Market Challenges And Opportunities

Global Tauopathies Treatment Market - Drivers

Increasing research and development activities in tauopathies treatment

Increasing research and development in the field of tauopathies treatment is expected to drive the global tauopathies treatment market growth over the forecast period. For instance, according to article published by the journal Annals of Neurology on March 10, 2023, a class of drugs called Dual Orexin Receptor Antagonists (DORAs) developed to help treat insomnia may play a role in the development of Alzheimer\'s disease. In this study, 38 volunteers were participated. All participants were between the ages of 45 to 65 and cognitively healthy. The researchers randomly assigned them to receive either two higher doses of a DORA called suvorexant over 36 hours, two lower doses of suvorexant, or a placebo. The team then measured changes in levels of amyloid-β and a form of tau called phosphorylated tau in the cerebrospinal fluid. People receiving suvorexant did not show an increase in sleep time or quality over the night of the study. But those who received the higher dose of the drug showed a 10-15% drop in phosphorylation at a site on tau that contributes to tau tangles. By 12 hours after receiving high-dose suvorexant, participants had amyloid-β levels 10-20% lower than those in the placebo group. These levels increased over time, then dropped again after a second dose of the drug.

Increasing launch of new products for the treatment of tauopathies

Increasing launch of new products for the efficient treatment of tauopathies is expected to drive the global tauopathies treatment market growth. For instance, on January 6, 2023, Eisai Co., Ltd., a Japan-based pharmaceutical company, along with Biogen Inc., a U.S.-based biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved LEQEMBI, lecanemab-irmb 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer\'s Disease (AD). The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai Co., Ltd., will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

On January 13, 2020, Biogen Inc., a U.S.-based biotechnology company announced the acquisition of Alzheimers and Parkinson\'s disease assets from Pfizer Inc., a U.S.-based multinational pharmaceutical and biotechnology corporation for US$ 710 million. Biogen is buying novel CNS penetrate inhibitor of casein kinase 1 (CK1) to develop for patients with behavioral and neurological symptoms in various psychiatric and neurologic diseases. Biogen Inc. indicates its initial focus will be to develop the Phase I compound for Sundowning in Alzheimer\'s disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson\'s Disease (PD). Under the terms of the deal, Biogen Inc. is paying Pfizer Inc. US$ 75 million upfront with up to US$ 635 million in various milestones, as well as tiered royalties in the high single digits to sub-teens.

Failure of clinical trials associated with treatment drugs

The failure of clinical trials associated with treatment drugs is expected to hamper the global tauopathies treatment market growth. For instance, on December 21, 2022, new experimental antibody that appears to slow cognitive decline in some Alzheimer\'s patients caused death of 79-year-old Florida woman participating in an ongoing trial of the antibody after experiencing extensive brain swelling and bleeding as well as seizures. The death is believed to be likely caused by the antibody, lecanemab. It was concluded that brain swelling and microhemorrhages could be a serious side effect of the study medication by trial investigator.

To counterbalance this restraint, more research should be done to introduce and develop effective drug against neurodegenerative disorders.

Costly treatment development for neurodegenerative diseases

High cost of treatment development of neurodegenerative diseases is expected to hamper the global tauopathies treatment market growth. For instance, according to an article published in Journal Alzheimer\'s & Dementia, on September 28, 2021, the cumulative private expenditures on clinical stage AD R&D were nearly US$ 42.5 billion, with the greatest costs US$ 24,065 million incurred during Phase 3. Out of 235 agents analyzed, 112 remain in active clinical development, six reached commercialization and 117 had negative outcomes equating 95% failure rate. The information was collected from AD clinical trials (n = 1099; phases 1–4) conducted between January 1, 1995 and June 21, 2021 from various databases.

To counterbalance this restrain, more funding by governments for research activities should be allocated.