Global Gastrointestinal Drugs Market Outlook, 2031

The global gastrointestinal drugs industry covers medicines for disorders of the digestive system, including inflammatory bowel disease, which comprises Crohn's disease and ulcerative colitis, gastro-oesophageal reflux disease and peptic ulcers, irritable bowel syndrome, chronic constipation, eosinophilic oesophagitis, gastroparesis, Helicobacter pylori infection, nausea and vomiting, diarrhoea, pancreatic insufficiency and liver diseases such as metabolic dysfunction-associated steatohepatitis, known as MASH, and primary biliary cholangitis. The market combines very large volumes of over-the-counter and generic products, such as proton pump inhibitors, antacids, H2 blockers, laxatives and antidiarrhoeals, with high-value biologics and advanced therapies for inflammatory bowel disease. Leading companies include AbbVie, with Skyrizi, Rinvoq and Humira; Johnson & Johnson, with Stelara and Tremfya; Takeda, with Entyvio and Takecab; Eli Lilly, with Omvoh; Pfizer, with Velsipity and Xeljanz; Bristol Myers Squibb, with Zeposia; Sanofi and Regeneron, with Dupixent for eosinophilic oesophagitis; AstraZeneca and Phathom Pharmaceuticals, with vonoprazan; Ironwood and AbbVie, with Linzess; Madrigal, with Rezdiffra for MASH; and Gilead and Ipsen for primary biliary cholangitis. Generic and consumer health companies such as Haleon, Kenvue, Bayer, Sun Pharma, Dr. Reddy's, Teva and Sandoz supply many common digestive medicines, and biosimilar makers such as Amgen, Samsung Bioepis, Celltrion and Alvotech compete with off-patent biologics. Inflammatory bowel disease has been the main source of value growth as new biologics and oral drugs have entered the market and older blockbusters have lost exclusivity. Humira faced biosimilar competition in the United States from 2023, and Stelara biosimilars launched in Europe in 2024 and the United States from January 2025, sharply reducing prices for these drugs. At the same time, IL-23 inhibitors expanded rapidly: AbbVie's Skyrizi was approved for Crohn's disease in 2022 and ulcerative colitis in June 2024, Lilly's Omvoh for ulcerative colitis in 2023 and Crohn's disease in January 2025, and Johnson & Johnson's Tremfya for ulcerative colitis in September 2024 and Crohn's disease in March 2025. Oral options, including JAK inhibitors such as Rinvoq and S1P receptor modulators such as Velsipity and Zeposia, gave patients alternatives to injections. Large acquisitions targeted the next wave of IBD drugs, particularly anti-TL1A antibodies, with Merck buying Prometheus Biosciences for USD 10.8 billion in 2023 and Roche acquiring Telavant for USD 7.1 billion. Beyond IBD, vonoprazan brought a new acid-suppression class to the United States in 2023, Dupixent became the first approved treatment for eosinophilic oesophagitis in 2022, and liver disease emerged as a major new area when Madrigal's Rezdiffra became the first MASH drug in March 2024 and the FDA approved Wegovy for MASH in August 2025. Market Dynamics Market Drivers • Rising Prevalence of Chronic Digestive DiseasesInflammatory bowel disease is increasing in newly industrialised countries in Asia, the Middle East and Latin America, while prevalence remains high in North America and Europe. Obesity and diabetes have made MASH one of the most common liver diseases worldwide, and reflux disease, irritable bowel syndrome and chronic constipation affect large shares of adults. Ageing populations, changing diets and greater awareness increase diagnosis and treatment of these conditions. • Innovation in Advanced IBD and Liver TherapiesNew drug classes, including IL-23 inhibitors, JAK inhibitors, S1P receptor modulators and integrin blockers, have broadened options for patients who fail older treatments, and anti-TL1A antibodies and oral IL-23 receptor antagonists are in late-stage development. The first MASH treatments, Rezdiffra and semaglutide, have opened a large new market, and new therapies for primary biliary cholangitis, eosinophilic oesophagitis and acid-related diseases are expanding the specialist gastrointestinal market. Market Challenges • Biosimilar Erosion and Pricing PressureThe loss of exclusivity for Humira and Stelara has cut prices and revenues for these major IBD drugs, and biosimilars for other biologics, including Entyvio and Simponi, will follow. Pharmacy benefit managers in the United States increasingly favour lower-cost biosimilars and private-label products. Payers also restrict access to advanced therapies through step therapy, requiring patients to fail cheaper drugs first, which slows adoption of new products. • Incomplete Response and Safety ConcernsMany IBD patients do not respond to a given advanced therapy or lose response over time, and remission rates in trials often remain below 50%. JAK inhibitors carry warnings about cardiovascular events, blood clots and cancer, limiting their use. Chronic proton pump inhibitor use has been linked to potential side effects, and treatments for irritable bowel syndrome and gastroparesis provide only partial symptom relief, leaving considerable unmet need. Market Trends • Oral Targeted Therapies and Combination TreatmentOral drugs are gaining share in IBD, including JAK inhibitors, S1P receptor modulators and oral peptides such as icotrokinra, an IL-23 receptor antagonist being tested in ulcerative colitis and Crohn's disease. Researchers are testing combinations of biologics, such as guselkumab with golimumab, to achieve higher remission rates. Treat-to-target strategies using endoscopic and biomarker goals, rather than symptoms alone, are increasing demand for more effective therapies. • Growth of Liver and Metabolic GastroenterologyMASH has become a major focus, with Rezdiffra and semaglutide approved and other drugs, including FGF21 analogues such as efruxifermin and pegozafermin, lanifibranor and tirzepatide, in late-stage trials. Large acquisitions, including GSK's purchase of efimosfermin and Novo Nordisk's acquisition of Akero Therapeutics in 2025, show strong interest. Primary biliary cholangitis gained new treatments in 2024 with elafibranor and seladelpar, while Ocaliva's use has declined. Segment Analysis Biologics and advanced therapies for inflammatory bowel disease generate the largest share of gastrointestinal drug value, while acid suppressants, laxatives and antidiarrhoeals account for the largest volume of use. Biologics used in IBD include TNF inhibitors such as adalimumab, infliximab and golimumab, the integrin blocker vedolizumab, the IL-12/23 inhibitor ustekinumab and IL-23 inhibitors such as risankizumab, mirikizumab and guselkumab. These drugs account for the largest share of gastrointestinal drug revenue, with IL-23 inhibitors gaining share as TNF inhibitors and ustekinumab face biosimilars. Oral small molecules for IBD, including JAK inhibitors upadacitinib and tofacitinib and S1P receptor modulators ozanimod and etrasimod, are an important and growing segment. Aminosalicylates, corticosteroids and immunomodulators such as azathioprine remain widely used first-line treatments. Acid suppressants, including proton pump inhibitors such as omeprazole, esomeprazole and pantoprazole, H2 blockers and the potassium-competitive acid blocker vonoprazan, treat reflux and ulcers and are among the most widely used medicines worldwide. Laxatives and secretagogues, including polyethylene glycol, linaclotide, lubiprostone and plecanatide, treat constipation and IBS with constipation. Antidiarrhoeals, antiemetics, antispasmodics and probiotics address common symptoms. Liver disease drugs, including resmetirom, semaglutide for MASH, obeticholic acid, elafibranor and seladelpar, form a fast-growing segment. Pancreatic enzyme replacement, bile acid sequestrants and drugs for hepatic encephalopathy, such as rifaximin, add further categories. Inflammatory bowel disease is the largest gastrointestinal indication by value, while gastro-oesophageal reflux disease and irritable bowel syndrome are the largest by patient numbers, and MASH is the fastest-growing new indication. Inflammatory bowel disease affects about seven million people worldwide, and its chronic, relapsing nature requires long-term treatment with high-cost biologics and oral targeted drugs, making it the most valuable gastrointestinal indication. Crohn's disease and ulcerative colitis have similar treatment options, although some drugs are approved for only one. Gastro-oesophageal reflux disease affects roughly one in five adults in Western countries and is treated mainly with generic proton pump inhibitors, while vonoprazan offers an alternative for erosive oesophagitis. Irritable bowel syndrome affects about 5% to 10% of adults and is treated with symptom-based drugs according to the predominant bowel habit. Chronic idiopathic constipation, opioid-induced constipation and functional dyspepsia are common conditions. Eosinophilic oesophagitis has become a recognised indication, with dupilumab and budesonide oral suspension approved. MASH affects a significant share of people with obesity and diabetes, and the approval of resmetirom and semaglutide has created a new market expected to grow rapidly. Primary biliary cholangitis, Helicobacter pylori infection, Clostridioides difficile infection, gastroparesis, exocrine pancreatic insufficiency and short bowel syndrome are additional indications. Oral formulations account for the largest share of gastrointestinal drug use, while subcutaneous and intravenous biologics generate most of the value in inflammatory bowel disease. Oral tablets, capsules and liquids are the most common route for gastrointestinal drugs, including acid suppressants, laxatives, antidiarrhoeals, aminosalicylates, oral IBD drugs and liver disease drugs. Oral targeted therapies are gaining importance in IBD as patients prefer to avoid injections. Subcutaneous injections are used for maintenance therapy with most IBD biologics, including adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab and subcutaneous vedolizumab and infliximab, often after intravenous induction doses, and for dupilumab in eosinophilic oesophagitis and semaglutide in MASH. Intravenous infusions are used for induction therapy with many IBD biologics and for maintenance with infliximab and vedolizumab in infusion centres. Guselkumab was notable for offering subcutaneous induction in ulcerative colitis. Rectal formulations, including mesalamine suppositories and enemas and corticosteroid foams, treat distal ulcerative colitis. Oral suspensions and dispersible formulations serve children and patients with swallowing difficulties. Microbiome therapies, such as faecal microbiota products for recurrent Clostridioides difficile infection, are delivered orally or rectally. Retail pharmacies and over-the-counter channels account for the largest volume of gastrointestinal drugs, while specialty pharmacies and hospitals dominate distribution of high-value IBD biologics and liver therapies. Retail pharmacies dispense most prescription gastrointestinal drugs, including proton pump inhibitors, laxatives, antispasmodics and oral IBD treatments. Over-the-counter sales through pharmacies, supermarkets and online retailers are a major channel for antacids, H2 blockers, low-dose proton pump inhibitors, laxatives, antidiarrhoeals and probiotics, and consumer health companies such as Haleon, Kenvue, Bayer and Reckitt are important suppliers. Specialty pharmacies manage self-injected biologics for IBD, eosinophilic oesophagitis and MASH in the United States, handling prior authorisation, patient support and cold-chain delivery. Hospital pharmacies and infusion centres administer intravenous biologics and treat severe flares, complications and liver disease. Online pharmacies and telehealth services have grown for reflux, IBS and weight-related liver treatments. Gastroenterology clinics play a central role in diagnosis and prescribing, often supported by endoscopy services. Government procurement and national formularies influence access in Europe and Asia, and China's volume-based procurement has lowered prices for generic proton pump inhibitors. Regional Analysis North America leads the gastrointestinal drugs market by value because of high use and prices of IBD biologics, early adoption of new advanced therapies and the first approvals of MASH drugs, while Asia-Pacific has the largest patient population and fast-rising IBD incidence. North America, led by the United States, accounts for the largest share of gastrointestinal drug revenue. The United States has a large IBD population, extensive use of advanced therapies and high drug prices, and it was the first market for many new drugs, including Skyrizi, Omvoh and Tremfya in IBD, vonoprazan for erosive oesophagitis and Rezdiffra and Wegovy for MASH. Biosimilars for Humira from 2023 and Stelara from 2025 have reduced prices, with pharmacy benefit managers favouring private-label biosimilars. Canada has high IBD prevalence and strong biosimilar adoption policies. Europe is the second largest market, with high IBD prevalence in northern and western Europe and fast uptake of biosimilars driven by tenders and national policies, which has lowered costs. The EU approved Rezdiffra for MASH in 2025. Asia-Pacific is the fastest-growing region, as IBD incidence rises in China, India, Japan and South Korea, and acid-related diseases and Helicobacter pylori infection are common. Japan pioneered vonoprazan, marketed as Takecab, and has a large gastrointestinal market. China has a large and growing gastroenterology market, with volume-based procurement lowering generic prices and access to biologics expanding through national reimbursement. Latin America, the Middle East and Africa have growing IBD and liver disease burdens, with Brazil and Mexico the largest Latin American markets and the Gulf states expanding access to advanced therapies. Key Developments August 2025: The FDA granted accelerated approval to semaglutide for adults with MASH and moderate to advanced liver fibrosis, becoming the second approved MASH treatment. March 2025: Johnson & Johnson's guselkumab was approved for Crohn's disease, including subcutaneous induction, following its ulcerative colitis approval in September 2024. January 2025: The first US biosimilars to ustekinumab entered the market, reducing prices for one of the most widely used Crohn's disease and ulcerative colitis biologics. January 2025: Eli Lilly's mirikizumab, an IL-23p19 inhibitor, was approved for moderately to severely active Crohn's disease, adding to its ulcerative colitis approval. March 2024: Madrigal's resmetirom received accelerated approval for adults with MASH and moderate to advanced liver fibrosis, the first therapy for the condition. June 2023: Merck agreed to buy Prometheus for about USD 10.8 billion to gain its anti-TL1A antibody tulisokibart for ulcerative colitis and Crohn's disease. Considered in this report • Historic Year: 2020 • Base Year: 2025 • Estimated Year: 2026 • Forecast Year: 2031 Aspects covered in this report • Global Gastrointestinal Drugs Market with its value and forecast along with its segments • Various drivers and challenges • Ongoing trends and developments • Top profiled companies • Strategic recommendation By Drug Class • Biologics • Oral Targeted Therapies • Acid Suppressants • Laxatives and Secretagogues • Antidiarrhoeals and Antiemetics • Liver Disease Drugs • Aminosalicylates and Corticosteroids By Indication • Inflammatory Bowel Disease • Gastro-Oesophageal Reflux Disease • Irritable Bowel Syndrome • Chronic Constipation • Eosinophilic Oesophagitis • MASH and Liver Diseases By Route of Administration • Oral • Subcutaneous • Intravenous • Rectal By Distribution Channel • Retail Pharmacies • Over-the-Counter Channels • Specialty Pharmacies • Hospital Pharmacies • Online Pharmacies

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Sikandar Kesari

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