Drugs in ATC Class A09

Up to Top Level ATC Classes

Up to A - Alimentary tract and metabolism

Subclasses in ATC: A09 - DIGESTIVES, INCL. ENZYMES

A09A - DIGESTIVES, INCL. ENZYMES

A09 Market Analysis and Financial Projection

The ATC Class A09 - Digestives, including enzymes represents a critical segment in pharmaceuticals and nutraceuticals, driven by technological advancements, rising digestive health concerns, and dynamic intellectual property strategies. Below is an in-depth analysis of its market dynamics and patent landscape.

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Market Dynamics

Current Market Size and Growth

• The global digestive enzymes market was valued at $644.32 million in 2023, projected to grow at a 9.4% CAGR through 2032 [3][14].
• Supplements alone reached $1.48 billion in 2024, growing at 6.2% CAGR (2025–2030) due to dietary trends and aging populations [11][16].

Key Growth Drivers

1. Rising Digestive Disorders: Increasing cases of lactose intolerance, gluten sensitivity, and pancreatic insufficiency are driving demand [3][14].
2. Technological Innovations:
   • DSM-Firmenich’s Maxilact®Next (fastest lactase enzyme) and Creative Enzymes’ recombinant proteases enhance production efficiency [3].
   • Microbial-derived enzymes dominate with 60% market share (2023) due to scalability and stability [3].
3. Functional Foods: Integration into yogurt, granola bars, and lactose-free dairy products [3][12].

Regional Insights

Region	2023 Market Size	Growth Drivers
Europe	$173.12 million	Strong healthcare infrastructure, functional food trends, and regulatory rigor [3].
Asia-Pacific	Fastest-growing	Urbanization, rising disposable incomes, and demand for plant-based enzymes [3][13].
North America	Leading	High R&D investment and patent activity (e.g., Clara Foods’ animal-free pepsin) [9][11].

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Patent Landscape

Key Trends and Innovations

• Targeted Formulations:
  • Curemark LLC holds patents for enzyme therapies addressing neuropsychiatric disorders and celiac disease [5].
  • Aptalis Pharma developed enteric-coated enzyme particles with <15% activity loss over six months [5].
• Delivery Systems: Encapsulated enzymes (e.g., US20160045576A1) and chewable formats improve stability and user compliance [10].

Competitive IP Strategies

• Freedom-to-Operate (FTO) Analyses: Critical for commercializing ADCs (antibody-drug conjugates) and enzyme therapies [2].
• Litigation Examples:
  • Seagen vs. Daiichi Sankyo: Seagen’s ADC patent invalidated in 2023, highlighting risks in linker technology [2].
  • Recombinant Enzyme Patents: Clara Foods’ US10,927,360 covers stable, animal-free pepsin for industrial use [9].

Emerging Opportunities

• Sustainability: Compostable packaging (e.g., Acutia Gut Health) and eco-friendly production methods [13].
• Personalized Nutrition: AI-driven enzyme formulations tailored to microbiome profiles [14].

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Challenges and Future Outlook

• Regulatory Hurdles: Strict quality controls raise production costs but ensure consumer trust [3][14].
• Market Competition: Dominance by players like Britannia, Nestle, and Kellogg in functional foods [12].
• Future Projections:
  • $1.6 billion market by 2030, driven by plant-based enzymes and microbiome research [14].
  • Asia-Pacific to lead growth, with Japan pioneering probiotic innovations [13][16].

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“The ADC patent landscape is more dynamic than ever, requiring strategic IP navigation for commercial success.” – FB Rice, 2024 [2]

This sector’s evolution hinges on balancing innovation with IP agility, ensuring therapies and products meet global health demands efficiently.

References

1. https://en.wikipedia.org/wiki/ATC_code_A09
2. https://www.fbrice.com.au/ip-news-insights/traversing-a-dynamic-adc-patent-landscape-2/
3. https://www.gminsights.com/industry-analysis/digestive-enzymes-market
4. https://becarispublishing.com/doi/10.2217/cer-2022-0162
5. https://patents.justia.com/patents-by-us-classification/424/94.21
6. https://atcddd.fhi.no/atc_ddd_index/?code=A09A&showdescription=yes
7. https://farmaciajournal.com/wp-content/uploads/art-25-Pana_Craciun-Taerel_813-820.pdf
8. https://www.knowmade.com/wp-content/uploads/2025/01/Bispecific-Ab-Patent-Landscape-2025-FLYER.pdf
9. https://go.gale.com/ps/i.do?id=GALE%7CA654175630&sid=sitemap&v=2.1&it=r&p=HRCA&sw=w
10. https://patents.google.com/patent/US20160045576A1/en
11. https://www.grandviewresearch.com/industry-analysis/digestive-enzyme-supplements-market
12. https://view.publitas.com/99562/2215180/pdfs/99d0e3d0-ca84-473c-8673-76943d4be9fb.pdf?response-content-disposition=attachment%3B+filename%2A%3DUTF-8%27%27PDFReporttech%2520-%2520Digestive%2520Biscuits%2520Market%2520to%2520See%2520Robust%2520Growth-%2520%255B7.4%2525%2520CAGR%255D%2520Forecast.pdf
13. https://www.mordorintelligence.com/industry-reports/digestive-health-supplements-market
14. https://www.giiresearch.com/report/ires1613361-digestive-enzymes-market-by-enzyme-type-alpha.html
15. https://www.wipo.int/en/web/patent-analytics
16. https://www.skyquestt.com/report/digestive-enzyme-supplement-market