Respiratory API Market Insights Supporting Future Healthcare Needs

Revenue, 2025

USD 20.78 Billion

Forecast, 2035

USD 39.9 Billion

CAGR, 2026-2035

6.74%

Report Coverage

Global

Respiratory API Market Size, Growth with Forecast and Key Players

The global respiratory API market size is expected to be worth around USD 39.9 Billion by 2035, from USD 20.78 billion in 2025, growing at a CAGR of 6.74% during the forecast period from 2026 to 2035.

The respiratory API market is experiencing robust growth, driven by the growing geriatric population and increasing demand for small molecules as therapeutics. The rising burden of respiratory disorders globally encourages developers to manufacture large quantities of active pharmaceutical ingredients (APIs) for the treatment of respiratory diseases. Technological advancements, such as artificial intelligence (AI) and machine learning (ML), present future opportunities for market growth.

Key Takeaways

• Respiratory API industry poised to reach USD 22.18 billion by 2026.
• Forecasted to grow to USD 39.9 billion by 2035.
• Expected to maintain a CAGR of 6.74% from 2026 to 2035.
• North America held a major revenue share of the respiratory API market in 2025.
• Asia-Pacific is expected to host the fastest-growing market in the coming years.
• By type, the bronchodilators segment dominated the market in 2025.
• By type, the combination drugs segment is expected to grow with the highest CAGR in the market during the studied years.
• By formulation type, the oral segment held the largest revenue share of the market in 2025.
• By formulation type, the inhalation segment is expected to witness the fastest growth in the market over the forecast period.

Key Indicators and Highlights

Respiratory APIs: The Backbone of Respiratory Therapeutics

The respiratory API market encompasses the development, manufacturing, and supply of APIs for the treatment of a wide range of respiratory disorders, including asthma, COPD, and allergies. APIs help combat infections of the upper respiratory tract (nose, nasal passages, sinuses, and throat), respiratory airways (larynx, trachea, and bronchi), and lungs. Some common examples of respiratory APIs include budesonide, beclomethasone, ciclesonide, formoterol, and azelastine that act through different mechanisms.

Intelligent Molecules: AI Transforming Respiratory APIs

AI has emerged as a promising tool in various aspects of respiratory disorders, from research to manufacturing and the supply chain. AI and ML can analyze vast amounts of data and help design novel, potent candidates. They can enhance the accuracy, reliability, and interpretability of research data related to respiratory illnesses. AI can also streamline the manufacturing process through predictive analytics and automation. This enables manufacturers to detect potential errors and make proactive decisions. Moreover, AI and ML can reduce the time-to-market by accelerating the regulatory process.

Trends & Future Outlook in the Respiratory API Market

• Rising Prevalence of Respiratory Disorders: The prevalence of respiratory disorders is rapidly rising, with the growing geriatric population, smoking, air pollution, and viral infections.
• Increasing Investments: Several major players invest billions of dollars in R&D and clinical trials to build a robust pipeline of respiratory drugs.
• Government Initiatives: Government bodies launch initiatives to encourage people to screen for and seek early diagnosis of respiratory disorders, enabling healthcare professionals to provide early intervention.

What are the Government Efforts for Respiratory Disorders?

• The U.S. government’s Healthy People 2030 initiative focuses on increasing prevention, detection, and treatment of respiratory diseases among Americans.
• The Chinese government has improved the capacity of screening and management of COPD in primary health care through its Medium-to-long term plan of China for the prevention and treatment of chronic diseases (2017-2025).
• The Joint Action of Respiratory Diseases (JARED) is a joint initiative between 14 Member States of Europe, backed with EUR 5 million, to improve lung health across Europe by focusing on tackling chronic respiratory diseases.

Segmental Insights

Type Insights

Which Type Segment Dominated the Respiratory API Market?

The bronchodilators segment held a dominant position in the market in 2025, due to the need to manage respiratory conditions at the target site. Bronchodilators help relieve symptoms by relaxing the muscles around the airways and also help clear mucus from the lungs. They are generally delivered through inhalers and nebulizers. They are available in short-acting and long-acting forms, providing a wide range of responses to patients based on their conditions.

Combination Drugs

The combination drugs segment is expected to grow at the fastest CAGR in the market during the forecast period. Combination drugs offer the benefits of multiple drugs and provide a synergistic effect. They enhance patient compliance, reduce different dose regimens, achieve higher disease control, and boost therapeutic effectiveness. They are essential to maintain and improve the quality of life.

Formulation Type Insights

Why Did the Oral Segment Dominate the Respiratory API Market?

The oral segment contributed the biggest revenue share of the market in 2025, due to high patient convenience and ease of administration. Oral drugs are comparatively cost-effective and do not require any specialized device to deliver within the body. They are the safest method of drug delivery and convenient for repeated or prolonged use. They are available in various forms, including liquids and tablets. They can be sustained-release or immediate-release.

Inhalation

The inhalation segment is expected to expand rapidly in the market in the coming years. The inhalation route is highly preferred as it provides targeted treatment directly into the lungs. Drugs administered through the inhalation route can be delivered by patients of all age groups. They bypass the first-pass metabolism and are considered to be the most effective anti-inflammatory treatment for long-term management of respiratory conditions.

Regional Analysis

Which Factors Drive the Respiratory API Market in North America?

North America dominated the global market in 2025. The availability of state-of-the-art research and development facilities, a robust healthcare infrastructure, and favorable regulatory support are major factors that drive market growth in North America. The region has a well-established clinical trial infrastructure, encouraging sponsors to conduct their clinical trials. Government organizations provide research funding to promote the development of novel APIs.

U.S. Market Trends

The U.S. conducts the highest number of clinical trials in the world. As of 9th January 2025, a total of 34 clinical trials were registered on the clinicaltrials.gov website related to respiratory APIs, out of the total 69 trials. In addition, the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) recently invested $44 million to bolster the supply chain of essential medicines.

How is Asia-Pacific Growing in the Respiratory API Market?

Asia-Pacific is expected to grow at the fastest CAGR in the market during the forecast period. The increasing burden of respiratory illnesses, the growing geriatric population, and the presence of key players augment the market. Countries like China, India, Japan, and South Korea have a favorable manufacturing infrastructure, encouraging foreign players to set up their manufacturing facilities in the region. The growing demand for generic alternatives and the increasing number of pharmaceutical startups also contribute to market growth.

India Market Trends

Key players, such as Dr. Reddy’s Laboratories, Cipla Ltd., and Lupin Ltd., are major contributors to the market in India. India is a leading global market for generic APIs and drugs. Favorable trade policies in India also bolster market growth. India exports nearly 25% of the global supply of generic respiratory APIs. The majority of the exports go to Latin America, Africa, ASEAN, CIS, and the Middle East.

Will Europe Grow in the Respiratory API Market?

Europe is expected to grow at a notable CAGR in the foreseeable future. Favorable government support and increasing R&D investments propel market growth. Government organizations support the development of respiratory APIs through initiatives and funding. People are becoming aware of screening and early diagnosis of respiratory disorders. The growing demand for personalized medicines and the rising adoption of advanced technologies foster market growth.

UK Market Trends

In the UK, the rate of emergency admissions for respiratory disease in England increased by 7% from FY2023 to FY2024, accounting for 854,922 admissions. In response, the British Thoracic Society (BTS) urged the UK government to prioritize improvements in services for people with lung conditions. The NHS 10 Year Health Plan aims to provide greater access to high-quality care.

Value Chain Analysis – Respiratory API Market

R&D

• The latest research focuses on developing smaller, purer particles of inhalation APIs to enhance accessibility to the lungs.
• Key Players: Teva Pharmaceuticals, Inke S.A., and Cipla Ltd.

Clinical Trials & Regulatory Approval

• Trials assess the safety and efficacy of respiratory APIs in humans, and regulatory agencies approve these APIs based on trial data.
• Key Players: AbbVie, Inc., GlaxoSmithKline, Cure HHT, and Apotex, Inc.

Distribution to Hospitals, Pharmacies

• Respiratory APIs are distributed to hospitals or drug stores through distributors or wholesalers.
• Key Players: Spectrum Chemical, OLON, and Cambrex Corporation.

Top Companies & Their Offerings in the Respiratory API Market

SWOT Analysis in the Respiratory API Market

Strengths

• Respiratory APIs help pharmaceutical companies to develop advanced formulations for targeted delivery.
• The availability of generic APIs benefits patients from low- and middle-income groups, enhancing treatment affordability.
• Patients prefer small molecules as therapeutics due to their ease of administration and cost-effectiveness.

Weaknesses

• Complex manufacturing techniques, such as advanced control of particle engineering, environmental conditions, and contamination risks, present significant challenges to the market.
• Supply chain disruption of raw materials, mainly due to excessive demand and geopolitical issues, restricts market growth.

Opportunities

• The integration of AI, ML, data analytics, and robotics transforms the research, manufacturing, and supply chain processes of respiratory APIs.
• The increasing development of smart inhalers and nebulizers improves the targeted delivery of respiratory APIs.

Threats

• Evolving cell and gene therapy and other biologics landscape for respiratory diseases negatively impacts the use of APIs.
• Respiratory APIs need to undergo stringent regulatory pathways requiring rigorous documentation and testing.

Recent Developments in the Respiratory API Market

• In August 2025, PureTech Health announced the launch of a new Founded Entity, Celea Therapeutics, to deliver therapies that transform the lives of people with serious respiratory diseases. Celea is currently investigating deupirfenidone (LYT-100) in a Phase 3 clinical trial for idiopathic pulmonary fibrosis.
• In June 2025, Glenmark Pharmaceuticals launched Tevimbra (tislelizumab-jsgr), a novel lung cancer drug, following the approval from the Central Drug Standard Control Organization (CDSCO). The drug is indicated for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC).

Segments Covered in the Report

By Type

• Bronchodilators (significant growth over the forecast period)
• Corticosteroids
• Combination Drugs (significant growth over the forecast period)
• Antihistamines
• Antivirals

By Formulation Type

• Inhalation
• Oral
• Injectable

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA