Orthopedic Biomaterials
Realities of the Material World
Aarti Shetty, Industry Analyst
Medical Devices, Healthcare
September 25, 2008

Focus Points
• Introduction
• Segmentation
• Advances in Implant Materials
• Advances in Bone Graft Materials
• Challenges of the Material Market
• Market Future
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Introduction
• While the orthopedic industry has enjoyed double-digit growth
over the past few years, the future is expected to be even
brighter.
• With this anticipated growth in the orthopedic industry, the
demand for raw materials will also increase.
• Our focus today –
Trends and Future of the Biomaterials Market
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Segmentation
Orthopedic
Biomaterials
Orthopedic Bone
Implants Grafts
4

Biomaterials: Booming Business Opportunity
• The global orthopedic biomaterials market, valued at $4 billion in 2006, is
projected to more than double by 2012, to $8.8 billion
• Ageing Population and Lifestyle Changes
• Technology Innovation
• Growth through Partnerships
• Growing Acceptance of Bone Graft Products
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Market Challenges
• Limited Number of Suppliers
• Demonstrating Product Efficacy and Cost Savings
• Costs Involved in R&D
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Orthopedic Implants

Metals
• In the past few years, high demand
for titanium by the aerospace
industry has driven up the price by a
magnitude of four.
• It is estimated that titanium is costing
companies approximately 10 times
the cost of certain grades of stainless
steels.
• A variety of other metals can be used
in orthopedic applications, including
cobalt-chrome and newer materials http://www.indiamart.com/rajorthopaedic/pcat-gifs/homepage/hp2.jpg
such as Nitinol
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Implantable Plastics
• Biocompatibility and High Performance
• Mechanical Properties/Processing
Technologies
• Non-metallic
• UHMWPE, PEEK, Bioabsorbables
http://www.ptonline.com/mag_images/200107cu2b.jpg
• Adoption
http://mdtmag.com/images/0712/image2.jpg
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Ceramics
• Ceramic product sales, which
made up 25% of the market in
2006, are projected to grow at a
steady CAGR of 10% between
now and 2012
• Widely used in Europe and Japan
than in the United States
• Higher cost
• Bio-ceramic materials
http://www.zimmer-orthopedics.com/
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Bone Grafts Market

Spinal Fusion Using Human Bone
100
80
60
40
20
0
2001 2002 2003 2004 2005 2006 2007
Lumbar Cervical
% of Interbody Spinal Fusion made of human bone
• Well-publicized events involving the safety and legality of donated tissue and
the general hassles involved in obtaining human tissue
• Trend toward increased usage of non-human devices in the spine
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Bone Morphogenetic Protein (BMP)
• These products are expected to
grow at a CAGR of 25% to $2.9
billion by 2012, accounting for
39% of the ortho biomaterials
Revenue ($ Million)
market. 800
600
400
• The BMP market segment grew 200
9% YOY in 2007 in contrast to its 0
39% in 2006. 2005 2006 2007
Year
• Two products commercially Source: Frost & Sullivan
available in the U.S. in the BMP
sector: Medtronic’s InFuse and
Stryker’s OP-1.
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Bone Graft Substitutes
• New technologies will drive U.S.
bone graft substitute market to
reach almost $1.9 billion by 2012
• Advanced BGS technologies has
increased competition within the
field
• With the acquisition of Osiris
Therapeutics' Osteocel business,
NuVasive has obtained the first off-
the-shelf bone graft substitute
(BGS) product to incorporate viable
stem cells
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Companies in Spotlight
Intergra Lifesciences/Isotis
ISTO Technologies
Fziomed
Pegasus
ETEX
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Recent Products
• Pioneer Surgical Technology, Inc. received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) to market
FortrOss, a novel bone graft substitute utilizing the power of
nanotechnology for orthopedic applications in September 2008.
• ETEX Corporation launched an innovative orthobiologic in
August 2008, EquivaBone(TM). EquivaBone(TM) is a bone graft
substitute that remodels and is replaced with new bone during
the healing process.
• Biocomposites received FDA 510(k) clearance for their unique
bone graft substitute, geneX putty in July 2008.
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Conclusion – Market Future
• The biomaterials market is expected to be the next big factor in
competitiveness for orthopedic implant manufacturers to
differentiate themselves in the market.
• As materials research continues, more options will become
available for orthopedic manufacturers. These new materials will
not only help improve products already on the market, but also
will enable the creation of products previously thought
impossible.
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