U.S. Depyrogenated Sterile Empty Vials Market Size, Share & Trends Report

U.S. Depyrogenated Sterile Empty Vials Market Size, Share & Trends Analysis Report By Product (2 ml, 5 ml, 10 ml, 20 ml), By End Use (Clinical Labs, Componding Pharmacies), And Segment Forecasts, 2018 - 2025

  • Published Date: Oct, 2018
  • Base Year for Estimate: 2017
  • Report ID: GVR-2-68038-620-2
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2016
  • Number of Pages: 71

Industry Insights

The U.S. depyrogenated sterile empty vials market size was valued at USD 2.37 billion in 2017. It is expected to expand at a CAGR of 5.2% during the forecast period. Technological advancements in pharmaceutical packaging, rapid expansion in the pharmaceutical sector, and rising number of clinical laboratories are some of the primary growth stimulants for the market.

Increasing government support for development of innovative packaging of pharmaceutical products is likely to help the market gain significant momentum over the coming years. For instance, in 2017, the U.S. President promoted a pharmaceutical packaging initiative, which is led by specialty glass marker Corning, Inc. and two pharmaceutical companies namely, Merck, Co. and Pfizer, Inc. Collaboration is made to enhance storage and delivery of pharmaceutical formulations.

U.S. depyrogenated sterile empty vials market

Recent technological advancements in vial manufacturing process are resulting in development of innovative vials that enhance storage and dispensing of drug formulations. This, in turn, is fueling the demand for depyrogenated sterile empty vials. For instance, Stevanato Group developed EZ-fill Platform, which is used in the manufacturing of sterile depyrogenated vials. This platform allows more flexibility, costs reductions, quality improvement, production process improvement, and mitigates risks of breakage, thereby reducing rejection rate.

Flourishing biotechnological market in the U.S. is also one of the factors boosting the demand for depyrogenated sterile empty vials. In addition, rising number of research institutes, labs, and biopharmaceutical companies is working in favor of the market. It is estimated that there were about 449 public biotech companies functioning in the U.S. in 2016.

Surging demand for compounding medications coupled with trend of personalized medications is further bolstering the demand for the product. According to the International Academy of Compounding Pharmacists, about 7,500 compounding pharmacies in the U.S. specialize in advanced compounding services, where 3,000 of these pharmacies are involved in compounding of sterile products. There are stringent regulatory guidelines in the country for manufacturing and packaging of parenteral products, which include requirements of sterilization and no presence of endotoxin, RNase & DNase. This results in an increased demand for depyrogenated sterile vials.

Product Insights

In 2017, the more than 20 ml vials segment dominated the market and accounted for 40.0% of the overall market revenue. These vials are mainly used in packaging of injectable. Rising incidence of infectious & noninfectious diseases in the U.S. and increasing R&D in the area of biopharmaceuticals are contributing to the growth of the segment. According to the Pharmaceutical Research and Manufacturers of America, in 2016, biopharmaceutical companies invested around USD 90 billion in research & development activities in the U.S.

Mounting disease burden and growing number of clinical studies are resulting in increased demand for injectable, which in turn is fueling the demand for depryrogenated sterile empty vials of more than 20 ml. Moreover, recent technological advancements in parenteral packaging are playing a vital role in the development of the segment. For instance, Coring Internal Thread Cryogenic Vials manufactured by Corning, Inc. offers special barrier property that enhances shelf life of the drug. It is used for parenteral applications.

The 2 ml segment is poised to register the highest CAGR of 6.5% during the forecast period. Growing number of clinical & diagnostics labs and research institutes is projected to drive the demand for these vials for the purpose of sample collection, storage, and transportation. According to several sources, the U.S. has the highest number of innovative research institutes in the world. Apart from this, rising government funding for promotion of pharmaceutical, medical, and biotechnological researches is further anticipated to bolster the growth of the segment during the forecast period.

End-use Insights

In 2017, the others end-use segment led the U.S. depyrogenated sterile empty vials market owing to factors such as rapid growth in the pharmaceutical manufacturing sector, rising number of research institutes and increasing government funding for research activities. The National Institutes of Health (NIH) spends around USD 37.3 billion in medical research in the U.S. The segment comprises of pharmaceutical manufacturers and academic & research institutes.

In addition, factors such as growing innovation in pharmaceutical packaging processes, rapid development of new biologics, and rising number of medical and biotech research projects are supplementing the growth of the market. According to an article published by American Pharmaceutical Review in 2016, around 900 biologic molecules were in clinical stage in the U.S., which were targeting more than 100 diseases.

U.S. depyrogenated sterile empty vials market share

Clinical labs are expected to post the highest CAGR of 5.8% during the forecast period. Growing incidence of communicable as well as non-communicable diseases and widening base of testing labs are stimulating the growth of the segment. According to the estimates of the Laboratory of Florida, LLC, about 200,000 clinical labs are present in the U.S. that provide testing services to people.

U.S. Depyrogenated Sterile Empty Vials Market Share Insights

Thermo Fisher Scientific, Inc.; Gerresheimer AG; SCHOTT AG; DWK Life Sciences; and Stevanato Group are some of the key players operating in the market. The market is highly fragmented in nature. Market entry barrier is high and players can penetrate the market through product differentiation strategies. Companies are investing in R&D to gain competitive advantages. Moreover, growing collaborations between market players is also one of the strategies to acquire new technologies.

Report Scope



Base year for estimation


Actual estimates/Historical data

2014  -  2016

Forecast period

2018  -  2025

Market representation

Revenue in USD Million and CAGR from 2018 to 2025

Country scope


Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

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Segments Covered in the Report

This report forecasts revenue growth at country level and provides an analysis of industry trends in each of the subsegments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the U.S. depyrogenated sterile empty vials market report on the basis of product and end-use:

  • Product Outlook (Revenue, USD Million, 2014 - 2025)

    • 2 ml

    • 5 ml

    • 10 ml

    • 20 ml

    • More than 20 ml

  • End-use Outlook (Revenue, USD Million, 2014 - 2025)

    • Clinical Labs

    • Compounding Labs

    • Others

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