Omeprazole Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By End-Use Application (Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease, Erosive Esophagitis, and Others), By Sales Channel (Direct Sale and Indirect Sale) By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	22.67 Thousand Tonnes
CAGR (2026-2031)	5.62%
Fastest Growing Segment	Gastroesophageal Reflux Disease
Largest Market	North America
Market Size (2031)	31.47 Thousand Tonnes

Market Overview

The Global Omeprazole Market will grow from 22.67 Thousand Tonnes in 2025 to 31.47 Thousand Tonnes by 2031 at a 5.62% CAGR. Omeprazole is a proton pump inhibitor utilized widely for the suppression of gastric acid secretion to treat conditions such as gastroesophageal reflux disease, peptic ulcers, and Zollinger-Ellison syndrome. The market is primarily driven by the rising global prevalence of chronic gastrointestinal disorders, which is closely correlated with aging populations and lifestyle factors including poor dietary habits and obesity. This sustained clinical demand is evidenced by high prescription volumes; for instance, according to the NHS Business Services Authority, in 2025, Omeprazole was among the most dispensed medications in England, with approximately 36 million items dispensed during the financial year.

Despite robust consumption, a significant challenge impeding market expansion is the increasing scrutiny regarding the long-term safety profile of prolonged acid suppression therapy. Clinical concerns linking extended usage to adverse effects such as bone fractures, micronutrient deficiencies, and kidney disease have prompted healthcare providers to implement stricter deprescribing protocols. These safety considerations, combined with intense competition from low-cost generic alternatives, create substantial pressure on revenue growth for manufacturers within the sector.

Key Market Drivers

The escalating global prevalence of Gastroesophageal Reflux Disease (GERD) and peptic ulcers stands as the primary catalyst for market growth, influenced by shifting lifestyles. As urbanization increases, populations are adopting sedentary routines and consuming processed foods, leading to a surge in obesity-related gastrointestinal disorders. This correlation substantiates clinical demand for acid suppressants. According to the National Institutes of Health, in 2024, the global pooled prevalence of GERD was estimated at approximately 13.98%, highlighting the immense scale of the patient pool. Furthermore, metabolic health trends directly amplify this need; according to ResearchGate, January 2024, in the 'Obesity is associated with higher prevalence of gastroesophageal reflux disease' study, patients with obesity exhibited a 30% prevalence of GERD compared to 24% in non-obese individuals, underscoring how weight-related health factors drive therapeutic intervention.

Concurrently, the widespread market penetration of cost-effective generic proton pump inhibitors has fundamentally sustained revenue streams. Following patent expirations, the availability of affordable generic Omeprazole has democratized access, making it a staple in both prescription and over-the-counter channels. This accessibility ensures that cost barriers do not hinder adherence, maintaining high dispensation rates. The volume of utilization is significant; according to ClinCalc, August 2025, in the 'Omeprazole - Drug Usage Statistics' database, Omeprazole ranked as the tenth most prescribed medication in the United States, with over 45 million prescriptions issued. This frequency validates the drug's entrenched status as a standard of care, ensuring stable performance despite pricing pressures.

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Key Market Challenges

The increasing scrutiny regarding the long-term safety profile of prolonged acid suppression therapy stands as a critical challenge hampering the growth of the Global Omeprazole Market. As clinical evidence mounts linking extended proton pump inhibitor usage to severe adverse effects such as bone fractures, micronutrient deficiencies, and chronic kidney disease, healthcare providers are aggressively implementing stricter deprescribing protocols. This shift in clinical practice prioritizes the reduction of unnecessary medication use, which directly constrains the volume of repeat prescriptions that historically drove market revenue. The concerted effort to reassess long-term therapy necessitates a contraction in dispensing frequencies, thereby limiting market expansion.

This contraction is reinforced by recent data underscoring the prevalence of unjustified prolonged use. According to the Royal College of General Practitioners, in 2025, an evaluation highlighted that approximately 62% of patients on continuous proton pump inhibitor treatment had no recorded medical indication for such long-term therapy. This high rate of inappropriate usage provides a strong impetus for medical boards and insurers to enforce rigorous discontinuation strategies. Consequently, manufacturers face a tangible decline in consumption rates as healthcare systems align prescription patterns with safety guidelines, directly eroding the projected growth of the omeprazole sector.

Key Market Trends

The Development of Patient-Centric Liquid Formulations is significantly reshaping the Global Omeprazole Market by addressing the critical needs of pediatric and geriatric populations suffering from dysphagia. Unlike traditional solid dosage forms, these novel liquid solutions ensure accurate dosing and improved adherence for patients unable to swallow tablets or capsules, creating a specialized high-value niche within the broader sector. This trend is characterized by increased investment in manufacturing capabilities to support complex delivery systems that maintain drug stability. For instance, according to Alkaloid AD Skopje, December 2024, in the 'ALKALOID AD Skopje 2025 BUSINESS PLAN - SUMMARY', the company projected a 10% growth in R&D expenses to further modernize its portfolio and support the commercialization of patented value-added medicines, including its recently introduced ready-to-use liquid omeprazole.

Concurrently, the Emergence of Novel Combination Therapies is gaining momentum as a strategy to combat rising antibiotic resistance in the treatment of Helicobacter pylori infections. Manufacturers are developing fixed-dose combinations that pair omeprazole with advanced antibiotics to enhance eradication rates and clinical efficacy, moving beyond simple acid suppression. This innovation allows companies to differentiate their products in a saturated market by offering all-in-one therapeutic regimens that simplify patient compliance. The commercial success of such targeted therapies is evident; according to RedHill Biopharma, September 2025, in the 'RedHill Biopharma Announces First Half 2025 Financial Results' report, net revenues for Talicia, an omeprazole-based combination therapy, increased to $3.8 million in the first half of 2025, underscoring the growing market adoption of these specialized formulations.

Segmental Insights

The Gastroesophageal Reflux Disease segment is currently positioning itself as the fastest-growing category within the global omeprazole market. This expansion is primarily driven by the rising global prevalence of lifestyle-related risk factors, such as obesity and poor dietary habits, which significantly increase the incidence of chronic acid reflux. Furthermore, consistent approval and labeling by regulatory authorities like the U.S. Food and Drug Administration support omeprazole as a standard treatment for frequent heartburn associated with this condition. Consequently, the escalating need for effective long-term symptom management continues to accelerate demand within this specific market sector.

Regional Insights

North America holds a dominant position in the Global Omeprazole Market, primarily driven by the high prevalence of gastrointestinal disorders such as Gastroesophageal Reflux Disease (GERD) and peptic ulcers. This strong market demand is supported by the region's established healthcare infrastructure and significant healthcare expenditure. Furthermore, favorable regulatory policies from the U.S. Food and Drug Administration (FDA) have facilitated widespread access to omeprazole through both prescription and over-the-counter channels. The presence of key pharmaceutical manufacturers in the region further solidifies North America's leadership in this sector.

Recent Developments

• In October 2024, PL Developments announced that it had received approval from the U.S. Food and Drug Administration (FDA) for its Omeprazole Magnesium Tablet, an over-the-counter (OTC) generic equivalent to Prilosec OTC. The company stated that this approval made it the only manufacturer of this specific OTC omeprazole product within the United States. Following this regulatory clearance, PL Developments revealed plans to commence commercial shipments to its retail partners in early 2025, targeting the robust U.S. consumer healthcare market for frequent heartburn treatments.
• In March 2024, Dr. Reddy’s Laboratories received a favorable recommendation from the Subject Expert Committee (SEC) under India's Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Omeprazole delayed-release orally disintegrating tablets (10 mg). The approval process involved the review of the company's proposal and bioequivalence study reports, which supported the safety and efficacy of this new dosage form. This regulatory milestone allows the company to expand its portfolio of proton pump inhibitors in the Indian market, offering a more convenient option for patients with acid-related disorders.
• In March 2024, Viva Pharm, a pharmaceutical manufacturer based in Kazakhstan, reported the successful development of a new bioequivalent generic delayed-release formulation of omeprazole. The research, which was highlighted in industry publications, detailed the creation of enteric-coated capsules that met all quality and stability criteria during accelerated and long-term testing. The company confirmed the bioequivalence of this new generic formulation to the reference innovative drug through a study involving healthy volunteers, paving the way for the production of affordable omeprazole options in the region.
• In February 2024, Alkaloid AD launched a novel ready-to-use liquid formulation of omeprazole in the United Kingdom and Macedonia. This new product, which was developed to address the needs of patients with difficulty swallowing tablets and capsules, features a dual-chamber packaging system that mixes two separate solutions upon opening. The launch followed the company's successful patent registration for this value-added medicine, which aims to improve adherence and ease of administration for pediatric and geriatric patients suffering from gastroesophageal reflux disease (GERD).

Key Market Players

• Dr. Reddy’s Laboratories Inc
• Sandoz AG
• Perrigo Company Plc.
• Astrazeneca Plc
• Amneal Pharmaceuticals, Inc
• Mylan N.V.
• Apotex, Inc.
• Watson Co., Ltd..
• Santarus Inc.

By End-Use Application	By Sales Channel	By Region
Duodenal Ulcer Gastric Ulcer Gastroesophageal Reflux Disease Erosive Esophagitis and Others	Direct Sale and Indirect Sale	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Omeprazole Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Omeprazole Market, By End-Use Application:

• Duodenal Ulcer
• Gastric Ulcer
• Gastroesophageal Reflux Disease
• Erosive Esophagitis
• and Others

• Omeprazole Market, By Sales Channel:

• Direct Sale and Indirect Sale

• Omeprazole Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE