China - PharmaceuticalsChina – Pharmaceuticals
Drivers for China’s healthcare market, such as the country’s aging population, rising health awareness, and increasing total and per capita expenditures on healthcare, will boost the growth of the pharmaceutical market, but the growth rate will be volatile year-to-year. Macro-economic influences on pharmaceutical industry growth are becoming negative. Chinese hospitals will have to confront severe issues related to restriction of the use of antibacterial drugs and stricter control on health insurance disbursement. Multinational pharmaceutical firms in China are facing challenges including pricing pressure, uncertain drug approval times, and the implementation of drug regulatory reforms.
Provincial and county level healthcare markets in China will become increasingly important for multinational pharmaceutical companies. This follows government reforms to channel patient volumes to local medical facilities as well as the saturation of the major hospital markets in tier one cities. Foreign firms seeking to make this shift will have to navigate the significant variances across provinces, strong competition from local drug makers, as well as lower levels of disease awareness among the rural populace.
The market is dominated mostly by the generics and ingredients sectors, which focus on small margins and are often associated with questionable quality. Due to low purchasing power and a robust local manufacturing sector, generic drugs ($85.3 billion) seized a large share of China’s pharmaceutical market ($219.9 billion). Sales of over-the-counter (OTC) medicines ($18.37 billion) are supported by a cultural acceptance of self-medication and fairly liberal sales channels while patented drugs ($30.0 billion) account for just 13.9% of China’s pharmaceutical market. The World Health Organization (WHO) reported that Chinese pharmaceutical companies typically only reinvest 5% to R&D activities, which is largely geared towards “me-too” or “me-better” initiatives.
|Pharmaceutical Market in China||2016||2017||2018||2019 (Estimated)|
|Prescription Drug Sales||92.495||103.833||116.158||124.727|
|Generic Drug Sales||68.635||76.722||85.385||91.252|
|OTC Medicine Sales||15.646||16.998||18.367||19.041|
|Patent Drug Sales||23.860||27.161||30.774||33.474|
Market AccessPositive developments:
China Joins the International Council for Harmonization (ICH).
In 2017, China joined the ICH as its eighth regulatory member. China promised to gradually transform its pharmaceutical regulatory authorities, industry, and research institutions to implement the international coalition’s technical standards and guidelines, and to actively accelerate the entry of international drugs into the Chinese market, as well as support the innovation and competitiveness of its domestic pharmaceutical industry.
Acceptance of International Clinical Trial Data.
On July 10, 2018, China’s National Medical Products Administration (NMPA) published Technical Guidelines for the Acceptance of Overseas Clinical Trial Data for Drugs. The guidelines open the door for the registration of pharmaceutical drugs and medical devices that have already undergone clinical trials in other countries, which previously could not be approved for the Chinese market without undergoing domestic clinical trials. This allows for faster access to the Chinese market with much lower costs for foreign pharmaceutical and medical device manufacturers.
Revision of the National Essential Medicines List (NEML) and National Drug Reimbursement List (NDRL).
- These two drug lists are critical for foreign pharmaceutical companies interested in the Chinese market. The NEML was updated in October 2018 and the NDRL was last updated in 2017 after 8 years without any changes. The 2017 NDRL saw a 15% growth to include 2,535 drugs, which included 1,297 western-style medicines (an increase of 11%). This included a focus on pediatrics and major illnesses including cancer, hepatitis, and renal and cardiovascular diseases. China’s newly established National Healthcare Security Administration (NHSA) is working on updating the NDRL in 2019 along with plans for more frequent revisions as well as plans to include more innovative drugs.
- Chemical Drugs
- Biotechnology market
- Traditional Chinese Medicine (TCM)
OpportunitiesAlthough there have been significant regulatory improvements, foreign firms continue to raise concerns about the regulatory and IP protection challenges as well as pricing, procurement, and reimbursement. Nonetheless, opportunities exist in the following areas:
- Patent drugs for Tier-3 hospitals
- Drugs for life-threatening diseases such as cancer, lung and liver diseases
- New drug research and development
- Pharmaceutical manufacturing
- Off patent generic growth (as GQCE enforcement improves)
May 13-15, 2019
Natural Health & Nutrition Expo (NHNE)
May 13-15, 2019
2019 China BioMed Innovation & Investment Conference – International Forum Series – USA
September 20-23, 2019
China’s National Medical Products Administration (NMPA): http://www.nmpa.gov.cn/
Center for Drug Evaluation of the CFDA (CDE): http://www.cde.org.cn/
National Institute for Food and Drug Control (NIFDC): http://www.nicpbp.org.cn/
Ministry of Human Resources and Social Security (MOHRSS): http://www.mohrss.gov.cn/
National Development and Reform Commission (NDRC): http://www.en.ndrc.gov.cn/
National Health Commission (NHC): http://www.nhc.gov.cn/
U.S. Commercial Service Contact for Pharmaceuticals
U.S. Embassy in Beijing
Huiling Shi, Commercial Specialist
(86 10) 8531-3419
U.S. Consulate in Chengdu
Mini Tian, Commercial Specialist
(86 28) 8558 3992 ext. 6567
U.S. Consulate in Shanghai
Xiaoli Pan, Commercial Specialist
(86 21) 6279-8750
U.S. Consulate in Shenyang
Yang Liu, Commercial Specialist
(86 24) 2322 1198 – 8143
U.S. Consulate in Guangzhou
Jenesy Wang, Commercial Specialist
(86 20) 3814-5405
U.S. Consulate in Wuhan
Catherine Le, Commercial Specialist
(86 27) 8555 7791