Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor - Target Population, Competitive Landscape, and Market Forecast - 2034

Key Highlights:

• The DPP1 inhibitor Market Size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• DPP1, also known as Cathepsin C (CTSC), is expressed ubiquitously in mammals; the highest expression levels are in the lung, spleen, kidney, liver, and myeloid cell lineages, particularly neutrophils, mast cells, monocytes, macrophages, and their precursors.
• DPP1 is a novel therapeutic target in various pulmonary diseases driven by neutrophil activity, such as Non-Cystic Fibrosis Bronchiectasis (NCFB), Chronic Obstructive Pulmonary Disease (COPD), and Asthma, along with inflammatory skin disorders such as Hidradenitis Suppurativa.
• Insmed's BRINSUPRI (brensocatib), a first-in-class DPP1/Cathepsin C inhibitor, represents a significant milestone as the first therapy targeting this mechanism to receive regulatory US approval recently in August 2025 for NCFB, a serious, chronic lung disease.
• BRINSUPRI sales uptake will be dependent on the eligible NCFB patient population (roughly 400,000 prevalent cases in the US only) undergoing treatment, cost of therapy (dependent on pricing decisions taken by Insmed, and acceptibility by country-specific regulatory bodies), broader geographical expansion, confidential rebates, and efficacy established during post marketing studies.
• Apart from Pulmonary Diseases, and Skin Disorders, upregulation of DPP1 expression has also been observed in various cancer indications also, such as Breast and Lung Cancer.
• DPP1 is increasingly recognized as a pharmacological target for the blocking of neutrophil serine proteases and NETosis in neutrophil-driven inflammatory and autoimmune diseases as well.
• Apart from Insmed being the leading player in this area, other key players developing drugs for DPP1 inhibitors include Boehringer Ingelheim (Verducatib [BI 1291583]), Shanghai Fosun Pharmaceutical and Expedition Therapeutics (XH-S004), Melodia Therapeutics and Alivexis (MDI-0151), and others.
• In August 2025, Fosun Pharma announced that its subsidiary Fosun Pharma Industrial had signed a License Agreement with Expedition Therapeutics to grant Expedition the rights to develop, manufacture, and commercialize XH-S004 in all regions globally except the Chinese Mainland, Hong Kong SAR, and Macau SAR. Fosun Pharma will retain the rights to develop, manufacture, and commercialize XH-S004 in the Chinese Mainland, Hong Kong SAR, and Macau SAR.
• In June 2024, Alivexis and Melodia Therapeutics entered into an exclusive license agreement for the worldwide development, manufacturing, and commercialization of Alivexis' MDI-0151. MDI-0151 is an innovative clinical candidate identified in Alivexis' MOD-A discovery program.

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DelveInsight's "Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the DPP1 inhibitor, competitive landscape, eligible patient population as well as the DPP1 inhibitor therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The DPP1 inhibitor market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM DPP1 inhibitor market size from 2025 to 2034. The report also covers current DPP1 inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Study Period 2020 to 2034

Forecast Period 2024-2034

Geographies Covered * The US, EU4 (Germany, France, Italy, and Spain) and UK, Japan

DPP1 inhibitor Market * Total Market Size

• Market Size by Therapies
• Market Size by Class

DPP1 inhibitor Companies Insmed Incorporated, Boehringer Ingelheim, Shanghai Fosun Pharmaceutical, Expedition Therapeutics, Melodia Therapeutics, Alivexis, and others.

DPP1 inhibitor Epidemiology Segmentation * Total Prevalent Cases in Selected Indications for DPP1 Inhibitor

• Total Eligible Patient Pool in Selected Indications for DPP1 Inhibitor
• Total Treated Cases in Selected Indications for DPP1 Inhibitor

Key Factors Driving the Growth of DPP1 Inhibitors Market

Growing DPP1 Inhibitors Target Patient Pool

The increasing prevalence of chronic respiratory diseases, such as bronchiectasis, has expanded the patient population in need of effective treatments. In 2024, approximately 390K individuals in the US were diagnosed with NCFB, while millions more are estimated to be affected globally. This figure is projected to exceed 470K by 2034. Additionally, the rising prevalence of diseases such as ANCA-associated vasculitis, COPD, SLE, Hidradenitis suppurativa, Palmoplantar pustulosis, IBD, and others will propel the DPP1 inhibitor market.

Launch of Insmed's BRINSUPRI

Insmed's BRINSUPRI (brensocatib) has reached a key regulatory milestone, emerging as the first FDA-approved DPP inhibitor and the first therapy specifically approved for NCFB. As the only treatment designed exclusively for this condition, its approval represents a major scientific breakthrough, addressing a market with persistent unmet needs.

Rising DPP1 Inhibitors Clinical Trial Activity

Following the BRINSUPRI approval, leading companies such as Boehringer Ingelheim [Verducatib (BI 1291583) for bronchiectasis], Fosun Pharma/Expedition Therapeutics (XH-S004 for NCFB and COPD), Haisco Pharmaceutical Group/Chiesi (HSK31858 for NCFB and asthma), and Melodia Therapeutics/Alivexis (MDI-0151, currently in preclinical stages but showing potential in ANCA-associated vasculitis, bronchiectasis, COPD, and other conditions), geared up to launch their products in the DPP1 inhibitor market.

Strategic Collaborations and DPP1 Inhibitors Market Expansion

Partnerships between pharmaceutical companies and healthcare providers have accelerated the development and distribution of DPP1 inhibitors. For example, Chiesi Group's licensing agreement with Haisco Pharmaceutical to develop and commercialize HSK31858, a novel reversible DPP1 inhibitor, exemplifies strategic collaboration.

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Treatment Market

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Overview

DPP1 inhibitors are agents that block the activity of DPP1, an enzyme that activates neutrophil serine proteases during neutrophil development. By inhibiting DPP1, these compounds reduce excessive protease activity, which drives tissue damage and chronic inflammation. They are being investigated across multiple inflammatory and respiratory diseases where neutrophilic inflammation plays a central role.

These inhibitors work by preventing the activation of enzymes that cause airway damage, mucus overproduction, and recurrent infections. By targeting this upstream mechanism, oral DPP1 inhibitors aim to interrupt the cycle of inflammation and tissue destruction, potentially modifying disease progression rather than just alleviating symptoms. Their novel mechanism and oral administration make them an important emerging approach for conditions marked by unchecked neutrophil-driven damage.

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Epidemiology

• The DPP1 inhibitor epidemiology chapter in the report provides current as well as forecasted epidemiology segmented as total prevalent cases in selected indications for DPP1 inhibitor, total eligible patient pool in selected indications for DPP1 inhibitor, and total treated cases in selected indications for DPP1 inhibitor in the 7MM covering the US, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan from 2020 to 2034.
• Based on DelveInsight's assessment in 2024, the 7MM had approximately 1,055,000 diagnosed prevalent cases of SLE.
• In the EU4 and the UK, among age-specific prevalent cases of SLE, the 40-59-year age group accounted for the highest number of cases.
• According to DelveInsight's 2024 assessment, based on the Hurley classification of disease severity in Hidradenitis Suppurativa-comprising Stage I (mild), Stage II (moderate), and Stage III (severe)-Stage I was identified as the most prevalent stage among affected individuals in the US.
• Among the subtype-specific diagnosed prevalent cases of COPD in Japan-comprising chronic bronchitis, emphysema, and unclassified or mixed forms-chronic bronchitis accounted for approximately 58% of the total in 2024.

Epidemiology of Top Indications

Indication Estimated Prevalent Cases in 2024 in the US

Chronic Obstructive Pulmonary Disease (COPD) ~16,500,000

Non-Cystic Fibrosis Bronchiectasis (NCFB) ~389,000

Systemic Lupus Erythematosus (SLE) ~530,000

Hidradenitis suppurativa ~895,000

NOTE: The list of indications is not exhaustive and will be provided in the final report. Also, numbers are indicative and are subject to change as per report updation.

Key Updates Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor

• In August 2025, Fosun Pharma announced that its subsidiary Fosun Pharma Industrial had signed a License Agreement with Expedition Therapeutics to grant Expedition the rights to develop, manufacture, and commercialize XH-S004 in all regions globally except the Chinese Mainland, Hong Kong SAR, and Macau SAR. Fosun Pharma will retain the rights to develop, manufacture, and commercialize XH-S004 in the Chinese Mainland, Hong Kong SAR, and Macau SAR.
• In June 2024, Alivexis and Melodia Therapeutics entered into an exclusive license agreement for the worldwide development, manufacturing, and commercialization of Alivexis' MDI-0151. MDI-0151 is an innovative clinical candidate identified in Alivexis' MOD-A discovery program.

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Drug Chapters

The drug chapter segment of the DPP1 inhibitor report encloses a detailed analysis of approved as well as emerging drugs in late, mid, early, and preclinical-stage (Phase III, Phase II, Phase I, and preclinical) pipeline drugs. It also helps understand the DPP1 inhibitor clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

DPP1 Inhibitor Marketed Drugs

BRINSUPRI (brensocatib): Insmed Incorporated

BRINSUPRI is a small molecule, once-daily, oral, reversible inhibitor of DPP1 indicated for the treatment of NCFB in adult and pediatric patients 12 years of age or older. Recently approved, BRINSUPRI is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. BRINSUPRI is also being evaluated for its potential role in other neutrophil-mediated diseases.

In August 2025, the US Food and Drug Administration (FDA) approved first-in-class BRINSUPRI (brensocatib 10 mg and 25 mg tablets) NCFB in adults and children 12 years and older. The efficacy of BRINSUPRI was assessed in two randomized, double-blind, placebo-controlled, clinical trials, ASPEN (NCT04594369) and WILLOW (NCT03218917).

DPP1 Inhibitor Emerging Drugs

Verducatib (BI 1291583): Boehringer Ingelheim

Verducatib is a novel DPP1 inhibitor with the potential to improve symptoms and quality of life for patients with bronchiectasis. Currently, Boehringer Ingelheim is investigating the efficacy, safety, and tolerability of verducatib versus placebo in individuals with bronchiectasis, independent of underlying etiologies in AIRTIVITY (NCT06872892), a Phase III, multicenter, multinational, prospective, randomized, double-blind, placebo-controlled trial.

Earlier, Verducatib received FDA breakthrough therapy designation in 2024 for the treatment of bronchiectasis.

XH-S004: Shanghai Fosun Pharmaceutical and Expedition Therapeutics

XH-S004 is a small molecule orally administered DPP-1 inhibitor independently developed by Fosun Pharma. It reduces inflammatory responses and blocks the infection cycle and airway structural damage by inhibiting DPP-1 and the neutrophil serine proteases activated by it.

As of now, XH-S004 is in Phase II clinical trials in China for the treatment of NCFB and in Phase Ib clinical trials for the treatment of COPD.

• In August 2025, Fosun Pharma announced that its subsidiary Fosun Pharma Industrial had signed a License Agreement with Expedition Therapeutics to grant Expedition the rights to develop, manufacture, and commercialize XH-S004 in all regions globally except the Chinese Mainland, Hong Kong SAR, and Macau SAR. Fosun Pharma will retain the rights to develop, manufacture, and commercialize XH-S004 in the Chinese Mainland, Hong Kong SAR, and Macau SAR.

Comparison of Key Emerging DPP1 Inhibitors

Product Company Molecule type RoA Phase NCT ID Indication

Verducatib

(BI 1291583) Boehringer Ingelheim Small molecule Oral III NCT06872892 (AIRTIVITY) Bronchiectasis

XH-S004 Shanghai Fosun Pharmaceutical and Expedition Therapeutics Small molecule Oral II NCT06981091 NCFB

Ib NCT07035652 COPD

MDI-0151 Melodia Therapeutics and Alivexis Small molecule - Preclinical - IBD, SLE, Hidradenitis suppurativa, and Palmoplantar pustulosis

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Market Outlook

Currently, BRINSUPRI (brensocatib) is the only DPP1 inhibitor approved treatment option for NCFB. DPP1 inhibitors represent a promising treatment class that targets the upstream activation of neutrophil serine proteases, which are key mediators of tissue damage and chronic inflammation. In respiratory diseases like NCFB and COPD, these agents help reduce protease activity that drives airway destruction and exacerbations. Emerging applications also include dermatological and autoimmune conditions where excessive neutrophil activity plays a critical role. Novel compounds in this class aim to provide disease-modifying benefits by intervening early in the inflammatory cascade, offering a more targeted approach compared to conventional anti-inflammatory therapies. By reducing neutrophilic inflammation and protease-mediated tissue injury, DPP1 inhibitors hold promise for improving outcomes in conditions with significant unmet needs.

DPP-1 inhibition may also be a promising treatment avenue in other diseases where neutrophilic inflammation is implicated. Future directions include establishing direct and downstream effects of DPP-1 inhibitors in humans and seeking biomarkers to guide clinical application.

Several key players, including Boehringer Ingelheim, Shanghai Fosun Pharmaceutical and Expedition Therapeutics, Melodia Therapeutics and Alivexis, and others, are involved in developing drugs for the DPP1 inhibitor for various indications such as Bronchiectasis, COPD, NCFB, SLE, Hidradenitis suppurativa, Palmoplantar pustulosis, IBD, and others.

DPP1 Inhibitor Drugs Uptake

BRINSUPRI market forecast is dependent on factors such as therapy uptake in upcoming years, competitive stiffness in NCFB patient segment, key pricing decisions taken by Insmed, confidential discounts offered by the company, decision making by payers and HTA bodies in terms of accessibility and reimbursement in various countries, safety and efficacy parameters along with anticipated launches in wider geographies during 2025-2034.

Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Pipeline Development Activities

The DPP1 Inhibitor pipeline report provides insights into different DPP1 Inhibitor clinical trials within Phase III, Phase II, Phase I, and preclinical. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs at different stages is expected to generate immense opportunities for the DPP1 inhibitor market growth over the forecasted period.

DPP1 Inhibitor Pipeline development activities

The DPP1 Inhibitor clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for DPP1 inhibitor emerging therapies.

The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion. For example, in August 2025, Fosun Pharma's subsidiary, Fosun Pharma Industrial, signed a License Agreement with Expedition Therapeutics to grant Expedition the rights to develop, manufacture, and commercialize XH-S004 in all regions globally except the Chinese Mainland, Hong Kong SAR, and Macau SAR.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on DPP1 inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the US. Centers such as the University of Tours, University of Dundee, Ninewells Hospital and Medical School, University of Birmingham, etc., were contacted.

Their opinion helps understand and validate current and emerging therapy treatment patterns or DPP1 inhibitor market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

KOL Views

"DPP-1 inhibition with brensocatib had the greatest effect in reducing Cathepsin G activity in sputum and the least effect on PR3 activity. There may be multiple factors accounting for the differential response in neutrophil serine protease activity to DPP-1 inhibition. In the absence of a DPP-1 inhibitor, nearly all of the neutrophil serine protease zymogens are converted to active forms during neutrophil maturation."

MD, Ninewells Hospital and Medical School, UK

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement Key Developments in 2025

Region/Country Key 2025 Developments

United States * Ongoing tariff threats and delays

• Most-Favored-Nation drug pricing policy seen as a major concern
• Proposal: Nations to spend set GDP % on innovative medicines (NATO-style commitment)

Europe (EU-wide) * Joint Clinical Assessment launched (6 drugs under review)

• EU pharma law revision in trilogue; hard to reach consensus
• EU Life Sciences Strategy supports innovation but faces uncertain implementation

Germany * AMNOG reform: focus on rebates & personalized medicine

• Ongoing disputes between parliament and insurers over HTA/pricing

France * Expanding use of health economic evaluations and value metrics

• Aligning drug pricing with geopolitical factors

Italy * AIFA revised innovation criteria

• Innovative Medicines Fund updated

Spain * Ongoing gradual reform of HTA and pricing system

• More legislative updates expected

United Kingdom * VPAG renegotiation delayed; sector plan postponed

• NHS 10-Year Plan: major changes for pharma sector

China * Lower market access barriers, fair competition promoted

• Hybrid reimbursement model supports high-priced drugs
• Promotes global pharma growth

Japan * Structural pharmaceutical reform and focus on drug discovery

• HTA review may broaden economic evaluation

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

DPP1 Inhibitor Market Report Insights

• Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Targeted Patient Pool
• DPP1 Competitive Landscape
• Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Pipeline Analysis
• Dipeptidyl Peptidase 1 (DPP1)/Cathepsin C Inhibitor Market Size and Pricing Trends
• DPP1 Inhibitor Reimbursement Scenario
• Existing and Future Market Opportunity

DPP1 Inhibitor Market Report Key Strengths

• Ten-Years Forecast
• The 7MM Coverage
• Key Cross Competition
• DPP1 Inhibitor Drugs Uptake
• Key DPP1 Inhibitor Market Forecast Assumptions
• Physicians perspective on Drug Performance and Prescribing feasibility

DPP1 Inhibitor Market Report Assessment

• Current DPP1 Inhibitor Treatment Practices
• DPP1 Inhibitor Unmet Needs
• Safety and Efficacy head to head comparison
• DPP1 Inhibitor Pipeline Product Profiles
• Market Attractiveness
• Cost analogues and pricing trends
• Anticipated launch years
• Qualitative Analysis (SWOT and Conjoint Analysis)
• DPP1 Inhibitor Market Drivers
• DPP1 Inhibitor Market Barriers

Key Questions Answered In The DPP1 Inhibitor Market Report:

• What could be the possible DPP1 inhibitor total market size, the market size by therapies, market share (%) distribution in next 5 years, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• What is the most lucrative market for the DPP1 inhibitor?
• Which drug will account for maximum DPP1 inhibitor sales?
• What are the pricing variations among different geographies?
• What are the risks, burdens, and unmet needs of treatment with a DPP1 inhibitor? What will be the growth opportunities across the 7MM for the patient population of the DPP1 inhibitor?
• What are the key factors hampering the growth of the DPP1 inhibitor market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for the DPP1 inhibitor?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy DPP1 Inhibitor Market Forecast Report

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the DPP1 inhibitor market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies reforms in 2025, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.