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U.S. and Asia Markets for Bone Morphogenic Proteins in Spine FusionPublished by: Frost & Sullivan Published: Jan. 14, 2004 Table of Contents1 | TOTAL BONE MORPHOGENIC PROTEIN (BMP) IN SPINE FUSION MARKET Overview 1. Executive Summary 2. Anatomy of Human Spine 3. Low Back Pain & other Spinal Disorders 4. Treatment of Spinal Pathologies 5. Spinal Fusion and role of Bone Morphogenic Proteins (BMP) 6. The Importance of Surgical Approach in Low-back fusions 7. Forecast Methodology Market Trends and Forecasts 1. Market Drivers 2. Market Restraints 3. Revenue Forecasts Reimbursement Issues 1. Cost of BMP 2. Procedure Code for BMP Use 3. Reimbursement Policies of Private Healthcare Organizations 4. Medicare Competitive Analysis 1. Major Players 2. Patents- Market Closed to New Entrants? 3. Surgical Indications 4. Development Status 5. Regulatory Environment 6. Surgeon Opinions Frost & Sullivan Awards 1. Technology Leadership Award 2. Market Leadership Award 2 | BONE MORPHOGENIC PROTEINS (BMP) IN SPINE FUSION Forecasts for the Spine Fusion Market 1. Source of Data 2. Comparison with Previous Frost & Sullivan Research Services 3. Total Number of Spine Fusion Procedures 4. Spine Fusion Procedures by Geographic Region 5. Spine Fusion Procedures by Anatomy 6. Anterior (ALIF) and Posterior (PLIF) Lumbar Interbody Fusion Procedures Forecasts for the BMP Market 1. Introduction 2. Procedural and Unit Forecast 3. Pricing Forecast 4. Revenue Forecast Medtronic Infuse 1. History of Development 2. Description 3. Pre-Clinical and Clinical Studies 4. FDA Indications and Contraindications 5. FDA Warnings and Precautions 6. Future Developments 7. Strategic Recommendations for Medtronic Stryker Biotech OP-1 1. History of Development 2. Description 3. Pre-Clinical and Clinical Studies 4. FDA Indications and Contraindications 5. FDA Warnings and Precautions 6. Future Developments 7. Strategic Recommendations for Stryker DePuy Spine MP52 1. History of Development 2. Description 3. Pre-Clinical and Clinical Studies 4. FDA Status 5. Strategic Recommendations for DePuy Spine Product Comparisons- Infuse, OP-1 and MP52 1. Summary 3 | REIMBURSEMENT ISSUES Private Healthcare Organizations 1. Aetna 2. Kaiser Permanente 3. Anthem 4. Empire Blue Cross Blue Shield 5. Blue Cross Blue Shield of Illinois 6. WellPoint Health Networks Centers for Medicare & Medicaid Services (CMS) 1. Reimbursement Policy 4 | SURGEON'S CORNER BMP in spine practice 1. Overview 2. Current standard of care 3. Surgeon's Preference among Infuse OP-1 and MP52 4. Patient Selection & Price Factor 5. Surgical Technique 6. Will BMP use cannibalize traditional spinal implant application? 7. BMP Usage in Other Regions of Spine 8. Effect of Non-fusion Technologies on BMP Usage 5 | ASIAN PERSPECTIVE Surgeons' Opinions 1. Surgeon Interviews 2. How will BMP Make a Difference to Spine Surgeons in Asia? 3. Surgical Technique 4. Influence of Price Australia 1. Important Statistics 2. Market size for spine fusions 3. Pricing of Spinal implant and BMP products 4. Status of BMP products in the market China 1. Important Statistics 2. Market size for Spine fusions 3. Pricing of Spinal Implants and BMP Products 4. Status of BMP Products in the Market India 1. Important Statistics 2. Market Size for Spine Fusion 3. Pricing of Spinal Implants and BMP Products 4. Status of BMP Products in the Market Japan 1. Important Statistics 2. Market Size for Spine Fusion 3. Pricing of Spinal implant and BMP products 4. Status of BMP Products in the Market South Korea 1. Important Statistics 2. Market size for spine fusions 3. Pricing of Spinal implant and BMP products 4. Status of BMP products in the market List Of Figures Chapter 1 Bone Morphogenic Proteins in Spine Fusion Market: Family of Bone Morphogenic Proteins (U.S.), 2003 Bone Morphogenic Proteins in Spine Fusion Market: Market Drivers Ranked in Order of Impact (U.S.), 2003-2008 Bone Morphogenic Proteins in Spine Fusion Market: Market Restraints Ranked in Order of Impact (U.S.), 2003-2008 Chapter 2 Bone Morphogenic Proteins in Spine Fusion Market: Unit Shipment Forecasts (U.S.), 2003-2008 Bone Morphogenic Proteins in Spine Fusion Market: Price Forecasts (U.S.), 2003-2008 Bone Morphogenic Proteins in Spine Fusion Market: Revenue Forecasts (U.S.), 2003-2008 Bone Morphogenic Proteins in Spine Fusion Market: Results of Pre-Clinical Animal Studies Using rhBMP-2 (Medtronic Infuse) (U.S.), 2003 Bone Morphogenic Proteins in Spine Fusion Market: Results of Clinical Studies Using Medtronic Infuse for Spine Fusions (U.S.), 2003 Chapter 5 Fast Facts on Australia Fast Facts on China Fast Facts on India Fast Facts on Japan Fast Facts on South Korea AbstractBiotech Meets Orthopedics in Latest Technology for Spine ProceduresWhile spine implants is the fastest growing segment in the $7-billion U.S. orthopedic implants market, surgeons have long been awaiting a way to get more reliable results in spinal fusion surgeries. Growth factors called bone morphogenic proteins (BMP) are expected to hold the key to increasing success rates among the 300,000 plus spine fusions that take place each year in the country. Although this is an emerging field, with little history in the United States or the rest of the world, the novelty of the technology coupled with its ease-of-use is expected to generate high interest in it. This research analyzes the U.S. and Asian markets for BMP in spine fusions. It offers different viewpoints--of medical device manufacturers, healthcare organizations, spine surgeons, and scientists--to highlight the factors that drive/restrain this market. Strategic recommendations are also offered to those device manufacturers involved in this emerging market. Raising the Standard of Patient Care "With the rate of fusion failure in spine surgeries being 30 to 50 percent, there is no doubt of the huge potential for BMPs in these procedures," notes the analyst of the research. "Their success will raise the bar in patient care for spine surgeries." BMPs are wonder products for those suffering from chronic back pain and requiring spine fusion. At present, the gold standard for spine fusion is the use of autograft harvested from the patient's pelvic bone through a separate surgery. BMP products may eliminate the use of autograft, doing away with the patient's additional pain at the graft site and also saving surgeons the time required to harvest/shape the graft. Increasing Cost-to-benefit Ratio Will Drive Adoption The widespread interest among spine surgeons in the application of BMP needs to be translated into regular use. "Ultimate success depends on the cost-to-benefit ratio as perceived by surgeons and healthcare organizations," says the analyst. "If the price is right, surgeons are expected to use BMPs for up to 30 percent of their surgeries." Manufacturers need to strive toward increasing the cost-to-benefit ratio of BMP products by either reducing the cost and/or widening its indications to other spinal surgeries. Investment must be made in proper training of surgeons to reduce incidences of unfavorable outcomes due to improper use. Healthcare organizations need to be convinced of the importance of BMPs to approve add-on payments. The aim of the device manufacturers should be to make BMP a part and parcel of every spine fusion.
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