Pre-filled syringes continue to dominate the current market of subcutaneous drug delivery systems
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
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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
8.4. Arecor
8.4.1. Company Overview
8.4.2. Technology Overview
8.4.2.1. Arestat™ Technology
8.4.3. Product Portfolio
8.4.4. Recent Developments and Future Outlook
8.5. Alteogen
8.5.1. Company Overview
8.5.2. Technology Overview
8.5.2.1. Hybrozyme Technology
8.5.3. Product Portfolio
8.5.4. Recent Developments and Future Outlook
8.6. Ascendis Pharma
8.6.1. Company Overview
8.6.2. Technology Overview
8.6.2.1. TransCon Technology
8.6.3. Product Portfolio
8.6.4. Financial Performance
8.6.5. Recent Developments and Future Outlook
8.7. Avadel Pharmaceuticals
8.7.1. Company Overview
8.7.2. Technology Overview
8.7.2.1. Medusa™ Technology
8.7.3. Product Portfolio
8.7.4. Financial Performance
8.7.5. Recent Developments and Future Outlook
8.8. Camurus
8.8.1. Company Overview
8.8.2. Technology Overview
8.8.2.1. FluidCrystal® Injection Depot Technology
8.8.3. Product Portfolio
8.8.4. Financial Performance
8.8.5. Recent Developments and Future Outlook
8.9. Creative BioMart
8.9.1. Company Overview
8.9.2. Technology Overview
8.9.2.1. High Concentration Formulation Technology
8.9.3. Product Portfolio
8.9.4. Recent Developments and Future Outlook
8.10. Creative Biolabs
8.10.1. Company Overview
8.10.2. Technology Overview
8.10.2.1. Long-Acting Injectable Technology
8.10.3. Product Portfolio
8.10.4. Recent Developments and Future Outlook
8.11. DURECT
8.11.1. Company Overview
8.11.2. Technology Overview
8.11.2.1. SABER® Platform
8.11.2.2. CLOUD™ PLATFORM
8.11.3. Product Portfolio
8.11.4. Financial Performance
8.11.5. Recent Developments and Future Outlook
8.12. Eagle Pharmaceuticals
8.12.1. Company Overview
8.12.2. Technology Overview
8.12.2.1. Unnamed Technology
8.12.3. Product Portfolio
8.12.4. Financial Performance
8.12.5. Recent Developments and Future Outlook
8.13. Halozyme Therapeutics
8.13.1. Company Overview
8.13.2. Technology Overview
8.13.2.1. ENHANZE® Technology
8.13.3. Product Portfolio
8.13.4. Financial Performance
8.13.5. Recent Developments and Future Outlook
8.14. MedinCell
8.14.1. Company Overview
8.14.2. Technology Overview
8.14.2.1. BEPO® Technology
8.14.3. Product Portfolio
8.14.4. Recent Developments and Future Outlook
8.15. Xeris Pharmaceuticals
8.15.1. Company Overview
8.15.2. Technology Overview
8.15.2.1. XeriJect™ Technology
8.15.2.2. XeriSol™ Technology
8.15.3. Product Portfolio
8.15.4. Recent Developments and Future Outlook
8.16. Serina Therapeutics
8.16.1. Company Overview
8.16.2. Technology Overview
8.16.2.1. POZ™ Drug Delivery Technology
8.16.3. Product Portfolio
8.16.4. Recent Developments and Future Outlook
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Subcutaneous Formulation Technologies: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Most Active Players: Analysis by Number of Partnerships
9.3.4. Regional Analysis
9.3.5. Intercontinental and Intracontinental Agreements
10. SUBCUTANEOUS DRUG DELIVERY SYSTEMS: CURRENT MARKET LANDSCAPE
10.1. Chapter Overview
10.2. Different Types of Subcutaneous Drug Delivery Systems
10.3. Subcutaneous Drug Delivery Systems: Overall Market Landscape
10.3.1. Large Volume Wearable Injectors
10.3.1.1. Overview
10.3.1.2. Current Market Landscape of Devices for Non-insulin Biologics
10.3.1.2.1. Analysis by Stage of Development
10.3.1.2.2. Analysis by Type of Device
10.3.1.2.3. Analysis by Type of Dose Administered
10.3.1.2.4. Analysis by Volume / Storage Capacity
10.3.1.2.5. Analysis by Usability
10.3.1.2.6. Analysis by Mode of Injection
10.3.1.2.7. Analysis by Mechanism of Action
10.3.1.2.8. Most Active Players: Analysis by Number of Devices
10.3.1.2.9. Product Competitiveness Analysis
10.3.1.3. Current Market Landscape of Devices for Insulin
10.3.1.3.1. Analysis by Stage of Development
10.3.1.3.2. Analysis by Type of Device
10.3.1.3.3. Analysis by Volume / Storage Capacity
10.3.1.3.4. Analysis by Usability
10.3.1.3.5. Analysis by Availability of Integrated CGM / BGM System
10.3.1.3.6. Most Active Players: Analysis by Number of Devices
10.3.1.3.7 Product Competitiveness Analysis
10.3.2. Autoinjectors
10.3.2.1. Overview
10.3.2.2. Current Market Landscape
10.3.2.2.1. Analysis by Usability
10.3.2.2.2. Analysis by Type of Primary Container
10.3.2.2.3. Analysis by Volume / Storage Capacity
10.3.2.2.4. Analysis by Type of Dose
10.3.2.2.5. Analysis by Actuation Mechanism
10.3.2.2.6. Most Active Players: Analysis by Number of Devices
10.3.2.2.7. Product Competitiveness Analysis
10.3.2.3. Drug Device Combination Products
10.3.3. Pen Injectors
10.3.3.1. Overview
10.3.3.2. Current Market Landscape
10.3.3.2.1. Analysis by Usability
10.3.3.2.2. Analysis by Volume / Storage Capacity
10.3.3.2.3. Analysis by Type of Dose
10.3.3.2.4. Most Active Players: Analysis by Number of Devices
10.3.3.3. Drug Device Combination Products
10.3.4. Needle-Free Injection Systems
10.3.4.1. Overview
10.3.4.2. Current Market Landscape
10.3.4.2.1. Analysis by Stage of Development
10.3.4.2.2. Analysis by Volume / Storage Capacity
10.3.4.2.3. Analysis by Usability
10.3.4.2.4. Analysis by Actuation Mechanism
10.3.4.2.5. Most Active Players: Analysis by Number of Devices
10.3.4.2.6. Product Competitiveness Analysis
10.3.5. Drug Reconstitution Delivery Systems
10.3.5.1. Overview
10.3.5.2. Current Market Landscape
10.3.5.2.1. Analysis by Usability
10.3.5.2.2. Analysis by Type of Device
10.3.5.2.3. Analysis by Type of Drug Container
10.3.5.2.4. Most Active Players: Analysis by Number of Devices
10.3.6. Prefilled Syringes
10.3.6.1. Overview
10.3.6.2. Current Market Landscape
10.3.6.2.1. Analysis by Barrel Fabrication Material
10.3.6.2.2. Analysis by Number of Barrel Chambers
10.3.6.2.3. Analysis by Type of Needle System
10.3.6.2.4. Analysis by Volume / Storage Capacity
10.3.6.3.5. Most Active Players: Analysis by Number of Devices
10.3.6.3. Product Competitiveness Analysis
10.3.6.4. Drug Device Combination Products
10.3.7. Implants
10.3.7.1. Overview
10.3.7.2. Current Market Landscape
10.3.7.2.1. Analysis by Stage of Development
10.3.7.2.2. Analysis by Target Therapeutic Area
10.3.7.2.3. Analysis by Implant Material
10.3.7.2.4. Analysis by Treatment Duration
10.3.7.2.5. Most Active Players: Analysis by Number of Devices
11. SWOT ANALYSIS
11.1. Chapter Overview
11.2. Comparison of SWOT Factors
11.2.1. Strengths
11.2.2. Weaknesses
11.2.3. Opportunities
11.2.4. Threats
12. MARKET FORECAST AND OPPORTUNITY ANALYSIS
12.1. Chapter Overview
12.2. Subcutaneous Biologics Market
12.2.1. Forecast Methodology and Key Assumptions
12.2.2. Overall Subcutaneous Biologics Market, 2020-2030
12.2.2.1. Subcutaneous Biologics Market, 2020-2030:Distribution by Phase of Development
12.2.2.2. Subcutaneous Biologics Market, 2020-2030:Distribution by Type of Pharmacological Molecule
12.2.2.3. Subcutaneous Biologics Market, 2020-2030:Distribution by Target Therapeutic Area
12.2.2.4. Subcutaneous Biologics Market, 2020-2030:Distribution by Key Geographical Regions
12.3. Subcutaneous Drug Delivery Systems Market
12.3.1. Device Type 1: Large Volume Wearable Injectors
12.3.1.1. Forecast Methodology and Key Assumptions
12.3.1.2. Global Large Volume Wearable Injectors Market for Non-Insulin Drugs, 2020-2030
12.3.1.2.1. Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Type of Device, 2020-2030
12.3.1.2.2. Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Usability, 2020-2030
12.3.1.2.3. Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Target Therapeutic Area, 2020-2030
12.3.1.2.4. Global Large Volume Wearable Injectors Market for Non-Insulin Drugs: Distribution by Key Geographical Regions, 2020-2030
12.3.1.3. Global Large Volume Wearable Injectors Market for Insulin , 2020-2030
12.3.1.3.1. Global Large Volume Wearable Injectors Market for Insulin: Distribution by Type of Device, 2020-2030
12.3.1.3.2. Global Large Volume Wearable Injectors Market for Insulin: Distribution by Usability, 2020-2030
12.3.1.3.3. Global Large Volume Wearable Injectors Market for Insulin: Distribution by Key Geographical Regions, 2020-2030
12.3.2. Device Type 2: Autoinjectors
12.3.2.1. Forecast Methodology and Key Assumptions
12.3.2.2. Global Autoinjectors Market, 2020-2030
12.3.2.2.1. Global Autoinjectors Market: Distribution by Usability, 2020-2030
12.3.2.2.2. Global Autoinjectors Market: Distribution by Type of Pharmacological Molecule, 2020-2030
12.3.2.2.3. Global Autoinjectors Market: Distribution by Key Geographical Regions, 2020-2030
12.3.3. Device Type 3: Prefilled Syringes
12.3.3.1. Forecast Methodology and Key Assumptions
12.3.3.2. Global Prefilled Syringes Market, 2020-2030
12.3.3.2.1. Global Prefilled Syringes Market: Distribution by Type of Syringe Barrel Material, 2020-2030
12.3.3.2.2. Global Prefilled Syringes Market: Distribution by Type of Chamber System, 2020-2030
12.3.3.2.3. Global Prefilled Syringes Market: Distribution by Type of Pharmacological Molecule, 2020-2030
12.3.3.2.4. Global Prefilled Syringes Market: Distribution by Target Therapeutic Area, 2020-2030
12.3.3.2.5. Global Prefilled Syringes Market: Distribution by Key Geographical Regions, 2020-2030
12.3.4. Device Type 4: Needle-Free Injection Systems
12.3.4.1. Forecast Methodology and Key Assumptions
12.3.4.2. Global Needle-Free Injection Systems Market, 2020-2030
12.3.4.2.1. Global Needle-Free Injection Systems Market: Distribution by Usability, 2020-2030
12.3.4.2.2. Global Needle-Free Injection Systems Market: Distribution by Actuation Mechanism, 2020-2030
12.3.4.2.3. Global Needle-Free Injection Systems Market: Distribution by Target Therapeutic Area, 2020-2030
12.3.4.2.4. Global Needle-Free Injection Systems Market: Distribution by Key Geographical Regions, 2020-2030
12.3.5. Device Type 5: Novel Drug Reconstitution Systems
12.3.5.1. Forecast Methodology and Key Assumptions
12.3.5.2. Global Novel Drug Reconstitution Systems Market, 2020-2030
12.4. Subcutaneous Formulation Technologies Market
12.4.1. Subcutaneous Formulation Technologies Market: Distribution by Upfront and Milestone Payments, 2020-2030
13. CONCLUDING REMARKS
14. EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. Lindy Biosciences
14.2.1. Company Snapshot
14.2.2. Interview Transcript: Deborah Bitterfield, Chief Executive Officer and Founder
14.3. Oval Medical Technologies
14.3.1. Company Snapshot
14.3.2. Interview Transcript: Matthew Young, Chief Technology Officer and Founder
14.4. Xeris Pharmaceuticals
14.4.1. Company Snapshot
14.4.2. Interview Transcript: Steve Prestrelski, Chief Scientific Officer and Founder; Hong Qi, Vice President, Product Development; and Scott Coleman, Sr. Scientist Formulation)
14.5. DALI Medical Devices
14.5.1. Company Snapshot
14.5.2. Interview Transcript: David Daily, Chief Executive Officer and Co-Founder
14.6. Excelse Bio
14.6.1. Company Snapshot
14.6.2. Interview Transcript: Michael Reilly, Chief Executive Officer and Co-Founder
14.7. i-novion
14.7.1. Company Snapshot
14.7.2. Interview Transcript: Poonam R Velagaleti, Co-Founder
14.8. Enable Injections
14.8.1. Company Snapshot
14.8.2. Interview Transcript: Michael Hooven, Chief Executive Officer
14.9. Immunovaccine Technologies
14.9.1. Company Snapshot
14.9.2. Interview Transcript: Frederic Ors, Chief Executive Officer
14.10. Portal Instruments
14.10.1. Company Snapshot
14.10.2. Interview Transcript: Patrick Anquetil, Chief Executive Officer
14.11. Elcam Medical
14.11.1. Company Snapshot
14.11.2. Interview Transcript: Menachem Zucker, Vice President and Chief Scientist
14.12. West Pharmaceutical Services
14.12.1. Company Snapshot
14.12.2. Interview Transcript: Tiffany H Burke, Director, Global Communications and Graham Reynolds, Vice President and General Manager, Global Biologics
14.13. MedinCell
14.13.1. Company Snapshot
14.13.2. Interview Transcript: David Heuzé, Communication Leader
15. APPENDIX 1: TABULATED DATA
16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION
Contact Details
Gaurav Chaudhary
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