注射剤のPOCにおける再構成

生物学的製剤に固有の不安定性は、ドラッグデリバリー分野に直接的な影響を与える制限事項です。治療用タンパク質は、特殊な条件下で保存するか、製造から調剤まで効能を維持できるように調合する必要があります。液状のタンパク質医薬品は、調剤されるまで冷蔵保存が必要です。また、タンパク質は粉体として製剤化（凍結乾燥）することができますが、注射の前に再構成する必要があります。

当レポートでは、注射剤のPOCにおける再構成について調査し、薬物再構成の概要とともに、生物製剤の動向、競合情勢、および市場に参入する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
• 注射剤のPoCでの再構成
• 薬物再構成市場力学
• 再構成- 生物学的薬物生活の事実
• 注射薬のエコシステム
• デバイス設計の進化
• 配合要因
• 製品固有のデバイス開発
• 特殊注射デバイスの需要促進要因
• 慢性疾患と自己管理
• 生物製剤の成長
• 処方および投薬
• 患者層の変化
• 安全性と遵守
• デバイスの設計とイノベーション
• 競合情勢
• 技術市場の促進要因
• POC再構成のための統合デバイス
• デュアルチャンバーカートリッジ
• デュアルチャンバーインジェクター
• デュアルチャンバーシリンジ
• ウェアラブル自動偵察システム
• デバイス評価
• 製品固有のデバイス
• 特殊機器
• OEMデバイス
• デュアルチャンバーセーフティシリンジ
• 治療セグメント- データと予測
• ホルモン補充
• 感染症
• 代謝状態
• 骨粗鬆症
• 神経学
• 腫瘍学
• 再生医療
• その他の治療セグメント
• 市場要因
• デバイス製品戦略
• デバイスの経済性
• 製品ブランディング
• 消費者への直接販売
• マネージドケアの動向
• 企業プロファイル

“POC Reconstitution of Injectable Drugs ” 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, disease segments, and commercial opportunities for reconstitution systems for injectable drug products . Provider organization business managers, healthcare administrators and investors will also benefit from this study.

Engineered Injectables that Address Chronic Conditions

The inherent instability of biological drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed. Alternatively, proteins can be formulated as powders (lyophilization) and must be reconstituted prior to injection. Historically, this was accomplished by including a disposable syringe and diluent vial for manual reconstitution. As the number of drugs developed for self-administration has grown, devices that integrate a reconstitution step with the injection step have gained traction. As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of specialty devices will increase.

What You Will Learn:

• What is the impact of lyophilized injectable drugs on today's therapeutic market, how are they packaged, and who markets them?

• Who are the suppliers of integrated reconstitution devices, and what is their market impact?

• What are the major factors driving the demand for integrated devices for injectable drug reconstitution?

• What is the relative impact of integrated reconstitution systems to OEM or standalone reconstitution devices and how will this change by the end of the decade?

• What are the essential design factors, material selection issues, technologies and market development issues for drug reconstitution systems and devices?

• What is the role of integrated drug reconstitution systems on drug life cycle management?

• What are the significant economic, technology, and regulatory factors affecting the market for injectable drugs and reconstitution systems in particular?

Table of Contents

• Executive Summary
• Reconstituting Injectables at the PoC
• Drug Reconstitution Market Dynamics
• Reconstitution - A Fact of Biological Drug Life
• The Injectable Drug Ecosystem
• Evolution in Device Design
• Formulation Factors
• Product Specific Device Development
• Specialty Injection Device Demand Drivers
• Chronic Conditions and Self-Administration
• The Growth of Biologicals
• Formulation and Dosing
• Shifting Patient Demographics
• Safety and Adherence
• Device Design and Innovation
• Competitive Landscape
• Technology Market Drivers
• Integrated Devices for POC Reconstitution
• Dual Chamber Cartridges
• Dual Chamber Injectors
• Dual Chamber Syringes
• Wearable Automated Recon System
• Device Assessments
• Product-Specific Devices
• Specialty Devices
• OEM Devices
• Dual Chamber Safety Syringe (Credence
• Therapeutic Segments - Data & Forecasts
• Hormone Replacement
• Infectious Disease
• Metabolic Conditions
• Osteoporosis
• Neurology
• Oncology
• Reproductive Health
• Other Therapeutic Segments
• Market Factors
• Device Product Strategies
• Device Economics
• Product Branding
• Direct-to-Consumer Marketing
• Managed Care Trends
• Company Profiles