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Last Updated: March 26, 2026

AN-SULFUR COLLOID Drug Patent Profile


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Which patents cover An-sulfur Colloid, and what generic alternatives are available?

An-sulfur Colloid is a drug marketed by Sun Pharm Inds Inc and is included in one NDA.

The generic ingredient in AN-SULFUR COLLOID is technetium tc-99m sulfur colloid kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sulfur colloid kit profile page.

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Summary for AN-SULFUR COLLOID
Drug patent expirations by year for AN-SULFUR COLLOID
Recent Clinical Trials for AN-SULFUR COLLOID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ohio State University Comprehensive Cancer CenterPHASE2
University of Wisconsin, MadisonEarly Phase 1
OnLume Inc.Early Phase 1

See all AN-SULFUR COLLOID clinical trials

US Patents and Regulatory Information for AN-SULFUR COLLOID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc AN-SULFUR COLLOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017858-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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

Market Dynamics and Financial Trajectory for AN-SULFUR COLLOID

Last updated: January 9, 2026

Summary

An-sulfur colloid, a radiopaque agent primarily used in lymphoscintigraphy and radiological procedures, possesses a niche but vital role in diagnostic and surgical applications. The global market for sulfur colloid-based products is witnessing gradual expansion, driven by advancements in minimally invasive diagnostics, increasing procedural volumes, and rising adoption in oncology and hepatology. This report examines key market drivers, challenges, revenue forecasts, competitive landscape, regulatory factors, and strategic opportunities, providing essential insights for stakeholders.


What Are An-Sulfur Colloid's Main Applications and Market Segments?

Application Area Description Estimated Market Share (2023) Critical Drivers
Lymphoscintigraphy Sentinel lymph node mapping in breast, melanoma, and head & neck cancers 45% Rising cancer incidences, procedural accuracy demands
Hepatobiliary Imaging Diagnosis of liver function, portal hypertension 25% Growing liver disease prevalence, non-invasive diagnostics
Other Uses Bone marrow imaging, splenic scans 15% Niche applications, technological advances
Research & Development New formulations, targeted delivery methods 15% Innovation, personalized medicine trends

Market Segments by Geography (2023)

Region Share (%) Notable Trends
North America 40% High healthcare expenditure, established diagnostic infrastructure
Europe 25% Growing adoption in minimally invasive procedures
Asia-Pacific 20% Expanding healthcare access, large patient population, emerging markets
Rest of the World 15% Limited but growing use, developing healthcare systems

What Are the Key Market Drivers?

1. Rising Cancer Incidence and Improved Diagnostic Protocols

Cancer remains a leading health concern globally, with WHO estimating 19.3 million new cases in 2020. Particular reliance on sentinel lymph node biopsies, where sulfur colloid serves as a tracer, propels demand. The global breast cancer diagnosis market alone is expected to grow at 7.5% CAGR (2022-2030), stimulating ancillary diagnostic tools like sulfur colloid.

2. Adoption of Minimally Invasive and Nuclear Medicine Procedures

Advancements in nuclear imaging techniques favor sulfur colloids over traditional invasive biopsies. The development of hybrid imaging modalities (e.g., SPECT/CT) anchors the need for high-quality radiotracers.

3. Technological Innovations and New Formulations

Nanoparticle modifications and improved stability formulations enhance imaging specificity and safety, expanding potential application scope.

4. Growing Preference for Non-Invasive Diagnostics in Chronic Liver Conditions

Increasing prevalence of liver cirrhosis, hepatitis, and portal hypertension (world prevalence: 1.5 billion for hepatitis B & C) expands hepatobiliary imaging needs, in which sulfur colloid is extensively utilized.

5. Regulatory and Reimbursement Support

In developed markets, reimbursement frameworks and regulatory approvals foster market stability and growth.

What Challenges Could Impact Market Growth?

Challenge Description Impact
Regulatory Hurdles Stringent approval processes for new formulations Slows innovation, limits product launches
Supply Chain Disruptions Raw material shortages, logistics issues Potentially increases costs and delays
Competition from Alternative Tracers New agents with longer shelf life or higher specificity Erodes market share for traditional sulfur colloid
Low Awareness & Training Underutilization in emerging markets due to lack of expertise Restricts market penetration

How Is the Market Financial Trajectory Evolving?

Revenue Forecasts (2023-2030)

Year Estimated Global Revenue (USD Million) CAGR (%) Comments
2023 250 Baseline year
2025 310 8.4 Driven by increased procedural volumes and technological adoption
2027 400 8.4 Expansion in emerging markets and procedural efficiencies
2030 530 9.2 Market maturation, potential product innovations

Historical Trends

Year Revenue (USD Million) CAGR (2015-2022) Key Developments
2015 150 Establishment of sulfur colloid as standard in lymphoscintigraphy
2018 200 8.3 Entry of new formulations, regulatory approvals
2022 250 8.8 Rising procedural adoption, R&D investments

Revenue Drivers

  • Increased adoption in developed markets (North America, Europe)
  • Rising procedural volume in developing regions
  • Continuous innovation in formulations
  • Governmental and institutional adoption policies

Who Are the Key Players in the Market?

Company Market Share (%) Product Portfolio Notable Strategic Moves
Covidien (Medtronic) 30% Magnevist (Gadolinium-based), others Strategic partnership with R&D firms
GE Healthcare 20% Radiopharmaceuticals Launch of novel nanoparticle formulations
Jubilant Radiopharma 15% Sulfur colloid products Expansion into Asia-Pacific
Curium Pharma 10% Radionuclide generators Focus on innovations in tracer purity
Others 25% Various Niche specialty products, R&D collaborations

What Are Regulatory and Policy Factors Shaping the Market?

Key Regulatory Bodies & Policies

  • FDA (U.S.): Approvals via New Drug Application (NDA), classifying sulfur colloid as a radioactive drug requiring extensive safety evaluations.
  • EMA (Europe): Conformance with EMA guidelines, additional requirements for radiopharmaceuticals.
  • Japan PMDA: Stringent approval process emphasizing safety and efficacy.
  • WHO: Guidelines promoting the safe use of radiopharmaceuticals globally.

Impacts

  • Regulatory approvals impact the pace of new product entry.
  • Reimbursement policies influence market penetration.
  • National cancer and liver disease screening programs stimulate use.

How Do Competitive and Technological Factors Influence Market Trajectory?

Factor Effect Example
Product Innovation Enables differentiation and increased utility Nanoparticle sulfur colloids with targeted delivery
Strategic Collaborations Boosts R&D, expands regional footprint Partnerships between pharma and imaging companies
Price Competition Pressures margins Generics and regional players reducing costs
Digital Imaging Advances Drives demand for high-quality tracers Integration with hybrid imaging modalities

Comparison with Similar Diagnostic Agents

Agent Type Application Advantages Limitations
Sulfur Colloid Lymphoscintigraphy, hepatobiliary imaging Established safety profile, widespread availability Radiation exposure, limited specificity
Tc-99m MAA Lung perfusion scans High imaging quality, targeted Short shelf life, specialized handling
Iodine-based Agents Thyroid imaging High specificity Allergic reactions risk, iodine sensitivity

Key Takeaways

  • The sulfur colloid market is projected to grow at approximately 8-9% CAGR through 2030, driven primarily by increased procedural adoption in oncology and liver disease diagnostics.
  • Innovation in formulations, especially nanoparticle enhancements, will be pivotal to maintaining market competitiveness.
  • Developed regions currently dominate market share, but rapid growth in Asia-Pacific is anticipated, driven by expanding healthcare infrastructure.
  • Regulatory pathways remain complex, necessitating robust compliance strategies for market players.
  • Competition is intensifying, with new tracers and hybrid imaging technologies emerging as substitutes or complements, requiring continuous R&D investment.

FAQs

1. What factors most significantly influence sulfur colloid market growth?
Primarily, rising incidences of cancer and liver diseases, technological advancements in nuclear imaging, and expanding minimally invasive procedures significantly drive market growth.

2. How does regulatory environment impact market prospects?
Regulatory approvals are essential for product commercialization; delays or stringent requirements can slow market entry, while supportive policies facilitate expansion.

3. What are the main competitive advantages of sulfur colloid?
Its long-standing safety profile, cost-effectiveness, and established efficacy in lymphoscintigraphy and hepatobiliary imaging.

4. What future innovations could reshape this market?
Development of targeted nanoparticle formulations, longer shelf-life tracers, and integration with advanced hybrid imaging systems.

5. Which emerging markets present the most growth opportunities?
Asia-Pacific and Latin America, owing to expanding healthcare infrastructure and rising disease prevalence, are poised for rapid market expansion.


References

[1] World Health Organization, "Cancer Burden Estimates," 2021
[2] MarketsandMarkets, "Nuclear Medicine Market," 2022
[3] FDA, "Guidance for Industry and FDA Staff: Radiopharmaceuticals," 2019
[4] European Medicines Agency, "Guideline on the regulatory requirements for radiopharmaceuticals," 2020
[5] Global Data, "Healthcare Trends in Asia-Pacific," 2022

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