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Last Updated: December 23, 2024

Technetium tc-99m sulfur colloid - Generic Drug Details


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

Technetium tc-99m sulfur colloid is the generic ingredient in six branded drugs marketed by Ge Healthcare, Mallinckrodt, Sun Pharm Inds Inc, Jubilant, and Bracco, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for technetium tc-99m sulfur colloid
US Patents:0
Tradenames:6
Applicants:5
NDAs:7
Clinical Trials: 19
DailyMed Link:technetium tc-99m sulfur colloid at DailyMed
Recent Clinical Trials for technetium tc-99m sulfur colloid

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
University of Wisconsin, MadisonEarly Phase 1
OnLume Inc.Early Phase 1

See all technetium tc-99m sulfur colloid clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for technetium tc-99m sulfur colloid

US Patents and Regulatory Information for technetium tc-99m sulfur colloid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant TECHNETIUM TC-99M SULFUR COLLOID KIT technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 213516-001 Nov 9, 2023 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mallinckrodt TECHNETIUM TC 99M SULFUR COLLOID technetium tc-99m sulfur colloid SOLUTION;ORAL 017724-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare TECHNETIUM TC 99M SULFUR COLLOID technetium tc-99m sulfur colloid SOLUTION;INJECTION, ORAL 017456-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare TECHNETIUM TC 99M TSC technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017784-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bracco TESULOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 016923-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mallinckrodt TECHNECOLL technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017059-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Technetium tc-99m sulfur colloid Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Technetium Tc-99m Sulfur Colloid

Introduction

Technetium Tc-99m sulfur colloid is a versatile radiopharmaceutical used in various diagnostic procedures, including lymph node localization, evaluation of peritoneo-venous shunt patency, and imaging of reticuloendothelial cells. Here, we delve into the market dynamics and financial trajectory of this crucial diagnostic agent.

Market Size and Growth

The technetium-99m market, which includes Tc-99m sulfur colloid, has been experiencing steady growth. As of 2023, the technetium-99m market was valued at approximately USD 6.0 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.3% from 2024 to 2034, reaching USD 8.6 billion by the end of the forecast period[3].

Another report indicates that the technetium-99m market size was valued at USD 4.95 billion in 2023 and is expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030[5].

Drivers of Market Growth

Several factors are driving the growth of the technetium-99m market, including:

Increasing Demand for Diagnostic Imaging

The rising demand for advanced nuclear imaging infrastructure for illness detection and treatment is a significant driver. Technetium-99m is used in over 80% of all nuclear medicine procedures in the United States, highlighting its critical role in diagnostic imaging[5].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure, particularly in regions with advanced healthcare systems like North America, is bolstering the demand for technetium-99m. The high prevalence of chronic diseases and significant investments in medical imaging technology are key contributors[5].

Technological Advancements

Advancements in Single Photon Emission Computed Tomography (SPECT) detector technology and the development of new radiopharmaceuticals based on technetium-99m are enhancing diagnostic accuracy and driving market growth. These innovations are leading to more accurate and early disease detection, which in turn increases the demand for technetium-99m[3][5].

Government Health Initiatives

Governments are implementing health programs to increase diagnostic imaging and treatment options, further fueling the demand for technetium-99m. The emphasis on early disease detection and precise imaging techniques is a significant factor in the market's growth[3].

Applications and Segmentation

Technetium Tc-99m sulfur colloid is used in a variety of clinical applications:

Lymph Node Localization

It is used to localize lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma. This application is crucial for understanding the spread of cancer and planning treatment[2][4].

Evaluation of Peritoneo-Venous Shunt Patency

The radiopharmaceutical is administered intraperitoneally to assess the patency of peritoneo-venous (LeVeen) shunts. This helps in managing patients with ascites or other conditions requiring shunt placement[2][4].

Imaging of Reticuloendothelial Cells

Technetium Tc-99m sulfur colloid is used to image areas of functioning reticuloendothelial cells in the liver, spleen, and bone marrow. This is essential for assessing organ function and detecting abnormalities[2][4].

Esophageal Transit and Gastroesophageal Reflux Studies

Oral administration of the radiopharmaceutical is used in studies of esophageal transit and gastroesophageal reflux, as well as for the detection of pulmonary aspiration of gastric contents[2][4].

Market Segmentation

The technetium-99m market is segmented based on application, isotopic services, and end-users:

  • Application: Cardiovascular imaging, bone scans, respiratory imaging, tumor imaging, and others. The cardiovascular segment holds the largest market share due to its critical role in myocardial perfusion imaging[5].
  • Isotopic Services: Gamma camera and Single Photon Emission Computed Tomography (SPECT)[5].
  • End Users: Hospitals, diagnostic centers, and others. North America, particularly the United States and Canada, leads the global market due to advanced healthcare infrastructure and high prevalence of chronic diseases[5].

Financial Trajectory

The financial trajectory of the technetium-99m market is positive, driven by the increasing demand for diagnostic imaging and the expanding use of technetium-99m in various clinical applications.

  • Revenue Growth: The market is expected to grow significantly, with projections indicating a rise from USD 6.0 billion in 2023 to USD 8.6 billion by 2034, and from USD 4.95 billion in 2023 to USD 6.54 billion by 2030[3][5].
  • Investment and Innovation: Continuous innovation in radiopharmaceuticals and imaging technologies is attracting investments, which in turn is driving the market's financial growth. The development of new radiopharmaceuticals based on technetium-99m is expected to increase the demand for this isotope[3][5].

Challenges and Opportunities

While the market for technetium Tc-99m sulfur colloid is growing, there are challenges and opportunities to consider:

Challenges

  • Supply Chain Issues: The production and supply chain of technetium-99m can be complex and vulnerable to disruptions, which can impact market stability[3].
  • Regulatory Frameworks: Strict regulatory requirements and the need for continuous compliance can pose challenges for manufacturers and distributors[2].

Opportunities

  • Emerging Markets: Expanding healthcare infrastructure in emerging markets presents significant opportunities for growth. Governments in these regions are investing heavily in healthcare, which includes advanced diagnostic imaging[3].
  • New Clinical Applications: The development of new clinical applications for technetium-99m, such as in the treatment of chronic and noncommunicable diseases, offers lucrative opportunities for market expansion[3].

Key Takeaways

  • The technetium-99m market, including Tc-99m sulfur colloid, is experiencing steady growth driven by increasing demand for diagnostic imaging and technological advancements.
  • The market is segmented based on application, isotopic services, and end-users, with cardiovascular imaging being a major segment.
  • Financial projections indicate significant revenue growth, driven by investments in healthcare infrastructure and innovation in radiopharmaceuticals.
  • Challenges include supply chain issues and regulatory compliance, while opportunities lie in emerging markets and new clinical applications.

FAQs

What is Technetium Tc-99m Sulfur Colloid used for?

Technetium Tc-99m sulfur colloid is used as a diagnostic agent for various clinical applications, including lymph node localization, evaluation of peritoneo-venous shunt patency, and imaging of reticuloendothelial cells in the liver, spleen, and bone marrow[2][4].

What are the key drivers of the technetium-99m market growth?

Key drivers include increasing demand for diagnostic imaging, expanding healthcare infrastructure, technological advancements in SPECT detector technology, and government health initiatives emphasizing early disease detection and precise imaging techniques[3][5].

What is the projected market size of the technetium-99m market by 2030?

The technetium-99m market is projected to reach approximately USD 8.6 billion by 2034 and USD 6.54 billion by 2030, depending on the source[3][5].

Which region leads the global technetium-99m market?

North America, particularly the United States and Canada, leads the global market due to its advanced healthcare infrastructure and high prevalence of chronic diseases[5].

What are the main challenges facing the technetium-99m market?

Challenges include supply chain issues, strict regulatory requirements, and the need for continuous compliance[3].

Sources

  1. Hung et al., "Filtered Technetium-99m-Sulfur Colloid Evaluated for Lymphoscintigraphy," Journal of Nuclear Medicine, 1995.
  2. FDA Label, "Sulfur Colloid - accessdata.fda.gov," 2019.
  3. Transparency Market Research, "Technetium-99m Market Size, Share, Growth & Overview, 2034," 2023.
  4. DrugBank, "Technetium Tc-99m sulfur colloid," 2015.
  5. Maximize Market Research, "Technetium-99m Market: Industry Analysis and Forecast 2030," 2023.

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