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 claims Roots Analysis
Several approved therapeutic products, which are currently available as intravenous dosage forms, are being reformulated and evaluated for subcutaneous administration. Further, many existing drug delivery devices, including prefilled syringes, pen injectors, auto-injectors, needle-free injectors, and large volume wearable injectors, have been/are being designed for subcutaneous administration of biologics.
The USD 180+ billion (by 2030) financial opportunity associated with subcutaneous biologics, affiliated drug delivery systems, and subcutaneous formulation technology licensing deals, has been analyzed across the following segments:

Subcutaneous Biologic Drugs and Affiliated Technologies Market, Trends by 2030 Market Segment:

Phase of development

• Approved
• Pre-registration & Phase III
• Phase II & Phase II/III
Type of molecule
• Cell and gene therapies
• Monoclonal antibodies
• Proteins
• Peptides (recombinant)
• Vaccines
• Others

Target therapeutic area

• Autoimmune disorders
• Blood disorders
• Bone disorders
• Genetic disorders
• Metabolic disorders
• Neurological disorders
• Oncological disorders
• Respiratory disorders
• Others

Type of drug delivery system

• Large volume wearable injectors
• Autoinjectors
• Prefilled syringes
• Needle-free injectors
• Drug reconstitution systems
• Revenues from licensing deals
• Upfront payments
• Milestone payments

Key geographical regions

• North America
• Europe
• Asia Pacific
• Rest of the World

The Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030 report features the following companies, which we identified to be key players in this domain:

Market Key Players:

• Adocia
• Ajinomoto Bio-Pharma Services
• Arecor
• Alteogen
• Ascendis Pharma
• Avadel Pharmaceuticals
• Camurus
• Creative BioMart
• Creative Biolabs
• DURECT
• Eagle Pharmaceuticals
• Halozyme Therapeutics
• MedinCell
• Xeris Pharmaceuticals
• Serina Therapeutics

Scope of the Report

The ‘Subcutaneous Biologics, Technologies and Drug Delivery Systems (3rd Edition), 2020-2030’ report provides a detailed study on the current market landscape and future potential of biologics designed for subcutaneous administration. In addition, the study provides an in-depth analysis of the formulation technologies and drug delivery systems (focusing on large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, drug reconstitution systems, prefilled syringes, and implants) that enable subcutaneous delivery of the biologic drugs. Amongst other elements, the report features the following:

A detailed assessment of the current market landscape of commercially available and clinical-stage biologics that are designed for delivery via the subcutaneous route, along with information on approval year, phase of development, type of pharmacological molecule, target therapeutic area, dosing frequency, available dosage forms, and key players.

A case study on leading subcutaneous biologics (in terms of revenues generated), featuring details on the mechanism of action, development history, annual sales, technology platform (if available), and a comparison of their intravenous and subcutaneous formulations (if applicable).

An assessment of the various subcutaneous formulation technologies along with information on developers, type of pharmacological molecule, route of administration, mechanisms of action, and primary advantage(s).
An insightful three-dimensional comparison of the subcutaneous formulation technology developers, based on pipeline strength (number of drugs developed using a particular technology), supplier power (number of years of experience and company size) of the developer, and primary advantages offered by their respective technologies. Also, the study includes a detailed benchmark analysis of the technology developers based in North America and Europe, highlighting the primary advantage(s) offered by their proprietary technologies, applicability to other types of pharmacological molecules, and other possible routes of drug administration.

Elaborate profiles of key technology developers, featuring a brief overview of the company, its technology portfolio, product portfolio, financial information (if available), recent developments, and an informed future outlook.
An analysis of collaborations and partnership agreements inked by the subcutaneous formulation technology developers since 2011; it includes details of deals that were/are focused on subcutaneous formulation technologies, which were analyzed on the basis of a year of the agreement, type of agreement, and upfront and milestone payments.

An in-depth review of the most advanced and popular subcutaneous drug delivery systems, including large volume wearable injectors, autoinjectors, pen injectors, needle-free injectors, drug reconstitution systems, prefilled syringes, and implants, providing information on their developer(s) and device-specific features. Details of specific parameters captured for different device categories are mentioned as follows:

Large volume wearable injectors: Stage of development (commercialized and under development), type of device (infusion pump and patch pump), type of dose administered (continuous and bolus), volume/storage capacity (in mL), mode of injection (needle, needle/cannula, and needle/catheter) and mechanism of action (driving force).
Autoinjectors: Usability (disposable and reusable), type of primary container (syringe, cartridge, and others), volume/storage capacity (in mL), type of dose (fixed-dose and variable dose), and actuation mechanism (automatic, semi-automatic, and manual).

Pen injectors: Usability (disposable and reusable), volume/storage capacity (in mL), and type of dose (fixed-dose and variable dose).

Needle-free injection systems: Stage of development (commercialized and under development), volume/storage capacity (in mL), usability (disposable and reusable), an actuation mechanism (spring-based, gas-powered, and others).

Drug reconstitution systems: Usability (disposable and reusable), device type (dual-chambered systems and other novel systems), and type of drug container (cartridge, vials, and others).
Prefilled syringes: Barrel fabrication material (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, Luer lock, and Luer cone), and volume/storage capacity (in mL).

Implants: Stage of development (commercialized and under development), target therapeutic area, implant material (silicone, titanium, polymers, and others), and treatment duration.

A comprehensive product competitiveness analysis of subcutaneous large volume wearable injectors, subcutaneous autoinjectors, subcutaneous needle-free injectors, and pre-filled syringes, taking into consideration the supplier power and product-specific information.

A discussion on affiliated trends, key drivers, and challenges, which are likely to impact the industry’s evolution, under a comprehensive SWOT framework; includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall subcutaneous products market.

Table of Contents

1. Preface
2. Executive Summary
3. Introduction
4. Subcutaneous Biologics: Current Market Landscape
5. Case Study: Leading Subcutaneous Biologics
6. Subcutaneous Formulation Technologies: Current Market Landscape
7. Subcutaneous Formulation Technology Developers: Company Competitiveness Analysis
8. Subcutaneous Formulation Technology Developers: Company Profiles
9. Partnerships and Collaborations
10. Subcutaneous Drug Delivery Systems: Current Market Landscape
11. Swot Analysis
12. Market Forecast and Opportunity Analysis
13. Concluding Remarks
14. Executive Insights
15. Appendix 1: Tabulated Data
16. Appendix 2: List Of Companies And Organization

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