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