About 85% of lung cancer patients suffer from NSCLC (non-small cell lung cancer), of which about 5% are ALK positive. ALK+NSCLC is caused by a gene fusion or rearrangement that over-activates the ALK protein, which is conducive to cancer cell growth and survival. ALK+NSCLC is a distinct cancer type commonly found in relatively younger lung cancer groups (at a median age of 52 years old) with no history of smoking. 50% in the groups are younger than 50 years old and approximately 70% in the groups have never smoked.
ALK inhibitors can suppress tumor growth by effectively disabling ALK activity. Among the ALK inhibitors that have been marketed, alectinib is one of the superior drugs.
Alectinib, originally developed by Roche, was first approved by the FDA on December 11, 2015, for patients with crizotinib-resistant ALK-positive non-small cell lung cancer. on November 6, 2017, the FDA also approved alectinib as a first-line agent for ALK-positive patients. Phase III clinical trials comparing alectinib and crizotinib for the first-line treatment of ALK-positive lung cancer patients showed that alectinib could significantly reduce the risk of disease progression or death by up to 57%, prolong patient disease-free survival by up to 34.8 months and delay brain metastases.
Because of the favorable efficacy of alectinib, authoritative guidelines at home and abroad like NCCN Guidelines 2019, CSCO Guidelines 2019 and ESMO Guidelines 2019 have unanimously recommended alectinib as a first-line priority for patients with ALK+ NSCLC.
According to Researcher’s market research, Roche's alectinib (trade name: Alecensa®, manufactured by Excella GmbH & Co. KG) was approved for marketing in China in August 2018 for the indication of monotherapy of ALK-positive patients with locally advanced or metastatic NSCLC.
In the China National Reimbursement Drug List Negotiation 2019, Alectinib (only Alecensa is available in China as of August 2021) was included in the Category B of the National Drug Catalogue for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, which came into effect on 1 January, 2020. In the Chinese market, a one-month dose of alectinib (150mg *224 capsules) cost CNY49,980 (USD7,690) before 2020. Then from 1 January, 2020, the price has reduced by more than 60%. However, for most Chinese patients, the monthly expenditure of approximately CNY15,230 (USD2,340) on alectinib is still too high. Since the annual disposable income per capita in China was only CNY32,189 (USD4,952) in 2020, which means the monthly disposable income per capita was less than USD500, there are still many Chinese patients cannot afford to purchase alectinib.
According to Researcher’s market research, the sales value of alectinib in the Chinese market reached approximately CNY307 million (USD47.18 million) in 2020, with a CAGR of 815% from 2018 to 2020. The COVID-19 outbreak in early 2020 posed certain impact on the Chinese healthcare industry, but had minimal impact on its alectinib market.
Researcher 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, there 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. Local Chinese pharmaceutical companies may also accelerate the production of generic alectinib drugs, but due to the great difficulty in production, it is expected that generic alectinib drugs from local Chinese pharmaceutical companies will not be available until around 2025 at the earliest.
Impact of COVID-19 on China’s Alectinib Market
Development Environment of Alectinib in China
Sales Volume of Alectinib in China
Sales Volume and Value of Alectinib in China by Region
Major Alectinib Manufacturers in China and Their Market Shares
Sales Price of Alectinib in China
Prospects of China’s Alectinib Market, 2021-2025
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