Lactulose: a cornerstone therapy with growing market perspectives

A well-established therapeutic profile

Lactulose is a synthetic disaccharide derived from lactose and has been widely used in clinical practice for decades. Recognized for its safety and efficacy, it is included in the WHO List of Essential Medicines and remains one of the most prescribed osmotic laxatives worldwide. The compound is usually available as syrup, solution, or powder and is commonly prescribed in both hospital and outpatient settings. Its long history of use has contributed to its reputation as a reliable, cost-effective, and versatile treatment option.

Clinical relevance in gastroenterology and hepatology

From a therapeutic standpoint, lactulose plays a pivotal role in two main areas. First, it is considered a first-line osmotic agent for the treatment of chronic constipation, especially in older adults and patients who require long-term management. Second, it is a cornerstone in the treatment of hepatic encephalopathy, where it helps reduce the absorption of ammonia in the intestine, thereby preventing neurological complications of advanced liver disease.
Beyond these primary indications, research has also highlighted its prebiotic properties, as lactulose stimulates the growth of beneficial gut bacteria. This has sparked increasing scientific interest in its potential contribution to microbiota modulation, linking it to broader areas of gastrointestinal health.

Global market dynamics

The global lactulose market is currently estimated at around USD 700–750 million (2023), with a projected CAGR of 3.5–4% through 2030. Demand is fueled by several drivers: the growing prevalence of gastrointestinal disorders, the rising incidence of liver disease worldwide, and the aging population in developed countries.
Europe remains the largest regional market, accounting for approximately 40% of global revenues. Within Europe, Italy is among the top five countries in terms of consumption, reflecting both the widespread use of lactulose and the maturity of the prescribing landscape. While generic products dominate, there is still room for differentiation through novel formulations, improved tolerability, and patient-friendly presentations.

Opportunities in emerging markets

While Europe and North America represent consolidated, stable markets, the most dynamic growth is occurring in emerging regions. In Asia-Pacific, countries such as China, Japan, and India are experiencing rising awareness of gastrointestinal and hepatic conditions, driving increased demand for accessible therapies like lactulose.
Similarly, Latin America and the Middle East show steady market expansion, supported by greater access to healthcare services and growing recognition of the importance of treating liver disease. In these regions, the projected CAGR reaches 4–4.5%, slightly above the European average. These figures indicate that while Europe remains the backbone of lactulose consumption, the Rest of the World offers the highest growth potential in the coming years.

Strategic outlook

For pharmaceutical companies, the lactulose segment presents a dual challenge: consolidating their position in mature, highly competitive markets such as Italy and the EU, while proactively expanding into high-growth regions. Success will depend on a balanced approach that combines innovation in formulations, strong distribution networks, and market education initiatives to raise awareness of the therapeutic benefits of lactulose.

Conclusion

Lactulose continues to stand out as both a clinically essential therapy and a commercially attractive market. Its proven efficacy in constipation and hepatic encephalopathy ensures a solid clinical foundation, while the ongoing expansion in emerging markets opens new business opportunities. The coming decade is likely to see lactulose maintain its central role in gastroenterology and hepatology, confirming its status as a cornerstone therapy with a global growth trajectory.

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