Bronchopulmonary Dysplasia - Market Insight, Epidemiology and Market Forecast - 2034

The “Bronchopulmonary Dysplasia - Market Insights, Epidemiology, and Market Forecast - 2034” report delivers an in-depth understanding of Bronchopulmonary Dysplasia, historical and forecasted epidemiology, as well as the bronchopulmonary dysplasia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The bronchopulmonary dysplasia market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM bronchopulmonary dysplasia market size from 2020 to 2034. The report also covers bronchopulmonary dysplasia treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Bronchopulmonary Dysplasia Market

• The incidence of bronchopulmonary dysplasia is on the rise, possibly attributed to the growing population of premature infants worldwide due to infection during pregnancy, preeclampsia, and substance abuse (smoking). Additionally, environmental factors such as air pollution, water pollution, and tobacco exposure may amplify the likelihood of causing the disease.
• Moreover, the COVID-19 pandemic has brought the fear of bronchopulmonary dysplasia among healthcare professionals and parents. Consequently, there will be a significant surge in demand for the treatment of bronchopulmonary dysplasia during the forecast period (2024-2034).
• In 2023, the US had the largest market size of bronchopulmonary dysplasia among the 7MM, and is expected to increase further by 2034.
• There is no US FDA-approved drug for treating bronchopulmonary dysplasia. Current treatment focuses on minimizing the baby’s lung damage and providing support for the lung to heal and grow.
• Infants with bronchopulmonary dysplasia often require intensive hospital care until they can breathe independently. Treatments involve bronchodilators like albuterol to keep airways open, diuretics such as furosemide to reduce lung fluid, and inhaled steroids like budesonide to alleviate inflammation. In severe cases, short-term steroid courses may be administered orally or intravenously, despite their notable short-term and long-term adverse effects.
• Despite the availability of effective therapies, patients and caregivers may struggle to adhere to treatment regimens due to various factors such as the long-term side effects of drugs in certain cases, the complexity of the bronchopulmonary dysplasia regimen, financial limitations, insufficient understanding of the disease and its treatment, and obstacles in accessing healthcare services.
• Another major challenge in bronchopulmonary dysplasia treatment is the lack of guidelines outlining effective monitoring protocols for children with established bronchopulmonary dysplasia, leaving healthcare providers without standardized approaches to track their progress and intervene as needed to optimize outcomes.
• However, the ongoing research has led to the discovery of potential therapies that aim to address these unmet needs in bronchopulmonary dysplasia treatment. Emerging therapies like Takeda/Oak Hill Bio OHB-607/TAK-607/SHP607 (mecasermin rinfabate), Medipost Pneumostem, and others.
• OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in-utero, and its binding protein, IGFBP-3. Its anticipated introduction in the US market in 2028 is expected to significantly challenge existing therapies in the field.

Bronchopulmonary Dysplasia Treatment Market

Bronchopulmonary dysplasia is a chronic respiratory disease that often occurs in low-weight or premature infants who have received supplemental oxygen or have spent long periods on a breathing machine (mechanical ventilation), such as infants with acute respiratory distress syndrome. In addition, older infants with abnormal lung development, prenatal infections, placental anomalies (such as preeclampsia), or chorioamnionitis may also develop bronchopulmonary dysplasia. Thus, bronchopulmonary dysplasia, also known as chronic lung disease of prematurity, is a condition related to the way a baby's lung tissue develops and is not present at birth.

The risk of developing bronchopulmonary dysplasia increases the earlier a baby is born and the lower the birth weight. Affected infants have rapid, labored breathing, tachypnea, cyanosis, feeding difficulties, and recurrent lung infection. The pathogenesis of bronchopulmonary dysplasia remains complex and poorly understood. It results from various factors that injure small airways and can interfere with alveolarization, leading to alveolar simplification with a reduction in the overall surface area for gas exchange. The developing pulmonary microvasculature is also injured. Damage to the lung during a critical stage of lung growth results in clinically significant pulmonary dysfunction bronchopulmonary dysplasia is divided into three severity grades (mild, moderate, or severe) based on respiratory support needs at 36 weeks postmenstrual age (PMA). The exact, underlying mechanisms that cause classic or new bronchopulmonary dysplasia are complex and not fully understood. The causes of bronchopulmonary dysplasia in one infant may be different from the causes in another. Most likely, multiple different environmental and genetic factors all play a role in the development of the disorder.

The cases of bronchopulmonary dysplasia have been increasing, most likely because of modern advances in medicine, which have enabled doctors to keep more low birth weight, premature babies alive than in the past.

Bronchopulmonary dysplasia diagnosis

Infants with bronchopulmonary dysplasia show substantial heterogeneity in clinical presentation and long-term outcomes. The manner and precision with which bronchopulmonary dysplasia is defined have far-reaching consequences for translational and clinical research.

Diagnosis is done based on the identification of characteristic symptoms, detailed patient history, thorough clinical evaluation, and a variety of specialized tests, including blood tests, chest X-rays, and echocardiograms. Many infants now, diagnosed with bronchopulmonary dysplasia, are born at an earlier gestational age than before. These cases are sometimes referred to as “new bronchopulmonary dysplasia.” they generally have less inflammation and scarring than classic bronchopulmonary dysplasia.

Bronchopulmonary dysplasia treatment

As of now, there is no specific cure for bronchopulmonary dysplasia, prompting a focus on minimizing lung damage and fostering lung healing and growth. Treatment encompasses mechanical ventilation and supplemental oxygen to enhance lung capacity and aid breathing. Antenatal steroid administration before preterm birth and early surfactant treatment decreases the need for extensive respiratory support post-birth. Infants receive various medications like bronchodilators, diuretics, antibiotics, and steroids to alleviate lung inflammation and congestion. Proper nutritional management is crucial for healthy lung development.

Preventive strategies for bronchopulmonary dysplasia mainly involve antenatal pharmacologic interventions such as maternal progesterone and steroids, alongside postnatal pharmacologic interventions. Despite advancements in perinatal strategies, bronchopulmonary dysplasia remains the primary complication of prematurity and a significant cause of respiratory issues. Its prevention and management pose ongoing challenges for neonatologists, especially with the growing survival rates of extremely premature infants.

Bronchopulmonary Dysplasia Epidemiology

As the market is derived using a patient-based model, the bronchopulmonary dysplasia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by incident cases of bronchopulmonary dysplasia, weight-specific cases of bronchopulmonary dysplasia, severity-specific cases of bronchopulmonary dysplasia, in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to the analysis, in 2023, approximately 17 thousand incident cases of bronchopulmonary dysplasia were estimated in the 7MM. These cases are anticipated to increase by 2034 driven by the increasing number of premature births.
• In 2023, approximately 13 thousand incidence cases of bronchopulmonary dysplasia in the US were reported. These cases are expected to increase by 2034 due to increased prenatal factors such as maternal smoking, infections, and inadequate care.
• Among the EU4 and the UK, Germany had the highest incident population of bronchopulmonary dysplasia with approximately 930 cases, followed by France with 920 cases. On the other hand, Italy had the lowest incident population with nearly 390 cases in 2023.
• In the US, there were nearly 5 thousand cases of bronchopulmonary dysplasia in ≤750 g birth weight group preterm infants followed by approximately 5 thousand cases in 751-1000 g, 2 thousand cases in 1001-1250 g, and 709 cases in ≥1250 g in 2023. These cases are expected to increase by 2034.
• In the US, there were a total of nearly 5 thousand, 5 thousand and 3 thousand severity-specific cases of mild, moderate, and severe cases of bronchopulmonary dysplasia respectively, in 2023. As per analysts, the severity-specific cases of bronchopulmonary dysplasia will increase by 2034 owing to the increasing incidence of premature babies in the US.
• As per the analysis, the total incident cases of bronchopulmonary dysplasia in Japan were approximately 442 cases, out of which there were 191, 76, and 175 severity-specific cases of mild, moderate, and severe bronchopulmonary dysplasia respectively, in 2023.

Bronchopulmonary Dysplasia Drug Chapters

The drug chapter segment of the Bronchopulmonary Dysplasia report encloses a detailed analysis of bronchopulmonary dysplasia-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the bronchopulmonary dysplasia 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.

Emerging Drugs

OHB-607/TAK-607/SHP607 (Mecasermin Rinfabate): Takeda/Oak Hill Bio/ Chiesi

OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in-utero, and its binding protein, IGFBP-3.

IGF-1 plays an important role in the development of the fetus. It is supplied by the mother until about 30 weeks of gestation, after which the fetus begins producing the growth factor on its own. Levels of IGF-1 dramatically decrease in infants born extremely prematurely (before 28 weeks of gestation), thereby increasing the risk for complications related to the lungs, brain, eyes, and other organs. OHB-607, as a human IGF-1 replacement, is designed to help promote the continued development and maturation of vital organs and the vasculature that supports them.

Recently the company posted regarding the execution of an agreement to develop, manufacture, and commercialize OHB-607 with Chiesi. Furthermore, this license and development agreement intends to restart the Phase IIb clinical trial of OHB-607.

Pneumostem: Medipost

Pneumostem by Medipost is an allogeneic, umbilical cord blood-derived mesenchymal stem cell product, currently under development for preventive treatment of bronchopulmonary dysplasia in premature infants. Currently, Phase II clinical trial is ongoing in Korea and the drug candidate has been an orphan drug designated by the US FDA and EMA. Recently, the US FDA granted a fast-track designation for pneumocytes.

Drug Class Insights

Treatment for bronchopulmonary dysplasia encompasses a range of medications aimed at enhancing lung capacity and facilitating breathing. Bronchodilators like albuterol widen the airways, enhancing airflow and lessening respiratory distress. Diuretics, such as furosemide, diminish fluid accumulation in the lungs, easing pulmonary congestion and enhancing respiratory function. Surfactant replacement therapy is utilized to enhance lung compliance and diminish the risk of respiratory distress syndrome, a precursor to bronchopulmonary dysplasia in premature infants. Corticosteroids, despite potential risks, are employed to mitigate lung inflammation in infants with bronchopulmonary dysplasia, aiming to enhance respiratory function. Additionally, antibiotics are administered to combat respiratory infections, which can worsen lung damage and compromise respiratory function in bronchopulmonary dysplasia patients.

Bronchopulmonary Dysplasia Market Outlook

Once bronchopulmonary dysplasia develops, the primary goal of the treatment of bronchopulmonary dysplasia is to provide adequate respiratory support and nutrition to promote optimal lung growth. Multiple pharmacologic and non-pharmacologic treatment strategies have been proposed to support survival, minimize further lung injury, and facilitate recovery. Despite advancements like prenatal steroids, surfactants, and improved resuscitation methods boosting premature infant survival, safeguarding their underdeveloped organs from the stress of life-saving measures at birth remains a challenge. Respiratory therapies span from noninvasive ventilator support to mechanical ventilation with a tracheostomy. Infants with mild bronchopulmonary dysplasia often require oxygen support solely to enhance lung function, without necessitating pharmacological intervention. Pharmacological treatments for bronchopulmonary dysplasia encompass bronchodilators, diuretics, antibiotics, surfactants, and corticosteroids. Although corticosteroids, with their anti-inflammatory properties, have been widely employed in bronchopulmonary dysplasia treatment or prevention, systemic steroid use is linked to significant short- and long-term adverse effects.

However, a few assets in development for bronchopulmonary dysplasia include OHB607 (mecasermin rinfabate), pneumocytes (Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells), CHF5633, AT-100 is being developed and expected to launch during the forecast period.

The current market segmentation is based on the off-label therapies prescribed. The drugs that are being used in the present market include bronchodilators, diuretics, antibiotics, steroids, and others. These are the major segments covered in the forecast model.

• Several key players are evaluating their lead candidates in different stages of clinical development like OHB607 (mecasermin rinfabate) by Takeda/Oak Hill Bio, pneumostem by Medipost, and others.
• The market for bronchopulmonary dysplasia is expected to experience positive growth.
• The market size of bronchopulmonary dysplasia in the US was highest in the 7MM in 2023, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of EU4 and the UK was calculated to be approximately 19.73% of the total market revenue for the 7MM. These numbers are expected to change during the forecast period (2024-2034).
• According to estimates, among EU4 and the UK, Germany accounted for the highest market size in 2023.
• In 2023, Japan with a revenue of approximately 2.58% of the total market revenue for the 7MM, which is expected to increase significantly by 2034.

Bronchopulmonary Dysplasia Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Takeda/Oak Hill Bio’s OHB607(TAK 607), a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), is expected to enter the US market in 2028 with a “medium-fast” uptake.

Bronchopulmonary Dysplasia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Bronchopulmonary Dysplasia.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on bronchopulmonary dysplasia evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

Analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like Duke University Medical Centre, US, Children's National Health System, Washington, US, Max Planck Institute for Heart and Lung Research, Germany, Newcastle University, UK, University of Padua, Italy, and Saitama Medical University, Japan were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or bronchopulmonary dysplasia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician’s View

According to our primary research analysis, despite advancements in the treatment of bronchopulmonary dysplasia, significant unmet needs persist in effectively managing this complex disorder. One primary challenge lies in a lack of personalized treatment strategies tailored to individual patient characteristics, including gestational age, severity of bronchopulmonary dysplasia, and genetic factors, which could optimize outcomes and reduce complications. Furthermore, comprehensive long-term follow-up protocols are needed to monitor the respiratory health, growth, and neurodevelopmental outcomes of bronchopulmonary dysplasia survivors, ensuring early detection and intervention for potential complications

According to a KOL in the US, at present, there is no curative therapy for bronchopulmonary dysplasia in the US. Though infants can recover from bronchopulmonary dysplasia, it is linked to severe morbidity and mortality in premature infants, and survivors often have long-term repercussions throughout adulthood. When compared to females of the same age, preterm males have a larger risk of developing more severe symptoms.

As per another KOL, despite advancements in the understanding of bronchopulmonary dysplasia’s pathophysiology, just a few of the available treatments are backed up by high-quality research. Novel therapeutics to prevent or lessen the severity of bronchopulmonary dysplasia could thereby improve healthcare outcomes for a growing community of preterm survivors. To better understand how biomarkers and “omic” techniques might be used to predict bronchopulmonary dysplasia early and define distinct phenotypes, more research is needed.”

Another KOL found that over the last several years, there have been several changes in practice regarding the clinical prevention and treatment of bronchopulmonary dysplasia, including increasing antenatal steroid use and a shift in the pattern of inhaled and systemic steroid use for bronchopulmonary dysplasia treatment. Despite changes in bronchopulmonary dysplasia management, the incidence of bronchopulmonary dysplasia among extremely low birth weight infants has been rising in Japan for the past decade.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple 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; for instance incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation, and others.

Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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 route of administration, order of entry and designation, 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

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The reimbursement challenges related to medical care and treatment for individuals with bronchopulmonary dysplasia can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, and therapies specific to bronchopulmonary dysplasia. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

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

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of bronchopulmonary dysplasia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the bronchopulmonary dysplasia, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Bronchopulmonary Dysplasia market.

Bronchopulmonary Dysplasia report insights

• Patient Population
• Therapeutic Approaches
• Bronchopulmonary Dysplasia Pipeline Analysis
• Bronchopulmonary Dysplasia Market Size and Trends
• Existing and Future Market Opportunity

Bronchopulmonary dysplasia report key strengths

• 11 years Forecast
• The 7MM Coverage
• Bronchopulmonary Dysplasia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Bronchopulmonary dysplasia report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market Insights

• What was the total market size of bronchopulmonary dysplasia, the market size of bronchopulmonary dysplasia by therapies, and market share (%) distribution in 2020, and what would it look like by 2034?
• What are the contributing factors for this growth?
• At what CAGR, the bronchopulmonary dysplasia market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of bronchopulmonary dysplasia? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to bronchopulmonary dysplasia?
• What is the historical and forecasted bronchopulmonary dysplasia patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent bronchopulmonary dysplasia population during the forecast period (2024-2034)?
• What factors are contributing to the growth of bronchopulmonary dysplasia cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of bronchopulmonary dysplasia? What are the current clinical and treatment guidelines for treating bronchopulmonary dysplasia?
• How many companies are developing therapies for the treatment of bronchopulmonary dysplasia?
• How many emerging therapies are in the mid-stage and late stage of development for treating bronchopulmonary dysplasia?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of bronchopulmonary dysplasia?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the bronchopulmonary dysplasia market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for bronchopulmonary dysplasia, barriers to accessibility of approved therapy, 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.