How Will Digital Therapeutics Fare in 2022? Insights and Expectations from 11 Industry Leaders

If we were to select the top ten buzzwords in the healthcare industry for 2021, “digital therapeutics” would undoubtedly secure a place on the list. This concept, first proposed by the Digital Therapeutics Alliance (DTA), has gained rapid popularity in recent years and has seen accelerated development in China since 2020.

In 2021, VCBeat (WeChat ID: Vcbeat), the earliest research institution in China to continuously focus on digital therapeutics, conducted in-depth exploration of this sector. In April 2021, the 5th Future Healthcare 100 Conference, hosted by VCBeat, held a Digital Therapeutics Innovation Forum. As one of the first forums in China dedicated specifically to digital therapeutics, it garnered significant attention. Subsequently, various academic summits emerged within the industry, reflecting concerted efforts by leading Chinese digital therapeutics companies to jointly build an industry ecosystem.

Beyond the digital therapeutics industry itself, companies from fields such as artificial intelligence, healthcare informatics, wearables, mental health, neuroscience and brain science, and internet-based healthcare have also paid close attention to the digital therapeutics sector. For this reason, 2021 was hailed as the “Year One” of digital therapeutics in China.

Needless to say, with the influx of capital, China’s digital therapeutics industry also achieved breakthroughs at several key milestones in 2021.

First, in late 2020, Chengdu Shangyi Information Technology Co., Ltd.’s Shukang APP (an exercise testing and exercise prescription video software) garnered significant attention due to its integration with physician prescriptions. Subsequently, medical devices meeting the definition of digital therapeutics were successively approved in 2021. By January 2022, several digital therapeutic products received approval in rapid succession.

Meanwhile, the NMPA is also exploring the existing regulatory framework for digital therapeutics. For instance, the Center for Technical Evaluation of the NMPA has published a dedicated article stating that, with regard to the classification and definition of digital therapeutics, regulatory requirements will be clarified under the digital health regulatory framework in future technical evaluations. This underscores the growing attention paid by regulatory authorities to digital therapeutics.

Meanwhile, healthcare institutions have increasingly focused on digital therapeutics (DTx) and begun to gradually integrate them into clinical practice, achieving notable results. In terms of intervention efficacy and patient retention, DTx products have demonstrated considerable competitiveness. This is regarded as one of the key milestones for digital therapeutics in 2021.

Secondly, Chinese digital therapeutics companies, including Miao Health, Weimai, Shuyu Technology, MedSci, Wangli, Good Doctor Hui, and Jianhai Technology, joined the Digital Therapeutics Alliance (DTA) in 2021. As the originator of the digital therapeutics concept, DTA’s definition of digital therapeutics has gained widespread global acceptance. The alliance has established collaborations with healthcare regulatory authorities in various countries to discuss the formulation of standards related to digital therapeutics, thereby promoting industry development.

The participation of domestic digital therapeutics companies also largely demonstrates the booming digital therapeutics sector in China, as well as the recognition of DTA by Chinese digital therapeutics enterprises. This will further strengthen the voice of China's digital therapeutics industry within the global landscape.

Furthermore, digital therapeutics (DTx) come in various forms and manifestations, and can be integrated with services and hardware. Novel digital technologies, such as gaming and virtual reality (VR), have emerged in commercially available DTx products. This has undoubtedly attracted attention and participation from multiple industries. From artificial intelligence to mixed reality, from healthcare informatization to wearables, mental health, neuroscience and brain science, and internet-based healthcare, along with pharmaceutical and medical device companies and insurance payers, nearly the entire healthcare sector is asking itself one question: “How can I integrate with digital therapeutics?”

Finally, the digital economy will feature prominently in China’s 14th Five-Year Plan. The digital economy is transitioning to a new stage characterized by deepened application, standardized development, and inclusive sharing. To address new situations and challenges, seize new opportunities for digital development, expand new spaces for economic growth, and promote the healthy development of China’s digital economy, the State Council has specifically formulated the “14th Five-Year Plan for Digital Economy Development.”

As a component of the digital economy, the burgeoning field of digital therapeutics has garnered attention across various regions, prompting the gradual formulation of relevant policies. For instance, Hangzhou has proposed the establishment of a digital therapeutics industrial park. Additionally, according to VCBeat, other localities are also exploring pilot programs for digital therapeutics.

Nevertheless, digital therapeutics (DTx) remains an emerging sector in its early stages of development. It was not until December 2021 that Pear Therapeutics, a leading company in the industry, completed its public listing via a SPAC merger. Meanwhile, regulatory frameworks across various countries remain incomplete. DTx companies, despite their rapid expansion, face multifaceted challenges in clinical validation, regulatory approval, reimbursement, and market adoption.

Will Digital Therapeutics Continue to Thrive in 2022? What Are the Emerging Trends, Industry Perspectives, and Expectations? VCBeat interviewed key players in the digital therapeutics sector (listed in no particular order) to gather their insights on the question: “What trends or expectations do you foresee for China’s digital therapeutics market in 2022?” For ease of reading, VCBeat has edited the responses without altering their original meaning.

Zhang Dan, Founder and CEO of Chengyi Jiaren:Digital therapeutics (DTx) have established clear concepts and strategic directions, with clinical cases and practical experience already emerging in certain specialized fields. This has provided significant confidence and valuable references for startups positioning themselves in the DTx sector. Orange Intent’s exploration and R&D in digital therapeutics for chronic respiratory diseases need to be more focused, in-depth, and robust. Our primary concern is whether the clinical endpoints of our products are effective. We firmly believe that all product value and business models must be discussed on the foundation of proven clinical efficacy, including the selection of specific indications, safe and effective intervention methods, goals and priorities of clinical treatment, and the boundaries for expansion into chronic disease management. Orange Intent believes that these aspects require data validation through rigorous clinical research in real-world clinical settings, rather than assuming that any casually developed software can qualify as a digital therapeutic.Secondly, the business model for digital therapeutics requires holistic consideration across the entire industry, especially amid considerable skepticism. Key questions remain: Who will pay? Whose problems are being solved? What does the service loop look like? Taking digital therapeutics for chronic respiratory diseases as an example, extensive communication and collaboration among upstream and downstream players in the industry chain are necessary. Various models and pathways should be explored, including collaborations with clinical institutions, pharmaceutical companies, and internet healthcare providers, thereby accumulating achievements and experience. Perhaps, following further innovation and breakthroughs in 2022, we will be able to provide an answer to the question of whether digital therapeutics possess genuine clinical and commercial value, offering a reference for the industry.

Dr. Luo Xiaobin, Senior Vice President and Chief Medical Officer of Miao Health:The entire healthcare industry will continue to revolve around patient-centricity. Driven by core values, the digital therapeutics (DTx) industry is poised for greater prosperity in 2022, with more digital innovation enterprises promoting DTx advancements from novel perspectives. Collaboration between traditional pharmaceutical companies and DTx firms will become increasingly frequent. Digital therapeutics will continue to empower pharmaceutical companies through intelligent solutions, supply-demand optimization, and innovative marketing strategies, while pharmaceutical companies can support the iterative innovation of DTx, creating a virtuous cycle.In terms of policy and regulation, policies, regulations, and standards specific to digital therapeutics will become clearer in 2022. Regulatory authorities are expected to make breakthroughs in reporting procedures and detailed industry oversight guidelines. We also believe that the DTx industry will yield high-quality clinical outcomes in the coming period. We look forward to the generation of more valuable clinical results across different diseases and therapeutic areas, thereby solidifying the clinical value of digital therapeutics as an innovative treatment modality.Furthermore, commercialization efforts and innovations in payment models for digital therapeutics will be key focuses for the industry this year. Resolving payment issues is essential to driving and facilitating industry growth; only by addressing commercial application challenges can business models be successfully implemented.Finally, we hope for a more standardized, normalized, and professional DTx industry that achieves sustainable and healthy development. We anticipate greater participation from interdisciplinary and cross-sector professionals. At the same time, we expect clinical experts to adopt a more open and inclusive attitude within the scope of traditional medicine, participating in the establishment of DTx standards and validating scientific efficacy, thereby collectively helping digital therapeutics realize greater clinical value.

Zhang Jing, Founder and CEO of Senmei Medical:It is certain that digital therapeutics (DTx) hold significant opportunities for the future. The core DNA of Senmei is rooted in intensive clinical engagement. Through our close interaction with clinical practice, we have recognized that clinicians are highly interested in such initiatives, provided that they are feasible, demonstrate genuine efficacy, and help resolve previously intractable problems. We hope that industry definitions and landmark frameworks will become increasingly standardized and mature. However, at its core, the therapeutic efficacy of DTx must be proven and gain academic recognition. Meanwhile, we anticipate the emergence of several leading companies in the sector to alleviate widespread skepticism. By 2022, a few companies should have risen to prominence; after all, even in the United States, the number of such players remains limited. Furthermore, we hope to see the development of robust business models within this track, exploring innovations beyond the existing paradigms.

Lei Zhen, Founder and CEO of Shangyi Information Technology (Shukang App):Since the outbreak of the COVID-19 pandemic, ensuring the safety of frontline healthcare workers—who bear the critical responsibility of treating and rehabilitating patients with COVID-19—has become a top priority for global healthcare systems. In response to this crisis, regulators swiftly introduced policies to support the development of telemedicine. As the value of such services has gained clear recognition, digital therapeutics (DTx) are moving from the margins to the mainstream. With continuous capital inflows, related technologies are also advancing rapidly. Governments are strongly supporting the growth of digital health, and healthcare institutions are expected to embrace and adopt digital therapeutics in practice. This will enable patients to receive more efficient medical services, ultimately reshaping the daily health journey of every individual. Over the next decade, we will see digital therapeutics enhance national healthcare standards by improving healthcare delivery, disease prevention, care coordination, and health management, while simultaneously reducing expenditures for patients, national health insurance programs, and commercial insurers. Digital therapeutics can significantly alleviate the workload of healthcare professionals, improve medical efficiency, reduce hospital admission and readmission rates, and minimize unnecessary emergency department visits. Furthermore, they allow us to control and lower healthcare costs while improving quality of care and expanding coverage. This is particularly important for China and other developing countries with relatively scarce medical resources.

Chen Kaishen, Founder and CEO of Shuyu Medical Technology:We observed that the Chinese government began to pay close attention to the emerging field of digital therapeutics in 2022. In the first month of the year, a medical device registration certificate was approved for the digital therapeutics industry. We look forward to the introduction of clearer regulatory requirements by the state in this field in 2022, helping companies clarify the registration pathway; thereby enabling more patients to benefit from remote diagnosis and treatment in the era of mobile healthcare.

Ying Li, General Manager of the Market and Digital Therapeutics Center at Weimai:As an emerging field, digital therapeutics (DTx) faces numerous challenges during its development, such as the lack of unified industry standards, policy guidelines for clinical trials, and clear classification definitions. However, with the growth of the domestic DTx ecosystem, more innovative DTx enterprises and industry associations are expected to emerge, establishing DTx standards tailored to China’s medical environment through continuous development and exploration. In the initial stage, DTx must be patient-centered, grounded in evidence-based medicine, and involve the joint participation of clinicians and multidisciplinary teams (MDT). It is essential to address the needs and value of physicians in healthcare services to gain their recognition and engagement. On this basis, DTx can accumulate substantial clinical data, validating its clinical pathways by linking hospital electronic medical records (EMR) with real-world data from whole-disease management service systems. I believe that more DTx products validated by evidence-based medicine will be implemented in public hospitals. Meanwhile, guided by the concept of the metaverse and framed by evidence-based medicine, the DTx industry will create more convenient human-computer interaction models for health care services and foster the development of supporting industrial chains in 2022. This will further propel the advancement of DTx, bring new hope to patients with specific diseases, and promote the integrated development of “prevention-treatment-rehabilitation” in China’s healthcare services.

Kang Cheng, CEO of Xuzhishi Technology:The key trends in 2022 are primarily threefold. First, digital therapeutics (DTx) and the metaverse will begin to converge, significantly accelerating the widespread adoption of DTx. Second, DTx will expand its comprehensive applications across various medical specialties, evolving from a current focus on single, isolated indications to a broader range of conditions. Third, pharmaceutical and medical device companies will develop profound and urgent demands for DTx, potentially progressing from their current wait-and-see stance to small-scale pilot trials.

Zhang Liang, Deputy General Manager of Yuanxin Huibao:First, the fundamental purpose of corporate product innovation is to achieve commercialization. The key lies in whether the commercial pathway for digital therapeutics (DTx) can be validated, and identifying who will “pay” for DTx remains one of the most pressing concerns within the industry. For instance, in the mental health sector, due to limited service accessibility and insufficient breadth and depth of payer coverage, although DTx can attract a certain volume of self-paying users, the high churn rate among these users restricts the stability and scale of company revenues. Consequently, there is a need to pivot toward B2B business models, leveraging payers to expand revenue streams. Second, at present, the overall logic for scaling and commercializing digital therapeutics remains undetermined. The application of DTx is still in its early stages, and it may take several more years to clarify which business models will yield win-win outcomes for various stakeholders in society. Third, digital therapeutics have become one of the significant innovative trends in the digitalization of the healthcare industry, with the market poised for rapid expansion over the next five years. With increased capital injection, greater investment in research and development, and improved public awareness, DTx will soon penetrate deeper into rehabilitation and clinical treatment fields for a wider range of diseases, making significant strides in high-profile areas such as depression and autism. Its pace of development depends on multiple factors, including government policies, market education, and patient awareness. Fourth, the post-pandemic era has pressed the acceleration button for the development of digital therapeutics. To meet the surging demand for remote consultations, online diagnosis and treatment, and industrial digitalization, the advantages of DTx—such as remote accessibility, portability, and personalization—will become increasingly important in healthcare, acting as a “depth charge” that disrupts the digital health industry. Fifth, China will establish and leverage collaborative platforms for proactive health intervention technologies, further deepening international exchange and cooperation in the field of digital therapeutics. Sixth, most digital therapeutic products will remain in the design and proof-of-concept stages. While the algorithms of DTx can demonstrate efficacy in small-sample randomized controlled trials (RCTs) and obtain regulatory approval for market launch, these algorithms will continue to be optimized as real-world patient cohorts expand rapidly. Therefore, how to regulate the updates and iterations of these software-based digital therapeutic products after they enter the market is another challenge the industry will face in the future.

Wang Kai, Assistant General Manager of Yuanxin Medical Technology:After several years of development, digital therapeutics (DTx) are poised to integrate with a broader range of technologies, optimizing medical device performance and assisting in diagnosis and treatment. Through integration into clinical practice, DTx is gradually becoming a standard component of clinical care. For patients, particularly those with chronic diseases, comprehensive digital disease management will improve adherence by enhancing disease management strategies and promoting lifestyle changes, thereby achieving better therapeutic outcomes. From a regulatory perspective, digital therapeutics are likely to be incorporated into government regulatory frameworks. Furthermore, DTx will facilitate integrated treatment models for a wider variety of conditions, leveraging Internet-plus and artificial intelligence to collect more real-world data and fully realize the advantages of digital therapeutics. Finally, an increasing number of clinical certifications and translations into practice are expected to occur, enabling China’s digital therapeutics technologies to exert greater influence on global healthcare.

Lin Zhaoyu, CEO and Founder of Zhaoyang Doctor:We have two expectations for digital therapeutics in 2022. First, we anticipate the emergence of more innovative and inclusive digital therapeutics that integrate artificial intelligence, big data, and evidence-based medicine principles, particularly in disease areas with large patient populations and substantial unmet needs, such as depression, anxiety, and sleep disorders. These solutions should serve as a robust complement to existing diagnostic and treatment systems, thereby benefiting a broader range of patients. Second, we expect regulatory authorities to provide clearer guidelines on the definition, industry standards, and policy frameworks for digital therapeutics, thereby fostering orderly, sound, and sustainable development within the industry.

Gao Yunlong, General Manager of Zhilan Health:First, the industry is expected to reach a relatively mature Phase 1.0 by 2022. Most vertical sectors will see the emergence of large-scale companies, including digital therapeutics (DTx) CDMOs, CROs, and sales and distribution platforms. For instance, by aggregating full-process CDMO services for DTx, providers can rapidly assist developers with end-to-end product R&D, covering everything from medical protocol design and regulatory registration to post-market sales and real-world studies, thereby accelerating product launch and the generation of medical value. Second, the medical value of DTx will continue to be realized, with the integration of data and medicine yielding further breakthroughs. As more DTx products enter the market, the value of underlying serious healthcare data will continue to grow. For example, in the management of mother-to-child transmission of hepatitis B, DTx solutions have generated multiple high-impact academic papers based on their data, which have served as the basis for relevant United Nations diagnostic and treatment guidelines, all due to the medical value derived from innovative data.