Research is looking beyond using implants, screws, metallic cages, to incorporating biologic bone substitutes with regenerative potential to address orthopedic conditions.
Scope and Segmentation
Research is looking beyond using implants, screws, metallic cages, to incorporating biologic bone substitutes with regenerative potential to address orthopedic conditions. For example, Medtronic Sofamor Danek of Memphis licensed the growth factor rhBMP-2 developed by Wyeth and this powerful bone stimulant has been coupled with their LT-CAGE Lumbar Tapered Fusion Device.
However, a biologic substitute can be any material that dynamically alters and affects the surrounding environment to proceed in an active biological manner, which manifests as cellular activity, growth, and differentiation. For instance, orthopedic surgery required surgeons to use biocompatible specifically designed metal implants to structurally support a fractured bone or in some cases to fuse bones in spinal conditions. Now surgeons are looking towards a biologic component incorporated with the metal implant so that the latter serves to regenerate living bone tissue while the metal implant functions in a structural manner. Definitely, the next stages of technology development would reduce the amount of metal in implants and use biodegradable scaffolds for the structural function.
An ideal biologic bone substitute is required to have either or all of the following--osteogenic, osteoconductive, and osteoinductive properties. Steady progress in biologic material sciences assures that the future treatment of injury and tissue loss will be altered and more biologically correct.
The objective of this research service is to analyse and report new and emerging orthopedic biologic substitutes; advances in research and development (R&D) and product development in the orthopedics arena. The research service plans to identify key players (with contact information)--those in the forefront of technology development and commercialisation pertinent to this market and end-user information. The scope has been sketched to include bone substitutes or biologics that fill voids, support and enhance the repair of biological defects. The first chapter gives an introduction to orthopedics, followed by an overview of the technology developments observed in orthopedics till date. The scope and segmentation of the study and the methodology adopted for it are also discussed here.
A technology primer of the different kind of biologic substitutes--allografts, demineralized bone matrix (DBM), synthetics, factors and stem cells are discussed in the second chapter. A heads-up of the trends in the orthopedics industry and important clinical trials has also been included under relevant headings.
Developments in technology, products, and research studies in orthopedic biologic substitutes that have osteogenic, osteoconductive and osteoinductive potential constitute the third chapter. Challenges faced by the industry participants, and the drivers to the biologics industry are discussed under relevant heads in the fourth chapter. This chapter also comprises an analysis of the impact of the biologic substitutes (allografts/DBM, synthetics and factors/cells) on different orthopedic applications.
The factors include funding, partnerships, intellectual property (IP) portfolio, regulatory impact, biocompatibility, and scalability.
Patents and the contact details of company officials and university faculty members who have participated in the study are listed in the fifth chapter. (Patents are listed by area and contacts are listed separately for companies and universities).
Decision support database tables form the sixth chapter of this study. Frost & Sullivan’s healthcare decision support database service offers a valuable collection of tables that provide historic and forecast data for medical devices.
Methodology
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 players and their processes. 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.
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.
The analysts conduct primary research with the 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 enduser companies, among other key organisations.
tOur analysts contact the major commercial players 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.
The project management and research team reviews and analyses 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 reports for each project and sometimes present key findings in analyst briefings to clients.
