세계의 동결건조 주사제 시장 : 산업 규모, 점유율, 동향, 기회, 예측, 포장별, 투여 방식별, 적응증별, 최종 사용자별, 지역별, 경쟁(2020-2030년)
Lyophilized Injectable Market - Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Packaging, By Delivery, By Indication, By End-User, By Region and Competition, 2020-2030F
세계의 동결건조 주사제 시장은 2024년에 31억 4,000만 달러로 평가되었고, 2030년에는 54억 1,000만 달러에 이를 것으로 예측되며, 예측 기간 중 CAGR은 9.49%를 나타낼 전망입니다.
동결건조 주사제는 동결건조 과정을 거쳐 제품의 안정성, 유통기한, 운송 편의성을 향상시키는 중요한 제약 제형입니다. 이 기술은 주사제 용액을 동결시킨 후 승화 과정을 통해 수분을 제거하여 투여 전 쉽게 재구성할 수 있는 고체 형태로 변환합니다. 이 방법은 생물학적 제제, 백신, 온도 민감성 화합물 등에 특히 유용합니다. 연구 개발 활동 증가, 제약 대기업과 계약 제조업체 간의 글로벌 협력, 장기 작용형 및 안정적인 약제 제형에 대한 수요 증가가 시장 성장을 촉진하고 있습니다. 특히, 업계 주요 기업들은 연구 개발 역량을 확대하고 있으며, 예를 들어 화이자의 인도 개발 센터는 API 및 완제 제형(동결건조 제품 포함)에 초점을 맞춘 프로젝트를 진행 중입니다. 생물학적 제제와 맞춤형 치료법이 계속 확산됨에 따라 동결건조 주사제의 채택은 의료 생태계 전반에서 가속화될 것으로 예상됩니다.
| 시장 개요 |
| 예측 기간 |
2026-2030년 |
| 시장 규모(2024년) |
31억 4,000만 달러 |
| 시장 규모(2030년) |
54억 1,000만 달러 |
| CAGR(2025-2030년) |
9.49% |
| 급성장 부문 |
일회용 바이알 |
| 최대 시장 |
북미 |
시장 성장 촉진요인
생물학적 제제 및 특수 의약품에 대한 수요 증가
주요 시장 과제
높은 개발 및 제조 비용
주요 시장 동향
생물학적 제제 및 바이오시밀러의 확장
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 목소리
제5장 세계의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 포장별(일회용 바이알, 현장 재구성, 특수 포장)
- 투여 방식별(프리필드 희석액 주사기, 전용 재구성 디바이스, 싱글 스텝 디바이스, 멀티 스텝 디바이스)
- 적응증별(자가면역질환, 감염증, 대사성질환, 기타)
- 최종 사용자별(병원 약국, 소매 약국, 기타)
- 지역별
- 기업별(2024년)
- 시장 맵
제6장 북미의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 북미 : 국가별 분석
제7장 유럽의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 유럽 : 국가별 분석
제8장 아시아태평양의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 아시아태평양 : 국가별 분석
제9장 남미의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 남미 : 국가별 분석
제10장 중동 및 아프리카의 동결건조 주사제 시장 전망
- 시장 규모와 예측
- 시장 점유율 및 예측
- 중동 및 아프리카 : 국가별 분석
- 남아프리카
- 사우디아라비아
- 아랍에미리트(UAE)
제11장 시장 역학
제12장 시장 동향과 발전
제13장 세계의 동결건조 주사제 시장 : SWOT 분석
제14장 경쟁 구도
- 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
제15장 전략적 제안
제16장 기업 소개와 면책사항
HBR
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.
| Market Overview |
|---|
| Forecast Period | 2026-2030 |
| Market Size 2024 | USD 3.14 Billion |
| Market Size 2030 | USD 5.41 Billion |
| CAGR 2025-2030 | 9.49% |
| Fastest Growing Segment | Single-Use Vials |
| Largest Market | North America |
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
- 5.2. 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
- 6.2. 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
- 6.3.1.2. 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
- 6.3.2.2. 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
- 6.3.3.2. 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
- 7.2. 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
- 7.3.1.2. 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
- 7.3.2.2. 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
- 7.3.3.2. 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
- 7.3.4.2. 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
- 7.3.5.2. 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
- 8.2. 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
- 8.3.1.2. 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
- 8.3.2.2. 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
- 8.3.3.2. 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
- 8.3.4.2. 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
- 8.3.5.2. 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
- 9.2. 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
- 9.3.1.2. 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
- 9.3.2.2. 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
- 9.3.3.2. 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
- 10.2. 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
- 10.3.1.2. 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
- 10.3.2.2. 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
- 10.3.3.2. 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
