Drugs in ATC Class J05

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Up to J - Antiinfectives for systemic use

Subclasses in ATC: J05 - ANTIVIRALS FOR SYSTEMIC USE

J05A - DIRECT ACTING ANTIVIRALS

J05 Market Analysis and Financial Projection

The global market and patent landscape for ATC Class J05 – Antivirals for Systemic Use reflects rapid innovation driven by pandemic preparedness, emerging viral threats, and advancements in drug delivery systems. Here's an in-depth analysis:

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Market Dynamics

Current Market Valuation

• The systemic infection treatment market (encompassing J05 antivirals) was valued at $2.21 billion in 2023 and is projected to reach $3.39 billion by 2032 at a CAGR of 4.9% [3][13].
• The broader antiviral drugs market (including J05 drugs) is larger, expected to grow from $67.04 billion in 2025 to $96.3 billion by 2032 with a CAGR of 5.3% [9]. Key drivers include demand for broad-spectrum antivirals and COVID-19-related R&D acceleration.

Key Therapeutic Segments

• HCV Treatments: J05AP-class drugs (e.g., sofosbuvir, ledipasvir) dominate due to high cure rates. Combinations like sofosbuvir/velpatasvir generate significant revenue [1][5].
• HIV Antivirals: Integrase inhibitors (e.g., dolutegravir) and combination therapies (e.g., nirmatrelvir/ritonavir) are growth drivers [1][15].
• COVID-19 Innovations: Remdesivir (J05AB16) and molnupiravir (J05AB18) saw accelerated approval pathways post-pandemic [1][9].

Geographic Trends

• North America leads with 39.7% market share (2025), driven by robust healthcare infrastructure and companies like Gilead and Johnson & Johnson [9][13].
• Asia-Pacific is the fastest-growing region, fueled by expanding pharmaceutical industries in India and China, and rising viral infection rates [3][9].

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Patent Landscape

Leading Players and Innovations

• Johnson & Johnson: Holds top patents for coronavirus antivirals (e.g., adenovirus-based vaccines) [4].
• CureVac and Moderna: Lead RNA-based vaccine patents (e.g., mRNA delivery systems) with applications for influenza and COVID-19 [4][10].
• ImmuneMed: Patented novel "virus suppressing factor (VSF)" proteins targeting multiple viruses, including HIV and hepatitis, through hybridoma technology [2].
• Recent Patent Activity:
  • US10426780B2: Combines HIV integrase inhibitors with other agents to enhance efficacy [15].
  • WO 03 064 461 A1: Broad-spectrum antiviral VSF proteins with applications in humans and animals [2].

Emerging Trends

• RNA Vaccine Boom: Patent filings for self-amplifying RNA (saRNA) vaccines doubled from 2021–2022, led by CureVac and BioNTech [10][14].

• Biologics vs. Small Molecules:	Aspect	Biologics	Small Molecules
  Patent Focus	Targeted therapies (e.g., monoclonal antibodies)	Broad-spectrum antivirals (e.g., protease inhibitors)
  Growth Rate	23% of valid patents in gene therapy (e.g., AAV carriers) [14]	Dominates traditional markets (e.g., HCV/HIV)
  Regulatory Challenges	Higher complexity in manufacturing	Faster approval pathways

• Patent Oppositions: Over 13 ongoing disputes in Europe for saRNA vaccine patents, reflecting high stakes in RNA technology [10].

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Growth Drivers and Challenges

Opportunities

• Government Funding: $2 billion U.S. federal grants for COVID-19 R&D (e.g., Novavax, Regeneron) [9].
• Combination Therapies: Drugs like sofosbuvir/velpatasvir/voxilaprevir (J05AP56) extend treatment efficacy and patent lifecycles [1][5].

Barriers

• Regulatory Hurdles: Adenovirus-based vaccines (e.g., Johnson & Johnson) face slower development than RNA counterparts [4].
• Generic Competition: Key drugs like acyclovir (J05AB01) face revenue decline post-patent expiry, pushing innovation toward novel biologics [8][5].

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Key Takeaways

1. Market Expansion: Antiviral demand will grow at 4.9–5.3% CAGR, led by RNA vaccines and HCV/HIV therapies.
2. Innovation Hotspots: RNA-based technologies and biologics dominate recent patents, with Asia-Pacific emerging as a manufacturing hub.
3. Strategic Moves: Companies are prioritizing combination therapies and broad-spectrum biologics to combat resistance and extend market exclusivity.

"The strength of a company’s patent portfolio is a leading indicator of its ability to bring transformative therapies to market." – PatentSight Analysis [4].

References

1. https://en.wikipedia.org/wiki/ATC_code_J05
2. https://adisinsight.springer.com/drugs/800052898?bpIds=3000093925%2C3001592458&checksum=51595e6efe465c2d5f499731a1162e0d9b080b9f-1586786579049-cd636dd5586a851acb27bb09e574e6f0979854bdf911905893237a83e0d9ad4a05397e65a874c51567277828def432d0
3. https://www.zionmarketresearch.com/report/systemic-infection-treatment-market
4. https://www.lexisnexisip.com/resources/analysis-reveals-companies-with-strongest-patents-related-to-covid-19-vaccines/
5. https://www.drugpatentwatch.com/p/atc-class/J05A
6. https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0174616
7. https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2019/belgian-regmedbest-performers-for-april-2019.pdf?la=en&hash=3EE2841A13277B5367525739F10659C5
8. https://go.drugbank.com/drugs/DB00787
9. https://www.coherentmarketinsights.com/market-insight/antiviral-drugs-market-4912
10. https://www.knowmade.com/patent-analytics-services/patent-report/life-sciences-patent-landscape/self-amplifying-rna-vaccines-patent-landscape-analysis-2023/
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC9702942/
12. https://dspace.mit.edu/bitstream/handle/1721.1/62181/Bernt-2010-Characterizing%20Markets%20for%20Biopharmaceutical%20Innovations%20Do%20Biologics%20Differ%20from%20Small%20Molecules.pdf?sequence=1&isAllowed=y
13. https://www.mordorintelligence.com/industry-reports/anti-viral-therapeutics-market
14. https://www.geneonline.com/patent-landscape-analysis-of-gene-therapy/
15. https://patents.google.com/patent/US10426780B2/en