Invisalign uses 3D printing and data from millions of mouths to generate their aligners. For each patient, a 3D image of teeth is taken with an iTero Element scanner. ClinCheck software, which is built on data from 6 million individuals, is used to map tooth shifts. A preview shows the predicted outcome of the treatment. Aligners are printed using SmartTrack material engineered for the Invisalign system.
In North America in 2016 Invisalign products were used in about 8% of the 3 million new orthodontic patients. Several patents for Invisalign products expired in 2017 but it is thought that their lead in process development and scale of delivery can keep them competitive.An average Invisalign case will entail design and prediction of individual tooth movement from start to finish for production of 30-60 custom aligners.The Invisalign Smile Concierge program was launched in January 2017 in the U.S. to help consumers schedule appointments with Invisalign providers in their area.
Invisalign products include Invisalign Full, Invisalign Teen, Invisalign Assist, Invisalign Express and Vivera Retainers. For Dentists and Orthodontists who wish to become providers, Align Technology they can take a live in-person Invisalign Fundamentals course or complete a completely online course.
Align’s proprietary SmartTrack aligner material, launched commercially in 2013 and patented in 2017, is a multi-layer polymer (aromatic thermoplastic polyurethane/copolyester) which delivers gentle, constant force for tooth movements and conforms precisely to teeth, attachments and interproximal spaces. SmartForce attachments are small tooth-colored shapes that are placed onto the teeth before and during an Invisalign treatment. The attachments act as handles and help aligners apply the right amount of force in the right direction. Not all Invisalign users will need SmartForce attachments. Align Technology has clinical data which shows that compared with clear aligners made with off-the-shelf single-layer 0.30-inch material, Invisalign aligners with SmartTrack material achieves more than 75 percent improvement in overall tooth movement predictability.
Invisalign is offered in more than 100 countries, as of 2016, including North America, Europe, Asia Pacific and some Middle Eastern, African and Latin American countries. Prices are determined by the doctor and depend on the treatment plan.
The cost of Invisalign treatment varies even from city to city and from patient to patient. The cost can depend on the reputation and experience of the dentist or clinic and for the patient, the amount of treatment required. Providers may cautious about estimating the price until after a full consultation. The cost will be affected by the conditions such as prior tooth decay, missing teeth and how severe the teeth are misaligned. Corrective dental work may be needed before Invisalign braces can be fitted.
Prices are higher for Invisalign treatment in the US, United Kingdom and Australia. In the US, price ranges from $4000-$10000 (as of 2014) and is not usually covered by medical insurance. In the UK Invisalign average cost as of 2014 was £1,500-£5,000 ($2,162-$7,231) and the treatment is covered by the NHS only in cases where the health of the patient is significantly compromised by dental problems, but not for esthetic reasons. In Australia the 2014 average price was between $6000-$9000 and some medical insurances may cover part of the cost.
Align Technology was estimated in 2017 to have 80 percent of the North America clear aligner orthodontics market. In 2017 Invisalign was reported to be offered by more than 50,000 orthodontists and dentists and reached its 4 millionth patient in September of 2016 and sales hit $1 billion that year. Align Technology had a monopoly on clear braces and the technology to digitally map and build the multiple aligners which make up the treatment.
Beginning in October 2017 Align’s patents began to expire and 23 are expected to expire per year until about 2028. Invisalign lost exclusivity on 40 patents in October 2017. Loss of exclusivity plus more sophisticated 3D printing is allowing for more competition in the clear aligner space. In 2018 clear aligners were the largest and fastest-growing global invisible orthodontics market category. At this time Invisalign captured 80 percent of this category, competing with products from companies such as 3M Co. and ClearCorrect. Align was among the best performers in the 2017 S&P 500 Index.
Align has increased its spending on research and development nearly 240 percent since 2009 and the company releases about one new Invisalign product per year. Align Technology initially had pending litigation against SmileDirectClub (SDC) for patent infringement. SDC had a business model whereby customers register online and submit putty impression of their teeth from home, with orthodontists reviewing remotely. Align Technology dropped their lawsuit and made a deal with SDC to supply them with a portion of aligners it ships to customers, have a 17% stake in the company and a seat on the board.
Align entered the China market in 2011. In 2017, Align Technology opened a software facility in mainland China in Chengdu which will help orthodontist design treatments and reduce waiting times. The facility has locally hired technicians and Chinese language software. The Asia-Pacific market was the fastest growing region from about 2014 until 2016.
In November 2017, Align opened its first Invisalign store in San Francisco. It was announced in 2019 that it would close 12 Invisalign stores due to a decision by an arbitrator that it breached noncompete provisions that apply to SDC Financial LLC. In a March 5, 2019 press release, Align Technology stated that the supply agreement with SDC will continue.
Invisalign was invented in the 1990s by Stanford University student, Zia Chishti, while he was undergoing orthodontic treatment and wore a removable retainer. Chishti partnered with Kelsey Wirth and together they founded Align Technology in 1997. At the time of founding Chishti had undergraduate degrees in economics and computer science and Wirth had degrees in literature and American History.
Invisalign aligners were initially developed in Menlo Park, California garage. The early developers had access to a campus lab to develop the computer programming needed for generating the aligner products. In 1998, the Invisalign product was granted FDA approval.
Since the two founders did not have orthodontic credentials or expertise, the Invisalign technology was initially met with resistance from orthodontists. A $31 million TV advertising campaign launched in 2000 helped turn the tides. Orthodontists in the United States were driven by consumer demand to take Invisalign training so they could offer Invisalign as an alternative to traditional braces. In 2001, 75 percent of North America orthodontists had been officially trained to do so.
Align began to turn an annual profit in 2004, a turnaround led by CEO Tom Prescott who joined in 2002. Prescott cut marketing to consumers and focused on marketing to orthodontists and dentists, as well as emphasizing growth in North America over global expansion.
In 2004, co-founder Zia Chishti left Align Technologies and started a competing company, OrthoClear. Align had lawsuits against the competitor with patent infringement allegations, which were settled in 2006. At that time Align effectively forced OrthoClear to shut down when it agreed to buy OrthoClear’s IP for $20 million.
Align Technology opened a software facility in mainland China in Chengdu