The market for subcutaneous formulation technologies is


London, May 03, 2022 (GLOBE NEWSWIRE) — Root analysis announced the addition of Subcutaneous biologicsDrug Delivery Technologies and Systems Market (4th Edition), Industry Trends and Global Forecast, 2022 – 2035 » against its list of offers.

Challenges associated with parental drug administration may be mitigated if candidates are administered subcutaneously; the latter approach also allows self-medication by patients. In addition, in order to ensure the administration of biological products in large quantities, companies have developed a number of new technological platforms. In this context, several solutions for subcutaneous self-administration of drugs, equipped with a range of user-friendly features, are already available on the market.

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Key market information

Over 120 biologics have been approved for subcutaneous administration

Over 75% of the aforementioned therapeutics were approved after 2001. Additionally, the majority (~90%) of approved subcutaneous biologics are either protein-based molecules 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 the clinical setting

The majority (~70%) of the above therapies are being evaluated in the early stages of development (phase I, phase I/II and phase II). Among these, more than 55% of the therapeutic candidates would act by inhibiting the target molecule.

The Success Protocol framework can be used by developers to improve the chances of success of their proprietary therapies
The proprietary framework rates the top ten approved subcutaneous biologics based on more than 5 metrics including disease indication burden, drug efficacy, geographic reach, global competition, patient compliance, prevalence and drug price.

Over 90% of subcutaneous formulation technology suppliers are small to medium sized players

The majority (90%) of industry players are based in North America/Europe. It should be noted that more than 30% of subcutaneous formulation technologies work by forming complexes. In addition, 40% of these technologies offer high concentration and prolonged/controlled/sustained delivery of biologics

Partner activity in this area has grown at a CAGR of over 35%, between 2011 and 2021

Around 50% of reported deals were concluded between 2019 and 2021. The majority of cases identified in the report (about 60%) were examples of license agreements or formulation development agreements.

Over 450 subcutaneous drug delivery systems are currently available/under development

Of the aforementioned devices, more than 36% are high-volume portable injectors/auto-injectors. In addition, 85% of auto-injectors deliver a fixed/variable dose. Additionally, we have identified approximately 70 injection pens and nearly 40 needleless injectors designed to facilitate subcutaneous drug delivery.
Approved subcutaneous biologics market expected to grow at a CAGR of over 21%
As the demand for subcutaneous drug formulations continues to grow, more licensing agreements between drug and technology developers are likely to be signed. It is estimated that approximately 85% of subcutaneous technology vendors’ overall revenue is generated through milestone payments.

North America and Europe are expected to capture 55% of the global market for approved subcutaneous biologics in 2035
By 2035, subcutaneous biologics approved for the treatment of autoimmune diseases, genetic diseases, and infectious diseases are expected to capture the highest market share (~45%). Additionally, more than 65% of market revenue is expected to be generated by therapies approved to be provided as monotherapies.

By 2030, auto-injectors are expected to take over 75% of the drug delivery system market

North America is expected to take the largest share (~40%) of the global auto-injector market. Similarly, in the large-volume portable injector market, the majority of the share (more than 80%) is believed to be occupied by devices intended for the administration of insulin-based drugs.

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Answers to key questions

  • Who are the main players who marketed their proprietary subcutaneous biologics?
  • Who are the main players currently engaged in the development of subcutaneous biologics at the clinical stage?
  • What are the popular therapeutic areas targeted by clinical-stage subcutaneous biologics?
  • What are the crucial factors that impact subcutaneous biologics market?
  • Who are the main players involved in the development of subcutaneous formulation technologies?
  • What types of drug delivery systems are most commonly used for delivery of subcutaneous biologics?
  • What types of partnership models are most commonly adopted by players 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 in the following segments:
[A] Approved Subcutaneous biologics:

  • Type of organic product
  • Type of therapy
  • Therapeutic area
  • Geographic region

[B] Subcutaneous Formulation Technologies:

  • Mode of payment
  • Fundamental principle
  • Final user
  • Therapeutic area
  • Region

[C] Subcutaneous drug delivery systems:

  • Large Volume Portable Injector Type
  • Usability of Large Volume Portable Injectors
  • Therapeutic area targets large volume portable injectors
  • Type of auto-injector
  • Target Therapeutic Indication of Auto-injectors
  • Syringe body material type for pre-filled syringes
  • Type of chamber system for pre-filled syringes
  • Therapeutic area for pre-filled syringes
  • Type of needleless injection systems
  • Type of actuation mechanism for needleless injection systems
  • Target therapeutic area for needleless injection systems
  • Container type for New drug reconstitution systems
  • Type of manufacturing equipment used for new drug reconstitution systems
  • Physical state of drug in syringe and cartridge for new drug reconstitution systems
  • Physical state of the drug in the infusion bag for new drug reconstitution systems
  • Volume of new drug reconstitution systems
  • Key geographic regions

The report presents contributions from prominent industry players, according to which subcutaneous biologics are likely to be increasingly adopted considering their wide range of applications and availability of formulation technologies and drug delivery systems that allow for better compliance and easier self-administration. . The report features detailed interview transcripts with the following industry stakeholders:

  • Steve Prestrelski (Chief Scientific Officer and Founder, Xeris Pharmaceuticals), Hong Qi (Vice President, Product Development, Xeris Pharmaceuticals) and Scott Coleman (Former Senior Formulation Scientist, Xeris Pharmaceuticals)
  • Patrick Anquetil (CEO, Portal Instruments)
  • Deborah Bitterfield (CEO and Founder, Lindy Biosciences)
  • David Daily (CEO and co-founder, DALI Medical Devices)
  • Poonam R Velagaleti (co-founder, i-novion)
  • Frederic Ors (former President and CEO, Immunovaccine Technologies)
  • David Heuzé (Communication Manager, MedinCell)
  • Menachem Zucker (Vice President and Chief Scientist, Elcam Medical)
  • Tiffany H. Burke (Director, Global Communications, West Pharmaceutical Services) and Graham Reynolds (Vice President and General Manager, Global Biologics, West Pharmaceutical Services)
  • Michael Reilly (CEO and Co-Founder, Excelse Bio)
  • Michael Hooven (General Manager, Enable Injections)
  • Matthew Young (Founder and Chief Technology Officer, Oval Medical Technologies)

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

  • Adocia
  • Ajinomoto Biopharmaceutical Services
  • Arecor
  • Alteogenic
  • Ascendis Pharmaceuticals
  • Avadel Pharmaceuticals
  • Camurus
  • Creative biolabs
  • Creative BioMart
  • HARD
  • Eagle Pharmaceuticals
  • Therapeutic Halozyme
  • MediCell
  • Therapeutic Serina
  • Xeris Pharmaceuticals

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