How Off-Label Sales are Challenging the Dental Biomaterials Market in Latin America

Dental biomaterials

In Latin America, off-label sales within the dental biomaterials market have become increasingly popular as they promise to deliver premium quality products at a reduced cost, which is appealing to many customers in the current economy. Our latest dental biomaterials and dental bone graft substitute (DBGS) market report indicates that many imitation products are likely a major component of the market, with a particularly heavy presence in the more lightly regulated areas such as xenografts and synthetic materials. Through this blog post, we will explore the current market and dive into the complications that are associated with off-label sales.

​​What is the Current State of the Latin American Dental Biomaterials Market?

The dental biomaterials market is growing at a slightly higher rate to that of dental implants. In 2022, the market displayed double-digit growth and surpassed its historic pre-COVID-19 market value level. Growth in this market is generally driven by the same trends observed in the dental implant market (such as technological developments and increased consumer awareness) and is closely tied to growth in the dental implant market as a greater proportion of implant procedures require the use of biomaterials.

Which Dental Materials are at Risk of Being Imitated?

Off-label sales tend to replicate those products that are less regulated, such as xenografts and synthetics. Xenograft materials are bone graft substitute (BGS) materials derived from another species. In dentistry, bovine bone is the most common source of xenograft materials. Xenografts are known for their high degree of osteoconductivity but, like allografts, have low levels of osteoinductivity. On the other hand, synthetic materials are the only type of BGS materials that do not come from human or animal bone. Synthetic materials pose no risk for disease transmission and are not harvested from patients. Typically, there are three primary materials used in synthetic BGS: hydroxyapatite (HA), collagen and hard-tissue replacement (HTR) polymer.

Why are Cheaper/Off-Label Alternatives Preferred (in some cases)?

The fragile economy within Latin America and the current economic situation has altered the consumer preferences for dental biomaterials, making them more price-sensitive. As such, inexpensive alternatives offered by local brands have dominated the market and will continue to do so for the foreseeable future. Due to poor income standards, the bulk of the population cannot afford an expensive dental procedure. Furthermore, the lack of accessibility to insurance policies encourages customers to turn to inexpensive solutions.

What are the Complications of Off-Label Sales?

First and foremost, off-label dental biomaterials jeopardize patient safety and health. Using untested and unapproved products can lead to severe complications such as infection, tissue death, and implant failure. Additionally, off-label sales hinder the growth of the legitimate dental biomaterials  industry, leading to revenue loss for authorized companies like Geistlich and Strauman Group. In countries like Brazil, Mexico, and Colombia, the regulatory framework for dental biomaterials is not as robust as in other regions, making it easier for companies to engage in off-label sales.It is projected that going forward, off-label sales will remain a substantial portion of the Latin American dental market, given that cost consciousness is still a prominent factor, substantially dragging down the average selling price of DBGSs.


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