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.

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 revenues.

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Table of Contents

1. PREFACE
   • Scope of the Report
   • Research Methodology
   • Chapter Outlines
2. EXECUTIVE SUMMARY
4. INTRODUCTION
   • Chapter Overview
   • Types of Therapeutic Molecules
   • Biologically Derived Therapeutics
     • Types of Products
     • Routes of Administration and Formulations
     • Subcutaneous Formulations
       • Approaches in Subcutaneous Delivery of Biologics
         • Reformulation
         • Differing Potencies
         • Novel Technologies
       • Method of Subcutaneous Administration
       • Advantages of Subcutaneous Administration
       • Limitations of Subcutaneous Administration
     • Regulatory Considerations
       • Medical Devices
       • Drug Device Combination Products
     • Future Perspectives

1. SUBCUTANEOUS BIOLOGICS: CURRENT MARKET LANDSCAPE
   • Chapter Overview
   • Subcutaneous Administration of Biologics
   • Subcutaneous Biologics: List of Approved Drugs
     • Analysis by Approval Year
     • Analysis by Type of Pharmacological Molecule
     • Analysis by Target Therapeutic Area
     • Analysis by Type of Formulation
     • Analysis by Dosing Frequency
     • Analysis by Dosage Form
     • Key Players: Analysis by Number of Drugs Approved
   • Subcutaneous Biologics: List of Clinical-Stage Drug Candidates
     • Analysis by Phase of Development
     • Analysis by Type of Pharmacological Molecule
     • Analysis by Target Therapeutic Area
     • Analysis by Dosing Frequency
     • Key Players: Analysis by Number of Drug Candidates in Trials

1. CASE STUDY: LEADING SUBCUTANEOUS BIOLOGICS
   • Chapter Overview
   • Subcutaneous Biologics: Leading Drugs by Annual Sales
   • Case Studies
     • HUMIRA® (AbbVie, Eisai)
       • Drug Overview

1. 3.1.2. Development History
2. 3.1.3. Target Indications and Dosage Forms
3. 3.1.4. Historical Sales

• Enbrel® (Amgen, Pfizer, Takeda Pharmaceutical)
  • Overview

1. 3.2.2. Development History
2. 3.2.3. Target Indications and Dosage Forms
3. 3.2.4. Historical Sales

• RITUXAN® / MabThera® (Biogen, Roche, Chugai Pharmaceutical)
  • Overview

1. 3.3.2. Development History
2. 3.3.3. Target Indications and Dosage Forms
3. 3.3.4. Historical Sales
4. 3.3.5. ENHANZE™ Technology (Halozyme Therapeutics)
5. 3.3.6. Advantages of Subcutaneous RITUXAN® / MabThera® Over Intravenous RITUXAN® / MabThera®

• Herceptin® (Roche, Chugai Pharmaceutical)
  • Overview

1. 3.4.2. Development History
2. 3.4.3. Target Indications and Dosage Forms
3. 3.4.4. Historical Sales
4. 3.4.5. ENHANZE™ Technology (Halozyme Therapeutics)
5. 3.4.6. Advantages of Subcutaneous Herceptin® Over Intravenous Herceptin®
6. 3.4.7. Herceptin® - Large Volume Wearable Injector Combination Product

• Neulasta® (Amgen, Kyowa Hakko Kirin)
  • Overview
  • Development History
  • Target Indications and Dosage Forms
  • Historical Sales

1. SUBCUTANEOUS FORMULATION TECHNOLOGIES: CURRENT MARKET LANDSCAPE
   • Chapter Overview
   • Subcutaneous Formulation Technologies: List of Technology Developers
     • Analysis by Year of Establishment
     • Analysis by Company Size
     • Analysis by Geographical Location
   • Subcutaneous Formulation Technologies: List of Technologies
     • Analysis by Type of Pharmacological Molecule
     • Analysis by Route of Administration
     • Analysis by Advantage(s) Offered

1. SUBCUTANEOUS FORMULATION TECHNOLOGY DEVELOPERS: COMPANY COMPETITIVENESS ANALYSIS
   • Chapter Overview
   • Subcutaneous Formulation Technology Developers: Competitive Landscape
     • Methodology
     • Three-Dimensional Bubble Analysis based on Supplier Power, Pipeline Strength and Primary Advantage(s)
   • Subcutaneous Formulation Technology Developers: Benchmark Analysis
     • Methodology
     • North America
     • Europe

1. SUBCUTANEOUS FORMULATION TECHNOLOGY DEVELOPERS: COMPANY PROFILES
   • Chapter Overview
   • Adocia
     • Company Overview
     • Technology Overview
       • BioChaperone® Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Ajinomoto Althea
     • Company Overview
     • Technology Overview
       • Crystalomics® Formulation Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Arecor
     • Company Overview
     • Technology Overview
       • Arestat™ Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • Alteogen
     • Company Overview
     • Technology Overview
       • Hybrozyme Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • Ascendis Pharma
     • Company Overview
     • Technology Overview
       • TransCon Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Avadel Pharmaceuticals
     • Company Overview
     • Technology Overview
       • Medusa™ Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Camurus
     • Company Overview
     • Technology Overview
       • FluidCrystal® Injection Depot Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Creative BioMart
     • Company Overview
     • Technology Overview
       • High Concentration Formulation Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • Creative Biolabs
     • Company Overview
     • Technology Overview
       • Long-Acting Injectable Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • DURECT
     • Company Overview
     • Technology Overview
       • SABER® Platform
       • CLOUD™ PLATFORM
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Eagle Pharmaceuticals
     • Company Overview
     • Technology Overview
       • Unnamed Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • Halozyme Therapeutics
     • Company Overview
     • Technology Overview
       • ENHANZE® Technology
     • Product Portfolio
     • Financial Performance
     • Recent Developments and Future Outlook
   • MedinCell
     • Company Overview
     • Technology Overview
       • BEPO® Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • Xeris Pharmaceuticals
     • Company Overview
     • Technology Overview
       • XeriJect™ Technology
       • XeriSol™ Technology
     • Product Portfolio
     • Recent Developments and Future Outlook
   • Serina Therapeutics
     • Company Overview
     • Technology Overview
       • POZ™ Drug Delivery Technology
     • Product Portfolio
     • Recent Developments and Future Outlook

1. PARTNERSHIPS AND COLLABORATIONS
   • Chapter Overview
   • Partnership Models
   • Subcutaneous Formulation Technologies: Partnerships and Collaborations
     • Analysis by Year of Partnership
     • Analysis by Type of Partnership
     • Most Active Players: Analysis by Number of Partnerships
     • Regional Analysis
     • Intercontinental and Intracontinental Agreements

1. SUBCUTANEOUS DRUG DELIVERY SYSTEMS: CURRENT MARKET LANDSCAPE
   • Chapter Overview
   • Different Types of Subcutaneous Drug Delivery Systems
   • Subcutaneous Drug Delivery Systems: Overall Market Landscape
     • Large Volume Wearable Injectors
       • Overview
       • Current Market Landscape of Devices for Non-insulin Biologics
         • Analysis by Stage of Development
         • Analysis by Type of Device
         • Analysis by Type of Dose Administered
         • Analysis by Volume / Storage Capacity
         • Analysis by Usability
         • Analysis by Mode of Injection
         • Analysis by Mechanism of Action
         • Most Active Players: Analysis by Number of Devices
         • Product Competitiveness Analysis
       • Current Market Landscape of Devices for Insulin
         • Analysis by Stage of Development
         • Analysis by Type of Device
         • Analysis by Volume / Storage Capacity
         • Analysis by Usability
         • Analysis by Availability of Integrated CGM / BGM System
         • Most Active Players: Analysis by Number of Devices

1. SWOT ANALYSIS
   • Chapter Overview
   • Comparison of SWOT Factors
     • Strengths
     • Weaknesses
     • Opportunities
     • Threats

1. MARKET FORECAST AND OPPORTUNITY ANALYSIS
   • Chapter Overview
   • Subcutaneous Biologics Market
     • Forecast Methodology and Key Assumptions
     • Overall Subcutaneous Biologics Market, 2020-2030
       • Subcutaneous Biologics Market, 2020-2030:Distribution by Phase of Development
       • Subcutaneous Biologics Market, 2020-2030:Distribution by Type of Pharmacological Molecule
       • Subcutaneous Biologics Market, 2020-2030:Distribution by Target Therapeutic Area
       • Subcutaneous Biologics Market, 2020-2030:Distribution by Key Geographical Regions
     • Subcutaneous Drug Delivery Systems Market
       • Device Type 1: Large Volume Wearable Injectors
         • Forecast Methodology and Key Assumptions
         • Global Large Volume Wearable Injectors Market for Non-Insulin Drugs, 2020-2030
           • Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Type of Device, 2020-2030
           • Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Usability, 2020-2030
           • Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Target Therapeutic Area, 2020-2030
           • Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Key Geographical Regions, 2020-2030
         • Global Large Volume Wearable Injectors Market for Insulin , 2020-2030
           • Global Large Volume Wearable Injectors Market for Insulin: Distribution by Type of Device, 2020-2030
           • Global Large Volume Wearable Injectors Market for Insulin: Distribution by Usability, 2020-2030
           • Global Large Volume Wearable Injectors Market for Insulin: Distribution by Key Geographical Regions, 2020-2030
         • Device Type 2: Autoinjectors
           • Forecast Methodology and Key Assumptions
           • Global Autoinjectors Market, 2020-2030
             • Global Autoinjectors Market: Distribution by Usability, 2020-2030
             • Global Autoinjectors Market: Distribution by Type of Pharmacological Molecule, 2020-2030
             • Global Autoinjectors Market: Distribution by Key Geographical Regions, 2020-2030
           • Device Type 3: Prefilled Syringes
             • Forecast Methodology and Key Assumptions
             • Global Prefilled Syringes Market, 2020-2030
               • Global Prefilled Syringes Market: Distribution by Type of Syringe Barrel Material, 2020-2030
               • Global Prefilled Syringes Market: Distribution by Type of Chamber System, 2020-2030
               • Global Prefilled Syringes Market: Distribution by Type of Pharmacological Molecule, 2020-2030
               • Global Prefilled Syringes Market: Distribution by Target Therapeutic Area, 2020-2030
               • Global Prefilled Syringes Market: Distribution by Key Geographical Regions, 2020-2030
             • Device Type 4: Needle-Free Injection Systems
               • Forecast Methodology and Key Assumptions
               • Global Needle-Free Injection Systems Market, 2020-2030
                 • Global Needle-Free Injection Systems Market: Distribution by Usability, 2020-2030
                 • Global Needle-Free Injection Systems Market: Distribution by Actuation Mechanism, 2020-2030
                 • Global Needle-Free Injection Systems Market: Distribution by Target Therapeutic Area, 2020-2030
                 • Global Needle-Free Injection Systems Market: Distribution by Key Geographical Regions, 2020-2030
               • Device Type 5: Novel Drug Reconstitution Systems
                 • Forecast Methodology and Key Assumptions
                 • Global Novel Drug Reconstitution Systems Market, 2020-2030
               • Subcutaneous Formulation Technologies Market
                 • Subcutaneous Formulation Technologies Market: Distribution by Upfront and Milestone Payments, 2020-2030

1. CONCLUDING REMARKS
3. EXECUTIVE INSIGHTS
   • Chapter Overview
   • Lindy Biosciences
     • Company Snapshot
     • Interview Transcript: Deborah Bitterfield, Chief Executive Officer and Founder
   • Oval Medical Technologies
     • Company Snapshot
     • Interview Transcript: Matthew Young, Chief Technology Officer and Founder
   • Xeris Pharmaceuticals
     • Company Snapshot
     • Interview Transcript: Steve Prestrelski, Chief Scientific Officer and Founder; Hong Qi, Vice President, Product Development; and Scott Coleman, Sr. Scientist Formulation)
   • DALI Medical Devices
     • Company Snapshot
     • Interview Transcript: David Daily, Chief Executive Officer and Co-Founder
   • Excelse Bio
     • Company Snapshot
     • Interview Transcript: Michael Reilly, Chief Executive Officer and Co-Founder
   • i-novion
     • Company Snapshot
     • Interview Transcript: Poonam R Velagaleti, Co-Founder
   • Enable Injections
     • Company Snapshot
     • Interview Transcript: Michael Hooven, Chief Executive Officer
   • Immunovaccine Technologies
     • Company Snapshot
     • Interview Transcript: Frederic Ors, Chief Executive Officer
   • Portal Instruments
     • Company Snapshot
     • Interview Transcript: Patrick Anquetil, Chief Executive Officer
   • Elcam Medical
     • Company Snapshot
     • Interview Transcript: Menachem Zucker, Vice President and Chief Scientist
   • West Pharmaceutical Services
     • Company Snapshot
     • Interview Transcript: Tiffany H Burke, Director, Global Communications and Graham Reynolds, Vice President and General Manager, Global Biologics
   • MedinCell
     • Company Snapshot
     • Interview Transcript: David Heuzé, Communication Leader

1. APPENDIX 1: TABULATED DATA
3. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION

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