Market evolution: Insulin preparations (CN 300431) — 2015–2025

Introduction

This report examines the trade dynamics of CN 300431 — medicaments containing insulin (excluding antibiotics), put up in measured doses or retail packaging — traded by the European Union with non-EU countries over the period 2015–2025. The data reveal a dramatic transformation of the EU's position in the global insulin market. What was once a dominant export industry generating over €5.7 billion annually has contracted to under €860 million, while imports have more than tripled. Yet these headline figures mask a complex story of price collapse, geographic reorientation, and internal restructuring across EU member states. The sections that follow unpack these dynamics in detail.

I. The price-driven collapse of EU insulin exports

The most striking feature of the 2015–2025 period is the precipitous decline in the EU's export value for insulin preparations. Total export value fell by 85.1%, from €5.75 billion in 2015 to €856 million in 2025. Crucially, this was overwhelmingly a price phenomenon: export volumes declined by only 20.7%, while unit export prices plunged by 81.2%.

Unit prices tell the real story

The collapse in unit prices — from nearly €783,000 per tonne to under €147,000 per tonne — points to structural market changes. The expiry of patents on major insulin products (such as Sanofi's Lantus/insulin glargine, which lost key patent protection around 2015) and the subsequent rise of biosimilar competition are the most likely explanations for this dramatic repricing.

The United States: from dominant market to residual destination

The decline in export value was concentrated overwhelmingly in one partner: the United States. EU exports to the US fell from €3.68 billion to €272 million (−92.6%). In 2015, the US accounted for roughly 64% of all EU insulin exports by value; by 2025, its share had fallen to approximately 32%.

This concentration made the EU's export profile exceptionally vulnerable to a single-market shock. The export HHI (Herfindahl–Hirschman Index) fell from 4,179 to 1,295 (−69%), reflecting not a strategic diversification but rather the collapse of the dominant US-bound flow.

Other traditional export markets also contracted significantly:

The United Kingdom was the most resilient major destination, with a comparatively moderate decline of 42.7%, likely reflecting regulatory and supply-chain proximity as well as post-Brexit trade adjustments.

A persistently positive but shrinking trade surplus

The EU's trade balance in insulin preparations remained positive throughout the period, declining from €5.67 billion to €614 million (−89.2%). The net import reliance stayed deeply negative (from −87.2% to −103.3%), confirming that the EU remained a net exporter, but the margin of self-sufficiency narrowed considerably.

II. The surge in imports and the rise of China as a dominant supplier

While exports contracted, EU imports of insulin preparations moved in the opposite direction. Import value more than tripled, rising from €78 million in 2015 to €242 million in 2025 (+211.7%). Import volumes grew by 72.6% while unit import prices rose by 80.7%.

China's meteoric rise

The single most significant shift in the import landscape was the emergence of China as the EU's dominant insulin supplier. In 2015, Chinese exports of insulin preparations to the EU were negligible (€2,472). By 2025, they had surged to €207 million — representing roughly 85% of all EU insulin imports by value.

China's rise was accompanied by extreme price volatility (coefficient of variation 1.36), with a major price shock detected in 2017 (abnormality score 931.1, value shift of 292%). This suggests that Chinese insulin production scaled up rapidly, with initial pricing highly variable before stabilising at scale.

Simultaneously, traditional suppliers lost ground. US imports fell by 78.5%, and imports from the United Kingdom collapsed by 99.7% (from €25 million to €75,000), likely reflecting the impact of Brexit-related regulatory divergence.

Increasing import concentration

Despite the diversification of the supplier base in terms of number of countries, import concentration actually increased: the import HHI rose from 5,245 to 7,360 (+40.3%). This apparent paradox is explained by the sheer dominance of China, which single-handedly accounts for the bulk of the higher concentration. The EU's import dependency shifted from a diversified set of Western partners to a structure heavily reliant on a single new entrant.

Which EU countries absorbed the import surge?

Not all EU member states contributed equally to the import growth. France was the primary driver, with imports surging from €7.7 million to €218 million (+2,726%). The Netherlands also saw significant growth (from €1.5 million to €15 million). By contrast, Spain, Ireland, and Czechia saw their import activity collapse, suggesting a consolidation of import gateways within the EU.

III. Internal restructuring: a new geography of EU insulin production and exports

Beneath the headline trade figures lies a profound restructuring of the EU's internal geography of insulin production and export. Traditional pharmaceutical powerhouses have seen their export dominance erode, while several smaller member states have emerged as major exporters.

Germany and France: the old guard in retreat

In 2015, Germany and France together accounted for over €5.6 billion in insulin exports — nearly 98% of the EU total. By 2025, their combined exports had fallen to €663 million (−88%). Germany's exports dropped from €4.27 billion to €525 million (−87.7%), and France's from €1.35 billion to €138 million (−89.8%).

Yet EU production value grew modestly, from €2.8 billion to €3.38 billion (+20.7%). This implies that the decline in export values reflected lower unit prices rather than a collapse in production — the EU was producing more insulin but earning far less per unit in international markets.

New export hubs: Hungary, Poland, Slovenia, and Belgium

While Germany and France retrenched, several smaller EU members rapidly expanded their export footprints:

These four countries collectively exported €146 million in 2025 — still a fraction of Germany's output, but their rapid growth suggests that insulin manufacturing and/or packaging capacity has been relocating within the EU, likely driven by cost advantages and supply-chain optimisation.

Specialisation patterns confirm the shift

The revealed comparative advantage (RCA) and RSCA indicators for 2025 paint a clear picture:

France remains the most specialised EU insulin exporter by far, with an RCA of 9.24, though this may partly reflect the denominator effect of a smaller overall export base. Germany, despite being the largest exporter in absolute terms, shows a below-average RCA (0.62), indicating that insulin is a relatively minor share of its overall pharmaceutical export basket.

Poland's case is instructive: despite rapid absolute growth in insulin exports, its RCA is near zero (0.0004), meaning insulin remains a negligible fraction of its total exports. Its export growth likely reflects contract manufacturing or intra-company transfers rather than a deliberate national specialisation.

Trade intensity remains high and stable

The EU's trade intensity for insulin preparations stood at 53.7% in 2025 (up from 49.4% in 2015), while export propensity rose to 52.8% (from 48.5%). These figures indicate that the EU remains deeply integrated into global insulin trade — a situation that, given the essential nature of insulin for millions of patients, carries both opportunities and vulnerabilities.

Conclusion

The EU's insulin market (CN 300431) underwent a fundamental transformation between 2015 and 2025. The era of high-value, patent-protected insulin exports — concentrated in Germany and France and directed overwhelmingly at the United States — came to a decisive end. The primary driver was a collapse in unit prices (-81%), consistent with the wave of patent expirations and biosimilar entry that swept the global insulin market during this period.

Simultaneously, the EU's import profile was reshaped by China's emergence as the overwhelmingly dominant external supplier, rising from virtually zero to €207 million and accounting for 85% of all insulin imports. This concentration of supply in a single country represents a new vulnerability that contrasts with the relatively diversified import base of 2015.

Within the EU, production and export capacity underwent a geographic redistribution. While Germany and France saw their export values collapse by nearly 90%, smaller member states — notably Hungary, Poland, Slovenia, and Belgium — scaled up rapidly, suggesting a shift in manufacturing, packaging, or distribution footprints. EU production value itself grew modestly, confirming that the problem was not a loss of productive capacity but a repricing of the global insulin market.

Looking ahead, the key questions for EU policymakers relate to supply-chain resilience (particularly regarding dependence on Chinese imports), the competitive positioning of European insulin producers in a biosimilar-dominated market, and the implications of this restructuring for pharmaceutical security of supply.