Report Code : CVMI_070332 | Published Date : March 7, 2025

The North American depyrogenated sterile empty vials market is a dominant player in the global pharmaceutical packaging industry, primarily driven by robust regulatory frameworks, advanced pharmaceutical infrastructure, and a growing demand for sterile packaging solutions. The region hosts leading pharmaceutical companies, contract manufacturing organizations (CMOs), and biotech firms that require high-quality sterile vials for injectable drugs and vaccines biologics.

 

Market Size and Growth Projection

  • 2019 Market Value: USD 190 million
  • 2023 Market Value: USD 340 million
  • Projected 2031 Market Value: USD 720 million
  • CAGR (2024-2031): 9.6%

The North American market is projected to experience significant growth, driven by increasing investments in pharmaceutical R&D, the rising prevalence of chronic diseases, and the region’s crucial role in global vaccine production distribution.

 

Key Market Drivers

  1. High Demand for Injectable Drugs and Vaccines: The U.S. and Canada have witnessed rising demand for injectable biologics and vaccines, leading to increased consumption of depyrogenated sterile vials.
  2. Stringent FDA and Health Canada Regulations: The regulatory landscape in North America is stringent, with agencies like the FDA and Health Canada mandating rigorous sterilization processes for pharmaceutical packaging.
  3. Technological Advancements in Vial Manufacturing: Companies in North America are at the forefront of glass vial innovation, introducing borosilicate glass, coated vials, and prefilled sterile vials to enhance product safety and extend shelf life.
  4. Expansion of Biologics and Biosimilars Market: North America is the leading hub for biologics and biosimilars, which require sterile and contamination-free packaging, boosting demand for depyrogenated vials.

 

Market Segmentation

By Material Type:

  • Glass Vials – Preferred for their superior sterility and chemical resistance.
  • Plastic Vials – Gaining popularity for their durability and lightweight properties.

By End-User:

  • Pharmaceutical and Biopharmaceutical Companies – Largest consumers due to high production of sterile injectable drugs.
  • Research Laboratories – Increased funding for clinical trials and drug research fuels demand.
  • Hospitals and Compounding Pharmacies – Rising requirement for customized sterile packaging in hospital settings.

 

Regional Insights

  1. United States:
    • Largest market share due to major pharmaceutical companies and CMOs.
    • Strong regulatory oversight by the FDA ensuring compliance with strict sterility norms.
    • Significant investments in vaccine production post-COVID-19.
  2. Canada:
    • Increasing number of clinical research facilities and government-funded healthcare programs.
    • Strong presence of biotech firms and innovative drug manufacturers.
    • Growing adoption of pre-sterilized vials in personalized medicine.

 

Competitive Landscape

Top players operating in North America include:

  • Schott AG
  • Gerresheimer AG
  • Stevanato Group
  • DWK Life Sciences
  • Nipro Corporation

 

Recent Developments

  • Schott AG expanded its North American production capacity for depyrogenated vials in 2023 to meet the growing demand from the pharmaceutical sector demand.
  • Gerresheimer AG has introduced new prefilled sterile glass vials designed to enhance drug stability and patient care safety.
  • Stevanato Group has signed partnerships with leading biotech firms to supply vials for next-generation therapies biologics.

 

Future Outlook

The North American Depyrogenated Sterile Empty Vials Market is set to grow at a CAGR of 9.6% due to the increasing demand for biologics, continued innovation in pharmaceutical packaging, and stringent sterility regulations. Companies focusing on sustainability, automation, and advanced sterilization techniques are likely to gain a competitive edge.





Reasons To Buy

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Scope

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Key Players

  • Thermo Fisher Scientific Inc
  • VWR International LLC
  • Stevanato Group
  • SiO2 Medical Products Inc
  • DWK Life Sciences
  • SCHOTT AG
  • Gerresheimer AG

North America Depyrogenated Sterile Empty Vials Market Report

  1. 1. Global North America Depyrogenated Sterile Empty Vials Market Research Report
    1. 1.1 Studyt Objectives
      1.2 North America Depyrogenated Sterile Empty Vials Market - Overview
      1.3 Reason to Read This Report
      1.4 Methodology and Forecast Analysis

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    2. Global North America Depyrogenated Sterile Empty Vials Market Research Report - Preface
    1. 2.1 Global North America Depyrogenated Sterile Empty Vials Market Research Report – Detailed Scope and Definitions
      1. 2.1.1 By Material Type
        2.1.2 By End-User
        2.1.3 By Country
        2.1.4 By Region



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    3. Global North America Depyrogenated Sterile Empty Vials Market Dynamics
    1. 3.1. Drivers - Macro-Economic Based, Supply Side, and Demand Side Drivers
      3.2. Restraints – By Material Type, By End-User, By Country, By Country
      3.3. Opportunities – By Material Type, By End-User, By Country, By Country
      3.4. Trends – By Material Type, By End-User, By Country, By Country
      3.5. PEST Analysis
      3.6. Porters Five Rule Analysis
      3.7. Company’s Share Analysis (CSA) by Region or By Country
      3.8. Global North America Depyrogenated Sterile Empty Vials Market Research Report – DROTs Impact Analysis



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    4. Global North America Depyrogenated Sterile Empty Vials Market Research Report , Historic Data 2019 - 2023 and Forecast Analysis Data 2024 - 2031
    1. 4.1.Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
      4.2.Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%).
      4.3.Incremental Market Value/Volume Opportunity between 2019 - 2023 and 2024 - 2031
      4.4.Market Shares Analysis in Years - 2019, 2023, 2024 and 2031



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    5. Global North America Depyrogenated Sterile Empty Vials Market, By Material Type, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
    1. 5.1 Glass Vials
      1. 5.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        5.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        5.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        5.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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      5.2 Plastic Vials
      1. 5.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        5.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        5.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        5.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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    6. Global North America Depyrogenated Sterile Empty Vials Market, By End-User, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
    1. 6.1 Pharmaceutical and Biopharmaceutical Companies
      1. 6.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        6.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        6.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        6.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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      6.2 Clinical and Research Laboratories
      1. 6.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        6.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        6.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        6.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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      6.3 Hospitals and Compounding Pharmacies
      1. 6.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        6.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        6.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        6.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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    7. Global North America Depyrogenated Sterile Empty Vials Market, By Country, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
    1. 7.1 USA
      1. 7.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        7.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        7.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        7.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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      7.2 Canada
      1. 7.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        7.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        7.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        7.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031




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    8. Global North America Depyrogenated Sterile Empty Vials Market Forecast, By Region, 2019 - 2023 and 2024 - 2031 (Market Value, In USD Mn)
    1. 8.1 North America
      1. 8.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
        8.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
        8.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
        8.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031



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      8.2 Global North America Depyrogenated Sterile Empty Vials Market - Opportunity Analysis Index, By Material Type, By End-User, By Country, and Region, 2024 - 2031

    9. North America North America Depyrogenated Sterile Empty Vials Market Analysis, 2019 - 2023 and Forecast, 2024 - 2031 (Market Value, In USD Mn)
    1. 9.1 By Material Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
      1. 9.1.1 Glass Vials
        9.1.2 Plastic Vials




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      9.2 By End-User Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
      1. 9.2.1 Pharmaceutical and Biopharmaceutical Companies
        9.2.2 Clinical and Research Laboratories
        9.2.3 Hospitals and Compounding Pharmacies




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      9.3 By Country Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
      1. 9.3.1 USA
        9.3.2 Canada




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      9.4 Country Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
      1. 9.4.1 United States
        9.4.2 Canada



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      9.5 North America North America Depyrogenated Sterile Empty Vials Market – Opportunity Analysis Index, By Material Type, By End-User, By Country, and Country, 2024 - 2031

      9.6 Regional Trends Analysis

      9.7 North America North America Depyrogenated Sterile Empty Vials Market Research Report - Company Profiles
      1. 9.7.1 Company 1 (United States)
        9.7.2 Company 2 (Canada)
        9.7.3 Company 3 (Canada)



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    10. Competition Landscape
    1. 10.1 Strategic Dashboard of Top Market Players

      10.2 Company Profiles (Introduction, Financial Assessments, Portfolio of Offerings, Milestones and Achievements, Strategic Initiative, and SWOT Analysis)
      1. 10.2.1 Thermo Fisher Scientific Inc
        10.2.2 VWR International LLC
        10.2.3 Stevanato Group
        10.2.4 SiO2 Medical Products Inc
        10.2.5 DWK Life Sciences
        10.2.6 SCHOTT AG
        10.2.7 Gerresheimer AG



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    11. Data Collection Method and Research Approach

    12. Principal Presumptions and Acronyms





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