Serotonin Reuptake Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Serotonin or 5-hydroxytryptamine (5-HT) is a monoamine neurotransmitter. Its biological function is complex and multifaceted, modulating mood, cognition, reward, learning, memory, and numerous physiological processes such as vomiting and vasoconstriction. Approximately 90% of the serotonin the human body produces is in the gastrointestinal tract's enterochromaffin cells, where it regulates intestinal movements. Serotonin is also produced in the central nervous system (CNS), specifically in the brainstem's raphe nuclei, the skin's Merkel cells, pulmonary neuroendocrine cells, and the tongue's taste receptor cells. The mechanism of action (MOA) of Serotonin Reuptake Inhibitor is by inhibiting the reuptake of the neurotransmitter serotonin (5-hydroxytryptamine, or 5-HT) by blocking the action of the serotonin transporter (SERT). This in turn leads to increased extracellular concentrations of serotonin and, therefore, an increase in serotonergic neurotransmission. Serotonin Reuptake Inhibitors are used for the treatment of CNS disorders, mood disorders, bipolar disorders, musculoskeletal disorders, autoimmune diseases, colonic diseases, depressive disorders, intestinal disorders, migraine disorders, and others. Increased prevalence of neurological diseases and work-life imbalance in the community are the key drivers for the Serotonin Reuptake Inhibitor market. For instance, according to the World Health Organization (WHO) report, the worldwide occurrence of neurological health problems is expected to reach nearly 103 million by the year 2030. Launch of newer products by the market players could seek opportunities that influence extensive research and development in Serotonin Reuptake inhibitors. For instance, AbbVie’s Savella (Milnacipran Hydrochloride) is launched for the treatment of fibromyalgia. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Otsuka’s Centanafadine SR (EB-1020) for the indication of Attention-deficit hyperactivity is under the various stages of clinical studies.

Key Market Developments:

• In May 2023, Allergan in collaboration with AbbVie received an FDA grant for an expanded indication of Lexapro (Escitalopram) for the treatment of generalized anxiety disorder (GAD) in pediatric patients 7 years of age and older.

Approved Drug Molecules and Brand Names for Serotonin Reuptake Inhibitor:

 Savella (Milnacipran Hydrochloride)

Drugs under the Pipeline for Serotonin Reuptake Inhibitors:

Centanafadine SR (EB-1020)

Deudextromethorphan/Quinidine Ultra-Low Dose (AVP-786)

CSTI-500

IP2015

TNX-1600

Long-Acting Lumateperone (ITI-007 LAI)

Clinical Activity and Developments of Serotonin Reuptake Inhibitor:

Till July 2023, more than 10 companies have approximately 19 molecules targetting 188 diseases. For these molecules, more than 170 clinical trials are being conducted and the majority are in phase-2, and phase-3 clinical trials by players across the globe. For instance,

• In July 2023, Algo Therapeutics conducted a Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain using Capsaicin and Amitriptyline.
• In May 2023, Otsuka Pharmaceutical completed a phase 2 study to evaluate the efficacy of Centanafadine SR as a potential smoking cessation treatment.