The subcutaneous biologic drugs and affiliated technologies market

by Steffan Joe on Oct 19, 2021 Health and Fitness 29 Views

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

 

For more information, please visit https://www.rootsanalysis.com/reports/view_document/subcutaneous-biologics-delivery/314.html or email sales@rootsanalysis.com

 

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

 

 

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