China's Medical Trade Surpasses $200 Billion: Pharma and MedTech Going Global Enters the Era of Compliance, Technology, and Innovation

VCBeat: According to data monitored by the Chamber of Commerce, China’s pharmaceutical trade exceeded $200 billion in 2025. Behind this performance, what structural changes have you observed? How specifically have exports of innovative drugs and high-end medical devices performed?

Zhang Xiaohui: The 200 billion mark is indeed highly symbolic, signaling that China’s pharmaceutical industry has bid farewell to the era of “scale expansion” dominated by active pharmaceutical ingredients (APIs) and low-end consumables, and has begun to enterA New Stage of “Value Leap” Centered on Innovation and High Quality。

The data is intuitive.1. Continued Optimization of Export Markets. In 2025, both imports from and exports to the United States declined by approximately 10% year-on-year, while exports to the European Union, Russia, Africa, Latin America, and other regions and countries all exceeded 10%, gradually reducing reliance on a single market and demonstrating the effectiveness of diversification strategies.2. Continuous Enhancement of Product Technological ContentExports of Western pharmaceutical preparations increased by nearly 30% year-on-year, exports of surgical robots surged by 368.1% year-on-year, and magnetic resonance imaging (MRI) systems grew by 14.4%, among others.3. Innovative Drugs Achieve New Breakthroughs in InternationalizationIn 2025, the total value of out-licensing deals for innovative drugs exceeded $130 billion. In cutting-edge fields such as antibody-drug conjugates (ADCs), bispecific antibodies, and GLP-1 therapies, we are keeping pace with global leaders, with some products even taking the lead.

VCBeat: Behind these achievements, we are also reflecting on the core strengths and major weaknesses of Chinese pharmaceuticals and medical devices in the international market.

Zhang Xiaohui: In summary, relying onComprehensive Competitive Advantages Derived from Cost Control, Quality Compliance, Industrial Efficiency, Scale Synergies, Innovation Iteration, and the Level of Opening-Up, we can efficiently integrate resources across the entire upstream and downstream industrial chain, strengthening coordination and synergy at every stage—a feat that other individual countries or regional markets would find difficult to replicate.

Specifically:Outstanding Advantages in Full Industry Chain Support and Large-Scale Manufacturing, with significantly superior manufacturing costs and R&D efficiency compared to Europe and the United States;Rapid Enhancement of Innovation CapabilitiesIn recent years, the number of innovative drugs and innovative medical devices approved in China has steadily increased, with the scale of products under development ranking among the top globally;Strong Supply Chain Resilience, with exports covering Europe, the United States, and emerging markets along the "Belt and Road," effectively hedging against risks arising from fluctuations in any single region;Policy Environment Continues to Optimize, the gradual alignment of regulatory frameworks with international rules has provided institutional safeguards for enterprises expanding overseas.

However, the shortcomings are also evident:Relatively Weak Internationalization Capabilities, many enterprises lack mature overseas registration teams, and their capabilities in international registration and compliance operations remain insufficient;Weak Overseas Commercialization and Brand-Building Capabilities, most enterprises going global still rely primarily on product trade or licensing partnerships; while their products reach overseas markets, they fail to achieve substantial sales volumes, command premium prices, or establish strong brand presence.Original Innovation Capacity Still Needs ImprovementFirst-in-class (FIC) drugs, high-end core technologies, and key foundational patents are prone to infringement disputes and market barriers in international competition.Rising geopolitical risks,An Increase in Non-Tariff Barriers.

VCBeat: In such a competitive landscape, what types of pharmaceutical and medical device companies are better suited for international expansion? Which enterprises find it easier to get started?

Zhang Xiaohui: We believe that enterprises more suited for international expansion are defined not by their scale or past achievements, but byCan we seize policy opportunities, build supply chain resilience, continuously innovate and iterate products, and adapt flexibly and compliantly to a changing market?。

The first category comprises industry leaders with integrated full-chain capabilities, such as those combining active pharmaceutical ingredient (API) production with finished dosage forms, enabling stable entry into European and American markets. The second category includes innovative enterprises possessing core technology platforms, which hold differentiated advantages in frontier targets, antibody-drug conjugates (ADCs), and bispecific antibodies, thereby demonstrating global clinical value and competitiveness. The third category consists of cost-effective medical device leaders whose products in imaging, patient monitoring, in vitro diagnostics (IVD), and surgical instruments offer both performance and cost competitiveness, allowing them to penetrate emerging markets as well as mid-to-high-end segments in Europe and the United States. The fourth category features “hidden champions” in niche sectors, such as orthopedics, electrophysiology, and minimally invasive consumables, which have established technical barriers in these vertical tracks and possess clear, controllable pathways for international expansion.

VCBeat: Drawing on your experience with the chamber of commerce and your practical expertise, what are the most prominent bottlenecks currently faced by companies going global in areas such as registration, certification, and compliance verification?

Zhang Xiaohui: Based on our observations, my summary is as follows"Incomplete documentation, inconsistent data, lax systems, and chaotic management"。

Data Integrity and Regulatory Compliance. In regulated markets such as Europe and the United States, there are stringent requirements for data integrity and traceability in registration dossiers. Issues faced by Chinese companies, including missing source records and non-compliant electronic data management, have led to prolonged review cycles.

GMP Quality System Compliance and Qualification Management. Domestic enterprises face varying degrees of export barriers due to non-compliance issues such as inadequate production environment monitoring, insufficient sterility assurance, and flawed traceability systems. Additionally, expired qualification documents and discrepancies between registration certificates and actual production addresses have led to registration rejections or customs clearance obstacles for some companies.

Further advancement of mutual recognition mechanisms is expected to accelerate localization in emerging markets. Currently, many emerging markets mandate local production, presenting the “Four Barriers”: local clinical trials, local partners, local language, and local manufacturing. Conducting these processes in every country prolongs market access timelines and drives up localization costs.

VCBeat: Market performance varies across different regions. In 2025, China’s exports to the European Union grew by 10.98%. What are the drivers behind this growth in the EU? Additionally, following the upgrade of the EU Medical Device Regulation (MDR), what impact has it had on market access in other countries that use CE marking as a reference?

Zhang Xiaohui: There are several reasons for the growth in exports to the EU. First, China’s cost-effective products have become a priority for EU procurement, especially as high US tariffs and supply chain fluctuations have highlighted our competitive advantages. Second, Chinese companies have improved their compliance capabilities, obtaining an increasing number of MDR and CE certificates. Third, the upgrade in product structure has led to significant growth in categories such as PET/CT scanners, surgical robots, patient monitors, and high-value consumables, aligning well with EU demand.

As for the impact of the MDR upgrade, it depends on the scoring area.

This is beneficial for market access in countries that recognize CE (MDR/IVDR) certification., a single certification covers multiple markets. Countries like Norway and Iceland directly adopt the MDR without additional barriers; Turkey’s medical device regulations are highly aligned with the EU, mandating MDR compliance; the UK is advancing a policy of “indefinite recognition of the CE mark,” and it is widely believed that “one certification for dual access to both the UK and EU markets” will essentially be realized in the future.

For countries that use CE (MDR) as a core reference or simplified pathway, the overall threshold has increased.. Some countries in the Middle East, Southeast Asia, and Latin America regard CE certification as the core technical documentation for registration, with decreasing acceptance of certificates issued under the old Medical Devices Directive (MDD).

For countries where CE marking is for reference only and local registration is still required, the overall impact is limited.In India, Russia, and most African countries, CE certification is an important "plus."

However,CE-IVDD Certificates Are Not Fully Invalidated but Conditionally ExtendedClass D devices may be deferred until the end of 2027, Class C devices until the end of 2028, and Class B and lower-class devices until the end of 2029; therefore, companies should promptly review their product portfolios and must not become complacent due to the extensions.

VCBeat: What do you see as the greatest opportunities and the greatest risks for the global expansion of pharmaceuticals and medical devices in the next one to two years? Which sectors, technologies, or products possess the strongest global competitiveness?

Zhang Xiaohui: Over the next two yearsThe Greatest Opportunities Lie in “Innovative Development of Chinese Pharmaceuticals and Medical Devices” and “Global Pharmaceutical Markets’ Dependence on China’s Supply Chain”The Emergence of a Dual Dividend. On one hand, the global expansion of innovative drugs through technology licensing has entered an explosive growth phase, with License-out evolving into Stage 2.0 characterized by co-development, risk-sharing, and profit-sharing, enabling Chinese enterprises to begin capturing global commercialization profits. On the other hand, there is a "structural substitution" occurring in active pharmaceutical ingredients (APIs) and high-end medical devices. From 2026 to 2030, approximately $300 billion worth of branded drug patents will expire globally, creating favorable conditions for Chinese pharmaceutical companies to absorb the resulting market shifts. Meanwhile, in certain segments of the high-end medical device sector, Chinese manufacturers are rapidly filling gaps in European and American markets, leveraging their cost-effectiveness and supply chain advantages.

The primary risks are mainly the “escalation of compliance barriers” and the “spillover effects of geopolitical gaming.”of mutual superposition. Risks are no longer confined to commercial competition, with explicit and implicit barriers gradually increasing. Meanwhile, the priority in closing transactions has shifted from “price and efficiency” to “security and controllability,” while the influence of geopolitical factors and supply chain “de-risking” continues to spread.

Based on recent export data and business development (BD) transactions, antibody-drug conjugates (ADCs) and bispecific antibodies in the biologics sector, endoscopes and imaging equipment in the high-end medical device sector, as well as specialized active pharmaceutical ingredients (APIs) and GLP-1 receptor agonists, demonstrate strong competitiveness. In summary, over the next two yearsEnterprises with Core Technologies and Global Compliance CapabilitiesWill occupy a favorable position in the competition.

VCBeat: You have been invited as a guest speaker for the [Global First Lesson] session at the Pharmaceutical and Medical Device International Market Expansion Forum, part of the 2026 Top 100 Future Healthcare and Medicine Conference. What content do you plan to share?

Zhang Xiaohui: Content is still being prepared, with the core focusing on panoramic insights and actionable recommendations for the global expansion of Chinese pharmaceuticals and medical devices.

2026 Future Healthcare & Pharmaceutical Top 100 Conference · Forum on International Market Expansion for Pharmaceuticals and Medical DevicesSet to Grandly Open in Shanghai on May 19, the event will invite companies with extensive overseas experience, such as Shinva Medical, Autek China, MicroTech Medical, and Pushi Lihua, to share practical insights, while institutions specializing in channel distribution, market access compliance, and cross-border finance will provide empowering perspectives.

Which market are you most interested in? What resources do you most want to connect with? What insights do you most want to hear?

The forum is launching a [Call for Needs in Pharmaceutical and Medical Device Global Expansion and Forum Topics], and we sincerely invite your participation.

Return on Participation:

● Topic contributors will receive one complimentary ticket to the Pharmaceutical and Medical Device International Market Expansion Forum at the 2026 Future Healthcare & Pharma Top 100 Conference

● Top contributors will receive one opportunity to post supply and demand information on the VCBeat platform (related to overseas expansion).

Submission Portal:

Conference Consultation, Business Cooperation: Ms. Wang 17774983530