According to the current statistics, there are more than 70 enterprises involved in digital therapy in China, and mental, behavioral and cognitive obstacles are the most competitive tracks, including more than 20 enterprises such as Enqi, Weimai and Xinjing Technology. Endocrine, nutritional and metabolic disorders, including diabetes, take the second place, and there are many enterprises such as Miao health and micro-sugar. The most unpopular is the field of tumor diseases, with only three companies: Zero Krypton and Haixin Huihui. More than 19 digital therapeutic products (in the form of medical device software) have been approved by the medical device registration certificate in China.
According to the data of a research report released by Yi Kai Capital 202 1,1,there were 127 transactions in 59 digital therapy projects in China in 202 1 year, with 80 participating institutions1,and the accumulated financing amount was nearly 4.3 billion. The Research Report on the Development of Digital Therapy Industry in China pointed out that digital therapy still faces practical challenges, such as non-uniform industry standards, lack of guidance on clinical trial policies and regulations, lack of classification and supervision, and embryonic business model, and there is still a long way to go to establish a mature market.
20 15 put forward the concept of "digital therapy" for the first time, and Sepah and others made it clear for the first time in the paper. At present, DTA (Digital therapeutics Alliance), the largest industry alliance in the field of digital therapy, defines digital therapy as a kind of therapy based on software programs, which provides evidence-based treatment intervention for patients to prevent, manage or treat diseases.
Digital therapy can be divided into prevention, treatment and management according to its technical principle and function in disease intervention. The product form of digital therapy is based on software, which can be independent software or combined with one or more products of general computing equipment, other medical devices and drugs.
It has two main features. First of all, it is based on software programs, not just online. If online consultation is conducted, it cannot be classified as digital therapy, because it can be used without software. Secondly, it must be handled according to evidence-based medicine, that is, doctors must control the direction and guide and intervene the specific behavior of patients in combination with the evidence-based principles of medicine.
On 20 17, FDA approved the treatment scheme of Prescribed Digital Therapy for Substance Use Disorder (SUD) for clinical use. Since then, digital therapy, as a brand-new digital health solution, has begun to enter the public eye. In June 2020, 165438+ 10, Kang Shu APP was officially approved by NMPA, becoming the first "digital medicine" in China. At present, the types of digital therapy that have achieved efficacy verification mainly include game interaction, wearable devices, AR/VR experience and application operation.
Among them, the most widely used field of digital therapy is psychology. For example, the approved digital therapies reSET and reSET-O can be used to treat drug dependence, Deprexis can be used to treat depression, and EndeavorRx, as the first video game supported by clinical randomized trial data and officially approved for medical treatment, can significantly improve the attention of ADHD children through the combination of video game experience and drugs.
According to the report "Digital Therapy Global Market Report 202 1: Coronavirus Pneumonia-19 Insight and Growth" released by the international market research institute Research And Markets Research, it is estimated that the global digital therapy market will grow from $3.53 billion in 2020 to $4.20 billion in 20021year. It is estimated that by 2025, the market scale will reach 654.38+0.062 billion US dollars, with a compound annual growth rate of 26. 1%.
In recent years, the incidence and mortality of malignant tumors remain high, and the serious imbalance of medical resources and the lack of hospital follow-up mechanism also make patients face many challenges.
At the 22nd World Lung Cancer Conference (WCLC) held earlier, the research report jointly published by Zero Krypton Technology and Professor Sun Daqiang, Dean of Tianjin Chest Hospital and Chief Physician of Thoracic Surgery, showed that by comparing the 5-year survival rate of patients with stage Ⅰ Ⅲ A non-small cell lung cancer (non-small cell lung cancer) after operation with different follow-up methods, it was found that the 5-year survival rate of patients who actively participated in the follow-up could reach 865,438 0.8%, which was significantly higher than that of patients who were passively followed up.
However, according to Chen, in the domestic cancer treatment environment, the positive role of patients' active participation in follow-up to improve their survival efficiency is often ignored by most enterprises, and few domestic products use digital therapy to intervene and manage cancer patients.
Therefore, the application of digital therapy in the field of cancer not only requires doctors to provide effective treatment plans in the hospital and innovate in the field of diagnosis and treatment, but also needs to care for patients outside the hospital, improve their rehabilitation experience, improve their quality of life and improve the way of medical payment.
Tumor is one of the first areas where digital therapy is approved for clinical use. The 20021China Insight Report on Digital Therapy shows that the value of digital therapy in tumor treatment lies in studying the internal process of drugs (including absorption, distribution, metabolism and excretion) and its influencing factors through the combination of in vitro research technology and AI big data, so as to provide individualized medication guidance for patients.
On the one hand, digital therapy can improve cancer patients' cognition of medication norms under the background of precise treatment, on the other hand, it can improve the problem of patients' difficulty and distance in seeing a doctor, improve the stickiness of follow-up outside the hospital, and thus enhance their survival benefits.
Chen said that the approval of the certificate of digital treatment equipment in the field of cancer is a positive signal to fill the gap in the application of digital treatment in cancer treatment in China. Through algorithms and knowledge maps, digital therapy can predict the problems of patients at different levels and levels, thus giving patients intervention suggestions. At present, the field of digital therapy in China is still in its infancy, and there has not been a comprehensive competition. The application scenario is relatively narrow and needs more mature technical and clinical data support.
At the same time, doctors can combine patients' past symptoms and past treatments to conduct grading evaluation. When the situation that requires the doctor's intervention is triggered, the doctor can quickly give an early warning according to the patient's previous treatment, and help and manage the patient.
In the past few years, the innovation in the field of digital medical care in China is still in its infancy, with "connection" as its main function. In 20021year, it was praised as "the first year of digital treatment in China" by the industry, and digital treatment began to really enter the medical field to assist the intervention of diseases.
The 20021China Digital Therapy Industry Development Research Report pointed out that digital therapy will reshape the ecology of chronic disease management. With the increasing challenges of aging population and high incidence of chronic diseases, and people's awareness and acceptance of digital medical care and Internet medical care, the digital therapy industry will become an important leader and leader in the payment of chronic disease management market, and will play an important role in reshaping the ecological management of chronic diseases.
In addition, traditional drugs will inevitably be accompanied by adverse reactions while taking effect. Although digital therapy will not cause adverse reactions to patients because of chemical composition, it does not mean that it is zero risk. For example, the user fails to use it correctly, or because of the hardware or software problems of the device itself, the intervention of digital therapy may be ineffective, or the disease may be further aggravated. As a new therapy, the effectiveness and risk of digital therapy need more experimental results.
Zheng, general manager of the Department of Intelligent Medicine of Shanghai International Human Phenotype Research Institute, said earlier that 2022 will be a crucial year for digital therapy, which will be an important period for it to take root downwards, germinate upwards and multiply to the surrounding areas. At present, information and digital technologies in the fields of medical and health services, such as meta-universe, medical informatization, mobile medical care, medical artificial intelligence and medical platform, go hand in hand and blossom everywhere. Digital therapy is not a system that can run through the whole medical and health service ecosystem, and it needs to be integrated into the whole ecosystem to advance in an orderly manner, empower each other and develop synergistically.
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