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Drugs in ATC Class J05A
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Subclasses in ATC: J05A - DIRECT ACTING ANTIVIRALS
J05AB - Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AD - Phosphonic acid derivatives
J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
J05AG - Non-nucleoside reverse transcriptase inhibitors
J05AH - Neuraminidase inhibitors
J05AP - Antivirals for treatment of HCV infections
J05AR - Antivirals for treatment of HIV infections, combinations
J05A Market Analysis and Financial Projection
The market for ATC Class J05A (Direct-Acting Antivirals) is shaped by rapid therapeutic advancements, patent disputes, and evolving access challenges. Below is an analysis of the market dynamics and patent landscape:
Market Dynamics
Growth Drivers
- Rising Disease Burden: Chronic HCV and HIV infections drive demand, with 71 million global HCV cases and high HIV prevalence in regions like sub-Saharan Africa[2][7][10].
- Innovative Therapies: Direct-acting antivirals (DAAs) like sofosbuvir (HCV) and tenofovir alafenamide (HIV/HBV) dominate the market due to high efficacy and shorter treatment cycles[7][9].
- Emerging Markets: Improved healthcare infrastructure and government initiatives in countries like India and Egypt have expanded access, though middle-income nations still face cost barriers[7][10].
- Combination Therapies: Fixed-dose combinations (e.g., sofosbuvir/ledipasvir) reduce viral resistance risks and simplify regimens, capturing over 60% of HCV treatment protocols[1][8].
Challenges
- High Costs: A 12-week HCV treatment costs ~$300 in generic markets but exceeds $30,000 in high-income countries, limiting access[10][14].
- Insurance Barriers: Prior authorization requirements delay treatment initiation for HCV in the U.S. and Europe[7].
Market Segmentation
- By Indication:
- HCV therapies (e.g., glecaprevir/pibrentasvir) held a 48% market share in 2022[7][14].
- HIV treatments (e.g., lamivudine/raltegravir) grow at 8.4% CAGR due to lifelong demand[4][12].
- By Distribution: Hospital pharmacies account for 65% of sales, driven by inpatient DAA use[2].
Projections
The global DAA market is projected to reach $17.8 billion by 2027 (13.6% CAGR), fueled by Asia-Pacific’s 19.2% growth rate[2][7].
Patent Landscape
Key Players & Strategies
- Gilead Sciences: Holds patents for sofosbuvir and tenofovir alafenamide until 2031. Sub-licensed to generics manufacturers like Cipla for 112 low-income countries[9][15].
- AbbVie: Filed 23 patents (2013–2019) for glecaprevir/pibrentasvir combinations, extending exclusivity through formulation and indication claims[14].
- Regulus Therapeutics: Secured global patents for miR-122 inhibitors (HCV), positioning them as complementary to DAAs[3].
Patent Challenges
- Sofosbuvir: Opposed in Argentina (2017) and India (2022) over prior-art claims, enabling generic versions at 1/100th the original price[10][15].
- Daclatasvir/Velpatasvir: Invalidity petitions filed in India (2022) to overcome secondary patents on dosing regimens[10].
Barriers to Access
- Evergreening: Companies file patents on drug combinations (e.g., sofosbuvir/velpatasvir) and crystalline forms to delay generics[8][14].
- Middle-Income Gaps: Brazil and South Africa face licensing restrictions, forcing reliance on parallel imports despite high HCV/HIV rates[10][14].
Strategic Implications
| Factor | Impact | Example |
|---|---|---|
| Generic Competition | Prices drop 90% post-patent expiry | Sofosbuvir generics in Egypt: $300/treatment[10] |
| Government Partnerships | Accelerate generic approvals | Medicines Patent Pool’s sub-licenses for tenofovir[9] |
| Therapeutic Substitution | Demand shifts to newer DAAs | Post-relabeling, HIV drug sales fell 5.1% as prescribers switched regimens[11][15] |
"The unchecked power of pharmaceutical patents perpetuates inequities. Challenging flawed IP is critical to expanding access." – Tahir Amin, I-MAK Co-Founder[10].
This landscape underscores the tension between innovation incentives and global health equity, with DAAs representing both medical breakthroughs and access battlegrounds.
References
- https://en.wikipedia.org/wiki/ATC_code_J05
- https://www.researchnester.com/reports/direct-acting-antiviral-medicines-market/3005
- https://ir.regulusrx.com/2012-04-23-Regulus-Receives-Allowance-from-Japan-and-U-S-Patent-Offices-for-HCV-Intellectual-Property,-Expanding-Leading-Worldwide-Patent-Estate
- https://pubchem.ncbi.nlm.nih.gov/compound/Lamivudine-and-raltegravir
- https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.681492/pdf
- https://atcddd.fhi.no/atc_ddd_index/?code=J05A
- https://www.businesswire.com/news/home/20221229005168/en/Global-Direct-acting-Antiviral-Drug-Market-Report-2022-2027-Availability-of-Directly-Acting-Antiviral-Medicines-Presents-Opportunities---ResearchAndMarkets.com
- https://cdn.who.int/media/docs/default-source/essential-medicines/intellectual-property/sofosbuvir-report.pdf?sfvrsn=5a6c06ea_2
- https://adisinsight.springer.com/drugs/800017062?bpIds=3000093925%2C3000118986&checksum=207ab8974a432bcffc591fd16c6166777ec712a1-1523327359224-1f32aaa6fc36caeb60a7891f312ed370979854bdf911905893237a83e0d9ad4a4dd87f752524ca51b15f3911efa7a85e
- https://www.pharmacytimes.com/view/patent-challenges-seek-to-expand-access-to-hepatitis-c-drugs
- https://www.nber.org/system/files/working_papers/w24957/revisions/w24957.rev1.pdf
- https://www.drugpatentwatch.com/p/atc-class/J05A
- https://health.ec.europa.eu/system/files/2016-11/creativ_ceutical_eu_pharmaceutical_expenditure_forecast_0.pdf
- https://www.treatmentactiongroup.org/wp-content/uploads/2021/11/hcv_tb_longacting_patent_trends.pdf
- https://www.nber.org/system/files/working_papers/w24957/revisions/w24957.rev0.pdf
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