The subcutaneous biologic drugs and affiliated technologies market is estimated to be worth over USD 180 billion by 2030, claims Roots Analysis

Published: June 2020

The growing pipeline of therapeutics designed for subcutaneous delivery, coupled to the rising preference for self-medication, is expected to present lucrative opportunities for subcutaneous formulation technology and drug delivery device developers

Roots Analysis has announced the addition of Subcutaneous Biologics Market report to its list of offerings. 

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, autoinjectors, needle-free injectors and large volume wearable injectors, have been / are being designed for subcutaneous administration of biologics.

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Key Market Insights 

More than 180 organizations claim to be engaged in the development of subcutaneous biologics 
The market is characterized by the presence of over 100 approved biologics, while more than 350 such drug candidates are presently being evaluated across different clinical stages. Of the total number of such drugs, over 115 are intended for treating autoimmune disorders, followed by metabolic disorders (65+) and oncological disorders (60+). 

300+ subcutaneous drug delivery systems are presently available / under development
More than 100 of these subcutaneous drug delivery systems are large volume wearable injectors and autoinjectors. In addition, we identified around 80 pen-injectors and close to 40 needle free injectors that are designed to facilitate subcutaneous drug delivery.

Over 90% of subcutaneous formulation technology developers are small or mid-sized players 
Further, more than 60% of such companies are based in North America; key hubs in the region include (in decreasing order of number of companies) Massachusetts, California and New Jersey. It is also worth noting that most of the available technology platforms (over 70%) are either focused on facilitating the delivery of highly concentrated / viscous protein formulations, or enabling extended / controlled / sustained delivery of biologics.

Several partnerships have been inked by subcutaneous formulation technology developers since 2011 
The report covers over 50 deals, most of which (18) were signed in 2018 and 2019. It is worth highlighting that around 40% of the total partnerships were technology licensing agreements, followed by deals related to formulation development (30%).

By 2030, revenues from sales of self-medication enabling devices are estimated to reach USD 10 billion
Currently, prefilled syringes are estimated to be responsible for the dominant share (over 40%) of revenues generated in this market. However, in the foreseen future, the contributions of other drug delivery devices, such as large volume wearable injectors (for non-insulin biologics) and autoinjectors, are expected to grow at a relatively faster pace (CAGR ~40% and ~10%, respectively).

Moreover, ~80% of revenues of subcutaneous technology developers are estimated to be generated through milestone payments
As the demand for subcutaneous drug formulations continues to increase, more licensing agreements between drug and technology developers are likely to be inked. From the technology licensing perspective, the opportunity is anticipated to grow at a CAGR of over 15% during the forecast period (2020-2030).

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Key Questions Answered

  • Who are the leading drug developers engaged in the development of subcutaneous biologics?
  • Who are the leading subcutaneous drug delivery device developers?
  • How many subcutaneous biologics are presently marketed / under clinical evaluation?
  • What are the popular technologies / platforms being used for the development and formulation of subcutaneous biologics?
  • What kind of partnership models are commonly adopted by stakeholders in this industry? 
  • What are the factors that are likely to influence the evolution of this market?         
  • How is the current and future market opportunity likely to be distributed across key market segments?

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:

  • 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 report also features inputs from eminent industry stakeholders, according to whom, a significant increase in demand for subcutaneous biologics and affiliated drug delivery systems is likely to be observed in the foreseen future. The report includes detailed transcripts of discussions held with the following experts:

  • Chief Scientific Officer and Founder, Vice President, Product Development and Former Sr. Scientist Formulation, Mid-sized Company, US
  • Chief Executive Officer, Small Company, US
  • Chief Executive Officer and Founder, Small Company, US
  • Chief Executive Officer and Co-Founder, Small Company, Israel
  • Co-Founder, Very Small Company, US
  • Former Chief Executive Officer, Mid-sized, Canada
  • Communication Leader, Mid-sized, France
  • Vice President and Chief Scientist, Large Company, Israel
  • Director, Global Communications and Vice President and General Manager, Global Biologics, Very Large, US
  • Chief Executive Officer and Co-Founder, Very Small, US
  • Chief Executive Officer, Mid-sized, UK
  • Founder and Chief Technology Officer, Mid-sized, UK

The research covers detailed profiles of key players (listed below); each profile features overview of the company, its technology portfolio, product portfolio, financial information (if available), recent developments and an informed future outlook.

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

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You may also be interested in the following titles: 

  1. Global Autoinjectors Market
  2. Prefilled Syringes Market
  3. Microneedles and Needle-Free Injection Systems / Jet Injectors (Devices based on Spring, Gas and Other Mechanisms) Market
  4. Large Volume Wearable Injectors Market

Gaurav Chaudhary
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