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Accelerating the Go-To-Market of Nasal Combination Products with Integrated Solutions   

Ear, Nose, Throat Market Trends Outlook 

The overall Ear, Nose, and Throat (ENT) market was heavily impacted by Covid-19 pandemic due to masks-wearing, lockdown, and less social interactions, exposing people less to respiratory viruses as well as allergens. People also tend to avoid going to the drugstores for non-vital treatment during the pandemic, leading to a significant 9,5% drop in Over the Counter (OTC) volume demand in 2020. When we start returning to our normal life post-pandemic, the market need is clearly observed to rebound in 2021, reaching an increase of 5,7%, requiring an agile and fast turnaround from the pharmaceutical industry to secure supply for patients in need of medications. The ENT market is estimated at 1,9 billion devices, with the majority of drug products for nasal applications.[1] 

The topical therapies still dominate the nasal market to treat allergic rhinitis, sinusitis, and nasal congestion. Allergic rhinitis is mostly seasonal and is usually relieved by nasal spray containing topical-acting medications. Corticosteroids are today the first line treatment for allergic rhinitis as they reduce swelling, inflammation, and mucus secretion in the nasal cavity. This long-standing historic market is still very dynamic following incoming pipelines from the generic players, representing opportunities for growth. In fact, today 65% of the topical treatments are generics.[2] 

Most of these topical treatments are available Over the Counter (OTC). In many developed countries, OTC regulations have come a long way becoming more and more stringent, approaching Rx drugs dossier requirements, strengthening barriers to entry, ensuring patient’s safety. For instance, recent Medical Devices Regulations (MDR) for European Market opens an opportunity to upgrade the required standard on raw material compliance, control strategy and documentations on products as well as processes for the registration of OTC drug products, implying similar exigence level as per prescription bound solutions.  

The nasal route is non-invasive and does not require healthcare professionals’ intervention. Unlike injectables, patients can self-administer their medication with a rapid onset. It offers better bioavailability as nasal administration avoids hepatic first-pass effect which could be encountered when taking medications orally. Nasal devices are needle-free hence increasing patient acceptance level, leading to positive therapy outcomes following improved patients’ adherence and compliance. 

More recently, there has been a growing interest and further exploration in delivering drugs through the nose for systemic-acting drugs, by targeting nasal turbinates. Turbinate occupies a large surface area of the nasal mucosa and is highly vascularised, offering a convenient pathway for a systemic delivery. 

A rising number of prescribed systemic-acting drugs originally administered in injectable forms have been successfully repurposed and made available as unit-dose nasal sprays. Patients and/or their caregivers are now able to administer a one-shot spray easily and rapidly to manage emergency and crisis situations, such as overdoses, seizures, and migraines. This allows a broader patient population targeting, increasing its accessibility to different end-user groups. To ensure patient’s safety, the regulatory bodies impose strict regulations on this alternative route to optimise its drug efficacy with equivalence as per injectables, especially for life-saving drugs. The reliability of the device plays a key role to ensure success in saving patients’ lives.