Chronic Refractory Cough Market Still Unexplored, with Pharma Companies Eyeing First-Mover Advantage in the US | DelveInsight

As per DelveInsight analysis, in 2023 the 12-month prevalent cases of chronic cough in the 7MM were estimated to be approximately 30 million cases, out of which the US accounted for nearly 13 million cases. These cases are expected to increase during the forecast period (2024–2034) driven by the aging population that has an increased likelihood of developing chronic conditions such as asthma, chronic obstructive pulmonary disease, and chronic cough.

The total diagnosed prevalent cases of CRC in the 7MM were approximately 12 million in 2023. Of these, the US accounted for nearly 42% of the total diagnosed prevalent cases of CRC. These cases may change due to an increase in various respiratory infections, which can either induce or worsen chronic cough.

Presently, there are no approved treatments for chronic cough in the US. The condition is estimated to affect about 10% of the adult population globally.

Treatment options for chronic refractory cough include various pharmacological therapies aimed at neural sensitization. These consist of neuromodulators like opiates (such as morphine, codeine, and tramadol), gabapentin, pregabalin, amitriptyline, and baclofen, as well as proton pump inhibitors (PPIs), inhaled corticosteroids (ICS), and other medications. These drugs target heightened neural sensitization, which plays a significant role in the development of CRC.

PPIs, often used to treat gastroesophageal reflux disease (GERD), can worsen chronic cough. By decreasing gastric acid production, they help relieve cough symptoms associated with reflux. Inhaled corticosteroids are mainly utilized for asthma and chronic obstructive pulmonary disease (COPD), but they can also be helpful for CRC linked to airway inflammation. These medications reduce airway inflammation and enhance cough symptoms.

Learn more about the FDA-approved chronic refractory cough drugs @ Drugs for Chronic Refractory Cough Treatment

Gefapixant, known as LYFNUA, received approval in Japan in 2022 and in the European Union in 2023 for the treatment of adults suffering from refractory or unexplained chronic cough. It functions as a P2RX3 receptor antagonist and has demonstrated effectiveness in decreasing cough frequency in clinical trials. Although it has encountered difficulties with the US FDA in the United States, Gefapixant has been acknowledged for its advantages in managing chronic cough in other areas.

However, the US CRC market faces a significant unmet need, as there are no approved curative therapies available. Current pharmacologic treatments cannot be administered long-term due to several adverse effects, including drowsiness, dizziness, and fatigue. Therefore, there is an urgent need to develop new therapies for CRC to address patient demands.

To know more about chronic refractory cough treatment options, visit @ New Treatment for Chronic Refractory Cough

Various novel promising drugs like P2X3 inhibitors, TRPM8 agonists, etc. are being developed for the treatment of refractory chronic cough and unexplained chronic cough and are in different stages of trials. Once approved they will address the unmet need for developing effective therapies which particularly target cough that is persistent/refractory.

Expected launch of emerging therapies, such as MK-7264 (gefapixant) (Merck/Kyorin Pharmaceuticals), orvepitant maleate (ORV-PF-01) (Nerre Therapeutics), camlipixant/BLU-5937 (GSK), AX-8 (Axalbion), and others shall further create a positive impact on the chronic refractory cough market during the forecast period (2024-2034).

Discover which therapies are expected to grab major chronic refractory cough market share @ Chronic Refractory Cough Market Report

Gefapixant is an investigational, non-narcotic medication taken orally that acts as a selective P2X3 receptor antagonist, potentially aimed at treating refractory or unexplained chronic cough. P2X3 receptors are located on sensory nerve fibers, mainly C fibers, within the airway lining. Airway inflammation, irritation, and mechanical stress can lead to the release of chemical stimuli like ATP from airway lining cells. When ATP binds to P2X3 receptors on the C fibers, it signals potential damage, generating an action potential that may trigger coughing. By inhibiting the binding of ATP to these receptors, gefapixant is believed to reduce sensory nerve activation and consequently decrease cough reflex. 

In 2020, Merck concluded Phase III trials for MK-7264 and submitted a New Drug Application (NDA) based on the results. However, in January 2022, the FDA issued a Complete Response Letter (CRL) regarding Merck's NDA, requesting additional information on efficacy measurement. In December 2023, the FDA issued another CRL, expressing concerns that Merck's data for the chronic cough medication might not sufficiently demonstrate the drug's benefits. Merck is currently reviewing the FDA's feedback to decide on the next steps.

Camlipixant, previously called NEO5937, is a highly selective and potent small molecule antagonist of the P2X3 receptor, which is a clinically validated target for chronic cough (CC). This drug has the potential to become a leading treatment option for patients with chronic respiratory conditions (CRC). Currently, it is being tested in Phase III clinical trials, which include two key studies (CALM-1 and CALM-2). The primary efficacy endpoint is the measurement of cough frequency over 24 hours at 12 and 24 weeks, respectively. These trials are expected to conclude by 2025, with regulatory approval and market launch anticipated in 2026.

ORV-PF-01 is a groundbreaking first-in-class, selective, and potent neurokinin (NK)-1 receptor antagonist. This drug specifically targets the human NK-1 receptor to inhibit the action of its associated agonist, substance P (SP), which plays a role in peripheral neurogenic inflammation and functions as a neuromodulator in the central nervous system. By reducing central neural hypersensitivity associated with chronic cough (CC), it shows promise in treatment. The company reported encouraging results from its Phase II pilot study (VOLCANO-2) on orvepitant for chronic refractory cough and is currently exploring its effectiveness and safety in a study focusing on chronic cough in patients with idiopathic pulmonary fibrosis (IPF-COMFORT).

AX-8 is a powerful and selective agonist of the transient receptor potential melastatin 8 (TRPM8) aimed at treating chronic cough. TRPM8 is found in numerous sensory fibers that innervate the upper airways and can help alleviate persistent chronic cough by counteracting cough hypersensitivity syndrome (CHS), reducing or eliminating pathological coughing, and limiting or suppressing abnormal sensations related to coughing. Currently, AX-8 is in Phase II clinical trials, which are in the recruitment phase, to evaluate its effectiveness and safety for treating chronic cough. Additionally, this drug candidate is also being studied for its potential application in dry eye syndrome.

Discover more about drugs for chronic refractory cough in development @ Chronic Refractory Cough Clinical Trials

The anticipated launch of these emerging therapies for chronic refractory cough are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the chronic refractory cough market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for chronic refractory cough is expected to grow fromUSD 8.8 billion in 2023 with a significant CAGR by 2034. The increasing awareness about chronic refractory cough may increase market size in the coming years, assisted by emerging therapies.

DelveInsight's latest published market report titled as Chronic Refractory Cough Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the chronic refractory cough country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The chronic refractory cough market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Download this chronic refractory cough market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the chronic refractory cough market. Also, stay abreast of the mitigating factors to improve your market position in the chronic refractory cough therapeutic space.

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