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全球冻干/冷冻干燥设备市场-2022-2029
市场调查报告书
商品编码
1146450

全球冻干/冷冻干燥设备市场-2022-2029

Global Lyophilization/Freeze Drying Equipment Market - 2022-2029
出版日期: | 出版商: DataM Intelligence | 英文 200 Pages | 商品交期: 约2个工作天内

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简介目录

市场概览

冷冻干燥/冷冻干燥设备的全球市场规模预计在预测期内（2022-2029 年）将以 8.1% 的复合年增长率增长。

冷冻干燥机或冻干机从样品中去除水或其他溶剂，使冰直接从固体变为蒸气，而无需通过液相。冷冻干燥以各种能力完成，从小型家用冷冻干燥机（用于冷冻干燥食品）到大型生产规模的设备。实验室冷冻干燥机通常用于生物和环境研究以及几种先进药物的开发。

市场动态

全球冷冻干燥/冷冻干燥设备市场的增长受到技术进步、对冷冻干燥产品和腌製食品的需求增加以及生命科学领域研发活动增加的推动。

冷冻干燥工艺优势的增加推动市场增长

製药和生物技术行业不断增加的研发活动正在推动市场发展。根据 2021 年 11 月发表在《国际药剂学杂誌》上的一篇文章，肠外生物药物以液体或固体产品的形式销售，这些产品是通过各种填充和完成技术製造的。大约 34% 的生物製药在欧洲市场以冻干产品的形式出售，这使得通过冻干脱水成为製造固体生物製药的黄金标准。冷冻干燥被认为具有几个优点。冷冻干燥可提高对热敏感和易腐烂的生物药品的保质期，并减少对冷链的需求。加工过程中的极低温度限制了化学分解，加工后的低残留水分 (RMC) 使产品保持稳定。

2022年7月，NJM推出了适用于研发实验室和商业灌装包装线的Dara Coolvacuum冻干设备。该仪器采用符合 FDA 21 CFR 第 11 部分的 Scada 软件设计，可满足 FDA GAMP5 和 GMP 规定。同样在 2020 年，Coolvavuum 成为 Dara Pharma Group 的一部分，使 Dara 成为冻干注射剂交钥匙解决方案的全球製造商。

与冷冻干燥工艺相关的缺点阻碍市场增长

然而，传统的冷冻干燥工艺有一些缺点。处理时间从几天到几週不等，高昂的资本成本和能源消耗降低了整个过程的效率。如果过程失败，静态过程也会增加整个批次被拒绝的风险。批处理仅限于处理小单位剂量并且需要许多小瓶。儘管目前有良好的生产规范 (cGMP)，但在该过程中的人为干预会增加污染的风险。此外，还存在有关干燥器设计、容器密封性、负载条件、取决于产品配方的传热和传质以及工艺放大的问题。

COVID-19 影响分析

针对 COVID-19 的疫苗和 PCR 诊断试剂盒对于抗击这一流行病至关重要。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。冻干在开发均匀可靠的药物化合物方面发挥着重要作用。根据 Hudson Valeriomac 的说法，冷冻干燥可以稳定药物，并能够工业化生产用于压片和封装的粉末。製药客户使用冷冻干燥来製造保质期长的产品，例如疫苗和其他注射剂。 COVID-19 增加了对冻干产品的需求，并增加了全球对冻干设备的需求。

最近，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製造固体生物药物提供了广阔的前景，同时又不影响其安全性、质量和功效。这些潜在的干燥技术不仅将减少製造救生药物所涉及的时间、能源消耗和相关成本，而且还有助于生物製药行业降低 COVID-19 期间与药物供应相关的任何风险。

细分分析

在预测期内（2022-2029 年），研究部门预计将以最快的复合年增长率增长。

研究部门占据了最大的市场份额。近年来，生物製药已成为改善各种自身免疫性疾病、癌症和遗传疾病患者生活质量的突破性工具。随着对生物製药的需求不断增长，必须在不影响产品安全性、质量和功效的情况下降低製造成本。冻干用于生产固体生物药物。

冷冻干燥机具有以下优点：冷冻干燥易碎、不稳定或热敏感的药物和生物製剂可以在低温下干燥，而不会影响其物理结构。冻干产品可以快速轻鬆地复原。这对于需要尽快接种的紧急疫苗和抗体尤其有价值。

根据 2022 年 8 月发表在 Advanced Drug Delivery Reviews 上的一篇论文，当不需要特定生物化合物的液体稳定性时，冻干或冷冻产品开发是配方设计师的最佳选择。这将是一种可能的情况。例如，冻干活病毒疫苗（LVV）的开发。

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. 提供全面可靠的冷冻干燥解决方案，旨在满足工业和学术研发设施不断增长的需求。

区域分析

亚太地区在全球冷冻干燥/冷冻干燥设备市场中占有最大的市场份额。

亚太地区在冷冻干燥/冷冻干燥设备市场占据主导地位，预计在预测期内将呈现类似趋势。市场增长的背后是对生物技术行业研发投资的增加、对冻干产品的需求不断增长、技术进步以及亚太地区主要参与者的存在。

用于生物技术行业研究的资金不断增加正在推动市场。例如，2022 年 7 月，MaxHealth Biotechnology 以 7400 万美元的 B 轮融资位居亚太私营生物技术投资集团之首。该组织将利用这笔资金扩大针对大流行性流感、季节性流感、狂犬病和冠状病毒等传染病的疫苗开发。

此外，食品行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的冷冻干燥/冷冻干燥设备市场。例如，2021 年 6 月，日本可口可乐推出了速溶啤酒冻干大麦茶、咖啡块和绿茶。冷冻干燥可以将茶叶和咖啡豆的原始香气和风味浓缩成立方体，提供美味的杯子，非常适合外出时打包或在家中少洗漱享用。

内容

第 1 章市场研究方法和范围

  • 调查方法
  • 调查目的和范围

第 2 章市场定义和概述

第 3 章执行摘要

第 4 章市场动态

  • 市场影响因素
    • 促进因素
      • 对冻干类型的需求不断增长
      • 冷冻干燥技术的技术进步
    • 限制因素
    • 缺乏熟练工人
    • 商机
    • 影响分析

第 5 章行业分析

  • 波特五力分析
  • 供应链分析
  • 监管分析

第 6 章 COVID-19 分析

  • COVID-19 的市场分析
    • COVID-19 之前的市场情景
    • COVID-19 的当前市场情景
    • COVID-19 后或未来情景
  • COVID-19 期间的价格动态
  • 供需范围
  • 大流行期间与市场相关的政府举措
  • 製造商的战略举措
  • 总结

第 7 章按类型

  • 製冷系统
  • 真空系统
  • 控制和监控系统
  • 产品室/歧管
  • 就地清洗 (CIP) 系统
  • 烘干室
  • 装卸系统
  • 其他设备

第 8 章技术

  • 托盘式冷冻干燥机
  • 歧管冷冻干燥机
  • 旋转式冷冻干燥机

第 9 章按经营规模

  • 实验室规模冷冻干燥机
  • 中试规模冷冻干燥机
  • 工业冷冻干燥机

第 10 章按应用程序

  • 营养保健品
  • 药物开发
  • 医学诊断
  • 调查研究
  • 其他

第 11 章按地区划分

  • 北美
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 其他欧洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 澳大利亚
    • 其他亚太地区
  • 中东和非洲

第 12 章竞争格局

  • 主要发展和战略
  • 公司份额分析
  • 产品基准

第 13 章公司简介

  • Thermo Fisher Scientific Inc.
    • 公司简介
    • 产品组合和描述
    • 主要亮点
    • 财务摘要
  • Millrock Technology Inc.
  • SP Scientific
  • Zirbus Technology GmbH
  • Azbil Telstar SL
  • LTE Scientific
  • Biopharma Process Systems Ltd.
  • GEA Group
  • Martin Christ GmbH
  • Cuddon Freeze Dry

第 14 章全球冷冻干燥机市场DataM

简介目录
Product Code: DMMD1110

Market Overview

The global lyophilization/freeze drying equipment market size was growing at a CAGR of 8.1% during the forecast period (2022-2029).

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.

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.

Segment Analysis

The research segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)

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.

Geographical Analysis

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.

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.

Table of Contents

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. Global Lyophilization/Freeze Drying Equipment Market - DataM

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