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- Align markets its products mainly to dentists and orthodontists, with small attention also given to direct-to-consumer (DTC) sales.

- Align has established marketing campaigns in all countries where their products are sold in order to help educate dentists and orthodontists in determining eligible candidates for their clear aligner process. The goal is to inform potential patients on treatment options and to then direct them to high volume Invisalign providers.

- In addition, Align has recently emphasized an effort to increase sales through quota-carrying sales representatives

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- Align is unique in the way they have a small product line that focuses on a very specific market - therefore there are few comparable companies that focus on a similar market and operate under a similar business plan.

- Danaher Corp. - A global conglomerate in the Healthcare Equipment and Supplies Industry that produces traditional braces, which is a direct substitute for Align's Invisalign technology.

- Dentsply Sirona - A dental equipment maker and dental consumables producer which poses competition to Align
through its CAD/CAM software, traditional brackets, and
BioBite Corrector. Dentsply also produces the MTM Clear
Aligner, which is in direct competition with Align’s Invisalign,
but only for mild cases of malocclusion.

- Henry Schein - A healthcare product and service distributor that distributes the DEXIS Platinum Digital Radiography System, the Dentsply Sirona Intraoral Sensor, and other dental scanners that are in competition with Align’s iTero Scanner and Software

- SmileDirectClub - Align's most direct competitor in the clear aligner market. Offers an at-home solution of clear aligners to patients with mild cases of malocclusion. Align currently hold 19% ownership in SDC and manufacture the SmileDirectClub aligners

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Background Information about Align Technology Inc.

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Background Information about Align Technology Inc.

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"Align Technology is a global medical device company engaged in the design, manufacture and marketing of the Invisalign® system, the most advanced clear aligner system in the world, and iTero® intraoral scanners and services for orthodontic and restorative dentistry. Align’s products help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients"

Founded: 1997
Employees: 13,685
Annualised Revenue: $2.2B
Over 7.2 million patients treated using Invisalign

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- The legal framework and institutions need to be robust enough to protect Align's intellectual property rights - if the data protection laws are not robust enough and data is stolen then Align will lose its competitive advantage

- Discrimination laws are placed by the government to protect the employees and ensure that everyone in Align is treated fairly and given the same opportunities, regardless of gender, age, disability, ethnicity, religion or sexual orientation

- Health and safety laws for employees must be implemented - ethical and social responsibility

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- Develop a new material for Invisalign that is recyclable as opposed to having to throw each pair in the bin is a top priority for Align in the near future

- Align does produce a large amount of waste and certain countries may require them, by law, to manage their environmental habits through pollution fines and quotas

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- Advances in technology have the potential to completely disrupt any industry - e.g the transportation industry, Uber now dominates the taxi industry, automation has been disrupted by Google and manufacturing has been disrupted by Tesla with its electronic cars.

- It is extremely important to constantly and consistently innovate, not only for the sake of maximizing possible profits and becoming a market leader but also to prevent obsolescence in the near future

- Align needs to monitor any technological breakthroughs and developments made by its competitors and see its potential impact on the industry in terms of improvements in revenue and productivity - this will determine how quickly they need to act

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- Demographics and skill level of the population, the class structure, hierarchy and power structure in society

- The differences in educational background between the marketers and the target market may make it difficult to relate to and draw in the target market effectively. Align should be very careful not to lose the connection to the target market's interests and priorities.

- The class distribution among the population is of paramount importance: Align would be unable to promote a premium product to the general public if the majority of the population was a lower class; rather, they would have to rely on very niche marketing.

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- The economic system that is currently operational in the Medical Appliances and Equipment sector (Monopoly, Oligopoly, etc) and the stability of the it

- Rate of GDP growth, the interest rates and the exchange rate of the country. The unemployment rate as well as the skill level and education level of the workforce.

- The level of government intervention in the free market as well as the labour costs and productivity in the economy

- The quality of the infrastructure in the industry and any comparative advantage of the country in the sector

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- Level of political stability that the country has had in recent years and the importance of the Medical Appliances and Equipment sector in the country's economy

- Level of corruption, for example in levels of regulation in the Healthcare sector

- The laws that the country enforces, especially with regards to business, such as contract law, as they dictate what Align is and is not allowed to do

- Whether or not Align's intellectual property (IP) is protected

- The trade barriers that the host country has would protect Align; however, trade barriers that countries have with potential trade partners would harm companies by preventing potential exports

- The level of taxation and whether the company has a minimum wage set up in place are also factors that must be considered if Align are going to set up or supply their products to a country.

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- As of December 31, 2017, Align Technology had 420 active U.S. patents, 456 active foreign patents, and 416 pending global patent applications. However, one of the largest threats Align is currently facing is increased competition due to patent expirations. In October 2017, over 40 of Align’s early patents,
mainly protecting their clear aligner manufacturing process, expired. Over the next ten years, Align will experience patent expirations at a rate of 23 per year. This is concerning as it will allow other firms to start using Align’s far superior process for making and designing clear aligners.

- Align has a large dependence on single-source suppliers when it comes to raw materials used to construct their products. Align relies on these suppliers for resins, polymers, and a number of
mechanical components. If one supplier fails to meet the company’s needs, it could potentially create a concerning roadblock for future case shipments.

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- Align Technology has expanded into China and India with its
Invisalign treatment plants and doctor training facilities. These
centres will train local dentists and orthodontists and provide
them with Invisalign products to prescribe to patients. This
represents a tremendous opportunity for expansion for Align.

- Two of the biggest opportunities Align will encounter moving forward are their growth potential in foreign markets and recent product development and innovation. From 2016 to 2017 Align saw a 52.3% year-over-year increase in the volume of Invisalign cases shipped. This increase was driven primarily by stronger performances in their Asia-Pacific (APAC) and European, Middle East, and Africa (EMEA) markets. Therefore, Align will continue to see above-average growth in these countries due to the large potential case population and the already high adoption rate. These regions saw a particularly large growth in revenues from iTero scanners. This will directly correlate with an increase in the number of case shipments due to orthodontists’ ability to conduct intraoral scans on patients – a must for an Invisalign case to be sold

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- Align’s greatest weakness is their dependence on a rather small number of products, with 70% of net revenues coming from clear aligners alone. If the clear aligner segment underperforms as compared to expectations, if comprehensive product revenue growth is not met, or if at any time demand falls, Align could experience a significant reduction in their bottom line.

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- Since company inception in 1997, Align Technology has
maintained a clear focus on product and manufacturing
innovation.

- Over the next year, Align is looking to roll out two new
products: “Phase 1” and the modified G5 precision bite ramps.
“Phase 1” will be the first set of clear aligners in the industry
designed for treating younger patients between the ages of 6 and
10. This will significantly affect case volume as 20% of all orthodontic case volume comes from patients ages 6-10. The G5 precisions bite ramps will extend the application of Invisalign products to treat deepbite malocclusion. This is very positive for Align’s continued success and longevity as 45% of orthodontic cases worldwide involve occurrence of deep-bite malocclusion. The modified G5 will enable Align to market the Invisalign product to an entire new set of customers.

- Currently, Align’s clear aligner product lines address 60% of the
orthodontic market. However, management released statements
in early April conveying the ability of their new products to
increase their addressable market to 70% of orthodontics.
Entire Orthodontics Market

- Manufacturing innovation has been another staple of Align’s
vision. Some of Align’s earliest patents centred around cutting edge clear aligner manufacturing processes. Starting in 2018,
Align will begin to replace its SLA 3D printer with the new
Figure 4, which will allow aligners to be formed directly
(without a mold), and with trimming and quality inspection in
one machine (compacting four steps into one). In addition, this equipment will enable Align to produce its products quicker, more efficiently, and with less defects. Ultimately, the new Figure 4 will allow Align to realise significant reductions in their cost of net revenues.

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- The Healthcare Equipment and Supplies industry operate in a
fast-evolving market where technological innovations oftentimes dictate company differentiation.

- For companies operating within this industry, it is a constant race for competitive advantage through product innovation, in order to ultimately meet consumer demand.

- In addition, in the face of ever-changing government regulation, it can be somewhat difficult for companies operating in this industry to stay on top of such regulation while also maintaining focus on evolving customer needs.

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- Firms in the Healthcare Equipment and Supplies industry have a
high risk of substitute products capturing market share. High
margins in the industry, along with a changing technological
environment, enable companies to produce more products that
have the capability of becoming substitutes.

- A clear substitute for Align’s products are of course traditional braces; four million people in the U.S. alone wear braces. However, Align has a major competitive advantage in the clear aligner space when it comes to the threat of substitutes because of their patents protecting their cutting-edge treatment of moderate-to-severe malocclusion.

- Align's competitors include Smile Direct Club (SDC) who are the most direct competitor in the clear aligner market. SDC offers an at-home solution of clear aligners to patients with mild cases of
malocclusion.

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-  The main suppliers in this industry are firms that provide raw materials to be used in the production of medical devices and supplies - this is fairly standardised, low differentiation and has low switching costs and there are also a lot of potential suppliers of similar materials for Align to pick from

-  Healthcare Equipment and Supplies providers can often negotiate with multiple suppliers, thus reducing their dependency on a single supplier

-  The large firms in the industry
do not simply look to bargain on price for raw materials; they
also look to reduce the risk to their supply chain by decreasing
their dependency on one supplier

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- The number of suppliers in the industry in which Align Technology Inc operates is a lot more than the number of firms producing the products. This means that the buyers have a few firms to choose from, and therefore, do not have much control over prices -  the bargaining power of buyers a weaker force within the industry

- The product differentiation within the industry is high, which means that the buyers are not able to find alternative firms producing a particular product - this difficulty in switching makes the bargaining power of buyers a weaker force within the industry

- Align’s customers have few choices if they are looking to begin using
clear aligners, especially if they suffer from moderate-to-severe
malocclusion - for a buyer to gain bargaining power over Align,
they must be willing to accept using traditional braces

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- As is the case for most firms in the healthcare sector, R&D costs are extremely high and require significant cash, capital and labour to finance - creating a moderately high barrier to entry

- Economies of scale are difficult to achieve in this industry - Align is already producing and supplying at large capacities they have a cost advantage over new firms - therefore the threat of entrants is a weak force

- Products in the healthcare sector need to have a high degree of differentiation to stand out in a crowded marketplace - customers are inclined to look for differentiated products - strong emphasis on advertising and customer services - therefore the threat of new entrants is a weak force

- Strict government policies mean that companies require strict licencing and legal requirements to be fulfilled before they start selling to consumers - more difficult for new firms to enter the market

- Access to distribution channels for new entrants is easy - there are only a few major players so a new entrant can get noticed easier - the threat of new entrants is a strong force

- Code of Federal Regulations Code 21, medical devices are classes into 3 categories, with Class III being the most regulated - Both of the devices Align produce are Class II devices (Invisalign + iTero Scanner)