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Drugs in ATC Class C09CA
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Drugs in ATC Class: C09CA - Angiotensin II receptor blockers (ARBs), plain
C09CA Market Analysis and Financial Projection
The Angiotensin II Receptor Blockers (ARBs) market, classified under ATC code C09CA, is shaped by evolving therapeutic demands, patent expirations, and shifting competitive dynamics. Here's a detailed analysis:
Market Overview
The global ARBs (plain) market is projected to grow from $8.08 billion in 2024 to $10.56 billion by 2031, reflecting a 3.40% CAGR[1]. Short-term growth is steadier, with estimates of $8.51 billion in 2024 rising to $8.87 billion in 2025[4]. This growth is driven by:
- Hypertension prevalence: 1.28 billion adults globally[1][4], with ARBs preferred for their efficacy and tolerability over ACE inhibitors[3][8].
- Chronic kidney disease (CKD): 700 million cases worldwide, where ARBs slow progression[1][4].
- Aging populations: Increased cardiovascular and renal disease risks[1].
Key Market Drivers
1. Rising Disease Burden
ARBs are first-line treatments for hypertension and diabetic nephropathy, with 29.6–41.8% usage rates in key demographics[13]. Their mechanism—blocking angiotensin II receptors—reduces blood pressure and organ damage[8][9].
2. Combination Therapies
Fixed-dose combinations (e.g., ARBs + calcium channel blockers [C09DB]) grew by 114.2% annually in South Korea (2015–2019)[10], driven by enhanced efficacy and convenience[6][11].
3. Healthcare Investments
Asia-Pacific governments, like India’s 137% healthcare budget increase, are expanding access to cardiovascular treatments[1].
Challenges
1. Generic Competition
Generic ARBs dominate 90% of U.S. prescriptions, pressuring branded products[1]. For example:
- Diovan (valsartan): Patent expired in 2012, but generics faced delays due to manufacturing issues[16].
- Avapro (irbesartan): Patents expired in 2015, accelerating generic entry[15].
2. Safety Concerns
Nitrosamine contamination warnings (e.g., EMA, 2018) and side effects like hyperkalemia have impacted prescription rates[1][8].
Patent Landscape
Most core ARB patents have expired, leading to widespread genericization:
| Drug (Brand) | Generic Name | Patent Expiry | Impact |
|---|---|---|---|
| Diovan (Novartis) | Valsartan | 2012 | Generic launch delayed until 2014 due to Ranbaxy’s FDA compliance issues[16]. |
| Avapro (BMS) | Irbesartan | 2015 | Generics rapidly captured market share post-expiry[15]. |
| Cozaar (Merck) | Losartan | 2010 | Early genericization reduced brand revenue[8]. |
Innovation now focuses on combination therapies (e.g., C09DB ARBs + CCBs) and novel formulations like Azilsartan Medoxomil, approved in 2022[4].
Competitive Landscape
Top Players: Novartis, Merck, AstraZeneca, and Boehringer Ingelheim lead through strategic pricing and combination products[1][4]. Generic manufacturers like Lupin and Mylan hold significant shares[4][16].
Market Strategies:
- Combination drugs: Telmisartan/amlodipine (Micardis HCT) and valsartan/sacubitril (Entresto) cater to complex hypertension cases[12][8].
- Geographic expansion: North America remains dominant (2024), but Asia-Pacific is the fastest-growing region[1][4].
Regional Insights
- North America: Largest market (2024) due to high hypertension rates and established healthcare infrastructure[4].
- Asia-Pacific: Growth driven by India’s healthcare investments and rising CKD prevalence[1][11].
- Europe: Safety regulations and cost containment policies moderate growth[1][10].
Future Outlook
- R&D: Sparsentan (dual endothelin/angiotensin blocker) and pediatric formulations highlight innovation[9].
- Generics vs. Combinations: While generics dominate plain ARBs, combination therapies will drive revenue growth, projected to account for 60% of ARB spending by 2030[6][11].
“The ARBs market’s future hinges on balancing generic affordability with innovative combinations to address unmet clinical needs.” – Verified Market Research[1]
This landscape underscores a sector in transition, where generics ensure accessibility, while strategic R&D focuses on differentiated products to sustain growth.
References
- https://www.verifiedmarketresearch.com/product/angiotensin-receptor-blockers-arbs-market/
- https://pubmed.ncbi.nlm.nih.gov/31021185/
- https://en.wikipedia.org/wiki/Angiotensin_II_receptor_blocker
- https://www.thebusinessresearchcompany.com/report/angiotensin-receptor-blockers-arbs-global-market-report
- https://www.credenceresearch.com/report/angiotensin-converting-enzyme-ace-inhibitors-market
- https://journals.plos.org/plosone/article/file?id=10.1371%2Fjournal.pone.0259467&type=printable
- https://ised-isde.canada.ca/site/canadian-intellectual-property-office/sites/default/files/attachments/2022/Shale-Oil-Gas-report-May-2017.pdf
- https://www.ahajournals.org/doi/10.1161/01.cir.0000072344.12827.13
- https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=C09CA
- https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0259467
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8673596/
- https://en.wikipedia.org/wiki/ATC_code_C09
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10709829/
- https://atcddd.fhi.no/atc_ddd_index/?code=C09A&showdescription=yes
- https://pharsight.greyb.com/drug/avapro-patent-expiration
- https://blogs.jwatch.org/cardioexchange/2012/09/25/another-one-bites-the-dust-diovan-patent-expires-but-generic-valsartan-is-mia/
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