Technetium tc-99m medronate kit - Generic Drug Details

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

Technetium tc-99m medronate kit is the generic ingredient in five branded drugs marketed by Ge Healthcare, Sun Pharm Inds Inc, Pharmalucence, and Cardinal Health 414, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for technetium tc-99m medronate kit

US Patents:	0
Tradenames:	5
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	2
Clinical Trials:	2
DailyMed Link:	technetium tc-99m medronate kit at DailyMed

Recent Clinical Trials for technetium tc-99m medronate kit

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

Sponsor	Phase
University of Utah	Phase 2
Winnipeg Regional Health Authority	Phase 3
University of Manitoba	Phase 3

See all technetium tc-99m medronate kit clinical trials

Pharmacology for technetium tc-99m medronate kit

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	TECHNETIUM TC 99M MPI MDP	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018141-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	TECHNETIUM TC 99M MPI MDP	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018141-002	Jun 12, 1989		DISCN	No	No
Ge Healthcare	AMERSCAN MDP KIT	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018335-001	Aug 5, 1982		DISCN	No	No
Pharmalucence	OSTEOLITE	technetium tc-99m medronate kit	INJECTABLE;INJECTION	017972-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cardinal Health 414	TECHNETIUM TC-99M MEDRONATE KIT	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018107-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Sun Pharm Inds Inc	CIS-MDP	technetium tc-99m medronate kit	INJECTABLE;INJECTION	018124-001	Approved Prior to Jan 1, 1982	AP	RX	No	No

Technetium tc-99m medronate kit Market Analysis and Financial Projection Experimental

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

Market Overview

Technetium Tc-99m Medronate Kit, a crucial component in nuclear medicine, is used primarily for bone imaging to delineate areas of altered osteogenesis. Here’s a detailed look at the market dynamics and financial trajectory of this essential diagnostic tool.

Market Size and Growth

The Technetium-99m market, which includes the Tc-99m Medronate Kit, is projected to experience significant growth. As of 2023, the global Technetium-99m market was valued at approximately USD 4.95 billion and is expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the Technetium Tc-99m Medronate Kit market:

Increasing Demand for Diagnostic Imaging

The rising demand for advanced nuclear imaging infrastructure, particularly for the detection and treatment of chronic and noncommunicable diseases, is a key driver. Technetium-99m is used in about 85% of all nuclear medicine diagnostic imaging procedures worldwide, with over 110,000 procedures conducted daily, including more than 40,000 in the United States alone[1].

Technological Advancements

Advancements in Single Photon Emission Computed Tomography (SPECT) detector technology are expanding the applications of Tc-99m in preclinical research and improving diagnostic accuracy. This evolution in technology is further fueling the demand for Tc-99m-based radiopharmaceuticals[3].

Healthcare Infrastructure and Expenditure

The expansion of healthcare infrastructure and the rise in per-capita healthcare expenditure globally are significant drivers. Governments are implementing health programs to increase diagnostic imaging and treatment options, which in turn boosts the demand for Technetium-99m[3].

Clinical Applications

Technetium Tc-99m Medronate is specifically used for bone imaging, which is a critical application in diagnosing and managing bone-related disorders. The kit's ability to delineate areas of altered osteogenesis makes it indispensable in clinical practice[5].

Market Segmentation

The Technetium-99m market, including the Tc-99m Medronate Kit, is segmented based on various criteria:

By Application

• Cardiovascular Imaging: Although not the primary use for Tc-99m Medronate, the cardiovascular segment holds the largest market share due to its critical role in myocardial perfusion imaging.
• Bone Scans: This is the primary application for Tc-99m Medronate, used to detect areas of altered osteogenesis.
• Respiratory Imaging
• Tumor Imaging
• Others: Including urinary tract imaging and other diagnostic procedures[1].

By End User

• Hospitals
• Diagnostic Centers
• Others: Such as research institutions and private clinics[1].

Competitive Landscape

The Technetium-99m market is highly competitive, with several key players dominating the landscape:

Major Players

• GE Healthcare
• Siemens Healthineers
• Lantheus Holdings, Inc.
• NorthStar Medical Radioisotopes, LLC
• Medi-Radiopharma

These companies are well-established and have extensive experience in nuclear medicine, advanced technology, and significant market presence[1].

Financial Trajectory

Current Market Value

As of 2023, the Technetium-99m market was valued at USD 4.95 billion[1].

Projected Growth

The market is expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030. This growth is driven by the increasing demand for Tc-99m-based radiopharmaceuticals and advancements in diagnostic imaging technologies[1].

Cost Factors

The production and distribution of Tc-99m radiopharmaceuticals, including the Tc-99m Medronate Kit, involve significant costs. These include the costs of manufacturing Mo-99, the conversion from highly-enriched uranium to low-enriched uranium, and the establishment of a sustainable domestic supply. These costs are often passed through the supply chain to healthcare organizations, which can impact the overall financial trajectory of the market[2].

Regional Analysis

North America

North America, particularly the United States and Canada, holds a significant share of the global Technetium-99m market. This is due to advanced healthcare infrastructure, a high prevalence of chronic diseases, and significant investments in medical imaging technology[1].

Asia Pacific

The Asia Pacific region is also expected to contribute substantially to the market growth, driven by increasing healthcare expenditure and the expansion of healthcare infrastructure[3].

Challenges and Opportunities

Supply Chain Challenges

The reliance on foreign reactors for the production of Mo-99 and the aging reactor fleet pose significant challenges to the supply chain. These issues can lead to production delays and increased costs, affecting the market's financial stability[2].

Innovation and Collaboration

Recent collaborations, such as the one between IBA and NorthStar Medical Radioisotopes, aim to expand global access to Tc-99m. Such innovations and partnerships present opportunities for market growth and stabilization[1].

Key Takeaways

• The Technetium Tc-99m Medronate Kit is a vital component in nuclear medicine, particularly for bone imaging.
• The market is driven by increasing demand for diagnostic imaging, technological advancements, and expanding healthcare infrastructure.
• Major players like GE Healthcare and Siemens Healthineers dominate the market due to their advanced technologies and extensive distribution networks.
• The market is expected to grow significantly, reaching nearly USD 6.54 billion by 2030.
• Regional markets, especially North America, play a crucial role in the global Technetium-99m market.

FAQs

Q: What is the primary use of Technetium Tc-99m Medronate Kit?

A: The primary use of Technetium Tc-99m Medronate Kit is for bone imaging to delineate areas of altered osteogenesis.

Q: How large is the global Technetium-99m market expected to grow by 2030?

A: The global Technetium-99m market is expected to reach nearly USD 6.54 billion by 2030, growing at a CAGR of 4.05% from 2024 to 2030[1].

Q: Which region dominates the Technetium-99m market?

A: North America, particularly the United States and Canada, holds a significant share of the global Technetium-99m market due to advanced healthcare infrastructure and high prevalence of chronic diseases[1].

Q: What are the key drivers of the Technetium-99m market growth?

A: The key drivers include increasing demand for diagnostic imaging, technological advancements in SPECT detector technology, and the expansion of healthcare infrastructure and expenditure[1][3].

Q: Who are the major players in the Technetium-99m market?

A: Major players include GE Healthcare, Siemens Healthineers, Lantheus Holdings, Inc., and NorthStar Medical Radioisotopes, LLC[1].

Sources

1. Maximize Market Research: Technetium-99m Market: Industry Analysis and Forecast 2030
2. Vizient, Inc.: Can the SPECT nuclear imaging modality be sustained?
3. Transparency Market Research: Technetium-99m Market Size, Share, Growth & Overview, 2034
4. DailyMed: Kit for the Preparation of Technetium Tc 99m Medronate for Injection
5. Mallinckrodt: TechneScan MDP Kit for the Preparation of Technetium Tc 99m Medronate Diagnostic for Intravenous Use