高粘度注射剤用ハンドヘルドデバイス市場

高粘度薬剤の成長は、バイオテクノロジーと宿主ベクター工学の進歩が牽引しています。バイオテクノロジーと宿主ベクター工学の進歩は、多くの疾患や症状に対する生物学的製剤の安定した供給につながっています。このような強力な医薬品は、投与量あたりのコストが高く、重大な副作用のリスクを伴うため、投与効率、安全性、信頼性が重視されます。このクラスの薬剤の多くは、薬剤の商業化エコシステムにとって課題となる物理的特性や感受性を特徴としています。例えば、モノクローナル抗体は、治療上および商業上の重要性という点で、おそらく最も重要なカテゴリーですが、通常、皮下注射デバイスや技術の通常の限界をはるかに超える粘度を有しています。技術的な解決策がなければ、このような高粘度の薬剤は点滴用に製剤化され供給されることになりますが、この動向は患者の物流とヘルスケア経済にさらなる圧力をかける恐れがあります。高粘度注射剤の皮下投与という目標に取り組むため、医薬品開発者と機器設計者の協力体制はますます強まっています。

当レポートは、世界の高粘度注射剤用ハンドヘルドデバイス市場について詳細に考察し、市場の概要と競合情勢、技術動向、規制問題、および市場参入企業のプロファイルなどを提供しています。

目次

• エグゼクティブサマリー
• 点滴用に承認された生物学的製剤
• 競合情勢
• 環状オレフィンプレフィルシリンジ
• 投与量と患者の服薬遵守
• 薬物の特性
• 医薬品の保管要件
• 配合技術
• 製剤関連の高粘度
• 高粘度デバイス
• 人間工学/人間工学
• 注射部位の修正
• レガシー医薬品：静注から皮下への移行
• 液化ガス配送サービス
• ニードルフリーインジェクター
• 一次包装
• 危険因子
• 特殊自動インジェクター
• 特殊ガラスシリンジ
• 特殊プラットフォームインジェクター
• 徐放性注射剤
• ドラッグデリバリーの経済学
• 高粘度医薬品市場
• 市場の機会
• 市場要因
• 規制の問題
• デバイスのブランディング
• 使いやすさ
• 市場参入企業のプロファイル

“Handheld Devices for High Viscosity Injectables: Devices, Markets, Strategies and Forecasts” is a comprehensive evaluation and analysis of the technology, products and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, opportunities for handheld injection devices that are capable of injecting drugs with high viscosities. Provider organization business managers, healthcare administrators and investors will also benefit from this study.

Evolving Engineered Solutions

Growth in high viscosity drugs is being driven by advances in biotechnology and host-vector engineering - advances that have led to a steady stream of biologics for a number of ailments and conditions. These powerful drugs come with a high cost-per-dose and the risk of significant side effects - factors that place an elevated emphasis on administration efficiency, safety and reliability. Many drugs in this class are characterized by physical properties and sensitivities that challenge the drug commercialization ecosystem. For example, monoclonal antibodies, perhaps the most significant category in terms of therapeutic and commercial importance, typically possess viscosities that are well above the normal limits of subcutaneous injection devices and techniques. Without a technical solution, these high viscosity drugs are formulated and supplied for infusion, a trend that threatens to put additional pressure on patient logistics and healthcare economics. Drug developers and device designers are increasingly working in collaboration to address the goal of subcutaneous administration of high viscosity injectables.

Numerous graphs, charts, tables and visualizations complement the analysis.

Forecasts, projections of future market activity are derived using standard modeling and statistical techniques.

What You Will Learn:

• What are the handheld device classes and individual devices that can inject high viscosity drugs; what are the key market segments, market dynamics and market demographics?

• What are the therapeutic demand drivers and commercial devices in key product segments?

• What are the design factors, material selection issues, technologies and market development issues?

• How big is the market? How is it growing?

• Who are the leading injectable drug and device participants in this sector, what are their product development activities, business strategies, and corporate alliances and affiliations?

• What is the importance of pharma-device alliances and design partnerships for high viscosity device commercialization and market access?

• What are the significant economic, technology, and regulatory factors affecting the market for high viscosity injection devices?

Table of Contents

• Executive Summary
• Biological Drugs Approved for Infusion
• Competitive Landscape
• Cyclic Olefin Prefillable Syringes
• Dosing and Patient Adherence
• Drug Properties
• Drug Storage Requirements
• Formulation Technology
• Formulation-related High Viscosity
• High Viscosity Devices
• Human Engineering/Ergonomics
• Injection Site Modification
• Legacy Drugs: IV-to-Subcutaneous Migration
• Liquified Gas Assisted Delivery
• Needle-free Injectors
• Primary Packaging
• Risk Factors
• Specialty Autoinjectors
• Specialty Glass Syringes
• Specialty Platform Injectors
• Sustained Release Injectables
• The Economics of Drug Delivery
• The High Viscosity Drug Market
• The Market Opportunity
• Market Factors
• Regulatory Issues
• Device Branding
• Ease of Use
• Market Participant Profiles