This Market Spotlight report covers the Norovirus market, comprising key pipeline drugs, clinical trials, probability of success, key upcoming events, and an epidemiological overview.

Key Takeaways

• Worldwide, about one out of every five cases of acute gastroenteritis is associated with norovirus. Norovirus is responsible for approximately 685 million cases of gastroenteritis every year.
• Globally, norovirus is estimated to cause approximately 200,000 deaths annually, including an estimated 50,000 child deaths, mainly in developing countries.
• The majority of industry-sponsored drugs in active clinical development for norovirus are in Phase I. All clinical candidates currently in the pipeline for norovirus are vaccines. These are administered via the oral, intranasal, and intramuscular routes.
• High-impact upcoming events for drugs in the norovirus space comprise topline Phase IIb trial results for Monovalent Norovirus VLP Vaccine, and topline Phase II trial results for VXA-G1.1-NN.
• The overall likelihood of approval of a Phase I antiviral asset is 14.1%, and the average probability a drug advances from Phase III is 74.6%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
• The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for norovirus have been in the early and mid-phases of development, with 90% of trials in Phase I–II, and only 10% in Phase III–IV.
• The US has a substantial lead in the number of norovirus clinical trials globally.
• Takeda has the highest number of completed clinical trials for norovirus, with 12 trials.
• Takeda leads the industry sponsors with the highest overall number of clinical trials for norovirus.