Germany Mouth Ulcer Therapeutics Market Analysis

Germany Mouth Ulcer Therapeutics Market Executive Summary

The Germany Mouth Ulcer Therapeutics Market is at around $55.6 Mn in 2023 and is projected to reach $64.3 Mn in 2030, exhibiting a CAGR of 2.1% during the forecast period 2023-2030.

Mouth ulcers, also known as canker sores, are classified into three main types: minor aphthous ulcers which are the most common small oval lesions, major aphthous ulcers that are larger and deeper causing more pain, and herpetiform ulcers which start as multiple small ulcers that can merge into one large ulcer. While the exact cause is unknown, several risk factors have been identified including stress, anxiety, hormonal changes, nutritional deficiencies (iron, vitamin B12, folic acid, zinc), certain medical conditions like celiac disease, Crohn's disease, and HIV/AIDS, as well as trauma from dental work, braces, or ill-fitting dentures. In most cases, mouth ulcers are self-limiting and resolve within 1-2 weeks without treatment. However, complications can arise such as secondary infection, severe pain affecting one's ability to eat or drink properly, and potential scarring in cases of severe recurrent ulcers. Prevention involves reducing stress, avoiding potential food triggers like citrus fruits, nuts, and chips, using soft-bristled toothbrushes and waxed dental floss, and replacing toothpaste if it seems to be a trigger. Treatment involves symptomatic relief with topical gels containing anaesthetics, antiseptics, and antibiotics, as well as supportive care with multivitamins or vitamin supplements, antipyretics, and antibiotics. Medications include antibiotics, oral painkillers, oral steroids, antiseptics, chlorhexidine gluconate mouthwash, and sucralfate. Home care includes good oral hygiene, avoiding trigger foods, warm saline gargles, ice packs, and a balanced diet. Medical attention is necessary if the ulcers fail to heal within a week or two, are unusual, spreading, or large, or if there is severe pain, fever, or difficulty while chewing, talking, or swallowing.

The prevalence of oral mucosal lesions in Germany found that the overall prevalence was 7.76%, with the most common lesions being tobacco-associated lesions, tongue lesions, oral potentially malignant disorders, ulcers, and infectious lesions. The market therefore is driven by significant factors like the increasing incidence of mouth ulcers, rising awareness about oral hygiene, and unhealthy lifestyle habits, however, factors such as limited approved drugs, and challenges in patient compliance and treatment adherence limit market growth.

The key players of the market are Sandoz, Hexal, Reckitt Benckiser, Takeda, Bayer, Boehringer Ingelheim, Merck KGaA among others.

Market Dynamics

Market Growth Drivers

Increased occurrence of mouth ulcers: The prevalence of oral mucosal lesions in Germany found that the overall prevalence was 7.76%, the increasing prevalence of mouth ulcers in Germany is driven by factors such as smoking cessation, tobacco use, and consumption of citric and chemical-laden foods. This rising prevalence is expected to lead to a higher demand for effective treatments, driving market growth.

Unhealthy Lifestyles: The growing prevalence of unhealthy lifestyles, such as poor diet and lack of exercise, is also contributing to the rise in mouth ulcers. These factors can weaken the immune system, making individuals more susceptible to mouth ulcers.

Public Awareness Campaigns: Public awareness campaigns by governments and key players in the market are promoting the importance of oral hygiene and the availability of effective treatments for mouth ulcers. These campaigns are increasing awareness and driving demand for treatments.

Market Restraints

Limited Approved Drugs: In Germany, the treatment options for oral aphthous ulcers (mouth ulcers) are limited to a few approved drug categories. Corticosteroids, topical antiseptic/anti-inflammatory agents, and local anaesthetics are the primary pharmaceutical treatments available. The lack of a wider range of approved drugs may limit the treatment choices for healthcare professionals and patients, potentially hindering market growth.

Challenges in Patient Compliance and Adherence: Patient compliance and adherence to prescribed treatments can impact the effectiveness of oral ulcer management. Factors such as ease of use, side effects, and affordability of treatments can influence patient adherence. Addressing patient compliance challenges may drive the development of more user-friendly and convenient treatment options, shaping market trends.

Regulatory Landscape and Reimbursement Scenario

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health, and is responsible for the authorization, supervision, and post-market surveillance of drugs and medical devices. The BfArM also works closely with other regulatory agencies in Europe to facilitate the approval of new therapeutic products. Germany has several advantages for pharmaceutical companies, such as its market size, reliable legal framework for approval and reimbursement, as well as the quality and cost-effectiveness of its clinical research. Germany has the world’s fourth largest market. The German market is Europe’s largest market. Germany ranks third worldwide in clinical drug trials initiated by pharmaceutical companies.

Health insurance is mandatory for German citizens, Germany has approximately 83 Mn inhabitants. 73.2 Mn citizens are covered by the GKV (Gesetzliche Krankenversicherung = statutory health insurance), around 8.7 Mn are covered by the PKV (Private Krankenversicherung = private health insurance) including citizens are insured via state aid. GKV is provided by around 100 statutory health insurance funds.

The reimbursement system in Germany is complex and involves several steps. Initially, pharmaceutical companies set the ex-factory price for their products for a period of 12 months after market launch. After this period, the reimbursement price is negotiated based on the product's additional benefit to the patient compared to an appropriate comparative therapy. This assessment is conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) or third parties.

The German government has also implemented measures to strengthen local production of medicines in Germany and the EU. This includes considering local production as a factor in the evaluation of new AMNOG provisions. The AMNOG market access rules apply to all new patented medicines introduced in the German market, except those with a conditional marketing authorization. These rules involve a benefit assessment process to determine the reimbursement price based on the product's additional benefit to the patient.

The reimbursement system in Germany is designed to ensure that pharmaceutical products are safe, effective, and affordable for patients in the country.

Competitive Landscape

Key Players

Here are some of the major key players in the Germany Mouth Ulcers Therapeutics Market:

• Bayer
• Boehringer Ingelheim
• Merck KGaA
• Takeda
• Sanofi
• Hexal
• Taro Pharmaceutical Industries Ltd.
• Bristol-Myers Squibb Company
• BLISTEX, INC.
• GlaxoSmithKline plc.
• Reckitt Benckiser