Oral transmucosal drugs are available in different dosage forms such as tablets, thin films, and gels and administered orally to dissolve immediately in the mouth. Oral transmucosal drugs can bypass hepatic first-pass metabolism and avoid drug degradation in the gastrointestinal tract.

Market Dynamics
The global oral transmucosal drugs market growth is driven by the rise in R&D activities and product launches and increase in the prevalence of targeted diseases are likely to drive the market growth over the forecast period.

The rise in R&D activities and product launches and increase in the prevalence of targeted diseases is expected to drive the growth in the forecast period

An increase in R&D activities and product launches and the prevalence of targeted diseases are likely to drive market growth over the forecast period. For instance, in June 2021, Shilpa Medicare Ltd. launched Molshil, a pediatric dose Paracetamol Oral Thin Film in India. The company received approval after complying with bioequivalence requirements. In addition, according to the World Health Organization, in 2021, approximately 275 million people used drugs at least once in 2019. Among them, approximately 62 million people used opioids. Also, about 0.5 million people died due to drug use, and more than 70% of these deaths were associated with opioids. This is expected to raise the demand for oral transmucosal drugs to treat opioid dependence in the industry.

Moreover, the rising burden of Parkinson’s disease and migraine is likely to propel the growth of the oral transmucosal drugs market over the forecast period. For instance, as per the study published by the International Parkinson and Movement Disorder Society in 2020, “Estimation of the 2020 Global Population of Parkinson’s Disease (PD)”, an estimated 9.4 million people were living with Parkinson’s disease in 2020, higher than the previously reported 6 million cases in 2016. According to the report, approximately 930,000, 344,000, and 266,000 people affected by Parkinson’s disease in the United States, Japan, and Germany in 2020, respectively.

Disadvantages associated with oral transmucosal drug delivery is likely to hamper the market growth

Disadvantages of drug delivery by this route are the low permeability of the buccal membrane, specifically when compared to the sublingual membrane, and a smaller surface area.

Industry Analysis
Supply Chain Analysis

COVID-19 Impact Analysis
The COVID-19 pandemic had a short-term negative impact on the oral transmucosal drugs market due to supply chain disruption, government-imposed lockdown, workforce unavailability, and manufacturing activities restrictions. However, oral transmucosal drug manufacturers are capitalizing on offering reduced first-pass metabolism with rapid onset of action in coronavirus outbreaks. These abilities make oral transmucosal drugs suitable for end-of-life care and palliative to offer fast relief of symptoms. It was crucial in the COVID-19 pandemic since the health of some patients tends to deteriorate rapidly in certain cases. For instance, according to a study published by the National Center for Biotechnology Information in 2020, orodispersible or transmucosal drugs offer benefits such as reducing injection frequency and inherent delays in medication administration in the community setting during the COVID-19 pandemic.

Segment Analysis
The tablets segment is expected to hold the largest share in this market segment

Oral transmucosal tablets easily dissolve in the mouth with little or no residue. As the oral transmucosal tablets absorb quickly, they play a crucial role during medical emergencies such as heart attacks. The tablets segment is anticipated to dominate the global market in 2020, owing to the advantages of oral transmucosal tablets, such as quick absorption, predictable potency, ease of administration, and reduced interaction with other medications.

Moreover, the rise in oral transmucosal tablet approvals is expected to drive the segment growth over the forecast period. For example, in May 2021, Breckenridge Pharmaceutical, Inc got final approval of its Abbreviated New Drug Application from the United States Food and Drug Administration for Asenapine (5mg) Sublingual Tablets. The product was developed by Breckenridge Pharmaceutical, Inc and MSN Laboratories Private Limited. Also, in June 2018, Torii Pharmaceutical Co., Ltd launched CEDARCURE, a Japanese Cedar Pollen Sublingual Tablets. It is the sublingual immunotherapy drug for Japanese Cedar Pollen.

Geographical Analysis
North America region holds the largest market share of global oral transmucosal drugs market

North America holds the major market share in the oral transmucosal drugs market and is expected to dominate the overall market, throughout the forecast period owing to the high prevalence of dysphagia, increase in the geriatric population, and the high acceptance of novel oral transmucosal drugs in the region. According to a study published by Clinical Gastroenterology and Hepatology in 2020, “Prevalence and Characteristics of Dysphagia Based on a Population-Based Survey”, dysphagia is very common in the United States and affects about 16.1% of Americans at some point during their lives. In the North America region, the United States is slated to be the largest market due to the presence of many oral transmucosal drug manufacturers and suppliers. Additionally, according to the United States Census Bureau, about 54.1 million Americans were 65 years and older in July 2019. The above-mentioned factors indicate that the prevalence of dysphagia and demand for the oral transmucosal drug is high in North America, which may drive the market over the forecast period.

Competitive Landscape
The global oral transmucosal drugs market is highly competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include ZIM Laboratories Limited, Aquestive Therapeutics, Inc., IntelGenx Corp., Novartis AG, C.L.Pharm Co., Ltd., Seoul Pharmaceuticals, Shilpa Therapeutics, Sunovion Pharmaceuticals, Inc., Pfizer Inc., and GW Pharmaceuticals plc. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the calcium channel blocker globally. For instance, In September 2021, IntelGenx Corp. announced the launch of RIZAPORT in Spain. Exeltis Healthcare S.L. is a commercialization partner of IntelGenx Corp .in the European Union for RIZAPORT. It is an oral film formulation of rizatriptan benzoate.

Key Companies to Watch
Pfizer Inc

Overview: Pfizer Inc. (Pfizer), incorporated on June 2, 1942, is a research-based global biopharmaceutical company. The Company is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio includes medicines and vaccines. The Company manages its commercial operations through two business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients' lives. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology and rare diseases. EH includes legacy brands, branded generics, generic sterile injectable products, and biosimilars and infusion systems. EH also includes a research and development (R&D) organization, as well as its contract manufacturing business. The Company sold its products in over 125 countries.

Product Portfolio: On November 05, 2021, PAXLOVID- is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness which can lead to hospitalization and death.

For more information:

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