表紙
市場調査レポート

プレフィルドシリンジ市場における技術革新 - 今後のR&Dトレンドを形成する生物製剤と自己注射器

Innovation in the Prefilled Syringe Market - Biologics and Autoinjection Devices Shaping Future R&D Trends

発行 GBI Research 商品コード 257408
出版日 ページ情報 英文 28 Pages
即納可能
価格
本日の銀行送金レート: 1USD=105.69円で換算しております。
Back to Top
プレフィルドシリンジ市場における技術革新 - 今後のR&Dトレンドを形成する生物製剤と自己注射器 Innovation in the Prefilled Syringe Market - Biologics and Autoinjection Devices Shaping Future R&D Trends
出版日: 2012年12月14日 ページ情報: 英文 28 Pages
概要

生物療法の台頭から、プレフィルドシリンジ(薬剤充填済みシリンジ)市場の成長拡大が見込まれる一方、それには製造者による現行製品の問題解消が条件となる、それが医療産業のエキスパート、GBI Researchの最新レポートの結論です。

当レポートでは、プレフィルドシリンジの世界市場に注目し、独自のデータベースおよび一次・二次情報源から、現行装置の問題点、技術開発の方向性および市場の将来展望を探る最新の分析情報をまとめて、概略以下の構成でお届けします。

第1章 目次

  • 図表一覧

第2章 プレフィルドシリンジの技術革新 - 概要

  • 概要

第3章 プレフィルドシリンジの技術革新 - イントロダクション

  • プレフィルドシリンジとは
  • 医薬品市場におけるプレフィルドシリンジの現在位置
  • プレフィルドシリンジの成長推進ファクター
  • プレフィルドシリンジの使用をめぐる問題点
  • 技術革新の余地

第4章 プレフィルドシリンジの技術革新 - 現行装置技術および関連する推進・阻害要因

  • ガラス製シリンジとプラスチック製シリンジを比較する
    • 壊れやすさ
    • 寸法の多様性
    • シリコン化
    • 層間剥離
    • タングステン汚染
  • 自己注射器
  • プレフィルドシリンジの安全機構
  • 希釈剤充填済みシリンジ
  • プレフィルドシリンジの技術革新を加速する生物製剤

第5章 プレフィルドシリンジの技術革新 - 製剤設計と製薬会社の課題

  • 薬粘性
  • 抽出物と漏出物
  • 凍結乾燥製剤と液体安定製剤の組成を比較する

第6章 プレフィルドシリンジの技術革新 -現行障壁の克服と開発トレンド

  • 既存製品のライフサイクル延長に向けた斬新な方法
  • 従来型ガラス製シリンジに何らかの改良をもたらすプラスチック製
    • ポリプロピレン
    • シクロオレフィンポリマー
  • 抽出物と漏出物
  • ガラスコーティング - シリコン焼き付け
  • コーテッドストッパー
  • 安全技術革新
  • 一体型針 - ルアーロック方式の改良
  • 充填技術と気泡除去方法
  • 針長 - 短針化で皮下注射の精度を増す期待
  • 製造利点 - 滅菌シリンジ
    • アクセス制限バリアシステム(RABS)
    • 電子線滅菌トンネル
  • プレフィルドシリンジ製造の自動化と整備
  • 製造柔軟性と一体型機構
  • プレフィルドシリンジの検査
  • プレフィルドシリンジのカスタマイズ
  • 自己注射の改良
  • 最高マーケティング責任者(CMO)にとっての特許中心視点

第7章 付録

  • 市場の定義
  • 略語
  • 参考文献一覧
  • 調査方法
  • お問い合わせ先
  • 免責事項

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: GBIHC258MR

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Innovation in the Prefilled Syringe Market - Biologics and Autoinjection Devices Shaping Future R&D Trends", which provides insights into possible future avenues of R&D in the prefilled syringe market. This includes an overview of problems and possible solutions, as well as discussion of how the devices have developed to date to address problems with contamination, safety, fragility and ease of use.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

The market for prefilled syringes is being driven by the rise in popularity of autoinjection devices for the home-use market. As health authorities seek to reduce costs, facilitating patients in self-administering their medication is one major way of reducing the strain on resources for providers. Additionally, patients prefer this option as it does not require them to travel to hospital and can be accommodated in their own home.

Innovation is also being driven by safety. This area has seen increasing innovation in response to regulations and guidelines concerning needlestick injury. This is an area of rising concern as the number of logged needlestick injuries in healthcare workers is high and thought to be considerably under-reported. Measures to ensure healthcare provider safety have been put in place, and pharmaceutical companies are responding by improving the safety of their prefilled syringes in order to increase their appeal and gain market share. Safety devices have moved from active devices, which require activation by the user, to passive, which are automatically activated. The next steps are being made in integrating the safety device into the needle during manufacture.

The development of injectable biologic therapies is a major factor in the future prospects of prefilled syringes. Although oral biologics are something that companies are aiming for and there are some in development, many peptides are broken down too quickly in the stomach and are therefore not useful in treatment. The mainstay of biologic treatment is likely to remain injectable, whether intravenous, subcutaneous or intramuscular, for the foreseeable future. As such, companies need to overcome the limitations of prefilled syringes in order to provide convenient method of administration and win market share.

Scope

  • An overview of issues in the market.
  • Innovative solutions to these problems.
  • Future developments expected in the market by leading players

Reasons to buy

  • Understand how the prefilled syringe market has adapted to issues.
  • Predict which innovations are likely to be most successful in the future.
  • Gain an understanding of areas of unmet need in the market

Executive Summary

Syringe Innovation Required to Take Advantage of Biologics Boom

The rise of biologic therapies will power growth in the prefilled syringes market - but only if manufacturers can solve current product problems, says a new report from healthcare industry experts GBI Research.

As explained in the business intelligence firm's latest release*, the development of injectable biologic therapies is a major factor for the future prospects of prefilled syringes, as many peptides contained in oral formulations are broken down too quickly in the stomach, compromising their effectiveness.

Currently, many biologic therapies are incompatible with the silicone used in glass syringes, necessitating a move to plastic variations and the development of new polymers and coatings that minimize reactions between the syringe material and the drug that cause contamination.

Glass has been the primary material in syringe manufacturing for decades, but is slowly being replaced as the advantages of polymer-based alternatives become apparent. Other than the possibility of product contamination, glass syringes are more fragile and are prone to flaking, but existing plastic versions are not without their own faults.

Cyclo-olefin polymers and co-polymers are the most commonly used plastic syringe variants in the market today, with several companies offering prefilled syringes in this form. However, while they are more durable and less likely to feature manufacturing defects than their glass counterparts, they are also more expensive to produce and are economically unsuitable for low price drugs.

Polypropylene syringes have been around since the 1990s, and although cheaper than the aforementioned plastics, it is a less transparent material and more difficult to sterilize.

GBI Research's new report also predicts that the prefilled syringe market will be driven by the growth of home use and auto-injection devices that use a button-push mechanism - an innovative response to the common fear of needles.

Innovation in the Prefilled Syringe Market - Biologics and Autoinjection Devices Shaping Future R&D Trends

This report includes an overview of problems and possible solutions, as well as discussion of how the devices have developed to date to address problems with contamination, safety, fragility and ease of use.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

  • 1.1. List of Figures

2. Innovation in Prefilled Syringes - Overview

  • 2.1. Overview

3. Innovation in Prefilled Syringes - Introduction

  • 3.1. What are Prefilled Syringes?
  • 3.2. The Current Position of Prefilled Syringes in the Pharmaceutical Market
  • 3.3. Factors Fueling Growth of Prefilled Syringes
  • 3.4. Issues around the Use of Prefilled Syringes
  • 3.5. Where Does Innovation Lie?

4. Innovation in Prefilled Syringes - Current Device Technologies and Associated Drivers and Barriers

  • 4.1. Glass Syringes versus Plastic Syringes
    • 4.1.1. Fragility
    • 4.1.2. Dimensional Variability
    • 4.1.3. Siliconization
    • 4.1.4. Delamination
    • 4.1.5. Tungsten Contamination
  • 4.2. Autoinjection Devices
  • 4.3. Safety Devices on Prefilled Syringes
  • 4.4. Prefilled Diluent Syringes
  • 4.5. Biologics Driving Innovation in Prefilled Syringes

5. Innovation in Prefilled Syringes - Formulation Considerations and Challenges for Pharmaceutical Companies

  • 5.1. Drug Viscosity
  • 5.2. Extractables and Leachables
  • 5.3. Lyophilized Drugs versus Liquid-stable Formulations

6. Innovations in Prefilled Syringes - Overcoming Current Barriers and Trends in Development

  • 6.1. Innovative Ways of Gaining Life Cycle Extensions for Existing Products
  • 6.2. Plastic Syringes Offer Some Improvements over Traditional Glass Syringes
    • 6.2.1. Polypropylene
    • 6.2.2. Cyclo-olefin Polymers and Co-polymers
  • 6.3. Extractables and Leachables
    • 6.3.1. Glass Coatings - Reducing Silicone and Silicone Baking
    • 6.3.2. Coated Stoppers
  • 6.4. Safety Innovations
  • 6.5. Integrated Needles - Advancements on the Luer Lock System
  • 6.6. Filling Technologies and Removing the Air Bubble
  • 6.7. Needle Length - Reducing Length can Increase Accuracy of Subcutaneous Injections
  • 6.8. Manufacturing Advances - Sterilizing Syringes
    • 6.8.1. Restricted Access Barrier Systems
    • 6.8.2. Electron Beam Sterilization Tunnels
  • 6.9. Automating and Streamlining the Manufacture of Prefilled Syringes
  • 6.10. Manufacturing Flexibility and Integrated Systems
  • 6.11. Testing of Prefilled Syringes
  • 6.12. Customization of Prefilled Syringes
  • 6.13. Self-injection Improvements
  • 6.14. Patient-centric Focus for CMOs

7. Appendix

  • 7.1. Market Definitions
  • 7.2. Abbreviations
  • 7.3. Bibliography
  • 7.4. Research Methodology
    • 7.4.1. Coverage
    • 7.4.2. Secondary Research
    • 7.4.3. Primary Research
    • 7.4.4. Expert Panel Validation
  • 7.5. Contact Us
  • 7.6. Disclaimer

List of Figures

  • Figure 1: Innovation of a Drug Product to Improve Market Differentiation, Prefilled Syringes, 2012
Back to Top