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Last Updated: December 15, 2025

Technetium tc-99m mertiatide kit - Generic Drug Details


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What are the generic drug sources for technetium tc-99m mertiatide kit and what is the scope of patent protection?

Technetium tc-99m mertiatide kit is the generic ingredient in three branded drugs marketed by Curium, Medi-radiopharma, Sun Pharm Inds Inc, and Jubilant Draximage, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for technetium tc-99m mertiatide kit
US Patents:0
Tradenames:3
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 3
DailyMed Link:technetium tc-99m mertiatide kit at DailyMed

US Patents and Regulatory Information for technetium tc-99m mertiatide kit

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Curium TECHNESCAN MAG3 technetium tc-99m mertiatide kit INJECTABLE;INJECTION 019882-001 Jun 15, 1990 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sun Pharm Inds Inc TECHNETIUM TC99M MERTIATIDE KIT technetium tc-99m mertiatide kit INJECTABLE;INJECTION 208994-001 Jul 12, 2019 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Medi-radiopharma TECHNETIUM TC99M MERTIATIDE KIT technetium tc-99m mertiatide kit INJECTABLE;INJECTION 206489-001 Feb 6, 2020 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Jubilant Draximage TECHNETIUM TC 99M MERTIATIDE KIT technetium tc-99m mertiatide kit POWDER;INTRAVENOUS 216820-001 Jan 30, 2023 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Technetium Tc-99m Mertiatide Kit

Last updated: July 28, 2025


Introduction

Technetium Tc-99m Mertiatide Kit, also known as MAG-3, represents a pivotal innovation in nuclear medicine. Used primarily for renal imaging, it provides critical diagnostic data for assessing renal function and blood flow. As the global demand for advanced diagnostic imaging grows, understanding the market dynamics and financial trajectory of Technetium Tc-99m Mertiatide Kits becomes essential for stakeholders across pharmaceutical companies, healthcare providers, and investors.


Market Overview

The Technetium Tc-99m Mertiatide Kit occupies a significant niche within the broader nuclear medicine segment. Its utility in dynamic renal imaging positions it as a preferred radiopharmaceutical owing to its favorable safety profile, high-quality imaging capabilities, and regulatory approvals, particularly in North America and Europe. Market penetration remains high in developed regions; however, emerging markets exhibit substantial growth potential due to increased awareness and healthcare infrastructure expansion.

Key Market Drivers

  • Rising Incidence of Renal Diseases
    The global increase in chronic kidney disease (CKD) and related renal pathologies drives demand for diagnostic tools like Technetium Tc-99m Mertiatide. According to the World Health Organization (WHO), CKD prevalence is accelerating, which correlates with increased utilization of renal scintigraphy.

  • Advancements in Nuclear Imaging Technologies
    Innovations in imaging resolution, reduced radiation doses, and ease of kit preparation bolster the appeal of Technetium Tc-99m Mertiatide, enhancing its clinical adoption.

  • Regulatory Approvals and Reimbursements
    Wide approvals by agencies like the U.S. Food and Drug Administration (FDA) and favorable reimbursement policies facilitate market expansion, especially in North America.

  • Aging Populations
    The geriatric demographic, more susceptible to renal dysfunction, propels demand for diagnostic procedures involving MAG-3.

Market Restraints

  • Supply Chain Limitations
    The short half-life of Technetium-99m (~6 hours) necessitates efficient logistics; any disruptions impact availability and cost.

  • Radiopharmaceutical Competition
    Competing agents such as Renogram agents or alternative imaging modalities (e.g., MRI) may affect its market share.

  • Regulatory and Manufacturing Challenges
    As a radiopharmaceutical, it faces stringent regulatory standards, and the need for specialized manufacturing facilities increases costs.

Competitive Landscape

Major players include:

  • Bracco Diagnostics Inc. and subsidiaries of GE Healthcare: These companies dominate in the supply, leveraging established distribution channels and extensive R&D pipelines.

  • Lantheus Medical Imaging: Known for its innovation and strategic partnerships, pushing for newer formulations and indications.

Emerging regional manufacturers are intensifying competition by focusing on cost-effective local manufacturing, especially in Asia-Pacific markets.


Financial Trajectory and Market Forecast

Historical Revenue Trends

The global renal radiopharmaceuticals market, inclusive of Technetium Tc-99m Mertiatide Kits, was valued at approximately $650 million in 2021 [1]. Within this, the MAG-3 kits account for a dominant share, owing to their widespread clinical acceptance.

Projected Growth

The market is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years (2023-2028), driven by the increasing adoption in emerging markets and technological advancements.

Factors influencing this growth include:

  • Expansion of nuclear medicine infrastructure in Asia-Pacific and Latin America.
  • Innovative radiotracer developments improving imaging accuracy.
  • Regulatory approvals for new indications such as cardiac or whole-body scans, potentially broadening application scope.

Revenue Forecasts

By 2028, the market for Technetium Tc-99m Mertiatide Kits could surpass $1 billion worldwide, with North America and Europe constituting the largest markets, accounting for over 60% combined [2]. The Asia-Pacific region is anticipated to exhibit the fastest growth rate, attributable to expanding healthcare expenditure and increased detection rates of renal diseases.

Pricing and Margins

Pricing strategies are influenced by manufacturing costs, branding, regulatory compliance, and competitive pressures. High upfront R&D costs and recurring logistics expenses challenge profitability, but established market players maintain healthy margins (~15-20%).


Market Challenges and Opportunities

Challenges:

  • Supply chain disruptions, especially considering the global reliance on Technetium-99m derived from aging reactor infrastructure.
  • Regulatory hurdles, notably in regions with differing approval pathways.
  • Competition from alternative imaging agents and modalities.

Opportunities:

  • Development of next-generation kits with improved pharmacokinetics and safety profiles.
  • Expansion into new indications, including cardiac and oncological imaging.
  • Strategic partnerships and licensing agreements to improve global reach, especially in underserved markets.
  • Investment in supply chain resilience, including alternative production methods like non-reactor-based Technetium-99m supply.

Regulatory and Ethical Landscape

Stringent regulations affect manufacturing, distribution, and clinical use. Efforts to transition from reactor-dependent Technetium-99m to cyclotron-produced variants may alter market dynamics, potentially reducing API costs and expanding access [3]. Ethical considerations around radiation exposure and patient safety remain central, influencing market acceptance and policymaking.


Conclusion

The Technetium Tc-99m Mertiatide Kit market is positioned for steady growth, supported by rising diagnostic needs and technological advancements. While supply chain and regulatory challenges persist, strategic innovations and expanding healthcare demands, particularly in developing regions, offer substantial opportunities. Stakeholders must focus on supply chain resilience, regulatory navigation, and product innovation to capitalize on market potential.


Key Takeaways

  • The global market for Technetium Tc-99m Mertiatide Kits is expected to surpass $1 billion by 2028, driven by increasing renal disease prevalence and technological advancements.
  • North America and Europe dominate current sales, but Asia-Pacific presents lucrative growth opportunities.
  • Supply chain disruptions and competition from alternative imaging modalities are key challenges.
  • Innovations, including non-reactor-based Tc-99m production, could significantly impact supply stability and costs.
  • Collaboration with regulatory bodies and expansion into new indications can drive revenue growth and market share.

FAQs

  1. What are the main clinical applications of Technetium Tc-99m Mertiatide Kits?
    Primarily used for renal Dynamic scintigraphy, MAG-3 assesses renal perfusion, drainage, and function, aiding in diagnosing obstructive uropathy and renal impairment.

  2. How does supply chain disruption affect the market?
    Since Tc-99m is derived from aging nuclear reactors, outages or shutdowns can lead to shortages of MAG-3 kits, impacting procurement, escalating prices, and limiting clinical availability.

  3. What regulatory developments could influence the market trajectory?
    Approval of new production methods (e.g., cyclotron-based Tc-99m), and faster pathways for expanded indications, can enhance supply stability and market expansion.

  4. Are there emerging competitors or alternative agents impacting the market?
    While MAG-3 remains dominant, alternative agents like DTPA and emerging imaging modalities such as MRI challenge its market share, especially as they offer different diagnostic advantages.

  5. What strategic moves should manufacturers consider?
    Investing in alternative production infrastructure, forging partnerships for market access in emerging economies, and R&D for next-generation kits are crucial strategies.


References

[1] Global Market Insights. (2022). Nuclear Medicine Radiopharmaceuticals Market Report.

[2] Persistence Market Research. (2021). Renal Radiopharmaceuticals Market Forecast.

[3] IAEA. (2020). Transition from Reactor-based to Cyclotron-based Technetium-99m Supply.

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