China is a huge inhalation drug market, whose value reached 35.48 billion yuan in 2021. The market shows two trends:
1. Though nebulizers take the highest market share in China, dry powder inhalers and metered-dose inhalers are expected to increase in their shares.
2. Overseas inhalation drugs account for the most shares, while Chinese generics seek to improve their shares via volume-based procurement.
Inhalations are preparations with devices which deliver medicine through mouth or nose to the lungs. In the global market, 93% inhalations are drugs for asthma and chronic obstructive pulmonary disease (COPD); while the rest 7% are anesthetics, upper respiratory tract infection drugs, and general antiviral drugs, etc.1
Huge Market Needs for Inhalation Drugs in China
As China has 45.7 million2 asthma patients over 20 years old and 99.9 million3 COPD patients respectively, the need for inhalation drugs is substantial. In 2021, China's inhalation drug market achieved 35.48 billion yuan4 (circa 4.97 billion USD). In the future, the market is predicted by the Intelligence Research Group to grow in size due to air pollution and ageing population.
Top 10 Inhalation Drugs with the Highest Sales in 2021
Based on non-proprietary names, the top 10 inhalation drugs with the highest sales at public medical institutions in 2021 are listed in the table below. The top 1 drug Budesonide Suspension for Inhalation's sales exceeded 6.6 billion yuan. The top 2, 3 and 4 drugs each realized over 2 billion yuan sales.5 All the top 10 drugs grew in sales comparing with 2020.
Table 1: Top 10 Inhalation Drugs (based on non-proprietary names) with the Highest Sales in 2021 | ||
2021 Sales Rank | Inhalation Drug | Year-on-year (YoY) Growth |
1 | Budesonide Suspension for Inhalation | 19.82% |
2 | Sevoflurane for Inhalation | 10.67% |
3 | Budesonide and Formoterol Fumarate Powder for Inhalation (II) | 4.63% |
4 | Acetylcysteine Solution for Inhalation | 59.64% |
5 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 5.40% |
6 | Terbutaline Sulfate Nebuliser Solution | 39.95% |
7 | Salbutamol Sulfate Nebules Inhalation Solution | 43.25% |
8 | Ipratropium Bromide Solution for Inhalation | 30.55% |
9 | Mometasone Furoate Aqueous Nasal Spray | 51.20% |
10 | Tiotropium Bromide Powder for Inhalation | 37.38% |
Data source: Menet Database |
Among the top 10 best-selling inhalation drugs based on different brands, AstraZeneca's Budesonide Suspension for Inhalation and Budesonide and Formoterol Fumarate Powder for Inhalation (II) took the first two places. Jiangsu Hengrui Pharmaceuticals' Sevoflurane for Inhalation ranked the third. Chai Tai Tianqing (CTTQ)'s Budesonide Suspension for Inhalation, approved in February 2020, entered the top 10 for the first time with the rapid YoY growth of 279.2%.
Table 1: Top 10 Inhalation Drugs (based on brands) with the Highest Sales in 2021 | ||||
2021 Sales Rank | Inhalation Drug (non-proprietary name) | Brand | YoY Growth | |
1 | Budesonide Suspension for Inhalation | Pulmicort Respules | AstraZeneca | -2.17% |
2 | Budesonide and Formoterol Fumarate Powder for Inhalation (II) | Symbicort Turbuhaler | AstraZeneca | 4.63% |
3 | Sevoflurane for Inhalation | Kai Te Li (凯特力) | Hengrui | 6.40% |
4 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | Seretide | GSK | 5.40% |
5 | Terbutaline Sulfate Nebuliser Solution | Bricanyl | AstraZeneca | 31.45% |
6 | Budesonide Suspension for Inhalation | Tianqing Suchang (天晴速畅) | CTTQ | 279.20% |
7 | Acetylcysteine Solution for Inhalation | Fluimucil | Zambon | 40.08% |
8 | Ipratropium Bromide Solution for Inhalation | Atrovent | Boehringer Ingelheim | 21.20% |
9 | Acetylcysteine Solution for Inhalation | Bo Fen (博芬) | Hainan Star Pharmaceutical | 69.32% |
10 | Tiotropium Bromide Powder for Inhalation | Tianqing Sule (天晴速乐) | CTTQ | -13.30% |
Data source: Menet Database |
Dry Powder Inhalers and Meter-dosed Inhalers on the Rise
According to different inhalers, inhalation drugs are classified into three categories:
Inhaler | Mechanism | Characteristics | Examples |
Releasing one or more types of drug powders from the device to act on the body's local or general area | 1) Without needing propellant 2) Without needing high coordination between the patient and the device 3) High portability 4) Higher lung deposition rate than MDIs 5) Relatively high price 6) Inner obstruction of the device may affect the drug's release and distribution | 1) Indacaterol Maleate Powder for Inhalation 2) Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation 3) Budesonide and Formoterol Fumarate Powder for Inhalation | |
Releasing the drug solution, emulsion, or suspension in aerosol form through the metering valve driven by the pressure from the propellant. The drug is stored with the propellant in a pressurized container. | 1) Fast acting on local area 2) High portability 3) Relatively low price 4) About 15-30% lung deposition rate 5) Requiring high coordination between the patient and the device 6) Requiring propellant | 1) Budesonide Pressurised Inhalation Solution 2) Compound Salbutamol Sulfate Aerosol 3) Tiotropium Bromide Inhalation Spray | |
Generating continuous or metered amount of mist containing aerosolized drug solution, emulsion or suspension. | 1) Wide scope of application, including pediatric and aged patients 2) About 10% lung deposition rate 3) Low portability 4) Taking long time for applying a single dose and with low drug utilization ratio | 1) Ambroxol Hydrochloride Solution for Inhalation 2) Salbutamol Sulfate Inhalation Solution 3) Ipratropium Bromide Solution for Inhalation |
In China, nebulizers take the highest market share, which is expected to decrease as they face competition from other two kinds of inhalers that are more portable.
Chinese Generic Inhalations Endeavoring to Improve Market Share
From 2015-2020, most inhalation drugs sold in China were imported from overseas as Chinese domestic production did not meet the demand. However, Chinese generic drugs have chances to take bigger market shares via Chinese government's volume-based procurement (VBP) that purchase large amounts of drugs for public medical institutions.
If Chinese generic inhalations pass the quality and therapeutic equivalence evaluations, they get the qualification to bid for VBP. So far, five inhalation drugs, which are all manufactured by Chinese companies, have been included in China's VBPs.
Five Inhalation Drugs Involved in China's VBPs7 | ||
National VBP | Inhalation Drug | Bid Winners |
4th | Salbutamol Sulfate Inhalation Solution | 1) Suzhou Homesun Pharmaceutical 2) Hebei Renhe Yikang Pharmaceutical 3) Zhejiang Fresh Pharmaceutical 4) Sichuan Scpurity Pharmaceutical |
5th | Compound Ipratropium Bromide Solution for Inhalation | 1) Renhe Lijian Pharmaceutical (manufacturing entrusted to Hebei Renhe Yikang Pharmaceutical) 2) Joincare Pharmaceutical Group (manufacturing entrusted to Shenzhen Taitai Pharmaceutical and Joincare Haibin Pharmaceutical) 3) Sichuan Scpurity Pharmaceutical 4) Zhejiang Fresh Pharmaceutical |
Ipratropium Bromide Solution for Inhalation | 1) Renhe Yikang (manufacturing entrusted to Hebei Renhe Yikang Pharmaceutical) 2) Joincare Pharmaceutical Group (manufacturing entrusted to Shenzhen Taitai Pharmaceutical and Joincare Haibin Pharmaceutical) 3) Sichuan Scpurity Pharmaceutical 4) Wuhan LEADPHARM (manufacturing entrusted to Sichuan Herbease Pharmaceutical) | |
Budesonide Suspension for Inhalation | 1) Sichuan Scpurity Pharmaceutical 2) CF PharmTech 3) Joincare Pharmaceutical Group (manufacturing entrusted to Shenzhen Taitai Pharmaceutical and Joincare Haibin Pharmaceutical) 4) CTTQ | |
7th | Terbutaline Sulfate Nebuliser Solution | 1) Hebei Renhe Yikang Pharmaceutical 2) Joincare Pharmaceutical Group (manufacturing entrusted to Joincare Haibin Pharmaceutical) 3) Nanjing Hengdao Pharmaceutical (Manufacturing entrusted to Jiangsu Dahongying-Hengshun Pharmaceutical) 4) Suzhou Homesun Pharmaceutical 5) Sichuan Scpurity Pharmaceutical |
Data source: China Joint Drug Procurement Office |
Following China Center for Drug Evaluation (CDE)'s Bioequivalence Research Guidelines for Oral Inhalations and other relevant guidelines, Chinese companies, such as Joincare, CTTQ, and Hengrui, are developing generic and new inhalation drugs. For example, CTTQ is currently conducting the phase II clinical trial for innovative drug TQC3721 suspension for inhalation.