Drugs in ATC Class A05

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Subclasses in ATC: A05 - BILE AND LIVER THERAPY

A05A - BILE THERAPY

A05 Market Analysis and Financial Projection

The ATC Class A05 (BILE AND LIVER THERAPY) encompasses treatments targeting cholestatic liver diseases, primary biliary cholangitis (PBC), and biliary tract cancers (BTC). Below is a detailed analysis of its market dynamics and patent landscape:

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Market Dynamics

Therapeutic Demand and Growth Trends

1. Primary Biliary Cholangitis (PBC) Market:

   • Valued at $684 million in 2022, it is projected to reach $1.4 billion by 2032 (CAGR: 8.2%) [5]. Growth is driven by increased R&D for therapies like ursodiol and OCALIVA (obeticholic acid), alongside novel candidates like seladelpar and HTD1801 [5][8].
   • Iqirvo® (elafibranor), a PPARδ agonist, recently received FDA approval as a second-line PBC treatment, addressing unmet needs in reducing alkaline phosphatase (ALP) levels [8].

2. Biliary Tract Cancers (BTC):

   • The market is expected to grow from $372.5 million in 2025 to $824.2 million by 2035 (CAGR: 8.2%) [2].
   • Targeted therapies (e.g., FGFR inhibitors like pemigatinib and IDH1 inhibitors like ivosidenib) dominate, holding 63.1% market share in 2025 [2].

3. Liver Disease Therapeutics:

   • The broader market is forecast to grow from $15.04 billion in 2024 to $31.53 billion by 2033 (CAGR: 8.57%), fueled by rising NAFLD cases and advancements in transplant technologies [11].

Key Drivers

• Rising Prevalence: Increasing liver diseases linked to obesity, diabetes, and aging populations [11][2].
• Innovation: Focus on combination therapies (e.g., immunotherapy + targeted drugs) and precision medicine (biomarker-driven treatments) [2][5].
• Regulatory Support: Orphan drug designations expedite approvals for rare diseases like PFIC and Alagille syndrome [4][17].

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Patent Landscape

Key Innovations and Players

Drug/Company	Mechanism	Patent Highlights
Bylvay® (Ipsen)	Ileal bile acid transporter inhibitor	Approved for cholestatic pruritus in PFIC (2021) and Alagille syndrome (2024) [4][17]. Patent covers oral formulation with minimal systemic exposure.
Maralixibat (Mirum)	Apical sodium-dependent BA inhibitor	Granted patent (US11918578B2) for 400–800 µg/kg/day dosage in Alagille syndrome, emphasizing pediatric use [18].
ASBT Inhibitors	Non-systemic bile acid modulation	Genetic Therapy/Shire secured patents for treating hypercholemia and cholestasis via ASBT inhibition [16].

Emerging Trends

1. Pediatric Formulations: Mirum’s liquid maralixibat (10 mg/mL) targets younger populations, with dosing protocols spanning 1–3 years [18].
2. Combination Therapies: Clinical trials for FGFR/IDH inhibitors + immunotherapies aim to improve BTC survival rates [2].
3. Gut-Liver Axis Research: Patents explore microbiome-derived lipid metabolites (e.g., C. aerofaciens) for NAFLD treatment [14].

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Competitive Strategies

• Geographic Expansion: Companies like CymaBay target high-prevalence regions (Asia-Pacific) for PBC therapies [5].
• Diagnostic Partnerships: Companion diagnostics for FGFR2 fusions and IDH1 mutations enhance personalized treatment adoption [2].
• Real-World Evidence: Post-marketing studies (e.g., Bylvay’s safety monitoring) support long-term efficacy claims [17].

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Future Outlook

• Innovation Pipeline: Over 42 Phase III trials for liver therapies are active, focusing on fibrosis reversal and immunomodulation [13][19].
• Market Consolidation: Strategic acquisitions (e.g., Ipsen’s Iqirvo®) and partnerships aim to capture niche markets like cholestatic pruritus [8][17].
• Regulatory Pathways: Priority reviews and orphan exclusivity expedite drug launches, as seen with Bylvay’s approval in Canada and the EU [4][17].

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Highlight:

"The approval of Iqirvo® spotlights the push for second-line PBC therapies that address both biochemical markers and patient quality of life." [8]

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Key Takeaways:

• A05 therapies are pivoting toward targeted mechanisms (e.g., bile acid transport inhibition) and precision dosing.
• Pediatric formulations and non-systemic delivery are critical for compliance in chronic liver diseases.
• Market growth hinges on combination therapies and geographic penetration into Asia-Pacific and North America.

FAQs:

1. What drives the A05 market growth?
   Rising NAFLD/BTC prevalence and innovations in targeted therapies.
2. Which drug recently expanded its A05 indications?
   Ipsen’s Bylvay® now treats Alagille syndrome-associated pruritus [4].
3. How do patents influence A05 competition?
   They secure exclusivity for dosage regimens (e.g., maralixibat) and novel delivery systems [16][18].

References

1. https://www.financialexpress.com/life/technology-samsung-galaxy-a05-lands-silently-in-india-brings-50mp-camera-25w-fast-charging-for-under-rs-15000-3317586/
2. https://www.futuremarketinsights.com/reports/biliary-tract-cancers-treatment-market
3. https://atcddd.fhi.no/atc_ddd_index/?code=A05AA
4. https://www.ipsen.com/press-releases/u-s-fda-approves-bylvay-for-patients-living-with-cholestatic-pruritus-due-to-alagille-syndrome/
5. https://www.alliedmarketresearch.com/primary-biliary-cholangitis-pbc-therapeutics-market-A108539
6. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2018/belgian-reg-med-best-performers-for-october-2018.pdf?la=sk-sk&hash=5F03C3AA6255CA928A6446DA47F98DC6
7. https://www.expertmarketresearch.com/reports/primary-biliary-cholangitis-therapeutics-market
8. https://www.ipsen.com/us/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/
9. https://www.knowmade.com/patent-analytics-services/patent-report/semiconductor-patent-landscape/semiconductor-advanced-packaging-patent-landscape/antenna-in-package-patent-landscape-2021/
10. https://pubchem.ncbi.nlm.nih.gov/compound/Odevixibat
11. https://www.globenewswire.com/news-release/2025/03/14/3042877/0/en/Liver-Disease-Therapeutic-Market-Forecast-Report-and-Company-Analysis-2025-2033-Featuring-Abbott-Astellas-BMS-Gilead-Sciences-GSK-F-Hoffmann-La-Roche-Merck-Novartis-Sanofi-Pfizer-a.html
12. https://farmaciajournal.com/wp-content/uploads/art-25-Pana_Craciun-Taerel_813-820.pdf
13. https://go.drugbank.com/drugs/DB01586
14. https://www.crc1382.org/a05/
15. https://pubchem.ncbi.nlm.nih.gov/compound/Cholic-Acid
16. https://patents.justia.com/assignee/genetic-therapy-inc
17. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1713457878482
18. https://www.pharmaceutical-technology.com/data-insights/mirum-pharmaceuticals-gets-grant-for-treatment-of-cholestatic-pruritus-in-alagille-syndrome-with-maralixibat-2/
19. https://journals.physiology.org/doi/full/10.1152/ajpgi.00121.2015