Drugs in ATC Class A05AA

Up to Top Level ATC Classes

Up to A - Alimentary tract and metabolism

Up to A05 - BILE AND LIVER THERAPY

Up to A05A - BILE THERAPY

Drugs in ATC Class: A05AA - Bile acids and derivatives

Tradename	Generic Name
CHOLBAM	cholic acid
OBETICHOLIC ACID	obeticholic acid
OCALIVA	obeticholic acid

A05AA Market Analysis and Financial Projection

The market for bile acids and derivatives (ATC Class A05AA) is experiencing robust growth, driven by therapeutic demand and innovation, while the patent landscape reflects active R&D and strategic expansion.

---

Market Dynamics

Growth Drivers

• Rising Prevalence of Liver and Metabolic Disorders:

  • Conditions like bile acid synthesis disorders, peroxisomial disorders (e.g., Zellweger syndrome), and non-alcoholic fatty liver disease (NAFLD) are increasing globally. Cholic acid, a key A05AA drug, addresses these disorders, with its market projected to grow at a 7.5% CAGR (USD 380 million by 2032)[4][17].
  • Ursodeoxycholic acid (UDCA), used for primary biliary cholangitis (PBC) and gallstones, dominates with a 59% market share and an 11.3% CAGR (USD 1.13 billion by 2033)[17].

• Orphan Drug Designations and Regulatory Support:

  • Cholic acid and obeticholic acid hold orphan drug status, accelerating approvals and market access. Europe leads cholic acid adoption due to EMA approvals like Orphacol[4][17].

• Expansion into Emerging Markets:

  • Asia-Pacific is the fastest-growing region for 5-aminolevulinic acid (ALA) (7.29% CAGR), driven by rising cancer cases and healthcare investments[3].

---

Key Market Segments

Segment	Key Insights
Product Types	- Tablets dominate UDCA (>52% share) due to cost-effectiveness[17].
Applications	- PBC treatment holds >59% UDCA market share[17].
Regions	- North America: 36.6% market share (UDCA) due to healthcare infrastructure[17]. - Europe: Leads in cholic acid use via EMA approvals[4].

---

Patent Landscape

Innovation Trends

• Novel Derivatives and Synthesis Methods:

  • AtheroNova[2] and Albireo Pharma[6] hold patents for cardiovascular/metabolic therapies using bile acid derivatives. Albireo’s benzothiazepine derivatives target liver and GI diseases[6].
  • Recent patents focus on intermediates for obeticholic acid synthesis using plant sterols[10] and "click" chemistry for quasi-podands with antitumor potential[14].

• Drug Delivery Enhancements:

  • Bile acids improve drug bioavailability through micellar solubilization and transporter-mediated absorption[11]. Companies like Teva are expanding generics in Asia-Pacific markets[17].

---

Strategic Moves

• Generics and Market Penetration:
  • Post-patent expirations (e.g., UDCA) have led to 85% price reductions, broadening access in developing regions[17].
• R&D Collaborations:
  • Dr. Falk Pharma’s partnership for new UDCA formulations highlights innovation targeting niche indications[17].

---

Challenges and Opportunities

• Restraints: Adverse effects at high doses (e.g., hepatotoxicity with cholic acid)[5] and limited efficacy in late-stage diseases[17].
• Opportunities:
  • Personalized Medicine: Research on bile acid metabolism as biomarkers for Alzheimer’s and tailored therapies[4].
  • Geographic Expansion: North American firms invest in Asia-Pacific growth, while Europe strengthens orphan drug pipelines[3][4].

---

"The development of our platform is significantly advanced by this achievement."
— Thomas W. Gardner, CEO of AtheroNova, on expanding bile acid patent portfolios[2].

---

Key Takeaways

1. Market Growth: A05AA drugs are transitioning from niche liver therapies to broader metabolic applications, with cholic and UDCA markets leading.
2. Patent Activity: Focus on derivatives (e.g., obeticholic acid) and synthesis efficiency drives R&D, while generics reshape pricing dynamics.
3. Regional Shifts: North America and Europe dominate, but Asia-Pacific’s CAGR highlights untapped potential.

This evolving landscape underscores the interplay of innovation, regulatory strategy, and market accessibility in shaping the future of bile acid therapeutics.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=A05AA
2. https://www.dicardiology.com/content/atheronova-receives-notice-issuance-second-us-patent
3. https://www.thebrainyinsights.com/report/5-aminolevulinic-acid-hydrochloride-ala-market-13106
4. https://www.stellarmr.com/report/Cholic-Acid-Market/2076
5. https://pubchem.ncbi.nlm.nih.gov/compound/Cholic-Acid
6. https://www.pharmaceutical-technology.com/data-insights/albireo-pharma-gets-grant-for-treatment-of-diseases-with-specific-benzothiazepine-and-benzothiadiazepine-derivatives/
7. https://www.gminsights.com/industry-analysis/alpha-1-antitrypsin-deficiency-disease-treatment-market
8. https://www.zva.gov.lv/sites/default/files/2018-05/zva-zstat-2017.pdf
9. https://farmaterverantwoording.nl/wp-content/uploads/2022/08/20220531-Italian-Comp-Auth-decision-A524chiusura-ENGLISH-inoff-translationpdf.pdf
10. https://patents.justia.com/patent/10968250
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC6237018/
12. https://pure.hud.ac.uk/files/67009246/28_Final_thesis.pdf
13. https://patents.google.com/patent/US3919266A/en
14. https://pubs.acs.org/doi/10.1021/acs.joc.4c00195
15. https://github.com/vjorelaclliv/Market-Research-Report-List-1/blob/main/bile-acid-market.md
16. https://pubchem.ncbi.nlm.nih.gov/patent/US-4793948-A
17. https://market.us/report/ursodeoxycholic-acid-drug-product-market/
18. https://patents.google.com/patent/EP0232788A1/en