Study: Regulations Limit Orthopedic Biomaterials Across U.S., European Markets

Orthopedic biomaterials are highly desirable. They are capable of producing specific biological actions or regenerative responses that are beyond what is observed in normal healing. As such, these materials are often used as substitutes for autograft materials. iData Research reports notable growth is happening in the $3.6 billion dollar U.S. market, as well as the just over $600 million dollar European market. However, regulations in both Europe and the United States are significantly limiting the growth potential.
 
In the United States, a ban was placed on embryonic stem cell research in 2001, which restricted research to mesenchymal stem cells (MSCs), which are less potent. Although the ban was lifted under the Obama administration in 2009, MSC research continues to be focused on, due to the long research times of embryonic stem cells.
 
New orthopedic biomaterials are an attractive option for patients who are looking to avoid surgical implantation of permanent devices or hardware. Orthopedic surgeries are generally complicated, multi-stage procedures that result in longer recovery times and increased blood loss. In particular, bone marrow concentrates, stem cells and synthetics are promising agents for the treatment of orthopedic disorders.
 
The cellular allograft segment only accounted for one-tenth of the total U.S. market value. However, it is currently experiencing the greatest growth, with a market value that’s expected to double by 2025. Cellular allografts combine allograft bone with stem cells. This allows the stem cells to display unprecedented regenerative abilities in that they can differentiate into new osteoblasts and provide osteogenic properties, leading to new bone formation. Growth in this market is expected to continue as it stabilizes throughout the forecast period at a CAGR in the double-digits.
 
In the European market, regulations on growth factors and stem cells will place more stringent regulatory hurdles on new products than those introduced in the past, which adds considerable expense to product development.
 
The cartilage repair industry is currently experiencing the most significant growth of any segment in Europe, with autologous chondrocyte implantation taking center stage. This segment is expected to grow at a substantial CAGR of around 11 percent throughout the forecast period, assuming favorable regulation shifts take place.
 
iData Research is an international consulting and market research firm dedicated to empowering confident strategic decisions within the medical device, dental, and pharmaceutical industries.