North America Lyophilization Services for Biopharmaceuticals Market Forecast to 2028 - COVID-19 Impact and Regional Analysis

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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.

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Product Code: BMIRE00028842

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