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Sustained Release Injectable Drugs to Exceed $17 Billion in 2020

Greystone Associates Analyzes the Branded Formulation Technologies, Therapeutic Demands and Commercial Potential of Engineered Release Injectable Drugs

(PresseBox) (Amherst, NH, ) For many chronic and refractory conditions, the need for frequent and continual drug injections is a therapeutic necessity, one that can be accompanied by harsh side effects and safety issues that often lead to erosion in patient compliance and therapeutic outcomes. While the pharmaceutical industry has made significant progress in developing and introducing extended release formulations of orally administered drugs, the complexities associated with injectables go far beyond simply protecting an API from first-pass GI degradation. As a result, less than two dozen sustained release injectables are currently FDA-approved.

Several drug formulation companies have been attempting to address this unmet need by working with drug developers to create drugs that can be administered at dosing frequencies that are measured in weeks or months. The technologies that are being used to create these extended release formulas include a range of approaches such as microsphere encapsulation, drug conjugation, and physical chemistry processing. The advantages of these drug products have allowed sustained release injectables to quietly carve out a healthy space for themselves in a number of therapeutic indications, sometimes achieving more than a billion dollars in annual revenue.

The majority of formulation technology companies have migrated to a business model based on a development collaboration, under which the technology IP owner develops or co-develops a sustained release version of an injectable in return for milestone payments and licensing revenue once the drug is launched. A few sector participants attempt to increase the value of their services by developing a sustained release formulation to a predetermined point - typically Phase II clinical trials - before partnering with a larger, more established therapeutic market player. Infrequently, the formulation technology company develops sustained release injectables independently, only partnering for marketing purposes when the drug is about to be approved. Alkermes, with two approved sustained release injectables on the market, is an example of this go-it-alone strategy. As experience with extended release injectables mount, formulation companies and their drug development partners, are working to push the dosing envelope further.

A new report analyzes the current market and potential for extended release injectables. The report examines the therapeutic impact of approved 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 .

Greystone Associates

Greystone Research 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.