Market evolution: Orthopaedic appliances (CN 9021) — 2015–2025

Introduction

This report examines the evolution of EU external trade in orthopaedic appliances and related medical devices (Combined Nomenclature code 9021) over the period 2015–2025. The product group encompasses a broad range of goods including orthopaedic and fracture appliances, artificial joints and other body parts, dental fittings, hearing aids, and pacemakers — collectively representing a critical segment of the medical technology industry.

Over the decade under review, the EU's trade position in this sector has strengthened markedly. Total exports rose from €12.3 billion to €21.4 billion (+74.6%), while imports grew from €9.1 billion to €14.5 billion (+60.3%). The resulting trade surplus more than doubled, expanding from €3.2 billion to €6.9 billion. This divergence in growth rates — with exports outpacing imports — signals a structural shift in the EU's competitive positioning within global orthopaedic and medical device markets.

The analysis that follows is organised around three main themes: the overall trajectory of EU trade flows and their evolving price–volume composition; the geographic reorientation of trade partnerships; and the product-level and intra-EU dynamics that underpin the sector's transformation. All figures are drawn from the General Overview and related sections of the EU Trade Dashboard.

1. A decade of value-driven growth: exports outpace imports in both magnitude and sophistication

1.1 Export growth has been driven primarily by rising unit values rather than volume expansion

The EU's export performance in CN 9021 has been impressive in absolute terms, growing from €12.3 billion in 2015 to €21.4 billion in 2025 — a cumulative increase of 74.6%. However, the composition of this growth reveals an important distinction. Export volumes (measured in net tonnes) rose by a more modest 23.1%, from 18,423 tonnes to 22,685 tonnes. The bulk of the value expansion is therefore attributable to a significant increase in unit export prices, which climbed from €661,775 per tonne to €942,977 per tonne — a gain of 42.5%.

This pattern suggests that the EU is increasingly specialised in higher-value-added segments of the orthopaedic and medical devices market. Rather than competing on volume, EU producers appear to be leveraging technological sophistication, regulatory compliance, and brand reputation to command premium prices in global markets. This is consistent with the EU's known strengths in advanced medical implants, high-end hearing aids, and precision orthopaedic devices.

1.2 Import growth has been more volume-driven, reflecting demand for cost-competitive components

Imports into the EU followed a different trajectory. Total import value rose from €9.1 billion to €14.5 billion (+60.3%), but import volumes grew even faster — from 32,754 tonnes to 47,517 tonnes (+45.1%). Meanwhile, import prices increased only 11.1%, from €274,645 per tonne to €305,036 per tonne.

The comparatively modest rise in import prices — in stark contrast to the export price trajectory — indicates that the EU is sourcing an increasing share of its orthopaedic devices from lower-cost origins. This likely reflects the growing penetration of Asian manufacturers (particularly from China and Vietnam) into mid-range and commodity segments of the market, while EU producers retain dominance in premium, technology-intensive product categories.

1.3 The EU has transitioned from a modest net importer to a substantial net exporter

One of the most striking developments over the decade is the reversal of the EU's net trade position. In 2015, the EU exhibited a net import reliance of approximately 10.3% (i.e. imports exceeded exports in value terms relative to production). By 2025, this indicator had swung to –36.7%, meaning the EU had become a significant net exporter.

The trade balance expanded from €3.2 billion in 2015 to €6.9 billion in 2025 (+115.4%), while trade intensity — the combined share of exports and imports relative to production — rose from 60.3% to 91.6%. Even more notably, export propensity (exports as a share of production) nearly doubled from 39.9% to 86.6%, indicating that EU production is increasingly oriented towards global markets.

This transformation reflects both the globalisation of EU medical device firms and the sector's integration into international value chains, where the EU serves as an export hub for high-value products while simultaneously importing lower-cost components and finished goods for the domestic market.

2. Geographic reorientation: diversification of supply sources and concentration of export demand

2.1 The United States remains the EU's dominant trade partner, but the relationship is evolving asymmetrically

The United States is by far the EU's largest external partner for CN 9021 trade, accounting for the largest shares of both imports and exports. In 2025, the EU imported €5.5 billion from the US (a 35.8% increase from 2015) and exported €6.1 billion to the US (+39.2%). However, the growth dynamics differ. While EU imports from the US grew moderately, EU exports to the US expanded at a faster pace, suggesting a gradual shift in the bilateral balance of trade in this sector.

2.2 Asian suppliers have gained significant market share, led by China and Vietnam

Among the most notable shifts in the EU's import profile is the rapid growth of Asian suppliers. EU imports from China more than doubled, rising from €427 million to €1.0 billion (+137.8%), while imports from Vietnam surged by an extraordinary 630.6%, from €28 million to €207 million. Taiwan (+102.2%) and Malaysia also recorded strong growth. These dynamics reflect the ongoing relocation of manufacturing capacity for mid-range orthopaedic devices, dental fittings, and hearing aid components to lower-cost Asian production centres.

This shift has contributed to a reduction in import concentration, as measured by the Herfindahl-Hirschman Index (HHI), which declined from 2,792 to 2,051 (–26.5%). A lower HHI indicates a more diversified import base, reducing the EU's exposure to supply disruptions from any single origin. However, this diversification has come at the cost of increased reliance on regions that may pose different geopolitical or logistical risks.

2.3 Export concentration has also declined, with emerging markets gaining prominence

On the export side, the HHI for exports fell from 1,566 to 1,175 (–25.0%), indicating a broadening of the EU's export base. While the United States remains the primary destination, several other markets have gained prominence:

• United Kingdom: EU exports to the UK more than doubled (+121.8%), rising from €1.3 billion to €2.9 billion, despite the disruptions associated with Brexit. This may reflect the continued strength of medical device supply chains linking the EU and the UK, as well as the UK's growing demand for orthopaedic and hearing aid technologies.
• Türkiye: Exports surged by 139.1% to €561 million, albeit with notably high price volatility (coefficient of variation of 0.97).
• Russia: EU exports to Russia grew by 136.4% to €669 million, though geopolitical developments since 2022 may have disrupted this trajectory in ways not fully captured by the 2025 figures.

2.4 Intra-EU trade flows highlight the Netherlands as a key hub, with Poland emerging as a fast-growing exporter

Within the EU, the Netherlands has emerged as a dominant hub for CN 9021 trade, with both imports (+188.8%) and exports (+152.5%) growing at rates well above the EU average. The Netherlands' role likely reflects its position as a logistics and distribution centre, through which a significant share of EU medical device trade is routed.

Ireland is the EU's most specialised exporter in CN 9021, with a revealed symmetric comparative advantage (RSCA) of 0.64 and an export value of €4.9 billion in 2025. Ireland's dominance is driven by the presence of major multinational medical device manufacturers, particularly in the hearing aid and implantable device segments.

Poland has recorded the most dramatic growth among EU member states, with exports increasing by 541.6% — from €197 million to €1.3 billion. This extraordinary expansion positions Poland as an increasingly important production and export base within the European medical device ecosystem, likely reflecting lower labour costs, EU structural funds, and the relocation of manufacturing capacity from Western Europe.

3. Product-level dynamics: high-value implants and hearing aids drive the value premium, while orthopaedic appliances dominate volumes

3.1 The product mix is highly heterogeneous, with extreme price disparities across subcategories

CN 9021 is a broad heading encompassing products with vastly different characteristics, production processes, and price points. The segment breakdown reveals striking price differentials. For example, in 2025, EU export prices ranged from approximately €7,719 per kilogram for pacemakers (CN 902150) to around €285 per kilogram for artificial teeth (CN 902121). This heterogeneity underscores the importance of disaggregated analysis when interpreting aggregate trade trends.

3.2 Orthopaedic appliances (CN 902110) are the largest import category by volume, but with relatively low unit values

Orthopaedic and fracture appliances (CN 902110) represent the single largest import category by weight, accounting for 30,233 tonnes in 2025 — up from 18,184 tonnes in 2015 (+66.3%). However, the unit value of these imports remains relatively low (€77,728 per tonne in 2025), consistent with the importation of commodity-grade braces, supports, and basic orthopaedic devices, many of which are manufactured in Asia.

On the export side, CN 902110 volumes grew more modestly (from 5,099 to 5,850 tonnes, +14.7%), but export prices were significantly higher (€317,323 per tonne in 2025), suggesting that EU exports in this category are concentrated in higher-specification products such as advanced fracture fixation systems and custom orthopaedic implants.

3.3 Artificial joints (CN 902131) and other body parts (CN 902139) have seen strong export growth

Artificial joints (CN 902131) are a critical subcategory for the EU, reflecting the bloc's strengths in implantable medical devices. EU exports of artificial joints grew from €2.8 billion to €5.8 billion (+109.7%) over the period, with volumes rising from 3,379 to 5,667 tonnes (+67.7%). This combination of volume and value growth reflects both expanding global demand for joint replacement procedures and the EU's technological leadership in this segment.

Other artificial body parts (CN 902139) also performed strongly, with exports rising from €2.0 billion to €3.7 billion (+83.7%). Notably, export prices in this category increased from €748,311 to €917,008 per tonne (+22.6%), consistent with a shift towards more complex and higher-value prosthetic and implantable devices.

3.4 Hearing aids and pacemakers represent high-value niches with distinct trade profiles

Hearing aids (CN 902140) and pacemakers (CN 902150) are characterised by extremely high unit values, reflecting the technological intensity and regulatory requirements of these product categories. EU hearing aid imports were valued at €731 million in 2025, with a supplementary quantity of 10.9 million units. The decline in per-unit import prices (from €116 to €67 per unit) over the decade suggests increased competition from Asian manufacturers and the proliferation of lower-cost hearing aid models.

Pacemaker exports (CN 902150) totalled €2.4 billion in 2025, with 1.2 million units exported at an average price of €1,993 per unit — down significantly from €2,929 per unit in 2015. This decline in unit export prices may reflect the maturation of pacemaker technology and increasing price competition, even as volumes have more than doubled.

3.5 EU production has shifted decisively towards value, with volumes declining sharply

The most dramatic structural shift revealed by the data is in EU production. Production volumes (measured in items) collapsed from 216 million units in 2015 to just 86 million units in 2025 (–60.2%), while production values surged from €9.4 billion to €24.1 billion (+156.9%).

This stark divergence implies that the average value per produced item has more than tripled over the decade. The most plausible explanation is a strategic reorientation of EU manufacturing towards higher-value, lower-volume products — such as advanced implants, custom prosthetics, and premium hearing aids — while production of lower-value, higher-volume items (such as basic orthopaedic supports and disposable medical devices) has been relocated to lower-cost jurisdictions, particularly in Asia.

This production shift aligns with the observed trade dynamics: the EU imports growing volumes of lower-value products (particularly from China and Vietnam) while simultaneously ramping up exports of high-value devices. The result is a structurally transformed industry that competes on innovation and quality rather than cost.

Conclusion

Over the period 2015–2025, the EU's trade in orthopaedic appliances (CN 9021) has undergone a profound transformation. The bloc has evolved from a position of modest net import reliance to one of substantial net export strength, with the trade surplus more than doubling to €6.9 billion. This shift has been driven not by volume expansion alone, but by a decisive move up the value chain: EU export prices rose by 42.5% over the decade, while import prices increased by only 11.1%.

The geographic landscape of trade has also been redrawn. Asian suppliers — particularly China and Vietnam — have rapidly expanded their share of EU imports, contributing to a more diversified (though not necessarily less vulnerable) import base. On the export side, the EU has broadened its customer base, with strong growth in the UK, Türkiye, and several emerging markets, even as the United States remains the dominant partner.

At the product level, the data reveals a clear pattern of specialisation. EU production volumes have declined by 60.2%, while production values have surged by 156.9%, indicating a strategic pivot towards high-value implants, hearing aids, and advanced prosthetics. This transformation positions the EU as a global leader in premium medical devices, but also exposes the bloc to risks associated with reliance on imported components and finished goods for lower market segments.

Looking ahead, the sector's trajectory will likely be shaped by several factors: the pace of technological innovation in implantable devices and hearing aids, the evolution of regulatory frameworks (particularly the EU Medical Device Regulation), supply chain resilience considerations in the wake of recent global disruptions, and the competitive challenge from an increasingly capable Asian manufacturing base. The data suggests that the EU's strategy of competing on value rather than volume has served it well over the past decade, but maintaining this advantage will require continued investment in research, quality, and innovation.