Align Technology, Inc.

Overview

Align Technology, Inc. is a global medical device company that designs, manufactures, and markets:

• Invisalign clear aligners for treating malocclusions
• Vivera retainers for retention
• iTero intraoral scanners and related software and services for dentistry
• exocad CAD/CAM software for dental laboratories and practitioners

The company operates the Align Digital Platform, an end-to-end suite of software, systems, and services that connects patients, doctors, labs, and consumers across digital treatment workflows.

Core products and platforms

• Invisalign System: Doctor-prescribed clear aligners created from a computer-simulated ClinCheck treatment plan. The workflow includes transmission of diagnostic data, digital treatment planning, manufacture of custom aligners (using 3D-printed molds), and sequential wear of aligners.
• iTero intraoral scanners: Handheld scanners for digital impressions with integrated software for orthodontic and restorative workflows. Newer generations include iTero Lumina and Lumina Pro (with NIRI) for enhanced imaging and restorative capabilities.
• exocad CAD/CAM software: Digital restoration workflows for labs and dental practices; licensed and sold separately.
• Align Digital Platform: Integrates the stages Connect, Scan, Diagnose, Plan, Treat, Monitor, and Retain. Platform tools include Invisalign Outcome Simulator Pro, iTero TimeLapse, iTero Design Suite, and Align Oral Health Suite.
• 2025 technology updates: Restorative capabilities for iTero Lumina, AI-driven features such as X-ray Insights, and updates to multiple iTero software workflows.

Segments and revenue mix

• Operating segments:
  • Clear Aligner
  • Imaging Systems and CAD/CAM Services (Systems and Services)
• 2025 revenue mix: Clear Aligner net revenues ≈ 80% of worldwide net revenues; Systems and Services net revenues ≈ 20%.

Scale and reach

• Patients treated: Over 22 million people worldwide have been treated with the Invisalign System.
• Doctors: Approximately 130,015 active Invisalign-trained doctors (as of December 31, 2025). Active defined as doctors who submitted at least one Invisalign case in the prior 12 months.
• Employees: Approximately 20,290 employees (as of December 31, 2025), a decline from 2024 and 2023 levels.
• Global footprint:
  • Sold directly or through authorized distributors in more than 100 countries (as of end of 2025).
  • Fabrication and treatment planning locations: 11 worldwide.
  • Manufacturing facilities (regional): Americas (Mexico), APAC (China), and EMEA (Poland).
  • iTero scanner manufacturing and assembly: Wand fabrication in Ziyang, China and Petah Tikva, Israel; final scanner assembly in Blonie, Poland and Juarez, Mexico; service and repair in Juarez, Mexico.
• Headquarters and regional hubs:
  • Corporate HQ: 410 North Scottsdale Road, Tempe, Arizona 85288
  • Americas regional HQ: Raleigh, North Carolina
  • EMEA regional HQ: Rotkreuz, Switzerland
  • APAC regional HQ: Singapore

Market opportunity and adoption

• Global malocclusion market: Approximately 600 million people could benefit from straightening their teeth.
• Annual Invisalign case starts: About 22 million globally; Align estimates its share of this market at roughly 10% globally.

Manufacturing and resilience

• Regions and facilities are organized to provide proximity to customers and operational redundancy.
• Certified to ISO 13485:2016.
• Multiple manufacturing and digital treatment planning locations support scale and continuity.

Customer channels and delivery

• Primary customers: Orthodontists, general dentists (GPs), prosthodontists, periodontists, oral surgeons, and dental laboratories.
• Sales model: Direct sales force supplemented by distributors and sales agents; also sells to dental support organizations (DSOs) and dental labs.
• Consumer channels: Invisalign accessory products are sold through online and retail outlets, including accessories and whitening systems.
• Training and education: Invisalign training is required for doctors, supported by ongoing clinical support and education programs.

Intellectual property and regulatory footprint

• Intellectual property: Broad patent portfolio and proprietary software/algorithms, including ClinCheck, iTero software, and exocad integration.
• Regulatory framework: U.S. FDA premarket clearance/510(k) pathway; EU Medical Device Regulation compliance; ISO 13485:2016 certification; privacy, data protection, and cybersecurity compliance across multiple jurisdictions.

Strategic elements (2024–2025)

• Cubicure acquisition (completed January 2024): Provides direct fabrication and 3D printing capabilities to scale direct fabrication, reduce resin usage, and support mass production of custom devices.
• Product and workflow expansion: Continued push into restorative and digital workflows, AI-enabled insights, and expanded ortho-restorative capabilities (e.g., iTero Lumina Pro, Align X-ray Insights, Outcome Simulator Pro enhancements).

Summary

Align Technology designs and sells the Invisalign System and iTero intraoral scanners, supported by the Align Digital Platform and exocad CAD/CAM software. The company operates two main business segments (Clear Aligner and Systems & Services), maintains a large international footprint, serves thousands of doctors, employs tens of thousands of people, and had a revenue mix in 2025 weighted toward clear aligners at about 80%.