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Last Updated: December 23, 2024

TECHNETIUM TC-99M PYROPHOSPHATE KIT - Generic Drug Details


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

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

Two suppliers are listed for this compound.

Summary for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Recent Clinical Trials for TECHNETIUM TC-99M PYROPHOSPHATE KIT

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

SponsorPhase
Brigham and Women's HospitalPhase 2
Avid RadiopharmaceuticalsPhase 4
The Cleveland ClinicPhase 4

See all TECHNETIUM TC-99M PYROPHOSPHATE KIT clinical trials

Pharmacology for TECHNETIUM TC-99M PYROPHOSPHATE KIT

US Patents and Regulatory Information for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco PHOSPHOTEC technetium tc-99m pyrophosphate kit INJECTABLE;INJECTION 017680-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Curium TECHNESCAN PYP KIT technetium tc-99m pyrophosphate kit INJECTABLE;INJECTION 017538-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc CIS-PYRO technetium tc-99m pyrophosphate kit INJECTABLE;INJECTION 019039-001 Jun 30, 1987 AP RX 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 PYROPHOSPHATE KIT Market Analysis and Financial Projection Experimental

Technetium Tc-99m Pyrophosphate Kit: Market Dynamics and Financial Trajectory

Introduction

Technetium Tc-99m Pyrophosphate Kit is a crucial diagnostic tool in nuclear medicine, widely used for various imaging applications, including bone scans, cardiac imaging, and the detection of gastrointestinal bleeding. This article delves into the market dynamics and financial trajectory of this essential radiopharmaceutical.

Market Size and Growth

The Technetium-99m market, which includes the Tc-99m Pyrophosphate Kit, is projected to experience significant growth. As of 2023, the total Technetium-99m market size was valued at USD 4.95 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030[1].

Key Applications

The Tc-99m Pyrophosphate Kit is utilized in several critical diagnostic applications:

Cardiovascular Imaging

Cardiovascular imaging, particularly myocardial perfusion imaging (MPI), is one of the largest market segments for Tc-99m. This technique assesses blood flow in the heart and is essential for diagnosing cardiovascular diseases. The cardiovascular segment held the largest market share in 2023 due to its critical role in these procedures[1].

Bone Scans

The kit is also used for bone imaging to demonstrate areas of altered osteogenesis. This application is vital for diagnosing bone-related disorders and monitoring bone health[5].

Respiratory and Tumor Imaging

In addition to cardiovascular and bone imaging, Tc-99m Pyrophosphate is used in respiratory and tumor imaging, further expanding its market reach[1].

Regional Market Dynamics

North America

North America, particularly the United States and Canada, leads the global market for Technetium-99m. The region's advanced healthcare infrastructure, high prevalence of chronic diseases, and significant investments in medical imaging technology contribute to its dominant position. In the U.S., Tc-99m is used in more than 80% of all nuclear medicine procedures[1].

Emerging Markets

Emerging markets, such as China, present significant growth opportunities. The demand for reliable and cost-effective diagnostic tools like Tc-99m-based Single Photon Emission Computed Tomography (SPECT) imaging is increasing in these regions due to rapid healthcare infrastructure development[1].

Supply Chain and Availability

The supply chain for Tc-99m is prone to disruptions, which can lead to shortages and impact patient care. Economic pressures and insufficient investment in infrastructure contribute to these disruptions. However, emerging players in the market have opportunities to capitalize on this scenario by focusing on supplying and innovating within the SPECT imaging space[1].

Financial Considerations

Cost and Reimbursement

The cost of Tc-99m Pyrophosphate Kits varies, with different kits offering different pricing and reimbursement scenarios. For example, in Canada, the UltraTag kit is the most expensive but offers superior image quality, while pyrophosphate and gluceptate kits are less expensive but may have slightly decreased image quality and longer labeling times[2].

Market Value

The global radiopharmaceuticals market, which includes Tc-99m-based products, was valued at USD 5.60 billion in 2023 and is expected to grow to almost USD 11.30 billion by 2030. This growth is driven by the increasing demand for diagnostic procedures using Tc-99m[1].

Technological Advancements

Advancements in Tc-99m radiopharmaceuticals are a key driver of market growth. Ongoing research and development focus on creating new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity. These advancements enable more accurate diagnosis and targeted imaging of various diseases, including cancer, cardiovascular disease, and neurological disorders[1].

Clinical Significance

Tc-99m Pyrophosphate Injection has a specific affinity for areas of osteogenesis and is concentrated in injured myocardium, making it an invaluable tool for diagnosing acute myocardial infarction and other cardiac conditions. Its ability to remain in the blood pool for gated blood pool imaging and detect gastrointestinal bleeding further underscores its clinical significance[5].

Regulatory and Economic Factors

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Tc-99m Pyrophosphate Kits. Health Canada and other regulatory bodies license and monitor the use of these kits, ensuring compliance with safety and efficacy standards[2].

Economic Impact

The economic impact of Tc-99m Pyrophosphate Kits is significant, given their widespread use in diagnostic procedures. The cost-effectiveness of these kits, especially in emerging markets, contributes to their growing demand and market expansion[1].

Patient Impact

Diagnostic Accuracy

Tc-99m Pyrophosphate Kits provide high diagnostic accuracy, enabling early and precise detection of various diseases. This accuracy simplifies the diagnostic process, reducing the need for multiple tests and improving patient outcomes[1].

Safety Profile

The safety profile of Tc-99m Pyrophosphate Injection is favorable, with a relatively low radiation dose to the patient. However, dose selection for elderly patients requires caution due to potential renal function impairment[5].

Future Outlook

The future outlook for the Tc-99m Pyrophosphate Kit market is promising, driven by increasing demand for diagnostic imaging, advancements in radiopharmaceuticals, and growing healthcare infrastructure in emerging markets. As the global healthcare sector continues to evolve, the role of Tc-99m-based radiopharmaceuticals is expected to remain pivotal.

"Technetium-99m radiopharmaceuticals are applied in morphological and dynamic imaging of many organs in the body, to diagnose various diseases. It is estimated that about 25 million diagnostic investigations are performed annually using this single isotope."[4]

Key Takeaways

  • The Technetium-99m market, including the Tc-99m Pyrophosphate Kit, is expected to grow at a CAGR of 4.05% from 2024 to 2030.
  • The kit is widely used in cardiovascular imaging, bone scans, and other diagnostic applications.
  • North America leads the global market, with emerging markets like China presenting significant growth opportunities.
  • Supply chain disruptions can impact availability, but emerging players can capitalize on this by innovating within the SPECT imaging space.
  • Technological advancements and increasing demand for diagnostic procedures drive market growth.
  • The kit has a favorable safety profile and high diagnostic accuracy.

FAQs

Q: What is the projected market size of the Technetium-99m market by 2030?

A: The Technetium-99m market is expected to reach nearly USD 6.54 billion by 2030[1].

Q: What are the primary applications of the Tc-99m Pyrophosphate Kit?

A: The primary applications include cardiovascular imaging, bone scans, respiratory imaging, and tumor imaging[1].

Q: Which region leads the global market for Technetium-99m?

A: North America, particularly the United States and Canada, leads the global market[1].

Q: What are the key drivers of market growth for Tc-99m-based radiopharmaceuticals?

A: The key drivers include the rising demand for Tc-99m-based radiopharmaceuticals, advancements in radiopharmaceuticals, and growing healthcare infrastructure in emerging markets[1].

Q: How does the Tc-99m Pyrophosphate Kit impact patient care?

A: The kit provides high diagnostic accuracy, enabling early and precise detection of diseases, and has a favorable safety profile with a relatively low radiation dose to the patient[5].

Sources

  1. Maximize Market Research: Technetium-99m Market: Industry Analysis and Forecast 2030
  2. Journal of Nuclear Medicine: Evaluation of Available In Vitro 99m Tc-RBC Labeling Techniques
  3. UNM Pharmacy CE: Kit for the Preparation of Technetium Tc 99m Pyrophosphate
  4. IAEA: Technetium-99m Radiopharmaceuticals: Status and Trends
  5. DailyMed: Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection

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