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Last Updated: December 23, 2024

GALLIUM GA-68 EDOTREOTIDE - Generic Drug Details


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What are the generic sources for gallium ga-68 edotreotide and what is the scope of freedom to operate?

Gallium ga-68 edotreotide is the generic ingredient in one branded drug marketed by Uihc Pet Imaging and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for GALLIUM GA-68 EDOTREOTIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:GALLIUM GA-68 EDOTREOTIDE at DailyMed
Recent Clinical Trials for GALLIUM GA-68 EDOTREOTIDE

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

SponsorPhase
Jiangsu HengRui Medicine Co., Ltd.Phase 3
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterEarly Phase 1

See all GALLIUM GA-68 EDOTREOTIDE clinical trials

US Patents and Regulatory Information for GALLIUM GA-68 EDOTREOTIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Uihc Pet Imaging GALLIUM GA 68 EDOTREOTIDE gallium ga-68 edotreotide SOLUTION;INTRAVENOUS 210828-001 Aug 21, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Uihc Pet Imaging GALLIUM GA 68 EDOTREOTIDE gallium ga-68 edotreotide SOLUTION;INTRAVENOUS 210828-001 Aug 21, 2019 RX Yes Yes ⤷  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

GALLIUM GA-68 EDOTREOTIDE Market Analysis and Financial Projection Experimental

Gallium-68 Edotreotide Market Dynamics and Financial Trajectory

Market Overview

The gallium-68 edotreotide market is a segment of the broader gallium-68 market, which has been gaining significant traction in recent years due to its applications in medical diagnostic procedures, particularly in positron emission tomography (PET) imaging.

Market Value and Growth

The global gallium-68 market, which includes gallium-68 edotreotide, was valued at approximately US$ 100 million in 2020. It is projected to expand at a Compound Annual Growth Rate (CAGR) of about 8% from 2021 to 2031, reaching a market value of around US$ 200 million by 2031[1][4].

Drivers of Market Growth

Increasing Prevalence of Cancer and Neuroendocrine Tumors

The rise in the prevalence of prostate cancer and neuroendocrine tumors (NETs) is a significant driver of the gallium-68 edotreotide market. Over 12,000 people in the U.S. are diagnosed with NETs each year, and this number is expected to increase, driving the demand for diagnostic tools like gallium-68 edotreotide[1][3].

Advancements in Nuclear Medicine

Advancements in nuclear medicine, including the development of new radiopharmaceuticals and improvements in PET imaging technologies, are propelling the market forward. The sensitivity and specificity of gallium-68 radiopharmaceuticals have been validated in numerous clinical trials, further boosting their adoption[1][4].

Healthcare Infrastructure and Technological Advancements

North America, particularly the U.S., is a key market due to its advanced healthcare infrastructure and rapid adoption of new technologies in PET systems. The region's dominance is also driven by the increasing incidence and prevalence of prostate cancer and other cancers, which are expected to rise from 2.28 million cases in 2020 to 3.12 million cases by 2040[3].

Regional Analysis

North America

North America holds the largest market share due to its well-developed healthcare system, high access to advanced medical technologies, and a significant patient population suffering from cancers and NETs. The region is expected to continue dominating the market during the forecast period[1][3].

Europe

Europe is another significant market, driven by the increasing use of gallium-68 radiopharmaceuticals in diagnosing diseases related to cardiology, respiratory, and urology. The market in Europe is anticipated to expand at a high CAGR in the near future[1][4].

Asia Pacific

The Asia Pacific region is expected to grow rapidly due to improvements in healthcare infrastructure, an increase in the incidence of neurological disorders, and a surge in research and development activities. Countries like China and India offer significant opportunities for market expansion[1][4].

Market Segmentation

Application

The global gallium-68 market, including gallium-68 edotreotide, is segmented into oncology, neurology, cardiology, and others. The oncology segment dominated the market in 2020 and is expected to continue this trend due to the increasing number of cancer patients and the introduction of radioisotopes as a prominent treatment procedure[1][4].

Key Players and Growth Strategies

Key players in the gallium-68 edotreotide market include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals. These companies are engaged in research and development to expand their product offerings and customer base. For instance, ITM received marketing authorization for the ready-to-use radiopharmaceutical TOCscan (68Ga-Edotreotide) in Germany, Austria, and France in May 2018[1].

Challenges and Limitations

Short Shelf-Life

One of the significant challenges facing the gallium-68 market is the short half-life of gallium-68, which is 68 minutes. This necessitates careful logistics and handling to ensure the isotope is used effectively before it decays[3].

Radiation Risk

Gallium-68 edotreotide contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. This requires careful handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure[2].

Clinical Studies and Efficacy

The safety and efficacy of gallium-68 edotreotide have been established in clinical studies. For example, two single-center, open-label studies involving 282 patients with known or suspected somatostatin receptor-positive NETs showed high positive and negative percent agreement rates when compared to composite references such as histopathology and other imaging modalities[2].

Financial Projections

Given the projected CAGR of about 8% from 2021 to 2031, the gallium-68 market, including the segment for gallium-68 edotreotide, is expected to see significant financial growth. The market is anticipated to reach US$ 200 million by 2031, up from US$ 100 million in 2020[1][4].

Conclusion

The gallium-68 edotreotide market is poised for substantial growth driven by increasing cancer prevalence, advancements in nuclear medicine, and improvements in healthcare infrastructure. Despite challenges such as the short half-life of gallium-68 and radiation risks, the market is expected to expand significantly over the next decade.

Key Takeaways

  • The global gallium-68 market, including gallium-68 edotreotide, was valued at US$ 100 million in 2020 and is projected to reach US$ 200 million by 2031.
  • The market is driven by the increasing prevalence of cancer and neuroendocrine tumors.
  • North America dominates the market due to advanced healthcare infrastructure and high access to new technologies.
  • The oncology segment is the largest application segment for gallium-68.
  • Key players are investing in research and development to expand their product offerings.

FAQs

Q: What is the primary use of gallium-68 edotreotide?

A: Gallium-68 edotreotide is primarily used in positron emission tomography (PET) for the localization of somatostatin receptor-positive neuroendocrine tumors (NETs)[2].

Q: What is the projected CAGR of the gallium-68 market from 2021 to 2031?

A: The gallium-68 market is projected to expand at a CAGR of about 8% from 2021 to 2031[1][4].

Q: Which region is expected to dominate the gallium-68 market during the forecast period?

A: North America is expected to dominate the gallium-68 market during the forecast period due to its advanced healthcare infrastructure and high adoption of new technologies[1][3].

Q: What are the key challenges facing the gallium-68 market?

A: The key challenges include the short half-life of gallium-68 and the associated radiation risks[3].

Q: Who are the major players in the gallium-68 edotreotide market?

A: Major players include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals[1].

Sources

  1. BioSpace: Gallium-68 Market: Enhanced Research on Applications ... - BioSpace
  2. FDA: GALLIUM Ga 68 EDOTREOTIDE INJECTION - accessdata.fda.gov
  3. The Insight Partners: Gallium-68 Market Forecast to 2030 | Size, Share, Growth
  4. Transparency Market Research: Gallium-68 Market Survey Report 2031
  5. KEGG DRUG: Edotreotide gallium Ga-68 - KEGG DRUG

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