Depyrogenated Sterile Empty Vials Market Will Exceed $7,498.2 Mn By 2027

(Market Prediction via Comtex)

A research study by ARC foresees the Depyrogenated Sterile Empty Vials market growing at a CAGR around 4.8% throughout the forecast period and reach around $ 7,498.2 million by 2026.

Depyrogenation means the removal of pyrogens from the solution specifically from injectable pharmaceuticals. For the same, manufacturers are required to provide the certificate of sterility & pyrogen test with the final product. Depyrogenated sterile empty vials are available in the market with the capacity ranging from 1ml to 100ml. These are available in glass and plastic material such as borosilicate among others. The sterile vials can be assembled with stoppers and aluminum seals.

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In terms of end-use, compounding labs held the major share in 2018 due to the increasing demand for personalized medicines. The presence of stringent regulatory guidelines in major countries like the US for manufacturing and packaging of parenteral products, which needs the sterilization process to ensure the absence of endotoxin, RNase & DNase and other toxic substances. These kinds of regulation by regulatory bodies are supporting the market growth. Additionally, the presence of substantial compounding pharmacists in developed economies is further bolstering the market value. For instance, according to the International Academy of Compounding Pharmacists, approximately 7,500 compounding pharmacies in the U.S. itself are specialized in advanced compounding services, among them 3,000 pharmacies are involved in the compounding of sterile products.

On the basis of material, the glass segment accounted for the dominating share in 2018 owing to the benefits associated with the glass packaging. The depyrogenated sterile empty glass vials offer improved chemical durability and damage resistance which enable biopharmaceutical and pharmaceutical manufacturers to effectively store and deliver critical drug formulations is the primary factor supporting the segment market value. In addition to this, the increasing adoption of glass vials in plant cell culture, chemical and biological reactions, photobiological studies and in sample collection and storage is further accelerating the market growth.

In 2018, North America held the major share of the global depyrogenated sterile empty vials market. The increasing investment by pharma and biotech companies in R&D activities for the development of innovative packaging is primarily driving the regional market growth. The region is majorly dependent on the US market, which is the prominent segment of the North America region in terms of both volume and value of depyrogenated sterile empty vials market. For instance, the U.S. President promoted a collaboration in 2017, which was intended to enhance the storage and delivery of pharmaceutical formulations. The initiative was conducted and driven by specialty glass marker Corning, Inc. and two pharmaceutical companies namely, Pfizer, Inc. and Merck, Co. The increasing focus towards the technological advancements in healthcare sector packaging by governmental bodies and major players due to increasing focus towards the sterility is additionally propelling the market value. For instance, the EZ-fill Platform developed by Stevanato Group is particularly designed for use in the manufacturing of sterile depyrogenated vials. The platform offers cost reductions, production process improvement, more flexibility, quality improvement and mitigates risks of breakage, as in turn reduces rejection rate.

Some of the leading competitors are Corning Incorporated, Thermo Fisher Scientific, APG Pharma, DWK Life Sciences, VWR International, Nipro PharmaPackaging, Gerresheimer, Merck KGaA, Radpharm Scientific, Stevanato Group, and SCHOTT. Depyrogenated sterile empty vials companies have announced mergers and acquisitions to expand their position in the depyrogenated sterile empty vials industry. Major players are also moving into new regions with advanced technologies and product offerings. The major companies also offer the product with the Certificates of Analysis (COA) and Certificates of Conformance (COC) by lot number.

Market Segmentation

Market By Capacity

  • 2 ml
  • 5 ml
  • 10 ml
  • 20 ml
  • More than 20 ml

Market By Material

  • Glass
  • Plastic

Market By End-Use

  • Compounding Labs
  • Clinical Labs
  • Pharmaceutical Manufacturers
  • Others (Contract manufacturing organizations, Distributors)

Market By Geography

(Regional Output, Demand & Forecast by Countries)

  • North America (USA and Canada)
  • Europe (UK, Germany, France, Spain and Rest of Europe)
  • Asia Pacific (China, Japan, India, Australia, South Korea and Rest of Asia-Pacific)
  • Latin America (Mexico, Brazil and Rest of Latin America)
  • Middle East and Africa (GCC, South Africa and Rest of MEA).

Some of the key observations regarding depyrogenated sterile empty vials industry include:

  • Schott AG has collaborated with the SINDAC, a French engineering firm in 2019 in order to expand its portfolio in advance pharmaceutical packaging.
  • In 2018, SGD Pharma has introduced Clareo range of molded glass vials for injectable solutions and that too with more flat and uniform bottoms. The benefit of flat and uniform bottoms is easy thermal transfer during freeze-drying processes. The new product development is particularly to expand the product portfolio of the company.
  • The Environmental Protection Agency (EPA) has updated Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, 5. As result, companies are required to determine the applied definitions according to their offerings.
  • Cherwell Laboratories has introduced a new Redipor Broth Kit in 2019, which is designed to help with microbiological QA/QC and monitoring applications. The kit comprises of three empty 30 ml sterile injection vials, a 50 ml Tryptic Soy Broth (TSB) injection vial, a 100 ml TSB broth bag and one 10 ml TSB ampoule.

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TABLE OF CONTENT

CHAPTER 1. INDUSTRY OVERVIEW

CHAPTER 2. MARKET DYNAMICS AND COMPETITION ANALYSIS

CHAPTER 3. MANUFACTURING PLANTS ANALYSIS

CHAPTER 4. DEPYROGENATED STERILE EMPTY VIALS MARKET BY CAPACITY

CHAPTER 5. DEPYROGENATED STERILE EMPTY VIALS MARKET BY MATERIAL

CHAPTER 6. DEPYROGENATED STERILE EMPTY VIALS MARKET BY END-USER

CHAPTER 7. NORTH AMERICA DEPYROGENATED STERILE EMPTY VIALS MARKET BY COUNTRY

CHAPTER 8. EUROPE DEPYROGENATED STERILE EMPTY VIALS MARKET BY COUNTRY

CHAPTER 9. ASIA-PACIFIC DEPYROGENATED STERILE EMPTY VIALS MARKET BY COUNTRY

CHAPTER 10. LATIN AMERICA DEPYROGENATED STERILE EMPTY VIALS MARKET BY COUNTRY

CHAPTER 11. MIDDLE EAST & AFRICA DEPYROGENATED STERILE EMPTY VIALS MARKET BY COUNTRY

CHAPTER 12. COMPANY PROFILE

CHAPTER 13. RESEARCH APPROACH

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