You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 24, 2025

Drugs in ATC Class J05AG


✉ Email this page to a colleague

« Back to Dashboard


Drugs in ATC Class: J05AG - Non-nucleoside reverse transcriptase inhibitors

J05AG Market Analysis and Financial Projection

The Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) market, classified under ATC code J05AG, plays a pivotal role in HIV treatment by targeting the reverse transcriptase enzyme. Here’s a detailed analysis of its market dynamics and patent landscape:


Market Dynamics

  1. Market Growth and Segmentation

    • The global anti-retroviral drugs market was valued at USD 29.1 billion in 2023, projected to grow at 4.2% CAGR through 2032 [2]. NNRTIs, as part of multi-class combination therapies (e.g., lamivudine + tenofovir + efavirenz), dominate the market with USD 7.9 billion in 2023 revenue [2][6].
    • Branded drugs hold 67.2% market share, though generics are rising due to patent expirations and cost pressures in developing regions [2][10].
  2. Key Drivers

    • High HIV Prevalence: With 38.4 million people living with HIV globally (2021), demand for NNRTI-based regimens remains robust [2][7].
    • Shift to Advanced Therapies: Newer NNRTIs like rilpivirine and etravirine are replacing older agents (e.g., efavirenz) due to better resistance profiles [13][17]. However, integrase inhibitors (e.g., dolutegravir) are gaining preference, slowing NNRTI growth to 3.6% CAGR [14].
  3. Regional Insights

    • North America leads the market due to high healthcare spending and early adoption of novel therapies [2].
    • Asia-Pacific and Africa show growth potential driven by rising HIV incidence and generic production [6][10].

Patent Landscape

  1. Key Players and Innovations

    • Major NNRTI developers include Janssen Pharmaceuticals, Merck & Co., and ViiV Healthcare, with patents focusing on combination therapies (e.g., TMC278 + NRTIs) and once-daily formulations [4][11][12].
    • Ainuovirine (approved in China, 2021) exemplifies regional innovation in next-gen NNRTIs [8].
  2. Patent Expirations and Challenges

    • The 2025 patent cliff will see Biktarvy (HIV regimen) lose protection, accelerating generic competition [16].
    • Evergreening Strategies: Companies like Abbott Laboratories file follow-on patents for formulation tweaks (e.g., ritonavir’s polymorphs) to extend exclusivity [9][12]. Over 800 patent families exist for ritonavir alone [9].
  3. Litigation and Regulatory Trends

    • European Patent Office rulings highlight strict sufficiency of disclosure requirements for NNRTI combinations, emphasizing the need for clinical data to support dosing claims [4].
    • Regulatory Scrutiny: Post-marketing safety monitoring is critical, as seen with historical NNRTI-associated adverse events [1][7].

Clinical and Commercial Trends

  • Combination Therapies: Fixed-dose combinations (e.g., J05AR11: lamivudine + tenofovir + efavirenz) account for 95.9% of antiviral utilization in HIV care, driven by adherence benefits [6][7].
  • Resistance Management: Mutations like K103N and Y181C reduce NNRTI efficacy, spurring R&D into next-gen agents with higher barriers to resistance [17].
  • Cost Pressures: Generic NNRTIs (e.g., nevirapine API market at 6.67% CAGR) are vital for affordable HIV care in low-income regions [10][16].

Future Outlook

  • Scalability Challenges: Manufacturing and logistics for NNRTI-based regimens require robust supply chains to meet global demand [5].
  • Technological Integration: AI-driven drug design and automated manufacturing could streamline NNRTI development [5].
  • Allogeneic Therapies: Emerging cell/gene therapies may reshape HIV treatment paradigms, though NNRTIs remain a backbone in combination approaches [5][13].

"The rise of integrase inhibitors underscores the need for NNRTIs to evolve, focusing on resistance profiles and patient-centric formulations." – Frontiers in Tropical Diseases [6]

This analysis reflects a market balancing innovation with affordability, where patent strategies and generics will define access in the coming decade.

References

  1. https://research.rug.nl/files/80403460/A.H.Arnard_ttir.pdf
  2. https://www.gminsights.com/industry-analysis/anti-retroviral-drugs-market
  3. https://go.drugbank.com/drugs/DB00625
  4. https://www.epo.org/en/boards-of-appeal/decisions/t180391eu1
  5. https://www.cryoport.com/bio-blog-top-10-industry-predictions-for-2025/
  6. https://www.frontiersin.org/articles/10.3389/fitd.2021.723991/full
  7. https://clintonhealthaccess.org/wp-content/uploads/2017/09/2017-ARV-Market-Report_Final-2.pdf
  8. https://synapse.patsnap.com/drug/f6f9b694a54b4da48524387ec09d766c
  9. https://www.wipo.int/edocs/pubdocs/en/wipo_pub_946_1-tech1.pdf
  10. https://sites.google.com/view/inteleonpro/top-industry-report/nevirapine-api-market-by-application
  11. https://www.360iresearch.com/library/intelligence/non-nucleoside-reverse-transcriptase-inhibitors
  12. https://www.keionline.org/21711
  13. https://www.delveinsight.com/blog/hiv-1-treatment-market
  14. https://www.grandviewresearch.com/industry-analysis/human-immunodeficiency-virus-hiv-1-therapeutics-market
  15. https://www.patentnext.com/2024/08/wipo-issues-a-patent-landscape-report-on-generative-artificial-intelligence-genai/
  16. https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html
  17. https://en.wikipedia.org/wiki/Reverse-transcriptase_inhibitor
  18. https://patents.google.com/patent/US10189831B2/en
Last updated: 2025-03-25

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.