Sialorrhea Market

Key Highlights

• The market size for Sialorrhea in the 7MM will increase by 2034 and the United States grab the major share among the 7MM.
• MYOBLOC (rimabotulinumtoxinB) is the first neurotoxin approved for the treatment of chronic Sialorrhea in adults. The drug was originally developed by Elan Corporation, which sold its worldwide rights to Solstice Neurosciences in July 2004. It became part of US WorldMeds’ portfolio in August 2010 following the acquisition of Solstice Neurosciences by the company.
• The cases of Parkinson’s Disease-induced Sialorrhea were observed to be highest in the United States.

DelveInsight's “Sialorrhea – Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of Sialorrhea epidemiology, market, and clinical development in Sialorrhea. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Sialorrhea market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Sialorrhea market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Sialorrhea market size from 2020 to 2034 in 7MM. The report also covers current Sialorrhea treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Sialorrhea Understanding and Treatment Algorithm

Sialorrhea Overview and Diagnosis

Sialorrhea or hypersalivation means excessive saliva flow. Patients with Sialorrhea will manifest this problem in one of two principle ways. Anterior Sialorrhea is when patients have excessive anterior or forward spillage of saliva from their mouths, commonly called drooling, onto their faces and clothes causing difficulty with cleanliness, skin care, and socialization. Posterior Sialorrhea is when patients have excessive posterior spillage of saliva from their mouths down their airways (tracheas) rather than being swallowed normally. This results in chronic lung irritation called aspiration which can sometimes progress to pneumonia. Often patients have a mixture of both of these types of Sialorrhea.

Diagnosing Sialorrhea typically involves a thorough examination by a healthcare provider, including an assessment of symptoms such as swelling, bleeding, inflammation, and foul odor within the mouth. If one has a pre-existing chronic condition, the doctor may utilize a scale system to gauge the severity of Sialorrhea, aiding in the selection of appropriate treatment options. This comprehensive diagnostic approach enables healthcare professionals to tailor interventions to specific needs and improve overall quality of life.

The Sialorrhea report provides an overview of Sialorrhea pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report

Sialorrhea Treatment

Treating Sialorrhea is a difficult process and requires group efforts. The aim is to reduce or stop excess salivation. Current treatment practices vary among practitioners. Traditional treatment options include daily oral medications to diminish saliva production, periodic injections of a medication called Botox for a temporary reduction in saliva production, or a variety of open surgical procedures to remove some salivary glands or disconnect others from the mouth. Thus, the treatment ranges from conservative to more invasive treatment methods. Changes in diet or habits, oral-motor exercises, intra-oral devices such as palatal training devices, and medical treatments such as medication or botulinum toxin injections constitute conservative methods of treatment. However, radiation and surgery fall under more invasive treatment methods for Sialorrhea. Surgery is more permanent and less side-effect-producing method whereas radiation is rarely applied and is reserved for special cases like elder patients who cannot take medication therapies and surgery.

Sialorrhea Epidemiology

The Sialorrhea epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total Prevalent Cases of Selected Indications, total Prevalent Cases of Sialorrhea in Selected Indications, total Prevalent Cases of Chronic Sialorrhea in Selected Indications in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034. 

• • In 7MM, the United States accounts for the highest number of prevalent cases of Sialorrhea in 2023.
• • In the United States around 3,36,800 cases of Chronic Sialorrhea in Parkinson's disease were present in 2023.
• • Amongst EU4 and the UK, Germany had the highest prevalent population of Sialorrhea, followed by the United Kingdom. On the other hand, Spain had the lowest diagnosed prevalent population in 2023. 

Sialorrhea Drug Chapters

The drug chapter segment of the Sialorrhea report encloses a detailed analysis of Sialorrhea marketed drugs. It also deep dives into the Sialorrhea pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Marketed Drug

MYOBLOC (rimabotulinumtoxinB): US WorldMeds

MYOBLOC is the first and only FDA-approved botulinum toxin B for the treatment of chronic Sialorrhea (excessive drooling) in adults. MYOBLOC is an acetylcholine release inhibitor that blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve terminals. MYOBLOC was first approved by the US Food and Drug Administration (FDA) for cervical dystonia in December 2000. US WorldMeds submitted a supplemental biologics license application (sBLA) for the drug to the FDA for the treatment of chronic Sialorrhea in October 2018. MYOBLOC was approved for the condition in August 2019. The drug is marketed in Europe by US WorldMeds’ subsidiary Sloan Pharma along with Eisai, under the brand name NEUROBLOC, for the treatment of cervical dystonia. Eisai develops and markets the drug in Japan under the brand name NERBLOC for the same indication.

XEOMIN: Merz Pharmaceuticals

XEOMIN (incobotulinumtoxinA) for injection is indicated for the treatment of Chronic Sialorrhea in patients 2 years of age and older. In July 2018, the US FDA approved XEOMIN for chronic or excessive drooling (Sialorrhea) in adult patients. In December 2020, Merz Therapeutics announced that the US FDA has approved a sBLA for XEOMIN for the treatment of patients aged 2 years and older with chronic Sialorrhea, or drooling. XEOMIN is the first and only FDA-approved neuromodulator with this indication and was granted a priority review designation upon acceptance by the FDA. XEOMIN gained European approval for treating Chronic Sialorrhea in children in 2021, while its approval for adult patients dates back to 2019.

Note: Detailed current therapy assessment will be provided in the full report of Sialorrhea

Sialorrhea Market Outlook

Anticholinergic agents like glycopyrrolate are commonly used, with oral solutions like CUVPOSA gaining popularity due to their acceptability among children. Additionally, botulinum toxins, particularly Xeomin, have emerged as effective alternatives with fewer side effects, gaining FDA approval in the US and EMA approval in Europe. Market-wise, the landscape has seen significant shifts, especially with the introduction of MYOBLOC and other botulinum toxin formulations. These approved treatments are expected to dominate the market, reducing the reliance on off-label use of unlicensed products. Furthermore, ongoing research and development, including promising candidates like NT004, and OP-014 indicate a future trend towards targeted therapies with improved efficacy and reduced side effects, shaping a more optimistic outlook for Sialorrhea management.

• • The market size shall grow during the forecast period owing to the approval of MYOBLOC and XEOMIN, increased awareness among patients, updated diagnosis and treatment guidelines, and growth in the diseased population. 
• • Among 7MM, the United States accounted for the highest market size of Sialorrhea in 2023.
• • Among the EU4 and the UK, Germany had the highest market size in 2023, while Spain had the lowest market size for Sialorrhea.

Sialorrhea Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Sialorrhea Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics. 

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Sialorrhea emerging therapies. 

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Doctors, Professors, and Others.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such Department of Neurology, Yale School of Medicine, Neuro-Rehabilitation Medicine, the Walton Centre NHS Foundation Trust, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Sialorrhea market trends.