[Edaily Reporter NA EUN-KYUNG ] The technological competition between Align Technology, the undisputed leader in the global clear aligner market, and Graphy Inc., the South Korean company, is entering an intriguing phase. This comes as Align Technology—which has grown the market using thermoforming methods for over 20 years—has recently accelerated its efforts to secure direct 3D printing technology. It appears that the world’s leading company is now making a full-scale push into the direct printing method that Graphy Inc. was the first to commercialize.

Of course, there is still a significant gap in scale between the two companies. Align Technology’s “Invisalign” is estimated to hold approximately 50% of the global clear aligner market. The cumulative number of patients treated with Invisalign surpassed 23 million this year, and as of the end of last year, more than 295,000 healthcare professionals had completed Invisalign training and were treating patients.

In contrast, the cumulative number of clinical cases worldwide for Graphy Inc.’s shape-memory alloy (SMA) clear aligners is still only 300,000. While this figure—derived by extrapolating from material usage—cannot be directly compared to Invisalign’s cumulative patient count, it is clear that there is a significant gap in accumulated market experience.

In the Korean market as well, Graphy Inc. is still very much a challenger. Although the exact, up-to-date market share by brand has not been disclosed, the existing heat-forming method accounts for more than 90% of the domestic clear aligner market, while Graphy Inc.’s market share is estimated to be less than 10%. However, Graphy Inc. is experiencing rapid growth, with the number of domestic dental clinics subscribed to its SMA ordering platform increasing from approximately 300 at the end of 2024 to about 450 at the end of last year, and to about 800 as of this year.

“Direct Printing”

Instead of Thermoforming… A Technological Race That Even the World Leader Has Joined

The weapon Graphy Inc. has chosen to take on the global leader is a material and manufacturing process that differ from existing clear aligners. Align Technology’s flagship clear aligner is produced by scanning the patient’s mouth, 3D-printing step-by-step tooth models, and then thermoforming a clear sheet over them. Graphy Inc.’s SMA, on the other hand, uses TA-28—a shape-memory material—to directly 3D-print the aligners tailored to each patient’s needs.

What is particularly noteworthy is that Align Technology has also recently been actively pursuing the acquisition of direct 3D printing technology. In January 2024, Align Technology acquired Cubicure, a company specializing in direct 3D printing in the field of polymer additive manufacturing, for approximately 79 million euros (about 127.6 billion won). The company views this technology as the foundation for “next-generation aligner manufacturing” and plans to expand its production capabilities to enable the direct printing of millions of customized devices per day in the long term.

The company has also commercialized direct 3D-printed products. Align Technology is producing the “Invisalign Palatal Expander”—used to widen the upper jaw—using direct 3D printing. This is the company’s first directly 3D-printed orthodontic device. While its flagship aligners are still produced using the thermoforming method, the company is expanding its technological scope toward directly printing the clear aligners themselves in the future.

For Graphy Inc., the fact that the global market leader is moving in the same technological direction presents both an opportunity and a threat. While this signals the potential for direct-printing technology to establish itself as the next-generation manufacturing method for clear aligners, competition could intensify significantly if Align Technology fully enters the market, leveraging its massive R&D budget, production capacity, and network of healthcare professionals.

However, Graphy Inc. believes that the barriers to entry lie not in 3D printing itself, but in shape-memory materials and the technology required to transform them into actual orthodontic aligners.

Graphy Inc. official expressed confidence, stating, “The fact that global companies are entering the direct-printing market means that clear aligner manufacturing technology is evolving in the direction we have been focusing on from the very beginning,” but added, “To directly print shape-memory materials and transform them into aligners usable for actual treatment, we must secure not only material technology but also process technology that reliably ensures printing, post-processing, and stable shape-memory performance. “Graphy Inc. has built up significant barriers to entry by accumulating technology and experience throughout this entire process,” the representative said confidently.

‘23 Million Patients’ Clinical Data’ Align vs. ‘Shape-Memory’ Graphy Inc.

The TA-28 developed by Graphy Inc. has the property of returning to its originally designed shape at oral temperature. Graphy Inc. explains that by utilizing this restorative force, it can continuously apply a relatively constant force to the teeth, thereby increasing treatment efficiency compared to existing thermoformed clear aligners.

Another distinguishing feature is the ability to minimize the use of “attachments”—small protrusions bonded to the tooth surface. In conventional clear aligners, resin attachments are sometimes bonded to teeth to move them in specific directions. Graphy Inc. explains that by utilizing the restorative properties of shape-memory materials and adjusting the thickness of the aligners, the reliance on attachments can be reduced. The rationale is that reducing the treatment time required for attachment and removal not only enhances patient convenience but also improves the efficiency of dental practice.

Data presented by Graphy Inc. also revealed differences in treatment duration. When comparing cases with similar diagnoses and types of malocclusion, an Invisalign case involving Class I malocclusion accompanied by overbite (a condition where the upper teeth cover the lower teeth more than normal when the mouth is closed) and mild crowding took 2 years and 6 months to treat, whereas an SMA case with more severe crowding was completed in just 1 year.

In other similar cases, the treatment duration for SMA was found to be shorter: 9 months for SMA compared to 1 year and 4 months for Invisalign, and 6 months for SMA compared to 1 year and 5 months for Invisalign. Since there have been no clinical studies directly comparing SMA and Invisalign under identical conditions, it is difficult to generalize this data as a direct indication of one product’s superiority over the other; however, Graphy Inc. claims, based on these clinical cases, that SMA can reduce treatment time by approximately 6 to 18 months compared to existing heat-moldable clear aligners.

Price is another weapon Graphy Inc. has chosen to penetrate the market. As a late entrant, Graphy Inc. has set its prices lower than those of Invisalign. While prices vary depending on the clinic, case, and treatment duration—making a blanket comparison difficult—it is reported that the cost of SMA treatment for patients is approximately 50–80% of that of Invisalign.

Changes in manufacturing methods also make a difference from an environmental perspective. The conventional thermoforming method involves printing stage-by-stage dental models of the patient and then molding and cutting plastic sheets over them, resulting in waste from the used models and the cut-off sheets. In contrast, Graphy Inc. explains that since the aligners themselves are printed directly using a 3D printer, intermediate dental models are unnecessary, and material waste can be reduced.

Align Technology also emphasized, at the time of its acquisition of Cubicure, that direct 3D printing eliminates the process of creating intermediate molds, enabling more sustainable and efficient production. This means that both companies are moving in the same direction—direct printing—not only in terms of treatment efficiency but also in production efficiency and environmental impact.

Of course, changing market standards is not something that can be achieved through technology alone. Invisalign possesses a moat consisting of experience treating over 23 million patients, a vast amount of clinical data, high brand recognition, and a global network of healthcare professionals.

Ultimately, the key lies in how quickly Graphy Inc. can establish “direct printing” as the market standard. Graphy Inc. is also investing significant effort in the acquisition of Ray Co., Ltd. and its collaboration with Megagen Implant not only to demonstrate technological prowess but also to secure a business foundation spanning production, distribution, and clinical applications. The company plans to accelerate its expansion into overseas markets by combining the first-mover advantage of direct 3D printing and shape-memory materials with the global networks of Ray Co., Ltd. and Megagen Implant.

A dental industry insider noted, “Invisalign still holds overwhelming competitive advantage in terms of brand recognition and clinical data,” but added, “Changes in materials and manufacturing technologies are beginning to take shape in the clear aligner market as well. If Graphy Inc. can demonstrate the benefits of direct 3D printing and shape-memory materials through actual treatment outcomes and accumulate sufficient clinical data, it will have a chance to compete in the global market.”