Lung cancer is the most common type of cancer and the leading cause of cancer deaths. 19.29 million new cancer cases were diagnosed worldwide in 2020, 4.57 million of which were in China, accounting for 23.7%. There were 3 million cancer deaths in China in 2020, of which lung cancer deaths were up to 710,000, accounting for 23.8%.

Lung cancer is divided into small cell lung cancer and non-small cell lung cancer (NSCLC). Of all the lung cancer cases, NSCLC ones account for about 80-85% with most of them being diagnosed as advanced lung cancer (locally advanced or metastatic disease).

First-generation EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor), represented by gefitinib, can significantly prolong the median survival period of patients with advanced lung cancer carrying EGFR-sensitive mutations and improve the quality of life of patients.

Gefitinib, originally developed by AstraZeneca, is the world’s first marketed EGFR-TKI for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with sensitive mutations in the EGFR gene, as well as patients with locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy.

AstraZeneca’s gefitinib, with the trade name of Iressa^®, was approved in the United States in 2003 and in China in 2004.

Gefitinib was recommended by the Non-Small Cell Lung Cancer, Version 1.2020, NCCN Clinical Practice Guidelines and the Guidelines of Chinese Society of Clinical Oncology (CSCO) on Treatment of Primary Lung Cancer (2019) as a first-line drug for treatment for patients with EGFR-mutated non-small cell lung cancer, and has been included in the Category B in China’s medical insurance in 2019 and the National Essential Medicines List (2018 edition).

Before the launch of domestic generic drugs in China, the only gefitinib available in the market was the original drug Iressa with a high price. In 2017, the first generic drug from Qilu Pharmaceutical was approved for marketing in China to compete with Iressa, followed by generic drugs from Chia Tai Tianqing Pharmaceutical and Sichuan Kelun Pharmaceutical, Jiangsu Hengrui Medicine and Yangtze River Pharmaceutical.

In September 2019, in the Chinese government’s centralized drug-procurement, the gefitinib drugs of Qilu Pharmaceutical, Chia Tai Tianqing Pharmaceutical and AstraZeneca were selected at prices of CNY257, CNY450 and CNY547, with the specification of 25 mg (a box of 10 tablets). The price of AstraZeneca’s Iressa was reduced by 76%.

According to CRI’s market research, before 2019, the sales value of China’s gefitinib market kept growing year by year. In 2019, the average price of gefitinib decreased significantly due to the Chinese government’s centralized drug-procurement program. Therefore, although the sales volume of gefitinib in China increased in 2019, its sales value declined greatly.

In 2020, both of them decreased due to the COVID-19 outbreak, which impacted the proper function of Chinese healthcare institutions. The sales value of gefitinib in China was approximately CNY312 million (USD48.1 million) in 2020, with a CAGR of about 1.3% from 2016 to 2020.

According to CRI’s market research, although AstraZeneca’s original drug, Iressa, is much more expensive than generic drugs from local Chinese companies, it still held more than 70% share of the market in 2020 in terms of sales value.

CRI expects that from 2021 to 2025, China’s gefitinib market will show a recovery growth in both sales volume and value due to the effective control of COVID-19 and the resumption of proper operation of healthcare facilities.

CRI expects that, from 2021 to 2025, new cases of lung cancer in China will continue to grow as a result of environmental pollution and poor lifestyles. And with the growing income of Chinese residents, they are able to pay more for medical expenses. Therefore, China’s alectinib market is expected to grow in both sales volume and value during this period.

Topics Covered:

• Impact of COVID-19 on China’s Gefitinib Market
• Development Environment of Gefitinib in China
• Sales Volume of Gefitinib in China
• Sales Volume and Value of Gefitinib in China by Region
• Major Gefitinib Manufacturers in China and Their Market Shares
• Sales Price of Gefitinib in China
• Major Gefitinib Producers in China
• Prospects of China’s Gefitinib Market, 2021-2025

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