360 Chinese API makers just scored the EU’s golden ticket—CEP certified：who’s future-proof?

360 Chinese Pharma Companies Hold EU CEP — How Will Competition Unfold in Europe’s API Market?

According to World Bank data, the European Union’s 27 member states have a combined population of roughly 449 million and recorded a GDP of USD 16.6 trillion in 2021. That year, healthcare spending reached €1.6 trillion, or €3,562 per capita—accounting for 10.9% of GDP. This vast market is a powerful draw for Chinese pharmaceutical companies looking to expand internationally.

Notably, the EU has experienced continuous population decline since 2012. According to the *2024 Aging Report* of the European Union, people aged 65 and above accounted for 21% of the population in 2022, with Italy and Portugal showing the highest aging rates at 24% each. This demographic shift will continue to drive demand growth in the EU pharmaceutical market.

According to a Frost & Sullivan report, the pharmaceutical market in just five EU countries is expected to exceed USD 24.7 billion by 2030. As the population continues to age, the EU pharmaceutical market will present significant growth opportunities for Chinese pharmaceutical companies.

This article provides a data-driven overview of Chinese API companies’ exports to the EU.

PART 01 Chinese Pharma’s Overseas Surge: CEP Certificates Grow at a 27.05% CAGR in Recent Years

As of June 30, 2025, China holds nearly 1,700 CEP certificates in the EU, with 200 obtained in 2025 alone. From 2019 to 2024, the number of CEP certifications grew at a CAGR of 27.05%, reflecting Chinese pharmaceutical companies’ accelerated global expansion.

Number of CEP Certificates Obtained by Chinese Pharmaceutical Companies, 2019–2024

Source: Yaozhi Data, Xinxiao

From a regional perspective, Zhejiang, Shandong, and Jiangsu lead by a wide margin, together accounting for 58.52% of all CEPs—particularly Zhejiang, which alone holds 31.47%.

Share of CEP Certificates by Province in China

Source: Yaozhi Data, Xinxiao

Top Three Provinces Exporting APIs to the EU: Zhejiang, Shandong, Jiangsu

Data shows that 360 Chinese companies currently hold EU CEP certificates. Zhejiang tops the list, with 22% of API-exporting enterprises to the EU, followed by Jiangsu at 15% and Shandong at 14%.

Share of Enterprises with CEP Certificates by Province in China

Source: Yaozhi Data, Xinxiao

PART 02 Fierce Competition for Chinese Companies in the EU Market

Humanwell Healthcare (Group) holds 85 CEP certificates in the EU, followed by Huahai Pharmaceutical and Qilu Pharmaceutical Group. As domestic companies accelerate their global expansion, competition in international markets remains intense.

Top 20 Companies by Number of CEP Certificates

Note: HEC Group is excluded from the ranking as its applicat

Source: Yaozhi Data, Xinxiao

Chinese pharmaceutical firms have obtained nearly 1,700 valid CEP certificates, covering around 500 products. Markets for certain APIs—such as rivaroxaban, ticagrelor, and levetiracetam—are particularly competitive, with 10 or more Chinese companies vying for each.

Top 20 Most Competitive Products for Chinese Pharma in the EU Market

Source: Yaozhi Data, Xinxiao

In 2024, Humanwell Healthcare (Group) recorded overseas revenue of RMB 3.235 billion, up 19.86% year-on-year; Huahai Pharmaceutical’s overseas API revenue reached RMB 3.154 billion, up 14.41%; and Guobang Pharma posted overseas revenue of RMB 2.664 billion, up 8.27%.

However, both Humanwell Healthcare (Group) and Huahai Pharmaceutical saw their gross profit margins from international sales decline year-on-year.

Overseas Revenue of Leading Companies

Source: Company financial reports, compiled by Xinxiao

PART 03 In 2024, NMPA Certificates for API Exports to the EU Fell by 9.41% Year-on-Year

According to data from the National Medical Products Administration (NMPA), the number of certificates issued for exporting active pharmaceutical ingredients (APIs) to the EU in 2024 was 616—a 9.41% decrease from the previous year.

API Export Certificates to the EU, 2019–2024

NMPA, compiled by Xinxiao

In 2024, Zhejiang had the largest share of enterprises exporting APIs to the EU, accounting for 17.45%, which aligns with its leading position in the number of CEP-certified companies.

Source: NMPA, compiled by Xinxiao

In the EU API market, Chinese companies face not only domestic competition but also intense rivalry from Indian firms. India holds nearly 4,000 CEP certificates—more than double China’s total. For Chinese pharmaceutical companies aiming to secure a larger share of the global API market, the road ahead remains challenging.

Reprinted from LINK WITS