Over the last decade, the role of the immune system in the etiology and pathophysiology of neurological diseases has steadily gained clarity, says GlobalData. The leading data and analytics company notes that the development of neuroimmunology drugs* has exploded as a result, with the top 20 neuroimmunology products being worth $20.1 billion in 2020 and set to increase to $26.6 billion by 2025.

GlobalData’s latest report, ‘Neuroimmunology Drug Development – Thematic Research’, states that there are nearly 220 neuroimmunology drugs in Phase I, II, and III stages of development across eight key diseases** in the eight major pharmaceutical markets (8MM***).The highest number of neuroimmunology drugs are in development for multiple sclerosis (MS) subtypes (86 drugs), followed closely by Alzheimer’s disease (AD) (75 drugs), as well as amyotrophic lateral sclerosis (ALS) (39 drugs), and Parkinson’s disease (PD) (35 drugs).

Rose Joachim, Associate Director of Neurology at GlobalData, comments: “Although MS remains a major space for the development of neuroimmunology products, there is strong interest in applying these types of approaches to other neurodegenerative diseases. For example, in AD, a wide variety of immunological mechanisms of action are being studied; the most common strategies involve the clearance of pathologic brain proteins like amyloid beta A4 tau via monoclonal antibody (mAb) binding or vaccine-induced immune responses.

“Similarly to AD, in PD, numerous mAb products are in development that target the clearance of the brain protein, alpha synuclein. In ALS, a key inhibitory target of interest is the complement system, an arm of innate immunity consisting of a number of small proteins with various functions in fighting pathogens.”

Of the ten key players involved in the neuroimmunology market, Roche, Biogen, AstraZeneca, Johnson & Johnson (J&J), Novartis, Sanofi, and UCB are all involved in marketing or developing neuroimmunology products across multiple neurological indications (among the eight indications** assessed for GlobalData’s report). The remaining three players are instead focused on neuroimmunological products in just one indication each—Merck KGaA in MS and Eisai and Lilly in AD.

Joachim continues: “Regarding the ways in which these ten companies currently compete, Roche, Biogen, Merck KGaA, Novartis, Sanofi, and J&J all market agents within the MS space, while AstraZeneca and Roche both market agents for neuromyelitis optica spectrum disorder (NMOSD). An important future arena for competition among these ten key players is AD, with Roche, Biogen, Eisai, AstraZeneca, J&J, Novartis, UCB, and Eli Lilly all with products in clinical development.”

GlobalData notes that key unmet needs include the early state of research in this field; the need for earlier diagnosis of neuro-inflammatory conditions; comparative data for neuroimmunological products; better strategies to deliver neuroimmunology drugs across the blood-brain barrier; biomarkers to help determine therapeutic response; and the lack of targeted neuroimmunological products.

Joachim concludes: “The neuroimmunology drug development space is dynamic and of high value. With burgeoning interest from the industry to utilize immunological strategies to target neurological diseases, it is expected that the space will make significant strides toward addressing crucial unmet needs in the coming years.”

* GlobalData defines neuroimmunology drugs as agents that aim to regulate immune system activity (promote, inhibit, or resolve) as a mechanism to treat neurological diseases with underlying immune pathologies.

** Multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), myasthenia gravis (MG), Alzheimer’s disease (AD), Parkinson’s disease (PD), and amyotrophic lateral sclerosis (ALS)

*** 8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China