Gadoterate meglumine - Generic Drug Details

What are the generic sources for gadoterate meglumine and what is the scope of freedom to operate?

Gadoterate meglumine is the generic ingredient in three branded drugs marketed by Ge Healthcare, Guerbet, Hainan Poly, and Hengrui Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for gadoterate meglumine

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	15
What excipients (inactive ingredients) are in gadoterate meglumine?	gadoterate meglumine excipients list
DailyMed Link:	gadoterate meglumine at DailyMed

Recent Clinical Trials for gadoterate meglumine

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

Sponsor	Phase
Bayer	Phase 3
Massachusetts General Hospital	Phase 2
Boehringer Ingelheim	Phase 2

See all gadoterate meglumine clinical trials

Pharmacology for gadoterate meglumine

Drug Class	Gadolinium-based Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

US Patents and Regulatory Information for gadoterate meglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-005	Jun 17, 2024	AP	RX	No	No
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-004	Jun 17, 2024	AP	RX	No	No
Ge Healthcare	CLARISCAN	gadoterate meglumine	SOLUTION;INTRAVENOUS	210016-003	Nov 1, 2019	AP	RX	No	No
Hainan Poly	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	218073-003	Jun 17, 2024	AP	RX	No	No
Hengrui Pharma	GADOTERATE MEGLUMINE	gadoterate meglumine	SOLUTION;INTRAVENOUS	215304-003	Apr 11, 2022	AP	RX	No	No

Gadoterate meglumine Market Analysis and Financial Projection Experimental

Gadoterate Meglumine: Market Dynamics and Financial Trajectory

Introduction

Gadoterate meglumine, marketed under the brand name DOTAREM, is a gadolinium-based contrast agent (GBCA) widely used in magnetic resonance imaging (MRI) procedures. Here, we delve into the market dynamics and financial trajectory of this critical medical imaging agent.

Market Drivers

Several factors are driving the growth of the gadoterate meglumine market:

Expanding Healthcare Access

The increasing access to healthcare services in emerging economies has led to a higher demand for diagnostic imaging procedures, including those requiring MRI contrast agents like gadoterate meglumine[1].

Technological Advancements

Advancements in MRI technology and the increasing need for precise diagnostic imaging have boosted the demand for high-quality contrast agents. Gadoterate meglumine, with its macrocyclic and ionic structure, offers superior kinetic and thermodynamic stability, making it a preferred choice among radiologists[2].

Pandemic Impact

Despite the challenges posed by the COVID-19 pandemic, including supply chain disruptions, the demand for gadoterate meglumine has seen significant growth. This is partly due to the critical role of diagnostic imaging in managing pandemic-related health issues[2].

Market Restraints

While the market for gadoterate meglumine is growing, there are several restraints to consider:

Safety Concerns

Gadolinium-based contrast agents, including gadoterate meglumine, carry the risk of nephrogenic systemic fibrosis (NSF) in patients with severe kidney disease. This has led to cautious use and strict guidelines for administration, particularly in patients with impaired renal function[5].

Regulatory Scrutiny

The use of GBCAs is heavily regulated due to safety concerns. Regulatory bodies like the FDA closely monitor the use and safety profiles of these agents, which can impact market growth if new restrictions are imposed[5].

Market Size and Forecast

The market for gadoterate meglumine is expected to grow at a compound annual growth rate (CAGR) of 3 to 5 percent from its current valuation to 2031. This growth is driven by increasing demand in both developed and emerging markets[4].

Geographical Distribution

Gadoterate meglumine is widely used across various regions, including Europe, Asia, Africa, the Middle East, and South America. It has been a leading MR contrast agent globally since its release in 1989 and received FDA approval in the U.S. in 2013[2].

Revenue and Sales

Guerbet LLC, the manufacturer of DOTAREM, reported record-breaking demand in 2021, with the highest monthly shipments since its U.S. release. The company has delivered over 120 million doses in 70 countries, solidifying its position as the number one MR contrast agent globally[2].

Key Players and Market Competition

The market for gadoterate meglumine is dominated by a few key players:

Guerbet LLC

As the manufacturer of DOTAREM, Guerbet LLC is a global leader in medical imaging. The company has a strong presence in the market, with a long history of innovation and commitment to the radiology community[2].

Other Competitors

Other companies in the medical imaging sector, such as Bayer and Takeda, also play significant roles in the market for contrast agents, though they may not be as dominant in the gadoterate meglumine segment[3].

Research and Development

Guerbet LLC invests significantly in research and development, dedicating 10% of its revenue to these efforts. This commitment to innovation helps in maintaining the company's competitive edge and ensuring the continuous improvement of its products[2].

Safety and Efficacy

Gadoterate meglumine is known for its high kinetic and thermodynamic stability, which reduces the risk of adverse reactions compared to other GBCAs. However, it is crucial to follow strict safety guidelines, especially for patients with renal impairment[5].

Market Opportunities

The growing need for advanced diagnostic imaging and the expansion of healthcare services in emerging markets present significant opportunities for the growth of the gadoterate meglumine market.

Emerging Markets

Countries in Asia, Africa, and South America are experiencing rapid growth in healthcare infrastructure, leading to an increased demand for diagnostic imaging services and, by extension, MRI contrast agents[1].

Technological Integration

The integration of AI and digital solutions in medical imaging is expected to enhance the use and efficacy of contrast agents like gadoterate meglumine, further driving market growth[2].

Challenges and Risks

Despite the opportunities, the market faces several challenges:

Supply Chain Disruptions

Global events like the COVID-19 pandemic can disrupt supply chains, affecting the availability of gadoterate meglumine. Companies must be prepared to mitigate such risks to ensure continuous supply[2].

Regulatory Changes

Changes in regulatory policies or the introduction of new safety guidelines can impact the market. Manufacturers must stay compliant with evolving regulations to maintain market share[5].

Financial Performance

Guerbet LLC, the primary manufacturer of DOTAREM, has seen significant financial growth. The company generated €712 million in revenue in 2020 and continues to invest heavily in research and development[2].

Conclusion

The market for gadoterate meglumine is poised for continued growth driven by expanding healthcare access, technological advancements, and the critical role of diagnostic imaging in healthcare. Despite safety concerns and regulatory scrutiny, the market is expected to expand at a CAGR of 3 to 5 percent until 2031.

Key Takeaways

• Growing Demand: Increasing access to healthcare and advancements in MRI technology drive the demand for gadoterate meglumine.
• Safety Concerns: The risk of NSF in patients with severe kidney disease is a significant concern.
• Regulatory Scrutiny: Strict guidelines and regulatory oversight impact market dynamics.
• Market Leaders: Guerbet LLC dominates the market with its flagship product, DOTAREM.
• Financial Growth: The market is expected to grow at a CAGR of 3 to 5 percent until 2031.

FAQs

What is gadoterate meglumine used for?

Gadoterate meglumine is used as a contrast agent in MRI procedures, particularly for brain (intracranial) imaging[5].

Who is the primary manufacturer of DOTAREM?

Guerbet LLC is the primary manufacturer of DOTAREM (gadoterate meglumine)[2].

What are the safety concerns associated with gadoterate meglumine?

The primary safety concern is the risk of nephrogenic systemic fibrosis (NSF) in patients with severe kidney disease[5].

How has the COVID-19 pandemic impacted the market for gadoterate meglumine?

Despite supply chain disruptions, the demand for gadoterate meglumine has seen significant growth due to its critical role in diagnostic imaging during the pandemic[2].

What is the expected growth rate of the gadoterate meglumine market?

The market is expected to grow at a CAGR of 3 to 5 percent until 2031[4].

Sources

1. 360iResearch - Gadoterate Meglumine Market Size & Share 2025-2030
2. PR Newswire - Medical Imaging Leader Reports Record-Breaking Demand for DOTAREM (gadoterate meglumine) Injection
3. Market Research Intellect - Gadopentetate Dimeglumine Sales Market Size and Forecast
4. Market Research Intellect - Gadoterate Meglumine Market Size And Forecast
5. Drugs.com - Gadoterate Injection: Package Insert / Prescribing Info