GHRH

DUBLIN--( BUSINESS WIRE )--The "United States Endometriosis and Uterine Fibroids Market (2024 Edition): Analysis By Drug Type, By Route of Administration, By Distribution Channel, By Region, By Country: Market Insights and Forecast (2020-2030)" report has been added to ResearchAndMarkets.com's offering. The United States Endometriosis and Uterine Fibroids Market showcased growth at a CAGR of 4.09% during 2020-2023. The market was valued at USD 415.70 Million in 2023 which is expected to reach USD 568.07 Million in 2030. The research report provides a complete analysis for the historical period of 2020-2023, the estimates of 2024 and the forecast period of 2025-2030. The United States has been experiencing a significant boom in recent years, driven by growing prevalence of the disease due to technological advancements in the diagnostics techniques in the United States, increased awareness towards reproductive disorders, and increased expenditure of capital in the Research and Development organizations in the United States. Due to the limited number of drugs available for the treatment of Endometriosis and Uterine Fibroids, it becomes imperative to find novel treatment outcomes for enhancing the quality of life of the patients. Surgical removal of the fibroids is the only effective treatment option available for treating the disease. However, many females prefer drug therapies over surgical procedures as they are non-invasive. Endometriosis, on the other hand not only affects the uterus but, it also spreads to other reproductive organs, if not treated properly. Increased investments by pharmaceutical companies on exploring the efficacy of different classes of hormonal drugs can pave way for a new drug in the market through different routes of administration such as oral, and parenteral. The emergence of newer technologies such as nanocarrier delivery of drugs, skin patches for epidermal drug delivery have increased the preference for drug therapies in the United States. The landscape of drug development in United States has changed dramatically. Precision medicine has emerged as a result of the elimination of conventional treatment options available for endometriosis and uterine fibroids. Clinicians can prescribe medications based on the clinical presentation, genetic profile, and the severity or stage of endometriosis. Scientists have focused their research on developing tailored medicines for the treatment of endometriosis and uterine fibroids by utilising high resolution omics data and meta-analysis of disease profile. New avenues in the research and development for endometriosis and uterine fibroids treatment have been made possible by incorporating artificial intelligence and machine learning in drug manufacturing processes. Various distribution channels such as Hospital pharmacies, retail pharmacies or online pharmacies offers widespread delivery of medicine to the consumers especially for those living in remote areas or facing time constraints. In the coming years, the online channels have the potential to elevate the market sales of drugs. Furthermore, the use of biodegradable implants for delivering hormonal drugs such as progesterone, Gonadotrophin releasing hormone agonists, and Gonadotrophin releasing agonists is one of the trends in the United States endometriosis and uterine fibroid market. These biodegradable implants are biocompatible and non-invasive in nature. In addition to these benefits, drug implants consume less time and can be implemented in the case of controlling the symptoms associated with the diseases. Scope of the Report The report analyses the Global, Americas and United States Endometriosis and Uterine Fibroids Market by Value (USD Million). The report includes a detailed assessment of United States Endometriosis and Uterine Fibroids Market by Value (USD Million). The report analyses the United States Endometriosis and Uterine Fibroids Market by Epidemiology. The report analyses the United States Endometriosis and Uterine Fibroids Market by Pipeline Scenario. The report presents the analysis of United States Endometriosis and Uterine Fibroids Market for the historical period of 2020-2023, the estimated year 2024, and the forecast period of 2025-2030. The report analyses the United States Endometriosis and Uterine Fibroids Market, By Drug Type (GnRH Antagonists, Progesterone, GnRh Agonist and Others). The report analyses the United States Endometriosis and Uterine Fibroids Market By Route of Administration (Oral and Parenteral). The report analyses the United States Endometriosis and Uterine Fibroids Market By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies). The key insights of the report have been presented through the frameworks of SWOT and Porter's Five Forces Analysis. Also, the attractiveness of the market has been presented By Drug Type, by Route of Administration & by Distribution Channel. Also, the major opportunities, trends, drivers, and challenges of the industry has been analyzed in the report. The report tracks competitive developments, strategies, mergers and acquisitions and new Drug development. Analyst Recommendations Augment the availability of combinational drugs Escalate Distribution through Online services Competitive Positioning Companies Product Positioning Market Position Matrix Market Share Analysis of United States Endometriosis and Uterine Fibroids Market Company Profiles AbbVie Inc. Pfizer Inc. AstraZeneca plc. Tolmar Inc. Glenmark Pharmaceuticals Ltd. Aspen Pharmacare Holdings Ltd. Agile Therapeutics Inc Medicines 360 Cipla Ltd Takeda Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/giumio About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Pictured: FDA's signage outside its office in Maryland/iStock, hapabapa The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday. In its Refusal to File letter, the regulator said that the application did not contain sufficient details to warrant a “substantive review,” according to the announcement. In particular, the FDA indicated that Theratechnologies had not provided data to establish “the pharmacokinetic bridge between the [intramuscular (IM)] and the intravenous infusion route of administration of Trogarzo.” Theratechnologies CMO Christian Marsolais in a statement said that while the company is “disappointed” with the FDA’s decision, it did not necessarily come as a surprise. “We were aware that the approval of this sBLA for Trogarzo IM administration could be challenging based on the results shared in October 2023 from the TMB-302 study.” TMB-302 enrolled 21 study participants, seven of whom had HIV. Study results showed that mean trough concentrations of Trogarzo exceeded 15 µg/mL, indicating that the intramuscular injection could sustain drug levels above the therapeutic threshold of 0.3 µg/mL. Trough concentrations were also comparable between patients who received intravenous and intramuscular infusions. Additionally, all HIV-positive participants were able to maintain viral suppression throughout the study period, regardless of Trogarzo’s route of administration. However, TMB-302 missed its primary endpoint with the 90% confidence interval of the ratio of Trogarzo’s intramuscular to intravenous doses falling short of equivalence limits. “We will now assess our options regarding this application,” Marsolais said. Trogarzo is a long-acting humanized monoclonal antibody that works by binding to the CD4 surface protein, which is found on immune cells. This mechanism of action allows Trogarzo to block HIV-1 from entering its target host cells without compromising the function of the body’s immune system. Trogarzo was approved in October 2022 for the intravenous treatment of heavily pretreated HIV-1 patients, in combination with other antiretroviral therapies. Tuesday’s Refusal to File letter continues Theratechonologies’ regulatory setbacks. Last month, the FDA declined to approve the biotech’s F8 formulation for tesamorelin, which it was proposing for the reduction of excess abdominal fat in patients with HIV and lipodystrophy. Tesamorelin is a peptide therapeutic mimicking the growth hormone-releasing factor. It is approved in an F4 formulation, which is four times more concentrated than the original tesamorelin product. In the FDA’s Complete Response Letter, it flagged problems with Theratechnologies’ chemistry, manufacturing and controls for the F8 formulation, especially in terms of product purity and the stability of the lyophilized product. The regulator also requested additional information regarding the immunogenicity risk of a more concentrated tesamorelin formulation. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Pictured: FDA signage at its office in Maryland/iStock, hapabapa The FDA has denied approval of Theratechnologies’ F8 formulation of tesamorelin, which the Canadian biotech was proposing to reduce excess abdominal fat in patients with HIV and lipodystrophy, the company announced Wednesday. In its Complete Response Letter, the regulator pointed to issues regarding tesamorelin’s chemistry, manufacturing and controls, particularly regarding impurities, microbiological assays the stability of the lyophilized drug as well as the final reconstituted product. The FDA is also seeking additional information on the potential effects of the more concentrated formulation of tesamorelin on immunogenicity risk. Theratechnologies CMO Christian Marsolais said in a statement that the company is “disappointed” by the FDA’s rejection but that it will “address these new comments as swiftly as possible.” “We remain focused to bringing this new formulation of tesamorelin to market as part of our commitment to innovate and simplify treatments for people with HIV,” Marsolais said. Tesamorelin is a peptide therapeutic that mimics the growth hormone-releasing factor. The treatment works by stimulating the pituitary gland to create and release growth hormone, which in turn facilitates lipolysis and breaks down abdominal fat. It first won the FDA’s approval in 2010 and an F4 formulation—which is four times more concentrated than the original drug product—cleared the regulatory hurdle in November 2018 and is being sold as Egrifta SV. Theratechnologies was hoping to bring an even more concentrated formulation of tesamorelin to the market, which would allow smaller administration volumes. The Montreal-based company was planning to sell the F8 version under the brand name Egrifta MDV, which would be available as multiple-dose vials that could be reconstituted just once weekly. The company backed its supplemental Biologics License Application—which it filed in September 2023—with pharmacokinetic data demonstrating the bioequivalence of the F8 formulation with the original F1 formulation. The FDA had an initial target action date of Jan. 22, 2024, but the regulator wrote to Theratechnologies on Tuesday notifying them of a delay in the review process. The CRL came a day later. Wednesday’s rejection will not affect Egrifta SV, which is the only FDA-approved treatment to cut abdominal fat in HIV patients with lipodystrophy, according to Theratechnologies’ announcement. Beyond the tesamorelin product line, Theratechnologies also sells Trogarzo (ibalizumab-uiyk), a long-acting injectable anti-CD4 monoclonal antibody approved for the treatment of HIV-1 in heavily pre-treated adults in combination with other antiretrovirals. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.