Frost & Sullivan globally releases the 'Blue Book on the Current Situation and Trends of Chinese Medical Devices Going Global in 2025' | Full text available upon request

According to data analysis by Frost & Sullivan, from 2018 to 2023, the overall market size of medical devices in China increased from 528.4 billion yuan to 973.1 billion yuan, with a CAGR of 13.0%. It is estimated that by 2030, the overall market size of medical devices in China will reach 1,627.5 billion yuan. From 2018 to 2023, the global overall market size of medical devices increased from 425.3 billion US dollars to 607.1 billion US dollars, with a CAGR of 7.4%. It is estimated that by 2030, the global overall market size of medical devices will reach 899.2 billion US dollars.

●Internal factors① There are numerous Chinese medical device manufacturers with large production capacity but low per-unit output; ② Centralized procurement of medical devices brings pressure on product prices; ③ China's R&D and innovation capabilities in medical devices are steadily enhancing; ④ The global pandemic has strengthened the overseas channels and brands of Chinese medical device enterprises; ⑤ China's policies support the export of innovative medical devices; ⑥ Chinese benchmark medical device enterprises started internationalization early and have rich practical experience.

●External factors① The global medical device market is vast; ② China has a price advantage when exporting medical devices overseas; ③ China's international influence has increased.

●strategic intent: ① Expand overseas markets to achieve revenue growth; ② Create opportunities for exchanges with overseas peers and promote cooperation between the enterprise and overseas research institutions; ③ Recruit overseas talents to enhance the enterprise's R&D and production capabilities; ④ Attract overseas financing; ⑤ Enhance brand influence, driving internal sales growth while increasing overseas revenue.

Chinese medical devices have gone through a journey of low-cost overseas expansion, technology-driven development during the pandemic, and mid-to-high-end transformation through process upgrading in the post-pandemic era. They have embarked on an international leapfrog path of 'resource accumulation - technology precipitation - demand-driven - compliance upgrade'.

In recent years, while maintaining their export advantage in medical consumables, enterprises have also made rapid progress in high-tech fields such as medical equipment and in vitro diagnostics. In the export data for 2024, medical equipment accounted for the highest proportion, reaching 43.6%, followed by medical consumables at 38.0%. IVD reagents and instruments accounted for 10.5% and 3.3%, respectively. Although the proportion of rehabilitation products and dental equipment and accessories is small, it also demonstrates the comprehensive competitiveness of China's medical devices in the global market.

With the global growth in demand for medical devices and strong support from domestic and international policies, Chinese enterprises are gradually expanding their overseas market footprint. They are not only continuing to make efforts in European and American markets but also actively entering emerging markets such as Southeast Asia, Africa, and the Middle East. In 2024, the United States remains China's largest single market for medical device exports, accounting for 25.0%, followed by Japan, South Korea, and countries in Europe such as Germany and the United Kingdom. At the same time, Russia provides new development opportunities for Chinese medical device companies due to its large population and growing medical needs, coupled with the reduction in Western businesses' operations in the region. Since 2023, the proportion of exports to Russia has risen significantly.

1. Dealer modelBased on years of deep cultivation in resource integration in the local market, customer relationship maintenance, and interpretation of regulations and policies, we can provide full-link services including inventory preparation, channel development, market promotion, logistics distribution, and after-sales support. The company relies on the dealer network, market awareness, and customer resources to lower the initial entry threshold, especially suitable for small and medium-sized enterprises that are not familiar with the regulations and culture of the target country.

2. Build factories overseasIt is a global layout strategy involving heavy assets and a long cycle. By directly investing in building production bases in target markets, enterprises achieve localization of the supply chain, proximity to end demand, and avoidance of trade restrictions. This model is suitable for leading companies with substantial capital, mature technology, and a desire for long-term market dominance. Its core advantage lies in enhancing supply chain resilience and brand premium capabilities, but it faces high initial investment, cross-cultural management challenges, and geopolitical risks.

3. OEM modelCentered on 'manufacturing for export', enterprises enter the international market by providing OEM production services to overseas brand owners. The advantage of this model lies in its low initial investment and rapid capacity absorption, especially suitable for circumventing trade barriers. However, OEM enterprises face long-term dilemmas such as low profits and weak bargaining power in the value chain, and are vulnerable to fluctuations in orders.

4. M&A modelThe core lies in rapidly acquiring scarce resources through capital leverage, with strategic intentions directly aimed at breaking through technological barriers and gaining access to high-end markets. The advantage lies in shortening the R&D cycle and strengthening industrial chain collaboration, especially suitable for areas with significant technology gaps or policy sensitivities. However, hidden liabilities of target assets, such as patent litigation and environmental fines, may lead to the failure of synergy effects, and developed countries are tightening their scrutiny of foreign mergers and acquisitions in sensitive technology fields.

5. Cross-border e-commerce modelBy directly reaching end-users through the platform, bypassing middlemen's profit margins and increasing gross profit margins; relying on data-driven decision-making, using user behavior analysis to accurately locate needs, dynamically adjusting product designs, and leveraging domestic manufacturing advantages for small-batch and multi-batch production to match fragmented demands in emerging markets.

In the field of basic medical equipment, Chinese enterprises have gained a significant price advantage in categories such as monitors, blood pressure monitors, and blood glucose meters by virtue of large-scale production and cost advantages, successfully penetrating the global market. At the same time, Chinese enterprises are gradually emerging in the high-end medical equipment sector. Domestic mid- to high-end devices such as MRI machines, ultrasound machines, endoscopes, and anesthesia machines are gradually gaining recognition from overseas medical institutions due to their high cost-effectiveness and continuously improving product quality.

●Life support medical equipment

According to data from the General Administration of Customs of China, the total export volume of anesthesia machines in China in 2024 was about 21.34 million units, with a total export value of about 1.88 billion yuan. The main export regions include the United States, Russia, Germany, the United Arab Emirates, Australia, Brazil, etc. In the African region, the export value of anesthesia machines has been increasing year by year since 2020, reaching 158 million yuan in 2024, with an annual compound growth rate of 39.39%. Another rapidly growing market is the Eurasian Economic Union (EAEU), which includes member states such as Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia.

●Imaging medical equipment

The current global high-end medical imaging equipment market is still dominated by three multinational giants: General Electric (GE), Philips Healthcare, and Siemens Healthineers. In 2022, they collectively accounted for more than 65% of the market share, forming a technological monopoly in core areas such as CT, MRI, and PET-CT. In recent years, with domestic equipment companies continuously breaking through technical bottlenecks in key components such as detectors, tubes, and magnets, the quality and clinical recognition of equipment have significantly improved. With the support of government procurement policies, domestic equipment is accelerating its penetration into the mid- to high-end market.

●High-value consumables

In 2023, the average proportion of overseas business revenue of Chinese high-value consumables enterprises was 17.50%, indicating that Chinese enterprises have already achieved a certain level of participation in overseas markets. However, due to the significant difficulty in exporting high-value consumables, overseas markets are still dominated by international established enterprises. Chinese enterprises, with their increasingly strong R&D capabilities and manufacturing levels, are gradually breaking through technical and market barriers. For example, enterprises such as Mindray Medical and VIP Group have achieved initial success in their overseas market layouts, with some products having obtained EU CE certification and US FDA certification, successfully entering high-end markets such as Europe and America, and achieving a certain market share in emerging markets in Southeast Asia and Latin America.

●In Vitro Diagnosis

In recent years, driven by multiple factors such as population aging, growth in per capita health expenditure, healthcare cost control policies, and technological progress, China's IVD industry has shown tremendous market potential. However, the global IVD market developed earlier, with rapid technological updates and fierce market competition. After 2000, with the implementation of healthcare cost control policies in various countries, small enterprises were gradually acquired due to cost disadvantages, marking the industry's entry into an integration phase. During this process, Chinese IVD companies are accelerating their international layout by leveraging technological progress and cost advantages.

Data from the General Administration of Customs of China show that in 2023, China's IVD product exports exhibited structural differentiation. Among them, the export value of IVD reagents was $2.11 billion, showing a certain decline compared to 2022; however, the export of IVD instruments remained stable, reaching $2.92 billion in total exports for the year, demonstrating strong international market competitiveness. In terms of regional market distribution, the United States continued to be the largest market for China's IVD instrument exports, with exports to the US reaching $350 million in 2023; Russia and Indonesia ranked second and third as important export destinations for China's IVD instruments, respectively. The important position of China's IVD industry in the global supply chain and the continuous optimization of its export structure.

The Blue Book comprehensively sorts out the basic population and economic development of developed countries' markets, including the United States, Japan, the European Union, and Canada. It analyzes their medical insurance systems, medical device regulatory standards, medical insurance payment situations, and the main challenges faced when going global. For emerging markets, starting from the policy background of the Belt and Road Initiative, the Blue Book discusses in detail the characteristics of medical device markets in Southeast Asia, the Middle East, Latin America, Africa, Russia, and India, regulatory policies, and the current situation and challenges faced in going global, fully demonstrating the potential of emerging markets. For more detailed content, please refer to the complete Blue Book.

1. The outbound route is unclear① Enterprises fail to systematically evaluate their own technical capabilities and resource endowments, which can easily lead to mismatched path choices and scattered strategic goals. ② Enterprises going global face problems in market selection, certification strategies, and channel construction due to the lack of systematic plans, complete process frameworks, and execution details. ③ Due to a lack of systematic research on overseas market competition patterns such as technical barriers built by overseas enterprises and channel monopolies formed by local brands, they face strategic blind spots in their globalization layout.

2. The assessment of overseas markets is inaccurate.: ① Insufficient attention to differences in the healthcare payment systems of target markets, and inaccurate evaluation of payment methods make it difficult for companies to accurately adjust product positioning and formulate differentiated market entry strategies; ② Over-reliance on a single market leads to inadequate response to environmental changes; ③ Insufficient awareness of compliance risks at destinations results in resource consumption for companies.

3. Don't understand the market access process: ① The ambiguity and dynamism of regulations and certifications; ② The improvement in medical device technology levels has placed higher demands on testing standards.

4. International localization has just begun① Weak local team building and supply chain; ② Lagging execution mechanisms: weakened organizational collaboration leads to 'difficulty in implementing' strategies; ③ Low brand trust and international competitive pressure

1. Chinese medical device companies need to deepen their global competitiveness through technological innovation and research and development, and accelerate overseas certification to break through market barriers

2. Align with international standards and promote the certification of our products by foreign institutions

3. Enhance the enterprise's cross-cultural communication capabilities and familiarize itself with local laws and regulations

4. Enhance overseas presence through diversified market strategies and build brand image

When medical device products enter the international market, they not only face fierce market competition but also increasingly stringent regulations and regulatory requirements. As a global expert in safety science, UL Solutions is committed to providing manufacturers of medical device equipment with comprehensive solutions throughout the product lifecycle. Our complete third-party regulatory approval, product testing and certification, auditing, cybersecurity testing, usability testing, and training services make us a reliable partner for the safety and compliance of medical device products. We also offer one-stop services for global market access for medical device products.

Shanghai Jintiancheng (Suzhou) Law Firm was officially established in 2010 with the approval of the Jiangsu Provincial Department of Justice and has currently firmly positioned itself as one of the top-tier law firms in Suzhou's legal industry. Jintiancheng has been repeatedly selected by the Ministry of Justice of China and its subordinate judicial administrative institutions, bar associations, internationally renowned legal media, and authoritative rating agencies as one of China's top legal service providers.

The Jintiancheng Healthcare and Medicine Industry Committee has rich experience in healthcare and medicine industry services. The team has years of experience rooted in the industry and a profound understanding of industry operation patterns. They closely monitor the dynamics and development trends of the industry, always providing professional one-stop legal services for clients under the backdrop of the industry, including but not limited to domestic and international capital markets, mergers and acquisitions, private equity and venture capital, intellectual property protection, company operations and compliance governance, dispute resolution, etc.