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“Bronchiectasis Market Insight, Epidemiology and Market Forecast report”

Key Bronchiectasis Market Highlights

• BRINSUPRI’s approval is expected to be a key bronchiectasis market driver, given its first-in-class status as a dipeptidyl peptidase 1 inhibitor.

• Bronchiectasis affects more than 1 million patients in the 7MM, with the US accounting for 37% of the total cases.

• Bronchiectasis Companies: Insmed Incorporated (NASDAQ: INSM), AstraZeneca (NASDAQ: AZN), Zambon, Chiesi Farmaceutici S.p.A., Armata Pharmaceuticals, Verona Pharma, Sanofi (NASDAQ: SNY), Regeneron Pharmaceuticals (NASDAQ: REGN), Boehringer Ingelheim, CSL Limited, among others

• The bronchiectasis market size was approximately USD 1.5 billion in 2023 and is projected to grow at a CAGR of 13.7% during the forecast period (2024–2034).

Market Impact and Bronchiectasis Patient Population

According to DelveInsight’s Bronchiectasis Market Insight, Epidemiology and Market Forecast report, there is a significant unmet bronchiectasis medical need with approximately 1 million diagnosed prevalent cases of non-cystic fibrosis bronchiectasis (NCFB) in the 7MM. In 2023, the US accounted for approximately 37% of cases, while EU4 and the UK accounted for around 54% collectively, and Japan represented nearly 9% of total cases.

The condition is a chronic, progressive lung disease characterized by irreversible bronchial airway dilation and impaired mucociliary function, resulting in persistent mucus buildup and heightened bacterial colonization. Although historically linked to childhood respiratory infections, the disease is now understood to have multifactorial origins, including idiopathic, acquired, or infection-related causes. A productive cough is the hallmark symptom, yet in nearly 40% of the bronchiectasis cases, the cause remains unidentified. According to Delveinsight’s bronchiectasis epidemiology analysis, among severity-specific cases in EU4 and the UK in 2023, there were approximately 240K moderate cases, 165K severe cases, and 15K mild cases.

Furthermore, the report highlights that the bronchiectasis treatment market is set for steady growth with a robust compound annual growth rate anticipated from 2024 to 2034. BRINSUPRI’s approval is expected to be a key driver of this growth trajectory, given its first-in-class status and differentiated therapeutic approach addressing underlying disease pathology.

Download the Bronchiectasis Market report to understand which other factors are driving the therapeutic market @ Bronchiectasis Market Trends.

BRINSUPRI Treatment Approach

BRINSUPRI represents a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor designed to target the underlying bronchiectasis pathophysiology by reducing neutrophil-mediated inflammation and tissue damage. Unlike current symptomatic treatments, BRINSUPRI addresses the root cause by inhibiting DPP1, an enzyme responsible for activating neutrophil serine proteases that contribute to airway inflammation and structural damage. The therapy is administered orally once daily, offering bronchiectasis patients a convenient treatment option that targets disease progression rather than merely managing symptoms.

“The BRINSUPRI approval addresses a critical unmet medical need in bronchiectasis treatment,” said Martina Flammer, Chief Executive Officer of Insmed. “This represents a paradigm shift from symptomatic management to disease-modifying therapy, offering patients the first treatment specifically designed to target the underlying inflammatory cascade driving bronchiectasis progression.”

BRINSUPRI Clinical Validation and Efficacy

The BRINSUPRI FDA approval was based on compelling clinical evidence from the pivotal Phase III ASPEN study, which demonstrated statistically significant efficacy in reducing pulmonary exacerbations. In October 2024, Insmed shared positive late-breaking subgroup data from the Phase III ASPEN study at the CHEST 2024 Annual Meeting. Key clinical outcomes include a significant reduction in the rate of pulmonary exacerbations (primary endpoint), improved time to first exacerbation, and enhanced quality of life measures. The bronchiectasis therapy was well-tolerated with a favorable safety profile across the study population, representing a significant advancement over current standard-of-care approaches.

Bronchiectasis Competitive Landscape and Market Positioning

BRINSUPRI enters a treatment landscape that has historically lacked disease-specific therapies, with current bronchiectasis management focusing primarily on symptomatic relief and infection control. The bronchiectasis competitive landscape includes established treatments such as inhaled antibiotics, mucolytics, bronchodilators, and corticosteroids for symptom management. AstraZeneca is developing FASENRA (benralizumab) for bronchiectasis associated with eosinophilic inflammation, having completed Phase III clinical trials in April 2024. Zambon is advancing CMS I-neb (inhaled colistimethate sodium) with Breakthrough Therapy Designation from the FDA, targeting patients colonized by P. aeruginosa.

The broader competitive ecosystem includes companies providing supportive care solutions and emerging pipeline therapies. BRINSUPRI’s first-in-class status as a disease-modifying therapy provides unprecedented competitive differentiation, supported by Breakthrough Therapy Designation and access to the EMA’s PRIME scheme for adult bronchiectasis patients.

Explore the Bronchiectasis Drug Battle: BRINSUPRI vs. other emerging therapies. Discover how these breakthrough Bronchiectasis therapies compare in efficacy, safety, cost, and market impact @ Bronchiectasis Drugs Market.

Emerging Bronchiectasis Pipeline Therapies

Several companies are actively developing next-generation bronchiectasis therapies, including Zambon with CMS I-neb targeting P. aeruginosa colonization with results from Phase III PROMIS-I and PROMIS-II studies published in The Lancet Respiratory Medicine. AstraZeneca’s FASENRA completed Phase III trials for bronchiectasis with eosinophilic inflammation, while Armata Pharmaceuticals, Verona Pharma, and other pipeline companies are pursuing innovative approaches, including synthetic phage therapy, dual PDE3/PDE4 inhibitors, and novel anti-inflammatory agents.

Furthermore, the bronchiectasis pipeline drugs include companies developing advanced drug delivery systems, combination therapies, and precision medicine approaches. Despite this evolving landscape, BRINSUPRI’s disease-modifying mechanism and proven clinical efficacy position Insmed to capture substantial market share in a therapeutic area with significant unmet medical needs and limited treatment options.

Discover more Bronchiectasis pipeline therapies and the clinical development progress they are making @ Bronchiectasis Clinical Pipeline.

Broader BRINSUPRI Therapeutic Pipeline

Beyond bronchiectasis, Insmed is investigating brensocatib’s potential in other neutrophilic inflammatory diseases and chronic respiratory conditions. The EMA has approved a Pediatric Investigational Plan for brensocatib in bronchiectasis patients, potentially expanding the addressable patient population and market opportunity significantly.

Industry Expert Perspective

Clinical experts emphasize the significance of targeting underlying disease pathophysiology. “The approval of BRINSUPRI represents a fundamental shift from symptom management to disease modification,” commented leading pulmonologists. “By inhibiting DPP1 and reducing neutrophil-mediated inflammation, this therapy addresses the core inflammatory cascade driving bronchiectasis progression, offering patients the potential for improved long-term outcomes.”

Learn more about what other Industry experts are saying about BRINSUPRI FDA Approval and how it will impact the Bronchiectasis treatment market @ Key Opinion Leaders on Bronchiectasis Market.

Looking Forward

The BRINSUPRI approval represents a paradigm shift in bronchiectasis treatment and demonstrates the potential for targeted therapeutic approaches to address complex chronic respiratory diseases. DelveInsight’s analysts underline that the absence of disease-modifying therapies has highlighted a critical gap in bronchiectasis treatment, with current approaches primarily managing symptoms without addressing the root causes. As the pharmaceutical industry continues to focus on precision medicine and disease-modifying therapies, BRINSUPRI’s success may pave the way for similar innovations in other underserved respiratory conditions with significant unmet medical needs.

Table of Contents

1. Key Insights

2. Executive Summary of Bronchiectasis

3. Competitive Intelligence Analysis for Bronchiectasis

4. Bronchiectasis Market Overview at a Glance

5. Bronchiectasis: Disease Background and Overview

6. Bronchiectasis Patient Journey

7. Bronchiectasis Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Bronchiectasis Unmet Needs

10. Key Endpoints of Bronchiectasis Treatment

11. Bronchiectasis Marketed Products

12. Bronchiectasis Emerging Therapies

13. Bronchiectasis: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Bronchiectasis

17. KOL Views

18. Bronchiectasis Market Drivers

19. Bronchiectasis Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight Business Research

DelveInsight is a leading business consultant and market research firm in the pharmaceutical and healthcare sectors. The company provides comprehensive market intelligence, competitive analysis, and strategic consulting services to pharmaceutical companies, biotechnology firms, and healthcare organizations worldwide.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: Bronchiectasis Treatment Landscape: FDA Approves BRINSUPRI, First Disease-Modifying Therapy | DelveInsight’s Perspective on Market Impact, Competitive Landscape and Pipeline Therapies

“PCSK9 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast”

DelveInsight’s comprehensive “PCSK9 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast” report, provides detailed insights into the rapidly evolving PCSK9 Inhibitor market, covering historical and forecasted patient pools, current treatment practices, emerging drugs, and market size trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Key Takeaways

• Market size projection: As per DelveInsight’s analysis, the total PCSK9 inhibitor market size in the 7MM is expected to expand significantly by 2034, from approximately USD 2 billion in 2023.

• Patient population data: The report provides the total PCSK9 inhibitors potential patient pool, revealing an estimated 640K diagnosed cases of Familial Hypercholesterolemia across the 7MM in 2023, with homozygous cases being very rare.

• Geographic market distribution: The United States dominates the PCSK9 inhibitor market share, accounting for approximately USD 900 million in 2023

• Key PCSK9 companies: Leading PCSK9 inhibitors companies, such as Sanofi (NASDAQ: SNY), Regeneron Pharmaceuticals (NASDAQ: REGN), Amgen (NASDAQ: AMGN), AstraZeneca (NASDAQ: AZN), LIB Therapeutics (NASDAQ: LIBT), Merck (NYSE: MRK), NOVARTIS (NYSE: NVS), Alnylam (NASDAQ: ALNY), and others, are actively driving innovation in this therapeutic space.

• Pipeline assets: Some of the key PCSK9 inhibitors in the pipeline include LIB003 (Lerodalcibep) by LIB Therapeutics in Phase III, MK-0616 by Merck in Phase II, AQR-008 by Aqur Biosciences, CIV 008 by CiVi Biopharma, and others in various development stages.

• Current approved therapies: Two FDA-approved monoclonal antibodies currently dominate the market: PRALUENT (alirocumab) by Sanofi/Regeneron Pharmaceuticals and REPATHA (evolocumab) by Amgen, both targeting PCSK9 inhibition through subcutaneous administration.

• In June 2025, Merck announced positive topline results from the first two Phase 3 CORALreef trials evaluating enlicitide decanoate, a potentially first-in-class oral PCSK9 inhibitor. The trials successfully met their primary and all key secondary endpoints.

Discover recent advancements in the PCSK9 Inhibitor landscape @ PCSK9 Inhibitor Recent Developments.

PCSK9 Inhibitor Market Dynamics

The PCSK9 inhibitors market represents a transformative segment in cardiovascular therapeutics, with the current market size of approximately USD 2 billion across the 7MM in 2023 positioning it for substantial expansion through 2034. The United States leads this market with approximately USD 900 million, reflecting the strong adoption of innovative lipid-lowering therapies in this region. The primary PCSK9 inhibitor market driver is the growing understanding of PCSK9’s critical role in cholesterol metabolism and cardiovascular risk management.

Other PCSK9 Inhibitor market drivers include the increasing recognition of LDL cholesterol’s pivotal role in cardiovascular disease development and the proven efficacy of PCSK9 inhibitors in achieving significant LDL-C reductions. The current treatment paradigm addresses patients with cardiovascular disease at very high risk with LDL-C levels remaining ≥70 mg/dL, those with severe primary hypercholesterolemia (LDL-C level ≥ 190 mg/dL), individuals aged 30 to 75 with heterozygous familial hypercholesterolemia and LDL-C levels of 100 mg/dL or higher, and patients aged 40 to 75 with baseline LDL-C levels of 220 mg/dL or higher.

The scientific rationale underlying PCSK9 inhibition centers on the enzyme’s role in binding to low-density lipoprotein receptors (LDL receptors), which prevents LDL removal from the blood and leads to increased blood LDL levels. PCSK9 inhibitors block this enzyme, resulting in more LDL receptors available to remove LDL from the blood, thereby producing a significant decrease in LDL blood levels. This mechanism has proven particularly valuable for patients who are intolerant to statins or have elevated LDL-C levels despite maximally tolerated statin therapy.

The PCSK9 Inhibitor clinical development is robust, with major pharmaceutical companies including AstraZeneca, LIB Therapeutics, Merck, Amgen, and others actively developing improved treatment options. The PCSK9 Inhibitor pipeline drugs span multiple development phases, from early-stage research through Phase III trials, indicating sustained industry confidence in this therapeutic approach. LIB003 is anticipated to garner significant market share in the coming decade due to its greater efficiency and convenient once-monthly dosing regimen, addressing key patient compliance challenges.

The PCSK9 inhibitor competitive landscape is characterized by both established players with approved therapies and emerging companies developing next-generation solutions. Current FDA-approved monoclonal antibodies, PRALUENT (alirocumab) and REPATHA (evolocumab), have established the clinical foundation, while emerging therapies like oral PCSK9 inhibitors and siRNA-based approaches promise to expand treatment options and improve patient convenience.

Challenges in this market include cost considerations, reimbursement complexities, and the need for continued patient education about the importance of aggressive LDL-C lowering in high-risk populations. However, opportunities abound as the market expands to include broader patient populations, new dosing regimens improve compliance, and innovative delivery mechanisms enhance patient experience. The increasing prevalence of cardiovascular diseases, growing focus on preventive healthcare, and wider adoption of innovative therapies are expected to drive continued market expansion through the forecast period to 2034.

Download the PCSK9 Inhibitor Market report to understand which factors are driving the therapeutic market @ PCSK9 Inhibitor Market Trends.

PCSK9 Inhibitor Targeted Patient Pool

The epidemiology of PCSK9 inhibitor-eligible conditions across the seven major markets reveals a substantial patient population requiring advanced lipid-lowering interventions. Across the 7MM, an estimated 640K diagnosed Familial Hypercholesterolemia cases were reported in 2023, representing the core target population for PCSK9 inhibitor therapy. This patient population is characterized by significantly elevated LDL cholesterol levels that remain inadequately controlled despite conventional statin therapy, creating a compelling medical need for additional therapeutic intervention.

DelveInsight’s epidemiological segmentation within the PCSK9 inhibitor market encompasses multiple patient categories, including those with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia (which represents very rare cases), patients with established atherosclerotic cardiovascular disease requiring additional LDL-C reduction, and individuals with severe primary hypercholesterolemia. The patient population extends beyond familial hypercholesterolemia to include high-risk cardiovascular patients with persistently elevated LDL-C levels despite optimal conventional therapy.

Total cases in selected indications span both primary and secondary prevention settings, with peripheral artery disease accounting for the highest number in total risk factor-specific cases of PCSK9 inhibitors in prophylactic/preventive settings across the 7MM in 2023. This distribution reflects the expanding recognition of PCSK9 inhibitors’ role in comprehensive cardiovascular risk management beyond traditional familial hypercholesterolemia indications.

The total eligible PCSK9 Inhibitor patient pool encompasses individuals aged 30 to 75 with heterozygous familial hypercholesterolemia and LDL-C levels of 100 mg/dL or higher, patients aged 40 to 75 with baseline LDL-C levels of 220 mg/dL or higher, those with cardiovascular disease at very high risk with LDL-C levels remaining ≥70 mg/dL, and patients with severe primary hypercholesterolemia with LDL-C levels ≥ 190 mg/dL. This broad eligibility criteria significantly expands the potential treatment population beyond the diagnosed familial hypercholesterolemia cases.

The geographic segmentation across the 7MM shows the United States leading in both market size and treatment penetration, followed by the European markets including Germany, France, Italy, Spain, and the United Kingdom, with Japan representing the Asian market component. Regional variations in epidemiology reflect differences in genetic predisposition, diagnostic practices, treatment guidelines, and healthcare infrastructure. The forecast period extending through 2034 anticipates continued growth in diagnosed cases and treatment penetration across all major markets, driven by improved screening, enhanced diagnostic capabilities, and expanded treatment guidelines.

Discover evolving trends in the PCSK9 Inhibitor patient pool forecasts @ PCSK9 Inhibitor Potential Patient Pool Analysis.

Key PCSK9 Inhibitor Companies and Treatment Market

The clinical and regulatory landscape for PCSK9 inhibitors is anchored by two FDA-approved monoclonal antibodies that have established the therapeutic foundation for this market segment. PRALUENT (alirocumab), developed by Sanofi in partnership with Regeneron Pharmaceuticals, and REPATHA (evolocumab/AMG 145) by Amgen represent the current standard of care for patients requiring PCSK9 inhibition. Both therapies function as human monoclonal antibodies that bind to PCSK9, preventing its interaction with LDL receptors and thereby increasing the number of receptors available to clear LDL cholesterol from the blood.

Current treatment options extend beyond these approved therapies to include emerging approaches that address key limitations of existing treatments. The clinical pipeline demonstrates significant activity across multiple development phases, with companies pursuing diverse strategies including oral formulations, extended-dosing regimens, and novel mechanisms of action. This development activity reflects industry recognition of substantial unmet medical needs in lipid management and cardiovascular risk reduction.

Key PCSK9 inhibitor companies include AstraZeneca (developing next-generation PCSK9 inhibitors), LIB Therapeutics (LIB003/Lerodalcibep in Phase III trials), Merck (MK-0616 in Phase II), Amgen (continuing development beyond REPATHA), Sanofi and Regeneron Pharmaceuticals (expanding PRALUENT applications), NOVARTIS, Alnylam (siRNA approaches), and Aqur Biosciences (AQR-008 oral therapy). CiVi Biopharma contributes CIV 008 in Phase I/II development, while IONIS and CIVIBIOPHARMA represent additional pipeline contributors across various development stages.

Market positioning of these companies reflects different strategic approaches to PCSK9 inhibition, with established players focusing on lifecycle management and indication expansion while emerging companies target improved convenience, efficacy, and patient compliance. LIB003 (Lerodalcibep) by LIB Therapeutics is positioned as a third-generation PCSK9 inhibitor designed to overcome current treatment limitations through convenient small-injection volume and once-monthly dosing with long-ambient stability, currently advancing through Phase III clinical trials.

The PCSK9 Inhibitor drug profiles within the pipeline showcase diverse mechanisms and delivery approaches. MK-0616 by Merck represents an oral PCSK9 inhibitor that has demonstrated positive Phase II results with significant LDL-C reduction compared to placebo. AQR-008 by Aqur Biosciences offers another oral approach with selective targeting of the EGF-A domain of the LDL receptor, designed to block PCSK9 binding while preserving other physiological functions. These oral alternatives address key patient preference and compliance challenges associated with injectable therapies.

Development milestones across the pipeline include positive Phase II results for MK-0616 demonstrating efficacy in lowering LDL-C in participants with hypercholesterolemia, advancement of LIB003 through Phase III trials with anticipated market leadership potential, and progression of various oral and injectable alternatives through clinical development phases. Regulatory designations include Orphan Drug status for both PRALUENT and REPATHA for homozygous familial hypercholesterolemia treatment, reflecting the significant unmet need in rare genetic forms of hypercholesterolemia.

Commercial arrangements within this space encompass licensing partnerships, development collaborations, and strategic alliances aimed at maximizing therapeutic potential and market access. The collaboration between Sanofi and Regeneron Pharmaceuticals on PRALUENT exemplifies successful partnership models, while emerging companies are establishing their own strategic relationships to support development and commercialization efforts. These arrangements facilitate resource sharing, risk mitigation, and accelerated development timelines across the competitive landscape.

Delve deeper into the major and specialised PCSK9 Inhibitor companies @ PCSK9 Inhibitor Competitive Landscape.

Conclusion

DelveInsight’s comprehensive PCSK9 inhibitors market report reveals a dynamic and rapidly expanding therapeutic segment poised for significant growth through 2034. With a current market size of approximately USD 2,000 million across the 7MM and a substantial patient population of 640,000 diagnosed familial hypercholesterolemia cases, the foundation for continued expansion is firmly established. The robust clinical pipeline, featuring innovative approaches from leading pharmaceutical companies, promises to address current treatment limitations while expanding therapeutic options for patients with challenging lipid disorders.

The convergence of increasing cardiovascular disease prevalence, growing recognition of LDL cholesterol’s critical role in disease development, and the development of more convenient and effective therapeutic options positions the PCSK9 inhibitors market for sustained growth. As the industry continues to innovate with oral formulations, extended-dosing regimens, and improved patient compliance solutions, the market is expected to realize its significant potential in transforming cardiovascular risk management across diverse patient populations.

For more information about DelveInsight’s PCSK9 Inhibitors Market Report, including detailed competitive analysis, pipeline assessments, and market forecasts, please visit DelveInsight’s report store or contact our research team for comprehensive market intelligence solutions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of PCSK9 Inhibitor

4. Key Events

5. PCSK9 Inhibitor Epidemiology Market Forecast Methodology

6. PCSK9 Inhibitor Market Overview at a Glance in the 7MM

7. PCSK9 Inhibitor: Background and Overview

8. Epidemiology and PCSK9 Inhibitor Patient Population in Different Indications

9. PCSK9 Inhibitor Target Patient Pool

10. PCSK9 Inhibitor Marketed Therapies

11. PCSK9 Inhibitor Emerging Therapies

12. PCSK9 Inhibitor: Seven Major Market Analysis

13. PCSK9 Inhibitor SWOT Analysis

14. KOL Views

15. PCSK9 Inhibitor Unmet Needs

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: PCSK9 Inhibitors Market Landscape: Clinical Pipeline, Competitive Strategies, and Growth Drivers Analysis by Delveinsight | AstraZeneca, Amgen, Regeneron, Sanofi, NOVARTIS, Merck, LIB Therapeutics

“Influenza Pipeline”

Influenza Pipeline Summary

DelveInsight’s Influenza Emerging Drugs report highlights innovative therapies advancing the treatment and prevention of influenza. Key candidates include Moderna’s mRNA-1010, a Phase III vaccine encoding HA glycoproteins of WHO-recommended strains; SAB Biotherapeutics’ SAB-176, a quadrivalent, broadly neutralizing polyclonal antibody for severe influenza; ENA Respiratory’s INNA-051, an immunomodulatory intranasal spray in Phase IIa; Codagenix’s CODA-VAX H1N1, a universal live-attenuated flu vaccine in Phase I; and AlloVir’s ALVR106, an allogeneic, off-the-shelf VST therapy targeting multiple respiratory viruses.

The report further analyzes over 120+ pipeline drugs across various clinical stages, including Phase III, II, I, preclinical, and discovery. It categorizes therapies by route of administration (oral, intravenous, intranasal, inhalation, subcutaneous, etc.), molecule type (antibodies, vaccines, peptides, proteins, immunotherapies, small molecules, stem cells), and product type (mono, combination, or both). Moderna currently leads the late-stage pipeline, showcasing the growing diversity and innovation in influenza treatment strategies.

Discover the latest drugs and treatment options in the Influenza Pipeline. Dive into DelveInsight’s comprehensive report today! @ Influenza Pipeline Outlook

Key Takeaways from the Influenza Pipeline Report

Influenza pipeline report depicts a robust space with 120+ active players working to develop 120+ pipeline therapies for Influenza treatment.

In August 2025, AstraZeneca launches the first FDA-approved influenza vaccine available for self- or caregiver administration, providing a convenient, household-based option for seasonal flu vaccination. AstraZeneca launches FluMist Home, the first-of-its-kind, at-home delivery service for FLUMIST®(Influenza Vaccine Live, Intranasal). FLUMIST is the first and only seasonal influenza vaccine approved to be self-administered by adults 18 to 49 years of age or administered by a parent or caregiver to individuals 2-17 years of age.

In July 2025, SK bioscience, a global innovative vaccine and biotech company dedicated to advancing human health from prevention to cure, announced that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for Phase 1/2 clinical trials of a new influenza vaccine candidate, ‘NBP607B’. This candidate integrates an adjuvant into its existing cell-based influenza vaccine, ‘SKYCellflu’, to improve protective efficacy. SK bioscience previously applied adjuvant technology in its COVID-19 vaccine, ‘SKYCovione’, and now aims to extend this approach to influenza vaccines as part of its broader platform strategy.

In July 2025, GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent seasonal influenza vaccines to US healthcare providers and pharmacies in preparation for the 2025-26 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA). Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months and older.

In March 2025, Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and delivery of its vaccine portfolio for the 2025-26 flu season in the US. As the world leader in flu vaccines, Sanofi had already begun its annual production of vaccines to ensure that robust supply is ready for the coming season. Strains selected by the FDA match those already used in production by the company to help protect eligible patients against flu and its potentially severe complications.

In December 2024:- ModernaTX, Inc.- A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age. The purpose the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).

In November 2024:- DiaSorin Molecular LLC- The DiaSorin Molecular LIAISON® NES FLU A/B, RSV & COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

In October 2024:- Pfizer- The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.

The leading Influenza Companies such as Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc., and others.

Promising Influenza Therapies such as OVX836 480µg, mRNA-1010, Oseltamivir, Baloxavir, and others.

Stay ahead with the most recent pipeline outlook for Influenza. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Influenza Treatment Drugs

Influenza Emerging Drugs

· mRNA-1010 (Moderna):

A Phase III vaccine targeting WHO-recommended influenza strains (A/H1N1, A/H3N2, B/Yamagata, B/Victoria). Encodes HA glycoproteins to generate broad protection against seasonal influenza.

· SAB-176 (SAB Biotherapeutics):

A quadrivalent polyclonal antibody therapy developed via DiversitAb™ platform. Designed to neutralize Type A and B influenza viruses, showing broad protection potential. Targeted for severe cases and high-risk groups like elderly and immunocompromised patients.

· INNA-051 (ENA Respiratory):

An intranasal immunomodulatory spray in Phase IIa trials. Intended for pre- and post-exposure prophylaxis of respiratory viral infections, with potential use across multiple viruses and at-risk populations.

· CODA-VAX H1N1 (Codagenix):

A live-attenuated universal flu vaccine in Phase I trials. Shows promise for multi-season protection by targeting conserved viral antigens and is being developed into a quadrivalent formulation.

· ALVR106 (AlloVir):

An allogeneic, off-the-shelf VST therapy in preclinical development. Targets RSV, influenza, PIV, and hMPV, with in vitro data showing strong antiviral activity and potential safety benefits.

Explore groundbreaking therapies and clinical trials in the Influenza Pipeline. Access DelveInsight’s detailed report now! @ New Influenza Drugs

Key influenza Companies:

The following are the leading companies in the influenza market. These companies collectively hold the largest market share and dictate industry trends.

• SNB 011: SyneuRx International
• naNO-Flu: Emergex Vaccines
• ARCT-2138: Arcturus Therapeutics
• PF-07985819: Pfizer
• OVX836: OSIVAX
• Neumifil: Pneumagen
• INNA-051: Ena Respiratory
• mRNA-1010: Moderna
• XC-221: Valenta Pharmaceuticals
• ZSP1273: Raynovent
• mRNA-1010: Moderna
• SAB-176: SAB Biotherapeutics
• INNA-051: ENA Respiratory Pty Ltd
• CODA-VAX H1N1: Codagenix
• ALVR106: AlloVir
• CD388: Cidara
• Quadrivalent influenza vaccine: Sinovac Biotech
• TIV: Novartis

Influenza Pipeline Drugs by Route of Administration

Influenza pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

Inhalation

Inhalation/Intravenous/Oral

Intranasal

Intravenous

• Intravenous/ Subcutaneous

• NA

• Oral

• Oral/intranasal/subcutaneous

• Parenteral

• Subcutaneous

Influenza Pipeline Drugs by Molecule Types

Influenza Products have been categorized under various Molecule types such as

• Antibody

• Antisense oligonucleotides

• Immunotherapy

• Monoclonal antibody

• Peptides

• Protein

• Recombinant protein

• Small molecule

• Stem Cell

• Vaccine

Unveil the future of Influenza Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Influenza Market Drivers and Barriers

Scope of the Influenza Pipeline Report

Coverage- Global

Influenza Companies- Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc., and others.

Influenza Therapies- OVX836 480µg, mRNA-1010, Oseltamivir, Baloxavir, and others

Influenza Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination

Influenza Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Influenza Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Influenza Clinical Trials and FDA Approvals

Table of Content

1. Influenza Report Introduction

2. Influenza Executive Summary

3. Influenza Overview

4. Influenza- Analytical Perspective In-depth Commercial Assessment

5. Influenza Pipeline Therapeutics

6. Influenza Late Stage Products (Phase II/III)

7. Influenza Mid Stage Products (Phase II)

8. Influenza Early Stage Products (Phase I)

9. Influenza Preclinical Stage Products

10. Influenza Therapeutics Assessment

11. Influenza Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Influenza Key Companies

14. Influenza Key Products

15. Influenza Unmet Needs

16 . Influenza Market Drivers and Barriers

17. Influenza Future Perspectives and Conclusion

18. Influenza Analyst Views

19. Appendix

20. 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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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“Fibromyalgia Market Insight, Epidemiology and Market Forecast report”

Key Fibromyalgia Market Highlights

• TONMYA’s approval is expected to be a key driver of the fibromyalgia treatment market growth, given its first-in-class status and differentiated therapeutic approach.

• Fibromyalgia has a mean prevalence of 2.7% worldwide, with significant age and gender disparity.

• Fibromyalgia Companies: Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie Inc. (NYSE: ABBV), Johnson & Johnson (NYSE: JNJ), Novartis AG (NYSE: NVS), Sanofi S.A. (NASDAQ: SNY), AstraZeneca PLC (NASDAQ: AZN), Abbott Laboratories (NYSE: ABT), GlaxoSmithKline PLC (NYSE: GSK), Amgen Inc. (NASDAQ: AMGN), Viatris Inc. (NASDAQ: VTRS), and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Exagen Inc. (NASDAQ: XGN), Dogwood Therapeutics, Inc. (NASDAQ: DWTX), among others.

Market Impact and Fibromyalgia Patient Population

According to DelveInsight’s Fibromyalgia Market Insight, Epidemiology and Market Forecast report, fibromyalgia represents a significant global health burden with a mean prevalence of 2.7% worldwide, showing regional variations with higher rates in America compared to Europe. In the United States, the condition affects approximately 2% of the general population, with a pronounced gender disparity where women are disproportionately affected, representing approximately 80% of total diagnosed cases.

The condition is characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive dysfunction, significantly impacting patients’ quality of life. It is the leading cause of generalized musculoskeletal pain in women and represents a significant economic burden, with annual costs estimated at over $9 billion in the United States alone.

Furthermore, the report highlights that the fibromyalgia treatment market is projected to grow at a significant CAGR. TONMYA’s approval is expected to be a key driver of this growth trajectory, given its first-in-class status and differentiated therapeutic approach.

Download the Fibromyalgia Market report to understand which other factors are driving the therapeutic market @ Fibromyalgia Market Trends.

TONMYA Treatment Approach

TONMYA represents a first-in-class, non-opioid analgesic designed for once-daily bedtime administration. The sublingual formulation allows for rapid absorption into the bloodstream while avoiding first-pass hepatic metabolism, potentially reducing the formation of long-lasting metabolites associated with traditional oral cyclobenzaprine formulations.

“The TONMYA approval addresses a critical unmet medical need in fibromyalgia treatment,” said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. “At Tonix, we recognized the transformative potential of pursuing a new approach with TONMYA for fibromyalgia, a chronic overlapping pain condition that has gone without innovation for many years.”

TONMYA Clinical Validation and Efficacy

The TONMYA FDA approval was based on robust clinical evidence from two pivotal Phase 3 trials (RELIEF and RESILIENT) involving nearly 1,000 fibromyalgia patients. Key clinical outcomes include a statistically significant reduction in daily pain scores versus placebo at 14 weeks (primary endpoint), with a greater percentage of patients experiencing clinically meaningful (≥30%) pain improvement after 3 months.

Fibromyalgia Competitive Landscape and Market Positioning

TONMYA, which is expected to be commercially available in the fourth quarter of 2025, enters a highly competitive fibromyalgia treatment landscape that has been dominated by three FDA-approved therapies for over 15 years: LYRICA (pregabalin) by Pfizer Inc., which historically commands the largest market share; CYMBALTA (duloxetine) by Eli Lilly and Company; and SAVELLA (milnacipran), now available through multiple generic manufacturers.

The broader competitive ecosystem includes established pharmaceutical giants such as Johnson & Johnson, AbbVie Inc., Novartis AG, Sanofi S.A., AstraZeneca PLC, Abbott Laboratories, GlaxoSmithKline PLC, Amgen Inc., Viatris Inc., and Teva Pharmaceutical Industries Ltd., which compete through off-label prescribing of pain management and antidepressant medications.

Explore the Fibromyalgia Drug Battle: TONMYA vs. LYRICA vs. CYMBALTA vs. SAVELLA. Discover how these breakthrough Fibromyalgia therapies compare in efficacy, safety, cost, and market impact @ Fibromyalgia Drugs Market

Emerging Fibromyalgia Pipeline Therapies

Several companies are actively developing next-generation fibromyalgia therapies, including Aptinyx Inc. with NMDA receptor modulator programs, Prismic Pharmaceuticals Inc. focusing on novel pain pathways, Scilex Holding advancing non-opioid analgesics, Tryptamine Therapeutics exploring psychedelic-assisted therapies, and Intec Pharma Ltd. developing gastroretentive drug delivery systems.

Furthermore, regional players such as Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Lupin Limited, Sun Pharmaceutical Industries Ltd., and Zydus Lifesciences Limited compete primarily in the generic space. Despite this crowded landscape, TONMYA’s first-in-class status and unique sublingual delivery mechanism provide significant competitive differentiation, positioning Tonix Pharmaceuticals to capture substantial market share in a therapeutic area that has remained largely unchanged for over a decade.

Discover more fibromyalgia pipeline therapies and the clinical development progress they are making @ Fibromyalgia Clinical Pipeline.

Broader TONMYA Therapeutic Pipeline

Beyond fibromyalgia, Tonix Pharmaceuticals is investigating TNX-102 SL (now TONMYA) for additional indications, including acute stress reaction, posttraumatic stress disorder, and Long COVID-associated multi-site pain, potentially expanding its market opportunity significantly.

Industry Expert Perspective

Dr. Andrea Chadwick, M.D., MSc, FASA, at the University of Kansas Health System, commented on the novel administration approach: “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. TONMYA is administered sublingually, which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Learn more about what other Industry experts are saying about TONMYA FDA Approval and how it will impact the fibromyalgia treatment market @ Key Opinion Leaders on Fibromyalgia Market.

Looking Forward

The TONMYA approval represents a paradigm shift in fibromyalgia treatment and demonstrates the potential for innovative drug delivery approaches to address complex chronic pain conditions. Delveinsight’s analysts underline that as the pharmaceutical industry continues to focus on patient-centric therapeutic solutions, TONMYA’s success may pave the way for similar innovations in other underserved therapeutic areas.

Table of Contents

1. Key Insights

2. Executive Summary of Fibromyalgia

3. Competitive Intelligence Analysis for Fibromyalgia

4. Fibromyalgia Market Overview at a Glance

5. Fibromyalgia: Disease Background and Overview

6. Fibromyalgia Patient Journey

7. Fibromyalgia Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Fibromyalgia Unmet Needs

10. Key Endpoints of Fibromyalgia Treatment

11. Fibromyalgia Marketed Products

12. Fibromyalgia Emerging Therapies

13. Fibromyalgia: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Fibromyalgia

17. KOL Views

18. Fibromyalgia Market Drivers

19. Fibromyalgia Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight Business Research

DelveInsight is a leading business consultant and market research firm in the pharmaceutical and healthcare sectors. The company provides comprehensive market intelligence, competitive analysis, and strategic consulting services to pharmaceutical companies, biotechnology firms, and healthcare organizations worldwide.

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Company Name: DelveInsight Business Research LLP
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Website: https://www.delveinsight.com/

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To view the original version on ABNewswire visit: Fibromyalgia Treatment Landscape: FDA Approves TONMYA, First New Therapy in 15 Years | DelveInsight’s Perspective on Market Impact, Competitive Landscape and Other Pipeline Therapies