Angelalign Achieves 13.5% Overseas Case Share in First Year of Global Commercialization, Files IPO Prospectus

The domestic clear aligner orthodontics market is experiencing rapid growth. According to estimates from Frost & Sullivan’s “Annual Insights Report on China’s Clear Aligner Orthodontics Industry,” the number of clear aligner orthodontic cases exceeded 500,000 in 2023, representing a year-on-year increase of approximately 14.6%, with its penetration rate continuing to rise relative to bracket-based orthodontics. Currently, the overall penetration rate of clear aligner orthodontics remains low, but its share is expected to continue increasing in the future.

Despite the vast market size and rapid growth in China, domestic clear aligner companies have already begun to expand globally amid the wave of overseas expansion, aiming to seize opportunities in broader markets.Over the past year, domestic companies represented by ANGELAIGN and Smartee have all taken steps to expand overseas. Notably, in its first year of formal commercialization of international business, ANGELAIGN achieved 33,000 cases in the international market, accounting for 13.5% of the company’s total cases.

Consumer healthcare and serious medical care differ significantly in their market logic; beyond fulfilling specific needs, consumer healthcare products can also stimulate demand. Therefore, the global expansion strategy for consumer healthcare products should inherently differ.Taking ANGELAIGN’s initial success as an example, how do consumer healthcare products expand into overseas markets?

According to the registration information from the National Medical Products Administration, as of June 2024, more than 100 clear aligner products had been approved in China. Prior to 2019, the number of newly approved products each year was only in the single digits; however, 2022 and 2023 saw an explosive growth period, with as many as 23 products approved in each of those years.

Approval Status of Clear Aligner Products in the Past 10 Years, Source: National Medical Products Administration

In addition to the two major brands, Invisalign and ANGELAIGN, Smartee has been developing rapidly, while companies and brands such as Zhengli and MyLike have emerged. Amid this industry wave, clear aligner orthodontics has gained favor from prominent investment firms, with multiple companies securing financing in succession. Meanwhile, dental material or service providers such as Aidite, Hugel, and Topchoice Medical have expanded their business scopes to include clear aligner products. Companies are continuously enriching their product lines for various age groups, giving rise to a steady stream of new concepts such as rapid correction and multi-colored aligners.

Domestic Clear Aligner Companies with Extensive Product Line Portfolios, Source: National Medical Products Administration, Public Corporate Information

In the early stages of clear aligner therapy, market penetration focused primarily on economically developed regions and first- and second-tier cities. As market education reached a certain level, significant efforts were made to expand into lower-tier markets. At the consumer end, clear aligners from various brands, priced from several thousand to tens of thousands of yuan, cater to different consumer segments.

In short, although the penetration rate of clear aligner orthodontics in China continues to rise, the market has become increasingly competitive as more players enter the field.

In 2023, ANGELAIGN officially launched the commercialization of its international business, expanding into more than 30 countries and regions; within a year, its international operations and performance metrics demonstrated outstanding results.

Annual report data shows that in 2023, ANGELAIGN completed a total of 245,000 cases, representing a year-on-year increase of 33.2%. Of these, 212,000 cases were from the domestic market, up by 15.3% year on year, while international cases reached 33,000, accounting for 13.5% of the total. This indicates that growth in international cases has become a key driver of the company’s overall case volume expansion.

In terms of revenue, ANGELAIGN’s total revenue in 2023 reached RMB 1.476 billion, a year-on-year increase of 16.2%. Of this, revenue from the domestic market was RMB 1.331 billion, up 5.5% year on year, while international market revenue amounted to RMB 145 million, accounting for 9.8% of total revenue and making a significant contribution to overall growth.

ANGELAIGN Case Volume Trends, Source: Company Financial Reports

Reviewing ANGELAIGN’s performance trends in recent years, the company maintained double-digit growth in both case volume and total revenue from 2019 to 2021. This trend shifted in 2022, with case volume increasing marginally by 0.3% and revenue declining slightly. While this change was partly attributable to the prevailing objective circumstances at the time, it also reflected intensifying competition in the clear aligner market.

ANGELAIGN also expressed this view in its annual report,A globalized business layout will significantly mitigate risks associated with reliance on a single market, foster robust competitive advantages, and increase market share.

By 2023, the efforts to expand into international markets yielded immediate results, directly driving a significant increase in case volume and total revenue, and restoring double-digit growth rates.

Selecting an overseas market destination requires evaluation from multiple dimensions, as it directly impacts the subsequent success of global expansion efforts.

The global clear aligner orthodontics market is broadly segmented into several major regions, including North America, Latin America, Asia-Pacific, the Middle East, and Africa. According toGrand View Researchresearch report shows that North America inInvisible Aligner Marketaccounting for the largest share,2021accounted for approximately % of the annual57.3%; however, as time passes and other regional markets_{As the market evolves, the aforementioned landscape will shift: the Asia-Pacific region’s market share will gradually increase, while North America’s market share will shrink.The report also points out that,2023Global Market Size of Invisible AlignersUSD 5.13 billion, with a projected compound annual growth rate (CAGR) of 30.7% from 2024 to 2030，Reach $32.35 billion by 2030.}

GlobalClear AlignersMarket Landscape Trends, Image Source:Clear Aligners Market Analesis

North America, as the birthplace of clear aligner therapy, has a relatively mature market; meanwhile, the Asia-Pacific region, as an emerging market, still holds significant growth potential. ANGELAIGN’s international expansion strategy has targeted more mature markets such as Europe, Australia and New Zealand, and North America.

Discussing the rationale behind this decision, Hu Jiezhang, CEO of ANGELAIGN, told VCBeat that while there are hundreds of small and medium-sized enterprises in the global clear aligner orthodontics sector distributed across various countries, most struggle to achieve scalable operations, with only a few managing to grow substantially and attain profitability. “To achieve operational success, companies must accumulate and iteratively refine their capabilities in product R&D, manufacturing, materials, software, clinical support, treatment plan design, and specialized sales, building profound foundational competencies over decades. We believe that highly professional orthodontists and patients with high standards will increasingly recognize the value of ANGELAIGN.”

Hu Jiezhang also believes that,The global clear aligner market is still in its early stages. Given the high prevalence of malocclusion and the low penetration rate of clear aligners worldwide, a large population stands to benefit from clear aligner therapy for malocclusion correction. It is worthwhile to invest in technological innovation and digital orthodontics to seize significant market opportunities.

In 2022, ANGELAIGN began preparing for its overseas expansion and clarified a strategy to accelerate international business growth through parallel approaches of deep local integration and strategic investments and acquisitions. That year, ANGELAIGN announced the acquisition of Aditek, a Brazilian orthodontic product manufacturer, aiming to leverage Aditek’s extensive local resources and distribution network in Brazil to successfully enter the Brazilian orthodontic market and other potential emerging markets in South America.

“Prior to the official launch of our global operations, we conducted extensive market research, data security and compliance studies, and product registration work, while recruiting professional and experienced local talent,” said Hu Jiezhang.

Building on its earlier foundations, ANGELAIGN officially entered the “global organization + local operations” phase in 2023. Specifically, ANGELAIGN established subsidiaries in the United States, Europe, and Australia, assembling teams of professionals with orthodontic market expertise and in-depth knowledge of local markets. It also set up eight international offices, with foreign employees stationed across Europe, the Asia-Pacific region, and the Americas. Additionally, international talent was recruited into headquarters’ middle- and back-office functions to provide business support to overseas regional markets.

As of the end of 2023, ANGELAIGN’s products and services covered more than 30 countries and regions worldwide, with Europe emerging as one of the fastest-growing markets. Judging from the phased achievements attained by ANGELAIGN,Expanding overseas does not necessarily require starting from untapped markets; mature markets still offer opportunities for breakthroughs. Meanwhile, physicians and patients in mature markets already have a well-established understanding of products, eliminating the need to build market awareness from scratch.

Since Align Technology launched the world’s first clear aligner in the United States in 1999, clear orthodontics has evolved over 25 years. Throughout this period, Align Technology has maintained a dominant position as the global market leader with a significant share advantage. During this time, in addition to the emergence of domestic companies such as Angelalign and Smartee, numerous other product and service providers have entered the global market.

Major Overseas Companies and Brands in the Clear Aligner Market, Source: Public Information

In the global market, dental equipment and consumables giants such as Envista, Dentsply Sirona, and Straumann have established a presence in the clear aligner sector by launching or acquiring clear aligner brands. These industry leaders naturally maintain extensive coverage in mature markets such as Europe and North America. Even dental services giant Henry Schein has launched its own clear aligner brand, Reveal.

Furthermore, Germany’s K Line is a clear aligner manufacturer that offers OEM production services; the company also owns its own clear aligner brand and, through material innovations, has developed a product capable of replacing multiple aligners with a single tray, thereby reducing aligner usage by half.

In summary,Multinational oral care corporations have extensive global business footprints, with years of accumulated expertise in dental devices, materials, technologies, market channels, and orthodontic services, enabling them to leverage existing advantageous resources when expanding into clear aligner orthodontics. Meanwhile, relatively large local enterprises in various countries also possess the advantage of being well-versed in their respective domestic markets.

According to a report by Frost & Sullivan, ANGELAIGN held the largest market share in China’s clear aligner market for three consecutive years from 2021 to 2023 (measured by number of cases). Upon entering the global market, ANGELAIGN faces new challenges, having to compete head-on with Invisalign and other dental giants in mature markets such as North America and Europe.

Hu Jiezhang believes that,Clear aligner orthodontics is a “service-intensive” sector. Going global requires building a large international team to provide customized products and software services to dentists in different countries and regions, as well as conducting professional marketing.“This is not a breakthrough in a single link, but requires companies to accumulate and iterate in product R&D, manufacturing, materials, software, clinical support, treatment plan design, and professional sales; meanwhile, becoming a global enterprise requires an open, inclusive, and collaborative corporate culture; furthermore, data compliance is a crucial foundational capability. ANGELAIGN has always strictly adhered to international and regional data security laws and regulations, adopted optimal measures, and continuously improved through methods such as introducing annual consultations and audits.”

To this end, ANGELAIGN has adopted different market strategies in different regions.

Specifically, in the European market, ANGELAIGN has engaged in in-depth collaboration and training programs with leading key opinion leaders (KOLs) in orthodontics, establishing the ANGELAIGN European Scientific Expert Committee and Clinical Expert Committee. In 2023, the company participated in more than 20 top-tier academic conferences across various European countries, showcasing its products and medical technical service capabilities.

In the Australia and New Zealand markets, ANGELAIGN has transitioned from its previous distribution model to a direct sales model, establishing a local business team with years of experience in the orthodontics market.

In the North American market, ANGELAIGN successively participated in the 123rd Annual Session of the American Association of Orthodontists (AAO) and the Orthopreneurs Summit. While showcasing its solutions, the company drove the adaptation of product technology and medical services based on clinicians’ needs and feedback.

In the Brazilian market, following its acquisition of Aditek, ANGELAIGN has supported the growth of Aditek’s clear aligner business through medical design and intelligent manufacturing. Specific initiatives include providing online training and on-site coaching for Aditek on the digital treatment planning platform and cloud service platform; assisting in the successful completion of Aditek’s digital factory, which has significantly enhanced its intelligent manufacturing capabilities; and enabling Aditek to establish over 50 doctor learning clubs, thereby delivering medical technical training and clinical support to a broader base of orthodontists.

Hu Jiezhang stated,Invisible orthodontic services are highly personalized, with patient needs varying across different countries and regions; however, in every market, physicians remain the core value of medical care.

During the service process, ANGELAIGN’s medical designers build design systems tailored to the treatment preferences of individual dentists worldwide, helping them continuously refine their cases. The middle- and back-office teams have been strengthening global service capabilities; for instance, iOrtho 11.0, the digital orthodontic platform serving dentists, now supports seven languages. “Throughout this process, dentists continually provide us with their expertise and experience, helping us improve our products and services. For example, the angelButton traction system, which has received widespread acclaim among international dentists, is an innovative technology that integrates insights from frontline practitioners. Analysis of hundreds of thousands of cases shows that angelButton can enhance overall treatment efficiency and shorten treatment duration,” said Hu Jiezhang.

In the healthcare sector, ophthalmology subfields such as orthokeratology (OK) lenses and rigid gas permeable (RGP) contact lenses share similarities with clear aligner therapy. From a global market perspective, they have many commonalities:

First, the product originated in developed countries in Europe and America. Domestic enterprises are also engaging in technological innovation. After multinational corporations entered the Chinese market, both parties jointly drove rapid growth in the domestic market.

Second, compared with the developed countries where the products originate, China has a low market penetration rate, rapid growth, and significant untapped market potential. This market characteristic is also a key driver for domestic “follow-on innovation” and for multinational corporations entering the Chinese market.

Third, these products are minimally affected by payment systems such as basic medical insurance and commercial insurance. Instead, they are closely tied to regional economic development, consumer awareness and willingness, and individual purchasing power. Even within the broader category of consumer healthcare—which includes ophthalmology, dentistry, and medical aesthetics—these products exhibit stronger consumer-oriented characteristics.

These commonalities mean that the aforementioned products and companies can draw mutual insights in terms of motivations for global expansion, destination selection, and business strategies. Among them, clear aligner therapy is a sector with a longer development history in the Chinese market and strong product competitiveness, and it has now become a pioneer in overseas expansion.

In general,The global expansion of consumer healthcare remains in its very early stages, with the introduction of new technologies and products still serving as the dominant theme; “going global” and “bringing in” are inherently intertwined.

However, as one of the earliest pioneers to expand overseas, it has been no easy feat to navigate countries with varying economic development levels, adapt to diverse healthcare systems and consumption habits, and compete against multinational corporations that already hold significant market share. The insights gained from these initial explorations are therefore invaluable.