Gastrointestinal Therapeutics Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 41.94 Billion |
| Market Size (2030) | USD 51.87 Billion |
| Growth Rate (2025 - 2030) | 4.34% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Gastrointestinal Therapeutics Market Analysis by Mordor Intelligence
The gastrointestinal therapeutics market size stood at USD 41.94 billion in 2025 and is forecast to reach USD 51.87 billion by 2030, growing at a 4.34% CAGR during 2025-2030. Robust demand stems from a rising digestive-disease burden, widening adoption of biologics and biosimilars, and continuous investment in microbiome-based pipelines. Specialist shortages in many countries, especially rural regions, intensify reliance on telehealth and AI-guided diagnostic tools, while regulatory support for biosimilar interchangeability accelerates price competition. Companies that combine advanced drug platforms with digital health services strengthen market access, and large-volume subcutaneous delivery systems position injectables as a viable alternative to traditional oral therapies. Meanwhile, regional expansion in Asia-Pacific, driven by healthcare infrastructure upgrades and dietary westernization, offsets pricing pressure in North America and Europe, making the gastrointestinal therapeutics market an attractive long-term play for diversified portfolios.
Key Report Takeaways
By drug class, proton pump inhibitors led with 24.12% of gastrointestinal therapeutics market share in 2024, while microbiome-based therapeutics are projected to expand at a 4.35% CAGR through 2030.
By disease indication, inflammatory bowel disease accounted for 29.57% of the gastrointestinal therapeutics market size in 2024, whereas gastrointestinal cancer therapeutics are growing at a 5.01% CAGR over the same period.
By route of administration, oral formulations commanded 63.18% of gastrointestinal therapeutics market share in 2024, and injectable products are forecast to advance at a 4.78% CAGR to 2030.
By distribution channel, hospital pharmacies held 45.78% of the gastrointestinal therapeutics market size in 2024, while online pharmacies are projected to rise at a 4.56% CAGR through 2030.
By geography, North America led with 39.12% revenue share in 2024; Asia-Pacific is the fastest-growing region at a 5.25% CAGR to 2030.
Global Gastrointestinal Therapeutics Market Trends and Insights
Driver Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Increasing prevalence of GI disorders | +1.2% | Global, with higher impact in Asia-Pacific and aging Western populations | Medium term (2-4 years) |
| Aging population & lifestyle shifts | +0.8% | North America, Europe, Japan, with spillover to urban Asia-Pacific | Long term (≥ 4 years) |
| Advancements in biologics & biosimilars | +0.9% | Global, concentrated in developed markets with regulatory frameworks | Short term (≤ 2 years) |
| Expansion of minimally-invasive smart-pill tech | +0.4% | North America, Europe, with gradual adoption in Asia-Pacific | Medium term (2-4 years) |
| Microbiome-based live biotherapeutics pipeline | +0.6% | North America, Europe, early adoption in select Asia-Pacific markets | Long term (≥ 4 years) |
| AI-guided drug-repurposing for orphan GI diseases | +0.3% | Global, with concentration in research-intensive markets | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Increasing Prevalence of GI Disorders
Colorectal-cancer screening age was lowered to 45 years in the United States, adding millions of procedures annually and amplifying demand for both diagnostics and follow-up therapeutics[1]Source: Eleazar E. Montalvan-Sanchez et al., “Delays in Colorectal Cancer Screening for Latino Patients,” Gastroenterology Research, gastrores.org . Rising incidence of inflammatory bowel disease in rapidly urbanizing Asian populations underscores the need for advanced biologics that surpass acid-suppression drugs in efficacy. Expanded national screening programs in China and India funnel more patients into treatment pathways, and this earlier detection improves long-term therapeutic adherence. Government reimbursement for preventive colonoscopy further buttresses prescription volumes for antispasmodics and prokinetic agents. Collectively, these factors lift the gastrointestinal therapeutics market by enlarging the treated-patient pool and extending treatment durations.
Aging Population & Lifestyle Shifts
Japan already records 29.1% of its citizens aged ≥65 years, and similar trajectories in Europe and North America increase chronic proton-pump-inhibitor use for reflux management. Sedentary behavior and processed-food consumption heighten functional gastrointestinal disorders, prompting broader uptake of prokinetics and microbiome modulators. Obesity magnifies gastroesophageal reflux disease prevalence, feeding sustained PPI prescriptions despite generic erosion. Lifestyle-induced stress links to irritable bowel syndrome, reinforcing demand for low-dose antidepressant adjuncts and antispasmodics. Overall, demographic and behavioral convergence lengthens therapy courses, driving stable revenue streams in the gastrointestinal therapeutics market.
Advancements in Biologics & Biosimilars
Stelara’s 2025 patent expiry triggers an influx of biosimilar candidates, with the FDA’s interchangeability guidance cutting time-to-market and lowering development costs. Next-generation JAK inhibitors and S1P modulators introduce oral options that challenge injectable dominance in inflammatory bowel disease management. Continuous bioprocessing slashes production overheads, enabling competitive pricing without quality compromise. Manufacturers also bundle digital-adherence platforms that remind patients of dosing schedules, enhancing real-world effectiveness. These developments collectively expand access, reduce payer resistance, and elevate biologic penetration within the gastrointestinal therapeutics market.
Microbiome-Based Live Biotherapeutics Pipeline
The FDA-approved VOWST for Clostridioides difficile infection prevention validates live biotherapeutic modalities and attracted a USD 175 million acquisition by Nestlé Health Science. Phase 1b data for SER-155 point to broader immunocompromised-patient applications, and multiple academic consortia are mapping strain-specific gene clusters to optimize efficacy. Early commercial success spurs venture funding for start-ups developing targeted consortia therapies for ulcerative colitis and hepatic encephalopathy. Manufacturing standardization via freeze-drying and encapsulation improves product stability, facilitating global distribution. As payer confidence builds, formulary placement widens, accelerating growth in this emerging slice of the gastrointestinal therapeutics market.
Restraint Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| High biologic therapy costs | -0.7% | Global, with higher impact in emerging markets and cost-sensitive healthcare systems | Short term (≤ 2 years) |
| Stringent reimbursement hurdles | -0.5% | North America, Europe, with varying impact across payer systems | Medium term (2-4 years) |
| Post-2026 patent cliffs driving price erosion | -0.6% | Global, concentrated in markets with established biosimilar frameworks | Short term (≤ 2 years) |
| Limited specialist availability in emerging nations | -0.4% | Asia-Pacific, Latin America, Africa, with rural area concentration | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
High Biologic Therapy Costs
Annual biologic treatment can exceed USD 50,000, straining public and private payers that increasingly impose prior-authorization hurdles. Value-based contracts tie reimbursement to real-world outcomes, compelling manufacturers to fund post-marketing studies. Specialty pharmacies consolidate to negotiate steeper discounts, eroding gross margins yet expanding patient reach through copay-assistance programs. Emerging-market governments explore pooled procurement to lower unit prices, but constrained budgets delay biologic uptake compared with small-molecule alternatives. Although biosimilars promise relief, originators often counter with life-cycle-management strategies such as high-concentration formulations, prolonging price rigidity.
Limited Specialist Availability in Emerging Nations
A projected shortfall of 1,630 gastroenterologists in the United States by 2025 mirrors shortages across Asia-Pacific and Latin America, where rural counties lack any GI specialists. Tele-endoscopy hubs and AI-assisted capsule-imaging interpretation mitigate access gaps but depend on broadband penetration and clinician training. Pharmaceutical firms partner with medical societies to expand fellowship slots, yet the pipeline lags behind demand growth. Private-equity-funded clinic chains are scaling endoscopy services in India and Brazil but face regulatory scrutiny over care quality. Persistent workforce deficits slow diagnosis and treatment initiation, tempering near-term sales potential for advanced therapies in underserved regions.
Segment Analysis
By Drug Class: Innovation Tilts Toward the Microbiome
Proton pump inhibitors remained the revenue anchor in 2024, holding 24.12% gastrointestinal therapeutics market share, underpinned by widespread management of gastroesophageal reflux disease and ulcer prophylaxis. Branded PPIs still command premiums in hospital formularies where rapid-acting IV formulations are required for acute bleeding, though generics dominate retail channels. The gastrointestinal therapeutics market size attributable to PPIs is expected to plateau as guideline revisions advocate step-down therapy to minimize long-term adverse effects. In parallel, the biologics segment captures incremental spend through anti-TNF agents, IL-12/23 inhibitors, and JAK inhibitors, but faces biosimilar erosion post-2025. Antibiotics, led by rifaximin, retain niche applications in hepatic encephalopathy and small-intestinal bacterial overgrowth, aided by label expansions.
Microbiome-based therapies comprise the fastest-growing drug class at a 4.35% CAGR, albeit from a low base, benefiting from VOWST’s commercial traction and promising pipelines like SER-155 for immunocompromised hosts. Live biotherapeutic product standardization and scalable anaerobic manufacturing processes cut production costs, narrowing the price gap with conventional biologics. Pharma-food cross-sector collaborations, as exemplified by Nestlé Health Science, infuse diet-adjacent capabilities such as prebiotic adjuncts that enhance colonization. Over the forecast period, the gastrointestinal therapeutics market size for microbiome products is expected to expand as payers accept real-world evidence of relapse reduction in recurrent C. difficile infection.
Note: Segment shares of all individual segments available upon report purchase
By Disease Indication: IBD Dominance Meets Oncology Momentum
Inflammatory bowel disease represented 29.57% of the gastrointestinal therapeutics market size in 2024, generating stable chronic-care revenues through treat-to-target protocols that emphasize mucosal healing. The approach elevates biologic dosing frequency and supports companion diagnostic uptake, aligning with value-based care metrics. Biosimilar entry for Stelara and Humira suppresses average selling prices yet widens eligible-patient cohorts, softening unit-price erosion. Emerging small-molecule S1P modulators and oral JAK inhibitors may cannibalize anti-TNF share but overall elevate category sales through oral-route convenience.
Gastrointestinal cancer therapeutics advance at a 5.01% CAGR, powered by precision-oncology regimens that integrate checkpoint inhibitors with targeted small molecules. AI-enabled colonoscopy improves adenoma detection, facilitating earlier intervention that increases adjuvant-therapy cycles and overall prescriptions. Biomarker-guided therapy for gastric and pancreatic cancers widens patient stratification, and companion diagnostics enhance reimbursement prospects. Though volumes remain smaller than reflux or motility disorders, oncology’s premium pricing and continuous line-extension strategies boost its revenue trajectory in the gastrointestinal therapeutics market.
By Route of Administration: Subcutaneous Surge Challenges Oral Mainstay
Oral formulations accounted for 63.18% gastrointestinal therapeutics market share in 2024, owing to patient convenience and well-established generics across acid-suppression and motility segments. Yet adherence issues persist in chronic regimens, prompting digital pill-dispensing solutions that track ingestion events and alert caregivers. Oral biologic platforms leveraging permeation enhancers and nano-carriers are in early clinical testing, aiming to capture share from injectables without efficacy compromise.
Injectables are the fastest-growing route, projected at 4.78% CAGR through 2030, as large-volume subcutaneous devices enable self-administration previously limited to infusion centers. Hyaluronidase-based co-formulation permits 10-mL subcutaneous dosing, cutting infusion-chair time and hospital overhead. Smart-injector pens offer biometric-based lockout to prevent dosing errors and capture adherence analytics for payer reporting. Although rectal and transdermal routes serve niche populations—such as maintenance therapy in distal ulcerative colitis—their market contribution remains marginal within the broader gastrointestinal therapeutics market.
Note: Segment shares of all individual segments available upon report purchase
Geography Analysis
North America delivered 39.12% of global revenue in 2024, propelled by high biologic penetration and supportive reimbursement environments despite pronounced specialist shortages across 69.3% of counties[2]Source: Arun B. Jesudian et al., “Geographic Disparities in Access to Gastroenterologists in the United States,” Gastroenterology, nyp.org . Tele-gastroenterology networks and capsule endoscopy interpretation centers extend reach, but the backlog for elective colonoscopy still stretches clinician capacity. Biosimilar adoption accelerates after updated interchangeability rules, with payer formularies quickly prioritizing cost-saving options.
Asia-Pacific is the fastest-growing region at a 5.25% CAGR as aging demographics in China and India intersect with government insurance expansion. Urban dietary shifts drive ulcerative colitis and Crohn’s disease incidence, steering investment toward biologics manufacturing facilities in Singapore and South Korea. Meanwhile, Japan’s super-aged society sustains steady demand for PPIs and prokinetics, although strict HTA controls temper price inflation. Digital-health startups capitalize on smartphone penetration to deliver microbiome-tracking apps, integrating seamlessly with hospital EMR systems to guide personalized therapy.
Europe maintains a balanced outlook, with Germany, the United Kingdom, and France jointly accounting for more than half of regional sales. HTA bodies negotiate aggressive price caps, spurring rapid biosimilar uptake that broadens patient access yet compresses margins. Southern European countries are exploring outcome-based payment models for high-cost biologics, mirroring pilot programs in Scandinavia. In South America and the Middle East & Africa, Brazil and Saudi Arabia spearhead adoption of endoscopy capital equipment and biologics, leveraging public-private partnerships to upgrade hospital infrastructure. Nonetheless, payer fragmentation and import tariffs slow widespread uptake, keeping these regions at an earlier stage of the gastrointestinal therapeutics market development curve.
Competitive Landscape
Moderate concentration characterizes the gastrointestinal therapeutics market, with the top five manufacturers controlling approximately half of the global revenue. AbbVie sustains leadership via Skyrizi’s rapid expansion into Crohn’s disease, reinforcing its franchise following Humira biosimilar erosion. Takeda leverages a diversified portfolio that spans motility, acid-suppression, and biologic therapies, complemented by extensive real-world-evidence datasets that support formulary negotiations. Johnson & Johnson faces patent-expiry headwinds on Stelara but accelerates next-generation IL-23 inhibitor development while preparing authorized biosimilars to defend share.
Mid-cap biotechs—Seres Therapeutics, Entera Bio, and Alimetry—focus on niche areas such as microbiome modulators and AI-enhanced diagnostics, partnering with larger players for commercialization once proof-of-concept milestones are met. Nestlé Health Science’s acquisition of VOWST signals convergence between nutrition and pharmaceutical paradigms, enabling cross-category bundling with medical nutrition products. Continuous-manufacturing investments by Pfizer and Lilly reduce cost-of-goods and improve resilience against supply shocks, a competitive advantage as payers scrutinize biologic pricing.
Strategic alliances also emerge in digital therapeutics; companies integrate gut-sensor wearables and cloud-based analytics to extend the value proposition beyond medication. Intellectual-property strategies shift toward platform patents covering delivery systems rather than single molecules, diversifying risk against looming patent cliffs. Overall, agile innovation pipelines and data-driven service add-ons underpin competitive differentiation within the gastrointestinal therapeutics market.
Gastrointestinal Therapeutics Industry Leaders
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Abbvie Inc.
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AstraZeneca
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Takeda Pharmaceutical Company Limited
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Bausch Health Companies Inc. (Salix Pharmaceuticals Inc.)
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Johnson & Johnson(Janssen Global Services LLC)
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- February 2024: gastrointestinal care startup Salvo Health closed a USD 5 million Seed Prime round led by City Light Capital and Human Ventures. The company offers a virtual care clinic for people with chronic gut issues and will use the funds to expand its reach with providers.
- March 2024: Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for the management of adults with moderately to severely active ulcerative colitis (UC).
Global Gastrointestinal Therapeutics Market Report Scope
As per the scope of the report, gastrointestinal disorders are medical conditions related to the digestive system that affect the colon, small and large intestine, and rectum. The disorders mainly include constipation, peptic ulcer diseases, and irritable bowel syndrome, characterized by various symptoms such as pain, bloating, diarrhea, nausea, and vomiting.
The gastrointestinal therapeutics market is segmented by drug type, dosage form, application, and geography. The drug type segment is further divided into biologics/ biosimilars, antacids, laxatives, antidiarrheal agents, antiemetics, antiulcer agents, and other drug types. The dosage form is further segmented into oral, parenteral, and other dosage forms. The application is further bifurcated into ulcerative colitis, irritable bowel syndrome, Crohn's disease, celiac disease, gastroenteritis, and other applications. The geography region is further divided into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for countries across major regions globally. The report offers the value (in USD) for the above segments.
| Proton Pump Inhibitors (PPIs) | |
| H2 Receptor Antagonists | |
| Antacids & Alginates | |
| Prokinetics | |
| Laxatives | Bulk-forming |
| Osmotic | |
| Stimulant | |
| Lubricant/Emollient | |
| Anti-emetics | 5-HT3 Antagonists |
| NK1 Antagonists | |
| Dopamine Antagonists | |
| Antispasmodics | |
| Biologics & Biosimilars | Anti-TNF Agents |
| Anti-integrin Agents | |
| IL-12/23 Inhibitors | |
| JAK Inhibitors (Small-molecule) | |
| S1P Modulators | |
| Antibiotics (e.g., Rifaximin) | |
| GLP-2 & GLP-1 Analogues | |
| Microbiome-based Therapeutics | |
| Others (Bile-acid sequestrants, enzymes) |
| Gastro-esophageal Reflux Disease (GERD) |
| Peptic Ulcer Disease |
| Functional Dyspepsia |
| Irritable Bowel Syndrome (IBS) |
| Chronic Idiopathic Constipation (CIC) |
| Ulcerative Colitis |
| Crohn’s Disease |
| Clostridioides difficile Infection |
| Short Bowel Syndrome |
| Gastrointestinal Cancer |
| GI Motility Disorders (e.g., Gastroparesis) |
| Others (Eosinophilic Esophagitis, etc.) |
| Oral | Immediate-release |
| Delayed / Enteric-coated | |
| Extended-release | |
| Injectable | Intravenous |
| Subcutaneous | |
| Rectal | Suppositories |
| Foams / Enemas | |
| Parenteral Infusion Pumps | |
| Others (Transdermal, Intranasal) |
| Hospital Pharmacies |
| Retail Pharmacies |
| Online Pharmacies |
| Specialty Clinics / Infusion Centers |
| Others (Homecare Settings) |
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia-Pacific | China |
| India | |
| Japan | |
| South Korea | |
| Australia | |
| Rest of Asia-Pacific | |
| South America | Brazil |
| Argentina | |
| Rest of South America | |
| Middle East and Africa | GCC |
| South Africa |
| By Drug Class | Proton Pump Inhibitors (PPIs) | |
| H2 Receptor Antagonists | ||
| Antacids & Alginates | ||
| Prokinetics | ||
| Laxatives | Bulk-forming | |
| Osmotic | ||
| Stimulant | ||
| Lubricant/Emollient | ||
| Anti-emetics | 5-HT3 Antagonists | |
| NK1 Antagonists | ||
| Dopamine Antagonists | ||
| Antispasmodics | ||
| Biologics & Biosimilars | Anti-TNF Agents | |
| Anti-integrin Agents | ||
| IL-12/23 Inhibitors | ||
| JAK Inhibitors (Small-molecule) | ||
| S1P Modulators | ||
| Antibiotics (e.g., Rifaximin) | ||
| GLP-2 & GLP-1 Analogues | ||
| Microbiome-based Therapeutics | ||
| Others (Bile-acid sequestrants, enzymes) | ||
| By Disease Indication | Gastro-esophageal Reflux Disease (GERD) | |
| Peptic Ulcer Disease | ||
| Functional Dyspepsia | ||
| Irritable Bowel Syndrome (IBS) | ||
| Chronic Idiopathic Constipation (CIC) | ||
| Ulcerative Colitis | ||
| Crohn’s Disease | ||
| Clostridioides difficile Infection | ||
| Short Bowel Syndrome | ||
| Gastrointestinal Cancer | ||
| GI Motility Disorders (e.g., Gastroparesis) | ||
| Others (Eosinophilic Esophagitis, etc.) | ||
| By Route of Administration | Oral | Immediate-release |
| Delayed / Enteric-coated | ||
| Extended-release | ||
| Injectable | Intravenous | |
| Subcutaneous | ||
| Rectal | Suppositories | |
| Foams / Enemas | ||
| Parenteral Infusion Pumps | ||
| Others (Transdermal, Intranasal) | ||
| By Distribution Channel | Hospital Pharmacies | |
| Retail Pharmacies | ||
| Online Pharmacies | ||
| Specialty Clinics / Infusion Centers | ||
| Others (Homecare Settings) | ||
| By Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Europe | Germany | |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Asia-Pacific | China | |
| India | ||
| Japan | ||
| South Korea | ||
| Australia | ||
| Rest of Asia-Pacific | ||
| South America | Brazil | |
| Argentina | ||
| Rest of South America | ||
| Middle East and Africa | GCC | |
| South Africa | ||
Key Questions Answered in the Report
What factors are driving growth in the gastrointestinal therapeutics market?
Rising digestive-disease prevalence, biologic and biosimilar innovation, and expanding microbiome therapeutics collectively propel a 4.34% CAGR through 2030.
Which drug class is growing fastest within gastrointestinal therapeutics?
Microbiome-based live biotherapeutics lead growth at a 4.35% CAGR due to successful commercialization of VOWST and a robust pipeline.
How significant is the specialist shortage for gastrointestinal care?
In 2025, 69.3% of U.S. counties lack a gastroenterologist, underscoring an access gap that boosts telemedicine and AI-driven diagnostic adoption.
Which region will post the highest CAGR to 2030?
Asia-Pacific is forecast to expand at 5.25% CAGR, fueled by aging populations, rising healthcare spending, and increased digestive-disease burden.
How will biosimilar entry affect market pricing?
Patent expiries such as Stelaras in 2025 invite biosimilars that lower average selling prices yet broaden patient access, sustaining revenue growth.
What is the outlook for injectable versus oral formulations?
Oral routes still dominate at 63.18% share but injectables are the fastest-growing at 4.78% CAGR, aided by large-volume subcutaneous delivery systems.
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