Unmet Need Remains for Subcutaneous Sustained Release Injectables

(Amherst, NH) - As patients live longer and the prevalence and incidence of chronic ailments increase across the general population, drug developers and their delivery device partners are adapting to address what will become a significant market opportunity. Chronic conditions require drug administration over long periods of time, placing a greater emphasis on self-administration and reduced dosing frequency. With the shift away from caregiver interaction, drug safety and compliance/adherence become prominent concerns. These concerns, which are not new, are becoming magnified as the number of powerful new drugs reaching the market increases. For healthcare managers and public health officials, one way to address these issues is less frequent dosing.

While sustained release tablets and capsules continue to evolve, there are limitations to this approach to the dosing issue, and these limits have essentially been reached. This reality, and the fact that biological drugs cannot be delivered orally, have resulted in an accelerating interest in alternative modes of administration (MoA), a group that includes injection, inhalation and transdermal administration. Our analysis concludes that recent growth has been uneven across non-oral delivery segments, and that future prospects will be determined to a large degree by the ability of drug and device developers to address formulation and patient issues across the new drug landscape.

The leading beneficiary of current drug development pipelines and the move toward self-administration is the Injectable segment. The transition of Injectable drug packaging from vials to sophisticated and customized injection devices is accelerating at a time when caregiver and patient expectations continue to evolve. The result is an emerging set of de facto requirements for drug developers that often dictates the device strategy for a particular parental drug. This trend is strongly aligned within and around specific drug classes and is accelerating with each new Injectable that reaches the market.

Using formulation technologies designed to modulate the effect of therapeutic substances, drug developers are creating injectable formulations that exhibit extended release profiles. These chemistries include polymers such as polyethylene glycol-complexed (PEGylated), which are used to product encapsulated and coated versions of new APIs. The goal is to address the requirement for patient-dependent, and therefore compliance-sensitive, drug treatment protocols such as multiple dosing through controlled release formulations that provide the desired therapeutic effect with dosing of once-a-day or less.

Large pharmaceutical and biotechnology companies are increasingly pursuing in-licensing to offset lower than expected drug development productivity and surging research costs. Data mining technologies, combined with data from genomics, combinational chemistry and outcome-based medicine, provide opportunities to search for new patterns. By using hypertext type tools, companies are finding it possible to build knowledge bases where scientists can link data and ideas to generate insights into new relationships between population groups, diseases, and treatment.

For sustained release formulations of Injectable drugs, development collaborations typically follow one of two business models. The majority of projects/products are marked by a contractual relationship between the formulation IP developer/holder and the drug developer. The second notable business model is more ambitious and is defined by formulation IP companies that develop sustained release formulations in-house before licensing the marketing rights to a partner, typically in late stage clinical development or after filing an NDA. This is a more powerful financial model, but has a higher level of risk and requires adequate capitalization to finance drug development into or up to Phase 3 trials.

A new report analyzes the current market and potential for extended release injectables. The report - Subcutaneous Sustained Release Injectables to 2024 - examines the therapeutic impact of approved SC sustained release injectable drugs and development-stage candidates, and analyzes key market segments, technology factors, demand drivers and the competitive landscape.

More information is available at www.greystoneassociates.org .



Source: Greystone Research Associates

About Greystone

Greystone Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets

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