4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape
LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD).
As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034.
Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy.
Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development.
To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market
DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies.
The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market.
Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast
Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics.
Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment
CSL Behring's ZEMAIRA
CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD.
Equillium/Biocon's EQ001
EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance.
Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data.
Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market
MaaT Pharma's MaaT013
MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA.
In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD.
medac's MC0518
MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment.
The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models.
Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials
The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total allogenic transplant cases
Total Graft Versus Host Disease Cases
Type-specific Cases of Graft Versus Host Disease
Acute Graft Versus Host Disease Cases by Grading
Acute Graft Versus Host Disease Cases by Organ Involvement
Chronic Graft Versus Host Disease Cases by Grading
Chronic Graft Versus Host Disease Cases by Organ Involvement
Total Treated Cases of Graft Versus Host Disease
Mortality Adjusted Treated Cases of Graft Versus Host Disease
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space.
Related Reports
Graft versus Host Disease Epidemiology Forecast
Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan.
Graft versus Host Disease Pipeline
Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen, among others.
Acute Graft versus Host Disease Pipeline
Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation, among others.
Ocular Graft versus Host Disease Pipeline
Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine, among others.
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.
Contact UsShruti Thakur info@delveinsight.com +14699457679
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4 hours ago
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Treatment Resistant Hypertension Market Set to Transform at a CAGR of 5% with Increasing Diagnosis and Treatment of Resistant Patients along with Approval and Development of Newer Therapies During the Study Period (2020-2034)
The treatment-resistant hypertension (TRH) market is expected to grow in the coming years due to the rising prevalence of uncontrolled hypertension and associated cardiovascular risks. Increasing awareness, improved diagnostic practices, and innovations in combination therapies, as well as device-based interventions, are driving market expansion. LAS VEGAS, July 31, 2025 /PRNewswire/ -- DelveInsight's Treatment Resistant Hypertension Market Insights report includes a comprehensive understanding of current treatment practices, treatment resistant hypertension 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]. Key Takeaways from the Treatment Resistant Hypertension Market Report Resistant hypertension is managed through a combination of nonpharmacological and pharmacological approaches. Resistant hypertension is initially managed with an ACEi or ARB, a CCB, and a long-acting thiazide diuretic; if uncontrolled, spironolactone is recommended as a fourth-line agent, with β-blockers or α-blockers added if further escalation is needed. The diagnosed prevalence of TRH ranges from 10–14% across the 7MM, suggesting a consistent yet notable burden of the condition. In 2024, there were nearly 13 million diagnosed prevalent cases of TRH across the 7MM, with the United States accounting for the highest number, driven by a major contribution by aging population(40+ age group majorly), heightened awareness of hypertension management as leading pharma companies are focusing on treating resistant patients now, along with ian ncrease diagnosis. In the US in 2024, the highest diagnosed prevalence of treatment-resistant hypertension was observed in adults aged 60 and above, while the lowest was seen in the 18–39 age group, reflecting a clear positive correlation between age and hypertension prevalence. According to DelveInsight's analysis, the market size for treatment resistant hypertension was found to be USD 6.8 billion in the 7MM in 2024, and is projected to grow significantly, driven by the anticipated launch of novel therapies and increased adoption of advanced device-based treatments expected to reshape the treatment landscape. TRYVIO, developed by Idorsia Pharmaceuticals, is the first new class of antihypertensive in nearly 40 years, targeting the endothelin pathway by inhibiting ET-1. Approved by the FDA and EMA in 2024 and by the UK's MHRA in January 2025 for use with other drugs in adults with TRH, it was commercially launched in the US in October 2024. With approval still pending in Japan, the market there remains a significant untapped opportunity for future growth. Followed by TRYVIO's launch in 2024, AstraZeneca's Baxdrostat and Mineralys Therapeutics' Lorundrostat are anticipated to enter the US market by 2026. Out of both the therapies, Lorundrostat's pivotal trial interim data is available; however, Baxdrostat's Phase III data is still awaited. Leading treatment resistant hypertension companies developing emerging therapies, such as AstraZeneca, Mineralys Therapeutics, E-Star BioTech, Ionis Pharmaceuticals, Kardigan, Regeneron Pharmaceuticals, Alnylam Pharmaceuticals, Roche, and others, are developing novel treatment resistant hypertension drugs that can be available in the treatment resistant hypertension market in the coming years. The promising treatment resistant hypertension therapies in the pipeline include Baxdrostat (CIN-107), Lorundrostat (MLS-101), MANP, Tonlamarsen (ION904), REGN5381, Zilebesiran (ALN-AGT01), and others. Discover more about the treatment resistant hypertension treatment market @ Treatment Resistant Hypertension Medication Treatment-Resistant Hypertension Market Dynamics The treatment resistant hypertension market dynamics are expected to change in the coming years. Advances in pharmaceuticals and procedures, along with innovations in pharmacogenomics, precision medicine, and digital health platforms, are expanding the landscape of treatment options for TRH by enabling personalized care, enhancing patient engagement and remote management, and necessitating multidisciplinary collaboration among cardiologists, nephrologists, endocrinologists, and other specialists for comprehensive care. Furthermore, potential therapies are being investigated for treatment resistant hypertension, and it is safe to predict that the treatment space will significantly impact the treatment resistant hypertension 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 treatment resistant hypertension market in the 7MM. However, several factors may impede the growth of the treatment resistant hypertension market. Managing TRH often necessitates complex medication regimens and lifestyle modifications, leading to challenges in patient adherence and treatment optimization; however, despite therapeutic advancements, a subset of patients remains resistant to current options, underscoring the need for alternative strategies, even as stringent regulatory and reimbursement hurdles delay new therapy development and adoption, further compounded by the significant economic burden TRH places on healthcare systems, highlighting the urgent need for cost-effective solutions. Furthermore, the treatment resistant hypertension 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 the treatment resistant hypertension market growth. Treatment Resistant Hypertension Treatment Market Resistant hypertension is managed through a combination of lifestyle modifications, pharmacological therapy, and, when necessary, interventional procedures. Key lifestyle changes include maintaining a healthy weight through regular exercise and a balanced diet, reducing salt intake, limiting alcohol consumption, and quitting smoking. Pharmacological treatment typically involves a combination of a renin–angiotensin system inhibitor, a long-acting calcium channel blocker, and a diuretic at the highest tolerable doses, preferably as a single-pill formulation. Spironolactone is currently the preferred fourth-line agent, while alternatives include alpha-blockers, beta-blockers, centrally acting sympatholytics, and vasodilators. For patients whose blood pressure remains uncontrolled despite these strategies, options such as renal denervation and emerging drug therapies should be considered. Lifestyle interventions are particularly important, with a recent meta-analysis identifying them as the most effective non-pharmacologic approach, achieving a reduction in office systolic blood pressure by approximately 7.26 mmHg. Dietary patterns such as the DASH and Mediterranean diets, characterized by high intake of fruits, vegetables, whole grains, and low-fat dairy, and low levels of saturated fats and sugars, have shown proven benefit. Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, offers a promising alternative by blocking aldosterone activity even in its absence. While spironolactone remains the standard add-on therapy, its anti-androgenic effects may limit its use, especially in men or those with hyperkalemia. TRYVIO (aprocitentan) marks a significant advancement as the first antihypertensive from a new drug class in over three decades, targeting the endothelin pathway. Approved by the FDA in early 2024, TRYVIO is a convenient once-daily oral therapy that simplifies prescribing and adherence. The removal of the REMS requirement by the FDA signals increased confidence in its safety. Though it's now available for patients at high cardiovascular risk, fluid retention, reported in 18% of patients at higher doses, which may affect its adoption compared to existing options. While Idorsia has not yet revealed a global commercialization partner, the positive Phase III outcomes indicate strong market potential for TRYVIO. To know more about FDA-approved drugs for treatment resistant hypertension, visit @ Treatment Resistant Hypertension Treatment Treatment Resistant Hypertension Pipeline Therapies and Key Companies Several TRH drugs with different mechanisms of action that are in development are aldosterone synthase inhibitors (baxdrostat, lorundrostat), Guanylyl Cyclase A (GC-A) receptor activators (MANP), Natriuretic Peptide Receptor 1 (NPR1) agonists (REGN5381), angiotensinogen expression inhibitors (zilebesiran), and targeting angiotensinogen (tonlamarsen). The success of these candidates could diversify the treatment landscape and intensify competition. Baxdrostat is an oral, small-molecule drug that selectively inhibits aldosterone synthase, the enzyme responsible for producing aldosterone in the adrenal glands. Baxdrostat emerges as a strong contender in the resistant hypertension pipeline, with AstraZeneca positioning it as a potential multi-blockbuster asset. As an oral aldosterone synthase inhibitor, it targets patients with uncontrolled or resistant hypertension. The Phase II results have shown significant reductions in SBP, outperforming TRYVIO, with a favorable safety profile. First, mention the drug's current phase. The Phase III results, expected in the second half of 2025, will be key in validating its commercial and clinical potential. Lorundrostat, another Phase III investigational oral therapy. It is gaining attention as a high-potential entrant in the antihypertensive market. Developed by Mineralys Therapeutics, the drug is a highly selective oral aldosterone synthase inhibitor, and early data positions it as a potential best-in-class option for patients with resistant or uncontrolled hypertension. Positive outcomes from both the Phase II Advance-HTN and Phase III Launch-HTN trials validate its clinical promise, with efficacy surpassing that of TRYVIO in terms of blood pressure reduction. What further strengthens Lorundrostat's profile is its superior selectivity and greater reduction in plasma aldosterone concentration compared to baxdrostat. With approximately four times higher selectivity, the drug may offer a more targeted approach to managing cardiorenal metabolic conditions, a segment with significant unmet clinical needs. The anticipated launch of these emerging therapies are poised to transform the treatment resistant hypertension market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the treatment resistant hypertension market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about treatment resistant hypertension drugs in development @ Treatment Resistant Hypertension Clinical Trials Recent Developments in the Treatment Resistant Hypertension Market In May 2025, Q1 presentation, Alnylam Pharmaceuticals and Roche announced plans to release the topline results from the KARDIA-3 study and to initiate a Phase III cardiovascular outcomes trial of zilebesiran in the second half of 2025. In the Q1 2025 presentation, Regeneron Pharmaceuticals announced the initiation of a Phase II clinical trial evaluating REGN5381 for the treatment of uncontrolled hypertension. In March 2025, Idorsia Pharmaceuticals announced that the US FDA had fully released TRYVIO from its REMS requirement. Idorsia has also released from the PMR to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation, as these data are no longer needed. In February 2025, Idorsia Pharmaceuticals announced that the exclusivity agreement signed in November 2024 with an undisclosed party for the global rights to aprocitentan had concluded without the party signing the deal as foreseen in the nonbinding term sheet. Treatment Resistant Hypertension Overview Resistant hypertension is characterized by blood pressure that remains elevated at or above 130 mmHg systolic and 80 mmHg diastolic, despite the use of three or four different classes of antihypertensive medications, including a thiazide diuretic, all at their highest tolerated doses. It can also refer to cases where blood pressure is controlled, but only with the use of four or more antihypertensive agents. This definition encompasses both resistant and refractory hypertension in patients whose blood pressure remains uncontrolled despite being on an adequate regimen that includes a diuretic. Individuals who require more than three medications to control their blood pressure may also benefit from referral to a hypertension specialist. The assessment of resistant hypertension begins with confirming the accuracy of blood pressure readings, as mistakes such as using an improperly sized cuff or incorrect arm positioning can lead to misleadingly high values. It is also important to rule out the white coat effect by using validated out-of-office monitoring methods, such as ambulatory or home blood pressure monitoring under clinical guidelines. Automated office blood pressure (AOBP) measurement, which involves repeated readings taken every 1–2 minutes with the patient alone in a quiet room using a specialized oscillometric device, is a useful technique to reduce this effect. Treatment Resistant Hypertension Epidemiology Segmentation The treatment resistant hypertension epidemiology section provides insights into the historical and current treatment resistant hypertension 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 treatment resistant hypertension market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Treatment Resistant Hypertension Gender-Specific Diagnosed Prevalent Cases of Treatment Resistant Hypertension Age-Specific Diagnosed Prevalent Cases of Treatment Resistant Hypertension Treatment Resistant Hypertension Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan]. Treatment Resistant Hypertension Market CAGR 5 % Treatment Resistant Hypertension Market Size in 2024 USD 6.8 Billion Key Treatment Resistant Hypertension Companies AstraZeneca, Mineralys Therapeutics, E-Star BioTech, Ionis Pharmaceuticals, Kardigan, Regeneron Pharmaceuticals, Alnylam Pharmaceuticals, Roche, Idorsia Pharmaceuticals, and others Key Treatment Resistant Hypertension Therapies Baxdrostat (CIN-107), Lorundrostat (MLS-101), MANP, Tonlamarsen (ION904), REGN5381, Zilebesiran (ALN-AGT01), TRYVIO/JERAYGO, and others Scope of the Treatment Resistant Hypertension Market Report Therapeutic Assessment: Treatment Resistant Hypertension current marketed and emerging therapies Treatment Resistant Hypertension Market Dynamics: Key Market Forecast Assumptions of Emerging Treatment Resistant Hypertension Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Treatment Resistant Hypertension Market Access and Reimbursement Download the report to understand the treatment resistant hypertension market trends @ Treatment Resistant Hypertension Market Report Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Epidemiology and Market Forecast Methodology 6 TRH Market Overview at a Glance in the 7MM 6.1 Market Share (%) Distribution by Therapies of TRH in 2024 6.2 Market Share (%) Distribution by Therapies of TRH in 2034 7 Disease Background and Overview 7.1 Introduction 7.2 Symptoms 7.3 Risk Factors 7.4 Pathophysiology of TRH 7.5 Diagnosis 7.6 Treatment 7.7 Diagnostic Guidelines and Recommendations TRH 7.7.1 European Society of Cardiology (ESC) Recommendations for Hypertension 7.8 Treatment Guidelines and Recommendations for TRH 7.8.1 European Society of Cardiology (ESC) Recommendations for Resistant Hypertension (2024) 7.8.2 European Society of Hypertension (ESH) Recommendations of Lifestyle Interventions in Management of Hypertension (2023) 7.8.3 American Heart Association (AHA) Recommendations for Resistant Hypertension (2020) 7.8.4 The Japenese Socitey of Hypertension Guidelines for the Management of Hypertension (JSH 2019) 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale 8.3 Total Diagnosed Prevalent Cases of TRH in the 7MM 8.4 The United States 8.4.1 Total Diagnosed Prevalent Cases of TRH in the United States 8.4.2 Gender-specific Diagnosed Prevalent Cases of TRH in the United States 8.4.3 Age-specific Diagnosed Prevalent Cases of TRH in the United States 8.5 EU4 and the UK 8.6 Japan 9 Patient Journey 10 Marketed Drugs 10.1 Key Cross 10.2 TRYVIO/JERAYGO (aprocitentan): Idorsia Pharmaceutical 10.2.1 Product Description 10.2.2 Regulatory Milestones 10.2.3 Other Developmental Activities 10.2.4 Safety and Efficacy 10.2.5 Analyst View 11 Emerging Drugs 11.1 Key Cross Competition 11.2 Baxdrostat (CIN-107): AstraZeneca 11.2.1 Product Description 11.2.2 Other Development Activity 11.2.3 Clinical Development 11.2.4 Safety and Efficacy 11.2.5 Analyst View 11.3 Lorundrostat (MLS-101): Mineralys Therapeutics 11.4 MANP: E-Star BioTech 11.5 Tonlamarsen (ION904): Ionis Pharmaceuticals and Kardigan 11.6 REGN5381: Regeneron Pharmaceuticals 11.7 Zilebesiran (ALN-AGT01): Alnylam Pharmaceuticals and Roche 12 TRH: Seven Major Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Key Market Forecast Assumptions 12.4 Conjoint Analysis 12.5 Total Market Size of TRH in the 7MM 12.6 Market Size of TRH by Therapies in 7MM 12.7 The United States Market Size 12.8 EU4 and the UK Market Size 12.9 Japan 13 Unmet Needs 14 SWOT Analysis 15 KOL Views 16 Market Access and Reimbursement 16.1 United States 16.2 EU4 and the UK 16.3 Japan 16.4 Market Access and Reimbursement of TRH 17 Bibliography 18 Report Methodology Related Reports Treatment Resistant Hypertension EpidemiologyTreatment Resistant Hypertension Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the TRH epidemiology trends. Hypertension MarketHypertension Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypertension companies, including Gossamer Bio, Addpharma Inc., Insmed Incorporated, Alnylam Pharmaceuticals, 35Pharma Inc., Pfizer, Pharmosa Biopharm Inc., Guangzhou Magpie Pharmaceuticals Co., Ltd., Suzhou Sanegene Bio Inc., JW Pharmaceutical, among others. Hypertension PipelineHypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hypertension companies, including Gossamer Bio, Addpharma Inc., Insmed Incorporated, Alnylam Pharmaceuticals, 35Pharma Inc., Pfizer, Pharmosa Biopharm Inc., Guangzhou Magpie Pharmaceuticals Co., Ltd., Suzhou Sanegene Bio Inc., JW Pharmaceutical, among others. Tyrosine Kinase Inhibitors MarketTyrosine Kinase Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key TKIs companies, including AstraZeneca, Novartis, AbbVie, Eisai, Pfizer, F. Hoffmann-La Roche, Bristol-Myers Squibb, Bayer, Boehringer Ingelheim, Johnson & Johnson, among others. 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. Contact UsShruti Thakur info@ + Logo: View original content: SOURCE DelveInsight Business Research, LLP Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Upturn
8 hours ago
- Business Upturn
Global Dermal Fillers Market is Predicted to Reach ~USD 12 Billion by 2032
By GlobeNewswire Published on July 31, 2025, 22:00 IST New York, USA, July 31, 2025 (GLOBE NEWSWIRE) — Global Dermal Fillers Market is Predicted to Reach ~USD 12 Billion by 2032 | DelveInsight The demand for dermal fillers is influenced by several major factors. First, the global increase in cosmetic procedures is largely driven by an aging population and a heightened desire to preserve a youthful look, coupled with growing aesthetic awareness. Additionally, there is a notable trend toward minimally invasive cosmetic treatments because they offer greater convenience, quicker recovery, and lower costs compared to traditional surgical options. DelveInsight's Dermal Fillers Market Insights report provides the current and forecast market analysis, individual leading dermal fillers companies' market shares, challenges, dermal fillers market drivers, barriers, trends, and key market dermal fillers companies in the market. Key Takeaways from the Dermal Fillers Market Report As per DelveInsight estimates, North America is anticipated to dominate the global dermal fillers market during the forecast period. In the material segment of the dermal fillers market, the hyaluronic acid (HA) category accounted for the largest market share in 2024. Notable dermal fillers companies such as AbbVie Inc., Galderma, Merz Pharma, Tiger BioSciences, Teoxane SA, Crown Laboratories, Inc., Prollenium Medical Technologies, Inc., Johnson & Johnson Services, Inc., Anika Therapeutics, Inc., Fillmed, VIVACY Laboratories, Sinclair, Medytox, HUGEL, Inc., Ipsen Pharma, Evolus, Inc., Symatese, LG Chem, KORU Pharma Co., LTD., BIOPLUS CO., LTD., and several others are currently operating in the Dermal Fillers market. and several others are currently operating in the Dermal Fillers market. In February 2025, Crown Laboratories, Inc., a privately held global leader in skincare innovation, announced the successful acquisition of Revance Therapeutics, Inc., a pioneering biotechnology company specializing in dermal fillers. Through this acquisition, Crown significantly enhanced its product portfolio and expanded its global presence in the dermal fillers market, particularly with RHA Redensity™ and its range of RHA® 2, RHA® 3, and RHA® 4-based dermal fillers. a privately held global leader in skincare innovation, announced the successful acquisition of Revance Therapeutics, Inc., a pioneering biotechnology company specializing in dermal fillers. Through this acquisition, Crown significantly enhanced its product portfolio and expanded its global presence in the dermal fillers market, particularly with RHA Redensity™ and its range of RHA® 2, RHA® 3, and RHA® 4-based dermal fillers. In October 2024, Allergan Aesthetics, an AbbVie company, announced the national availability of JUVÉDERM® VOLUMA® XC for the treatment of temple hollowing. This hyaluronic acid (HA) filler is approved for addressing moderate to severe temple hollowing in adults over 21. As the leading HA dermal filler brand preferred by both patients and providers, the JUVÉDERM® Collection of Fillers now offers the broadest range of treatment indications to help patients achieve their aesthetic goals. To read more about the latest highlights related to the dermal fillers market, get a snapshot of the key highlights entailed in the Global Dermal Fillers Market Report Dermal Fillers Overview Dermal fillers are injectable substances used to restore volume, smooth out wrinkles, and enhance facial contours. Composed primarily of hyaluronic acid, calcium hydroxylapatite, poly-L-lactic acid, or polymethylmethacrylate beads, these fillers work by replenishing lost volume in the skin and stimulating collagen production. They are commonly used to treat areas such as the cheeks, lips, nasolabial folds, and under-eye hollows, providing a non-surgical alternative for facial rejuvenation. The effects of dermal fillers are temporary, lasting anywhere from six months to two years, depending on the type of filler and individual patient factors. The procedure is minimally invasive, typically performed in a clinical setting with little to no downtime. Local anesthesia or numbing agents may be applied to minimize discomfort during injection. While generally safe when administered by trained professionals, dermal fillers can have side effects, including swelling, bruising, redness, and in rare cases, complications like vascular occlusion or infection. Due to these risks, proper patient assessment and adherence to safety protocols are essential. Increasingly popular for their convenience and effectiveness, dermal fillers remain a leading option in cosmetic dermatology for individuals seeking subtle yet noticeable aesthetic improvements. Dermal Fillers Market Insights North America is expected to dominate the dermal fillers market in the coming years, supported by several critical factors. This leadership is largely driven by the growing number of cosmetic procedures, which are influenced by an aging population and a strong desire to maintain youthful looks. Additionally, the preference for minimally invasive aesthetic treatments, combined with a robust healthcare infrastructure, has accelerated market expansion. Rising awareness and widespread acceptance of cosmetic enhancements further reinforce this trend. Moreover, frequent product approvals and new launches from leading players continue to strengthen North America's market position. These dynamics are anticipated to maintain the region's dominance throughout the forecast period of 2025–2032. A key growth driver in the region is the increasing volume of aesthetic procedures, reflecting the rising demand for non-surgical treatments that deliver quick results with minimal recovery time. This surge is fueled by greater awareness, societal acceptance of cosmetic improvements, and a growing elderly population seeking effective anti-aging solutions. In addition, major industry players are actively investing in R&D to develop advanced dermal filler products tailored for regional needs. For instance, in June 2023, Galderma received FDA approval for Restylane® Eyelight, specifically designed to treat under-eye hollows in adults over 21. It is the first and only HA filler in the U.S. featuring NASHA® Technology to restore under-eye volume and deliver natural results. Similarly, in February 2022, Allergan Aesthetics, an AbbVie company, secured FDA approval for JUVÉDERM® VOLBELLA® XC for treating infraorbital hollows in adults over 21. This product also serves as a lip augmentation solution and helps correct perioral lines, enhancing overall facial aesthetics. Together, the growing demand for cosmetic procedures and strategic product innovations are fueling the dermal fillers market in North America, solidifying its status as a leading region in the global market. To know more about why North America is leading the market growth in the dermal fillers market, get a snapshot of the Dermal Fillers Market Outlook Dermal Fillers Market Dynamics The dermal fillers market is experiencing significant growth, driven primarily by the increasing demand for minimally invasive aesthetic procedures. Rising awareness about cosmetic enhancements and the desire for youthful appearances have fueled the adoption of dermal fillers across various demographics. Factors such as the aging global population, especially in developed economies, and growing disposable incomes in emerging markets have further contributed to market expansion. These procedures are preferred for their relatively quick recovery time and non-surgical nature, which aligns with the current trend toward less invasive treatment options. Technological advancements in dermal filler products have also played a crucial role in shaping market dynamics. Innovations in filler composition, including the introduction of hyaluronic acid-based and biostimulatory fillers, have improved safety profiles, longevity, and natural results. Moreover, ongoing research and development efforts by key players to develop fillers with longer-lasting effects and fewer side effects continue to enhance product appeal. These advancements have not only expanded the scope of applications but have also increased patient satisfaction, encouraging repeat procedures and contributing to market growth. Regulatory approvals and favorable reimbursement policies in certain regions further support the expansion of the dermal fillers market. However, stringent regulations in countries with established healthcare systems can act as barriers for new entrants. Additionally, the rise of medical tourism in countries like Thailand, India, and Mexico has created new growth opportunities for service providers and manufacturers, as patients seek affordable yet high-quality aesthetic treatments. Despite these positive trends, the dermal fillers market faces challenges such as the risk of complications, including allergic reactions and improper injections leading to vascular occlusion. Additionally, the availability of counterfeit or substandard products in some markets poses safety concerns and threatens consumer confidence. Competition from alternative aesthetic procedures like botulinum toxin injections and energy-based devices also adds pressure to the market. Nevertheless, continuous innovation, increasing social acceptance, and the growing influence of social media on beauty standards are expected to sustain robust growth in the coming years. Get a sneak peek at the dermal fillers market dynamics @ Dermal Fillers Market Trends Report Metrics Details Coverage Global Study Period 2022–2032 Dermal Fillers Market CAGR ~8% Dermal Fillers Market Size by 2032 ~USD 12 Billion Key Dermal Fillers Companies AbbVie Inc., Galderma, Merz Pharma, Tiger BioSciences, Teoxane SA, Crown Laboratories, Inc., Prollenium Medical Technologies, Inc., Johnson & Johnson Services, Inc., Anika Therapeutics, Inc., Fillmed, VIVACY Laboratories, Sinclair, Medytox, HUGEL, Inc., Ipsen Pharma, Evolus, Inc., Symatese, LG Chem, KORU Pharma Co., LTD., BIOPLUS CO., LTD., among others Dermal Fillers Market Assessment Dermal Fillers Market Segmentation Dermal Fillers Market Segmentation By Product Type: Biodegradable Fillers and Non-Biodegradable Fillers Dermal Fillers Market Segmentation By Route of Material: Hyaluronic Acid (HA), Calcium hydroxylapatite (CaHA), Poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA), and Others Dermal Fillers Market Segmentation By Route of Gender: Male and Female Dermal Fillers Market Segmentation By End-User: Hospitals, Dermatology Clinics, and Others Dermal Fillers Market Segmentation By Geography : North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the dermal fillers market are set to emerge as the trendsetter explore @ Dermal Fillers Analysis Table of Contents 1 Dermal Fillers Market Report Introduction 2 Dermal Fillers Market Executive Summary 3 Competitive Landscape 4 Regulatory Analysis 5 Dermal Fillers Market Key Factors Analysis 6 Dermal Fillers Market Porter's Five Forces Analysis 7 Dermal Fillers Market Layout 8 Dermal Fillers Market Company and Product Profiles 9 KOL Views 10 Project Approach 11 About DelveInsight 12 Disclaimer & Contact Us Interested in knowing the dermal fillers market by 2032? 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These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study 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. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. 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Incyte Corp (INCY) Q2 2025 Earnings Call Highlights: Strong Revenue Growth and Strategic ...
Total Product Revenues: $1.06 billion, a 17% increase year over year. Total Revenues: $1.2 billion, up 16% from the previous year. Jakafi Net Product Revenue: $764 million, representing an 8% growth year over year. Opzelura Net Product Revenue: $164 million, a 35% increase year over year. Niktimvo Net Product Revenue: $36 million, driven by strong commercial execution. Other Hematology and Oncology Products Revenue: $131 million, a 66% increase year over year. Operating Expenses: Increased 13% year over year, compared to a 16% increase in revenues. R&D Expenses: $495 million for the second quarter, an 8% increase year over year. SG&A Expenses: $331 million for the second quarter, a 16% increase year over year. Contract Dispute Settlement Benefit: $242 million from Novartis relating to Jakafi royalty payments. Full-Year Revenue Guidance for Jakafi: Raised to a range of $3 billion to $3.5 billion. Full-Year Revenue Guidance for Other Oncology Products: Raised to a range of $500 million to $520 million. COGS Guidance: Revised to 8% to 9% of net product revenues. Full-Year R&D Guidance: Increased by $35 million to a range of $1.965 billion to $1.995 billion. Warning! GuruFocus has detected 3 Warning Sign with INCY. Release Date: July 29, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Incyte Corp (NASDAQ:INCY) reported strong financial results with total product revenues of $1.06 billion, a 17% increase year over year. The company raised its full-year revenue guidance for Jakafi to a new range of $3 billion to $3.5 billion due to strong demand. Opzelura showed exceptional growth with a 35% increase in net product revenue year over year. Niktimvo's launch exceeded expectations with rapid adoption among BMT centers, achieving 82% account penetration. Incyte Corp (NASDAQ:INCY) is making excellent progress with its R&D pipeline, with several important product launches expected by 2030. Negative Points Incyte Corp (NASDAQ:INCY) faces the challenge of navigating through 2029 and transitioning to new durable product growth drivers. There have been R&D setbacks, and the company needs to convert scientific advancements into regulatory approvals and business results. The early-stage pipeline involves uncertainties, and the company must continuously assess and compare programs based on strategic importance and return on investment. The company is experiencing increased legal costs related to the Novartis contract dispute settlement. The development of '989 in MF has been delayed to ensure a comprehensive data set, pushing the release of data to later in the year. Q & A Highlights Q: Can you share your thoughts on the relative importance of the three therapeutic areas at Incyte: oncology, hematology, and immunology? Do any of those get prioritized in your strategic plan? A: MPNs (myeloproliferative neoplasms) are our most important therapeutic area right now. We have an asymmetrical advantage in that space and a window of opportunity to transform the treatment of these blood cancers. Targeting driver mutations in MPNs is crucial, and we have the potential to create a series of innovations starting with '989. Strategically, this is our number one priority. In immunology, we have a credible path to building a large product, particularly with Povorcitinib. In oncology, we will apply principles to ensure we make good decisions regarding solid tumors. Q: What are your expectations for the CALR data in MF, and is there a minimum threshold for monotherapy activity? A: Mechanistically, the mutant CALR antibody '989 should work similarly in MF as it does in ET. The safety and efficacy seen in ET increase the probability of success in MF. We expect to see improvement in MF in endpoints like spleen size reduction and symptom improvement. The development in MF will likely involve combination with Ruxolitinib, and we aim to present a comprehensive data set later this year. Q: Can you discuss the enthusiasm for Povorcitinib in the HS market and its competitive differentiation? A: HS is one of the most challenging conditions in dermatology. IL-17s don't work almost half the time, and HS involves multiple pathways. Povorcitinib has shown remarkable effects on pain and flare control, making it competitive. It could have a place in the treatment paradigm for HS, either as a starting option or following biologics. The totality of evidence suggests a place for Povorcitinib alongside IL-17s. Q: How do you plan to balance investment in pipeline advancement relative to external opportunities and near-term commercial performance? A: We focus on capital allocation, both internally and externally, without forcing any ratio. We aim to set a new high watermark for the company by getting our growth portfolio right, prioritizing R&D, managing costs, and executing business development effectively. We have a window of opportunity in MPNs to build a great business, and we will focus on converting science into results. Q: What are your thoughts on the peak opportunity for Niktimvo, and has the launch trajectory changed your view? A: It's hard to predict five years out, but the launch has been reassuring. The potential of Niktimvo will depend on getting it into combination with Jakafi and steroids, and developing a subcu formulation. The current trajectory suggests that Niktimvo could perform similarly to or better than REZUROCK, especially if additional indications are achieved. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
