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“FcRn Inhibitor Market Forecast”

(Albany, USA) DelveInsight’s FcRn Inhibitor Market Insights report includes a comprehensive understanding of current treatment practices, FcRn Inhibitor emerging, market share of individual therapies, and current and forecasted FcRn Inhibitor market size from 2020 to 2034, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

The FcRn Inhibitor market size is anticipated to increase in the study period due to a direct consequence of an increase in R&D activity in the 7MM. Additionally, the competitive landscape is relatively sparse and the regulatory pathway for approval will likely involve extensive clinical trials to demonstrate safety and efficacy.

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Key Takeaways from the FcRn Inhibitor Market Report

• As per DelveInsight’s analysis, the FcRn market is anticipated to grow at a significant CAGR by 2034.
• The leading FcRn Inhibitor Companies such as argenX, UCB, Immunovant, Johnson & Johnson Innovative Medicine, and others.
• Some of the FcRn Inhibitor therapies include Vyvgart, Rystiggo, Batoclimab and others.
• In the full year 2023, the global net product revenues generated by VYVGART and VYVGART SC were USD 908 million and USD 246 million respectively.
• In April 2025, argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
• In January 2025, Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug Administration (FDA) for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
• In September 2024, Immunovant Announced positive results from its Phase IIa trial of batoclimab in Graves’ Disease. Immunovant also announced alignment with the U.S. FDA and received Investigational New Drug Application (IND) clearance, with a pivotal trial of IMVT-1402 in Graves’ Disease which is also a FcRn inhibitor expected to initiate by December 2024 (Immunovant, 2024).
• In September 2024, Janssen-Cilag International NV, a Johnson & Johnson company, announced the submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking the first approval of nipocalimab for the treatment of people living with gMG.
• In October 2023, UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that ZILBRYSQ® (zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.

Discover which therapies are expected to grab the FcRn Inhibitor market share @ https://www.delveinsight.com/sample-request/fcrn-inhibitor-competitive-landscape-and-market-forecast

FcRn Inhibitor Overview

FcRn inhibitors are a novel class of therapeutic agents targeting the neonatal Fc receptor (FcRn), a protein crucial for regulating the half-life of immunoglobulin G (IgG) antibodies. FcRn normally protects IgG from lysosomal degradation, extending their lifespan in the bloodstream. By inhibiting FcRn, these drugs reduce IgG levels, offering a promising approach to treat autoimmune diseases where pathogenic autoantibodies play a critical role.

Conditions such as myasthenia gravis, pemphigus, and immune thrombocytopenia are characterized by autoantibodies that attack the body’s tissues. FcRn inhibitors lower these autoantibody levels, thereby mitigating disease symptoms. Key FcRn inhibitors in development or recently approved include efgartigimod and rozanolixizumab.

Efgartigimod, approved for generalized myasthenia gravis, has demonstrated significant efficacy in reducing IgG and improving clinical outcomes. Rozanolixizumab, another promising candidate, is being investigated for several autoimmune indications.

These drugs are generally well-tolerated, with common side effects including mild to moderate infections and headaches. The therapeutic potential of FcRn inhibitors is considerable, offering a targeted approach to modulating the immune system with fewer side effects compared to broad immunosuppressants. Ongoing research continues to expand their application, potentially transforming the management of numerous autoimmune conditions.

Learn more about the FDA-approved FcRn Inhibitor @ FcRn Inhibitor Drugs and Therapies

FcRn Inhibitor Treatment Market

The FcRn inhibitor treatment market has witnessed significant growth and attention in recent years due to its potential in addressing various autoimmune diseases and other related conditions. FcRn (neonatal Fc receptor) is a protein found in humans that plays a crucial role in the recycling of Immunoglobulin G (IgG) antibodies, which are important components of the immune system.

FcRn Inhibitor Companies and Drugs

• Vyvgart – argenX
• Rystiggo – UCB
• Batoclimab – Immunovant
• And Many Others

To know more about FcRn Inhibitor clinical trials, visit @ FcRn Inhibitor Companies and Medication

FcRn Inhibitor Market Dynamics

The FcRn Inhibitor market dynamics are anticipated to change in the coming years. The enriching drug pipeline of FcRn Inhibitor holds significant potential for large-scale companies to acquire a substantial market share, especially given the unique and rich emerging pipelines.

Furthermore, many potential therapies are being investigated for the treatment of FcRn Inhibitor, and it is safe to predict that the treatment space will significantly impact the FcRn Inhibitor market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the FcRn Inhibitor market in the 7MM.

The FcRn Inhibitor market dynamics have been evolving rapidly in recent years, driven by advancements in gene editing technology and increasing applications across various industries. FcRn Inhibitor (Clustered Regularly Interspaced Short Palindromic Repeats) technology has revolutionized the field of genetic engineering, offering precise and efficient tools for editing DNA sequences.

Scope of the FcRn Inhibitor Market Report

• Coverage- 7MM
• FcRn Inhibitor Companies– argenx SE (EBR: ARGX), UCB S.A. (EBR: UCB), Immunovant Inc. (NASDAQ: IMVT), and Johnson & Johnson Innovative Medicine, a division of Johnson & Johnson (NYSE: JNJ), among others.
• FcRn Inhibitor Therapies- Vyvgart, Rystiggo, Batoclimab and others.
• FcRn Inhibitor Therapeutic Assessment: FcRn Inhibitor current marketed and emerging therapies
• FcRn Inhibitor Market Dynamics: Attribute Analysis of Emerging FcRn Inhibitor Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• FcRn Inhibitor Unmet Needs, KOL’s views, Analyst’s views, FcRn Inhibitor Market Access and Reimbursement

Discover more about FcRn Inhibitor Drugs in development @ FcRn Inhibitor Clinical Trials and FDA Approvals

Table of Content

1. Key Insights

2. Report Introduction

3. Executive Summary of FcRn Inhibitor

4. Key Events

5. FcRn Inhibitor Market Overview At A Glance

6. Background And Overview

7. FcRn Inhibitor Target Population

8. FcRn Inhibitor Marketed Drugs

9. FcRn Inhibitor Emerging Drugs

10. FcRn Inhibitor Market: The 7MM Analysis

11. FcRn Inhibitor Unmet Needs

12. FcRn Inhibitor SWOT Analysis

13. FcRn Inhibitor KOL Views

14. FcRn Inhibitor Market Access and Reimbursement

15. Appendix

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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“Sjogren’s Syndrome Drugs Market”

(Albany, USA) DelveInsight’s “Sjogren’s syndrome Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Sjogren’s syndrome, historical and forecasted epidemiology as well as the Sjogren’s syndrome market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Sjogren’s syndrome market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage pipeline products will significantly revolutionize the Sjogren’s syndrome market dynamics.

The Sjogren’s syndrome market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Sjogren’s syndrome market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Sjogren’s syndrome treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Sjogren’s syndrome market.

To Know in detail about the Sjogren’s syndrome market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Sjogren’s syndrome Market Insights

Some of the key facts of the Sjogren’s syndrome Market Report:

• The Sjogren’s syndrome market size was valued ~USD 1,900 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
• Novartis and Amgen are leading companies in the Sjogren’s syndrome market, with their drugs CFZ533 (iscalimab) and VIB4920 (dazodalibep) projected to achieve the highest revenue across the 7MM by 2034.
• Across the 7MM, approximately 1.5 million diagnosed prevalent cases of Sjogren’s syndrome were recorded in 2023, with this number anticipated to grow over the forecast period (2024–2034).
• In the US, antigen-specific cases were most commonly associated with auto-antibodies positivity, followed by anti-Ro/SSA positivity and anti-La/SSB positivity in 2023.
• In 2023, the United States recorded the highest number of treated cases of Sjogren’s syndrome, while Japan reported the lowest, with approximately 54,000 treated cases. These figures are projected to increase by 2034.
• Within the EU4 and the UK, Sjogren’s syndrome predominantly affected females, with the United Kingdom reporting the highest number of gender-specific cases in 2023.
• Sjogren’s Syndrome companies working in the treatment market are Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others, are developing therapies for the Sjogren’s Syndrome treatment
• Emerging Sjogren’s Syndrome therapies in the different phases of clinical trials are- R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others are expected to have a significant impact on the Sjogren’s Syndrome market in the coming years.
• In March 2025, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to its investigational therapy, nipocalimab, for treating adults with moderate-to-severe Sjögren’s disease (SjD). This follows the Breakthrough Therapy designation (BTD) received for the same therapy late last year. Presently, there are no advanced treatments approved specifically for this condition.
• In November 2024, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to nipocalimab for treating adults with moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody condition with significant prevalence and no approved advanced treatments available. Nipocalimab is the first investigational therapy to receive this designation for SjD. This marks the second BTD granted for nipocalimab, following the February designation for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).
• In June 2024, Johnson & Johnson reported results from the Phase II DAHLIAS dose-ranging study, where its monoclonal antibody nipocalimab showed significant improvements in Sjögren’s disease (SjD) activity in patients. DAHLIAS is a randomized, multicenter, placebo-controlled, double-blind trial that assessed the effects of nipocalimab in adults with primary SjD, a chronic and debilitating autoimmune disorder.

Learn more about Sjogren’s syndrome treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Sjogren’s syndrome Treatment Market

Sjogren’s syndrome Overview

Sjogren’s syndrome is a chronic autoimmune disorder that primarily targets the body’s moisture-producing glands, leading to symptoms such as dry eyes and dry mouth. Sjogren’s syndrome affects millions of individuals worldwide, with a higher prevalence in middle-aged women. This condition can occur as a primary disease or secondary to other autoimmune disorders like rheumatoid arthritis or lupus. Sjogren’s syndrome is caused by the immune system mistakenly attacking healthy tissues, particularly the salivary and lacrimal glands.

Sjogren’s syndrome symptoms include fatigue, joint pain, and swelling, dry skin, persistent cough, and swollen salivary glands. In severe cases, Sjogren’s syndrome can affect internal organs such as the kidneys, lungs, liver, and nervous system. Diagnosis of Sjogren’s syndrome involves blood tests for autoantibodies like anti-SSA/Ro and anti-SSB/La, as well as eye and salivary gland evaluations.

Sjogren’s syndrome treatment focuses on symptom management, using artificial tears, saliva substitutes, immunosuppressants, and anti-inflammatory medications. Early detection and personalized therapy can improve the quality of life for patients with Sjogren’s syndrome. Ongoing research into Sjogren’s syndrome pathogenesis and innovative therapies offers hope for more effective treatment options in the future. Sjogren’s syndrome requires a multidisciplinary care approach for optimal disease management.

Sjogren’s syndrome Epidemiology Segmentation:

The Sjogren’s syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Sjogren’s syndrome
• Prevalent Cases of Sjogren’s syndrome by severity
• Gender-specific Prevalence of Sjogren’s syndrome
• Diagnosed Cases of Episodic and Chronic Sjogren’s syndrome

Download the report to understand which factors are driving Sjogren’s syndrome epidemiology trends @ Sjogren’s syndrome Epidemiological Insights

Sjogren’s Syndrome Market Outlook

The Sjogren’s Syndrome market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Sjogren’s Syndrome market trends by analyzing the impact of current Sjogren’s Syndrome therapies on the market and unmet needs, and drivers, barriers, and demand for better technology

This segment gives a thorough detail of the Sjogren’s Syndrome market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Sjogren’s Syndrome market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The Sjogren’s syndrome market is driven by several factors, including the rising prevalence of autoimmune disorders, increased awareness and early diagnosis, and advancements in immunology and biologic therapies. As more patients and healthcare professionals recognize the chronic nature and systemic impact of Sjogren’s syndrome, the demand for effective treatment options continues to grow. Ongoing research into disease mechanisms has led to the development of targeted therapies, such as immunomodulators and biologics, which offer hope for improved symptom control and disease management. Additionally, government initiatives and healthcare investments in autoimmune disease research further support market expansion.

However, the Sjogren’s syndrome market also faces significant barriers. One of the primary challenges is the lack of a definitive cure and the limited availability of disease-specific therapies, with most treatments focusing only on symptom relief. Delayed diagnosis due to the overlapping symptoms with other conditions also hinders timely intervention. Furthermore, high costs of biologics, limited reimbursement policies in certain regions, and inadequate clinical trial data for emerging therapies restrict widespread adoption. Despite these obstacles, continued advancements in biotechnology and increased collaborations between pharmaceutical companies and research institutions are expected to address current limitations and drive future growth in the Sjogren’s syndrome market.

According to DelveInsight, the Sjogren’s syndrome market in 7MM is expected to witness a major change in the study period 2020-2034.

Sjogren’s syndrome Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Sjogren’s syndrome market or expected to get launched during the study period. The analysis covers Sjogren’s syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Sjogren’s syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyses recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Sjogren’s syndrome Therapies and Key Companies

• SALAGEN (pilocarpine): ADVANZ Pharma
• EVOXAC (cevimeline): Daiichi Sankyo
• CFZ 533 (iscalimab): Novartis
• VIB4920 (dazodalibep): Amgen
• SOTYKTU (deucravacitinib): Bristol Myers Squibb
• VAY736 (ianalumab): Novartis
• OXERVATE (cenegermin): Dompe Farmaceutici

To know more about Sjogren’s syndrome treatment, visit @ Sjogren’s syndrome Medications and Companies

Sjogren’s syndrome Market Drivers

• Increasing Prevalence
• Advancements in Diagnostics
• Sjogren’s syndrome Pipeline Therapies
• Supportive Regulatory Environment
• Growing Awareness

Sjogren’s syndrome Market Barriers

• Limited Treatment Options
• High Treatment Costs
• Side Effects of Therapies
• Delayed Diagnosis
• Lack of Awareness

Scope of the Sjogren’s syndrome Market Report

• Study Period: 2020–2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Sjogren’s syndrome Companies: Rise Therapeutics, Bristol-Myers Squibb (NYSE: BMY), Resolve Therapeutics, Novartis (SWX: NOVN), Horizon Therapeutics (acquired by Amgen (NASDAQ: AMGN)), Dompé Farmaceutici, Sylentis, OSE Immunotherapeutics (EPA: OSE), Servier, and Johnson & Johnson (NYSE: JNJ), among others.
• Key Sjogren’s syndrome Therapies: SALAGEN (pilocarpine), EVOXAC (cevimeline), CFZ 533 (iscalimab), VIB4920 (dazodalibep), SOTYKTU (deucravacitinib), VAY736 (ianalumab), OXERVATE (cenegermin), and others
• Sjogren’s syndrome Therapeutic Assessment: Sjogren’s syndrome current marketed and Sjogren’s syndrome emerging therapies
• Sjogren’s syndrome Market Dynamics: Sjogren’s syndrome market drivers and Sjogren’s syndrome market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Sjogren’s syndrome Unmet Needs, KOL’s views, Analyst’s views, Sjogren’s syndrome Market Access and Reimbursement

Learn more about the emerging Sjogren’s syndrome therapies & key companies at: Sjogren’s syndrome Clinical Trials and Pipeline Analysis

Table of Contents

1. Sjogren’s syndrome Market Report Introduction

2. Executive Summary for Sjogren’s syndrome

3. SWOT analysis of Sjogren’s syndrome

4. Sjogren’s syndrome Patient Share (%) Overview at a Glance

5. Sjogren’s syndrome Market Overview at a Glance

6. Sjogren’s syndrome Disease Background and Overview

7. Sjogren’s syndrome Epidemiology and Patient Population

8. Country-Specific Patient Population of Sjogren’s syndrome

9. Sjogren’s syndrome Current Treatment and Medical Practices

10. Sjogren’s syndrome Unmet Needs

11. Sjogren’s syndrome Emerging Therapies

12. Sjogren’s syndrome Market Outlook

13. Country-Wise Sjogren’s syndrome Market Analysis (2020–2034)

14. Sjogren’s syndrome Market Access and Reimbursement of Therapies

15. Sjogren’s syndrome Market drivers

16. Sjogren’s syndrome Market barriers

17. Sjogren’s syndrome Appendix

18. Sjogren’s syndrome Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Ankit Nigam
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/ats-conference-coverage

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: Sjogren’s Syndrome Drugs Market 2034: Clinical Trials, Epidemiology, EMA, PDMA, FDA Approval, Revenue, Statistics, Therapies, and Companies by DelveInsight

“IgA Nephropathy Therapeutics Market”

(Albany, USA) DelveInsight’s “IgA Nephropathy Market Insights, Epidemiology, and Market Forecast-2034” report delivers an in-depth understanding of IgA Nephropathy, historical and forecasted epidemiology as well as the IgA Nephropathy market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The IgA Nephropathy market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted IgA Nephropathy market size from 2020 to 2034, segmented by seven major markets. The Report also covers current IgA Nephropathy treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the IgA Nephropathy market.

Request for a Free Sample Report @ IgA Nephropathy Market Forecast

Some facts of IgA Nephropathy Market Report are:

• The total IgA Nephropathy market size in the 7MM and China is approximately USD 500 million in 2022 and is projected to increase during the forecast period (2023–2034).
• In 2022, the IgA Nephropathy Market Size was the highest in the US among the 7MM, accounting for approximately USD 160 million, which is further estimated to increase by 2034.
• Some of the key companies in the IgA Nephropathy therapeutics market include Calliditas Therapeutics AB, Travere Therapeutics, Inc., Omeros Corporation, Novartis, RemeGen, Chinook Therapeutics, Inc., Vera Therapeutics, Inc., Otsuka Pharmaceutical, and others
• IgA Nephropathy is more common in men than women.
• The prevalence is modest in the United States (10–20% of primary glomerulonephritis), higher in some European countries (20–30%) and highest in developed countries in Asia (40–50%).
• A systematic review of biopsy-based studies spanning multiple countries suggests an overall population incidence of at least 2.5 per 100,000. Only one study in this review was from Japan, and most were from Europe and North America.
• According to the surveyed literature, this disorder is thought to follow a benign course in most cases. However, many patients are at risk for slow progression to ESRD, which develops in approximately 15% of patients by 10 years and 20% by 20 years, though these percentages depend on how the disease is defined.
• On May 25, 2024, Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company’s IgA nephropathy (IgAN) portfolio. Atrasentan is an investigational potent and selective oral ETA receptor antagonist, currently in Phase III development for IgAN and early-stage development for other rare kidney diseases. The ALIGN study (NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of atrasentan versus placebo in patients with IgAN at risk of progressive loss of kidney function.
• On May 24, 2024, HI-Bio Presents Positive Interim Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at 61st European Renal Association (ERA) Congress. Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies.
• On May 28, 2024, Vera Therapeutics, Inc. (Nasdaq: VERA) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. The designation is based on an assessment of data from the Phase 2b ORIGIN clinical trial of atacicept for IgAN. Atacicept is an investigational recombinant fusion protein; Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies.

IgA Nephropathy Overview

IgA nephropathy, also known as Berger’s disease, is a kidney disorder characterized by the buildup of immunoglobulin A (IgA) antibodies in the kidneys. This abnormal immune response leads to inflammation and damage to the glomeruli, the filtering units of the kidneys. The exact cause of IgA nephropathy is unclear, but it is believed to involve a combination of genetic predisposition and environmental triggers, such as infections or autoimmune conditions. Patients may initially present with symptoms like blood in the urine (hematuria) or proteinuria, although some individuals may remain asymptomatic for years. Over time, IgA nephropathy can progress to chronic kidney disease and ultimately kidney failure. Treatment aims to manage symptoms, reduce inflammation, and slow disease progression through medications, blood pressure control, dietary changes, and lifestyle modifications. Close monitoring and regular follow-up with a healthcare provider are essential for managing IgA nephropathy effectively.

Learn more about IgA Nephropathy treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ IgA Nephropathy Prevalence

IgA Nephropathy Market

The IgA Nephropathy market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted IgA Nephropathy market trends by analyzing the impact of current IgA Nephropathy therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the IgA Nephropathy market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated IgA Nephropathy market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the IgA Nephropathy market in 7MM is expected to witness a major change in the study period 2020-2034.

IgA Nephropathy Epidemiology

The IgA Nephropathy epidemiology section provides insights into the historical and current IgA Nephropathy patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the IgA Nephropathy market report also provides the diagnosed patient pool, trends, and assumptions.

Explore more about IgA Nephropathy Epidemiology @ IgA Nephropathy Market Dynamics

IgA Nephropathy Drugs Uptake

This section focuses on the uptake rate of the potential IgA Nephropathy drugs recently launched in the IgA Nephropathy market or expected to be launched in 2020-2034. The analysis covers the IgA Nephropathy market uptake by drugs, patient uptake by therapies, and sales of each drug.

IgA Nephropathy Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on IgA Nephropathy market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

IgA Nephropathy Pipeline Development Activities

The IgA Nephropathy report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses IgA Nephropathy key players involved in developing targeted therapeutics.

Request for a sample report to understand more about the IgA Nephropathy pipeline development activities @ IgA Nephropathy Therapies and Drugs

IgA Nephropathy Therapeutics Assessment

Major key companies are working proactively in the IgA Nephropathy Therapeutics market to develop novel therapies which will drive the IgA Nephropathy treatment markets in the upcoming years are Calliditas Therapeutics AB (NASDAQ: CALT), Travere Therapeutics, Inc. (NASDAQ: TVTX), Omeros Corporation (NASDAQ: OMER), Novartis Pharmaceuticals (SWX: NOVN), Chinook Therapeutics, Inc. (NASDAQ: KDNY), Vera Therapeutics, Inc. (NASDAQ: VERA), and Otsuka Pharmaceutical (TYO: 4578), among others.

Learn more about the emerging IgA Nephropathy therapies & key companies @ IgA Nephropathy Clinical Trials and FDA Approvals

IgA Nephropathy Report Key Insights

1. IgA Nephropathy Patient Population

2. IgA Nephropathy Market Size and Trends

3. Key Cross Competition in the IgA Nephropathy Market

4. IgA Nephropathy Market Dynamics (Key Drivers and Barriers)

5. IgA Nephropathy Market Opportunities

6. IgA Nephropathy Therapeutic Approaches

7. IgA Nephropathy Pipeline Analysis

8. IgA Nephropathy Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the IgA Nephropathy Market

Table of Contents

1. Key Insights

2. Executive Summary

3. IgA Nephropathy Competitive Intelligence Analysis

4. IgA Nephropathy Market Overview at a Glance

5. IgA Nephropathy Disease Background and Overview

6. IgA Nephropathy Patient Journey

7. IgA Nephropathy Epidemiology and Patient Population

8. IgA Nephropathy Treatment Algorithm, Current Treatment, and Medical Practices

9. IgA Nephropathy Unmet Needs

10. Key Endpoints of IgA Nephropathy Treatment

11. IgA Nephropathy Marketed Products

12. IgA Nephropathy Emerging Therapies

13. IgA Nephropathy Seven Major Market Analysis

14. Attribute Analysis

15. IgA Nephropathy Market Outlook (7 major markets)

16. IgA Nephropathy Access and Reimbursement Overview

17. KOL Views on the IgA Nephropathy Market

18. IgA Nephropathy Market Drivers

19. IgA Nephropathy Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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Company Name: DelveInsight Business Research LLP
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“MASH Market”

(Albany, USA) DelveInsight’s Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

The MASH market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted MASH market size from 2020 to 2034, segmented by seven major markets. The Report also covers current MASH treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the MASH market.

Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report

• The total MASH market size in the 7MM was approximately USD 2,114 million in 2023 and is projected to increase during the forecast period (2024–2034).

• In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM.
• Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years.
• The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others.
• In March 2024, Madrigal Pharmaceuticals’ groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis.

Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report

Metabolic Dysfunction-Associated Steatohepatitis Overview

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer.

The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition.

MASH is often asymptomatic in its early stages. When MASH symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise.

MASH Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity.

Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation

The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Prevalent Cases of MASH
• Diagnosed Prevalent Cases of MASH
• Gender-specific Diagnosed Prevalent Cases of MASH
• Severity-specific Diagnosed Prevalent Cases of MASH

MASH Treatment Market

The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients’ quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease.

The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient.

To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management

Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies

• Lanifibranor (IVA337): Inventiva Pharma
• Semaglutide: Novo Nordisk A/S
• Azemiglitazone (MSDC-0602K): Cirius Therapeutics
• Efruxifermin (EFX): Akero Therapeutics
• BIO89-100 (Pegozafermin): 89bio
• Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma
• GR-MD-02 (Belapectin): Galectin Therapeutics
• LPCN1144: Lipocine
• VK2809: Viking Therapeutics
• Tirzepatide: Eli Lilly and Company
• BOS-580: Boston Pharmaceuticals
• Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer
• HTD1801: HighTide Biopharma
• Leronlimab (PRO 140): CytoDyn
• Efinopegdutide: Merck & Co./Hanmi Pharmaceutical
• HPG1860: Hepagene (Shanghai)
• Rencofilstat (CRV431): Hepion Pharmaceuticals
• EYP001 (Vonafexor): Enyo Pharmaceuticals
• Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences
• PXL065: Poxel SA
• Saroglitazar Magnesium: Zydus Therapeutics
• Denifanstat (TVB-2640): Sagimet Biosciences
• ION224: Ionis Pharmaceuticals
• Miricorilant (CORT118335): Corcept Therapeutics

Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials and Advancements

MASH Market Dynamics

The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation.

Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM.

However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA’s draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption.

Moreover, MASH treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth.

Download the report to understand which factors are driving MASH drugs and therapies in pipeline @ Metabolic Dysfunction-Associated Steatohepatitis Treatment Market

Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report

• Study Period: 2020–2034
• Coverage: 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
• Metabolic Dysfunction-Associated Steatohepatitis CAGR: 17.9 %
• Metabolic Dysfunction-Associated Steatohepatitis Market Size in 2023: USD 2.1 Billion
• Key Metabolic Dysfunction-Associated Steatohepatitis Companies: Hepion Pharmaceuticals (NASDAQ: HEPG), Ionis Pharmaceuticals (NASDAQ: IONS), Galectin Therapeutics (NASDAQ: GALT), Novo Nordisk A/S (NYSE: NVO), Cirius Therapeutics (Private), HighTide Biopharma (TSX-V: HBT), Boehringer Ingelheim (Private), Hepagene (Private), Eli Lilly and Company (NYSE: LLY), Pfizer (NYSE: PFE), Lipocine (NASDAQ: LPCN), Corcept Therapeutics (NASDAQ: CORT), Poxel SA (EPA: POXEL), Enyo Pharmaceuticals (Private), Akero Therapeutics (NASDAQ: AKRO), Zydus Therapeutics (NSE: ZYDUSLIFE), 89bio (NASDAQ: ETNB), Viking Therapeutics (NASDAQ: VKTX), Boston Pharmaceuticals (Private), Gilead Sciences (NASDAQ: GILD), Merck & Co. (NYSE: MRK), Zealand Pharma (CPH: ZEAL), Hanmi Pharmaceutical (KRX: 128940), Inventiva Pharma (EPA: IVA), CytoDyn (OTCQB: CYDY), Sagimet Biosciences (NASDAQ: SGMT).
• Key Pipeline Metabolic Dysfunction-Associated Steatohepatitis Therapies: Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others
• Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies
• Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL’s views, Analyst’s views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement

Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends

Table of Contents

1. Key Insights

2. Report Introduction

3. Country-wise MASH Market Overview at a Glance

4. MASH Market Overview by Therapeutic Class

5. Methodology of MASH Epidemiology and Market

6. Executive Summary

7. Key Events

8. Disease Background and Overview

9. MASH Epidemiology and Patient Population

10. MASH Patient Journey

11. Marketed MASH Drugs

12. Emerging MASH Drugs

13. MASH Market Analysis

14. Key Opinion Leaders’ Views

15. SWOT Analysis

16. Unmet needs

17. Market Access and Reimbursement

18. Appendix

19. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Ankit Nigam
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/ats-conference-coverage

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: MASH Market Report 2034: Statistics, Revenue, Patient Pool, EMA, PDMA, FDA Approvals, Clinical Trials, Medication, MOA, ROA and Companies by DelveInsight