凍結乾燥注射剤市場- 世界の産業規模、シェア、動向、機会、予測：包装別、送達別、適応症別、エンドユーザー別、地域別、競合：2020-2030年

世界の凍結乾燥注射剤市場は、2024年に31億4,000万米ドルと評価され、2030年には54億1,000万米ドルに達すると予測され、予測期間中のCAGRは9.49%で成長します。

凍結乾燥注射剤としても知られる凍結乾燥注射剤は、製品の安定性、保存期間、輸送の容易性を高めるために凍結乾燥工程を経る重要な医薬品製剤です。この技術では、注射液を凍結させた後、昇華によって水分を除去し、投与前に容易に再構成できる固形で乾燥した形態にします。この方法は、生物製剤、ワクチン、その他の温度に敏感な化合物にとって特に価値があります。研究開発活動の増加、製薬大手と製造受託機関の世界の提携、長時間作用型で安定した薬剤製剤に対する需要の高まりが、市場成長の原動力となっています。ファイザーがインドに開発ハブを設置し、凍結乾燥製剤を含む原薬や完成製剤の開発に注力しているように、業界各社は研究開発能力を拡大しています。生物製剤と個別化治療が引き続き勢いを増すにつれて、凍結乾燥注射剤の採用はヘルスケアのエコシステム全体で加速すると予想されます。

市場促進要因

生物製剤と特殊医薬品の需要増加

主な市場課題

高い開発・製造コスト

主要市場動向

生物製剤とバイオシミラーの拡大

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の凍結乾燥注射剤市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 包装別（使い捨てバイアル、ポイントオブケア再構成、特殊包装）
  • 配送（プレフィルド希釈液シリンジ、専用再構成デバイス、シングルステップデバイス、マルチステップデバイス）
  • 適応症別（自己免疫疾患、感染症、代謝性疾患、その他）
  • エンドユーザー別（病院薬局、小売薬局、その他）
  • 地域別
  • 企業別（2024）
• 市場マップ

第6章 北米の凍結乾燥注射剤市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第7章 欧州の凍結乾燥注射剤市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • ドイツ
  • 英国
  • イタリア
  • フランス
  • スペイン

第8章 アジア太平洋地域の凍結乾燥注射剤市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 日本
  • 韓国
  • オーストラリア

第9章 南米の凍結乾燥注射剤市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの凍結乾燥注射剤市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第13章 世界の凍結乾燥注射剤市場：SWOT分析

第14章 競合情勢

• 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 戦略的提言

第16章 調査会社について・免責事項

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