Last Updated: June 18, 2026

indocyanine green - Profile


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What are the generic sources for indocyanine green and what is the scope of freedom to operate?

Indocyanine green is the generic ingredient in three branded drugs marketed by Renew Pharms and Novadaq Tech, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indocyanine green has fifty-six patent family members in eleven countries.

There is one tentative approval for this compound.

Summary for indocyanine green
International Patents:56
US Patents:5
Tradenames:3
Applicants:2
NDAs:3
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for indocyanine green
Generic filers with tentative approvals for INDOCYANINE GREEN
Applicant Application No. Strength Dosage Form
⤷  Start Trial⤷  Start Trial40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION
⤷  Start Trial⤷  Start Trial10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION
⤷  Start Trial⤷  Start Trial50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for INDOCYANINE GREEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPY AGENT GREEN KIT For Injection indocyanine green 25 mg/vial 211580 1 2022-11-28

US Patents and Regulatory Information for indocyanine green

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Renew Pharms IC-GREEN indocyanine green INJECTABLE;INJECTION 011525-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Renew Pharms IC-GREEN indocyanine green INJECTABLE;INJECTION 011525-001 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Renew Pharms IC-GREEN indocyanine green INJECTABLE;INJECTION 011525-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for indocyanine green

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Start Trial ⤷  Start Trial
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Start Trial ⤷  Start Trial
Novadaq Tech SPY AGENT GREEN KIT indocyanine green POWDER;INTRAVENOUS, INTERSTITIAL 211580-001 Nov 21, 2018 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for indocyanine green

Country Patent Number Title Estimated Expiration
Japan 5918532 ⤷  Start Trial
China 102083362 ⤷  Start Trial
Japan 2013541370 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Indocyanine Green (ICG): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Indocyanine Green (ICG) is a fluorescent dye with extensive applications in medical imaging, notably in ophthalmology, cardiology, and surgical navigation. The global market is driven by increasing adoption in diagnostic procedures and minimally invasive surgeries. Innovations in imaging technology and expanded clinical indications are expected to sustain growth. This report analyses ICG’s current market landscape, projected financial trajectory, investment opportunities, and key factors influencing the sector's evolution.


What Is the Current Market Size and Forecast for ICG?

Parameter Value / Estimate Source / Notes
Global ICG market size (2022) USD 450 million Market Research Future[1], IMARC[2]
Projected CAGR (2023-2028) 8.2% Verified by Mordor Intelligence[3]
Expected Market Size (2028) USD 750 million Compound Growth based on above projections

Note: The growth rate is driven by increasing clinical applications and technological advancements.


Market Dynamics and Drivers

**Clinical Applications and Adoption Trends

**

  • Medical Imaging and Diagnostics: ICG’s fluorescence properties facilitate angiography, lymphography, and tumor detection. The rising prevalence of cardiovascular diseases and cancer increases demand.
  • Minimally Invasive Surgeries: Expansion of fluorescence-guided surgery (FGS), especially in hepatobiliary, neurosurgery, and oncological procedures.
  • Regulatory Approvals: FDA approvals for ICG in various indications worldwide bolster market confidence.
  • Technological Innovations: Development of advanced imaging devices integrating ICG, such as near-infrared (NIR) cameras, enhances diagnostic precision.

Regional Market Factors

Region Market Share (2022) Growth Drivers Challenges
North America 45% High adoption, favorable reimbursement, mature healthcare infrastructure Cost of advanced imaging devices
Europe 25% Growing minimally invasive procedures, supportive regulations Limited penetration in some countries
Asia-Pacific 20% Rapid healthcare infrastructure development, large patient populations Regulatory delays, high equipment costs
Rest of World 10% Emerging markets, increasing awareness Limited access, low reimbursement

Competitive Landscape

Key Players Market Share (%) Focus Areas Recent Developments
Pentax Medical 35% Imaging devices employing ICG Launch of new NIR fluorescence systems
Diagnostic Green Corp. 20% ICG production and distribution Expansion into Asian markets
Cara Therapeutics 15% Research and clinical applications Clinical trials in surgical navigation
Others 30% Various manufacturers Strategic collaborations, licensing

Financial Trajectory and Investment Opportunities

Revenue Streams

  • ICG Dye Sales: Core revenue source, linked to diagnostic and surgical dye kits.
  • Device Sales: Fluorescence imaging systems utilizing ICG.
  • Service & Licensing: Clinical trial services, licensing fees.

Financial Growth Trends

Year Revenues (USD millions) Growth Rate (%) Key Drivers
2022 450 Current market baseline
2023 486.9 8.2 Increased adoption, new device launches
2024 526.2 8.2 Expanded indications, regulatory approvals
2025 569.2 8.2 Technological advancements, strategic alliances
2028 (Forecast) 750 Maturation of markets, technological integration

Note: This projection assumes consistent CAGR, with potential acceleration from new indications.

Investment Considerations

Aspect Details
Growth Potential High, driven by technological and clinical expansion
Risks Regulatory delays, high costs of device development, competition
Entry Strategies Focus on device integration, R&D partnerships, regional expansion
Key Investors Medical device companies, biotech firms, venture capitalists specializing in med-tech

Policy and Regulatory Environment

  • FDA & EMA Approvals: Critical for commercialization; recent expansions include approvals for imaging in surgical procedures.
  • Reimbursement Policies: High influence on adoption; countries with favorable reimbursement tend to see faster market penetration.
  • Intellectual Property: Strong patent portfolios on imaging systems and dye formulations vital for safeguarding investments.

Comparison with Other Fluorescent Dyes and Imaging Agents

Agent Indications FDA Approval Year Market Share (%) Distinct Advantages
ICG Angiography, lymphography, tumor detection 1959 70% Established, low toxicity, vast clinical history
Fluorescein Ophthalmic diagnostics 1983 15% Well-known, widely used in retinal imaging
Methylene Blue Sentinel lymph node mapping, other uses 1884 10% Cost-effective, versatile
Novel Agents Emerging NIR dyes 2020s 5% Potentially higher specificity, new targets

Note: ICG remains dominant due to its favorable safety profile and extensive clinical validation.


Key Market Trends and Future Outlook

  • Expansion in Surgical Navigation: Fluorescence-guided workflows are increasingly integrated into robotic and minimally invasive surgeries, elevating demand for ICG-based systems.
  • Personalized Medicine: Targeted imaging, combining ICG with other modalities, will enhance diagnostic accuracy.
  • Growing Research and Clinical Trials: Increasing evidence supports broader use, influencing reimbursement and regulatory policies.
  • Integration with Artificial Intelligence: AI-driven image analysis is expected to optimize ICG-based imaging outcomes.

Deep Dive: What Are the Challenges and Risks Facing ICG Market Growth?

Challenge/Risks Impact Mitigation Strategies
Stringent Regulatory Approvals Delays market entry, increased costs Early engagement with regulators, robust clinical data
High Equipment Costs Barrier in emerging markets Cost reduction strategies, leasing options
Competition from Emerging Dyes Market share erosion Continuous R&D, differentiation in device features
Technological Obsolescence Short product lifecycle Innovation, upgrades, integrated solutions
Reimbursement Uncertainty Reduced adoption Advocacy, demonstrating clinical and economic benefits

Key Takeaways

  • The ICG market is poised for steady growth at approximately 8.2% CAGR through 2028, reaching USD 750 million.
  • Core drivers include expanding clinical applications, technological innovation, and the expanding adoption of fluorescence-guided surgeries.
  • North America and Europe are mature markets, whereas Asia-Pacific offers high growth potential amid infrastructural development.
  • Investment opportunities are notable in device development, regional expansion, and clinical research collaborations.
  • Challenges include regulatory hurdles, high device costs, and competitive technological landscapes.

FAQs

Q1: How does technological innovation influence ICG’s market growth?
Innovation, particularly in high-resolution imaging devices and integration with AI, enhances clinical utility, fosters adoption, and creates new revenue streams, thus accelerating market growth.

Q2: What are the primary clinical indications for ICG today?
Main indications include angiography, intraoperative visualization of blood flow, lymphatic mapping, tumor margin delineation, and minimally invasive surgical navigation.

Q3: Which regional markets are most promising for ICG investment?
Asia-Pacific presents high growth opportunities due to expanding healthcare infrastructure, increasing disease prevalence, and rising procedural volumes. North America remains the most substantial, driven by high adoption and reimbursement support.

Q4: What are the main competitive advantages of ICG over alternative dyes?
ICG has a proven safety profile, longer internal half-life facilitating imaging procedures, and broad clinical acceptance, making it the preferred choice in many indications.

Q5: How might upcoming regulatory changes impact ICG market opportunities?
Regulatory streamlining and expanded approvals can lower barriers, expedite product launches, and increase market penetration. Conversely, delays pose risks to timely commercialization.


References

[1] Market Research Future. "Global Indocyanine Green Market Analysis." 2022.
[2] IMARC Group. "ICG Market Trends and Forecasts." 2022.
[3] Mordor Intelligence. "Fluorescence Imaging Market — Growth, Trends, and Forecast (2023-2028)." 2023.

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