Germany - Country Commercial Guide
Healthcare and Medical Technology
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Overview

Note: Further and more detailed information on the German healthcare market is available in Commerce’s Global Markets Healthcare Team’s annual Healthcare Technologies Resource Guide.

Germany claims the third-largest medical technology market in the world after the United States and Japan and is by far the largest European market, twice the size of the French market and three times as large as those of Italy, the United Kingdom and Spain. The German medical device market is one of the most lucrative healthcare markets worldwide, accounting for roughly USD 42 billion annually, or 25 percent of the European market total.

Germany has a strong healthcare system, especially with regards to infrastructure, hospital beds and trained staff. One out of six jobs in Germany are linked to the healthcare sector, which generates an economic footprint of EUR 775 billion (USD 883 billion), or roughly 12 percent of Germany’s GDP. In 2022, the gross value added of the healthcare industry was EUR 439.6 billion. This corresponds to 12.7 percent of the gross value added of the overall German economy. In 2022, almost 8.1 million people were employed in the healthcare industry, or 17.7 percent of the total workforce in Germany. Since 2013, the number of people employed in the healthcare industry has risen by 1.4 million.

With EUR 186 billion (USD 202 billion) generated through foreign sales, HC contributes 9.8 percent to Germany’s total exports in 2022 (source: Federal Economics Ministry, BMWK). HC imports were at EUR 154 billion (USD 167). According to estimates by Fitch Solutions, the expected CAGR of the German medical equipment market for 2020-2025 is 5.1 percent in Euro-terms and 6.8 percent in USD-terms. Growth factors include the digitalization of the health economy and tackling the double-digit investment backlog in the hospital market with the funds allocated by the Hospital Future Act. This law was enacted in October 2020 providing EUR 3 billion (USD 3.5 billion) of federal funding and additional EUR 1.3 billion (USD 1.4 billion) of state funding to modernize and digitalize the German hospital system.

The Healthcare/Life Sciences (HCT) industry is a priority for both the EU and Germany as reflected in the European Regional Development Fund (ERDF – or EFRE, in German) program and cohesion policy 2021-2027, as well as the German Länder implementation and tendering of this program. “Horizon Europe”, a European Incentive Program for Research and Innovation agreed upon by the EU Council and Parliament and retroactively entered into force on January 1, 2021, after final adoption in April 2021, also focuses on health and health-sector-related R&D and innovation. Projects target conquering cancer, smart health, aging, and digital models of care. All of this aims to increase opportunities for U.S. suppliers to participate in healthcare infrastructure, hospital development projects and to partner with German and EU firms. However, the German healthcare system, because of its decentralized and self-governing structure, is complex and slow in adapting new trends. German health ministry officials are determined to move the German health system into the digital age and have amended the regulatory environment with several laws to mandate progress. This will offer excellent export and partnering opportunities for innovative U.S. health solution providers throughout the health technologies supply chain.

The German market for medical devices is regulated by German and EU directives, standards, and safety regulations. After a one-year delay of the start date of the EU Medical Device Regulation (MDR), which introduced increased testing, certification and compliance requirements, this regulatory framework came into full effect on May 26, 2021. The complementary In Vitro Diagnostic Regulation came into effect on May 26, 2022. Unlike EU directives, regulations do not need to be transposed into national law. The MDR and the IVDR will therefore limit interpretation discrepancies across the EU market. U.S. exporters are well-advised to become informed about MDR and obtain public or private sector counseling and assistance of the possible impact of their market entry plans into Germany. Companies seeking market entry should also carefully map their distribution strategy depending on their target group(s). CE marking is mandatory for selling into Europe.  

Opportunities

Entry strategies to be considered are top-down or bottom-up marketing, picking the right partners and ensuring patient- and customer-centric system solutions and support. Most medical equipment imported into Germany is either sold directly through a local subsidiary with a field sales force, through medical distributors with an established distribution network (often on a regional/territorial basis) or through appointed agents or manufacturer representatives. Local representation or market presence is essential when considering differing standards and certifications, warehousing costs, maintenance, accessibility, and local marketing/sales preferences/discussions. An agency agreement is often a cost-effective mechanism to enter the market, but under German law – even if the agent’s performance is not satisfactory – it can be difficult and costly to terminate an exclusive arrangement. A representation or distributorship agreement may be more difficult to arrange, but the German associate will, in fact, purchase the product to be sold, thus sharing the market risk. Licensing, partnering with large corporate partners or buying a local firm provide alternatives in times where traditional distributors are bought up by corporates and the market increasingly consolidates.

Leading Sub-Sectors

Key sub-sectors include medical technologies (MED), health IT, diagnostic products, biopharmaceuticals, and dental products.  

Medical Technologies (MED) is the key sector of the healthcare industry. U.S. medical device exporters continue to hold a 30 percent share of the German import market. U.S. exporters with innovative and cost-competitive medical devices and products will find good opportunities. Key sub-segments include cardiac monitoring; diagnostics products, including genomic health solutions and products/applications for the aging German society; Oncology; and POC products. Health IT products and services have experienced strong growth in recent years, with opportunities particularly in artificial intelligence, cybersecurity, patient monitoring, medical apps, and digitalization solutions for hospitals/other healthcare institutions. 

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