Industry Trend Analysis - Drug Approval Reforms To Be A Positive For Patented Medicine Market - APR 2017


BMI View : Reforms to Taiwan ' s drug approval process will be a positive for innovative drugmakers operating in the country. P art of a broader government effort to grow the biomedical sector in Taiwan, these changes will introduce a new process and a national agency to review applications . Potentially shorting the drug approval timeframe by one to two months, this will augment the attractiveness of Taiwan ' s patented medicine market , with new product launches supporting the sub-sector's growth outlook.

Changes to Taiwan's drug approval process will be imminent. This follows the Executive Yuan decision in February 2017 to adopt the 'Draft Regulations Governing the Establishment of the National Centre for Drug Evaluation' (Xing Zheng Fa Ren Guo Jia Yao Wu Shen Cha Zhong Xin ). Pending the consideration of the Legislative Yuan, the authorities will have a legal platform to establish a new national agency tasked with streamlining the drug review process which will not rely on government funding for its operations. This is expected to reduce the time required to launch a pharmaceutical product in Taiwan, improving upon the current system in place. According to the Taiwan Food and Drug Administration (TFDA), a total of 40 new chemical entities were approved in the country for the full year of 2016. While this is a decline from its peak of 49 in 2015, it does place Taiwan ahead of the US FDA, which approved 22 treatments.

Correspondingly, innovative drugmakers will be incentivised to launch their products in Taiwan, facilitating the growth of the patented medicine market. Innovative pharmaceuticals have performed well in the market, with Roche's Herceptin (trastuzumab) and AstraZeneca's Crestor (rosuvastatin) among the top selling products in the country for 2014. Bristol-Myers Squibb's hepatitis B treatment, Baraclude (entecavir), was the top selling drug in the country. We are forecasting patented medicine sales in Taiwan to increase from TWD117bn (USD3.6bn) in 2016 to TWD160bn (USD5.9bn) by 2026, with a compound annual growth rate of 3.2% in local currency terms and 5.0% in US dollar terms.

Drug Approvals On The Rise
Selected Countries: New Chemical Entity Approved
Source: Taiwan Food and Drug Administration

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