GERMANY MEDICAL DEVICES MARKET

INTRODUCTION

All items used in healthcare for the diagnosis, prevention, monitoring, or treatment of a sickness or disability that accomplish their primary intended action through physical means are referred to as "medical devices."

There is a huge variety of products available, thousands of which are used daily by both patients and healthcare professionals.

Pregnancy tests, blood glucose monitors, pacemakers, hospital beds, radiotherapy equipment, surgical instruments, syringes, contact lenses, walking frames, condoms, heart valves, resuscitators, and other assistive technology devices.

Some gadgets may contain a medication that has an additional effect. A medical device of this type can be a coronary stent that releases drugs. In vitro diagnostic (IVD) medical devices are included in the scope of medical device regulation.

Any medical device that is used alone or in combination and that is intended by the manufacturer to be used in vitro to provide information on, for example, a physiological or pathological state or to monitor therapeutic measures is considered an IVD medical device.

This includes reagents, reagent products, calibrators, control materials, instruments, and apparatus. These include urinalysis test strips, specimen containers, and pregnancy test kits (such as blood collection tubes).

The foundational area of the healthcare sector is medical technologies (MED). Every significant American supplier has a presence in Germany, including GE Healthcare, Johnson & Johnson, Becton Dickinson, Abbott, Abbvie, Thermo Fisher Scientific, Stryker, Zimmer, 3M, McKesson, Cardinal Health, and Henry Schein, to mention a few. Germany is one of the biggest importers and exporters of medical devices within the EU.

The German market offers a stable political, economic, and regulatory framework and is distinguished by fair competition. Germany is in a prime position to export goods throughout the continent thanks to its strategic position in Europe.

GERMANY MEDICAL DEVICES MARKET SIZE AND FORECAST

The Germany Medical Devices market accounted for $XX Billion in 2021 and is anticipated to reach $XX Billion by 2026, registering a CAGR of XX% from 2023 to 2030.

GERMANY MEDICAL DEVICES MARKET DYNAMICS

The introduction of its medical cannabis product in Germany has been announced by Dr. Reddy's Laboratories Ltd. and MediCane Health Inc.

In addition to providing logistical and regulatory support, MediCane will deliver the medical cannabis products to Dr. Reddy's from its EU-GMP-certified facilities in Portugal.

Dr. Reddy's will provide access to MediCane's medical cannabis products under its own brand in Germany as the sole distributor, supported by a trained field team that can instruct medical professionals on how to use the products and give advice on the health insurance reimbursement procedure.

In order to advance answers to the issues found in implementing the new EU Medical Devices Regulation at the European policy level, BVMed and SNITEM, Medtech organizations established a Franco-German initiative with representatives of the EU Commission (MDR).

The ultimate objective of the efforts must be to consistently provide patients with care using safe and cutting-edge medical equipment.

The CE mark, which must be secured for all products sold in Europe with a medical purpose in mind, is a rule that applies to all medical devices made in Germany. In Europe, organisations known as "notified entities" that work on behalf of the government certify medical equipment rather than governmental agencies.

Germany is home to 10 notified bodies, so manufacturers have numerous options when determining the safety of the equipment they make. 

NEW PRODUCT LAUNCH

ADVOS, a German medical device startup, creates a system to streamline and enhance the care for critically ill patients receiving intensive care.

ADVOS, which is authorised for use in Europe, supports the primary detoxification organs of the liver, lungs, and kidneys.

A patient in intensive care would often require individual machines for each of these organs as well as additional assistance to maintain the acid balance and detoxify the blood.

Multi-organ failure is the leading cause of death in the intensive care unit. In clinical testing, the ADVOS device was able to increase the survival rate of critically ill patients from 20% to 50%, which was previously the average.

The new ART Fixation System is now available in Europe, according to NGMedical GmbH, a medical device manufacturer solely dedicated to developing cutting-edge technology for spinal use.

The ART Fixation Method was created to give the surgeon a fixation system to easily, swiftly, and successfully perform dorsal spinal stabilizations.

With a small equipment set and sterile-packed implants, ART provides a secure and straightforward instrumentation.

One universal screw type is used in the lumbar fixation system's design to efficiently address all lumbar spinal fixing needs. This is yet another important addition to NGMedical's growing line of products.

Berlin Heart's objective is to join the treatment continuum at an earlier stage, enable patients to avoid transplants, and possibly even enable heart recovery, using both paracorporeal and implanted ventricular assist devices that are being developed for heart failure.

The very popular Wegovy obesity medical treatment was introduced by the Danish pharmaceutical firm Novo Nordisk in Germany, however it may take some time before many patients experience any positive effects.

Even as the business strives to replicate in Europe the astronomical success its weight reduction treatment has had in the U.S., high costs and supply issues threaten to severely hamper the distribution.

With more than half (52.1%) of its population categorised as overweight, Germany—Wegovy's third European launch area and the largest pharmaceuticals market on the continent—presents a sizable prospective consumer base.

However, tight legislation prevents the nation's public health insurance programme from providing coverage for slimming, weight-loss, and appetite-suppressant drugs, leaving the great majority of potential users to foot the expense on their own.

These prescriptions are not statutorily funded by the community of insured people who rely on solidarity, as such uses are regarded as a matter of private responsibility and personal lifestyle.

Wegovy's application to be covered by public health insurance was turned down even in Denmark, the country where Novo Nordisk is headquartered, on the grounds that its price was out of proportion to its therapeutic benefit.

Additionally, Danmark, the biggest private health insurer in the nation, declared that due to a "huge increase" in demand, it would no longer be able to subsidise prescription weight-loss medications starting in 2019.

Despite Ozempic, its predecessor, being reimbursed for the treatment of type 2 diabetes, the medicine is not covered by the public health system in Wegovy's second European market.

In contrast, in the UK, the two-year pilot programme will only allow patients with a BMI (body mass index) of at least 35 and one weight-related disease, such as diabetes or high blood pressure, access to Wegovy first through medical doctors.

Therefore, only about 35,000 individuals will be able to obtain treatment even though tens of thousands more individuals may be qualified. T

he German Obesity Society, which has received financing from Novo Nordisk, said that such regulations limit access to weight-loss treatments to the wealthy who can pay for such medications out of pocket. They urged public health institutions to do more to expand treatment and preventative efforts.

The cost of medical care for obese people frequently falls on their own shoulders. Evidence-based care is severely hampered by this, and health disparities are made worse.

As it struggled to keep up with the soaring demand, especially from non-obese people, Novo Nordisk stated that it was reducing the availability of initial dosages of its obesity medication in the United States.

The business earlier last month asked physicians in Germany to "prescribe responsibly," restricting prescriptions to those with medical needs.

Any launches outside of the United States are receiving relatively little attention from investors. They don't know how much of their available resources they're willing to devote to Europe because they are plainly operating in a capacity-constrained situation.

RECENT POLICIES AND INNOVATION

The Digital Care Act and digital health solutions known as "DiGA" are being aggressively implemented by the German Health Ministry and its organization, Health Innovation Hub.

DiGA Fast Track is Germany's route for digital health solutions to enter the statutory health system, gaining access to over 75 million Germans who are covered by the country's mandated health insurance.

The Federal Institute for Drugs and Pharmaceuticals, BfArM, a subsidiary of the German Health Ministry, is accepting online applications for DiGAs.

If certified as a medical app, DiGAs can be prescribed by any German doctor. German insurance funds will reimburse DiGA service providers.

German hospitals can speed up digitalization and maintain their competitiveness internationally thanks to the Hospital Future Act and its support.

Due to a lack of focus on digitalization among German health policy makers and hospital administration for years, as well as a dearth of specialized digital solution providers, there has been a current innovation vacuum in the German hospital sector.

This makes the market particularly accessible to American digital solution providers. With the addition of the new Patient Data Protection Act-related paragraph 360 to Germany's SGB V social code, e-medication is also on the horizon (PDSG).

The German government's "Medical Informatics" funding programme, which is a part of the Health Research Framework Program, aims to improve data exchange between various institutions and locations in an aging society where conditions like cancer, dementia, and various cardiovascular, metabolic, and muscular ailments will become more common.

The goal is to save expenses through quicker diagnoses and treatments while assisting patients in receiving quicker, more accurate care. 

The U.S. German Digital Health Forum, which was established by the U.S. Commercial Service in collaboration with a significant German digital health platform, continues to grow and provides access to cutting-edge U.S. digital health solution providers as well as opportunities for them to establish connections with German university hospitals.

Opportunities for U.S. businesses to work in Germany are provided by the German government's funding effort for health informatics and the activities of the German states on healthcare digitization.

A procurement for the public hospitals in North Rhine-Westphalia to redesign and renovate existing facilities might serve as an illustration. U.S. businesses will have the chance to take part in consortia or work as subcontractors during a four-year period.

COMPANY PROFILE

• Philips
• Stryker
• Siemens Healthineers
• Becton Dickinson & Company
• Cardinal Health

THIS REPORT WILL ANSWER FOLLOWING QUESTIONS

1. How many Medical Devices are manufactured per annum in Germany? Who are the sub-component suppliers in this region?
2. Cost breakup of a Germany Medical Devices and key vendor selection criteria
3. Where are the Medical Devices manufactured? What is the average margin per unit?
4. Market share of Germany Medical Devices market manufacturers and their upcoming products
5. Cost advantage for OEMs who manufacture Germany Medical Devices in-house
6. key predictions for next 5 years in Germany Medical Devices market
7. Average B-2-B Medical Devices market price in all segments
8. Latest trends in Medical Devices market, by every market segment
9. The market size (both volume and value) of the Medical Devices market in 2023-2030 and every year in between?
10. Production breakup of Medical Devices market, by suppliers and their OEM relationship