Article
Understanding the Surge in New Product Launches in China's Pharma Market
How is Forecast Link leveraging the trend?
Jun 19, 2024

The drug approval process in China underwent significant changes in 2015, which has led to an increase in the number of drug approvals and subsequently drug launches in the country. The reforms in the Chinese drug regulatory system have had a significant impact on the new drug approval process and the median New Drug Application (NDA) approval time has been reduced to 15.4 months between 2017 and 2021, which is the shortest approval time in the last decade for China.

In the periods 2011 to 2013 and 2014 to 2016, the NDA approval time in China was 22.1 months and 35.1 months, respectively. Priority Review (PR) and Urgently Needed Overseas Drugs (UNOD) pathways have contributed to this improved efficiency, enabling faster access to the Chinese market. In this article, we delve into the impact of these changes and explore how Forecast Link, IQVIA's powerful syndicated forecasting tool, adapts to this evolving trend.

A launch lag analysis was carried out using IQVIA MIDAS data for the years 2012 to 2023 for innovative branded products to determine the delay of the launch of new drugs in any country when compared to their first global launch country (launch lag), measured in quarters. IQVIA MIDAS is a unique database that provides product volumes, trends and market share through retail and non-retail channels across the globe.2 Innovative branded products are the unique new international products that are non-generic in MIDAS. The data for innovative branded, non-generic prescription drugs with quarterly sales in any of the 75 countries listed in Forecast Link from 2012 to 2022 was extracted from MIDAS. The first global launch quarter and first country launch was determined from the first quarter of data with sales. The difference between the first global launch quarter and the respective country launch quarter was used to identify the launch lag. Corporations were tagged based on sales and headquarters to various categories and classified as company peersets. This was done to identify companies with similar facilities and opportunities for launch of products. The entire dataset was then split by country and company peersets, to determine the quarterly launch lag in China.

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