Bones and Joints: Drugs, Devices, and Regenerative Technologies

Report Highlights

• Revenues derived from treatments various disorders will double from just over 20 billion in 2000 to 40 billion in 2005.
• Regenerative therapies, while still a small fraction of the total, are the fastest growing type of therapy, growing nearly 50% per year, versus 12.1% for drugs, and 10.9% for devices. The best is yet to come, as biologists learn to manipulate stem cells to create human tissue. The smallest rate of increase is seen for devices. Orthopedic implant sales, in particular, will grow only slowly. As drugs become more effect and new and better regenerative therapies are approved, the use of these implants will decline or at least be delayed until later years.

INTRODUCTION

REASON FOR THIS STUDY

B-143 Bones and Joints: Drugs, Designs, and Regenerative Technologies is a timely report. There is a huge bulge in the age structure of the U.S. and other developed nations corresponding to the Baby Boomer generation. Boomer women are reaching menopause, after which therapies to prevent osteoporosis may be needed. Boomer men are finding that they can no longer participate in their favorite sports because of joint problems. Spinal problems are beginning to take their toll.

Except for rare genetic diseases, most disorders of bones or joints, like osteoarthritis or osteoporosis, are the consequence of age. Even rheumatoid arthritis, which arguably has a genetic component, is exacerbated by aging.

A large industry has grown up to provide orthopedic implants for people with defective joints, osteoporotic fractures, or back problems. Fracture fixation is a long-established industry. Prosthetic joint implant design is constantly being improved. Manufacturers of these implants must surely be looking forward to the increase in demand for their products as Baby Boomers age.

However, pharmaceutical remedies for orthopedic problems are also improving. Boomers who begin taking preventative measures may never develop osteoporosis. One-third of post-menopausal women in the U.S. are already taking hormone-replacement therapy. A reduction in the percentage of people with osteoporosis would imply a reduction in the number of bone fractures. Spinal problems, too, would be substantially reduced.

New regenerative therapies are being introduced to treat joint problems. Who would not rather have his or her cartilage renewed rather than receive a replacement made of plastic and titanium? Rheumatoid arthritis is also being treated with new protein drugs that are substantially more effective than old remedies.

This study is made necessary because the balance of power is shifting between pharmaceutical, biological, and mechanical remedies for bone and joint disorders.

OBJECTIVE OF THIS STUDY

The objective of this study is to examine the various solutions available or proposed to treat disorders of the bones and joints, and to compare the strengths and weaknesses of each solution. The majority of focus will be on new procedures that have recently come to market or are in clinical trials. The size of the market addressed by each product and the achievable market share for the next five years will also be estimated. Reasoned predictions will be made for which treatments will prevail as medical standards in the future.

The state of the industry will be examined, and capsule profiles will be provided for major and minor companies involved in this industry. Since the orthopedic industry is now technology-driven, some of the new technologies being brought to bear will be explored.

THE AUDIENCE FOR THIS REPORT

This study is aimed at individuals involved in the design, manufacture, and marketing of drugs, devices, and regenerative therapies used to treat bone and joint disorders. Venture capitalists, entrepreneurs, medical analysts, and research directors with an interest in the orthopedic industry will also find this research valuable.

SCOPE AND CONTENT OF THE REPORT

This report covers products used to treat bone and joint diseases and disorders, including osteoporosis, osteoarthritis, rheumatoid arthritis, spinal problems, nonunion bone fractures, bone cancer, and genetic disorders of bone. Recently introduced diagnostic tests for these diseases and disorders are also covered.

BCC does not consider the of orthopedic surgeons within this report. Physician management-type companies are not included in the corporate profiles, for instance. Devices designed to make orthopedic surgery easier, like surgical instruments or robotic surgery devices, are also not covered. Because procedures and disorders in which hardware or medicine can be sold to the patient form the focus for concentration, arthroscopy and other soft tissue procedures, are not covered, per se, in much detail.

METHODOLOGY AND INFORMATION SOURCES

The information reported herein has been gathered from a variety of industry sources. The 10K forms and SEC filings from public companies have been examined, along with annual reports, catalogues, press releases, and similar materials. The World Wide Web is a rich source of information — almost every commercial concern now has its own webpage. Read eports from stock analysts for a number of companies have been read and referenced. Product literature has been consulted and trade journals monitored, such as Medical Device and Industry Magazine, as well as BCC's own Medical Materials Update, Drug Discovery/Technology News, and Applied Genetics News. Where appropriate, medical and scientific literature has served as a research source. Statistical information from the U.S. Government, the World Health Organization, and private foundations has also been gathered.

Armed with the industry and statistical information garnered above, market participants were interviewed in order to fill in the gaps in understanding the bone and joint industry.

ANALYST'S CREDENTIALS

The author of this report, Steven Edwards, Ph.D., has a broad background in the biological and health sciences, and is well acquainted with advancing technology. He received his doctorate in biology from the University of California, San Diego. His thesis work centered on the expression of murine leukemia virus genes, and was then awarded a National Institutes of Health (NIH) postdoctoral fellowship to study neuroendocrinology at the Salk Institute. Subsequently, Edwards was a Research Associate at La Jolla Cancer Research Foundation (now Burnham Institute). Later, he accepted a position as assistant professor in the biochemistry department of Meharry Medical College. There, he directed a research laboratory studying transcriptional regulation, his work being supported by grants from the American Heart Association and the NIH.

Edwards is now a medical industry analyst, as well as a science writer and editor. He is the editor of two BCC newsletters: Applied Genetics News and Drug Discovery/Technology News. His journalistic work has appeared in Massachusetts Institute of Technology's (It's written MIT's on the cover)Technology Review, Diabetes Forecast, Genetic Engineering News, and other publications.

Edwards was the Project Analyst responsible for the BCC reports B-119 Cell Therapy and Tissue Engineering, Emerging Products [1998] and B-127 Microelectronic Medical Implants, Products, Technology and Opportunity. He has performed market research on the orthopedics industry for Phaelixe, Inc. (Denver, CO), a consulting firm, and has consulted for venture capital companies.