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Last Updated: December 22, 2024

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GALLIUM GA 68 GOZETOTIDE Drug Patent Profile


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Which patents cover Gallium Ga 68 Gozetotide, and what generic alternatives are available?

Gallium Ga 68 Gozetotide is a drug marketed by Univ Ca Los Angeles and Univ Of Ca San Fran and is included in two NDAs.

The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

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Summary for GALLIUM GA 68 GOZETOTIDE
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SponsorPhase
Novartis PharmaceuticalsPhase 3
Mayo ClinicPhase 3
University of California, San FranciscoPhase 1/Phase 2

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Pharmacology for GALLIUM GA 68 GOZETOTIDE

US Patents and Regulatory Information for GALLIUM GA 68 GOZETOTIDE

GALLIUM GA 68 GOZETOTIDE is protected by zero US patents and two FDA Regulatory Exclusivities.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Univ Ca Los Angeles GALLIUM GA 68 GOZETOTIDE gallium ga-68 gozetotide SOLUTION;INTRAVENOUS 212642-001 Dec 1, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Univ Of Ca San Fran GALLIUM GA 68 GOZETOTIDE gallium ga-68 gozetotide SOLUTION;INTRAVENOUS 212643-001 Dec 1, 2020 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 GOZETOTIDE Market Analysis and Financial Projection Experimental

Gallium-68 Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Gallium-68 and Its Applications

Gallium-68, a positron-emitting radioisotope, has become a crucial component in medical diagnostic procedures, particularly in the field of nuclear medicine. It is produced from a germanium-68/gallium-68 (68Ge/68Ga) generator and has a half-life of 68 minutes. One of the most notable applications of Gallium-68 is in the form of Gallium Ga 68 Gozetotide Injection, used primarily for imaging in prostate cancer diagnosis.

Market Size and Growth Projections

The global gallium-68 market is projected to experience significant growth over the next few years. As of 2022, the market was valued at approximately $782.36 million and is expected to reach $1,070.34 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.0% during the forecast period[1][3][4].

Key Drivers of Market Growth

Several factors are driving the growth of the gallium-68 market:

Increase in Prevalence of Prostate Cancer and Neuroendocrine Tumors

The rising incidence and prevalence of prostate cancer and neuroendocrine tumors are major drivers. According to the International Agency for Research on Cancer (IARC), the number of cancer cases in the US is expected to increase from 2.28 million in 2020 to 3.12 million by 2040, which will boost demand for nuclear imaging techniques[1][3][4].

Advancements in Nuclear Medicine

Advancements in technologies such as hybrid imaging, the introduction of novel radiopharmaceuticals, and the development of molecular imaging techniques based on the tracer principle are significantly contributing to the growth of the gallium-68 market[1][3][4].

Theranostics and Precision Medicine

The increasing emphasis on theranostics, which combines diagnostic testing with targeted therapy, presents a promising opportunity for gallium-68. Using gallium-68 with therapeutic radiopharmaceuticals like lutetium-177 offers a personalized cancer treatment and management approach[3].

Market Segmentation

By Application

The gallium-68 market is segmented into various applications, with oncology holding the largest market share. The oncology segment is further subsegmented into prostate cancer, neuroendocrine tumors, and others. Prostate cancer diagnosis, particularly using Gallium Ga 68 Gozetotide Injection, is a significant area of application[1][3][4].

By End User

The market is also segmented by end user, with hospitals holding the largest share. Diagnostic and imaging centers are other key end users. Hospitals are anticipated to register the highest CAGR during the forecast period[1][3][4].

Geographical Analysis

North America

In 2022, North America held the largest gallium-68 market share, driven by advancements in nuclear medicine technologies, access to advanced healthcare infrastructure, and the rising incidence of prostate cancer. The US, in particular, has seen significant growth due to these factors[1][3][4].

Asia Pacific

The Asia Pacific region is expected to register the highest CAGR during the forecast period, driven by economic growth, improved healthcare facilities, and increasing consumer awareness in countries like India and China[3][5].

Challenges and Limitations

Short Half-Life of Gallium-68

One of the significant challenges facing the gallium-68 market is the short half-life of the isotope, which complicates its production, storage, and distribution. This limitation can impede market growth despite the high demand for nuclear imaging techniques[1][3][4].

Recent Developments and Innovations

FDA Approvals and Patents

Recent developments include FDA approvals for supplementary New Drug Applications (sNDAs) for products like Illuccix (Ga-68 gozetotide injection preparation kit) for the screening and staging of prostate cancer. Additionally, Ariceum Therapeutics was granted US and Canadian patents for its Gallium-68 radiopharmaceutical production kit, simplifying the production process and increasing the number of patient doses that can be produced[4].

Technological Advancements

Companies like Eckert & Ziegler Radiopharma GmbH are expanding their Gallium-68 Generator portfolios, offering generators with extended shelf lives and higher elution capacities. These advancements are expected to enhance the availability and efficiency of gallium-68 for diagnostic purposes[4].

Financial Trajectory

The financial trajectory of the gallium-68 market is positive, with a projected growth from $782.36 million in 2022 to $1,070.34 million by 2030. This growth is driven by increasing demand for nuclear imaging, particularly in oncology, and advancements in theranostics and precision medicine.

Key Players and Market Competition

Key players in the gallium-68 market include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals. These companies are investing in research and development, expanding their product portfolios, and adopting inorganic growth strategies to maintain their market positions[5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the gallium-68 market, particularly in terms of reduced demand due to stringent regulations and the redirection of healthcare resources towards COVID-19 patients. However, the market is expected to recover as healthcare systems normalize and the demand for nuclear imaging increases[5].

Conclusion

The gallium-68 market, particularly driven by the application of Gallium Ga 68 Gozetotide Injection, is poised for significant growth. With advancements in nuclear medicine, increasing prevalence of prostate cancer and neuroendocrine tumors, and the integration of theranostics, the market is expected to expand substantially over the next few years.

Key Takeaways

  • The gallium-68 market is projected to grow from $782.36 million in 2022 to $1,070.34 million by 2030 at a CAGR of 4.0%.
  • Oncology, particularly prostate cancer diagnosis, holds the largest market share.
  • North America currently dominates the market, but the Asia Pacific region is expected to register the highest CAGR.
  • The short half-life of gallium-68 is a significant challenge.
  • Recent FDA approvals and technological advancements are driving market growth.

Frequently Asked Questions (FAQs)

1. What is the primary application of Gallium-68 in medical diagnostics?

Gallium-68 is primarily used in the diagnosis of prostate cancer and neuroendocrine tumors through nuclear imaging techniques.

2. What are the key drivers of the gallium-68 market growth?

The key drivers include the increasing prevalence of prostate cancer and neuroendocrine tumors, advancements in nuclear medicine technologies, and the growing emphasis on theranostics and precision medicine.

3. Which region holds the largest market share for gallium-68?

As of 2022, North America holds the largest market share for gallium-68, driven by advanced healthcare infrastructure and the rising incidence of prostate cancer.

4. What are the challenges associated with the use of gallium-68?

The short half-life of gallium-68 is a significant challenge, complicating its production, storage, and distribution.

5. Which companies are key players in the gallium-68 market?

Key players include Siemens Healthineers AG, ITM Isotopen Technologien München AG, Advanced Accelerator Applications (a Novartis AG Company), and Telix Pharmaceuticals.

Cited Sources:

  1. The Insight Partners. "Gallium-68 Market will Record CAGR of 4.0% by 2030."
  2. FDA. "GALLIUM GA 68 GOZETOTIDE Injection."
  3. Research and Markets. "Gallium-68 Market Size and Forecast 2020 - 2030, Global and Regional Analysis."
  4. The Insight Partners. "Gallium-68 Market Forecast to 2030 | Size, Share, Growth."
  5. Transparency Market Research. "Gallium-68 Market Survey Report 2031."

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