Breaking Through the Barriers: How Chinese Enterprises Are Challenging the Big Three in the Multi-Billion-Dollar Inhaled Drug Market

Inhalation products are combination drug-device products comprising a pharmaceutical formulation and an inhalation device. The medication, in the form of a solution, powder, or mixed suspension, is loaded into a specialized inhalation device. Upon inhalation through the mouth or nose by the user, the drug reaches the respiratory tract and/or lungs to exert local or systemic effects. Compared with conventional oral administration, inhalation products deliver the drug directly to the respiratory tract and lungs, resulting in rapid onset of action. They also avoid the hepatic first-pass effect, allow for reduced dosing, minimize adverse reactions, and offer ease of use, thereby enhancing patient compliance. Currently, inhalation products are primarily used to treat chronic obstructive pulmonary disease (COPD) and asthma, but their applications are gradually expanding into areas such as vaccines, anesthetics, and diabetes management.

According to Frost & Sullivan statistics,The global market size for inhalation preparations is projected to grow to USD 29.3 billion in 2025 and to USD 33.7 billion in 2030, while the market size for inhalation preparations in China is expected to reach RMB 23.9 billion in 2025.. The global market for inhalation preparations is highly concentrated, dominated by the three giants: GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim. In China, the inhalation preparation market remains led by imported products; however, domestic substitution is accelerating as renowned pharmaceutical companies enter the market and national volume-based procurement drives adoption.

China has a vast patient population and strong clinical demand. As a common chronic respiratory disease, COPD is the third leading cause of death globally, with over 100 million patients in China. Meanwhile, there are approximately 45.7 million asthma patients aged 20 and above in China, and the prevalence rate is increasing year by year.Inhaled formulations have become the preferred route of administration recommended by clinical guidelines for the treatment of asthma and COPD.Meanwhile, spurred by the pandemic, inhaled vaccines are also undergoing rapid development. Furthermore, in certain non-respiratory disease areas, such as diabetes and mental disorders, inhalation formulations will enhance patients’ medication experience through a novel route of administration.

National policies strongly encourage the research and development (R&D) of inhalation formulations. With the release of the "Guidelines for Bioequivalence Studies of Generic Orally Inhaled Drug Products" by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in 2020, the R&D of inhalation formulations has become further standardized. In 2022,Nine departments, including the Ministry of Industry and Information Technology (MIIT) and the National Development and Reform Commission (NDRC), jointly issued the “14th Five-Year Plan for the Development of the Pharmaceutical Industry,” which proposes prioritizing the development of complex formulation technologies characterized by high selectivity and long-acting sustained/controlled release, including inhalation drug delivery systems.Meanwhile, in recent years, national medical insurance negotiations have gradually relaxed restrictions on the use of inhalation formulations, expanding their reimbursement coverage under the national medical insurance scheme. Furthermore, the inclusion of inhalation formulations in successive rounds of national centralized procurement has promoted their commercialization and accelerated the substitution of domestically produced alternatives.

Inhaled formulations can be categorized into dry powder inhalers, metered-dose inhalers, nebulizer solutions, and nasal sprays, based on the delivery device. Nebulizer solutions have relatively low barriers to research and development and manufacturing; generic versions can gain approval by demonstrating in vitro pharmaceutical equivalence, without the need for in vivo pharmacokinetic or pharmacodynamic studies. As a result, numerous products have been successively approved, leading to intense market competition. In contrast, metered-dose inhalers and dry powder inhalers are more challenging to develop, and their markets remain largely untapped.

Inhaled formulations involve multiple disciplines, including pharmaceutics, inhalation dynamics, fluid mechanics, and mechanical design and manufacturing. The high barriers to entry in their research and development are primarily reflected in two aspects: formulation design and inhalation device design. A formulation consists of active pharmaceutical ingredients (APIs) and excipients; for instance, metered-dose inhalers (MDIs) contain APIs, propellants, and additives. The ratio of APIs to excipients directly affects the stability and uniformity of the inhaled formulation. Meanwhile, the design of the inhalation device directly influences drug dosage, pulmonary deposition rate and efficacy, and adverse effects. The trend toward refined and miniaturized device design poses significant challenges in developing core components, such as metering valves and pressurized canisters for MDIs. Furthermore, the ease of use of the inhalation device impacts patient compliance, and improper operation can compromise therapeutic outcomes.

Driven by clinical needs, ideal inhalation formulations should feature stable drug dose output and accurate dosing, while also being user-friendly and cost-effective. Furthermore, in an environment characterized by intensifying market competition and the impending impact of centralized volume-based procurement, inhalation formulations with high cost-performance ratios hold a greater competitive advantage. As products that integrate pharmaceuticals with medical devices, the development of inhalation formulations must be closely aligned with drug development to enable timely adjustments to formulation and device design based on the drug’s characteristics. Throughout this process, pharmaceutical companies and inhalation device manufacturers must maintain close collaboration and strengthen interactions across the upstream and downstream segments of the industry chain.

April 16–18, 2024, the New Resources Conference on China’s Full Pharmaceutical Industry Chain will be held at the Nanjing International Exhibition Center. Concurrently,The Inhaled Formulations Alliance, Chengfeng Jihai, VCBeat, and VB100 will jointly host the “Symposium on R&D of Inhaled Formulations, In Vitro–In Vivo Correlations, and New Opportunities and Advances.” The event will feature in-depth discussions on hot topics such as technological innovation in inhaled formulations, in vitro–in vivo correlations (IVIVC), advancements in clinical applications, innovative design of drug delivery devices, and market opportunities and challenges for inhaled formulations.。

The conference invited senior industry experts, including the Deputy Secretary-General of the Inhaled Preparations Alliance, the Lifetime Honorary Director of the Aerosol Professional Committee of the China Packaging Federation, and the Standing Committee Member of the Drug Clinical Trial Professional Committee of the Chinese Pharmacological Society; clinical experts such as the Chief Physician of the Department of Respiratory and Critical Care Medicine at the First Affiliated Hospital of Nanjing Medical University; professors from universities including Jinan University and Southeast University; participants across the inhaled drug delivery industry chain, including clinical research institutions for inhaled preparations, pharmaceutical companies, and inhalation device manufacturers; as well as representatives from investment institutions.

The conference convened stakeholders across the entire value chain of inhaled drug products, from product definition to commercialization, to jointly explore development opportunities and key challenges in China’s inhaled drug market, while outlining directions for innovative products and the future trajectory of the industry. Concurrently, the accompanying exhibition provided a communication platform for companies throughout the upstream and downstream supply chains, facilitating effective matchmaking among pharmaceutical manufacturers, inhalation device companies, upstream raw material and equipment suppliers, third-party clinical service providers, and hospitals.

Interested parties may scan the QR code below to register:

Exhibition Area Conference TicketLimited-Time Free Access

Conference Business Pass/VIP PassLimited-Time Offer

Limited quantity, available on a first-come, first-served basis

09:00-09:15

Inhalation Formulation Alliance Helps Drive the Development of Inhalation Formulations

He Chunyi, Deputy Secretary-General of the Inhaled Drug Delivery Alliance; General Manager of Situ Vanke (Zhuhai Hengqin) Technology Co., Ltd.

09:15-09:45

Advances in Inhaled Pharmacotherapy for Chronic Airway Diseases

Yin Kaisheng, an expert enjoying the State Council’s special allowance; Advisor to the Respiratory Professional Committee of the Chinese Society of Integrated Traditional Chinese and Western Medicine; Head of the China Asthma Alliance; Second-level Professor, Chief Physician, and Doctoral Supervisor in the Department of Respiratory and Critical Care Medicine at the First Affiliated Hospital of Nanjing Medical University.

09:45-10:15

A Brief Discussion on Innovations in Inhalation Formulations

You Yizhong, Deputy Chief Pharmacist (Level II) and Associate Chief Physician at Changzhou First People’s Hospital. He has received the State Council Special Government Allowance since 1992. He serves as Lifetime Honorary Chairman of the Aerosol Professional Committee of China Packaging Federation, Honorary Chairman of the Inhalation Particles Professional Committee of Chinese Society for Particle Science and Technology, and Editorial Board Member of several domestic and international journals.

10:15-10:30

Tea Break

10:30-11:00

Discussion on In Vitro-In Vivo Correlation Studies for Improved New Inhaled Drug Products

Shen Danlei, General Manager, Nanjing Bailing Information Technology Co., Ltd.

11:00-11:30

Clinical Research on Inhalation Preparations

He Qing, GoBroad Healthcare Group, Chief Clinical Pharmacist, Master’s Supervisor, Standing Committee Member of the Clinical Drug Trials Committee, Chinese Pharmacological Society

11:30-12:00

In Vitro Testing and Evaluation of Liquid Inhalation Preparations

McDonough Tony, Copley, Senior Pharmaceutical Engineering Engineer

12:00-13:15

Lunch Time

13:15-13:45

Study on the Compatibility Between Drug Delivery Devices and Drugs

Cai Rong, Senior Engineer (Professor Level)

13:45-14:15

Best Practices for the Development of Dry Powder and Soft Mist Inhalation Devices

Zhao Guangtao, Executive Director, Suzhou Xinmaide Medical Device Technology Co., Ltd.

14:15-14:45

Inhalation Aerosol Delivery Systems and Their Core Components

Shi Lei, Founder, Chairman and CEO of Yisuo Intelligent Technology (Shanghai) Co., Ltd.

14:45-15:00

Tea Break

15:00-15:30

Research on Nasal Drug Delivery Formulation Technologies

Shao Qi, Deputy Director, Research Institute of Shanghai Sine Pharmaceutical Factory

15:30-16:10

Advancing Clinical Research on Orally Inhaled and Nasal Drug Products: Strategies and Insights

Gemma Budd, General Manager, Nanopharm

&Julie Suman, Aptar Pharma, Vice President, Global Scientific Affairs

16:10-16:40

Formulation Modulation Strategies for Nasal Inhalation Preparations and Their Application in Central Nervous System Diseases

Zhang Xuejuan, Associate Professor at Jinan University; Director of the Inhalation Formulation Research Institute at Xinji Pharmaceutical

16:40-17:10

Development and Quality Research of Nasal Sprays

Gu Li, Ph.D., Founder and General Manager of Nanjing Zhangyi Pharmaceutical Technology Co., Ltd.

09:30-10:00

Overview of Dry Powder Formulation Design

Zhou Peng, Daomeng (Shanghai) Industrial Co., Ltd., Technical Director

10:00-10:30

Research on Particle Size Characterization Method Based on MDRS Technology

Guan Lingling, Enfu (Shanghai) Testing Technology Co., Ltd., Technical Manager

10:30-11:00

Tea Break

11:00-11:30

Challenges in the Development and Industrialization Barriers of Modified Inhalation Preparations

Tong Zhenbo, Southeast University, Professor

11:00-12:00

Analysis of the Market Landscape for Pediatric Inhalation Products (Clinical Pain Points and R&D Project Initiation)

Zhang Xiubao, Senior Industry Researcher, China National Pharmaceutical Industry Information Center

12:00-13:30

Lunch Time

13:30-14:00

Opportunities and Challenges in the Field of Inhalation Preparations

Cao Shiyue, Sinopharm Investment, Chief Scientist

14:00-14:30

Analysis of Market Performance and Potential for Inhaled Drug Products on the Sales Side

Wang Chunyang, General Manager of the Out-of-Hospital Prescription Drug Division, Jointown Pharmaceutical Group

14:30-15:00

【Roundtable Discussion】 The Major Trend of Domestic Substitution: Forecasting the Direction of China’s Inhalation Preparations Industry Over the Next 5–10 Years

1. Domestic Substitution: Analysis of Policy, Market, and Economic Environment

2. How to Overcome the Challenges in the R&D and In Vitro-In Vivo Correlation of Inhalation Products

3. Building a Differentiated Strategic Layout and Establishing Core Competencies