NEWS! Biological Autoimmune Therapeutics

Biological Autoimmune Therapeutics Continue to Grow as Patients and Caregivers Seek Better Outcomes


Biosimilars Set to Expand the Addressable Market According to Greystone Research Associates


(Amherst, NH) – The administration of therapeutic immune modulators is becoming an increasingly important healthcare treatment option for a growing number of diseases and indications having broad implications for patient health and well-being. But to fully exploit the value of this class of therapeutics in both human and commercial terms, developers must successfully navigate the inherent limitations of drug storage and administration, moving away from infusion and toward injection as a route of administration.


Antibody drug products indicated for chronic conditions such as autoimmunity are often re-formulated, re-packaged and re-labeled into injectable form and re-introduced two to three years post-market launch to address the growing economic pressure and patient desire to avoid the need for out-patient infusion in favor of self-injection. There are several factors that are driving and influencing the market for autoimmune therapeutics.


Product Landscape


As more biosimilars enter the U.S. market, analysts expect to see U.S. price reductions similar to those that have occurred in Europe. However, of the seven biosimilars approved by FDA, sales of five biosimilars have been delayed by the actions of competitors. Three biosimilars (Erelzi, Amjevita, and Cyltezo) have had their marketing launch delayed by patent infringement lawsuits filed by brand-name manufacturers.


Biological Drug Supply Chain


During 2017, the biological drug supply chain experienced significant market consolidation as CMOs and CROs built out their scale and capability. A greater number of biologics manufacturers are seeking strategic partnerships while maintaining a global reach and access to the technologies they require. With this shift on the horizon, CMOs will find it necessary to enhance their capabilities in order to avoid account erosion.


As-supplied Packaging


As the administration of injectables moves increasingly from practitioner offices and healthcare facilities to patient homes, decisions regarding as-supplied packaging that were once considered boilerplate have moved to the early stages of the development process. A wide spectrum of device attributes, including form factor, device-patient interaction, security and safety, dosing, activation, off-device communication, and drug formulation factors have been incorporated into drug injection devices.




The correlation between patient adherence and the benefits of self-administration continues to influence therapeutic product decisions, managed care initiatives and regulatory actions. For chronic conditions, adherence has a direct effect on the patient’s quality-of-life. Injectable devices with increased functionality and features address the natural desire of patients for simplicity and encourage enhanced adherence and appropriate behavior. New features that are increasingly being integrated into injection devices include dose memory, dose time stamping, selectable cartridge concentration and audible prompts.


Shared Decision Making


Readily accessible health information has led to a new class of patients – the informed patient. Informed patients are increasingly arriving for medical engagements armed with at least basic knowledge regarding their symptoms and/or condition. A growing number of informed patients expect to discuss their care and have some input into treatment decisions. This has led to a concept called Shared Decision Making (SDM). SDM is most effective when patients feel empowered by their ability to speak about health issues and medical history freely with their provider. The patient empowerment inherent in the SDM process reportedly has led to a reduction in patient stress and anxiety.


These developments are detailed in a new and comprehensive report researched and written by Greystone Research Associates. The report – Biological Autoimmune Therapeutics:  Drugs, Devices, Packaging, Therapeutics & Forecasts analyzes autoimmune biologicals, how they’re administered and the way they’re packaged. The report includes analysis of competitive factors, therapeutic class product positioning, supply chain factors, device market share, and the product activities of sector participants.





Mark Smith

Voice: 603-595-4340


Source: Greystone Research Associates