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5 days ago
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IgG4-Related Disease Market Insights, Epidemiology, and Forecast to 2034: UPLIZNA and Obexelimab Expected to Compete Strongly
Dublin, June 03, 2025 (GLOBE NEWSWIRE) -- The "IgG4-Related Disease - Market Insight, Epidemiology, and Market Forecast - 2034" report has been added to offering. This report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. The report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential. Key Highlights from the Report There were nearly 148,970 diagnosed prevalent cases of IgG4-RD in 7MM in 2024. Among these, the US accounted for the highest number of diagnosed prevalent cases of IgG4-RD. Contrary to the scenario in the US and EU4, and the UK, there have been multiple studies conducted in Japan stating the diagnosed prevalence; therefore, based on 10-year cumulative diagnosed prevalence estimates from the National Database in Japan, along with evidence around drastic increase in the diagnosis of IgG4 related disease from 2015-2018, there were ~38,690 diagnosed cases in 2024 in Japan. Almost 20-30% of the diagnosed IgG4 patients do not undergo any treatment by systemic therapies, as they opt for either surgery or are under a watchful waiting strategy. There are no specific drugs to cure IgG4-RD due to unclear pathophysiology completely, and no approved therapies are available. The main treatment is corticosteroids like prednisone to manage inflammation and symptoms. If the disease relapses or doesn't respond, immunosuppressants like azathioprine or methotrexate may be used to reduce steroid dependence. Rituximab, an anti-CD20 monoclonal antibody, has also shown effectiveness in controlling inflammation and slowing disease progression. Glucocorticoids remain the first-line therapy. The current constrained pipeline features three emerging therapies: UPLIZNA (Amgen), obexelimab (Zenas BioPharma and Bristol Myers Squibb), and rilzabrutinib (Sanofi). Among these emerging therapies, UPLIZNA and obexelimab are expected to compete with each other strongly. The anticipated April 2025 approval of UPZILNA will transform the IgG4-RD market, marking the first-ever approved therapy for this underserved condition. It will redefine the treatment landscape, drive higher diagnosis rates, and shape commercial dynamics through pricing and physician adoption. However, market education, real-world validation, and future competition will influence its long-term impact. Rilzabrutinib, a Phase II therapy, represents a promising oral therapy targeting B-cell signaling pathways. If approved, it could disrupt the IV/SC biologic market by offering a more convenient, self-administered alternative. In 2024, the total market size of IgG4-RD in 7MM was nearly USD 170 million. The market size is expected to observe significant growth after the approval of potential emerging therapies in the pipeline. IgG4-RD EpidemiologyAs the market is derived using a patient-based model, the IgG4-RD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of IgG4-RD, gender-specific diagnosed prevalent cases of IgG4-RD, and age-specific diagnosed prevalent cases of IgG4-RD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034. In 2024, the total diagnosed prevalent cases of IgG4-RD in the United States were approximately 56,800 cases, projected to increase during the forecast period (2025-2034). In 2024, gender-specific diagnosed prevalent cases accounted for approximately 39,100 and 17,700 cases for males and females, respectively, in the US. The total diagnosed prevalent cases of IgG4-RD in EU4 and the UK were approximately 53,550 in 2024. Males accounted for approximately 38,850 cases, and 14,750 cases in females. We have considered six age groups for the categorization of age groups, i.e., 0-17 years, 18-29 years, 30-44 years, 45-64 years, 65-74 years, and =75 years. As per our analysis, a higher percentage of diagnosed prevalent cases was observed in the age group =75 years in Japan. In 2024, the age-specific diagnosed prevalent cases of IgG4-RD in Japan were approximately 12,800 cases in the age group =75 years. The cases will increase during the forecast period (2025-2034). Drug ChaptersThe drug chapter segment of the IgG4-RD report encloses a detailed analysis of IgG4-RD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IgG4-RD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press Drugs Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers SquibbObexelimab (XmAb5871) is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B-cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered SC injection regimen may broadly and effectively address the pathogenic role of B-cell lineage in chronic autoimmune Zenas is conducting multiple Phase II and Phase III trials of obexelimab in several autoimmune diseases, including IgG4-RD, multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. In August 2023, The Lancet Rheumatology published findings from a Phase II study evaluating obexelimab for the treatment of patients with IgG4-RD. Based on these results, a Phase III study in patients with IgG4-RD is ongoing to investigate further the efficacy and safety of obexelimab administered as an SC (inebilizumab): AmgenUPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). After two initial infusions, patients need one dose of UPLIZNA every 6 months. UPLIZNA is currently approved for the treatment of Neuromyelitis Optica. Currently, the drug has completed its Phase III results, and the FDA has granted a PDUFA action date of April 3, is anticipated to be the first approved cornerstone therapy for managing this complex and often debilitating condition, providing significant benefits to patients while addressing a critical gap in current treatment options for IgG4-RD. In the future, the drug could face competition with the approval of obexelimab, which operates through a bifunctional targeting mechanism of Class InsightsThe current IgG4-RD emerging landscape has only three drugs. Among them, obexelimab (bifunctionally) and UPLIZNA target CD-19. Targeting CD19, a protein found in B cells, shows promise as a treatment for IgG4-RD by depleting B cells, which are thought to play a role in the disease's pathogenesis. Specifically, UPLIZNA, a CD19-targeted antibody, has demonstrated efficacy in reducing flares and achieving remission in IgG4-RD OutlookAs the etiology of IgG4-RD is unclear and still being studied, no particular medications can cure the disease. For people with IgG4-RD, there are no approved treatments on the market at this time. The criteria for identifying the disease caused by IgG4 levels and patient treatment recommendations were recently detailed in the guidelines released by the "International Consensus Guidance Statement on the Management and Treatment of IgG4-RD."Patients with IgG4-RD that are active or untreated typically get glucocorticoids as their first line of therapy. Depending on the severity of the condition and the urgency of the situation, remission induction is frequently started with 30-40 mg/day of prednisone or a weight-adjusted dosage of 0.6 mg/kg of body weight each certain instances, conventional "Disease-Modifying Anti-Rheumatic Drugs" (DMARDs) are utilized to treat IgG4-RD. Plasmablasts are the first cell in any rheumatologic disorder to serve as an effective biomarker, and tailored therapy in B-cell employs total plasmablast concentration to track disease numerous potential therapies are being investigated to manage IgG4-RD, it is safe to predict that the treatment space will experience significant reconstitution during the forecast period. However, the challenges of pricing and reimbursement accompanied by will decide the fate of all these pipeline therapies and the impact they will have on overall revenue players such as Zenas Biopharma, Amgen, and Sanofi are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat IgG4-RD. In 2024, the US captured the highest market share, i.e., nearly USD 90 million out of all the 7MM countries. EU4 and the UK accounted for nearly USD 80 million of the market share, and Germany accounted for the highest share in Europe in 2024. In Japan, the IgG4-RD market size accounted for nearly USD 6 million and is expected to increase at a significant CAGR during the forecast period (2025-2034). The lack of an established regulatory precedent and standardized endpoints for IgG4-RD trials poses approval risks. Additionally, payer resistance to high-cost biologics may slow adoption, especially if off-label rituximab remains a cost-effective alternative. However this will not be an issue in Japan as rituximab is not yet permitted for use to treat IgG4-RD in Japan due to Japanese medical insurance reasons. Key Updates In November 2024, Zenas BioPharma announced the completion of its targeted enrollment for the Phase III INDIGO trial of its lead product candidate, obexelimab, for the treatment of patients with IgG4-RD. In November 2024, Zenas BioPharma announced that the company anticipates reporting topline results for the INDIGO trial by the end of 2025. In August 2024, Amgen announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to UPLIZNA for the treatment of IgG4-RD based on data from the MITIGATE study. In February 2025, Amgen announced that the FDA had accepted the regulatory submission for the Phase III MITIGATE study under priority review, with a PDUFA action date of April 3, 2025. IgG4-RD Drugs UptakeThis section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of IgG4-RD treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human ActivitiesThe report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted ActivitiesThe report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for IgG4-RD emerging ViewsTo keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or IgG4-RD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Massachusetts General Hospital, Hopital La Timone, Harvard Medical School, Hospital Universitari Vall d'Hebron, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, etc., were contacted. Their opinion helps understand and validate IgG4-RD epidemiology and market trends. Reasons to Buy The report will help in developing business strategies by understanding trends shaping and driving IgG4-RD. To understand the future market competition in the IgG4-RD market and an Insightful review of the SWOT analysis of IgG4-RD. Organize sales and marketing efforts by identifying the best opportunities for IgG4-RD in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors. Organize sales and marketing efforts by identifying the best opportunities for the IgG4-RD market. To understand the future market competition in the IgG4-RD market. For more information about this report visit About 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. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Politics
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Illinois may update missing person database policy with bill in Statehouse
SPRINGFIELD, Ill. (WCIA) — A bill overhauling how police respond to a missing persons case is gaining traction in the State Capitol. The proposal would require law enforcement to accept any missing persons cases without any waiting period. Police would also be required to share fingerprints and any DNA they have on the subject with National Databases. Senator Michael Hastings (D-Frankfort), the bill's Senate sponsor, said if this bill passes, no missing persons case will be closed until they are reported and identified, as cases will no longer be closed due to an exhaustion of leads. He also argues more rules will help bring more missing people home. School bus seat belt bill passes Illinois House, heading to Pritzker 'This bill actually makes sure that number one, that they do utilize fingerprints and DNA, that they do report it in the National Database, and that postmortem they have to go ahead and submit the information within seven days of recovery of the body,' Hastings said. Hastings worked with the Cook County Sheriff's Office on the bill. Their office runs Missing Women's Project, which works to locate women who have been missing for at least three years. According to the Department of Justice's National Missing and Unidentified Persons System, Illinois has 461 open missing persons cases, 429 open unidentified persons cases and 93 open unclaimed persons cases. 'Bring Your Own New Clean Energy': a proposed fix for Illinois' power grid shortcomings draws criticism from manufacturers 'Minorities are disproportionately affected by this. Homeless people are affected by this. All of those people have families,' Hastings said. 'And they should know where their loved one is, especially if they are found.' The bill passed the Senate with unanimous support and now heads to the House of Representatives, where it's sponsored by Rep. Bob Rita (D-Blue Island). Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
