The Future Of Biologics Delivery: High-Concentration Subcutaneous Injectables
By Bryan Mazlish, CEO, Surf Bio
Over the past decade, the biologics landscape has undergone a dramatic transformation. Once dominated by time-intensive intravenous (IV) infusions administered in hospital settings, the industry is now at a critical crossroads. The biologics market has expanded nearly tenfold, and the market is expected to grow another tenfold in the coming years. This explosion of monoclonal antibodies (mAbs) and other biologics represents groundbreaking opportunities for patients and pharmaceutical companies alike — and an urgent drug delivery challenge.
Infusion centers are already stretched to capacity. Delivering biologics via IV infusion not only consumes significant healthcare resources but also places a heavy burden on patients, who must spend hours traveling to and from clinics and sitting in infusion chairs. As more biologic therapies come to market, the traditional IV infusion model simply will not support their delivery. To address this, the biologics industry is embracing subcutaneous delivery as the standard for high-dose biologic therapies.
Subcutaneous Delivery: A Solution For An Industry Under Pressure
Subcutaneous (SC) delivery has emerged as a game changer for biologics, offering an alternative that is faster, more convenient, and scalable. By enabling patients to self-administer treatments at home, SC injectables eliminate the need for clinic-based infusions, reducing strain on healthcare infrastructure and improving patient access.
However, not all SC delivery systems are created equal. High-concentration, high-dose formulations are particularly challenging to develop, as they require overcoming issues of viscosity, stability, and manufacturability. Many biologics, especially mAbs, require doses up to 1,000 mg —quantities that have traditionally been delivered only through IV infusions. The ability to administer these high doses subcutaneously in a single injection represents a major scientific and engineering breakthrough.
Meeting The Challenge With High-Concentration Subcutaneous Delivery Technologies
Innovations in subcutaneous delivery are addressing the challenges of administering high-concentration, high-dose biologics, though hurdles remain. Key to success will be developing delivery systems for ultra-high concentration of active pharmaceutical ingredient (API)-loaded particles that are rapid, scalable using standard manufacturing processes, require no reconstitution, and enable self-administration. At Surf Bio, our technology leverages advanced polymer-based systems that enable biologics and mAbs to be delivered subcutaneously in ultra-high concentrations. This approach encapsulates APIs in a highly stable, low-viscosity format, allowing for smooth delivery of doses that would otherwise be too large or viscous for subcutaneous administration.
Unlike solutions that depend on enzymatic enhancers or require complex manufacturing processes, our technology is designed to work with standard manufacturing equipment, simplifying production and reducing barriers to scalability. With the ability to deliver doses up to 1,000 mg in seconds using a single autoinjector, such innovations offer a practical and scalable path forward for addressing the growing demand for biologics.
Paving The Way For Broader Access
Beyond addressing immediate capacity issues, subcutaneous delivery holds the promise of expanding access to biologics globally. High-concentration, temperature-stable formulations reduce the need for cold chain logistics and providers to administer them, making therapies more feasible to distribute in low- and middle-income countries where healthcare resources are limited. For patients in remote or underserved areas, subcutaneous injectables could mean the difference between receiving treatment and being left behind.
The biologics market is poised for unprecedented growth, but this growth is only sustainable if the industry can solve its delivery challenges. High-concentration, high-dose subcutaneous injectables represent the most promising path forward, offering a solution that benefits patients, providers, and pharmaceutical companies alike. At Surf Bio, we are proud to be leading the way in this critical area of innovation, helping to shape a future where biologic therapies are more convenient, more accessible, and within reach for patients everywhere.
The Role Of Manufacturing And Scalability In The Future Of Biologic Delivery
As the biopharmaceutical industry shifts to subcutaneous delivery models, manufacturing scalability and tech transferability are critical success factors. Traditionally, high-concentration biologic formulations required custom manufacturing processes, adding time, cost, complexity, and risk to development. With the anticipated surge in biologics, future-ready delivery platforms must not only enable high-concentration formulations but also integrate seamlessly into existing manufacturing infrastructures. Standardization will be key: technologies that allow high-concentration subcutaneous formulations to be produced with conventional equipment will significantly outpace those requiring specialized manufacturing solutions, offering faster scale-up, lower risk, and easier transfer across multiple manufacturing sites for dual sourcing strategies. Forward-thinking companies that prioritize delivery innovations focused on manufacturability and scalability will position themselves to meet the demands of an increasingly dynamic market and ensure sustained competitive advantage.
Strategic Considerations For Biopharma Companies Embracing Subcutaneous Delivery
As the shift toward subcutaneous delivery accelerates, biopharma companies face important decisions that will shape their competitiveness in the years ahead. Chief among these is whether and how to adapt current and future biologics pipelines for subcutaneous administration. The commercial advantage of offering high-dose subcutaneous versions of monoclonal antibodies is clear: greater patient convenience, improved adherence, expanded access, and lower health system costs. But making the transition is not simply a matter of packaging — overcoming existing formulation limitations requires identifying and utilizing novel platform technologies that can surmount them without introducing undue regulatory or manufacturing complexity.
For many organizations, the ideal solution will be one that enables ultra-high concentration formulations without the need for enzymatic enhancers, reconstitution, or proprietary device platforms. Compatibility with standard manufacturing processes is also critical to ensure cost-effective scale-up and manufacturer flexibility. In the coming wave of novel biologics, subcutaneous readiness will likely be a key differentiator — not just for convenience but as a core component of market access strategy. As such, delivery platform decisions are becoming strategic rather than operational. Companies that invest today in scalable, patient-centric subcutaneous delivery will be better positioned to lead tomorrow’s increasingly crowded biologics market.
A Critical Moment for the Industry
The shift toward subcutaneous delivery is not just a convenience — it is a necessity. In five years, the vast majority of biologic therapies are expected to be delivered subcutaneously. Pharmaceutical companies that fail to embrace a robust SC strategy risk falling behind in an intensely competitive market. Patients and providers alike are demanding treatments that are not only effective but also convenient and accessible. Companies that can meet this demand will have a significant advantage in the race to bring lifesaving therapies to market.
About The Author:
Bryan Mazlish is the CEO of Surf Bio, a biopharmaceutical company advancing subcutaneous delivery of high-dose, high-concentration biologics. His career spans quantitative finance, medical device innovation, and biopharma, with a focus on solving complex, system-level healthcare challenges. Previously, Bryan cofounded Bigfoot Biomedical, where he pioneered algorithm-driven insulin delivery systems for people with insulin-requiring diabetes. At Surf Bio, he is applying that same data-driven problem-solving approach to transform how biologics are delivered at scale.