The subcutaneous formulation technologies market is anticipated to grow at a CAGR of 22%, till 2035, while the subcutaneous drug delivery systems market is anticipated to grow at a CAGR of over 40%, till 2035, claims Roots Analysis

Published: August 2023

Subcutaneous drug delivery, given the use of tailored formulation development solutions, has brought a paradigm shift in at-home healthcare, enabling users to administer medications without having to rely on medical professionals

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

The challenges associated with drug delivery via the parental route can be mitigated by if the candidates are administered through the subcutaneous route; the latter approach also enables self-medication by patients. Further, in order to ensure administration of biologics in large quantities, companies have developed a number of novel technology platforms. In this context, several subcutaneous self-administration drug delivery solutions, equipped with a range of user-friendly features, are already available in the market. 

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Key Market Insights

Over 120 biologics have been approved for administration via the subcutaneous route 

Over 75% of the abovementioned therapeutics have been approved post 2001. Further, majority (~90%) of the approved subcutaneous biologics are either protein-based or antibody-based molecules. Of these, over 90% have been approved to be provided as monotherapies only.

Over 335 subcutaneous biologics are currently being evaluated in a clinical setting

Majority (~70%) of the aforementioned therapies are being evaluated in early stages of development (phase I, phase I / II and phase II). Of these, over 55% therapy candidates are reported to act via inhibiting the target molecule.

Success protocol framework can be used by developers to enhance the chances of success of their proprietary therapeutics

The proprietary framework evaluates top ten selling approved subcutaneous biologics, based on 5+ parameters, including disease indication burden, drug efficacy, geographical reach, global competition, patient compliance, prevalence and price of the drug.

Over 90% of subcutaneous formulation technology providers are small or mid-sized players 

Majority (90%) of the industry players are based in North America / Europe. It is worth highlighting that over 30% of the subcutaneous formulation technologies operate via complex formation. Further, 40% of these technologies offer high concentration and extended / controlled / sustained delivery of biologics

Partnership activity in this field has increased at a CAGR of over 35%, between 2011 and 2021

Around 50% of the reported deals were established between 2019 and 2021. Majority of the instances captured in the report (around 60%) were instances of either licensing agreements or formulation development agreements. 

450+ subcutaneous drug delivery systems are presently available / under development

Of the aforementioned devices, over 36% are large volume wearable injectors / autoinjectors. Further, 85% of the autoinjectors enable the delivery of a fixed / variable dose. In addition, we identified around 70 pen-injectors and close to 40 needle free injectors that are designed to facilitate subcutaneous drug delivery. 

The approved subcutaneous biologics market is anticipated to grow at a CAGR of over 21% 

As the demand for subcutaneous drug formulations continues to increase, more licensing agreements between drug and technology developers are likely to be inked. Around 85% of the overall revenues for subcutaneous technology providers are estimated to be generated via milestone payments. 

North America / Europe is likely to capture 55% share of the overall approved subcutaneous biologics market in 2035

In 2035, subcutaneous biologics approved for the treatment of autoimmune disorders, genetic disorders and infectious disorders are likely to capture the highest market share (~45%). Further, over 65% of the market revenues are anticipated to be generated by therapies approved to be provided as monotherapies.

In 2030, autoinjectors are expected to occupy over 75% of the drug delivery systems market

North America is expected to occupy the largest share (~40%) of the global autoinjectors market. Similarly, within the large volume wearable injectors market, majority of the share (over 80%) is estimated to be occupied by devices intended for the delivery of insulin drugs. 

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Key Questions Answered

  • Who are the key players that have marketed their proprietary subcutaneous biologics?
  • Who are the leading players currently engaged in the development of clinical-stage subcutaneous biologics?
  • Which popular therapeutic areas are being targeted by clinical-stage subcutaneous biologics?
  • What are the crucial factors that impact the sales of a subcutaneous biologic product?
  • Who are the leading players involved in the development of subcutaneous formulation technologies?
  • What type of drug delivery systems are being most commonly used for the delivery of subcutaneous biologics?
  • What types of partnership models are most commonly adopted by stakeholders engaged in this industry?
  • How is the current and future market opportunity likely to be distributed across key market segments?

The financial opportunity associated with this market has been analyzed across the following segments:

  • Approved Subcutaneous Biologics
    • Type of Biologic
    • Type of Therapy
    • Therapeutic Area
    • Geographical Region 
  • Subcutaneous Formulation Technologies
    • Type of Payment
    • Fundamental Principle 
    • End-User
    • Therapeutic Area 
    • Region
  • Subcutaneous Drug Delivery Systems
    • Type of Large Volume Wearable Injector
    • Usability of Large Volume Wearable Injectors
    • Target Therapeutic Area of Large Volume Wearable Injectors
    • Type of Autoinjector
    • Target Therapeutic Indication of Autoinjectors
    • Type of Syringe Barrel Material for Prefilled Syringes
    • Type of Chamber System for Prefilled Syringes
    • Therapeutic Area for Prefilled Syringes
    • Type of Needle-Free Injection Systems
    • Type of Actuation Mechanism for Needle-Free Injection Systems
    • Target Therapeutic Area for Needle-Free Injection Systems
    • Type of Container for Novel Drug Reconstitution Systems
    • Type of Fabrication Material Used for Novel Drug Reconstitution Systems
    • Physical State of Drug in Syringe and Cartridge for Novel Drug Reconstitution Systems
    • Physical State of Drug in Infusion Bag for Novel Drug Reconstitution Systems
    • Volume of Novel Drug Reconstitution Systems 
    • Key Geographical Regions 

The report features inputs from eminent industry stakeholders, according to whom, subcutaneous biologics, are likely to witness increased adoption given their broad scope of applications and the availability of formulation technologies and drug delivery systems that enable enhanced compliance and an easier mode of self-administration. The report features detailed transcripts of interviews held with the following industry stakeholders:

  • 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, details related to its financial information (if available), technology portfolio, product portfolio, recent developments and an informed future outlook.

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

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