Germany - Country Commercial Guide
Healthcare and Medical Technology

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2020-10-07

Overview

Germany has a very robust and well-established medical equipment market. Brands such as Siemens, Carl Zeiss and Draegerwerk were founded at the end of the 19th century and vouch for the long history of producing high quality medical equipment, with an emphasis on diagnostic imaging; precision medical and dental instruments; and optical technologies.  Germany claims the third-largest medical technology market in the world after the United States and Japan, and it 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 ranked no. 1 in Commerce’s Medical Device Top Market Report and still is one of the most lucrative healthcare markets worldwide.

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 scheduled to launch on Jan. 1, 2021, also has a focus on health and health sector related R&D and innovation.  Projects will focus on conquering cancer; smart health and 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.  On the downside, the German healthcare system, because of its decentralized and self-governing structure, is somewhat complex and slow in adapting new trends.  German health minister Jens Spahn is determined to move the German health system into the digital age and has amended the regulatory environment with a number of 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.

Medical Technologies (MED) is the key sector of the HCT industry. The U.S. is home to the world’s leading medical device manufacturers.  One in eight Americans is employed by the U.S. healthcare industry; there are 16 million medical-related jobs, with about $2.7 trillion in profits annually, according to U.S. Bureau of Labor Statistics.  Roughly 90 percent of the over 7,000 medical device manufacturers are often export-ready SMEs, and many of the world’s largest medical device manufacturers such as GE Healthcare, Medtronic, 3M, Abbott, Thermo Fisher are U.S.-based. Germany is Europe’s largest market for medical devices, accounting for roughly $37 billion annually, or 27.1 percent of the European market total.  Key industry drivers include the power of innovation, a solid financial basis of the industry (80 percent of which are SMEs) and a vibrant startup scene, all based on a strong German economy and a commitment to a high-quality health system.  Within the EU, Germany is the largest importer as well as exporter of medical devices (source: Medtech Europe, Facts & Figures 2020). All major U.S. suppliers, such as GE Healthcare, Johnson & Johnson; Becton Dickinson; Abbott; Abbvie; ThermoFisher Scientific; Stryker; Zimmer; 3M; McKesson; Cardinal Health; Henry Schein; and Medline, to name a few, have subsidiaries in Germany.  U.S. medical device exporters continue to hold a 35-40 percent share of the German import market.

Germany has a strong healthcare system, especially with regards to infrastructure, hospital beds and trained staff.  In 2018, there were 498,400 beds in 1,925 hospitals (around 552 public hospitals, 652 non-profit and 721 private hospitals); 1,142 rehabilitation centers; and 19,075 pharmacies (source: www.statista.de ). Well-established infrastructure makes the healthcare industry the largest employer in Germany with currently 5.6 million employees (source: Health Ministry), or under a broader definition of the German Economics Ministry, 7.6 million, 16.6% of the labor market total. One out of six jobs in Germany is linked to the healthcare sector, which generates an economic footprint of $775 billion ($429 billion attributed direct), or roughly 12 percent of Germany’s gross natural product; and with $150 million, contributes 8.4 percent to Germany’s export total (source: BMWi). The German medical device market grew by 4.1 percent in 2018, and 4.0 percent in 2019, and is expected to continue with 4-6 percent growth rates through 2021 (BVMed estimate), as the health economy is digitalized and the double digit investment backlog in the hospital market is attacked.  Business Monitor analysts even estimate the German medical devices market to grow a CAGR of 7.1% between 2018-2023.

Response to Covid-19

The unforeseeable coronavirus outbreak, COVID-19, has affected the medtech industry in Germany in multiple ways, particularly as listed below.

  • The start date of the Medical Device Regulation has been postponed by 12 months to May 26, 2021. Note, the In-Vitro Medical Devices Regulation application date, May 26, 2022 to date remains unaffected.
  • On April 3, 2020, the EU Commission announced temporary suspension of custom duties and VAT for medical equipment in order to aid EU Member States in receiving necessary protective equipment and medical devices including masks, protective gear, testing kits, ventilators, and other medical equipment. Tariffs will be waived for four months with a possibility for further extension.
  • The EU Commission has published guidance in order to outline temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions to ensure the availability of safe medical devices and the prevention of shortages. 
  • Medical and non-medtech related enterprises have redirected productions to meet the surging demand for personal protective equipment and vaccines.
  • The market saw new cross-tech market entrants, such as automotive and general industrial manufacturers, general textile manufacturers and general online platform providers such as Amazon and Alibaba, entering the health technology markets with Covid-19 products and solutions and set to stay in the healthcare arena, disrupting the previously rather consolidated market with new players and business models.
  • Major medical/digital health/biotech trade shows have been postponed, converted into virtual format or canceled.

Market Entry and Best Practices

The German market for medical devices is regulated by German and European Union (EU) directives, standards, and safety regulations. The EU Medical Device Regulation (MDR), with increased testing, certification and compliance requirements, has been postponed by a year to take effect on May 26, 2021, as a result of the Covid-19 pandemic and industry pressure. The complementary In Vitro Diagnostic Regulation will come into effect in May 2022. 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. 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.  Further information is available in Commerce’s Global Markets Healthcare Team’s annual Healthcare Resource Guide.

Germany hosts the world’s largest annual HCT trade show, MEDICA, making Germany a premier marketplace for U.S. companies to reach their global partners and buyers. The U.S. HCT industry, represented by 500+ U.S. exhibitors, converge every year for the 4-day long MEDICA trade show to sell to Europe and the rest of the world.

The German Medical Equipment Market 2018-2021 (USD billion)

 

2018

2019

2020 (proj.)

2021 (proj.)

Market Size

33.2

35.0

36.9

39.0

Local Production

34.9

37.6

40.5

43.6

Imports

19.9

20.2

20.5

20.8

Exports

21.6

22.8

24.1

25.4

Imports from the U.S.

4.3

4.9

5

5.1

Total Market Size = (Total Local Production + Total Imports) – (Total Exports)

Data Sources: Spectaris Trade Association; BVMED Trade Association; Medtech Europe; Statista (German Federal Statistics Office)

General statistics on Germany is available by the German Federal Statistics Office.

Leading Sub-Sectors

Leading HCT sectors include: Health IT, pharmaceuticals, dental products, and biotechnology.

Health IT:  Under the current German EU Council presidency, July 1-December 31, 2020, the German Health Ministry and its agency, Health Innovation Hub (www.hih-2025.de/en/ ), are ambitiously implementing the digital care law and digital health solutions, called “DiGA”.  DiGA Fast Track is Germany’s path for digital health solutions to get access to the German statutory health system, reaching over 75 million German citizens insured under the mandatory health insurance.  The German Health Ministry’s subordinate agency, the Federal Institute for Drugs and Pharmaceuticals, BfArM (German equivalent to the FDA) is talking online applications for DiGAs and once approved, DiGAs can be prescribed by any German physician.  DiGA providers will be reimbursed by German insurance funds.  Likewise, the telematics infrastructure including 5G rollout, is being developed at a dramatic pace, and the electronic medical record (in German: ePA) is taking shape and a mandatory right of every citizen as of January 1, 2021.  E-medication is also on its way, with the new paragraph 360 of Germany’s SGB V social law, relating to the Patient Data Protection Act (PDSG). It mandates doctors and dentists to issue prescriptions in digital format from January 1, 2022.  The law also makes it clear that even with digital prescriptions, the free choice of pharmacy of the insured remains and neither health insurance funds nor contract physicians have a right to assign or influence here. These developments will be decisive for Germany to catch up to its EU neighbors and will present excellent opportunities for U.S. HealthIT providers. HealthIT applications currently represent more than $450 million, with numerous projects throughout Germany and a University Hospital excellency network which drives innovation in treating key diseases such as stroke, Alzheimer’s, cancer and diabetes.  An ageing society (with significant share of chronic disease), rollout of e-health patient portals by public health plan providers and high Internet and mobile phone penetration, make Germany a strong HealthIT market and offers valuable potential to specialty solution providers.  The digital health ecosystem in Germany will be driven by:  Cloud computing solutions; Artificial Intelligence (AI), Robotics, Sensors, Big data analytics; and the Internet of Medical Things (IoMT).  The German Ministry of Health maintains a website on digitalization in healthcare; the German Ministry of Education and Research maintains a website on the medical informatics initiative. Costs associated with the purchase of the SNOMED CT license will amount to approximately 1.6 million Euros in 2021, which will be administered by the Federal Institute for Drugs and Medical Devices (BfArM).

Germany has an excellent base for HealthIT, with over 80 percent of its workforce holding a degree and a startup-friendly environment. This makes it a very strong market for m-health and e-health products and services. The strong German medical technology clusters develop telehealth and telemedicine solutions and form excellency clusters for oncology, neurological disorders, and chronic disease management in cooperation with hospitals and industry. The German government’s medical informatics initiative aims at improving medical R&D and patient care through innovative IT solutions for specific applications and integrated health data centers. This multi-million-dollar funding resource should pose excellent opportunities for U.S. solutions providers. E-procurement and e-commerce, Machine-to Machine communication (M2M), mHealth/apps and big data applications are areas of digitalization, in addition to telehealth and telemedicine, with windows of opportunity for U.S. suppliers.  It is strongly recommended to open an office in Germany or work with a knowledgeable partner to enter the German HealthIT market, which is dominated by some large players in the various segments, i.e. Compugroup, Cerner, Siemens Healthineers, to name a few. 

The German pharmaceutical market was valued at USD 69.7 billion in 2019 and remains one of the most attractive worldwide over the coming years. It accounted for 15.5 percent of total health expenditures and 1.8 percent of GDP.  Annual per capita spending is above average at $835, with prescription medication contributing 69 percent to the total. According to market analysts, the German pharmaceutical market is expected to grow to by an average of 4.6 percent annually until 2022. Major growth drivers are the aging population and chronic diseases.  Germany counts over 520 pharmaceutical companies; many global U.S. Corporations such as Pfizer; Eli Lilly; Abbott; and others have production facilities in Germany; Germany is regarded as a test market for other EU countries for pricing and distribution and it is a good location for API (active pharmaceutical ingredients) production. In 2018, the German pharmaceutical industry manufactured products worth $41.9 billion, an increase of 18% over the previous year. Exports of pharmaceuticals increased by 10.3 percent, generating sales of $96.5 billion, while imports were up by 8.1 percent to $66 billion in the same period.

Biopharmaceuticals: Sales of biopharmaceuticals in 2019 (pharmacies and hospital market) increased by 13 percent to $14.3 billion compared to 2018. The market share in the total pharmaceutical market rose from 27.1 percent to 28.7 percent. Growth was seen in nearly all fields of application. Among current focus areas are ATMPs (Advanced Therapy Medicinal Products), such as gene therapy products, cell therapy products, and tissue engineered products. Compared to classical medicines, where the active substance consists of a chemical molecule or protein, ATMPs are nucleic acids (such as genes) or can be whole cells or tissues. While classical medicines for the treatment of hereditary diseases usually require life-long use, ATMPs could achieve long-lasting therapeutic efficacy, possibly even a cure, after one use. The German term for ATMPs translates to ‘novel therapies’ and emphasizes the innovation aspect, which is reflected in their development, production, approval and market access, and reimbursement process.

Medical Biotechnology: Germany is Europe’s largest biotechnology market. In 2019, 686 dedicated* biotechnology companies (+3 percent to 2018) generated sales of $5.5 billion, a 10 percent growth over 2018. The number of employees in the biotech industry increased to 33,706, up 16 percent. This significant market growth is largely attributable to the key players listed on the stock exchange: among Germany’s dedicated biotech firms, the 23 listed companies generated roughly 46% of overall industry sales. Of these, major players QIAGEN, Evotec, and BioNTech alone contributed 40 percent to the market sales total. R&D spending registered $2 billion, an increase of 21 percent over 2018. Growth in spending was again attributable to the small number of listed companies (up 58 percent), while privately held firms recorded a minimal increase in R&D of 1 percent.  Growth sectors in Germany’s biotech industry continue to focus on new drug development and diagnostics, such as early disease detection.  In-vitro diagnostics are an important growth driver in the market, with more than two-thirds of all clinical diagnoses being made through IVDs.  With more than $2.3 billion in annual sales, Germany represents the largest IVD market in Europe and second worldwide behind the USA. Germany’s biotech clusters are Europe’s leading research and development hubs, and important partners for industry/academic R&D and technology transfer. Biotech is strong in Bavaria; North Rhine-Westfalen; Baden-Wuerttemberg; and the Berlin-Brandenburg region.  Some of the largest and most reputed clusters are in the Rhine-Neckar Triangle (Heidelberg), Cologne/Dusseldorf, Berlin/Brandenburg and Munich. Biotech is a priority for EU and German Governments and is central to Germany’s innovation and high-tech policies. Biotech action plans focus on diagnostics, therapy and preventive medicine in bio-medical research and care; and research-based bio-medical technologies in specialized clusters. Germany’s participation at the BioEurope trade show, and in the world’s leading annual biotech event, BIO Convention, in the United States, with an official Germany pavilion, shows the commitment and close transatlantic ties in this health tech subsector.  

(*is defined as a biotechnology active firm whose predominant activity involves the application of biotechnology techniques to produce goods or services and/or the performance of biotechnology R&D.)

Dental products: Germany is Europe’s largest market for dental equipment valued at $13.5 billion in 2019.  Total sales of dental products from 200 mostly medium-sized member companies of the Association of German Dental Industry (VDDI) amounted to $5.6 billion in 2019 (up 4.1 percent over 2018) and an export share of 63 percent with $3.3 billion.  These firms represent 85-90 percent of the German dental market and employ more than 21,300 people.  The Federal Dentists Chamber, BZAEK, expects the workforce in the dental industry to increase by 18.6 percent in the period 2010-2030, from 410,000 to 486,000 employees. This includes dentists’ offices; dental labs; and the trade with dental products.  The 2018-2023 CAGR market growth is estimated at 6.0 percent by BMI analysts.

Digitization with advanced 3D imaging and printing, the use of CAD/CAM systems and robotics as well as innovation in dental materials and minimally invasive techniques have a major impact on market development. Another key factor contributing to the upswing of Germany’s dental market is the growing dental health awareness among its population and an increasing willingness and ability to pay for preventative and corrective treatments.

U.S. exports to Germany amounted to $115 million for dental equipment and supplies, and $50.5 million for dental laboratory products in 2019. Over 200 U.S. companies are actively exporting, with heavyweights Henry Schein, Danaher Corp. and Dentsply Sirona holding a direct presence and major market share. The major U.S. dental technology supplier Henry Schein is one of the largest distributors in Germany’s dental market, with annual sales of more than $124 million and an estimated 11 percent market share in 2019. 

The United States is a technology leader and is competing with Germany in large markets such as China and India.  Both the U.S. and Germany have branded for top quality products and innovative technologies and have strong trade ties.  Traditionally the leading global trade fair for the dental community, the (IDS) in Cologne proves to be an arena where both the U.S. and Germany demonstrate strength and forge further ties in R&D and trade, in view of increasing Chinese competition. Staged biennially, the U.S. dental industry is represented by 200+ U.S. exhibitors in two USA Pavilions and independent exhibits; this number has remained solid over the past ten years with 15-20 percent newcomers at every show. 

Policy Objectives and Challenges

The Commercial Service is working to evaluate the broad impact of the German EU Council presidency respective health policy goals, as follows:

  • Europe to find ways to re-shore the manufacture of essential medicinal products and medical devices (such as face masks) to Europe and build a European stockpile;
  • Europe to become more attractive for research. This requires data. Europe to drive the creation of a European health data space and a respective code of conduct for dealing with patient data.
  • European public health organizations such as ECDC and EMA to be strengthened to allow them to work on equal terms with their U.S. counterparts.

We collaborate with the local MED cluster and their members on EU and German trade policies such as the MDR, IVDR, the SPC-Supplementary Protection Certificate for manufacturing pharma, IP and cybersecurity issues, with a focus on SMEs and countering malign third-country influence. We also report major procurement deals and opportunities to U.S. businesses and encourage a positive outlook on transatlantic trade among industry contacts we meet at events and in the context of partner search outreach.   An International Patient Day event in 2021 will raise awareness for innovation-based U.S. patient care solutions.

A short overview of the state-of-play of joint assessments of notified bodies in the medical device sector is available now from the European Commission’s webpage “Medical Devices - Sector - New Regulations - Implementing measures for Regulations”: https://lnkd.in/eg_NiQK

We are following the latest healthcare policy developments and discussions in Germany, and work with U.S. associations, such as the Advanced Medical Technology Association and PhRMA-Pharmaceutical Research-based Manufacturers Association based in Washington to ensure fair access, standards interoperability and IP protection for U.S. firms to and in the German and European markets.

Opportunities

Germany’s healthcare market offers more than just agents and distributors; it has various opportunities along the value supply chain route: design and research and development collaboration; strategic partnerships; equity partner and investor engagements; mergers and acquisitions; project collaboration, and other types of opportunities for SMEs to grow business and expand in the market. For example, the U.S. National Cancer Institute plans to promote the NIH’s Cancer Institute’s clinical study capabilities and resources to innovative German life science startups during a road show and virtual events in 2021.  Combining the resources of NIH and the networks of the German life science clusters, we will see a unique and powerful partnership that will bring the most innovative and brightest solutions to the U.S. market, and help both economies to grow and create jobs.  Likewise, the formation of a U.S. Digital Health Forum by the U.S. Commercial Service in partnership with a major German digital health platform has opened the door to a number of U.S. digital health solution providers, who have forged relationships with university hospitals in Germany.

The German government’s health informatics funding initiative and the German states’ initiatives on healthcare digitization offer prime opportunities for U.S. firms to engage in Germany. An example would be a procurement for NRW Public Hospitals to re-organize their system and reconstruct and upgrade existing facilities. In a four-year span, U.S. companies will have the opportunity to participate in consortia or as sub-contractors.

The German Government’s “Medical Informatics” funding scheme as part of the Health Research Framework Program offers an aging society where diseases like cancer, dementia and various cardiovascular, metabolic and muscular ailments will become more prevalent, to improve the exchange of data across different institutions and locations. The aim is that faster diagnoses and treatments will help to cut costs and help individuals receive faster and more precise care.

For more information on procurements you can get involved in, please contact us via www.trade.gov/germany to be added to a regular email of tender opportunities,  or visit http://ted.europa.eu/TED/main/HomePage.do  

Resources

Trade Events

BIO International Convention, Boston, June 14-17, 2021

HIMSS 20 – Health 2.0, Digital, September 7-11, 2020

American Hospital Association Leadership Summit, Virtual Conference, September 14-16, 2020

American Association for Clinical Chemistry: AACC Annual Meeting, Chicago, December 13-17, 2020

Rehacare, Dusseldorf, October 6-9, 2021

Expopharm, Dusseldorf, September 22-25, 2021

The virtual MEDTECH Conference, On Demand: Sep 8-Oct 23, 2020; Livestream: Oct 5-7, 2020

Bio-Europe, Digital, October 26-29, 2020

Medica, Dusseldorf, November 16-19, 2020

Analytica, Munich, October 19-22, 2020

Greater New York Dental Meeting, New York, November 27 – December 2, 2020  

International Dental Show (IDS), Cologne, March 9-13, 2021

DMEA, Berlin, April 13-15, 2021

Local Associations

BVMED

ZVEI Health Pages

Spectaris

DKGEV

BVITG

BiM

Government Links

Private provider for tender information

Government Health Plans:

International Federation of Health Plans

Association of Public Health Plan Providers