© Copyright khedmeh Wall
The
need for biologic-based therapeutics that can be administered via the
subcutaneous roue and emergence of supporting devices
Subcutaneous
Biologics, Technologies and Drug Delivery Systems Market: Over the years, the incidence and prevalence of chronic
diseases, such as diabetes, multiple sclerosis and rheumatoid arthritis, have
increased significantly. Presently, the recommended treatment options for such
clinical conditions are mostly biologics, which need to be administered via
parenteral routes in order to ensure maximum therapeutic benefit.
Given
the inherent requirement for frequent medication, patients suffering from such
long-lasting clinical conditions generally end up spending high amounts on not
only the prescribed therapeutic regimen, but also on numerous hospital visits
for dose administration. It is also worth highlighting that many of the
currently approved therapeutics which are administered by intravenous infusion
are more time consuming and require costlier administration infrastructures.
Therefore, subcutaneous administration has been developed as an alternative
delivery method for some of these therapeutic proteins.
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After switching an
intravenous drug to subcutaneous, the formulation must be capable of offering
the same set of therapeutic benefits. The dose volume which can be delivered by
subcutaneous route is much lower, as compared to the intravenous route. As a
result, subcutaneous formulations are more viscous, featuring high
concentrations of drug substance. Therefore, manufacturers must ensure that the
protein is adequately absorbed from the site of administration of subcutaneous
formulation.
Generally, reformulation of
intravenous products requires some adjustments in its established production
process for switching to subcutaneous route of administration. The following
figure provides a schematic representation of manufacturing changes that are
required to develop an established intravenous product into a subcutaneous product.
Due to various reasons, such
as limited solubility of the active substance and high viscosity of resultant
formulation, conventional prefilled syringes are incapable of successfully
enabling the administration of higher concentration (doses above 200 mg - 300
mg per injection) drug products. Therefore, the only alternative for delivering
high doses of therapeutic products is to increase the volume of the
formulation. As a result, many pharmaceutical companies have undertaken
initiatives to develop novel technologies to enable high volume dosing via the
subcutaneous route. Moreover, on-body delivery systems, such as large volume
wearable injectors, offer a technical solution for subcutaneous delivery of
high-concentration biotherapeutics drugs, at volumes up to 50 mL.
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Considering the fact that
these drug delivery technologies have the capability to overcome some of the
disadvantages associated with conventional drug delivery systems and deliver a
wide spectrum of therapeutic molecules (without compromising the treatment
regimen in anyway), indicating potential to replace traditional delivery
approaches.
Presently, there is a need
within the pharmaceutical industry to offer customization and further enhance
features of subcutaneous drug delivery devices, mostly for product
differentiation purposes. This has led device developers to collaborate with
digital health companies for integration of additional features and development
of affiliated mobile applications. The primary goal behind this is to include
patient-focused design elements with disease related information (dose
calculation, history of uptake and others) to optimize therapeutic outcomes and
improve medication adherence.
At
present, 30+ players are engaged in the development / deployment of
subcutaneous formulation technologies
Given the low
bioavailability associated with oral administration, as well as the challenges
related to intravenous dosing, there has been a rise in preference for
subcutaneous injections to deliver drugs. It is worth mentioning that more than
120 subcutaneous biologics have been approved, till date; in addition, around
350 such therapeutics are currently under development. Further, a number of
marketed / investigational products have been formulated with high
concentrations of biologics (>100 mg/mL) in order to realize the multiple
benefits associated with the subcutaneous formulation approach.
To
cope up with the current and future market demand, subcutaneous formulation
technologies developers are actively collaborating with various stakeholders
across the Globe
During our research, we came
across over 85 partnerships and collaborations that have been established by
various stakeholders engaged in the development of subcutaneous formulation
technologies, during the period pre-2016-2021 (till October).
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