INTRODUCTION
Regenerative medicine is a relatively large and rapidly evolving segment of the healthcare business. The regenerative medicine industry has been in existence for nearly 25 years. Actual product sales, along with research and development (R&D) expenditures, are projected to amount to approximately $2 billion in economic activity in 2009. Bone and joint applications account for a little more than half of those revenues, or $1.2 billion. The rapid evolution of this business is evidenced by the industry consolidation that has occurred since the first edition of this BCC Research report was published in 2003. In addition, intensive R&D efforts at universities and the National Institutes of Health that focus on cutting-edge technology underscore the importance of this industry.
The key objective of regenerative medicine is the utilization of living cells to repair or replace body tissue damaged by injury, disease, or the aging process. The most successful products have drawn upon multidisciplinary fields such as biology, medicine, engineering, and particularly biomedical engineering. The principal focus in this report is on bone and joint applications; however, other regenerative applications such as dental, neurologic, organ regeneration, cardiovascular, urologic, diabetes, and wound care are important. Stem-cell research is an important component of the sector as well. For example, the successful differentiation of embryonic stem cells into specific cell types is widely sought as a means to treat traumatic spinal-cord injury, as well as diseases such as diabetes, Duchenne muscular dystrophy, heart disease, and vision and hearing loss.
OBJECTIVES AND GOALS OF STUDY
This report focuses on the bone- and joint-related applications and markets for the various categories of regenerative medicine products currently available and projected to be introduced during the 5-year forecast period from 2009 to 2014. Market drivers discussed include an increase in diseases and disorders that will benefit from these products, primarily arthritis, osteoporosis, and various types of bone and joint trauma (e.g., hip fractures, knee injuries); increasing use of non-autograft products by physicians; and innovative devices that incorporate bone- and cartilage-growth-stimulating agents in a regenerative appliance. Products discussed include bone and cartilage grafting and regenerative products derived from autologous, allogeneic, and synthetic sources, as well as electrical stimulators for bone growth and regenerative cartilage products.
Profiles are provided of leading and emerging companies in the bone and joint regenerative medicine markets, along with analyses of the current and future positioning of their products and businesses in this active and rapidly changing market.
INTENDED AUDIENCE
The aim of this report is to provide an overview of regenerative medicine products, both available and emerging, for the treatment of diseases and disorders of the bones and joints. The information and analysis presented are important assets in decision making for managers involved in business development, marketing, market research, product development, mergers and acquisitions, licensing, business management, investment banking, and deal creation, as well as to consultants to the pharmaceutical and biotechnology industries. The study provides a comprehensive analysis of the current markets for regenerative medicine products for bones and joints, relevant applications, and the potential of products in development.
SCOPE OF REPORT
The U.S. has been the main regenerative medicine market both in terms of R&D innovation and product sales; hence, the scope of the study is mainly U.S., although worldwide developments are discussed where relevant. The Overview section provides a background of the demographics underlying the market for bone and joint products, a definition of regenerative medicine and the technologies involved, and a discussion of regenerative products in development for applications other than bones and joints. Various applications sections describe the leading bone and joint diseases and disorders applicable to regenerative technologies, including incidence and current methods of treatment.
The section on Products provides extensive descriptions and analyses (e.g., comparative analysis) of regenerative products used to treat bone and joint disorders, as well as a discussion of products in development.
The section on FDA clinical trials and newly approved products provides a discussion of regulatory issues affecting regenerative medicine products.
An extensive Company Profiles section provides a concise exploration of leading and emerging companies in the area of regenerative products for bones and joints, including product introductions, patents, and overall business strategies.
METHODOLOGY
Both primary and secondary research methodologies were used to prepare this market research report. The base year for this study is 2009. Sales data are estimated in nominal dollars (unadjusted for inflation). Information to prepare this study was derived from market intelligence provided by chief executive officers, marketing strategists, research executives, and others at leading companies involved in the regenerative medicine market. Data was accessed from government agencies and regulatory bodies that monitor and/or regulate medical devices. Searches of secondary material such as company annual reports and 10Ks, journal articles, prospectus assessments, government resources, and data from healthcare institutions were conducted.
INFORMATION SOURCES
The information and analyses presented in this report are based on an extensive survey of the biotechnology and pharmaceutical industries, as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations, and national and world health organizations.
ANALYST CREDENTIALS
Research analyst Kevin Gainer holds both B.A. and M.A. degrees in quantitative economic analysis, and has 25 years of economics and market research experience. He is the author of five published books; dozens of technical papers, analyses, and studies published in conference proceedings; and many unpublished reports within corporations. He has worked as a Research Editor and Project Analyst at BCC Research and over the last 25 years has authored many BCC technology market research reports.
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DISCLAIMER
The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal, or accounting advice; nor should it serve as a corporate policy guide, laboratory manual, or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or its use.
Report Code: PHM032B, Published: October 2009, Analyst: Kevin Gainer
