Bronchopulmonary Dysplasia (BPD) Treatment Market By Treatment Type (Caffeine Citrate Therapy, Pulmonary Surfactant Therapy, Corticosteroid Therapy, Diuretics, Bronchodilators, Pulmonary Vasodilators, Vitamin A Supplementation, Oxygen Therapy, Non-Invasive Respiratory Support, Mechanical Ventilation, Biologics and Growth-Factor Therapies, Cell-Based and Exosome Therapies); By Application (BPD Prevention in High-Risk Preterm Infants, Established Bronchopulmonary Dysplasia, Moderate-to-Severe Bronchopulmonary Dysplasia, Ventilator-Dependent Bronchopulmonary Dysplasia, BPD-Associated Pulmonary Hypertension, Post-Discharge Respiratory Management); By End User (Neonatal Intensive Care Units, Children’s Hospitals, Maternity and Perinatal Care Hospitals, Paediatric Pulmonology Clinics, Paediatric Cardiology Clinics, Specialty Neonatal Follow-Up Centres, Home Healthcare Providers); By Geography, Segment Revenue Estimation, Forecast, 2026–2032

Bronchopulmonary Dysplasia Treatment Market: Negative Budesonide Trials Raise the Evidence Bar for Neonatal Biologics

The Global Bronchopulmonary Dysplasia (BPD) Treatment Market was valued at USD 1.30 billion in 2025 and is projected to reach USD 2.48 billion by 2032, growing at a CAGR of 8.4% during the forecast period, according to Strategic Market Research.

 

The Bronchopulmonary Dysplasia Treatment Market is primarily characterized by neonatal intensive-care services rather than by a specific pharmaceutical product targeting the disease. The majority of current treatment efforts involve caffeine citrate, surfactant, non-invasive respiratory support, oxygen management, nutrition, and the selective use of corticosteroids. While diuretics, bronchodilators, pulmonary vasodilators, home oxygen, and mechanical ventilation are utilized to manage individual complications, they have not demonstrated a consistent disease-modifying effect.

 

The focus of commercial development is shifting towards preventive biologics and regenerative therapies, as treatments administered after significant lung injury have yielded limited clinical improvements. Oak Hill Bio and Chiesi are currently assessing recombinant IGF-1 through OHB-607, while Airway Therapeutics has progressed zelpultide alfa into a Phase 2b/3 trial. EXO Biologics is investigating an exosome product, and Medipost is advancing an umbilical cord-derived cell therapy. Additionally, HCW Biologics introduced a preclinical immune-senescence program in 2026. However, none of these approaches have yet shown registrational efficacy in a large randomized trial for BPD.

 

Furthermore, two significant trials involving budesonide and surfactant have altered expectations for development. The PLUSS trial enrolled 1,059 extremely preterm infants, revealing that 25.6% of the budesonide-surfactant group survived without BPD, compared to 22.6% in the surfactant-only group. The subsequent BiB trial, which included 641 infants, reported BPD or death in 68.5% and 67.9% of participants, respectively, leading to an early termination due to futility. These findings challenge the assumption that the direct delivery of a well-known anti-inflammatory drug alongside surfactant will result in a clinically significant reduction in BPD.

 

Improved Survival Is Increasing the Number of Infants Requiring BPD Care

Approximately 13.4 million babies were born before 37 weeks of gestation in 2024, but this total should not be used directly as the treatment population. BPD is concentrated among infants born before 28–29 weeks and those with very low or extremely low birth weight. Later-preterm infants account for much of the global preterm-birth denominator but carry substantially lower BPD risk.

A 2024 meta-analysis covering 105 studies and 780,936 infants estimated pooled BPD prevalence at 35% when assessed at 28 days and 21% at 36 weeks’ postmenstrual age. The 36-week estimate is more relevant to established disease. BPD at 36 weeks affected approximately 71% of infants weighing below 500 g, 60% of those weighing 501–750 g, and 10% of infants weighing 1,251–1,500 g. Gestational age and birth weight therefore provide a stronger basis for treatment forecasting than total preterm births.

The United States recorded 377,204 preterm births in 2024, representing 10.41% of births, while 1.33% of newborns had a birth weight below 1,500 g. The American Lung Association estimates that 10,000–15,000 U.S. newborns develop BPD each year. These infants generate prolonged NICU stays, respiratory-product use, specialist follow-up, and home-care expenditure that extends well beyond the initial neonatal admission.

Improved survival at the lowest gestational ages can raise BPD prevalence even when neonatal care improves. A Korean Neonatal Network analysis of infants born at 23–27 weeks found that BPD among survivors increased from 51.2% in 2014 to 62.7% in 2021, while mortality declined from 28.3% to 19.5%. Manufacturers and neonatal providers therefore face a larger population of extremely premature survivors requiring respiratory support, medication, nutrition, and follow-up.

 

Prevention Accounts for More Value Than Treatment After Diagnosis

Most neonatal interventions target the period before BPD is formally assessed at 36 weeks. Avoiding prolonged invasive ventilation, reducing oxygen injury, supporting lung growth, and facilitating earlier extubation can affect both disease severity and the duration of expensive NICU care.

Caffeine remains the clearest pharmacological benchmark. In the CAP trial, oxygen dependence at 36 weeks occurred in 36% of caffeine-treated infants and 47% of placebo recipients. Caffeine also shortened positive-pressure ventilation exposure and remains widely used because it combines established efficacy with low acquisition cost. New therapies must therefore provide additional benefit on top of a preventive treatment already embedded in neonatal practice.

Intramuscular vitamin A reduced death or BPD from approximately 62% to 55% in the largest trial, but the seven-percentage-point improvement has not produced uniform adoption. Repeated intramuscular dosing creates a treatment burden in extremely small infants, and a more recent high-dose oral trial reported death or moderate-to-severe BPD in 38% of both treatment and placebo groups. Route of administration can therefore determine commercial use even when an older efficacy signal exists.

Non-invasive respiratory support has a larger equipment and service impact than drug revenue. Pooled evidence comparing early CPAP with routine intubation indicates a modest reduction in death or BPD, while high-flow nasal therapy has not demonstrated superiority to CPAP for that outcome. Hospitals continue to invest in CPAP interfaces, nasal devices, ventilators, monitoring systems, and staff protocols because reducing invasive ventilation affects lung injury and NICU resource use.

 

Corticosteroid Use Is Moving Toward Risk-Selected Infants

Postnatal corticosteroids can improve respiratory status but expose neonatal units to neurodevelopmental, cardiovascular, metabolic, and gastrointestinal safety concerns. The market is consequently defined by treatment timing and baseline BPD risk rather than broad use across all premature infants.

PREMILOC enrolled 523 extremely preterm infants and reported survival without BPD in 60% of infants receiving early low-dose hydrocortisone, compared with 51% receiving placebo. The nine-percentage-point difference supports preventive use in carefully selected high-risk infants, but it does not justify routine administration in lower-risk populations.

Later hydrocortisone has produced less persuasive results. In a trial of 800 ventilator-dependent infants treated between days 14 and 28, survival without moderate or severe BPD reached 16.6% with hydrocortisone and 13.2% with placebo, a non-significant difference. Hypertension requiring treatment occurred more often with hydrocortisone. Later corticosteroid exposure therefore remains more closely tied to extubation and individual respiratory status than to a proven reduction in established BPD.

Low-dose dexamethasone produced a much stronger short-term extubation signal in the DART trial: 60% of treated infants were successfully extubated by day 10, compared with 12% of controls. The trial enrolled only 70 chronically ventilator-dependent infants and was not large enough to establish definitive effects on BPD, mortality, or long-term disability. Neonatal units use the regimen selectively where prolonged mechanical ventilation presents a greater immediate risk than corticosteroid exposure.

The Canadian Paediatric Society advises against routine early dexamethasone, permits consideration of early physiological-dose hydrocortisone in infants at particularly high risk, and supports a short low-dose dexamethasone course after the first week for selected ventilator-dependent infants. Risk-prediction models that identify infants likely to exceed a high BPD probability could therefore influence corticosteroid prescribing more than a new dosing formulation.

 

Negative Budesonide Trials Remove a Potential Near-Term Standard

Budesonide mixed with surfactant once represented one of the most scalable BPD-prevention concepts because both ingredients were familiar to neonatal units and intratracheal delivery concentrated exposure in the lung. Large randomized evidence has not supported routine adoption.

The international PLUSS trial found no clear improvement in survival without BPD among 1,059 infants born before 28 weeks. The adjusted difference was 2.7 percentage points, and the confidence interval crossed zero. The trial’s size and multinational design make the neutral result more influential than earlier single-centre studies that had suggested a larger benefit.

The U.S. BiB trial reinforced that conclusion. BPD or death occurred in 68.5% of infants receiving budesonide with surfactant and 67.9% receiving surfactant alone. Hyperglycemia occurred in 66.7% of the combination group and 49.8% of controls. Hospitals now have little clinical or economic justification for routine off-label mixing when two major trials failed to establish benefit and one identified additional metabolic toxicity.

The failed strategy raises the threshold for emerging intratracheal products. Zelpultide alfa, EXOB-001, Pneumostem, and future local biologics will need to show more than biomarker improvement or early safety. Registrational programmes must demonstrate lower grade 2–3 BPD, improved survival without BPD, reduced ventilator exposure, or a meaningful decrease in post-discharge respiratory dependence.

 

Wide Hospital Variation Creates Demand for Standardized Treatment Selection

Diuretics and bronchodilators are widely used despite limited evidence that they alter long-term BPD outcomes. Hospital-level variation is large enough to indicate that local practice often drives use more strongly than standardized efficacy criteria.

Published multicentre data found prolonged diuretic exposure in 4% to 86% of infants with BPD across hospitals. Furosemide was the most commonly used agent, while chlorothiazide produced the longest treatment duration. Diuretics can temporarily improve pulmonary mechanics in infants with edema, but chronic exposure adds electrolyte monitoring, renal surveillance, pharmacy cost, and potential bone or hearing complications without a proven reduction in long-term disease severity.

Bronchodilator use among hospitals ranged from 0% to 59%, while albuterol exposure ranged from 0% to 53%. A separate physiological study found bronchodilator responsiveness in 63% of 93 tested patients, but response during lung-function testing does not establish lower mortality, shorter hospitalization, or faster oxygen discontinuation. Objective response testing could reduce unnecessary medication while identifying infants with a reversible airway component.

The American Thoracic Society recommends against routine outpatient bronchodilator use in children without recurrent respiratory symptoms and supports a monitored trial in those with cough or wheeze. It also advises against routine outpatient diuretic treatment and recommends careful discontinuation for infants discharged on chronic therapy. These conditional recommendations increase the value of phenotype-based follow-up rather than uniform prescribing.

 

Pulmonary Hypertension Creates a Smaller High-Intensity Segment

Pulmonary hypertension affects an estimated 20% of infants with BPD and can approach 40% in severe disease. These patients require echocardiography, oxygen optimization, cardiology or pulmonary-hypertension input, and selected use of sildenafil, bosentan, diuretics, or other cardiovascular therapies.

Treatment demand decreases as pulmonary vascular disease improves with lung and somatic growth. Recent evidence indicates resolution in approximately 47% by one year and 79%–94% by around two years. Pulmonary vasodilator revenue is therefore concentrated in severe infants during a limited high-risk period rather than sustained throughout childhood for most survivors.

Patent ductus arteriosus management is also becoming more conservative. Randomized evidence has not shown that routine early pharmacological closure consistently reduces death or moderate-to-severe BPD, while a 2025–2026 trial found expectant management comparable with active drug treatment for the primary outcome. Neonatal units are likely to target ibuprofen, acetaminophen, catheter closure, or surgery toward infants with clearer haemodynamic compromise rather than treating ductal patency solely to prevent BPD.

 

Biologics and Regenerative Therapies Must Overcome Earlier Trial Failures

OHB-607 is the most advanced growth-factor programme. The ongoing Phase 2b study plans to compare recombinant human IGF-1/IGFBP-3 with standard neonatal care in at least 338 infants born at 23–27 weeks. Oak Hill Bio and Chiesi resumed enrolment in 2024, giving the programme multinational development support and access to Chiesi’s neonatal respiratory infrastructure.

Airway Therapeutics’ zelpultide alfa is a recombinant surfactant protein D delivered intratracheally. A Phase 1b dose study reported an acceptable early safety profile, and the company has registered an adaptive Phase 2b/3 trial in high-risk preterm infants. A programme progressing from dose selection into a confirmatory stage could become one of the first direct tests of whether immune-modulating surfactant proteins can prevent clinically important BPD.

EXO Biologics is testing EXOB-001, extracellular vesicles derived from umbilical cord mesenchymal stromal cells, in the Phase 1/2 EVENEW trial. Medipost’s Pneumostem uses living umbilical cord blood-derived mesenchymal cells and holds orphan and Fast Track designations, but an earlier randomized Phase II trial did not produce a significant overall reduction in death or moderate-to-severe BPD. Exosome developers may offer manufacturing, storage, and consistency advantages over living-cell products, but clinical efficacy remains unproven.

HCW Biologics reported in May 2026 that HCW11-040 prevented BPD-like injury in IND-enabling animal studies by targeting senescent cells. The asset has not entered a neonatal clinical trial, and its pembrolizumab-based immune construct will require extensive safety justification before exposure in extremely premature infants. The programme should be treated as an early preclinical option rather than a near-term competitor to OHB-607 or zelpultide alfa.

 

Competitive Outlook

Chiesi holds the strongest established neonatal respiratory position through surfactant products and its partnership on OHB-607. Airway Therapeutics is pursuing a direct pulmonary biologic through zelpultide alfa, while EXO Biologics and Medipost represent competing cell-free and cell-based regenerative strategies. HCW Biologics is attempting to enter through immune-senescence biology, but the programme remains several development stages behind the clinical pipeline.

Established suppliers of caffeine, surfactant, respiratory devices, oxygen systems, monitors, and neonatal nutrition will continue to capture most near-term spending. The absence of an approved disease-modifying therapy preserves a large unmet need, but recent negative trials show that biologic plausibility does not translate easily into lower BPD or death.

Future products will need to improve outcomes on top of caffeine, non-invasive ventilation, surfactant, modern oxygen management, and selective corticosteroid use. The most persuasive clinical endpoints will be survival without grade 2–3 BPD, fewer ventilation days, lower home-oxygen dependence, reduced pulmonary hypertension, and fewer rehospitalizations.

Risk selection will also determine commercial viability. Treating every premature infant would expose many lower-risk newborns to unnecessary therapy and make trials prohibitively large. Products that identify and treat infants born before 28 weeks, weighing below 1,000 g, or remaining ventilation-dependent are more likely to produce measurable benefit and justify neonatal biologic pricing.

BPD treatment growth will therefore come from two different sources. Improving survival will expand demand for NICU respiratory care, home oxygen, and specialist follow-up. A successful preventive biologic could create the first high-value pharmaceutical segment, but it must deliver a clinically important benefit that caffeine, steroids, surfactant, and respiratory-support improvements have not already achieved.
 

Bronchopulmonary Dysplasia Treatment Market Report Coverage Table

Report Attribute	Details
Forecast Period	2026 – 2032
Market Size Value in 2025	USD 1.30 Billion
Revenue Forecast in 2032	USD 2.48 Billion
Overall Growth Rate	CAGR of 8.4% (2026 – 2032)
Base Year for Estimation	2025
Historical Data	2019 – 2024
Unit	USD Million, CAGR (2026 – 2032)
Segmentation	By Treatment Type, By Application, By End User, By Geography
By Treatment Type	Caffeine Citrate Therapy, Pulmonary Surfactant Therapy, Corticosteroid Therapy, Diuretics, Bronchodilators, Pulmonary Vasodilators, Vitamin A Supplementation, Oxygen Therapy, Non-Invasive Respiratory Support, Mechanical Ventilation, Biologics and Growth-Factor Therapies, Cell-Based and Exosome Therapies
By Application	BPD Prevention in High-Risk Preterm Infants, Established Bronchopulmonary Dysplasia, Moderate-to-Severe Bronchopulmonary Dysplasia, Ventilator-Dependent Bronchopulmonary Dysplasia, BPD-Associated Pulmonary Hypertension, Post-Discharge Respiratory Management
By End User	Neonatal Intensive Care Units, Children’s Hospitals, Maternity and Perinatal Care Hospitals, Paediatric Pulmonology Clinics, Paediatric Cardiology Clinics, Specialty Neonatal Follow-Up Centres, Home Healthcare Providers
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Country Scope	U.S., Canada, UK, Germany, France, Italy, China, Japan, South Korea, India, Brazil, Mexico, Saudi Arabia, UAE, South Africa
Market Drivers	Rising prevalence of premature births and neonatal respiratory complications, increasing adoption of advanced respiratory support therapies, growing investment in neonatal intensive care infrastructure, and expanding research into regenerative and biologic treatment approaches
Customization Option	Available upon request