According to current statistics, more than 70 domestic enterprises involved in digital therapies, psychiatric, behavioral and cognitive disorders is the most competitive track, there are more than 20 enterprises layout EnQi, MicroPulse, New View Technology; endocrine, nutrition and metabolic disorders including diabetes, followed by more than 10 enterprises layout, such as Wonderful Health, MicroSugar, etc.; the coldest is the field of oncology diseases, only 3 companies, including Zero Kryptonite The coldest field is tumor disease, with only 3 enterprises including Zero Krypton and Haixin Zhihui. The domestic has been approved medical device registration certificate of digital therapy products (in the form of medical device software approved) more than 19 models.
According to the data of a research report released by eCapital in November 2021, in 2021, 127 transactions occurred in 59 digital therapy projects in China, with 180 participating organizations, and the cumulative financing amounted to nearly 4.3 billion yuan. The China Digital Therapy Industry Development Research Report pointed out that digital therapy is still facing the lack of industry uniform standards, the lack of clinical trial policies and regulations to guide, the lack of hierarchical classification and supervision, the business model is still in its infancy, and other real challenges, and there is still quite a long way to go before a mature market is established.
The concept of "digital therapies" was first proposed in 2015, and Sepah et al. first clarified this concept in their paper. What is now widely recognized is the definition of digital therapeutics by DTA (Digital Therapeutics Alliance), the largest industry alliance in the field of digital therapeutics, which states that digital therapeutics (DTx) is A software program-based therapy that provides patients with evidence-based therapeutic interventions to prevent, manage or treat disease.
Digital therapies can be categorized into three broad categories: prevention, treatment, and management, based on their technical principles and the role they play in disease intervention. The product form of digital therapies is software-based and can be stand-alone software or used in conjunction with general-purpose computing devices, other medical devices, and one or more products of pharmaceuticals.
Its main characteristics are two, firstly, it is based on a software program, not just online, such as online consultations can not be classified as digital therapies, because they can be used without software. Secondly, it must be handled in accordance with evidence-based medicine, i.e. there must be a doctor who controls the direction and incorporates the evidence-based principles of medicine to guide and intervene in the specific behavior of the patient.
In 2017, the U.S. FDA approved treatment programs for prescription digital therapies for the treatment of substance use disorders (SUD) for clinical use. Since then, digital therapies, as a new digital health solution, have begun to come into the public's field of vision. 2020, November 2020, the APP was officially approved by the NMPA, becoming the first "digital medicine" in China. Currently, the types of digital therapies that have achieved efficacy verification mainly include game interaction, wearable devices, AR/VR experience class and app operation class.
Among them, the most widely used field of digital therapy is the psychiatric field. For example, the approved digital therapies reSET and reSET-O are able to treat drug dependence, Deprexis can be used for the treatment of depression, and EndeavorRx, as the first e-game supported by clinical randomized trial data and formally approved for medical prescribing, can significantly improve the attention span of children with ADHD by combining medication with video game experience.
According to the report "Digital Therapeutics Global Market Report 2021: COVID-19 Implications and Growth" published by Research And Markets Research, a global market research organization, the global digital therapeutics market is expected to grow from USD 3.53 billion in 2020 to USD 4.20 billion by 2021, and is projected to reach USD 10.62 billion by 2025, at a CAGR of 26.1%.
In recent years, the morbidity and mortality rates of malignant tumors have remained high, while the serious imbalance in healthcare resources and the lack of hospital follow-up mechanisms have led to a number of challenges for patients.
A study released at the 22nd World Conference on Lung Cancer (WCLC) by Zero Krypton and Professor Sun Daqiang, Director of Tianjin Chest Hospital and Chief Thoracic Surgeon, shows that by comparing the 5-year survival rate of postoperative patients with different follow-up methods for patients with Stage I/IIIA non-small cell lung cancer (NSCLC), it was found that the 5-year survival rate of patients who took the initiative to actively participate in follow-up could reach 81.8 percent, and the 5-year survival rate of patients who actively participated in follow-up could reach 81.8 percent. survival rate was 81.8%, which was significantly higher than that of 74.2% for patients with passive follow-up.
However, according to Kaishen Chen, in the domestic oncology treatment environment, the positive effect of active patient participation in follow-up to improve survival benefit is often overlooked by most R&D companies, and few products utilize digital therapies to intervene and manage Chinese oncology patients.
Therefore, the use of digital therapies in oncology not only requires doctors to provide effective treatment plans in the hospital and carry out innovations in the areas of diagnosis and treatment, but also needs to care for patients outside the hospital, improve their recovery experience, enhance their quality of life, and improve the way of healthcare payment, etc.
The use of digital therapies in oncology is also a key factor in the development of new technologies.
Oncology is one of the first areas where digital therapies have been approved for clinical use, and the China Digital Therapeutics Insight Report 2021 shows that the value of digital therapies cutting into oncology treatment lies in the combination of in vitro research technology and AI big data to study the law of in vivo processes of drugs (including absorption, distribution, metabolism, and excretion) and their influencing factors, so as to provide patients with individualized guidance on the use of drugs.
Digital therapies can, on the one hand, improve tumor patients' knowledge of medication standardization in the context of precision therapy, and on the other hand, improve the problem of patients' difficulty in accessing the doctor and the distance of access to the doctor, and improve the stickiness of out-of-hospital follow-up and review and re-diagnosis, so as to enhance their survival benefit.
Chen Kaishen said that the approval of digital therapy device documents in the field of oncology is a positive signal for filling the gaps in the application of domestic digital therapies in oncology treatment. Through algorithms and knowledge graphs, digital therapies can make graded and stratified prognosis for the problems of patients, so as to give patients interventional recommendations. Today, the domestic digital therapy oncology treatment field is still in its infancy, has not formed a comprehensive competitive situation, the application of the relatively narrow scene, the need for more mature technology and clinical data support.
At the same time, doctors can combine the patient's past symptoms and past treatments to make a hierarchical assessment, and when triggered to the need for doctors to intervene in the situation, the doctor will be able to quickly give early warning based on the patient's past treatments to help the patient to help and manage.
In the past few years, innovation in China's digital healthcare sector has been in its infancy, with "connectivity" being the main focus. 2021 has been hailed by the industry as the "first year of digital therapies in China", with digital therapies starting to make their way into the realm of healthcare, and assisting with interventions in the treatment of illnesses. The company's main goal is to provide the best possible service to its customers.
The 2021 China Digital Therapy Industry Development Research Report points out that digital therapy will reshape the ecology of chronic disease management. With the aging population and high incidence of chronic disease challenges intensifying, as well as the public's awareness and acceptance of digital healthcare and Internet healthcare increasing, the digital therapy industry will become an important leader and dominant player in the payment of chronic disease management market, and will play an important role in reshaping the ecology of chronic disease management.
In addition, traditional medicines inevitably come with adverse reactions when they take effect. While digital therapies do not cause adverse reactions in patients due to their chemical composition, it does not mean that it is zero-risk. For example, if the user fails to use it correctly, or because of hardware or software problems with the device itself, the digital therapy intervention may not work or cause further deterioration of the condition. The effectiveness and risks of digital therapies as an emerging therapy need to be examined more closely.
Zheng Wentao, general manager of the Intelligent Medicine Department at the Shanghai International Human Phenome Research Institute, also said previously that 2022 is a critical year for digital therapies, in which it will be an important period for them to take root downward, sprout upward, and multiply around the periphery. The current medical health service field informationization, digital technology such as meta-universe, medical informatization, mobile medical, medical artificial intelligence, medical **** body platform and so on many heads, blossomed in all directions, digital therapy is not a system that can be penetrated through the whole medical health service ecosystem, need to be integrated into the overall ecosystem in an orderly manner to promote, mutually empower each other, and synergistic development.
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