임상시험용 포장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the clinical trial packaging market size is projected to be USD 4.08 billion in 2025, USD 4.44 billion in 2026, and reach USD 6.83 billion by 2031, growing at a CAGR of 9.01% from 2026 to 2031.

This report is Segmented by Product Type (Vials and Ampoules, Syringes, Blister Packs, Bottles, Bags and Pouches, Tubes, Sachets, and More), Material Type (Plastic, Paper and Corrugated Fiber, Glass, and Metal), End User (Research Laboratories, Clinical Research Organization, and Drug Manufacturing Companies), and Geography (Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Clinical Trial Packaging Market Trends and Insights

Growing Clinical Trial Volumes and R&D Intensity

Sponsor R&D budgets stayed elevated across 2023 to 2025 as companies refilled pipelines, responded to biosimilar pressure, and funded first-in-human work in newer modalities. That rise in trial activity directly affects the clinical trial packaging market, as each study phase requires its own labeling, blinding, accountability, and release process. Trial amendments add another layer of demand, since mid-study protocol changes can force relabeling or repackaging of inventory that has already been produced. Clinigen reported that its on-demand packaging model ships within 48 hours from U.S. facilities and within 72 hours from EU facilities, which shows how speed has become a standard service expectation rather than a niche premium offering. The UK also saw a 5% rise in first-in-human trial applications in 2025 compared with the prior year, suggesting a broader study base entering packaging workflows.

Rising Biologics and Injectable Drug Development

More than half of Phase I to Phase III clinical trials now focus on parenteral formulations, and that mix has been moving upward as biologics, biosimilars, and complex antibody programs take a larger share of development pipelines. The clinical trial packaging market benefits from that shift because injectable therapies need more control over extractables, leachables, moisture protection, and dose presentation than many oral drugs. VuRoyal highlighted the growing use of cyclic olefin polymer syringe formats for high-pH biologics, as these systems help avoid glass delamination and silicone-oil interaction issues. SCHOTT Pharma reported H1 2026 Drug Delivery Systems revenue of EUR 201.8 million (USD 228 million), supported by demand for prefillable glass syringes used in injectable biologics. Comparator management adds further complexity because placebo and active products often require custom masking and secondary packaging to appear identical during blinded biologic studies.

High Cost of Small-Batch Customized Packaging

Small-batch packaging campaigns incur fixed quality and release costs that do not scale with volume, making unit economics difficult for early-stage sponsors. Contract Pharma noted in April 2025 that regulations built around large commercial output create disproportionate burdens for small-batch operations, especially for companies that lack modular cleanrooms, robotic filling, or single-use systems. The challenge becomes sharper in advanced therapies because validation, stability packaging, and qualified person release can consume a large share of total campaign cost, even when only dozens of patients are being served. This pressure can delay study activation and also lead some sponsors to narrow the packaging scope, increasing the risk of protocol deviation later. The clinical trial packaging market, therefore, continues to grow, but providers without efficient small-batch systems face a tougher margin environment than headline demand numbers suggest.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Decentralized and Direct-To-Patient Trial Models
2. Increasing Outsourcing to Integrated Clinical Supply Partners
3. Fragmented Country-Level Labeling and Import Rules

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Syringes held 26.34% of the clinical trial packaging market share in 2025, reflecting the strong presence of parenteral biologics and the wider use of prefilled formats that reduce dosing errors in both site-based and home-use settings. The clinical trials packaging market continues to rely heavily on syringe formats because they support ready-to-administer dosing, controlled presentation, and easier accountability in blinded studies. Vials and ampoules formed the second-largest product group, especially in lyophilized biologics, vaccines, and oncology studies, where reconstitution at the point of care remains standard. Blister packs also remained relevant for oral oncology and central nervous system programs because their unit-dose structure helps site teams manage tamper evidence and patient-level accountability.

Kits and packs are projected to record the fastest growth at a 9.73% CAGR from 2026 to 2031, indicating that the clinical trials packaging market is moving beyond individual primary containers toward complete study-ready assemblies. These formats combine the drug product, administration device, instructions for use, and return materials into a single patient-facing unit and often require validated transit performance for home delivery routes. VuRoyal stated that decentralized supply programs increasingly require ISTA 7D or equivalent testing for such shipments, which raises the technical value of secondary packaging design. Thermo Fisher Scientific said its clinical trials innovation lab in Center Valley, Pennsylvania has been developing smart packaging with real-time temperature and GPS monitoring for decentralized kit formats, which shows how providers are adding data capture into packaging workflows.

Geography Analysis

North America held 38.56% of the clinical trial packaging market share in 2025, supported by a dense sponsor base, established cGMP clinical packaging capacity, and strong cold-chain infrastructure. The clinical trials packaging market in the region also benefited from clearer U.S. regulatory treatment of direct-to-patient investigational product dispensing, which widened the addressable use cases for home-delivery formats. Almac Group completed phase one of its Pennsylvania expansion in September 2025, adding 36,100 sq. ft. of warehouse space and ultra-low temperature storage for 76 freezers at -60°C to -80°C. PCI Pharma Services also announced investment commitments totaling above USD 1 billion in U.S. sterile fill-finish and drug-device capabilities, including a GMP-ready vial and lyophilization line in Bedford, New Hampshire, commissioned in May 2026.

Europe held the second-largest share of the clinical trials packaging market in 2025, with Germany, France, and the UK as the main centers for packaging, labeling, and blinding activities. The UK introduced reformed clinical trial regulations effective April 28, 2026, including a 14-day assessment route for Phase I studies, while the European Medicines Agency implemented ICH E6(R3) from July 23, 2025. EU GMP Annex 13 and the EU Clinical Trial Regulation continue to support demand for specialized labeling and blinding services because sponsors must limit mislabeling risk in blinded products. SCHOTT Pharma launched EVERIC lyo and amber vials in January 2026 for light-sensitive lyophilized antibody-drug conjugates, and the product was designed to meet light transmission requirements in the EU, the U.S., and Japan.

Asia-Pacific is projected to expand at a 10.54% CAGR through 2031 in the clinical trials packaging market, making it the fastest-growing regional cluster in the forecast period. Growth is being driven by China's larger domestic CDMO base, India's expanding CRO footprint, South Korea's role in biologic and antibody-drug conjugate manufacturing, and Japan's demand for self-injection and home-care packaging. TPC Marketing Research reported through Chem-Station that Japan's pharmaceutical container and packaging material market reached JPY 223.9 billion (USD 1.5 billion) in 2024 and was projected to reach JPY 227.65 billion (USD 1.53 billion) in 2025, with prefilled syringes and autoinjectors posting the strongest gains. China is projected to account for more than 30% of global cell and gene therapy clinical trials, which is lifting demand for local cryogenic packaging and validated cold-chain kit assembly. Samsung Biologics used Bio Japan 2025 to deepen partnerships with Japanese pharmaceutical companies, which points to tighter links between Asia-Pacific manufacturing and global clinical supply chains. South America and the Middle East and Africa remained the smallest regional pool, with Brazil and South Africa acting as the main trial locations while import-license friction and weaker cold-chain infrastructure limited broader scale.

1. Almac Group Limited
2. Sharp Services, LLC
3. Gerresheimer AG
4. Amcor plc
5. Thermo Fisher Scientific Inc.
6. Clinigen Limited
7. PCI Pharma Services
8. Bilcare Limited
9. Piramal Pharma Limited
10. Myonex, Inc.
11. BAP Pharma Ltd.
12. Corden Pharma International GmbH
13. West Pharmaceutical Services, Inc.
14. SCHOTT Pharma AG & Co. KGaA
15. Nipro Corporation
16. Stevanato Group S.p.A.
17. NextPharma Technologies Holding Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Growing Clinical Trial Volumes and R&D Intensity
  • 4.2.2 Rising Biologics and Injectable Drug Development
  • 4.2.3 Expansion of Decentralized and Direct-to-Patient Trial Models
  • 4.2.4 Increasing Outsourcing to Integrated Clinical Supply Partners
  • 4.2.5 ICH E6(R3) Traceability and Blinding Requirements
  • 4.2.6 Acceleration of Cell and Gene Therapy Trials
• 4.3 Market Restraints
  • 4.3.1 High Cost of Small-Batch Customized Packaging
  • 4.3.2 Fragmented Country-Level Labeling and Import Rules
  • 4.3.3 Dangerous-Goods and Reverse-Logistics Constraints
  • 4.3.4 EU Transport-Pack Compliance and Packaging Data Burden
• 4.4 Industry Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE)

• 5.1 By Product Type
  • 5.1.1 Vials and Ampoules
  • 5.1.2 Syringes
  • 5.1.3 Blister Packs
  • 5.1.4 Bottles
  • 5.1.5 Bags and Pouches
  • 5.1.6 Tubes
  • 5.1.7 Sachets
  • 5.1.8 Other Product Types
• 5.2 By Material Type
  • 5.2.1 Plastic
  • 5.2.2 Glass
  • 5.2.3 Metal
  • 5.2.4 Paper and Corrugated Fiber
• 5.3 By End User
  • 5.3.1 Research Laboratories
  • 5.3.2 Clinical Research Organizations
  • 5.3.3 Drug Manufacturing Companies
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 South America
    • 5.4.2.1 Brazil
    • 5.4.2.2 Argentina
    • 5.4.2.3 Rest of South America
  • 5.4.3 Europe
    • 5.4.3.1 Germany
    • 5.4.3.2 United Kingdom
    • 5.4.3.3 France
    • 5.4.3.4 Italy
    • 5.4.3.5 Spain
    • 5.4.3.6 Russia
    • 5.4.3.7 Rest of Europe
  • 5.4.4 Asia-Pacific
    • 5.4.4.1 China
    • 5.4.4.2 Japan
    • 5.4.4.3 South Korea
    • 5.4.4.4 India
    • 5.4.4.5 Australia and New Zealand
    • 5.4.4.6 Rest of Asia-Pacific
  • 5.4.5 Middle East and Africa
    • 5.4.5.1 Middle East
      • 5.4.5.1.1 Saudi Arabia
      • 5.4.5.1.2 United Arab Emirates
      • 5.4.5.1.3 Turkey
      • 5.4.5.1.4 Rest of Middle East
    • 5.4.5.2 Africa
      • 5.4.5.2.1 South Africa
      • 5.4.5.2.2 Nigeria
      • 5.4.5.2.3 Rest of Africa

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Strategic Moves
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.4.1 Almac Group Limited
  • 6.4.2 Sharp Services, LLC
  • 6.4.3 Gerresheimer AG
  • 6.4.4 Amcor plc
  • 6.4.5 Thermo Fisher Scientific Inc.
  • 6.4.6 Clinigen Limited
  • 6.4.7 PCI Pharma Services
  • 6.4.8 Bilcare Limited
  • 6.4.9 Piramal Pharma Limited
  • 6.4.10 Myonex, Inc.
  • 6.4.11 BAP Pharma Ltd.
  • 6.4.12 Corden Pharma International GmbH
  • 6.4.13 West Pharmaceutical Services, Inc.
  • 6.4.14 SCHOTT Pharma AG & Co. KGaA
  • 6.4.15 Nipro Corporation
  • 6.4.16 Stevanato Group S.p.A.
  • 6.4.17 NextPharma Technologies Holding Limited

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment