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The Future of Immunoglobulin Replacement Therapy

Posted by | Shiv Nayyar

Immunoglobulin replacement therapy (IgRT) has long been used to manage autoimmune and inflammatory diseases. It mainly involves preparing a cocktail of healthy immunoglobulins (Igs), or antibodies made from donated human blood plasma. After refining, the treatment is then most often injected into the bloodstream of the patient via intravenous therapy (IVIg).

This type of IVIg treatment has been very effective against several autoimmune diseases for decades and has been approved to treat several rare diseases. This specialized treatment also proved very effective during the recent pandemic, especially in the early days when no other treatments or vaccines were available to treat COVID-19. It especially displayed its clinical efficacy in critically ill patients infected with COVID-19.


Challenges in adoption

Even with all its promising potential, however, both mass production and adoption of IVIg therapy have been a challenge. This can be largely attributed to two factors. First, finding sufficient plasma donors for the antibodies is extremely challenging—a problem that was heightened during the pandemic when many blood collection centers were shut down. Second, patients have to visit a hospital or ambulatory center to get the IVIg treatment administered by a qualified medical professional.

Innovation in Ig therapy

Over the last decade, major players in the IVIg space, including companies such as CSL Behring, Grifols, Octapharma, and Takeda, have made significant investments in innovation to respond to the above challenges. One early example of innovation was the launch of Hizentra ten years ago. This subcutaneous immunoglobulin therapy (SCIg) formally introduced a new method of administration that helped reduce the number of patients’ hospital visits. As SCIg could be self-administered by patients at home, this opened the potential for major disruption in the industry. Some studies showed that using SCIg instead of IVIg could reduce treatment costs by 74% or US$5,736 per patient over a three-year period. Despite this, the adoption of SCIg at-home therapy has been sluggish.

An industry poised for disruption

At Fuld & Company, we monitor biopharma and IVIg trends very closely. Through our ongoing conversations with influential Ig therapy experts, we are seeing that a series of recent changes are setting the stage for a significant disruption. In a recent interview with the Medical Director at a Tier 1 University Hospital, for example, we learned the number of his patients taking at-home Ig replacement therapy had increased by 400% over just the past few years. Accelerated by the pandemic, some of the other reasons for this shift were the recent launches of additional SCIg products such as Xembify. Secondly, the recent launch of pre-filled syringes is also making it increasingly convenient for patients to self-administer SCIg. Following this trend, at least two other companies are working on launching pre-filled syringes.

How will these trends affect your company?

Fuld continuously tracks these and other innovations in the industry—such as smart pumps, smart monitors, AI-managed plasma collection centers, and upcoming therapies to keep our clients ahead of the next big wave of disruption.

If you are interested in learning more about your competition and the trends that will have the greatest impact on your company, please contact us to set up a brief intro call.





Author: Shiv Nayyar | Director, Consulting Services | Fuld & Company

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