Technology Breakthrough in Spinal Implants (Technical Insights)

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1 Technology Breakthrough in Spinal Implants (Technical Insights) Biomaterial innovations is a growth factor for spinal implant market June 2014

2 Table of Contents Section Page Number Executive Summary 4 Research Scope 5 Research Methodology 6 Key Findings 8 Technology Trends and Investment Opportunities 9 Industry Overview 10 Technology Snapshot Spinal Implants Products 11 Biomaterials Used for Spinal Implants 12 Novel Technology Offerings 19 Strategic Partnerships Distribution Partnerships 26 Strategic Partnerships Biomaterial Licensing 29 Materials and Suppliers 30 Technologies Available for Licensing and Stakeholders 31 2

3 Table of Contents Section Page Number Industry Challenges 33 Diffusion of Innovations and Needs Assessment 34 Biomaterial Adoption Cycle 35 Demand Side Analysis 36 Opportunity Evaluation and Road mapping 37 Technology Roadmap Introduction 38 Technology Roadmap 39 Technology Roadmap Emerging Opportunities Explained 41 Emerging Biomaterial Technologies 43 Technology Management Strategies 44 Key Patents and Key Contacts 45 The Frost & Sullivan Story 51 3

4 Research Scope Biomaterials are derived either naturally or synthetically which can be used to develop spinal implants. Research and development within this industry is focused to overcome biocompatibility issues by developing materials that could mimic human bone tissue. This is an area of extensive ongoing research and development. Several natural, bio-derived and synthetic biomaterial are being investigated and suitable technologies developed to advance spinal implants. The emergence of tissue engineering and biotechnology has expanded the role of biomaterials for tissue replacement, bone regeneration and surface coating applications. Younger market segments within this industry such as stem cells and combination products have tremendous growth potential while certain biomaterial technologies such as metals and alloys, that previously experienced rapid market growth have now entered maturity. But even still these markets is sustained by continued product evolution and incremental innovations within biomaterial technologies. This research service summarizes the technology breakthroughs in spinal implants with respect to biomaterial technologies such as metals; polymers; ceramics; combination products and stem cells. There is also a focus on industry trends and novel biomaterial technology offerings that are enabling the advancement of new and improved spinal implants. There is intense competition within the biomaterial industry for spinal implants today and some of the emerging opportunities lie in the areas of minimally invasive surgery, surgical robotics, tissue engineering, surface modification technologies, nanotechnology and 3D printing. The RS covers the following key points: Technology Trends and Investment Opportunities Strategic Partnerships Biomaterial Licensing Deals Industry Challenges Biomaterial Adoption Cycle Demand Side Analysis Technology Road map Technology Management Strategies 5

5 Research Methodology Technology Journals Periodicals Market Research Reports Technology Policy Information Sites Internal Databases Thought Leader Briefings 1. Patent Review Technology Capabilities and Stakeholder Initiatives R&D/Innovation/NPD Strategies Secondary Research Innovators and Innovations 3. Assess Innovations Application Market Potential and Needs Primary Research 2. Interview Participants Funding and Investments Engineers CTOs/CEOs/CIOs Technical Architects Research Heads Strategic Decision Makers Technology Policy Heads Stakeholder Insights, Perspectives, and Strategies OUTCOME--FORECAST FUTURE OF TECHNOLOGY, MARKET ADOPTION, and POTENTIAL APPLICATION SECTORS Source: Frost & Sullivan. 6

6 Research Methodology (continued) Step 1: To provide a thorough analysis of each topic, Technical Insights analysts perform a review of patents to become familiar with the major developers and commercial participants and their processes. Step 2: Building on the patent search, the analysts review abstracts to identify key scientific and technical papers that provide insights into key industry participants and the technical processes, on which they work. Step 3: The analysts then create a detailed questionnaire with content created to address the research objectives of the study, which functions as a guide during the interview process. While the analysts use structured questionnaires to guarantee coverage of all the desired issues, they also conduct interviews in a conversational style. This approach results in a more thorough exchange of views with the respondents, and offers greater insight into the relevant issues than more structured interviews may provide. Step 4: The analysts conduct primary research with key industry participants and technology developers to obtain the required content. Interviews are completed with sources located throughout the world, in universities, national laboratories, governmental and regulatory bodies, trade associations, and end-user companies, among other key organizations. Our analysts contact the major commercial participants to find out about the advantages and disadvantages of processes and the drivers and challenges behind technologies and applications. Our analysts talk to the principal developers, researchers, engineers, business developers, analysts, strategic planners, and marketing experts, among other professionals. Step 5: The project management and research team reviews and analyzes the research data that are gathered and adds its recommendations to the draft of the final study. Having conducted both published studies and custom proprietary research covering many types of new and emerging technology activities as well as worldwide industry analysis, the management and research team adds its perspective and experience to provide an accurate, timely analysis. The analysts then prepare written final research services for each project and sometimes present key findings in analyst briefings to clients. 7

7 Key Findings 1 Despite the spinal implants market being a mature market, increasing patient needs, end user demands and stringent regulatory approvals are pushing for continuous research and development of biomaterials for better biocompatibility and enhanced healing and clinical outcome. 2 Incremental innovations are commonly seen within the biomaterial market for spinal implants. Strict regulatory approvals does not permit the introduction of new biomaterials within the industry and hence researchers and developers prefer to combine existing biomaterials or incorporate biologics into commercially existing spinal implants. 3 There is an emergence of tissue enginerring and stem cell research as solutions for developing advanced spinal implants. Gene therapy and engineered stem cells in conjunction with biomaterials are expected to have huge impact for treating tissue and bone loss. 4 5 Surface coating or modification is a big industry within the spinal implants facilitating osseointegration, minimizing friction between implantable components, and bolstering fatigue resistance. Porous titanium, cobalt-chromium, bioactive ceramics are highly used as coatings for spinal implants. The spinal implants manufacturers are also looking into biologics coating. Advances in nanotechnology, additive manufacturing technologies and 3D printing are opening new frontiers particularly in the development of next generation spinal implant biomaterials and regenerative medicine strategies. This will enable the use of value-added design spinal implant device manufacturing sector. 6 Future developments reside in the synthesis of bio-inspired materials through processing methods and strategies that are characteristic of biological systems. These involve nanoscale self-assembly of the components and the development of hierarchical structures 8

8 Industry Overview Enabling Technologies Multidisciplinary and multi material Biomaterials within the spine market are enabling technologies utilized to treat spinal deformities, trauma, degeneration, and tumor. The biomaterials market for spinal implants include products that are used by spine surgeons for surgical treatment of spine and degenerative conditions to augment spinal implants and promote fusion for enabling/accelerating/substituting the natural body's healing process. There is vigorous research and development on biomaterials for spinal implants conducted by diverse companies within engineering, chemicals, material sciences, polymers, tissue engineering, biologics, and even medicine. The industry has multimaterials for spinal implants such as polymers, metals, alloys, ceramics, composites, scaffolds, and biological materials. Spinal implant devices nowadays have different materials each with specific properties and biological interactions. Need Driven Fabrication of novel biomaterials is being done to cater to increasing patient needs for repair and replacement of spinal tissues to provision of biomaterials that can offer self-healing properties. The number of people that are aged over 60 years is expected to drastically increase in the coming years and this increase in age related degenerative disc diseases is seeing significant government investments and development of novel biomaterial solutions. Large Market The spinal implants market is the largest sector within the orthopaedic industry and the magnitude and economic scope of biomaterials market within this space is huge. The demand for higher performance/longer lasting implants, and the desire to provide better clinical outcomes for the patients has created an attractive and highly profitable market for biomaterial companies to develop future biomaterials for spinal implant developers/manufacturers. Performance Requirements There are three major requirements that needs to be adhered by spinal implant developers when it comes to the biomaterials aspect that are pertaining to this market segment: clinical, manufacturing, and economical. Clinical means appropriate mechanical strength and biocompatibility, manufacturing refers to fabrication of the biomaterials for optimum implant design while economic refers to the cost requirements. Challenges A key deterrent is the regulatory policies as the market experiences quite a number of post implantation issues, recalls, and regulatory warnings. Spinal implant manufacturers need to be clearly aware of the scientific intricacies involved with introducing new materials in the human body. Lack of data for long-term performance of clinical studies and dicey reimbursement policies are other challenges that are present in the spinal implants market. 10

9 Technology Snapshot Spinal Implants Products Non-Fusion Based Classification Motion preservation technologies Artificial Discs Annulus Repair Dynamic Stabilization Definition Also called as disc replacements, disc prosthesis or spine arthroplasty devices, they are implanted in the spine to enable the person carry loads and allow spinal motion. Annular repair devices are reconstruction implants that are utilized to seal the opening made for a discectomy surgery. Also called soft or flexible stabilization devices they are used for stabilizing the spine while maintaining natural anatomy and motion. Spinal Implants Nucleus Replacement Facet Arthroplasty These implants are used to replace the disc nucleus in discs where the structure still remains intact. They are used to fill the disc following discectomy. These implants are used to restore the facet joints that have been damaged by spinal degeneration devices. Interbody fusion These implants are used in spinal fusion procedures to preserve foraminal height and decompression. Fusion- Based Motion restriction technologies Spine Fixation Spinal Bone Stimulators These implants are used for vertebrae fixation in cases of fracture, deformity, and degenerative disorders. Bone growth stimulators are implanted during spinal fusion surgery to induce osteogenesis and promote fracture healing. 11

10 Biomaterials used for Spinal Implants Spinal Implants and Biomaterials Spinal implants are devices that are used to correct spinal deformities, facilitate fusion, and stabilize and strengthen the spine. Some of the disorders treated using spinal implants are degenerative disc disease, scoliosis, kyphosis, spondylolisthesis, and fracture. They are made from materials that are biocompatible and can provide optimal spinal stabilization and strength. Some of the biomaterials used for fabricating spinal implants are metals, polymers, ceramics, and bio-derived materials. Classification of Biomaterials for Spinal Implants Metallic Biomaterials Polymers Bioceramics Metals are extensively used for spinal implants owing to their superior strength. Advances in refining technology have led to the development of corrosion resistant metals and alloys. The metals are made bioactive through surface modification techniques. Porous metallic biomaterial is currently being looked into for providing space for bone in growth and vascularization. Combination Products Biodegradable or resorbable polymers exhibit controlled breakdown and absorption of polymer chains within the body. Mechanical strength for bioabsorbable polymeric implants is enhanced through a self-reinforcing process. Biodegradable polymers reduce stress shielding effects and the need for subsequent surgeries for artefacts removal. Bioinert ceramics are used as spinal screws and plates. Bioactive ceramics are used as coatings for metallic spinal implants. Biodegradable ceramics are used for fusion surgeries. The porous structure of ceramics resembles bone tissue structure, and hence is used in conjunction with other materials and also as synthetic bones. Stem Cells These are composite products of either metal, polymer, or ceramics with bioengineered structures or biomaterials such as allografts, autografts, demineralized bone matrix, growth factors, and poly morphogenic proteins. These combination implants are used to stimulate molecular responses and induce bone formation. The natural biomaterials provide good osteointegrative and osteoconductive properties. Stem cells are being researched as biomaterials for spinal implants for addressing pathophysiology of the spinal cord injuries such as neuronal regeneration and anti-inflammatory. Stem cells can be injected or surgically implanted. They are still in pre-clinical studies and their success in treatment will depend on the use of multiple strategies such as rehabilitation. 12