冷冻干燥注射剂市场－全球产业规模、份额、趋势、机会和预测（按包装、按交付、按适应症、按最终用户、按地区和竞争细分，2020-2030 年）

2024 年全球冷冻干燥注射剂市值为 31.4 亿美元，预计到 2030 年将达到 54.1 亿美元，预测期内复合年增长率为 9.49%。冷冻干燥注射剂，也称为冷冻干燥注射剂，是经过冷冻干燥过程以提高产品稳定性、保质期和运输便利性的关键药物製剂。该技术包括冷冻注射溶液，然后透过昇华去除水分，从而形成固体干燥形式，可以在註射前轻鬆重建。此方法对于生物製剂、疫苗和其他温度敏感化合物特别有价值。不断增加的研发活动、製药巨头和合约製造组织之间的全球合作以及对长效和稳定药物製剂的需求不断增长正在推动市场成长。值得注意的是，产业参与者正在扩大研发能力，例如辉瑞在印度的开发中心，该中心专注于 API 和成品剂型，包括冷冻干燥产品。随着生物製剂和个人化治疗的持续发展，预计冷冻干燥注射剂在整个医疗保健生态系统中的应用将加速。

关键市场驱动因素

生物製剂和特种药物的需求不断增长

主要市场挑战

开发和製造成本高

主要市场趋势

生物製剂和生物相似药的扩张

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球冻干注射剂市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按包装（一次性小瓶、即时復溶、特殊包装）
  • 透过递送（预充式稀释剂注射器、专有重构装置、单步骤装置、多步骤装置）
  • 按适应症（自体免疫疾病、传染病、代谢性疾病、其他）
  • 按最终用户（医院药房、零售药房、其他）
  • 按地区
  • 按公司分类（2024）
• 市场地图

第六章：北美冷冻干燥注射剂市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第七章：欧洲冻干注射剂市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 德国
  • 英国
  • 义大利
  • 法国
  • 西班牙

第八章：亚太地区冷冻干燥注射剂市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：南美洲冻干注射剂市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第十章：中东和非洲冷冻干燥注射剂市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 最新动态
• 产品发布
• 併购

第 13 章：全球冷冻干燥注射剂市场：SWOT 分析

第 14 章：竞争格局

• B. Braun Melsungen AG
• Baxter International Inc.
• Becton, Dickinson and Company
• Schott AG
• Aristopharma Ltd.
• Vetter Pharma GmbH
• Jubilant HollisterStier LLC
• Bristol Myers Squibb
• F. Hoffmann-La Roche Ltd
• Novo Nordisk A/S

第 15 章：策略建议

第16章调查会社について・免责事项

The Global Lyophilized Injectable Market was valued at USD 3.14 billion in 2024 and is projected to reach USD 5.41 billion by 2030, growing at a CAGR of 9.49% during the forecast period. Lyophilized injectables, also known as freeze-dried injectables, are critical pharmaceutical formulations that undergo a lyophilization process to enhance product stability, shelf life, and ease of transport. This technique involves freezing the injectable solution and then removing moisture through sublimation, resulting in a solid, dry form that can be easily reconstituted before administration. The method is particularly valuable for biologics, vaccines, and other temperature-sensitive compounds. Increasing R&D activities, global collaborations between pharmaceutical giants and contract manufacturing organizations, and the rising demand for long-acting and stable drug formulations are driving market growth. Notably, industry players are expanding R&D capabilities, as seen in initiatives like Pfizer's development hub in India, which focuses on APIs and finished dosage forms, including lyophilized products. As biologics and personalized therapies continue to gain momentum, the adoption of lyophilized injectables is expected to accelerate across the healthcare ecosystem.

Key Market Drivers

Increasing Demand for Biologics and Specialty Drugs

The rising demand for biologics and specialty medications is a major factor boosting the growth of the lyophilized injectable market. Biologics have gained prominence due to their targeted effectiveness in treating chronic and complex conditions such as cancer, autoimmune diseases, and rare disorders. Unlike conventional small molecule drugs, biologics require specific storage and delivery conditions, making lyophilization an ideal method for maintaining their structural and therapeutic integrity. As pharmaceutical firms expand their biologics portfolios, lyophilized formulations are increasingly preferred to ensure long-term stability and patient safety. The demand for individualized treatment approaches, coupled with the need for advanced drug delivery systems, continues to push lyophilized technologies into the spotlight. Healthcare providers are also prioritizing injectables that combine extended shelf life with minimal preparation time, reinforcing the need for robust and reliable freeze-dried drug formats.

Key Market Challenges

High Development and Manufacturing Costs

One of the major challenges impeding market expansion is the high cost associated with developing and manufacturing lyophilized injectable products. The lyophilization process involves sophisticated technology, including specialized equipment and rigorous validation protocols, all of which demand significant capital investment. Moreover, maintaining stringent quality control and regulatory compliance adds to the financial burden. These elevated production expenses often translate into higher product prices, potentially limiting access to such therapies in price-sensitive markets. Additionally, small- and mid-sized pharmaceutical firms may hesitate to invest in lyophilized drug development due to the associated operational and financial risks, which can slow the pace of innovation and new product introductions.

Key Market Trends

Expansion of Biologics and Biosimilars

A key trend shaping the lyophilized injectable market is the rapid expansion of biologics and biosimilars. Biologic therapies-including monoclonal antibodies, therapeutic proteins, and vaccines-often require lyophilization to maintain efficacy throughout their lifecycle. As global demand for these therapies grows, pharmaceutical manufacturers are increasingly focused on enhancing lyophilization processes to meet regulatory standards and market expectations. Biosimilars, which offer cost-effective alternatives to branded biologics, are also contributing to the demand for freeze-dried injectable formulations. This trend is stimulating innovation in lyophilization equipment, packaging, and formulation techniques, resulting in greater product availability, improved patient compliance, and increased competitiveness across global markets.

Key Market Players

• B. Braun Melsungen AG
• Baxter International Inc.
• Becton, Dickinson and Company
• Schott AG
• Aristopharma Ltd.
• Vetter Pharma GmbH
• Jubilant HollisterStier LLC
• Bristol Myers Squibb
• F. Hoffmann-La Roche Ltd
• Novo Nordisk A/S

Report Scope:

In this report, the Global Lyophilized Injectable Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Lyophilized Injectable Market, By Packaging:

• Single-Use Vials
• Point-Of-Care Reconstitution
• Specialty Packaging

Lyophilized Injectable Market, By Delivery:

• Prefilled Diluent Syringes
• Proprietary Reconstitution Devices
• Single-Step Devices
• Multi-Step Devices

Lyophilized Injectable Market, By Indication:

• Autoimmune Diseases
• Infectious Diseases
• Metabolic Conditions
• Others

Lyophilized Injectable Market, By End-User:

• Hospital Pharmacy
• Retail Pharmacy
• Others

Lyophilized Injectable Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Lyophilized Injectable Market.

Available Customizations:

Global Lyophilized Injectable Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Indications
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Lyophilized Injectable Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Packaging (Single-Use Vials, Point-Of-Care Reconstitution, Specialty Packaging)
  • 5.2.2. By Delivery (Prefilled Diluent Syringes, Proprietary Reconstitution Devices, Single-Step Devices, Multi-Step Devices)
  • 5.2.3. By Indication (Autoimmune Diseases, Infectious Diseases, Metabolic Conditions, Others)
  • 5.2.4. By End-User (Hospital Pharmacy, Retail Pharmacy, Others)
  • 5.2.5. By Region
  • 5.2.6. By Company (2024)
• 5.3. Market Map

6. North America Lyophilized Injectable Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Packaging
  • 6.2.2. By Delivery
  • 6.2.3. By Indication
  • 6.2.4. By End-User
  • 6.2.5. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Lyophilized Injectable Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Packaging
      • 6.3.1.2.2. By Delivery
      • 6.3.1.2.3. By Indication
      • 6.3.1.2.4. By End-User
  • 6.3.2. Canada Lyophilized Injectable Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Packaging
      • 6.3.2.2.2. By Delivery
      • 6.3.2.2.3. By Indication
      • 6.3.2.2.4. By End-User
  • 6.3.3. Mexico Lyophilized Injectable Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Packaging
      • 6.3.3.2.2. By Delivery
      • 6.3.3.2.3. By Indication
      • 6.3.3.2.4. By End-User

7. Europe Lyophilized Injectable Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Packaging
  • 7.2.2. By Delivery
  • 7.2.3. By Indication
  • 7.2.4. By End-User
  • 7.2.5. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Lyophilized Injectable Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Packaging
      • 7.3.1.2.2. By Delivery
      • 7.3.1.2.3. By Indication
      • 7.3.1.2.4. By End-User
  • 7.3.2. United Kingdom Lyophilized Injectable Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Packaging
      • 7.3.2.2.2. By Delivery
      • 7.3.2.2.3. By Indication
      • 7.3.2.2.4. By End-User
  • 7.3.3. Italy Lyophilized Injectable Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Packaging
      • 7.3.3.2.2. By Delivery
      • 7.3.3.2.3. By Indication
      • 7.3.3.2.4. By End-User
  • 7.3.4. France Lyophilized Injectable Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Packaging
      • 7.3.4.2.2. By Delivery
      • 7.3.4.2.3. By Indication
      • 7.3.4.2.4. By End-User
  • 7.3.5. Spain Lyophilized Injectable Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Packaging
      • 7.3.5.2.2. By Delivery
      • 7.3.5.2.3. By Indication
      • 7.3.5.2.4. By End-User

8. Asia-Pacific Lyophilized Injectable Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Packaging
  • 8.2.2. By Delivery
  • 8.2.3. By Indication
  • 8.2.4. By End-User
  • 8.2.5. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Lyophilized Injectable Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Packaging
      • 8.3.1.2.2. By Delivery
      • 8.3.1.2.3. By Indication
      • 8.3.1.2.4. By End-User
  • 8.3.2. India Lyophilized Injectable Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Packaging
      • 8.3.2.2.2. By Delivery
      • 8.3.2.2.3. By Indication
      • 8.3.2.2.4. By End-User
  • 8.3.3. Japan Lyophilized Injectable Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Packaging
      • 8.3.3.2.2. By Delivery
      • 8.3.3.2.3. By Indication
      • 8.3.3.2.4. By End-User
  • 8.3.4. South Korea Lyophilized Injectable Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Packaging
      • 8.3.4.2.2. By Delivery
      • 8.3.4.2.3. By Indication
      • 8.3.4.2.4. By End-User
  • 8.3.5. Australia Lyophilized Injectable Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Packaging
      • 8.3.5.2.2. By Delivery
      • 8.3.5.2.3. By Indication
      • 8.3.5.2.4. By End-User

9. South America Lyophilized Injectable Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Packaging
  • 9.2.2. By Delivery
  • 9.2.3. By Indication
  • 9.2.4. By End-User
  • 9.2.5. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Lyophilized Injectable Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Packaging
      • 9.3.1.2.2. By Delivery
      • 9.3.1.2.3. By Indication
      • 9.3.1.2.4. By End-User
  • 9.3.2. Argentina Lyophilized Injectable Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Packaging
      • 9.3.2.2.2. By Delivery
      • 9.3.2.2.3. By Indication
      • 9.3.2.2.4. By End-User
  • 9.3.3. Colombia Lyophilized Injectable Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Packaging
      • 9.3.3.2.2. By Delivery
      • 9.3.3.2.3. By Indication
      • 9.3.3.2.4. By End-User

10. Middle East and Africa Lyophilized Injectable Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Packaging
  • 10.2.2. By Delivery
  • 10.2.3. By Indication
  • 10.2.4. By End-User
  • 10.2.5. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Lyophilized Injectable Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Packaging
      • 10.3.1.2.2. By Delivery
      • 10.3.1.2.3. By Indication
      • 10.3.1.2.4. By End-User
  • 10.3.2. Saudi Arabia Lyophilized Injectable Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Packaging
      • 10.3.2.2.2. By Delivery
      • 10.3.2.2.3. By Indication
      • 10.3.2.2.4. By End-User
  • 10.3.3. UAE Lyophilized Injectable Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Packaging
      • 10.3.3.2.2. By Delivery
      • 10.3.3.2.3. By Indication
      • 10.3.3.2.4. By End-User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. Global Lyophilized Injectable Market: SWOT Analysis

14. Competitive Landscape

• 14.1. B. Braun Melsungen AG
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Baxter International Inc.
• 14.3. Becton, Dickinson and Company
• 14.4. Schott AG
• 14.5. Aristopharma Ltd.
• 14.6. Vetter Pharma GmbH
• 14.7. Jubilant HollisterStier LLC
• 14.8. Bristol Myers Squibb
• 14.9. F. Hoffmann-La Roche Ltd
• 14.10. Novo Nordisk A/S

15. Strategic Recommendations

16. About Us & Disclaimer