For nearly 20 years, Align Technology — the maker of Invisalign — operated a virtual monopoly in clear aligners by fiercely protecting patents for its computer-aided design (CAD) and manufacturing (CAM) systems. CAD/CAM technology ensures each clear aligner fits the precise specifications of each unique patient at each stage of treatment. Without it, the type of mass customization required for clinically viable clear aligner treatment is impossible (or at the very least meaningfully inferior and extremely difficult to deliver at scale).

In 2017, these CAD/CAM patents expired, opening the doors to competition. One narrative prophesied new entrants would commoditize the market, compress margins, and cast Invisalign aside. That didn’t happen — and likely won’t — but the competitive landscape still looks vastly different now.

For most of Align’s history, the challenge was proving the clinical viability of clear aligners as a treatment for malocclusion (misaligned teeth). Today, clear aligners are a widely accepted alternative to metal braces, but the challenge is driving adoption (among both doctors and patients) and differentiation in a crowded marketplace.

The technology and processes required to produce a competent clear aligner offering takes time to develop, so real competition didn’t emerge overnight. But now, more than five years later, several firms have developed noteworthy solutions and are pursuing various strategies of differentiation.

On the direct-to-consumer side, Smile Direct Club, Candid, Byte (owned by Dentsply Sirona), Dr. Smile (owned by Straumann) and several others have joined the marketplace. I won’t spend too much time on this segment because I’m skeptical of the business model (it requires inordinate marketing expense to drive patient traffic), the application is generally limited to low acuity cases, and a truly viable competitor has yet to emerge.

DTC treatment also doesn’t use an intra-oral scan, which can result in overcorrection, poor bite formation, and other issues related to roots. Regardless of the business model challenges, the clinical efficacy is questionable.

Candid exited the DTC business in January 2022 (perhaps after recognizing this) to focus on CandidPro, which integrates its technology into practices. This may be a better strategy, but it remains nascent with only ~23,000 patients to date.

Invisalign’s direct competitors sell to orthodontic and dental practices. These include SureSmile (owned by Dentsply Sirona), Spark (owned by Envista), ClearCorrect (owned by Straumann), and Angel Aligner (in China).