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生物製劑

北美生物製藥凍乾服務市場預測至 2028 年 - COVID-19 影響和區域分析 - 按服務類型和最終用戶

市場調查報告書

商品編碼

1375116

北美生物製藥凍乾服務市場預測至 2028 年 - COVID-19 影響和區域分析 - 按服務類型和最終用戶

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: 2023年08月29日 | 出版商:

The Insight Partners | 英文 101 Pages | 訂單完成後即時交付

價格

簡介目錄圖表

北美生物製藥凍乾服務市場預計將從2023年的9.7405億美元成長到2028年的15.8777億美元。預計2023年至2028年的年複合成長率為10.3%。

對冷凍乾燥產品的需求不斷成長推動了北美生物製藥市場的冷凍乾燥服務

冷凍乾燥是一種冷凍乾燥方法，可去除材料中的水分，以延長其保存期限和穩定性。凍乾加工的產品在高真空下冷凍，主要用於製藥業，製造高品質且價格實惠的產品。許多新的胃腸外產品，包括生物技術衍生產品、體外診斷和抗感染藥物，都是以冷凍乾燥產品的形式生產的。冷凍乾燥過程可生產頭孢菌素、半合成青黴素、紅黴素鹽、氯黴素和強力黴素等抗生素。批處理抗生素製劑時預計生物負荷較低，可透過冷凍乾燥來實現。同樣，其他一些劑型如甲潑尼龍琥珀酸鈉、氫化可的松琥珀酸鈉和許多生物技術衍生產品也是冷凍乾燥的。

過去幾年，美國食品藥物管理局 (FDA) 每年批准 10 多種新型生物製劑。根據 FDA 2022 年 2 月公佈的資料，生物製劑繼續佔 FDA 接受的所有藥物的 25% 以上。大多數這些產品作為水性配方並不穩定，因此難以長期保存。因此，冷凍乾燥是製備乾燥生物藥物製劑的優選方法，以實現更長且商業上可行的保存期限。根據路博潤生命科學發布的資料，2019年10月，市場上超過60%的生物製劑生產離不開凍乾技術，並且由於生物學名藥和新型生物製劑的不斷發展，市場對凍乾技術的需求將會增加。當存在穩定性問題同時提供精確的生物製劑劑量（例如，非常小且高度濃縮的劑量）時，該方法被證明是有益的。此外，它也適用於對熱、氧和濕度敏感的生物製品。此外，凍乾在生物技術行業中已變得重要，因為一些供應商正在向市場推出凍乾或預凍乾產品。因此，凍乾服務的需求快速成長，推動生物製藥凍乾服務市場的成長。

北美生物製藥凍乾服務市場概述

北美生物製藥市場的冷凍乾燥服務進一步細分為美國、加拿大和墨西哥。 2022年，美國在北美生物製藥凍乾服務市場中佔據最大佔有率。美國市場的成長歸因於廣泛的研發活動、創新生物製藥和醫藥產品的先進製造等因素。同樣，加拿大生物製藥行業的顯著成長和國際公司投資的增加可能會加速市場的成長。美國、加拿大和墨西哥不斷發展的生物製藥產業正在為各國創造就業機會。

北美生物製藥凍乾服務市場收入及 2028 年預測（百萬美元）

北美生物製藥凍乾服務市場細分

北美生物製藥市場凍乾服務分為服務類型、最終用戶和國家。

根據服務類型，北美生物製藥市場凍乾服務分為冷凍乾燥循環開發、臨床製造、商業製造和冷凍乾燥分析服務。 2023年，商業製造領域在北美生物製藥凍乾服務市場中佔據最大佔有率。

根據最終用戶，北美生物製藥市場凍乾服務分為製藥和生技公司、研究機構等。 2023年，製藥和生技公司部門在北美生物製藥凍乾服務市場中佔據最大佔有率。

根據國家/地區，北美生物製藥市場凍乾服務分為美國、加拿大和墨西哥。 2023年，美國在北美生物製藥凍乾服務市場佔有率中佔據主導地位。

ATTWILL 醫療解決方案； Axcellerate Pharma LLC；伯克希爾無菌製造；庫裡亞全球公司；緊急生物解決方案公司；欣欣向榮的 HollisterStier 有限責任公司；迷宮生物製藥有限責任公司；凍乾技術有限公司；和 PCI Pharma Services 是北美生物製藥市場凍乾服務的領先公司。

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.

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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.
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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

簡介目錄圖表

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