The North America lyophilized injectable market is expected to grow from US$ 1,145.21 million in 2022 to US$ 1,612.66 million by 2028. It is estimated to grow at a CAGR of 5.9% from 2022 to 2028.

Increasing Demand for Biologics

The supply of numerous biologics in a liquid form is not possible. Pharmaceutical organizations may also have concerns that the pharmacodynamic and pharmacokinetic properties of certain biologics in a liquid stable format may diminish over time. The supply of biologics and other drugs is done in a lyophilized or powder form requiring reconstitution at the point of delivery, which is the only feasible pathway for the product’s commercial launch. A significant boom has been witnessed in the contract manufacturing of biologics. This can be attributed to difficulties in the production of large-scale biologics in-house. There is a need to scale up the production once novel technologies get approved—for instance, the manufacturing of CAR-T therapy. With more biological products and biosimilars entering the market, the competition within the biopharmaceutical sector is becoming fierce. Biologics manufacturers strive to reduce manufacturing costs, deliver high-quality drugs, improve process efficiency, and accelerate market entry. CMOs can adapt as per requirement, help in process innovation, and improve operational efficiency. As the pharmaceutical industry is shifting from large-scale production to more niche and targeted therapies (personalized medicine), the demand for flexible operational capabilities, production scales, and multiple-product operations is offering significant advantages to CMOs. Moreover, many companies are opting for CMO services to speed up the development process and lower production costs. Thus, the importance of lyophilization in the successful delivery of biologics boosts the use of lyophilized injectables, thereby driving the market across the region.

Market Overview

The North America lyophilized injectable market is segmented into the US, Canada, and Mexico. The US dominated the market in 2022. The market’s growth is attributed to growing healthcare expenditure, increasing production of generic pharmaceuticals, and growing government support to enhance pharmaceutical and biopharmaceutical industries. In addition, the growing incidence of chronic and acute diseases has led to the growth of the market indirectly. The supportive environment backs the development and commercialization of pharmaceutical and biopharmaceutical products. As per the International Trade Administration (ITA), the US is the biggest biopharmaceutical market, accounting for about a third of the global market, and is the dominant country in biopharmaceutical R&D. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), the US firms conduct over half the world’s R&D in pharmaceuticals (US$ 75 billion) and hold the intellectual property rights on most new medicines. Market players are adopting strategies such as partnerships, collaborations, and mergers & acquisitions to expand the market. For instance, in August 2022, Curia announced that it had completed the transaction to acquire Integrity Bio, Inc., a privately held formulation and fill-finish organization headquartered in Camarillo, California. Similarly, in October 2020, Credence MedSystems and SCHOTT AG collaborated on the application of Credence Companion technology with SCHOTT’s pre-fillable syriQ glass and SCHOTT TOPPAC polymer syringe systems. The two companies will work together to integrate the technologies and provide the pharmaceutical industry with an innovative and differentiated offering for the delivery of injectable medications via prefilled syringes. Thus, the growing pharmaceutical and biopharmaceutical industries has broadened the market’s growth opportunities. The changing health conditions and requirements are the factors that continually demand newer products.

North America Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)

North America Lyophilized Injectable Market Segmentation

The North America lyophilized injectable market is segmented based on type of packaging, type of delivery, indication, end user, and country.
Based on type of packaging, the North America lyophilized injectable market is segmented into single-use vials, point-of-care reconstitution, and specialty packaging. The single-use vials segment held the largest market share in 2022. Based on type of delivery, the North America lyophilized injectable market is segmented into prefilled diluent syringes, single-step devices, proprietary reconstitution devices, and multi-step devices. The prefilled diluent syringes segment held the largest market share in 2022. Based on indication, the North America lyophilized injectable market is segmented into metabolic and oncology conditions, infectious diseases, autoimmune diseases, and others. The metabolic and oncology conditions segment held the largest market share in 2022. Based on end user, the North America lyophilized injectable market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment held the largest market share in 2022. Based on country, the North America lyophilized injectable market is segmented into the US, Canada, and Mexico. The US dominated the market in 2022.
Aristopharma Ltd.; Baxter; CordenPharma International; Credence MedSystems, Inc.; Curia Global, Inc.; Jubilant HollisterStier (Jubilant Pharma Limited); Nipro; Recipharm AB; S.G. Biopharm Pvt. Ltd.; and Vetter Pharma are among the leading companies operating in the North America lyophilized injectable market.

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 Lyophilized Injectable Market – By Type of Packaging
1.3.2 North America Lyophilized Injectable Market – By Type of Delivery
1.3.3 North America Lyophilized Injectable Market – By Indication
1.3.4 North America Lyophilized Injectable Market – By End User
1.3.5 North America Lyophilized Injectable Market – By Country
2. Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. North America Lyophilized Injectable Market – Market Landscape
4.1 Overview
4.2 North America PEST Analysis
4.3 Experts Opinion
5. North America Lyophilized Injectable Market– Key Market Dynamics
5.1 Market Drivers
5.1.1 Increasing Demand for Contract Research Manufacturing Services
5.1.2 Increasing Demand of Biologics
5.2 Market Restraints
5.2.1 Product Recalls
5.3 Market Opportunities
5.3.1 Expansion of Pipeline of Lyophilized Injectable Drugs
5.4 Future Trends
5.4.1 Advancement in Lyophilized Packaging
5.5 Impact Analysis
6. Lyophilized Injectable Market– North America Analysis
6.1 North America Lyophilized Injectable Market Revenue Forecast and Analysis
7. North America Lyophilized Injectable Market Analysis – By Type of Packaging
7.1 Overview
7.2 North America Lyophilized Injectable Market Revenue Share, by Type of Packaging (2021 and 2028)
7.3 Single-use vials
7.3.1 Overview
7.3.2 Single-use vials: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
7.4 Point-of-Care Reconstitution
7.4.1 Overview
7.4.2 Point-of-Care Reconstitution: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
7.5 Specialty Packaging
7.5.1 Overview
7.5.2 Specialty Packaging: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8. North America Lyophilized Injectable Market Analysis – By Type of Delivery
8.1 Overview
8.2 North America Lyophilized Injectable Market Revenue Share, by Type of Delivery (2021 and 2028)
8.3 Prefilled Diluent Syringes
8.3.1 Overview
8.3.2 Prefilled Diluent Syringes: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.4 Single Step Devices
8.4.1 Overview
8.4.2 Single Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.5 Proprietary Reconstitution Devices
8.5.1 Overview
8.5.2 Proprietary Reconstitution Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.6 Multi-Step Devices
8.6.1 Overview
8.6.2 Multi-Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9. North America Lyophilized Injectable Market Analysis – By Indication
9.1 Overview
9.2 North America Lyophilized Injectable Market Revenue Share, by Indication (2021 and 2028)
9.3 Metabolic and Oncology Conditions
9.3.1 Overview
9.3.2 Metabolic and Oncology Conditions: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.4 Infectious Diseases
9.4.1 Overview
9.4.2 Infectious Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.5 Autoimmune Diseases
9.5.1 Overview
9.5.2 Autoimmune Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.6 Other Indications
9.6.1 Overview
9.6.2 Other Indications: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10. North America Lyophilized Injectable Market Analysis – By End User
10.1 Overview
10.2 North America Lyophilized Injectable Market, by End User, 2021 and 2028 (%)
10.3 Hospitals
10.3.1 Overview
10.3.2 Hospitals: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.4 Ambulatory Surgical Centers
10.4.1 Overview
10.4.2 Ambulatory Surgical Centers: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.5 Specialty Clinics
10.5.1 Overview
10.5.2 Specialty Clinics: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.6 Other End Users
10.6.1 Overview
10.6.2 Other End Users: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11. North America Lyophilized Injectable Market – Country Analysis
11.1 Overview
11.1.1 North America: Lyophilized Injectable Market, by Country, 2021 & 2028 (%)
11.1.1.1 US: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.1.1 Overview
11.1.1.1.2 US: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.1.3 US: Lyophilized Injectable Market, by Type of Packaging, 2019–2028 (US$ Million)
11.1.1.1.4 US: Lyophilized Injectable Market, by Type of Delivery, 2019–2028 (US$ Million)
11.1.1.1.5 US: Lyophilized Injectable Market, by Indication, 2019–2028 (US$ Million)
11.1.1.1.6 US: Lyophilized Injectable Market, by End User, 2019–2028 (US$ Million)
11.1.1.2 Canada: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.2.1 Overview
11.1.1.2.2 Canada: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.2.3 Canada: Lyophilized Injectable Market, by Type of Packaging, 2019–2028 (US$ Million)
11.1.1.2.4 Canada: Lyophilized Injectable Market, by Type of Delivery, 2019–2028 (US$ Million)
11.1.1.2.5 Canada: Lyophilized Injectable Market, by Indication, 2019–2028 (US$ Million)
11.1.1.2.6 Canada: Lyophilized Injectable Market, by End User, 2019–2028 (US$ Million)
11.1.1.3 Mexico: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.3.1 Overview
11.1.1.3.2 Mexico: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11.1.1.3.3 Mexico: Lyophilized Injectable Market, by Type of Packaging, 2019–2028 (US$ Million)
11.1.1.3.4 Mexico: Lyophilized Injectable Market, by Type of Delivery, 2019–2028 (US$ Million)
11.1.1.3.5 Mexico: Lyophilized Injectable Market, by Indication, 2019–2028 (US$ Million)
11.1.1.3.6 Mexico: Lyophilized Injectable Market, by End User, 2019–2028 (US$ Million)
12. Industry Landscape
12.1 Overview
12.2 Inorganic Growth Strategies
12.2.1 Overview
12.3 Organic Growth Strategies
12.3.1 Overview
13. Company Profiles
13.1 Baxter
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Nipro
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Curia Global, Inc.
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Recipharm AB
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Vetter Pharma
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Jubilant HollisterStier (Jubilant Pharma Limited)
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Aristopharma Ltd.
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 CordenPharma International
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Credence MedSystems, Inc.
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 S.G. Biopharm Pvt. Ltd.
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
14. Appendix
14.1 About The Insight Partners
14.2 Glossary of Terms

Table 1.             North America Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Table 2.             US Lyophilized Injectable Market, by Type of Packaging – Revenue and Forecast to 2028 (US$ Million)
Table 3.             US Lyophilized Injectable Market, by Type of Delivery – Revenue and Forecast to 2028 (US$ Million)
Table 4.             US Lyophilized Injectable Market, by Indication – Revenue and Forecast to 2028 (US$ Million)
Table 5.             US Lyophilized Injectable Market, by End User – Revenue and Forecast to 2028 (US$ Million)
Table 6.             Canada: Lyophilized Injectable Market, by Type of Packaging – Revenue and Forecast to 2028 (US$ Million)
Table 7.             Canada: Lyophilized Injectable Market, by Type of Delivery – Revenue and Forecast to 2028 (US$ Million)
Table 8.             Canada: Lyophilized Injectable Market, by Indication – Revenue and Forecast to 2028 (US$ Million)
Table 9.             Canada: Lyophilized Injectable Market, by End User – Revenue and Forecast to 2028 (US$ Million)
Table 10.          Mexico: Lyophilized Injectable Market, by Type of Packaging – Revenue and Forecast to 2028 (US$ Million)
Table 11.          Mexico: Lyophilized Injectable Market, by Type of Delivery – Revenue and Forecast to 2028 (US$ Million)
Table 12.          Mexico: Lyophilized Injectable Market, by Indication – Revenue and Forecast to 2028 (US$ Million)
Table 13.          Mexico: Lyophilized Injectable Market, by End User – Revenue and Forecast to 2028 (US$ Million)
Table 14.          Recent Inorganic Growth Strategies
Table 15.          Recent Organic Growth Strategies
Table 16.          Glossary of Terms
 
 

Figure 1.           North America Lyophilized Injectable Market Segmentation
Figure 2.           North America Lyophilized Injectable Market – By Country
Figure 3.           North America Lyophilized Injectable Market Overview
Figure 4.           North America Lyophilized Injectable Market, By Type of Packaging
Figure 5.           North America Lyophilized Injectable Market, By Country
Figure 6.           North America: PEST Analysis
Figure 7.           Experts Opinion
Figure 8.           North America Lyophilized Injectable Market Impact Analysis of Drivers and Restraints
Figure 9.           North America Lyophilized Injectable Market– Revenue Forecast and Analysis
Figure 10.        North America Lyophilized Injectable Market Revenue Share, by Type of Packaging (2021 and 2028)
Figure 11.        North America Single-use vials: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 12.        North America Point-of-Care Reconstitution: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 13.        North America Specialty Packaging: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 14.        North America Lyophilized Injectable Market Revenue Share, by Type of Delivery (2021 and 2028)
Figure 15.        North America Prefilled Diluent Syringes: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 16.        North America Single Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 17.        North America Proprietary Reconstitution Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 18.        North America Multi-Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 19.        North America Lyophilized Injectable Market Revenue Share, by Indication (2021 and 2028)
Figure 20.        orth America Metabolic and Oncology Conditions: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 21.        North America Infectious Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 22.        North America Autoimmune Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 23.        North America Other Indications: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 24.        North America Lyophilized Injectable Market, by End User, 2021 and 2028 (%)
Figure 25.        North America Hospitals: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 26.        North America Ambulatory Surgical Centers: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 27.        North America Specialty Clinics: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 28.        North America Other End Users: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 29.        North America: Lyophilized Injectable Market, by Key Country – Revenue (2021) (US$ Million)
Figure 30.        North America: Lyophilized Injectable Market, by Country, 2021 & 2028 (%)
Figure 31.        US: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 32.        Canada: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 33.          Mexico: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)

● Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the North America lyophilized injectable market.
● Highlights key business priorities to assist companies to realign their business strategies
● The key findings and recommendations highlight crucial progressive industry trends in the North America lyophilized injectable 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 lyophilized injectable market, as well as those hindering it
● Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing, and distribution

● Aristopharma Ltd.
● Baxter
● CordenPharma International
● Credence MedSystems, Inc.
● Curia Global, Inc.
● Jubilant HollisterStier (Jubilant Pharma Limited)
● Nipro
● Recipharm AB
● S.G. Biopharm Pvt. Ltd.
● Vetter Pharma