Roots Analysis has done a detailed report on Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030 covering key aspects of the industry and identifying future growth opportunities
To order this 530+ page report, which features 160+ figures and 190+ tables, please visit Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030
Key Market Insights
§ Eminent representatives from biopharmaceutical companies confirm the rising interest in the concept of subcutaneous drug delivery, highlighting some of the key drivers and upcoming trends in this domain
§ More than 100 subcutaneous biologics have been approved and over 350 such drug candidates are being evaluated in the clinical stages of development, for the treatment of a wide variety of disease indications
§ Antibodies and protein therapeutics represent the majority of subcutaneous biologics that are available / under investigation, designed for use against various therapeutic areas and having different dosing regimens
§ Advances in drug delivery have led to the development of novel technology platforms, enabling the administration of highly viscous formulations, and supporting the development of subcutaneous dosage forms
§ Several technology developers have out-licensed their proprietary platforms to pharmaceutical companies in order to enable them to develop subcutaneous formulations of their approved / pipeline products
§ The increasing interest in this field is reflected in the yearly growth in partnership activity, including a number of licensing and product development deals related to subcutaneous formulations of various drug candidates
§ There are several new and innovative drug delivery systems that facilitate subcutaneous administration; we identified over 300 such systems that are presently available / under development
§ With several self-medication enabling devices, such as wearable injectors and autoinjectors, available in the market, developers are actively differentiating their offerings by incorporating advanced, patient-friendly features
§ The market is anticipated to be worth over USD 180 billion in 2030; the projected opportunity is likely to be distributed across various types of molecules that are developed / being developed for different disease indications
§ Pre-filled syringes continue to dominate the current market of subcutaneous drug delivery systems; technology developers are expected to continue relying on licensing agreements as their primary source of revenues333
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Table of Contents
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Types of Therapeutic Molecules
3.3. Biologically Derived Therapeutics
3.3.1. Types of Products
3.3.2. Routes of Administration and Formulations
3.3.3. Subcutaneous Formulations
3.3.3.1. Approaches in Subcutaneous Delivery of Biologics
3.3.3.1.1. Reformulation
3.3.3.1.2. Differing Potencies
3.3.3.1.3. Novel Technologies
3.3.3.2. Method of Subcutaneous Administration
3.3.3.3. Advantages of Subcutaneous Administration
3.3.3.4. Limitations of Subcutaneous Administration
3.4. Regulatory Considerations
3.4.1. Medical Devices
3.4.2. Drug Device Combination Products
3.5. Future Perspectives
4. SUBCUTANEOUS BIOLOGICS: CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Subcutaneous Administration of Biologics
4.3. Subcutaneous Biologics: List of Approved Drugs
4.3.1. Analysis by Approval Year
4.3.2. Analysis by Type of Pharmacological Molecule
4.3.3. Analysis by Target Therapeutic Area
4.3.4. Analysis by Type of Formulation
4.3.5. Analysis by Dosing Frequency
4.3.6. Analysis by Dosage Form
4.3.7. Key Players: Analysis by Number of Drugs Approved
4.4. Subcutaneous Biologics: List of Clinical-Stage Drug Candidates
4.4.1. Analysis by Phase of Development
4.4.2. Analysis by Type of Pharmacological Molecule
4.4.3. Analysis by Target Therapeutic Area
4.4.4. Analysis by Dosing Frequency
4.4.5. Key Players: Analysis by Number of Drug Candidates in Trials
5. CASE STUDY: LEADING SUBCUTANEOUS BIOLOGICS
5.1. Chapter Overview
5.2. Subcutaneous Biologics: Leading Drugs by Annual Sales
5.3. Case Studies
5.3.1. HUMIRA® (AbbVie, Eisai)
5.3.1.1. Drug Overview
5. 3.1.2. Development History
5. 3.1.3. Target Indications and Dosage Forms
5. 3.1.4. Historical Sales
5.3.2. Enbrel® (Amgen, Pfizer, Takeda Pharmaceutical)
5.3.2.1. Overview
5. 3.2.2. Development History
5. 3.2.3. Target Indications and Dosage Forms
5. 3.2.4. Historical Sales
5.3.3. RITUXAN® / MabThera® (Biogen, Roche, Chugai Pharmaceutical)
5.3.3.1. Overview
5. 3.3.2. Development History
5. 3.3.3. Target Indications and Dosage Forms
5. 3.3.4. Historical Sales
5. 3.3.5. ENHANZE™ Technology (Halozyme Therapeutics)
5. 3.3.6. Advantages of Subcutaneous RITUXAN® / MabThera® Over Intravenous RITUXAN® / MabThera®
5.3.4. Herceptin® (Roche, Chugai Pharmaceutical)
5.3.4.1. Overview
5. 3.4.2. Development History
5. 3.4.3. Target Indications and Dosage Forms
5. 3.4.4. Historical Sales
5. 3.4.5. ENHANZE™ Technology (Halozyme Therapeutics)
5. 3.4.6. Advantages of Subcutaneous Herceptin® Over Intravenous Herceptin®
5. 3.4.7. Herceptin® - Large Volume Wearable Injector Combination Product
5.3.5. Neulasta® (Amgen, Kyowa Hakko Kirin)
5.3.5.1. Overview
5.3.5.2. Development History
5.3.5.3. Target Indications and Dosage Forms
5.3.5.4. Historical Sales
6. SUBCUTANEOUS FORMULATION TECHNOLOGIES: CURRENT MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Subcutaneous Formulation Technologies: List of Technology Developers
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by Geographical Location
6.3. Subcutaneous Formulation Technologies: List of Technologies
6.3.1. Analysis by Type of Pharmacological Molecule
6.3.2. Analysis by Route of Administration
6.3.3. Analysis by Advantage(s) Offered
7. SUBCUTANEOUS FORMULATION TECHNOLOGY DEVELOPERS: COMPANY COMPETITIVENESS ANALYSIS
7.1. Chapter Overview
7.2. Subcutaneous Formulation Technology Developers: Competitive Landscape
7.2.1. Methodology
7.2.2. Three-Dimensional Bubble Analysis based on Supplier Power, Pipeline Strength and Primary Advantage(s)
7.3. Subcutaneous Formulation Technology Developers: Benchmark Analysis
7.3.1. Methodology
7.3.2. North America
7.3.3. Europe
8. SUBCUTANEOUS FORMULATION TECHNOLOGY DEVELOPERS: COMPANY PROFILES
8.1. Chapter Overview
8.2. Adocia
8.2.1. Company Overview
8.2.2. Technology Overview
8.2.2.1. BioChaperone® Technology
8.2.3. Product Portfolio
8.2.4. Financial Performance
8.2.5. Recent Developments and Future Outlook
8.3. Ajinomoto Althea
8.3.1. Company Overview
8.3.2. Technology Overview
8.3.2.1. Crystalomics® Formulation Technology
8.3.3. Product Portfolio
8.3.4. Financial Performance
8.3.5. Recent Developments and Future Outlook
