生物學的注射藥 - 技術，治療方法，市場，策略，預測

器械工程為生物製劑輸送提供新平台

生物製劑在研發管線和臨床試驗中持續超越所有其他新化學實體 (NCE)。由於生物製劑通常用於治療慢性疾病，因此必須制定給藥策略和治療方案，使其能夠長期使用，並且在許多情況下，能夠方便那些可能因疾病狀態而受限的患者自行給藥。抗體、荷爾蒙、酵素和其他生物製劑的強效生理效應也推動了對安全性和依從性的需求。器械設計人員和藥物開發人員之間的合作在藥物開發週期的早期階段就已開始，這通常使得器械設計能夠根據特定藥物療法的生物利用度目標和藥物動力學特徵進行客製化。目前正在開發的新型注射用藥物輸送器械設計可能會為替代注射方法創造新的機會。器械供應商與製藥公司之間的合作有望促進市場對用於多種新興療法的新型注射器械的接受，包括治療性疫苗、DNA藥物和蛋白質生物製劑。

本報告探討了生物製劑注射劑市場，提供了用於注射生物製劑的注射器械的經濟性、技術、疾病細分和機遇方面的資訊。

了解更多

• 產品與使用者需求驅動生物製劑器械的選擇過程
• 用於注射生物製劑的注射器材的關鍵設計要素、技術和開發課題
• 生物製劑生產流程在開發過程中的變化如何影響器械的準備度，以及這些變化如何隨著最新趨勢而變化？
• 不同類別的生物製劑如何進行器械選擇決策？治療目標是什麼？哪些細分市場？
• 藥品-器材依賴性如何影響上市前後的產品生命週期管理？
• 影響生物製劑注射器材市場的關鍵經濟、技術和監管因素

"Therapeutic Biological Drugs for Injectable Delivery: Devices, Therapeutics, 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, disease segments, and commercial opportunities for injection devices for administering biologicals. Provider organization business managers, healthcare administrators and investors will also benefit from this study.

Device Engineering Providing New Platforms for Biological Drug Delivery

Biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones, enzymes and other biological drugs also increase the need for safety and adherence. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies. New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

What You Will Learn:

• What are the product and user requirements that drive the biological drug-device selection process?
• What are the essential design factors, technologies and market development issues for injection devices capable of administering biological dugs?
• What is the impact of development-stage biological manufacturing process changes on device go-to-market readiness and how has it changed in recent years?
• How do device selection decisions align across biological drug classes? Therapeutic targets? Market segments?
• What is the impact of drug-device dependencies on pre- and post-marketing product life cycle management?
• What are the significant economic, technology, and regulatory factors affecting the market for biological drug injection devices?

Methodology:

Research methodology is based on primary research in the form of in-depth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations.

Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations.

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

Table of Tables

Executive Summary

The Market Opportunity

• Unmet Patient Needs
• Biosimilars
• The Biological Drug Global Supply Chain

Biological Drug Delivery - Challenges and Limitations

• Drug Stability
• Pre- and Post-Manufacturing Engineering
• Lyophilization and Reconstitution
• Viscosities and Volumes

Drug Strategies & Therapeutic Protein Packaging

• As-Supplied Packaging
• Device Market Share
• Device Supplier Segment Activity
• Emerging Injection Devices for Biological Drugs

Injectable Biologicals - Product Analysis by Drug Class

• Cytokines
• Enzymes
• Fusion Proteins
• G-CSF/GM-CSF
• Hematopoietics
• Hormones
• Immune Modulators
• Insulins & GLP Analogs
• Monoclonal Antibodies
• Vaccines

Therapeutic Market Segment Analysis

• Cardiovascular
• Diabetes
• Hematology
• Immunology
• Metabolic
• Oncology

Market Factors

• Regulatory Issues
• Patient Preferences and Self-Administration
• Pre- and Post-marketing Device Evolution
• Compatibility Testing

Company Profiles