Forecast Period | 2026-2030 |
Market Size (2024) | USD 1.94 Billion |
Market Size (2030) | USD 3.93 Billion |
CAGR (2025-2030) | 12.43% |
Fastest Growing Segment | Software |
Largest Market | Germany |
Market Overview
Europe
Digital Therapeutics Market was valued at USD 1.94 Billion in 2024 and is
expected to reach USD 3.93 Billion by 2030 with a CAGR of 12.43% during the
forecast period. The Europe Digital Therapeutics Market is driven by several
key factors, including the increasing demand for personalized healthcare
solutions, advancements in technology, and the growing prevalence of chronic
diseases. Digital therapeutics (DTx) offer evidence-based, clinically validated
interventions through digital platforms, enabling patients to manage conditions
such as diabetes, cardiovascular diseases, mental health disorders, and chronic
respiratory diseases. The rise in chronic disease rates across Europe is
prompting a shift towards more accessible, cost-effective, and scalable
treatment options like digital therapeutics. The adoption of mobile health
applications and wearable devices has facilitated the widespread acceptance of
digital health solutions. Regulatory support from European healthcare agencies,
including the European Medicines Agency (EMA), is also driving growth by
ensuring that DTx products meet safety and efficacy standards. In 2021,
Belgium's INAMI-RIZIV introduced a reimbursement program for Digital
Therapeutics (DTx) that are CE-marked medical devices, closely following the
fast-track process for DTx in Germany. However, despite these regulations, no
DTx have yet attained the highest tier of the mHealthBelgium validation
pyramid, which is required for government funding. The increasing focus on
remote patient monitoring and virtual healthcare models, accelerated by the
COVID-19 pandemic, has further boosted the demand for digital therapeutics in
Europe.
Key Market Drivers
Rising Prevalence of Chronic
Diseases
Europe
is witnessing a steady rise in chronic diseases such as diabetes, hypertension,
obesity, cardiovascular diseases, and respiratory disorders. The World Health
Organization (WHO) has highlighted chronic diseases as the leading cause of
death and disability in Europe, which has led to an increased demand for
long-term disease management solutions. Traditional healthcare models often
struggle with the continuous monitoring required to manage chronic diseases
effectively, which makes digital therapeutics an attractive alternative. Cardiovascular
disease is the leading cause of death in Portugal, with atherosclerosis being
the most prevalent underlying pathophysiological condition. According to a study titled, “Profiling
chronic diseases and hospitalizations in older home care recipients: a
nationwide cohort study in Sweden”, in Sweden, 9% of
the population aged 70 and older depend on formal healthcare, and the majority
of them experience multiple chronic diseases. Half of the healthcare recipients
have five or more chronic conditions. The wide range of prevalent diseases presents
a varied picture of morbidity among those receiving healthcare services. Nearly
two-thirds of healthcare recipients are hospitalized at least once during a
two-year follow-up period, with falls and decompensated heart failure being the
most common causes.
DTx
platforms allow patients to manage their conditions from home, reducing
hospital visits and helping prevent complications. For example, mobile apps can
guide patients with diabetes in real-time on managing their blood sugar levels,
making it easier for them to stick to their treatment regimens. This
convenience and ability to track symptoms remotely are compelling drivers of
DTx adoption across Europe.
Growing Focus on Personalized
Medicine
Personalized
medicine is becoming a key focus in healthcare, as treatments tailored to
individual patients' genetic profiles, lifestyles, and environmental factors
have shown to improve outcomes. Digital therapeutics align well with this trend
by offering highly personalized, patient-specific interventions. DTx solutions
often use data-driven algorithms to customize treatment protocols based on a
patient's unique condition, medical history, and real-time data. This
personalized approach is particularly beneficial for managing chronic
conditions, mental health issues, and neurological disorders, where treatment
responses vary widely between individuals. The European healthcare system,
which places emphasis on improving patient outcomes and satisfaction, is increasingly
adopting personalized digital therapeutics to offer more effective,
individualized care. The shift toward precision medicine supports the growth of
the DTx market in Europe, as healthcare providers and patients alike see the
value in customized treatment plans.
Regulatory Support &
Reimbursement Policies
Europe’s
regulatory environment plays a crucial role in the growth of the digital
therapeutics market. The European Medicines Agency (EMA) and other national
regulatory bodies are increasingly supporting digital health solutions,
ensuring that they meet the required safety and efficacy standards. Regulatory
approval gives digital therapeutics credibility, and this fosters confidence
among healthcare providers, patients, and investors. Reimbursement policies
across European countries are evolving to include digital therapeutics,
recognizing them as legitimate treatment options. Some European nations, such
as Germany, have introduced reimbursement pathways for digital health
solutions, making them more accessible to patients. As reimbursement policies
improve and more health systems offer financial support for DTx interventions,
adoption is likely to grow. The regulatory clarity and reimbursement mechanisms
in place are driving the development and implementation of digital therapeutics
in Europe.
Improved Healthcare Efficiency
and Cost Reduction
Digital
therapeutics offer significant potential for improving healthcare efficiency
and reducing costs. Healthcare systems in Europe are facing increasing pressure
due to the rising burden of chronic diseases and an aging population. The need
for more sustainable, cost-effective care solutions has led to the adoption of
digital therapeutics, which reduce the need for in-person consultations,
hospital stays, and emergency interventions. DTx platforms enable continuous
monitoring of patients, making it possible to detect issues early and prevent
complications before they require expensive interventions. This shift from
reactive to preventive care helps reduce the long-term costs associated with
chronic disease management. By enabling remote care, digital therapeutics
alleviate the strain on healthcare infrastructure, reducing the demand for
hospital resources and allowing healthcare professionals to focus on more
complex cases.
Strategic Partnerships and
Investments
The growing interest
in digital therapeutics has attracted significant investments from private
companies, venture capitalists, and major healthcare organizations.
Pharmaceutical companies, health insurers, and digital health firms are
increasingly forming strategic partnerships to develop and commercialize DTx
products. In January 2022, The Stockholm-based Digital Therapeutics (DTx)
company Alex Therapeutics and world-leading pharmaceutical company Pfizer have
joined forces to provide evidence-based, clinically validated, and personalized
digital therapies to patients. Together, the companies cover a broad range of
expertise in the fields of medicine, marketing, clinical validation, AI,
software development, and psychology. The partnership will initially focus on
Germany, one of the world's largest unified healthcare markets. These
partnerships help combine expertise in healthcare, technology, and data
science, resulting in the creation of innovative solutions that meet the
complex needs of patients and healthcare providers. The influx of investments
is further accelerating the development of new digital therapeutics products,
while increasing competition in the market. As more healthcare systems and
insurance providers recognize the value of digital therapeutics, funding and
strategic collaborations will likely continue to increase, ensuring the rapid
growth and widespread adoption of digital therapeutics across Europe.
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Key Market Challenges
Regulatory and Compliance Challenges
One
of the primary challenges facing the Digital Therapeutics (DTx) market in
Europe is the regulatory landscape. While the European Medicines Agency (EMA)
has made strides in approving digital health solutions, regulatory frameworks
are still in development for digital therapeutics, creating uncertainty for
manufacturers, healthcare providers, and patients. Digital therapeutics often
fall into a grey area in terms of regulation since they blend software with
therapeutic outcomes. Unlike traditional drugs or medical devices, which have
well-defined approval processes, digital therapeutics may require a combination
of software regulatory standards and medical device regulations. This lack of
clarity can lead to delays in product approval and market entry.
The
complexity of regulations varies by country within Europe, which complicates
the process for companies looking to enter multiple markets simultaneously.
Different European countries have varying levels of regulatory readiness and
approaches toward digital health. For instance, Germany’s digital health
reimbursement pathway is more developed compared to some other European
nations. Manufacturers may need to adapt their products to comply with
different regulatory frameworks, which can be resource-intensive and
time-consuming.
The
dynamic nature of digital technologies also presents another challenge for
regulators. As digital therapeutics evolve rapidly, it becomes difficult for
regulators to keep pace with innovations. The lag in regulatory updates can
create uncertainty for developers, especially when their products undergo
continuous iterations or when new features are added. The lack of standardized
regulations and approval processes across Europe slows down market penetration,
making it difficult for DTx companies to scale their operations effectively
across borders. Until these regulatory frameworks become more harmonized,
companies may face challenges in navigating approval processes, which could
ultimately impact market growth.
Integration into Traditional
Healthcare Systems
Another
significant challenge for the Europe Digital Therapeutics Market is the
integration of digital health solutions into traditional healthcare systems.
While many healthcare systems in Europe are investing in digital solutions,
they still face barriers when it comes to the widespread adoption and
integration of digital therapeutics into existing workflows. Traditional
healthcare systems are often slow to adopt new technologies, and many
healthcare professionals remain unfamiliar with DTx platforms or hesitant to
incorporate them into their practices.
Healthcare
providers may be resistant to using digital therapeutics due to a lack of
awareness or training. Digital therapeutics require integration into Electronic
Health Record (EHR) systems, patient management systems, and other healthcare
IT infrastructures. This integration can be a complex and costly process,
especially in healthcare systems where technology infrastructure is outdated.
The healthcare workforce may also require training on how to use these new
tools effectively, which takes time and resources.
Many
healthcare providers may question the efficacy and cost-effectiveness of
digital therapeutics, particularly in comparison to traditional interventions.
While clinical evidence supporting the effectiveness of digital therapeutics is
growing, it may not always meet the level of evidence required by healthcare
professionals, particularly when compared to well-established treatments.
Overcoming these challenges requires more robust clinical trials, education for
healthcare providers, and better integration with existing healthcare systems
to make DTx a mainstream part of patient care.
Key Market Trends
Technological Advancements and
Innovation
Technological
advancements are one of the primary drivers of the Digital Therapeutics market
in Europe. With rapid progress in mobile health technologies, artificial
intelligence (AI), big data analytics, and wearable devices, the development of
digital therapeutics has been accelerated. Modern technologies enable
continuous monitoring of health data and allow the personalization of
treatments based on real-time information. These innovations have made it
easier for patients and healthcare providers to manage health conditions
remotely. In November 2023, Better and Stratiteq are unveiling their
strategic partnership, designed to transform healthcare solutions. By combining
the strengths of Stratiteq and Qinshift, particularly in data management and
custom software development, and incorporating openEHR into their service
offerings, this collaboration holds significant potential for the healthcare
sector. It will benefit not only Sweden but also global markets where Qinshift
operates. Wearables like fitness trackers, smartwatches, and medical-grade
devices help monitor parameters such as heart rate, glucose levels, or oxygen
saturation, providing clinicians with valuable insights that enable more
accurate interventions. These advancements in digital health tools are
transforming healthcare delivery, making it more efficient, accessible, and
patient-centric. As new technologies continue to emerge, digital therapeutics
are likely to become even more effective and integrated into mainstream
healthcare practices.
Increased Adoption of Remote
Patient Monitoring
The
COVID-19 pandemic played a pivotal role in accelerating the adoption of remote
patient monitoring (RPM) and telemedicine across Europe. Social distancing
measures and the increased demand for healthcare solutions that reduce
in-person visits created a surge in the need for virtual healthcare services.
Digital therapeutics, often integrated with remote monitoring capabilities,
allow patients to manage their health conditions without leaving their homes.
Patients with chronic conditions, such as heart disease or diabetes, can
monitor their symptoms and receive timely interventions from healthcare
professionals. The benefits of remote care, such as convenience, cost savings,
and enhanced patient outcomes, have contributed to the growing demand for
digital therapeutics. Even beyond the pandemic, remote patient monitoring is
expected to remain a key component of healthcare systems in Europe, further
driving the adoption of digital therapeutics.
Segmental Insights
Product Type Insights
Based on the product type, software is currently the dominant
segment over devices. Digital therapeutics (DTx) primarily encompass
software-driven solutions that provide evidence-based therapeutic interventions
through mobile applications, online platforms, and digital tools. These
software platforms are at the core of the digital health revolution, offering
treatments for chronic diseases, mental health conditions, and other
therapeutic areas. Unlike devices, which often require more complex hardware
components and infrastructure, software-based solutions offer greater
scalability, lower costs, and can be quickly adopted by healthcare providers
and patients alike.
The primary reason software is leading the market is its ability to
deliver flexible, accessible, and cost-effective therapeutic interventions. DTx
software enables real-time monitoring, symptom tracking, and patient engagement
through mobile apps, websites, and cloud-based systems. These applications
allow for continuous management of conditions like diabetes, hypertension, and
mental health disorders, without the need for expensive and complex devices.
Software solutions can also be easily updated and improved over time, making
them more adaptable to the needs of patients and clinicians. This ease of
scalability and continuous improvement is a key driver of the growing market
adoption of digital therapeutics software.
Application Insights
Based on the application, treatment/patient care-related
applications are currently dominating over preventive applications. This is
largely due to the significant need for managing chronic diseases and
conditions that require ongoing therapeutic interventions. Treatment-focused digital
therapeutics address a wide range of health conditions, including diabetes,
cardiovascular diseases, mental health disorders, and respiratory conditions,
offering evidence-based, clinically validated solutions. These applications aim
to help patients manage their conditions in real-time through digital platforms
such as mobile apps, wearable devices, and online tools, making them highly
relevant in healthcare systems across Europe.
The growing prevalence of chronic diseases in Europe, including
diabetes, hypertension, and obesity, has created an increasing demand for
continuous patient care. Traditional approaches often involve periodic visits
to healthcare providers, but digital therapeutics can bridge this gap by
offering continuous, remote monitoring and personalized care. Treatment
applications enable patients to track their symptoms, receive real-time
feedback, and adjust their treatment regimens accordingly, leading to improved outcomes
and better disease management. This approach is particularly important for
managing complex, long-term conditions where consistent monitoring and
intervention are critical for preventing complications.
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Country Insights
Germany was dominating the Europe
Digital Therapeutics Market. As Europe’s largest economy and a leader in
healthcare innovation, Germany is at the forefront of adopting digital health
technologies, including digital therapeutics (DTx). The country’s robust
healthcare system, strong regulatory framework, and progressive digital health
policies have made it a key player in the European market for digital
therapeutics. A major factor contributing to Germany’s dominance is the
introduction of the Digital Healthcare Act (DVG), which was enacted in 2019.
This act has paved the way for the reimbursement of digital health solutions
under the statutory health insurance system, facilitating broader access to
digital therapeutics for patients. The law allows doctors to prescribe digital
health applications that have received approval from the Federal Institute for
Drugs and Medical Devices (BfArM). This regulatory support has created a clear
pathway for digital therapeutics to be integrated into the German healthcare
system, providing a significant advantage over other European countries where
reimbursement systems for DTx are still developing.
Germany’s healthcare system is also highly
advanced, with a high level of infrastructure, a broad adoption of electronic
health records (EHRs), and widespread use of telemedicine, all of which are
essential for the successful implementation of digital therapeutics. This
infrastructure allows for seamless integration of DTx solutions into existing
patient care workflows, enhancing patient engagement and improving treatment
outcomes. Germany is home to a number of prominent pharmaceutical and
biotechnology companies, many of which are collaborating with digital health
startups to develop and commercialize digital therapeutics solutions. This
collaboration between tech firms and pharmaceutical giants drives innovation
and accelerates the development of new, evidence-based digital treatments.
Recent Developments
- In June 2024, Mahana Therapeutics, a leading provider of
prescription and wellness digital therapeutics, announced today that it has
successfully completed price negotiations with Germany's National Association
of Statutory Health Insurance Funds (GKV-SV). The GKV-SV, appointed by German
health insurance funds, is responsible for setting the permanent price of
digital therapeutics after they are officially listed on the DiGA-directory,
the BfArM (Federal Institute for Pharmaceuticals and Medical Devices) register
for approved Digital Health Applications (DiGAs). Cara Care for IBS has been
permanently reimbursed by all statutory health insurers in Germany since
November 2023, ensuring broad accessibility for patients with irritable bowel
syndrome (IBS).
- Dr. Reddy's Laboratories has announced the launch of Nerivio, a
drug-free, non-invasive wearable device for migraine management, in Germany
through its subsidiary betapharm. This launch marks the company's entry into
the digital therapeutics market in Europe. Nerivio, which is FDA-approved in
the United States and CE-mark certified in Europe, was first introduced by Dr.
Reddy’s at the 2023 DGN Kongress organized by the German Association of
Neurology in Berlin and the 17th European Headache Congress in Barcelona,
Spain. The device will also be presented and launched at the Neurological
Association of South Africa's annual congress on April 17, 2024.
- In November 2024, Digital therapeutics company GAIA has signed a
licensing agreement for attexis® with the German pharmaceutical company MEDICE
Arzneimittel Pütter. As a leading player in the ADHD market, the MEDICE Health
Family will leverage its market expertise and commercial reach to deliver
attexis to patients across Germany. Attexis is a personalized, fully automated
digital therapy aimed at helping adults with ADHD manage their symptoms more
effectively. The therapy's efficacy and safety are currently being evaluated in
an extensive clinical trial.
Key Market Players
- Mindable Health GmbH
- Cara Care
- Kaia Health Software GmbH
- HealthHero
- GAIA AG
- ResMed Germany Inc.
- Sidekick Health Germany GmbH
- Ada Health GmbH
- Flatiron Health GmbH
- Wellster Healthtech Group GmbH
By
Product Type
|
By
Application
|
By
Sales Channel
|
By
Country
|
|
- Treatment/Patient
Care-Related Applications
- Preventive
Applications
|
- Business-to-Business
- Business-to-Customer
|
- Germany
- France
- United
Kingdom
- Italy
- Spain
- Russia
- Poland
- Bulgaria
- Finland
- Portugal
|
Report Scope:
In this report, the
Europe Digital Therapeutics Market has
been segmented into the following categories, in addition to the industry
trends which have also been detailed below:
·
Europe Digital Therapeutics Market, By Product Type:
o
Software
o
Devices
·
Europe Digital Therapeutics Market, By Application:
o
Treatment/Patient
Care-Related Applications
o
Preventive Applications
·
Europe Digital Therapeutics Market, By Sales Channel:
o
Business-to-Business
o
Business-to-Customer
·
Europe Digital Therapeutics Market, By Country:
o Germany
o France
o United Kingdom
o Italy
o Spain
o Russia
o Poland
o Bulgaria
o Finland
o Portugal
Competitive Landscape
Company
Profiles: Detailed
analysis of the major companies present in the Europe Digital Therapeutics
Market.
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