세계의 흡입형 생물제제 시장 평가 : 생물제제의 유형별, 용도별, 제형/투여 디바이스별, 유통경로별, 지역별, 기회, 예측(2018-2032년)

Inhalable biologics market is experiencing robust growth, valued at 3.55 billion in 2024 and projected to reach 10.35 billion by 2032 at a CAGR of 14.30%. This market expansion is driven by the increasing prevalence of respiratory diseases such as asthma, COPD, and cystic fibrosis, as well as a growing elderly population. The rising demand for non-invasive drug delivery methods is further accelerating their adoption, offering patients enhanced convenience and improved drug efficacy. Advances in biologic formulations and inhaler device technology are enabling the development of more effective, targeted therapies.

The preference for non-invasive delivery methods among patients and healthcare providers is driving significant growth in the inhalable biologics market. Unlike traditional injectables, inhalation offers a painless, user-friendly, and targeted route of administration, making it particularly advantageous for chronic conditions that require frequent dosing. Inhalation enables rapid drug absorption, direct delivery to the lungs for respiratory diseases, and lower systemic exposure, reducing adverse effects. This is particularly important in diseases such as cystic fibrosis, asthma, and pulmonary infections, where localized treatment improves therapeutic outcomes. Inhalable biologics also enhance adherence, as they eliminate the discomfort and logistical barriers associated with injections.

For instance, in January 2024, Insmed Incorporated supported this trend and announced positive Phase 3 data for ARIKAYCE (amikacin liposome inhalation suspension), demonstrating its efficacy in treating non-tuberculous mycobacterial lung disease and underscoring the clinical value of inhaled delivery for complex conditions. The trial showed significant improvements in lung function and bacterial clearance compared to the placebo, reflecting how inhaling biologics can address unmet needs in respiratory care while offering a convenient alternative to injections. The market is therefore poised for sustained growth as more biological advances are reformulated for inhalation, enabling broader patient access and better compliance in both developed and emerging markets.

Rising Incidence of Respiratory and Infectious Diseases Fuels Demand

The increasing global burden of respiratory and infectious diseases remains a significant driver of the inhalable biologics market. Conditions like asthma, chronic obstructive pulmonary disease (COPD), tuberculosis, and post-COVID pulmonary complications are prevalent and require long-term management. Inhalable biologics offer a promising therapeutic avenue by delivering targeted, effective treatments directly to affected lung tissues, thereby minimizing systemic toxicity and improving efficacy.

According to the World Health Organization (WHO), asthma affected approximately 262 million people worldwide and caused over 455,000 deaths in 2023, underscoring the need for innovative therapies. Additionally, the ongoing challenge of antimicrobial resistance has highlighted the importance of novel delivery methods for treating lung infections.

Reflecting this demand, AstraZeneca PLC launched Tezspire (tezepelumab) in February 2023, a monoclonal antibody administered via inhalation for patients with severe, uncontrolled asthma. This milestone demonstrates how inhalable biologics can effectively control exacerbations and reduce hospitalizations, providing tangible benefits over standard therapies. As respiratory diseases remain among the top causes of morbidity globally, and infectious disease outbreaks continue to emerge, the role of inhalable biologics as frontline therapies will only expand, driving increased investment and market penetration across therapeutic areas.

Technological Advancements in Inhalation Devices Accelerate Market Growth

The success of inhalable biologics depends not only on drug formulation but also on the efficiency and precision of the delivery device. Over the past few years, significant advancements in inhalation devices, such as dry powder inhalers (DPIs), metered dose inhalers (MDIs), nebulizers, and smart digital devices, have enhanced the clinical performance and usability of inhalable therapies. These technologies are specifically designed to protect biologic molecules, ensure optimal deposition in targeted lung regions, and enable reproducible dosing even in patients with compromised respiratory function. Recent innovations include devices integrated with sensors, Bluetooth connectivity, and real-time feedback mechanisms to monitor patient adherence and inhalation technique.

For instance, in October 2023, Chiesi Farmaceutici S.p.A. launched a next-generation digitally connected DPI platform designed to improve adherence and personalize therapy for patients using inhaled biologics. The platform records inhalation parameters, provides reminders, and shares data with healthcare providers, helping to optimize treatment plans. Such advancements significantly improve patient outcomes, reduce healthcare costs associated with poor adherence, and expand the usability of inhalable biologics across diverse patient populations. The integration of innovative technology in delivery devices is transforming the market landscape, making inhalation a highly competitive alternative to traditional biologic administration routes.

Supportive Regulatory and Policy Environment Encourages Innovation

The regulatory and policy landscape has evolved to facilitate faster development, approval, and market entry of inhalable biologics, recognizing their potential in addressing critical healthcare challenges. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have introduced expedited pathways, guidance documents, and emergency authorizations for inhaled biologics, particularly in the wake of pandemics and the growing burden of chronic diseases. These measures reduce time-to-market, lower development risks, and provide clearer compliance pathways for innovators.

For instance, in May 2023, the U.S. FDA granted Emergency Use Authorization (EUA) for CanSino Biologics Inc.'s inhalable COVID-19 vaccine, Convidecia Air. This approval marked a milestone in vaccine innovation, demonstrating the feasibility and benefits of inhalable biologics for mass immunization programs. Regulatory support for such groundbreaking therapies encourages R&D investments, fosters public-private partnerships, and attracts new entrants to the market, creating a dynamic and competitive environment. The continued evolution of policies to accommodate novel biologic modalities ensures that inhalable therapies remain at the forefront of biopharmaceutical innovation, ultimately expanding treatment options and improving global health outcomes.

North America Dominates the Global Inhalable Biologics Market

North America holds a commanding position in the global inhalable biologics market, supported by its robust healthcare infrastructure, high research and development spending, and strong presence of leading biopharma companies. The U.S. is a particularly fertile ground for innovation, given its concentration of clinical research organizations, regulatory expertise, and early adoption of novel therapies. Companies like Pfizer Inc., Amgen Inc., and AbbVie Inc. have invested heavily in developing and commercializing inhalable biologics, capitalizing on the region's high burden of respiratory and chronic diseases.

For instance, in 2024, the Centers for Medicare & Medicaid Services (CMS) announced a 5% increase in reimbursement rates for inhalable biologics used in the management of chronic diseases, providing additional incentives for their adoption in clinical practice. This favorable reimbursement policy, coupled with growing physician awareness and patient demand for non-invasive therapies, has reinforced North America's leadership. The region also benefits from a supportive regulatory environment and advanced distribution networks, ensuring timely access to innovative treatments. As pipeline candidates advance to commercialization and new indications emerge, North America is expected to maintain its dominance, serving as the primary driver of global inhalable biologics market growth in the coming years.

Future Market Scenario: Personalized and Systemic Applications of Inhalable Biologics

The future of the inhalable biologics market is poised to evolve beyond respiratory diseases, with expanding applications in systemic and personalized medicine. Advances in nanoparticle formulations, carrier systems, and device engineering are enabling the development of inhalable therapies for oncology, diabetes, and rare genetic disorders. Personalized medicine is emerging as a key trend, where treatments are tailored to individual genetic profiles and delivered through smart inhalers equipped with artificial intelligence (AI) and data analytics capabilities.

According to a 2024 NIH report, inhalable insulin and GLP-1 receptor agonists for diabetes management are progressing into late-stage trials, signaling strong momentum toward broader applications. Furthermore, AI-driven adherence monitoring and real-world data integration will help optimize outcomes and refine treatment strategies. These innovations will expand the therapeutic reach of inhalable biologics, reduce healthcare costs by improving adherence and efficacy, and attract investments from both traditional pharma companies and digital health startups. As systemic and precision applications gain regulatory and clinical validation, the inhalable biologics market is expected to experience transformative growth, reshaping the future of biologic therapy delivery and broadening its impact across various therapeutic areas.

Key Players Landscape and Outlook

The global inhalable biologics market is characterized by intense competition, with leading players employing strategies such as mergers, acquisitions, partnerships, and technology licensing to strengthen their market positions.

For instance, in November 2023, Novartis AG announced a partnership with a U.S.-based device technology company to co-develop a smart dry powder inhaler for biologics targeting COPD and asthma, demonstrating the convergence of drug and device innovation.

Similarly, in December 2023, Boehringer Ingelheim International GmbH acquired a biologics-focused R&D firm to accelerate its inhalable biologics pipeline and expand its capabilities in advanced drug delivery systems.

These moves reflect a strategic focus on integrating cutting-edge delivery technologies, expanding therapeutic indications, and responding to increasing demand for patient-centric therapies. The competitive landscape is also characterized by heightened R&D investments, pipeline diversification, and collaborations with digital health companies to deliver personalized, data-driven solutions. Such strategic initiatives are expected to intensify market competition while improving access to innovative therapies and enhancing patient outcomes globally.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Inhalable Biologics Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Type of Biologic
    • 4.2.1.1. Peptides & Proteins
    • 4.2.1.2. Monoclonal Antibodies
    • 4.2.1.3. Vaccines
    • 4.2.1.4. Others
  • 4.2.2. By Application
    • 4.2.2.1. Respiratory Diseases
    • 4.2.2.2. Infectious Diseases
    • 4.2.2.3. Diabetes
    • 4.2.2.4. Others
  • 4.2.3. By Dosage Form/Delivery Device
    • 4.2.3.1. Dry Powder Inhalers
    • 4.2.3.2. Metered Dose Inhalers
    • 4.2.3.3. Nebulizers
    • 4.2.3.4. Others
  • 4.2.4. By Distribution Channel
    • 4.2.4.1. Hospital Pharmacies
    • 4.2.4.2. Retail Pharmacies
    • 4.2.4.3. Online Pharmacies
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Type of Biologic
  • 4.3.2. By Application
  • 4.3.3. By Dosage Form/Delivery Device
  • 4.3.4. By Distribution Channel
  • 4.3.5. By Region

5. North America Inhalable Biologics Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Type of Biologic
    • 5.2.1.1. Peptides & Proteins
    • 5.2.1.2. Monoclonal Antibodies
    • 5.2.1.3. Vaccines
    • 5.2.1.4. Others
  • 5.2.2. By Application
    • 5.2.2.1. Respiratory Diseases
    • 5.2.2.2. Infectious Diseases
    • 5.2.2.3. Diabetes
    • 5.2.2.4. Others
  • 5.2.3. By Dosage Form/Delivery Device
    • 5.2.3.1. Dry Powder Inhalers
    • 5.2.3.2. Metered Dose Inhalers
    • 5.2.3.3. Nebulizers
    • 5.2.3.4. Others
  • 5.2.4. By Distribution Channel
    • 5.2.4.1. Hospital Pharmacies
    • 5.2.4.2. Retail Pharmacies
    • 5.2.4.3. Online Pharmacies
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Inhalable Biologics Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Type of Biologic
        • 5.3.1.2.1.1. Peptides & Proteins
        • 5.3.1.2.1.2. Monoclonal Antibodies
        • 5.3.1.2.1.3. Vaccines
        • 5.3.1.2.1.4. Others
      • 5.3.1.2.2. By Application
        • 5.3.1.2.2.1. Respiratory Diseases
        • 5.3.1.2.2.2. Infectious Diseases
        • 5.3.1.2.2.3. Diabetes
        • 5.3.1.2.2.4. Others
      • 5.3.1.2.3. By Dosage Form/Delivery Device
        • 5.3.1.2.3.1. Dry Powder Inhalers
        • 5.3.1.2.3.2. Metered Dose Inhalers
        • 5.3.1.2.3.3. Nebulizers
        • 5.3.1.2.3.4. Others
      • 5.3.1.2.4. By Distribution Channel
        • 5.3.1.2.4.1. Hospital Pharmacies
        • 5.3.1.2.4.2. Retail Pharmacies
        • 5.3.1.2.4.3. Online Pharmacies
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Inhalable Biologics Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Turkey
• 6.9. Poland

7. Asia-Pacific Inhalable Biologics Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Inhalable Biologics Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Inhalable Biologics Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework

• 17.1. Clinical Trials
• 17.2. Regulatory Approvals

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. AbbVie Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 20.3.2. AstraZeneca
  • 20.3.3. Novartis AG
  • 20.3.4. Boehringer Ingelheim International GmbH
  • 20.3.5. Chiesi Farmaceutici S.p.A.
  • 20.3.6. CansinoBl0.
  • 20.3.7. Pfizer Inc.
  • 20.3.8. Amgen Inc.
  • 20.3.9. Ocugen, Inc.
  • 20.3.10. Insmed Incorporated

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

21. Strategic Recommendations

22. About Us and Disclaimer