Drugs in ATC Class V04C

Up to Top Level ATC Classes

Up to V - Various

Up to V04 - DIAGNOSTIC AGENTS

Subclasses in ATC: V04C - OTHER DIAGNOSTIC AGENTS

V04CA - Tests for diabetes

V04CC - Tests for bile duct patency

V04CD - Tests for pituitary function

V04CG - Tests for gastric secretion

V04CJ - Tests for thyreoidea function

V04CK - Tests for pancreatic function

V04CM - Tests for fertility disturbances

V04CX - Other diagnostic agents

V04C Market Analysis and Financial Projection

The ATC class V04C ("Other Diagnostic Agents") encompasses specialized diagnostic tests for conditions ranging from diabetes and thyroid function to fertility disturbances and pancreatic function. This category faces unique market dynamics and patent challenges shaped by technological complexity and regulatory landscapes.

Market Dynamics

Growth Drivers

• Rising Chronic Disease Burden: The increasing prevalence of diabetes, liver disorders, and hormonal imbalances is driving demand for precise diagnostic tools. For example, tests for diabetes (V04CA) and thyroid function (V04CJ) are critical for managing these widespread conditions[1][4][13].
• Technological Advancements: Innovations in imaging and molecular diagnostics, such as radiotracers for PET/SPECT scans, are expanding applications for V04C agents. The radioactive diagnostic agent market alone is projected to reach $10.8 billion by 2030 (CAGR 9.5%)[12][18].
• Aging Population: Tests for renal function (V04CH) and pituitary disorders (V04CD) are increasingly utilized in elderly care, aligning with global demographic shifts[12][18].

Market Challenges

• High Development Costs: Advanced diagnostic systems like automated immunoassays require significant R&D investment, with regulatory compliance adding to expenses[6][18].
• Limited Standardization: Only a few agents in V04C have Defined Daily Doses (DDDs), reflecting challenges in dosing uniformity and clinical adoption[1][2].

Market Segment	2022 Value	2030 Projection	CAGR
Radioactive Diagnostics	-	$10.8B	9.5%
Diagnostic Reagents	$48.9B	$84.0B	7.0%

Patent Landscape

Key Trends

• Eligibility Hurdles: In the U.S., diagnostic methods often face rejections under Section 101 for being "natural phenomena." Courts have invalidated patents for tests measuring biomarkers like in Mayo v. Prometheus[11][17].
• Legislative Shifts: The Proposed PERA 2023 seeks to abolish judicial exceptions (e.g., "abstract ideas"), potentially revitalizing patent prospects for pure diagnostic methods if enacted[11].
• Focus on Reagents and Devices: While biomarkers (e.g., glucose for V04CA) are unpatentable, novel reagents (e.g., synthetic secretin in V04CK) and sensing technologies (e.g., lateral flow assays[3][8]) dominate patent filings.

Competitive Strategies

• Trade Secrets Over Patents: Many manufacturers prioritize proprietary manufacturing know-how (e.g., chemical formulations for fertility tests (V04CM)) due to shorter commercial windows and patent litigation risks[17].
• Geographic Disparities: North America holds 42% of the radioactive diagnostics market, leveraging advanced healthcare infrastructure, while Asia-Pacific grows fastest (CAGR 9.5%) due to rising chronic disease awareness[12][18].

Regional and Regulatory Considerations

• EU vs. U.S. Patent Practices: The EU’s broader patent eligibility for diagnostic methods contrasts with the U.S.’s restrictive approach, prompting companies to file method-of-treatment claims in the U.S.[11][17].
• Emerging Markets: South Africa’s V04C sector reports only 2 active products, highlighting untapped potential in developing regions[5].

Future Outlook

• AI and Machine Learning: Tools like Unified Patents’ VVC OPAL model, which uses ML to predict patent essentiality, could streamline IP strategies for diagnostic technologies[10].
• Companion Diagnostics: Patent pools for oncology and infectious disease tests are emerging, though fragmentation risks persist, mirroring earlier challenges in video codec licensing[8][10].

"The diagnostics industry increasingly relies on proprietary manufacturing know-how rather than patents to maintain competitive edges." – FIND Policy Brief[17].

In summary, the V04C market is poised for growth driven by technological innovation and demographic trends, but patent eligibility reforms and regional regulatory alignment will shape its trajectory. Companies must balance IP protections with investments in trade secrets and global market adaptability.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=V04C&showdescription=yes
2. https://atcddd.fhi.no/atc_ddd_index/?code=V04C&showdescription=no
3. https://msfaccess.org/sites/default/files/2020-05/Patent%20Landscape%20Analysis%20-%202017%20-%20final%20report.pdf
4. https://www.atccode.com/V04C
5. https://hsf.org.za/publications/special-publications/pharmaceuticals-in-south-africa/pharma-report-2018.pdf
6. https://www.fortunebusinessinsights.com/air-traffic-control-atc-market-102957
7. https://www.atccode.com/V04
8. https://msfaccess.org/sites/default/files/2020-05/Diagnostics%20Lit%20Review%20Final.pdf
9. https://marketchameleon.com/Overview/VDC/
10. https://support.unifiedpatents.com/hc/en-us/articles/12900363504535-VVC-Landscape-Methodology
11. https://www.harnessip.com/news-and-awards/patent-eligibility-of-diagnostic-method-claims-following-proposed-pera-act-of-2023-bloomberg-law/
12. https://www.industryarc.com/Report/16903/radioactive-diagnostic-agent-market.html
13. https://www.drugpatentwatch.com/p/atc-class/V04C
14. https://stockinvest.us/stock/VDC
15. https://pmc.ncbi.nlm.nih.gov/articles/PMC5400798/
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC8563342/
17. https://www.finddx.org/wp-content/uploads/2024/03/20240321_rep_factsheet_dx_ip_FV_EN_20221201.pdf
18. https://www.databridgemarketresearch.com/reports/global-diagnostic-reagents-market