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Last Updated: December 12, 2025

TECHNETIUM TC-99M SUCCIMER - Generic Drug Details


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What are the generic sources for technetium tc-99m succimer and what is the scope of freedom to operate?

Technetium tc-99m succimer is the generic ingredient in two branded drugs marketed by Theragnostics and Ge Healthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for TECHNETIUM TC-99M SUCCIMER
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
DailyMed Link:TECHNETIUM TC-99M SUCCIMER at DailyMed
Pharmacology for TECHNETIUM TC-99M SUCCIMER
Drug ClassLead Chelator
Mechanism of ActionLead Chelating Activity

US Patents and Regulatory Information for TECHNETIUM TC-99M SUCCIMER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare MPI DMSA KIDNEY REAGENT technetium tc-99m succimer kit INJECTABLE;INJECTION 017944-001 May 18, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Theragnostics NEPHROSCAN technetium tc-99m succimer POWDER;INTRAVENOUS 214993-001 Feb 18, 2022 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 Succimer

Last updated: August 3, 2025


Introduction

Technetium Tc-99m Succimer, also known by its chemical name DMSA (Dimercaptosuccinic Acid), is a radiopharmaceutical used predominantly in diagnostic imaging procedures involving the kidneys. Its unique properties—efficient renal excretion and high affinity for renal cortex—make it invaluable for detecting renal cortical scarring, function, and certain tumors. As the global healthcare landscape evolves with technological advances and regulatory shifts, understanding the market dynamics and future financial trajectory of Tc-99m Succimer becomes critical for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policy-makers.


Overview of Technetium Tc-99m Succimer

Tc-99m Succimer is a radiopharmaceutical that contains the radioactive isotope technetium-99m (Tc-99m). Known for its suitable half-life (~6 hours) and gamma emission, Tc-99m ensures optimal imaging quality with minimal radiation exposure. The drug is primarily manufactured by specialized radiopharmacies and pharmaceutical companies under strict regulatory standards, including approval from authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Its primary application involves renal cortical imaging to evaluate renal function and scarring, particularly in pediatric populations and patients with urinary tract anomalies. The utility of Tc-99m Succimer in diagnosing renal impairment drives its steady demand in nuclear medicine.


Market Drivers

1. Increasing Prevalence of Renal Disorders

Chronic kidney disease (CKD) affects approximately 10% of the global population, with rising incidence driven by diabetes, hypertension, and aging demographics [1]. Early detection and morphological assessment of renal pathology rely heavily on diagnostic imaging, where Tc-99m Succimer remains a gold standard in nuclear medicine.

2. Growth in Nuclear Medicine Procedures

The global nuclear medicine market is projected to grow at a CAGR of approximately 5-7% from 2022 to 2030 [2]. Tc-99m-based imaging agents account for over 80% of all nuclear medicine procedures owing to their optimal imaging properties and widespread availability.

3. Regulatory Approvals and Reimbursements

While Tc-99m Succimer is FDA-approved in the United States, some regional variations exist concerning reimbursement frameworks. Favorable policies and approvals in emerging markets are anticipated to boost adoption rates further.

4. Technological Advancements and New Indications

Advances such as hybrid imaging modalities (SPECT/CT) improve diagnostic accuracy, thus reinforcing Tc-99m’s relevance. Additionally, research exploring expanded indications—such as detecting certain tumors—could expand the drug's utility.


Market Challenges

1. Supply Chain Constraints

The production of Tc-99m depends on aging nuclear reactors and Mo-99 generators, which generate the molybdenum-99 precursor required for Tc-99m synthesis [3]. Supply shortages periodically impact availability, risking procedural delays.

2. Emergence of Alternative Imaging Agents

Development of PET radiopharmaceuticals (e.g., F-18 compounds) with superior resolution and longer half-lives poses competitive threats, particularly in institutions equipped for PET imaging.

3. Regulatory and Safety Concerns

Stringent regulations governing radiopharmaceutical production and handling increase compliance costs. Additionally, radiation safety concerns may influence institutional adoption.


Financial Trajectory Analysis

1. Market Size and Revenue Streams

Current estimates place the global demand for Tc-99m radiopharmaceuticals (including Succimer) at approximately USD 450–600 million annually [2]. Tc-99m Succimer, as a specialized agent, accounts for a significant, but smaller, share (~USD 50–100 million), with demand tied to regional diagnostic volumes.

2. Pricing Trends and Cost Dynamics

Pricing varies globally, influenced by manufacturing costs, regulatory compliance, and procurement bargaining power. Though patent protections for Tc-99m agents are limited due to their widespread production, market saturation and the commoditization of radiotracers mitigate pricing power.

3. Growth Projections

According to industry reports, the nuclear medicine radiotracer market is expected to grow at a CAGR of approximately 6% through 2027, driven by technological adoption and expanding indications. For Tc-99m Succimer specifically, conservative estimates predict a CAGR of 3-5%, factoring in supply challenges and alternative modalities.

4. Investment and Revenue Opportunities

Pharmaceutical companies investing in production capacity enhancements or new regional markets may see revenue growth aligned with nuclear medicine expansion. The shift towards decentralized radiopharmacy models and new generator technologies could further optimize production costs and margins.


Market Demographics and Regional Insights

  • North America: Dominates the market owing to high procedural volumes, advanced healthcare infrastructure, and regulatory approvals. The U.S. leads with an estimated 60% share of global Tc-99m diagnostic imaging procedures.

  • Europe: Exhibits steady growth, driven by aging populations and expanding nuclear medicine programs.

  • Asia-Pacific: Expected to outperform the global average CAGR owing to increasing healthcare access, investments in nuclear medicine facilities, and rising prevalence of renal diseases.


Impact of Regulatory and Technological Innovations

New regulatory policies play a pivotal role in shaping the market. Initiatives like the U.S. NRC’s approval pathway for boutique radiopharmaceuticals and streamlined approval processes in the EU could accelerate market growth.

Technological evolution, such as improved generator efficiency and targetry innovations, will likely reduce costs and enhance supply resilience, positively impacting the financial trajectory of Tc-99m Succimer.


Strategic Outlook

Long-term prospects for Tc-99m Succimer hinge on stability in reactor operations and supply chains. Innovations in generator technology and alternative production methods, including cyclotron-based Mo-99, are poised to mitigate shortages and reduce pricing volatility.

Furthermore, expanding clinical evidence supporting the agent's efficacy in new indications will open additional revenue streams. Partnering with regional distributors and developing government or private healthcare partnerships can unlock underserved markets.


Key Takeaways

  • Growing demand for renal imaging in response to rising CKD prevalence sustains a steady market for Tc-99m Succimer.
  • Supply chain stability remains a critical determinant of market growth; technological innovations in isotope production are vital.
  • Regional disparities favor North America and Europe but present substantial opportunities in Asia-Pacific.
  • Regulatory advancements and investments in radiopharmacy infrastructure will shape future growth trajectories.
  • Competitive landscape faces challenges from emerging PET agents and alternative diagnostics but retains favor through well-established clinical utility.

FAQs

1. What factors influence the price of Technetium Tc-99m Succimer?
Pricing is primarily affected by production costs, supply chain stability, regulatory compliance costs, and regional procurement negotiations. The commodity nature of Tc-99m, due to its widespread generation, tends to keep prices relatively competitive.

2. How does supply shortage affect the market for Tc-99m Succimer?
Supply disruptions, stemming from reactor outages or Mo-99 shortages, can lead to procedure delays, reduced adoption, and revenue downturns for manufacturers.

3. Are there any emerging alternatives to Tc-99m Succimer in renal imaging?
While PET-based imaging agents (e.g., F-18 labeled compounds) are emerging, issues like higher costs and limited infrastructure hinder widespread adoption. Tc-99m remains the preferred agent due to its accessibility and established clinical efficacy.

4. What regulatory trends could impact the future market for Tc-99m Succimer?
Regulations calling for improved safety, waste management, and process standardization could increase compliance costs but also foster innovations that improve supply and reduce costs.

5. What is the outlook for regional markets such as Asia-Pacific?
The Asia-Pacific region exhibits high growth potential driven by expanding healthcare infrastructure, increasing awareness of nuclear medicine, and government investments. Market dynamics suggest a CAGR surpassing global averages.


Sources

[1] Global Kidney Disease Market Analysis, MarketsandMarkets, 2022.
[2] Global Nuclear Medicine Market Report, Grand View Research, 2022.
[3] Molybdenum-99 Shortage and Its Impact, Nuclear Medicine International, 2022.

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