Market Overview

$200 Billion Subcutaneous Biologics, Technologies and Drug Delivery Systems Market 2018 - Forecast to 2030


$200 Billion Subcutaneous Biologics, Technologies and Drug Delivery Systems Market 2018 - Forecast to 2030

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DUBLIN, July 25, 2018 /PRNewswire/ --

The "Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018-2030" report has been added to's offering.

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The Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018-2030' report provides a comprehensive 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, prefilled syringes, drug reconstitution systems and implants) that enable subcutaneous delivery of the aforementioned drugs.

Biologics constitute a majority of the top selling drugs of today and also represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, the share of biologics in the overall pharmaceutical market has increased from 16% in 2006 to over 25% in 2017.Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.Despite their clinical and commercial success, biopharmaceutical products are associated with high development costs, which are evidently reflected in their prices.

Moreover, such therapies are usually designed for intravenous administration, which require a clinical setting (hospitals/infusion centers) for dosing; this further adds to the overall treatment cost. Of late, the subcutaneous route of administration has emerged as a promising and viable approach for the parenteral delivery of biologic drugs. Owing to several compelling advantages, such as patient convenience, potential for self-administration, better therapy adherence and reduced healthcare costs, the concept is steadily gaining traction within the healthcare industry.

Given the robust pipeline of biologics, which include monoclonal antibodies, vaccines and other protein-based therapeutic products, subcutaneous delivery options are being investigated for various clinical candidates across different phases of development. In fact, several approved therapeutic products that are currently delivered intravenously are also being reformulated and evaluated for subcutaneous administration in order to improve their adoption, and for life cycle management of drugs nearing patent expiry.

In addition, several drug delivery devices that can be used for self-administration have been developed, and many others are under development. Some of the most popular self-administration enabling devices include large volume wearable injectors, autoinjectors, pen injectors, needle free injectors and prefilled syringes. In fact, these innovative drug-device combination products have witnessed high adoption rates over the past few years and have brought about marked improvements in adherence to prescribed therapeutic regimens. Further, to overcome the limitations and challenges associated with the delivery of subcutaneous formulations, several novel technology platforms have been developed to enable the delivery of (highly) viscous formulations.

The rising incidence of chronic clinical conditions (which are characterized by the need for frequent medications) and continuous efforts of therapy/device developers in this field are anticipated to drive the overall growth of this market in the coming years.

One of the key objectives of this study was to understand the primary growth drivers and estimate the future potential of the market. Based on historical trends and sales related information for subcutaneous biologic drugs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have segmented the market based on [A] therapeutic areas (autoimmune disorders, metabolic disorders, blood disorders, bone disorders, oncological disorders, genetic disorders, neurological disorders, respiratory disorders and others) and [B] molecule type (proteins, peptides (recombinant), monoclonal antibodies, other antibody based products, cell/gene therapies and vaccines).

In addition to the market forecast for subcutaneous biologic drugs, we have also provided an 8-year forecast for subcutaneous delivery systems, covering large volume wearable injectors, autoinjectors, prefilled syringes and drug reconstitution systems. Further, we have also forecasted the revenues that subcutaneous formulation technology developers are likely to generate through licensing agreements; for this, we have provided a view on the likely upfront payments and milestone payments that will be involved in the deals signed or planned with an aim to develop subcutaneous formulation of biologics. To account for the uncertainties associated with the growth of the subcutaneous formulation technologies market, we have provided three forecast scenarios, portraying conservative, base and optimistic tracks of the market's evolution.

Key Topics Covered:

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 Method of Subcutaneous Administration Advantages of Subcutaneous Administration Limitations of Subcutaneous Administration Challenges Associated with High Concentrated Subcutaneous Formulations

4. Subcutaneous Biologics: Current Market Landscape
4.1. Chapter Overview
4.2. Subcutaneous Biologics: Approved Drugs
4.2.1. Distribution by Approval Year
4.2.2. Distribution by Molecule Type
4.2.3. Distribution by Formulation Type
4.2.4. Key Players
4.2.5. Distribution by Target Therapeutic Area
4.2.6. Distribution by Dosing Frequency
4.2.7. Distribution by Dosage Forms
4.3. Subcutaneous Biologics: Clinical Drugs
4.3.1. Distribution by Phase of Development
4.3.2. Distribution by Molecule Type
4.3.3. Distribution by Target Therapeutic Area
4.3.4. Key Players

5. Subcutaneous Biologics: Case Studies of Leading Products
5.1. Chapter Overview
5.2. Subcutaneous Biologics: Leading Drugs by Annual Sales
5.3. Case Studies
5.3.1. HUMIRA (AbbVie, Eisai) Overview Development History Target Indications and Dosage Forms Historical Sales
5.3.2. Enbrel (Amgen, Pfizer, Takeda Pharmaceutical) Overview Development History Target Indications and Dosage Forms Historical Sales
5.3.3. RITUXAN/MabThera (Biogen, Roche, Chugai Pharmaceutical) Overview Development History Target Indications and Dosage Forms Target Patient Population Historical Sales ENHANZE Technology (Halozyme Therapeutics) Advantages of Subcutaneous RITUXAN/MabThera Over Intravenous RITUXAN/MabThera
5.3.4. Herceptin (Roche, Chugai Pharmaceutical) Overview Development History Target Indications and Dosage Forms Target Patient Population Historical Sales ENHANZE Technology (Halozyme Therapeutics) Advantages of Subcutaneous Herceptin Over Intravenous Herceptin Herceptin - Large Volume Wearable Injector Combination Product
5.3.5. Neulasta (Amgen, Kyowa Hakko Kirin) Overview Development History Target Indications and Dosage Forms 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. Distribution by Geographical Location of Technology Developers
6.2.2. Distribution by Founding Year of Technology Developers
6.2.3. Distribution by Employee Size of Technology Developers
6.2.4. Distribution by Application of the Technology (Type of Molecule)
6.2.5. Distribution by Possible Routes of Administration
6.2.6. Distribution by Primary Advantage(s) Provided

7. Subcutaneous Formulation Technology Developers: Company Competitiveness Analysis
7.1. Chapter Overview
7.2. Subcutaneous Technology Developers: Competitive Landscape
7.2.1. Scope and Methodology
7.2.2. Three-Dimensional Analysis Based on Supplier Power, Pipeline Strength and Collaborations
7.3. Subcutaneous Technology Developers: Benchmark Analysis
7.3.1. Scope and Methodology
7.3.2. North America
7.3.3. Europe

8. Subcutaneous Formulation Technology Providers: Company Profiles
8.1. Chapter Overview
8.2. Adocia
8.2.1. Company Overview
8.2.2. BioChaperone Technology
8.2.3. Product Portfolio
8.2.4. Financial Performance
8.2.5. Recent Developments
8.2.6. Future Outlook
8.3. Ajinomoto Althea
8.3.1. Company Overview
8.3.2. Crystalomics Formulation Technology
8.3.3. Product Portfolio
8.3.4. Financial Performance
8.3.5. Recent Developments
8.3.6. Future Outlook
8.4. Arecor
8.4.1. Overview
8.4.2. Arestat Technology
8.4.3. Product Portfolio
8.4.4. Recent Developments
8.4.5. Future Outlook
8.5. Ascendis Pharma
8.5.1. Company Overview
8.5.2. TransCon Technology
8.5.3. Product Portfolio
8.5.4. Financial Performance
8.5.5. Recent Developments
8.5.6. Future Outlook
8.6. Avadel Pharmaceuticals
8.6.1. Company Overview
8.6.2. Medusa Technology
8.6.3. Product Portfolio
8.6.4. Financial Performance
8.6.5. Recent Developments
8.6.6. Future Outlook
8.7. Camurus
8.7.1. Overview
8.7.2. FluidCrystal Injection Depot Technology
8.7.3. Product Portfolio
8.7.4. Recent Developments
8.7.5. Future Outlook
8.8. Halozyme Therapeutics
8.8.1. Company Overview
8.8.2. ENHANZE Technology
8.8.3. Product Portfolio
8.8.4. Financial Performance
8.8.5. Recent Developments
8.8.6. Future Outlook
8.9. MedinCell
8.9.1. Company Overview
8.9.2. BEPO Technology
8.9.3. Product Portfolio
8.9.4. Recent Developments
8.9.5. Future Outlook
8.10. Xeris Pharmaceuticals
8.10.1. Company Overview
8.10.2. Technology Platforms XeriJect Technology XeriSol Technology
8.10.3. Product Portfolio
8.10.4. Recent Developments
8.10.5. Future Outlook
8.11. Serina Therapeutics
8.11.1. Company Overview
8.11.2. Polymer poly(2-oxazoline) (POZ) Technology
8.11.3. Product Portfolio
8.11.4. Recent Developments
8.11.5. Future Outlook

9. Subcutaneous Drug Delivery Systems: Current Market Landscape
9.1. Chapter Overview
9.2. Subcutaneous Drug Delivery Systems: Types
9.3. Subcutaneous Drug Delivery Systems: Overall Market Landscape
9.3.1. Large Volume Wearable Injectors Overview Current Market Landscape of Devices for Non-insulin Biologics Product Competitiveness Analysis Current Market Landscape of Devices for Insulin
9.3.2. Autoinjectors Overview Current Market Landscape Product Competitiveness Analysis Drug Device Combination Products
9.3.3. Pen Injectors Overview Current Market Landscape Drug Device Combination Products
9.3.4. Needle Free Injection Systems Overview Current Market Landscape
9.3.5. Novel Drug Reconstitution Delivery Systems Overview Current Market Landscape
9.3.6. Prefilled Syringes Overview Current Market Landscape Glass Prefilled Syringes Plastic Prefilled Syringes Drug Device Combination Products
9.3.7. Implants Overview Current Market Landscape

10. Market Forecast and Opportunity Analysis
10.1. Chapter Overview
10.2. Subcutaneous Biologics Market
10.2.1. Forecast Methodology
10.2.2. Overall Market Distribution by Phase of Development Distribution by Molecule Type Distribution by Therapeutic Area
10.3. Subcutaneous Drug Delivery Systems Market
10.3.1. Large Volume Wearable Injectors Market
10.3.2. Autoinjectors Market
10.3.3. Prefilled Syringes Market
10.3.4. Novel Drug Reconstitution Systems Market
10.3.5. Other Devices Market
10.4. Subcutaneous Formulation Technology Licensing Revenues

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
11.2.5. Concluding Remarks

12. Conclusion
12.1. Rising Trend of Self-Administration and the Need to Improve Therapy Adherence have Increased the Popularity of Subcutaneous Formulations of Biologics
12.2. The Pipeline Features Contributions of Several Pharma Giants; Presently, Monoclonal Antibodies are the Most Popular Type of Molecules Being Evaluated Across Various Therapeutic Areas
12.3. Aiming to Overcome the Challenges Related to Formulating Biologics for Subcutaneous Delivery, Multiple Companies have Developed Innovative Technology Platforms
12.4. Large Volume Wearable Injectors and Autoinjectors are Amongst the Most Novel Device Types Being Developed for Subcutaneous Drug Administration
12.5. Despite Various Limitations, the Field Offers Significant Opportunities to a Variety of Stakeholders
12.6. Driven by the Demand for Self-Injectable Medications and Ongoing Innovation, the Market for Subcutaneous Biologics, Delivery Devices and Technologies is Anticipated to Witness Significant Growth in the Long Term

13. Executive Insights
13.1. Chapter Overview
13.2. DALI Medical Devices
13.2.1. Company Snapshot
13.2.2. Interview Transcript: David Daily, Chief Executive Officer & Co-Founder
13.3. Lindy Biosciences
13.3.1. Company Snapshot
13.3.2. Interview Transcript: Deborah Bitterfield, Chief Executive Officer & Founder
13.4. Immunovaccine Technologies
13.4.1. Company Snapshot
13.4.2. Interview Transcript: Frederic Ors, Chief Executive Officer
13.5. Oval Medical Technologies
13.5.1. Company Snapshot
13.5.2. Interview Transcript: Matthew Young, Founder & Chief Technology Officer
13.6. Elcam Medical
13.6.1. Company Snapshot
13.6.2. Interview Transcript: Menachem Zucker, Vice President & Chief Scientist
13.7. Excelse Bio
13.7.1. Company Snapshot
13.7.2. Interview Transcript: Michael Reilly, Chief Executive Officer & Co-Founder
13.8. Enable Injections
13.8.1. Company Snapshot
13.8.2. Interview Transcript: Michael Hooven, Chief Executive Officer
13.9. i-novion
13.9.1. Company Snapshot
13.9.2. Interview Transcript: Poonam R Velagaleti, Co-Founder
13.10. West Pharmaceutical Services
13.10.1. Company Snapshot
13.10.2. Interview Transcript: Tiffany H Burke, Director, Global Communications and Graham Reynolds, Vice President & General Manager, Global Biologics
13.11. MedinCell
13.11.1. Company Snapshot
13.11.2. Interview Transcript: David Heuz, Communication Leader

14. Appendix 1: Tabulated Data

15. Appendix 2: List of Companies and Organizations

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