片或封装的粉末。製药客户利用冷冻干燥来生产保质期长的产品，包括疫苗或其他注射药物。 COVID-19 专门增加了对冷冻干燥产品的需求，并增加了全球对冷冻干燥设备的需求。

近年来，批量冷冻干燥是大多数生物製药产品的现代干燥技术。多种替代干燥技术越来越多地为固体生物製药的生产提供了广阔的前景，同时又不影响生物製药产品的安全性、品质和功效。这些潜在的干燥技术对生物製药产业意义重大，因为它们不仅可以减少生产救命药物的时间、能源消耗和相关成本，还有助于减轻 Covid-19 期间药物供应的任何风险。

冷冻干燥/冷冻干燥设备市场細項分析

研究领域预计在预测期（2024-2031）将以最快的复合年增长率成长

研究领域占据最大的市场份额。近年来，生物製药在提高各种自体免疫疾病、癌症和遗传性疾病患者的生活品质方面取得了突破。随着生物製药需求的不断增长，在不影响产品安全、品质和功效的情况下降低製造成本至关重要。冷冻干燥用于固体生物药品的製造。

冷冻干燥机具有冷冻干燥等优点。脆弱、不稳定或热敏感的药物和生物製品可以在低温下干燥，而不会损坏其物理结构。冷冻干燥产品可以快速、轻鬆地重构，这对于需要尽快施用的紧急疫苗和抗体来说尤其有价值。

根据 2022 年 8 月发表在《Advanced Drug Delivery Reviews》上的文章，如果特定生物化合物的液体稳定性不理想，那么开发冻干或冷冻产品将是配方设计师最有可能遵循的方案。例如，开发冻干活病毒疫苗（LVV）。

此外，市场参与者正在设计用于研究目的的冷冻干燥机。例如，VertMarkets Inc. 提供值得信赖的冷冻干燥解决方案，旨在透过全面的设备系列满足工业界和学术界研发设施日益增长的需求。

冻干/冷冻干燥设备市场地域份额

亚太地区占据全球冷冻干燥/冷冻干燥设备市场最大市场份额

亚太地区在冷冻干燥/冷冻干燥设备市场上占据主导地位，预计在预测期内将呈现类似的趋势。市场的成长可归因于生物技术产业研发投资的增加、对冷冻干燥产品的需求增加、技术进步以及亚太地区的主要参与者。

生物技术产业研究资金的增加推动了市场的发展。例如，2022年7月，MaxHealth Biotechnology以7,400万美元的B轮融资在亚太地区私人生物技术投资领域占据主导地位。该组织将利用这笔资金扩大传染病疫苗的开发，包括大流行性流感、季节性流感、狂犬病和冠状病毒。

此外，食品业在该地区占据主导地位。对即食食品的需求推动了亚太地区冷冻干燥设备市场的发展。例如，2021年6月，可口可乐日本推出了冻干大麦茶、咖啡块和即溶绿茶。冷冻干燥有助于将茶叶和咖啡豆的原始香气和风味浓缩到立方体中，製成美味的冲泡品，非常适合包装旅行或仅在家中享用，无需清洗。

冻干/冷冻干燥设备市场竞争格局

冻干/冷冻干燥设备市场是本地和全球公司的适度竞争的市场。为市场成长做出贡献的一些主要参与者包括 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。主要参与者正在采取多种成长策略，例如产品发布、收购和合作，为全球冷冻干燥/冷冻干燥设备市场的成长做出贡献。

例如，

2020 年 3 月，泰事达开发了一款新型实验室冷冻干燥机 LyoQuest Arctic，使用天然气运行，专为研发实验室设计。它是一种桌上型、环保实验室冷冻干燥机。与使用 HFC 冷却气体的传统冷冻干燥机不同，Lyoquest Arctic 将 GWP 影响降低了 1,000 倍以上。

米尔洛克科技公司

概述：

Millrock Technology 是製药、生物技术、诊断和生命科学应用领域先进冷冻干燥机技术的创新者。它为生命科学提供製药级 (c-GMP) 冷冻干燥机或生产冷冻干燥机。每台生产型冷冻干燥机都是客製化设计和製造的，以满足用户的特定应用，并且具有成本效益。

产品组合：

QuantaS 蒸气灭菌生产冷冻干燥机：QuantaS 蒸气灭菌生产冷冻干燥机提供符合 21CFR 第 11 部分和蒸气灭菌 (SIP) 要求的 cGMP 製药冷冻干燥机，以满足生物製药和製药应用的要求。

全球冻干/冷冻干燥设备市场报告将提供约 40 多个市场资料表、45 多个图表，页数约为 200 页。

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/价格

全球冻干/冷冻干燥设备市场 - 2024-2031