The global lyophilized injectable market size was exhibited at USD 2.91 billion in 2022 and is projected to hit around USD 5.17 billion by 2032, growing at a CAGR of 5.9% during the forecast period 2023 to 2032.
Key Pointers:
Lyophilization is the most commonly used method for the manufacturing of parenteral pharmaceutical products, when the product is unstable in aqueous solution. It is central to the protection of materials, which require low moisture content (less than 1%) in order to ensure stability and require a sterile and gentle preservation process.
Improved quality and shelf life of lyophilized drugs has attracted industry experts to implement lyophilization in their manufacturing processes. Contract research and manufacturing organizations have increased the use of lyophilized injectable drugs to provide quality products to customers. Therefore, rapidly growing contract research manufacturing services (CRAMS) is projected to drive the global lyophilized injectable market.
Lyophilized injectable drugs are stable at ambient temperatures and only require simple rehydration to be ready to use. This removes many sources of pipetting errors, while streamlining and simplifying workflows.
Elimination of the cold chain minimizes costs and carbon footprint, and provides a positive environmental impact by minimizing the need of expanded polystyrene (EPS or ‘Styrofoam’) containers often utilized to ship temperature-controlled products
Lyophilized products are considered safe for use, while delivering the desired functionality compared to non-lyophilized products. Moreover, lyophilization helps retain the biological and chemical activity of the chemical compound in the final product. This drives the demand for lyophilized injectable drugs in the pharmaceutical and biotechnology industries.
The ever-evolving nature of coronavirus has become a major threat to the public health, owing to its severe respiratory symptoms. Ongoing studies are surfacing about the safety and efficacy of novel lyophilized therapeutic agents in hospitalized adult patients diagnosed with COVID-19. Amid all this, healthcare giant Cipla - a global pharmaceutical company is gaining recognition for introducing its CIPREMI, a remdesivir lyophilized powder for injection (100mg). Manufacturers in the lyophilized injectable market are taking cues from such innovations to increase the availability of the U.S. FDA-approved emergency use authorization (EUA) treatment for patients with severe COVID-19 symptoms.
Since India is suffering from a third wave of the pandemic, companies in the India lyophilized injectable market are increasing efforts to gain regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country.
Lyophilized injectable Market Segmentation
By Type of Packaging | By Type of Delivery | By Indication | By End User |
Single-use Vials Point-of-care Reconstitution Specialty Packaging |
Prefilled Diluent Syringes Proprietary Reconstitution Devices Single-step Devices Multi-step Devices |
Autoimmune Diseases Infectious Diseases Metabolic Conditions Others |
Hospitals Ambulatory Surgical Centers Specialty Clinics Others |
Lyophilized injectable Market Key Players And Regions
Companies Profiled | Regions Covered |
B. Braun Melsungen AG Baxter International, Inc. BD Schott AG Aristopharma Ltd. Vetter Pharma Jubilant HollisterStier LLC among others |
North America Europe Asia Pacific Latin America Middle East & Africa |
Chapter 1. Introduction
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Lyophilized Injectable Market
4. Market Overview
4.1. Introduction & Overview
4.2. Market Dynamics
4.2.1. Drivers
4.2.2. Restraints
4.2.3. Opportunities
4.3. Global Lyophilized Injectable Market Analysis and Forecast, 2018–2032
5. Market Outlook
5.1. COVID-19 Pandemics Impact on Industry
5.2. Key Industry Developments
5.3. Pipeline Analysis
5.4. Top 10 Lyophilized Drug Products
5.5. Regulatory Scenario
6. Global Lyophilized Injectable Market Analysis and Forecast, by Type of Packaging
6.1. Introduction & Definition
6.2. Global Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
6.2.1. Single-use Vials
6.2.2. Point-of-care Reconstitution
6.2.3. Specialty Packaging
6.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Type of Packaging
7. Global Lyophilized Injectable Market Analysis and Forecast, by Type of Delivery
7.1. Introduction & Definition
7.2. Global Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
7.2.1. Prefilled Diluent Syringes
7.2.2. Proprietary Reconstitution Devices
7.2.3. Single-step Devices
7.2.4. Multi-step Devices
7.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Type of Delivery
8. Global Lyophilized Injectable Market Analysis and Forecast, by Indication
8.1. Introduction & Definition
8.2. Global Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
8.2.1. Autoimmune Diseases
8.2.2. Metabolic Conditions
8.2.3. Infectious Diseases
8.2.4. Others
8.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Indication
9. Global Lyophilized Injectable Market Analysis and Forecast, by End-user
9.1. Introduction & Definition
9.2. Global Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
9.2.1. Hospitals
9.2.2. Ambulatory Surgical Centers
9.2.3. Specialty Clinics
9.2.4. Others
9.3. Global Lyophilized Injectable Market Attractiveness Analysis, by End-user
10. Global Lyophilized Injectable Market Analysis and Forecast, by Region
10.1. Key Findings
10.2. Global Lyophilized Injectable Market Value Forecast, by Region
10.2.1. North America
10.2.2. Europe
10.2.3. Asia Pacific
10.2.4. Latin America
10.2.5. Middle East & Africa
10.3. Global Lyophilized Injectable Market Attractiveness Analysis, by Region
11. North America Lyophilized Injectable Market Analysis and Forecast
11.1. Introduction
11.2. North America Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
11.2.1. Single-use Vials
11.2.2. Point-of-care Reconstitution
11.2.3. Specialty Packaging
11.3. North America Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
11.3.1. Prefilled Diluent Syringes
11.3.2. Proprietary Reconstitution Devices
11.3.3. Single-step Devices
11.3.4. Multi-step Devices
11.4. North America Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
11.4.1. Autoimmune Diseases
11.4.2. Metabolic Conditions
11.4.3. Infectious Diseases
11.4.4. Others
11.5. North America Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
11.5.1. Hospitals
11.5.2. Ambulatory Surgical Centers
11.5.3. Specialty Clinics
11.5.4. Others
11.6. North America Lyophilized Injectable Market Value Forecast, by Country, 2018–2032
11.6.1. U.S.
11.6.2. Canada
11.7. North America Lyophilized Injectable Market Attractiveness Analysis
11.7.1. By Type of Packaging
11.7.2. By Type of Delivery
11.7.3. By Indication
11.7.4. By End-user
11.7.5. By Country
12. Europe Lyophilized Injectable Market Analysis and Forecast
12.1. Introduction
12.2. Europe Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
12.2.1. Single-use Vials
12.2.2. Point-of-care Reconstitution
12.2.3. Specialty Packaging
12.3. Europe Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
12.3.1. Prefilled Diluent Syringes
12.3.2. Proprietary Reconstitution Devices
12.3.3. Single-step Devices
12.3.4. Multi-step Devices
12.4. Europe Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
12.4.1. Autoimmune Diseases
12.4.2. Metabolic Conditions
12.4.3. Infectious Diseases
12.4.4. Others
12.5. Europe Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
12.5.1. Hospitals
12.5.2. Ambulatory Surgical Centers
12.5.3. Specialty Clinics
12.5.4. Others
12.6. Europe Lyophilized Injectable Market Value Forecast, by Country/Sub-region, 2018–2032
12.6.1. Germany
12.6.2. U.K.
12.6.3. France
12.6.4. Spain
12.6.5. Italy
12.6.6. Rest of Europe
12.7. Europe Lyophilized Injectable Market Attractiveness Analysis
12.7.1. By Type of Packaging
12.7.2. By Type of Delivery
12.7.3. By Indication
12.7.4. By End-user
12.7.5. By Country/Sub-region
13. Asia Pacific Lyophilized Injectable Market Analysis and Forecast
13.1. Introduction
13.2. Asia Pacific Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
13.2.1. Single-use Vials
13.2.2. Point-of-care Reconstitution
13.2.3. Specialty Packaging
13.3. Asia Pacific Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
13.3.1. Prefilled Diluent Syringes
13.3.2. Proprietary Reconstitution Devices
13.3.3. Single-step Devices
13.3.4. Multi-step Devices
13.4. Asia Pacific Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
13.4.1. Autoimmune Diseases
13.4.2. Metabolic Conditions
13.4.3. Infectious Diseases
13.4.4. Others
13.5. Asia Pacific Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
13.5.1. Hospitals
13.5.2. Ambulatory Surgical Centers
13.5.3. Specialty Clinics
13.5.4. Others
13.6. Asia Pacific Lyophilized Injectable Market Value Forecast, by Country/Sub-region, 2018–2032
13.6.1. China
13.6.2. Japan
13.6.3. India
13.6.4. Australia & New Zealand
13.6.5. Rest of Asia Pacific
13.7. Asia Pacific Lyophilized Injectable Market Attractiveness Analysis
13.7.1. By Type of Packaging
13.7.2. By Type of Delivery
13.7.3. By Indication
13.7.4. By End-user
13.7.5. By Country/Sub-region
14. Latin America Lyophilized Injectable Market Analysis and Forecast
14.1. Introduction
14.2. Latin America Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
14.2.1. Single-use Vials
14.2.2. Point-of-care Reconstitution
14.2.3. Specialty Packaging
14.3. Latin America Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
14.3.1. Prefilled Diluent Syringes
14.3.2. Proprietary Reconstitution Devices
14.3.3. Single-step Devices
14.3.4. Multi-step Devices
14.4. Latin America Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
14.4.1. Autoimmune Diseases
14.4.2. Metabolic Conditions
14.4.3. Infectious Diseases
14.4.4. Others
14.5. Latin America Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
14.5.1. Hospitals
14.5.2. Ambulatory Surgical Centers
14.5.3. Specialty Clinics
14.5.4. Others
14.6. Latin America Lyophilized Injectable Market Value Forecast, by Country/Sub-region, 2018–2032
14.6.1. Brazil
14.6.2. Mexico
14.6.3. Rest of Latin America
14.7. Latin America Lyophilized Injectable Market Attractiveness Analysis
14.7.1. By Type of Packaging
14.7.2. By Type of Delivery
14.7.3. By Indication
14.7.4. By End-user
14.7.5. By Country/Sub-region
15. Middle East & Africa Lyophilized Injectable Market Analysis and Forecast
15.1. Introduction
15.2. Middle East & Africa Lyophilized Injectable Market Value Forecast, by Type of Packaging, 2018–2032
15.2.1. Single-use Vials
15.2.2. Point-of-care Reconstitution
15.2.3. Specialty Packaging
15.3. Middle East & Africa Lyophilized Injectable Market Value Forecast, by Type of Delivery, 2018–2032
15.3.1. Prefilled Diluent Syringes
15.3.2. Proprietary Reconstitution Devices
15.3.3. Single-step Devices
15.3.4. Multi-step Devices
15.4. Middle East & Africa Lyophilized Injectable Market Value Forecast, by Indication, 2018–2032
15.4.1. Autoimmune Diseases
15.4.2. Metabolic Conditions
15.4.3. Infectious Diseases
15.4.4. Others
15.5. Middle East & Africa Lyophilized Injectable Market Value Forecast, by End-user, 2018–2032
15.5.1. Hospitals
15.5.2. Ambulatory Surgical Centers
15.5.3. Specialty Clinics
15.5.4. Others
15.6. Middle East & Africa Lyophilized Injectable Market Value Forecast, by Country/Sub-region, 2018–2032
15.6.1. GCC Countries
15.6.2. South Africa
15.6.3. Rest of Middle East & Africa
15.7. Middle East & Africa Lyophilized Injectable Market Attractiveness Analysis
15.7.1. By Type of Packaging
15.7.2. By Type of Delivery
15.7.3. By Indication
15.7.4. By End-user
15.7.5. By Country/Sub-region
16. Competition Landscape
16.1. Market Position Analysis, by Company, 2019
16.2. Company Profiles
16.2.1. B. Braun Melsungen AG
16.2.1.1. Company Overview (HQ, Business Segments, Employee Strength)
16.2.1.2. Growth Strategies
16.2.1.3. SWOT Analysis
16.2.2. Baxter International, Inc.
16.2.2.1. Company Overview (HQ, Business Segments, Employee Strength)
16.2.2.2. Growth Strategies
16.2.2.3. SWOT Analysis
16.2.3. BD
16.2.3.1. Company Overview (HQ, Business Segments)
16.2.3.2. Growth Strategies
16.2.3.3. SWOT Analysis
16.2.4. SCHOTT AG
16.2.4.1. Company Overview (HQ, Business Segments, Employee Strength)
16.2.4.2. Growth Strategies
16.2.4.3. SWOT Analysis
16.2.5. Aristopharma Ltd.
16.2.5.1. Company Overview (HQ, Business Segments)
16.2.5.2. Growth Strategies
16.2.5.3. SWOT Analysis
16.2.6. Vetter Pharma
16.2.6.1. Company Overview (HQ, Business Segments, Employee Strength)
16.2.6.2. Growth Strategies
16.2.6.3. SWOT Analysis
16.2.7. Jubilant HollisterStier LLC
16.2.7.1. Company Overview (HQ, Business Segments, Employee Strength)
16.2.7.2. Growth Strategies
16.2.7.3. SWOT Analysis