Drugs in ATC Class H05A

Up to Top Level ATC Classes

Up to H - Systemic hormonal preparations, excluding sex hormones and insulins

Up to H05 - CALCIUM HOMEOSTASIS

Subclasses in ATC: H05A - PARATHYROID HORMONES AND ANALOGUES

H05AA - Parathyroid hormones and analogues

H05A Market Analysis and Financial Projection

The market for ATC Class H05A (Parathyroid Hormones and Analogues) is poised for significant growth, driven by aging populations and advancements in drug delivery, while facing evolving patent landscapes and biosimilar competition.

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Market Dynamics

Growth Drivers

• Rising Disease Prevalence: Increasing cases of osteoporosis, chronic kidney disease, and hypoparathyroidism are key drivers. Over 200 million people globally suffer from osteoporosis, with postmenopausal women and the elderly at highest risk[7][10].
• Aging Demographics: By 2050, the global population aged 65+ is projected to rise by 47%, amplifying demand for bone health therapies[10][13].
• Biosimilar Development: Cost-effective alternatives like Theramex’s Livogiva (teriparatide biosimilar) are enhancing accessibility[7][18].

Market Trends

• Innovative Drug Delivery: Extended-release formulations (e.g., palopegteriparatide, approved by the FDA/EMA in 2023–2024) reduce dosing frequency[12][15].
• Precision Medicine: Targeted therapies for genetic subtypes of hypoparathyroidism are under development, such as encaleret for autosomal dominant hypocalcemia[13].
• Digital Health Integration: Remote monitoring tools improve adherence to daily injectable regimens[2][7].

Market Size and Projections

• The global market was valued at $2.35 billion in 2024, with a projected CAGR of 9.6%, reaching $3.5 billion by 2028[2][7][10].
• Segmentation:
  • By Product: Recombinant PTH (e.g., teriparatide) dominates, while analogs like abaloparatide gain traction[5][10].
  • By Application: Hypoparathyroidism treatment accounts for >60% of use, driven by post-surgical cases[10][13].

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Patent Landscape

Key Patents and Expirations

• KAI Pharmaceuticals’ Patents:

  • US 8,377,880: Expires July 2030[1].
  • US 8,999,932: Expires February 2031[1].
  • US 9,278,995: Expires March 2036[1].
    These cover PTH analogs with thiol-containing subunits for treating hyperparathyroidism and bone disorders.

• Purification and Synthesis:

  • US 5,209,041 (expired) detailed methods for producing ultrapure human PTH via HPLC[9].
  • US 5,589,452 (expired) disclosed synthetic PTH analogs for osteoporosis[14].

Biosimilar Entry and Litigation

• Patent oppositions in Europe and the U.S. have surged, particularly around delivery systems (e.g., lipid nanoparticles)[3].
• Post-2030, biosimilars are expected to capture ~30% of the market, reducing costs by 40–60%[7][18].

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Competitive Environment

Major Players

• Pfizer (Forteo): Leads with teriparatide, generating $1.2 billion annually[4][10].
• Eli Lilly: Invests in next-gen PTH analogs for osteoporosis and rare diseases[4][17].
• Abbott Laboratories: Focuses on diagnostic tools for PTH level monitoring[17].

Strategic Moves

• Partnerships: Collaborations between pharma firms and biotech startups (e.g., BridgeBio’s encaleret trials)[13].
• R&D Focus: 65% of pipeline candidates target extended-half-life formulations to improve patient compliance[12][18].

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Future Outlook

• Opportunities:
  • Expansion in Asia-Pacific, where healthcare access improvements could drive 8.4% CAGR[17].
  • Gene Therapy: Early-stage research into PTH gene editing for hereditary disorders[13].
• Challenges:
  • Patent cliffs post-2030 risking revenue losses for originators[1][7].
  • Regulatory hurdles for biosimilars in emerging markets[18].

The H05A market remains dynamic, balancing innovation in biologics with cost pressures from generics, while demographic shifts ensure sustained demand.

References

1. https://www.drugs.com/availability/generic-parsabiv.html
2. https://www.openpr.com/news/3751082/parathyroid-hormone-market-outlook-critical-insights-trends
3. https://www.knowmade.com/downloads/rna-vaccine-patent-landscape-2021/
4. https://github.com/vandelmanize/Market-Research-Report-List-1/blob/main/parathyroid-hormone-analog-market.md
5. https://atcddd.fhi.no/atc_ddd_index/?code=H05AA&showdescription=no
6. https://patents.google.com/patent/US4086196A/en
7. https://www.researchandmarkets.com/report/parathyroid-hormone
8. https://www.knowmade.com/patent-analytics-services/patent-report/semiconductor-patent-landscape/power-electronics-devices-patent-landscape/next-generation-power-modules-patent-landscape-2021/
9. https://patents.justia.com/patent/5208041
10. https://www.thebusinessresearchcompany.com/report/parathyroid-hormones-global-market-report
11. https://en.wikipedia.org/wiki/ATC_code_H05
12. https://go.drugbank.com/drugs/DB18676
13. https://www.databridgemarketresearch.com/reports/global-parathyroid-disease-treatment-market
14. https://patents.google.com/patent/US5589452A/en
15. https://atcddd.fhi.no/atc_ddd_index/?code=H05AA&showdescription=yes
16. https://www.precedenceresearch.com/air-traffic-control-equipment-market
17. https://sites.google.com/view/precisionpulseresearch/home/report/parathyroid-hormone-analog-market-by-application
18. https://www.verifiedmarketreports.com/product/parathyroid-hormone-analog-market/