1    www.gtai.de

Medical Technology

Europe’s Biggest Market

Demand for innovative medical technology solutions continues to grow as we live longer, healthier lives. In

2018 spending on medical technology in Germany reached an estimated record high of EUR 36 billion.

This creates growth opportunities for the medical technology industry, which in Germany is made up almost entirely

of small and medium-sized companies. The positive outlook in the domestic market, combined with strong exports of

“Medtech Made in Germany,” resulted in a 10.4 percent domestic industry turnover increase. The following informa­

tion is designed to help international manufacturers understand how to expand in the German healthcare sector as

well as outlining the range of support services provided by GTAI.

Germany Trade & Invest Protective Mask Production Report

Germany Trade & Invest has produced a market analysis of protective mask demand in Germany and the po­

tential opportunities in a market opening up to non-traditional producers.

Domestic demand between 8 and 12 billion protective masks annually

Germany Trade & Invest has produced a short market study of protective mask production in Germany. The Covid-19

pandemic has created annual demand for 2.5 billion protective masks within the German healthcare sector. To increase

supply for the general population, the federal government has set up a funding program to incentivize mask produc­

tion in order to reach 7 billion units by summer 2021. 

According to the market analysis compiled by Germany Trade & Invest’s Chemicals & Healthcare team, short-term de­

mand for protective masks in Germany could be as high as 8 to 12 billion per year subject to infection rate develop­

ment, future availability of medications and vaccines and legal obligations to wear professional protective equipment

as consequence. This breaks down for example to an annual minimum demand of 2 billion protective masks for gener­

al private use; minimum demand of 2.5 billion protective masks in the workplace; and minimum demand of 5 billion

protective masks in the public transport sector.

MEDICAL TECHNOLOGY

2    www.gtai.de

Increase in meltblown fleece production

An increase in local production of meltblown fleece by 4,000 tons annually is also envisioned as part of the plan to

combat the coronavirus. The strategy followed here is threefold;  combining increased local production with diversifi­

cation of international procurement as well as building up a limited national stockpile. Making the products available

within the entire EU is an additional imperative, with domestic self-sufficiency considerations giving way to mutual

support within the community in order to combat the global pandemic. 

German companies leading suppliers of production equipment

German manufacturers are leading suppliers of production equipment for meltblown nonwoven- and protective

masks, with the country enjoying a supply chain surplus of polypropylene necessary for mask production. Fleece ca­

pacity for 10 billion masks is forecast from summer/fall 2020, with capacity for 2.5 billion surgical masks units for

healthcare system demand also expected for the same period.

MEDICAL TECHNOLOGY

3    www.gtai.de

Fashion industry diversifying into mask production

Demand has led 40 percent of member companies in Germany’s textile and fashion industry association to diversify

into the protective mask sector, with a focus on textile barrier “community masks.” Non-traditional manufacturers of

protective masks are already recording sustainable returns – even in the case of small production lines. A temporary

exemption is also allowing surgical masks and PPE to be brought to market without CE certification after successful

fast-track testing. 

Protective mask market opportunities 

There are significant export and partnering opportunities available to international companies seeking to enter the

protective mask market. Germany is Europe’s leading medtech and PPE export nation – over 50 percent of exports go

to other EU member countries. Established and novel producers of protective masks can also enter into partnership

with a diverse range of equipment manufacturers, intermediate product suppliers, R&D establishments and technolo­

gy clusters as well as local authority initiatives. Manufacturers investing in mask production lines located in Germany

can benefit from attractive financial incentives and cash grants including 30 percent cash grant for short-term avail­

ability of CE-compliant surgical masks and FFP2/FFP3 masks up to a maximum of EUR 10 million per applicant.

Germany’s Medical and Research Actors Respond to Corona Crisis

The German medtech market is the largest in Europe with record spending of around EUR 38 billion in 2019.

With increased demand being created by the Covid-19 pandemic, this figure will be surpassed in 2020 and

subsequent years.

Hospitals to double number of ICU beds

Although a number of industry sectors will experience significant to minimal foreign direct investment decline as a re­

sult of the ongoing crisis, the healthcare sector will record an increase according to forecasts. 

Germany’s two thousand hospitals currently have a 500,000 bed capacity. Intensive care unit capacity has been in­

creased from 12,000 beds to 40,000 beds in recent weeks. German federal and state governments intend to further

double the number of ICU beds in a joint effort and require hospitals to take immediate action in an effort to prepare

for worst case pandemic scenarios.

Increased manufacturing capacity through diversification and partnering

Ventilators and personal protective equipment (PPE), specifically masks and gowns, are among those products most

desperately needed in hospitals. Current demand exceeds available supply even though many global players including

Drägerwerke, B. Braun and Siemens Healthineers are German in origin, and have significant on-site manufacturing ca­

pacity (as do international players including Johnson&Johnson, Hamilton et al). The European Commissioner for the In­

ternal Market has called for quick action beyond the traditional medtech industry, urging manufacturers to increase

and diversify production. Positive examples include textile and shoe manufacturers who have begun producing masks

and gowns. 

In Germany, textile manufacturers and even automobile industry suppliers have proven to be capable of diversifica­

tion by adapting their production lines to make new products like filtering face piece (FFP) masks. MAHLE, a specialist

for combustion engine technology and car air conditioning, is working with underwear maker Triumph to this end,

forecasting short-term output of 1.5 million FFP3 masks a month. 

MEDICAL TECHNOLOGY

4    www.gtai.de

Medtech clusters to set up special corona networks

Bringing together industry partners has been a key capability of Germany’s network of 30 medtech cluster networks

across the country. In the face of the Covid-19 epidemic, this infrastructure has proven invaluable. MedicalMountains

in Tuttlingen has set up the “Corona Drehscheibe” (Corona Hub), an online partnering platform specifically designed to

coordinate regional demand and supply, purchasing agencies and manufacturing capacities. The national medtech in­

dustry association BVMed and SPECTARIS – covering optical, photonic, analytics and medtech industries – are also

hosting Covid-19 specific information and partnering services.

New European Medical Device Regulation (MDR) to be postponed

EU and German legislators have taken immediate steps to guarantee uncomplicated procedures of conformity assess­

ment with the European Medical Device Directive MDD and national Medical Device Law MPG. On March 30, EU Com­

missioner Stella Kyriakides announced the intention to postpone the more scrutinous European Medical Device Regu­

lation MDR for one year until May 2021, the initiative yet to be confirmed and legalized by EU Commission and EU Par­

liament. Industry associations and manufacturers had previously voiced concerns at being able to comply with the

new regulation, thereby putting supply and patient safety at potential risk. 

Exemption of conformity assessment for masks and ethanol disinfectants

As well as putting the more strict legal system of conformity assessment for medical devices MDR on hold, very spe­

cific steps have been taken to ease restrictions on related products including FFP2 and FFP3 masks which are not legal­

ly considered medical products. PPE with regulatory compliance in countries including Canada, China, USA, and Japan

may now be marketed in Germany without undergoing the standard non-medical CE conformity assessment proce­

dure. Germany’s testing institutes DGUV (IFA) and DEKRA have installed an alternate quick testing process to provide

momentary exemption of CE-marking obligation where certified products are unavailable. Ethanol-based hand disin­

fectants have also been exempted from conformity assessment entirely, allowing pharmacies and manufacturers to

immediately market such products after notifying the appropriate agency (BAuA).

Centralized PPE procurement

Protective mask and gown procurement of the German federal government has been put under centralized manage­

ment by the Federal Ministry of Health. A general call for offers has been put in place online in an “open house” format

with fixed pricing, date and means of delivery all being mandatory elements for offers (priority granted for products

made in Germany). 

For further information on medical technology in Germany please contact our .

Video: Smart Hospitals in Germany

With aging populations and increasing demand for medical services, AI and other digital innovations are going to be­

come a crucial part of the healthcare of the future. 

industry specialists

MEDICAL TECHNOLOGY

5    www.gtai.de

Latest Publications

Industry Overview: The Medical Technology Industry in Germany

Germany is the world's third largest manufacturing nation with a share of 9,9 percent of worldwide medical technolo­

gy production.

 

 

Industry Overview: The Medical Technology Industry in Germany

MEDICAL TECHNOLOGY

6    www.gtai.de

The publication provides a countrywide overview of more than 30 specialized medical technology clusters. Germany's

clusters provide benefits along the entire value chain.

Facts & Figures

••••

THE GERMAN MEDICAL TECHNOLOGY INDUSTRY IN NUMBERS (2019)

Sales

33,4 bn

10,4% increase in 2019

Lead market in Europe

Exports

65% (21,9 bn) of the production are exported, 10,9% increase in 2019. Target markets::

European Union 41.1%

Europe (non-EU) 9.6%

North America 18.5%

Asia 18.7%

R&D Expenditure 9% of annual turnover in 2017

Employees > 143.000; 15% in R&D

Companies Structure: approx. 1.350 manufacturers, dominated by SME’s

Manufacturing and Innovation Clusters in Germany

Fact Sheet: Medical Technology Clusters in Germany

MEDICAL TECHNOLOGY

7    www.gtai.de

Bo m