北美生物製药冻干服务市场预测至 2028 年 - COVID-19 影响和区域分析 - 按服务类型和最终用户
市场调查报告书
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1375116

北美生物製药冻干服务市场预测至 2028 年 - COVID-19 影响和区域分析 - 按服务类型和最终用户

North America Lyophilization Services for Biopharmaceuticals Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Service Type and End User

出版日期: | 出版商: The Insight Partners | 英文 101 Pages | 订单完成后即时交付

价格

北美生物製药冻干服务市场预计将从2023年的9.7405亿美元成长到2028年的15.8777亿美元。预计2023年至2028年的复合年增长率为10.3%。

对冷冻干燥产品的需求不断增长推动了北美生物製药市场的冷冻干燥服务

冷冻干燥是一种冷冻干燥方法,可去除材料中的水分,以延长其保质期和稳定性。冻干加工的产品在高真空下冷冻,主要用于製药业,製造高品质且价格实惠的产品。许多新的胃肠外产品,包括生物技术衍生产品、体外诊断和抗感染药物,都是以冷冻干燥产品的形式生产的。冷冻干燥过程可生产头孢菌素、半合成青霉素、红霉素盐、氯霉素和强力霉素等抗生素。批处理抗生素製剂时预计生物负荷较低,可透过冷冻干燥来实现。同样,其他一些剂型如甲泼尼龙琥珀酸钠、氢化可的松琥珀酸钠和许多生物技术衍生产品也是冷冻干燥的。

过去几年,美国食品药物管理局 (FDA) 每年批准 10 多种新型生物製剂。根据 FDA 2022 年 2 月公布的资料,生物製剂继续占 FDA 接受的所有药物的 25% 以上。大多数这些产品作为水性配方并不稳定,因此难以长期保存。因此,冷冻干燥是製备干燥生物药物製剂的优选方法,以实现更长且商业上可行的保质期。根据路博润生命科学发布的资料,2019年10月,市场上超过60%的生物製剂生产离不开冻干技术,并且由于生物仿製药和新型生物製剂的不断发展,市场对冻干技术的需求将会增加。当存在稳定性问题同时提供精确的生物製剂剂量(例如,非常小且高度浓缩的剂量)时,该方法被证明是有益的。此外,它也适用于对热、氧和湿度敏感的生物製品。此外,冻干在生物技术行业中已变得重要,因为一些供应商正在向市场推出冻干或预冻干产品。因此,冻干服务的需求快速成长,推动生物製药冻干服务市场的成长。

北美生物製药冻干服务市场概述

北美生物製药市场的冷冻干燥服务进一步细分为美国、加拿大和墨西哥。 2022年,美国在北美生物製药冻干服务市场中占据最大份额。美国市场的成长归因于广泛的研发活动、创新生物製药和医药产品的先进製造等因素。同样,加拿大生物製药行业的显着增长和国际公司投资的增加可能会加速市场的成长。美国、加拿大和墨西哥不断发展的生物製药产业正在为各国创造就业机会。

北美生物製药冻干服务市场收入及 2028 年预测(百万美元)

北美生物製药冻干服务市场细分

北美生物製药市场冻干服务分为服务类型、最终用户和国家。

根据服务类型,北美生物製药市场冻干服务分为冷冻干燥循环开发、临床製造、商业製造和冷冻干燥分析服务。 2023年,商业製造领域在北美生物製药冻干服务市场中占据最大份额。

根据最终用户,北美生物製药市场冻干服务分为製药和生技公司、研究机构等。 2023年,製药和生技公司部门在北美生物製药冻干服务市场中占据最大份额。

根据国家/地区,北美生物製药市场冻干服务分为美国、加拿大和墨西哥。 2023年,美国在北美生物製药冻干服务市场份额中占据主导地位。

ATTWILL 医疗解决方案; Axcellerate Pharma LLC;伯克希尔无菌製造;库里亚全球公司;紧急生物解决方案公司;欣欣向荣的 HollisterStier 有限责任公司;迷宫生物製药有限责任公司;冻干技术有限公司;和 PCI Pharma Services 是北美生物製药市场冻干服务的领先公司。

目录

第 1 章:简介

  • 研究范围
  • Insight Partners 研究报告指南
  • 市场区隔
    • 北美生物製药市场冻干服务 - 按服务类型
    • 北美生物製药市场冻干服务 - 按最终用户
    • 北美生物製药市场冻干服务 - 按国家/地区

第 2 章:北美生物製药市场冻干服务 - 要点

第 3 章:研究方法

  • 覆盖范围
  • 二次研究
  • 初步研究

第 4 章:北美生物製药市场冻干服务 - 市场格局

  • 概述
  • 北美 PEST 分析
  • 专家意见

第 5 章:北美生物製药市场冻干服务 - 主要市场动态

  • 市场驱动力
    • 对冻干产品的需求不断增长
    • 合约製造和冻干服务快速成长
  • 市场限制
    • 与冻干过程相关的缺点
  • 市场机会
    • 推出先进的冻干技术
  • 未来的趋势
    • siRNA 和抗体製剂的数量不断增加
  • 驱动因素和限制因素的影响分析

第 6 章:生物製药市场的冷冻干燥服务 - 北美分析

  • 北美生物製药冻干服务市场收入预测与分析

第 7 章:北美生物製药冻干服务市场分析和预测至 2028 年 - 按服务类型

  • 概述
  • 北美生物製药市场冻干服务,按服务类型划分 2022 年和 2028 年(%)
  • 商业製造
  • 临床製造
  • 冻干循环开发
  • 冷冻干燥分析服务

第 8 章:北美生物製药冻干服务市场分析和 2028 年预测 - 按最终用户

  • 概述
  • 北美生物製药市场冻干服务,按最终用户划分,2022 年和 2028 年 (%)
  • 製药和生物技术公司
  • 研究机构
  • 其他的

第 9 章:北美生物製药市场冻干服务 - 收入和 2028 年预测 - 国家分析

  • 概述
    • 北美生物製药市场冻干服务,按国家/地区划分,2022 年和 2028 年 (%)

第 10 章:北美生物製药市场冻干服务 - 产业格局

  • 概述
  • 北美生物製药冻干服务市场的成长策略
  • 无机成长策略
    • 概述
  • 有机成长策略
    • 概述

第 11 章:公司简介

  • ATTWILL Medical Solutions
  • Axcellerate Pharma LLC
  • Labyrinth BioPharma LLC
  • Berkshire Sterile Manufacturing
  • PCI Pharma Services
  • Curia Global Inc
  • Emergent BioSolutions Inc
  • Jubilant HollisterStier LLC.
  • Lyophilization Technology, Inc.

第 12 章:附录

  • 关于 Insight Partners
  • 专业术语
Product Code: BMIRE00028842

The North America lyophilization services for biopharmaceuticals market is expected to grow from US$ 974.05 million in 2023 to US$ 1,587.77 million by 2028. It is estimated to register a CAGR of 10.3% from 2023 to 2028.

Rising Demand for Lyophilized Products Fuel North America Lyophilization Services for Biopharmaceuticals Market

Lyophilization is a freeze-drying method that removes water from the material to extend its shelf life and stability. The products processed under lyophilization are frozen under high vacuum and are majorly used in pharmaceutical industries to manufacture high-quality and affordable products. Many new parenteral products, including biotechnology-derived products, in-vitro diagnostics, and anti-infectives, are manufactured as lyophilized products. The lyophilization process makes antibiotics such as cephalosporins, semi-synthetic penicillin, erythromycin salts, chloramphenicol, and doxycycline. Low bioburden is expected when batching antibiotics formulations, which can be attained using lyophilization. Similarly, a few other dosage forms such as methylprednisolone sodium succinate, hydrocortisone sodium succinate, and many biotechnology-derived products are lyophilized.

Over 10 novel biologics have been approved annually by the US Food and Drug Administration (FDA) in the last few years. According to the data published by FDA in February 2022, biologics continue to account for slightly more than 25% of all drugs accepted by the FDA. Most of these products are not stable as aqueous formulations, making it challenging to preserve them for longer durations. Thus, lyophilization is preferred for making dry biopharmaceutical formulations to achieve longer and commercially viable shelf lives. According to the data published by Lubrizol Life Science, in October 2019, over 60% of biologics production in the market would not be possible without lyophilization, and market demand for lyophilization technology will increase due to the growing biosimilars and novel biologics development. The method proves beneficial when there is a stability issue while providing exact biologics dosage (for instance, very small and highly concentrated doses). Furthermore, it is suitable for biologics sensitive to heat, oxygen, and humidity. Further, lyophilization has become important in the biotech industry, as several suppliers are introducing lyo-ready or pre-lyophilized products to the marketplace. As a result, the demand for lyophilization services is growing rapidly, driving the growth of the lyophilization services for biopharmaceuticals market.

North America Lyophilization Services for Biopharmaceuticals Market Overview

The lyophilization services for biopharmaceuticals market in North America is further segmented into the US, Canada, and Mexico. The US held the largest share of the North America lyophilization services for biopharmaceuticals market in 2022. The market growth in the US is attributed to factors such as extensive research and development activities, advanced manufacturing of innovative biopharmaceutical and pharmaceutical products. Likewise, the significant growth of the biopharmaceutical industry in Canada and increasing investment by international companies are likely to accelerate the market growth at a faster pace. The growing biopharmaceutical industry in the US, Canada, and Mexico is generating job opportunities across the countries.

North America Lyophilization Services for Biopharmaceuticals Market Revenue and Forecast to 2028 (US$ Million)

North America Lyophilization Services for Biopharmaceuticals Market Segmentation

The North America lyophilization services for biopharmaceuticals market is segmented into service type, end user, and country.

Based on service type, the North America lyophilization services for biopharmaceuticals market is segmented into lyophilization cycle development, clinical manufacturing, commercial manufacturing, and freeze drying analytical services. The commercial manufacturing segment held the largest share of the North America lyophilization services for biopharmaceuticals market in 2023.

Based on end user, the North America lyophilization services for biopharmaceuticals market is segmented into pharmaceutical & biotechnology companies, research institutes, and others. The pharmaceutical & biotechnology companies segment held the largest share of the North America lyophilization services for biopharmaceuticals market in 2023.

Based on country, the North America lyophilization services for biopharmaceuticals market is segmented into the US, Canada, and Mexico. The US dominated the share of the North America lyophilization services for biopharmaceuticals market in 2023.

ATTWILL Medical Solutions; Axcellerate Pharma LLC; Berkshire Sterile Manufacturing; Curia Global Inc; Emergent BioSolutions Inc; Jubilant HollisterStier LLC.; Labyrinth BioPharma LLC; Lyophilization Technology, Inc.; and PCI Pharma Services are the leading companies operating in the North America lyophilization services for biopharmaceuticals market.

Reasons to Buy:

  • Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the North America lyophilization services for biopharmaceuticals market.
  • Highlights key business priorities in order to assist companies to realign their business strategies.
  • The key findings and recommendations highlight crucial progressive industry trends in North America lyophilization services for biopharmaceuticals market, thereby allowing players across the value chain to develop effective long-term strategies.
  • Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.
  • Scrutinize in-depth North America market trends and outlook coupled with the factors driving the market, as well as those hindering it.
  • Enhance the decision-making process by understanding the strategies that underpin security interest with respect to client products, segmentation, pricing and distribution.

Table Of Contents

1. Introduction

  • 1.1 Scope of the Study
  • 1.2 The Insight Partners Research Report Guidance
  • 1.3 Market Segmentation
    • 1.3.1 North America Lyophilization Services for Biopharmaceuticals Market - by Service Type
    • 1.3.2 North America Lyophilization Services for Biopharmaceuticals Market - by End User
    • 1.3.3 North America Lyophilization Services for Biopharmaceuticals Market - by Country

2. North America Lyophilization Services for Biopharmaceuticals Market - Key Takeaways

3. Research Methodology

  • 3.1 Coverage
  • 3.2 Secondary Research
  • 3.3 Primary Research

4. North America Lyophilization Services for Biopharmaceuticals Market - Market Landscape

  • 4.1 Overview
  • 4.2 North America PEST Analysis
  • 4.3 Expert's Opinion

5. North America Lyophilization Services for Biopharmaceuticals Market - Key Market Dynamics

  • 5.1 Market Driver
    • 5.1.1 Rising Demand for Lyophilized Products
    • 5.1.2 Rapid Growth in Contract Manufacturing and Lyophilization Services
  • 5.2 Market Restraints
    • 5.2.1 Demerits Associated with Lyophilization Process
  • 5.3 Market Opportunities
    • 5.3.1 Launch of Advanced Lyophilization Technology
  • 5.4 Future Trends
    • 5.4.1 Growing Number of siRNA and Antibody-Based Formulations
  • 5.5 Impact Analysis of Drivers and Restraints

6. Lyophilization Services for Biopharmaceuticals Market - North America Analysis

  • 6.1 North America Lyophilization Services for Biopharmaceuticals Market Revenue Forecast and Analysis

7. North America Lyophilization Services for Biopharmaceuticals Market Analysis and Forecast to 2028 - by Service Type

  • 7.1 Overview
  • 7.2 North America Lyophilization Services for Biopharmaceuticals Market, by Service Type 2022 & 2028 (%)
  • 7.3 Commercial Manufacturing
    • 7.3.1 Overview
    • 7.3.2 Commercial Manufacturing: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.4 Clinical Manufacturing
    • 7.4.1 Overview
    • 7.4.2 Clinical Manufacturing: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.5 Lyophilization Cycle Development
    • 7.5.1 Overview
    • 7.5.2 Lyophilization Cycle Development: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • 7.6 Freeze Drying Analytical Services
    • 7.6.1 Overview
    • 7.6.2 Freeze Drying Analytical Services: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)

8. North America Lyophilization Services for Biopharmaceuticals Market Analysis and Forecast to 2028 - by End User

  • 8.1 Overview
  • 8.2 North America Lyophilization Services for Biopharmaceuticals Market, by End User, 2022 & 2028 (%)
  • 8.3 Pharmaceutical and Biotechnology Companies
    • 8.3.1 Overview
    • 8.3.2 Pharmaceutical and Biotechnology Companies: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • 8.4 Research Institutes
    • 8.4.1 Overview
    • 8.4.2 Research Institutes: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • 8.5 Others
    • 8.5.1 Overview
    • 8.5.2 Others: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)

9. North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 -Country Analysis

  • 9.1 Overview
    • 9.1.1 North America Lyophilization Services for Biopharmaceuticals Market, by Country, 2022 & 2028 (%)
      • 9.1.1.1 US: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.1.1 Overview
        • 9.1.1.1.2 US: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.1.3 US: North America Lyophilization Services for Biopharmaceuticals Market, by Service Type, 2020-2028 (US$ Million)
        • 9.1.1.1.4 US North America Lyophilization Services for Biopharmaceuticals Market, by End User, 2020-2028 (US$ Million)
      • 9.1.1.2 Canada: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.2.1 Overview
        • 9.1.1.2.2 Canada: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.2.3 Canada: North America Lyophilization Services for Biopharmaceuticals Market, by Service Type, 2020-2028 (US$ Million)
        • 9.1.1.2.4 Canada: North America Lyophilization Services for Biopharmaceuticals Market, by End User, 2020-2028 (US$ Million)
      • 9.1.1.3 Mexico: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.3.1 Overview
        • 9.1.1.3.2 Mexico: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
        • 9.1.1.3.3 Mexico: North America Lyophilization Services for Biopharmaceuticals Market, by Service Type, 2020-2028 (US$ Million)
        • 9.1.1.3.4 Mexico: North America Lyophilization Services for Biopharmaceuticals Market, by End User, 2020-2028 (US$ Million)

10. North America Lyophilization Services for Biopharmaceuticals Market - Industry Landscape

  • 10.1 Overview
  • 10.2 Growth Strategies in the North America Lyophilization Services for Biopharmaceuticals Market
  • 10.3 Inorganic Growth Strategies
    • 10.3.1 Overview
  • 10.4 Organic Growth Strategies
    • 10.4.1 Overview

11. Company Profiles

  • 11.1 ATTWILL Medical Solutions
    • 11.1.1 Key Facts
    • 11.1.2 Business Description
    • 11.1.3 Products and Services
    • 11.1.4 Financial Overview
    • 11.1.5 SWOT Analysis
    • 11.1.6 Key Developments
  • 11.2 Axcellerate Pharma LLC
    • 11.2.1 Key Facts
    • 11.2.2 Business Description
    • 11.2.3 Products and Services
    • 11.2.4 Financial Overview
    • 11.2.5 SWOT Analysis
    • 11.2.6 Key Developments
  • 11.3 Labyrinth BioPharma LLC
    • 11.3.1 Key Facts
    • 11.3.2 Business Description
    • 11.3.3 Products and Services
    • 11.3.4 Financial Overview
    • 11.3.5 SWOT Analysis
    • 11.3.6 Key Developments
  • 11.4 Berkshire Sterile Manufacturing
    • 11.4.1 Key Facts
    • 11.4.2 Business Description
    • 11.4.3 Products and Services
    • 11.4.4 Financial Overview
    • 11.4.5 SWOT Analysis
    • 11.4.6 Key Developments
  • 11.5 PCI Pharma Services
    • 11.5.1 Key Facts
    • 11.5.2 Business Description
    • 11.5.3 Products and Services
    • 11.5.4 Financial Overview
    • 11.5.5 SWOT Analysis
    • 11.5.6 Key Developments
  • 11.6 Curia Global Inc
    • 11.6.1 Key Facts
    • 11.6.2 Business Description
    • 11.6.3 Products and Services
    • 11.6.4 Financial Overview
    • 11.6.5 SWOT Analysis
    • 11.6.6 Key Developments
  • 11.7 Emergent BioSolutions Inc
    • 11.7.1 Key Facts
    • 11.7.2 Business Description
    • 11.7.3 Products and Services
    • 11.7.4 Financial Overview
    • 11.7.5 SWOT Analysis
    • 11.7.6 Key Developments
  • 11.8 Jubilant HollisterStier LLC.
    • 11.8.1 Key Facts
    • 11.8.2 Business Description
    • 11.8.3 Products and Services
    • 11.8.4 Financial Overview
    • 11.8.5 SWOT Analysis
    • 11.8.6 Key Developments
  • 11.9 Lyophilization Technology, Inc.
    • 11.9.1 Key Facts
    • 11.9.2 Business Description
    • 11.9.3 Products and Services
    • 11.9.4 Financial Overview
    • 11.9.5 SWOT Analysis
    • 11.9.6 Key Developments

12. Appendix

  • 12.1 About The Insight Partners
  • 12.2 Glossary of Terms

List Of Tables

  • Table 1. US North America Lyophilization Services for Biopharmaceuticals Market, by Service Type - Revenue and Forecast to 2028 (US$ Million)
  • Table 2. US North America Lyophilization Services for Biopharmaceuticals Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 3. Canada North America Lyophilization Services for Biopharmaceuticals Market, by Service Type - Revenue and Forecast to 2028 (US$ Million)
  • Table 4. Canada North America Lyophilization Services for Biopharmaceuticals Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 5. Mexico North America Lyophilization Services for Biopharmaceuticals Market, by Service Type - Revenue and Forecast to 2028 (US$ Million)
  • Table 6. Mexico North America Lyophilization Services for Biopharmaceuticals Market, by End User - Revenue and Forecast to 2028 (US$ Million)
  • Table 7. Recent Inorganic Growth Strategies in the North America Lyophilization Services for Biopharmaceuticals Market
  • Table 8. Recent Organic Growth Strategies in the North America Lyophilization Services for Biopharmaceuticals Market
  • Table 9. Glossary of Terms

List Of Figures

  • Figure 1. North America Lyophilization Services for Biopharmaceuticals Market Segmentation
  • Figure 2. North America Lyophilization Services for Biopharmaceuticals Market, by Country
  • Figure 3. North America Lyophilization Services for Biopharmaceuticals Market Overview
  • Figure 4. Commercial Manufacturing Segment Held Largest Share of Service Type Segment in North America Lyophilization Services for Biopharmaceuticals Market
  • Figure 5. The US Expected to Show Remarkable Growth During Forecast Period
  • Figure 6. North America: PEST Analysis
  • Figure 7. Experts' Opinion
  • Figure 8. North America Lyophilization Services for Biopharmaceuticals Market Impact Analysis of Drivers and Restraint
  • Figure 9. North America Lyophilization Services for Biopharmaceuticals Market - Revenue Forecast and Analysis - 2020-2028
  • Figure 10. North America Lyophilization Services for Biopharmaceuticals Market, by Service Type 2022 & 2028 (%)
  • Figure 11. Commercial Manufacturing: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 12. Clinical Manufacturing: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 13. Lyophilization Cycle Development: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 14. Freeze Drying Analytical Services: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 15. North America Lyophilization Services for Biopharmaceuticals Market, by End User, 2022 & 2028 (%)
  • Figure 16. Pharmaceutical and Biotechnology Companies: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 17. Research Institutes: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 18. Others: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 19. North America Lyophilization Services for Biopharmaceuticals Market, by Key Country - Revenue (2022) (US$ Million)
  • Figure 20. US: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 21. Canada: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 22. Mexico: North America Lyophilization Services for Biopharmaceuticals Market - Revenue and Forecast to 2028 (US$ Million)
  • Figure 23. Growth Strategies in the North America Lyophilization Services for Biopharmaceuticals Market