Regulations Limit Orthopedic Biomaterials Across U.S. and Europe Markets – New Study by iData Research

VANCOUVER, British Columbia–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/healthcare?src=hash" target="_blank"gt;#healthcarelt;/agt;–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.

Embryonic Stem Cell Research Limitations Hamper U.S. Market

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.

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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.

Growth Factors and Stem Cell Regulations Negatively Impact European
Market

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% throughout the forecast period, assuming
favorable regulation shifts take place.

Further Information

To browse all of our research on the orthopedic biomaterials market,
visit https://idataresearch.com/product-category/orthopedics/orthopedic-biomaterials/.
Reports include in detail analysis with forecasted market values, unit
sales, average selling prices, market shares, procedure volumes and much
more.

About iData

iData
Research is an international consulting and market research firm
dedicated to empowering confident strategic decisions within the medical
device, dental, and pharmaceutical industries.

Contacts

Joel Harrison
604-266-6933
[email protected]