藥品穩定性與儲存服務市場機會、成長動力、產業趨勢分析與預測 2025 - 2034

2024 年全球藥品穩定性和儲存服務市場價值為 150 億美元，預計 2025 年至 2034 年的複合年成長率為 6.5%。製藥公司面臨巨大的壓力，需要確保其產品符合嚴格的品質標準並在整個保存期限內保持安全有效。這大大增加了對穩定性和儲存服務的需求，這些服務對於在特定條件下維持藥物、生物製劑和醫療器材的功效至關重要。此外，隨著企業尋求具有成本效益和專業的解決方案來滿足監管和營運需求，將製藥流程外包給專業服務提供者的趨勢日益興起，進一步推動了市場成長。

藥品穩定性和儲存服務包括專門的解決方案，確保產品長期保持其預期的安全性、有效性和品質。這些服務包括在特定環境條件下進行控制儲存和系統穩定性測試，以評估藥物在整個生命週期內的行為。美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構要求進行嚴格的穩定性測試以確保合規性，從而推動全球對這些服務的需求。

按服務類型細分的市場包括穩定性服務和儲存服務。在穩定性類別中，藥物物質穩定性、穩定性指示方法驗證、加速穩定性測試、光穩定性測試和其他測試方法等服務占主導地位，在 2024 年佔據 60.7% 的市場佔有率。同時，儲存部分分為冷藏和非冷藏解決方案，以滿足醫藥產品的不同需求。

根據分子類型，市場分為小分子和大分子，分別進一步細分為商業產品和研究產品。小分子藥物在 2024 年將佔據 54.9% 的市場佔有率，仍然是製藥業的基石。它們在口服藥物中的廣泛應用、成熟的製造流程、成本效益和可擴展性使它們備受青睞。這些因素推動了對穩定性和根據其特定需求量身定做的儲存服務的持續需求。

在美國，藥品穩定性和儲存服務市場在 2024 年創造了 52 億美元的收入，成為全球收入的主要貢獻者。隨著生物技術的進步，對生物製劑的需求不斷成長，對冷藏和冷凍儲存等專業儲存解決方案的需求也激增。美國作為生物製劑和生物相似藥生產的領導者，嚴重依賴加速和光穩定性測試等服務來維持這些高價值產品的品質和安全。

目錄

第 1 章：方法論與範圍

第 2 章：執行摘要

第 3 章：產業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 越來越關注監理合規性
    • 增加對藥物開發和研究的投資
    • 提高藥品穩定性和儲存的技術創新
    • 全球供應鏈的擴張
  • 產業陷阱與挑戰
    • 專用儲存解決方案成本高昂
    • 與運輸和物流相關的擔憂
• 成長潛力分析
• 監管格局
• 技術格局
• 未來市場趨勢
• 差距分析
• 波特的分析
• PESTEL 分析

第4章：競爭格局

• 介紹
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 戰略展望

第 5 章：市場估計與預測：按服務類型，2021 年至 2034 年

• 主要趨勢
• 穩定
  • 藥物物質
  • 穩定性指示方法驗證
  • 加速穩定性測試
  • 光穩定性測試
  • 其他穩定性測試方法
• 貯存
  • 寒冷的
    • 冰凍
    • 冷藏
    • 受控
    • 低溫
  • 非冷

第 6 章：市場估計與預測：按分子類型，2021 – 2034 年

• 主要趨勢
• 小分子
  • 商業產品
  • 研究產品
• 大分子
  • 商業產品
  • 研究產品

第 7 章：市場估計與預測：依最終用途，2021 年至 2034 年

• 主要趨勢
• 生物製藥公司
• 合約製造組織
• 合約研究組織
• 其他最終用戶

第 8 章：市場估計與預測：按地區，2021 年至 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第9章：公司簡介

• Alcami Corporation
• Almac Group
• Auriga Research
• Catalent
• Charles River Laboratories
• Element Materials Technology
• Eurofins Scientific
• Intertek Group
• Lucideon
• PD Partners
• Precision Stability Storage
• Q Laboratories
• Q1 Scientific
• Reading Scientific Services
• Roylance Stability Storage

The Global Pharmaceutical Stability And Storage Services Market was valued at USD 15 billion in 2024 and is forecasted to grow at a CAGR of 6.5% from 2025 to 2034. The market is experiencing robust growth due to increasing emphasis on regulatory compliance, escalating investments in drug development and research, and the expanding global supply chains that necessitate specialized solutions. Pharmaceutical companies are under immense pressure to ensure their products meet stringent quality standards and remain safe and effective throughout their shelf life. This has significantly boosted demand for stability and storage services, which are integral to maintaining the efficacy of drugs, biologics, and medical devices under specified conditions. Additionally, the rising trend of outsourcing pharmaceutical processes to specialized service providers is further propelling market growth as companies seek cost-efficient and expert solutions to meet regulatory and operational demands.

Pharmaceutical stability and storage services encompass specialized solutions that ensure products retain their intended safety, efficacy, and quality over time. These services include controlled storage under specified environmental conditions and systematic stability testing to assess the behavior of pharmaceutical products throughout their lifecycle. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate rigorous stability testing to ensure compliance, driving demand for these services globally.

The market, segmented by service type, includes stability and storage services. Within the stability category, services such as drug substance stability, stability-indicating method validation, accelerated stability testing, photostability testing, and other testing methods dominate, contributing to 60.7% of the market share in 2024. Stability testing is crucial for ensuring the safety and efficacy of drugs and is a requirement for both new drug applications and post-market surveillance. Meanwhile, the storage segment is divided into cold and non-cold storage solutions, catering to the varying needs of pharmaceutical products.

By molecule type, the market is categorized into small molecules and large molecules each further segmented into commercial products and research products. Small molecules, which accounted for 54.9% of the market share in 2024, remain a cornerstone of the pharmaceutical industry. Their widespread use in oral medications, established manufacturing processes, cost-effectiveness, and scalability make them highly desirable. These factors drive consistent demand for stability and storage services tailored to their specific requirements.

In the United States, the pharmaceutical stability and storage services market generated USD 5.2 billion in 2024, making it a key contributor to global revenue. The growing demand for biologics, driven by advancements in biotechnology, has created a surge in the need for specialized storage solutions such as refrigerated and frozen storage. The U.S., being a leader in the production of biologics and biosimilars, relies heavily on services like accelerated and photostability testing to maintain the quality and safety of these high-value products.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing focus on regulatory compliance
    • 3.2.1.2 Increasing investments in drug development and research
    • 3.2.1.3 Technological innovations enhancing pharmaceutical stability and storage
    • 3.2.1.4 Expansion in global supply chains
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High cost associated with specialized storage solutions
    • 3.2.2.2 Concerns related to transportation and logistics
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Future market trends
• 3.7 Gap analysis
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Competitive analysis of major market players
• 4.3 Competitive positioning matrix
• 4.4 Strategy outlook

Chapter 5 Market Estimates and Forecast, By Service Type, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Stability
  • 5.2.1 Drug substance
  • 5.2.2 Stability indicating method validation
  • 5.2.3 Accelerated stability testing
  • 5.2.4 Photostability testing
  • 5.2.5 Other stability testing methods
• 5.3 Storage
  • 5.3.1 Cold
    • 5.3.1.1 Frozen
    • 5.3.1.2 Refrigerated
    • 5.3.1.3 Controlled
    • 5.3.1.4 Cryogenic
  • 5.3.2 Non-cold

Chapter 6 Market Estimates and Forecast, By Molecule Type, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Small molecule
  • 6.2.1 Commercial products
  • 6.2.2 Research products
• 6.3 Large molecule
  • 6.3.1 Commercial products
  • 6.3.2 Research products

Chapter 7 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Biopharmaceutical companies
• 7.3 Contract manufacturing organization
• 7.4 Contract research organization
• 7.5 Other end users

Chapter 8 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 Alcami Corporation
• 9.2 Almac Group
• 9.3 Auriga Research
• 9.4 Catalent
• 9.5 Charles River Laboratories
• 9.6 Element Materials Technology
• 9.7 Eurofins Scientific
• 9.8 Intertek Group
• 9.9 Lucideon
• 9.10 PD Partners
• 9.11 Precision Stability Storage
• 9.12 Q Laboratories
• 9.13 Q1 Scientific
• 9.14 Reading Scientific Services
• 9.15 Roylance Stability Storage