Abstract
THIS REPORT:
- Provides a comprehensive overview of the global market for regenerative
medicines for bone and joint applications
- Offers the background for demographics underlying the market for bone and
joint products
- Contains global market forecasts for regenerative medicines for bone and
joint applications, with trends and forecasts for growth through 2014
- Describes the leading bone and joint diseases and disorders using
regenerative technologies, including incidence and current methods of treatment
- Discusses regulatory issues affecting regenerative medicine products
- Profiles leading and emerging companies.
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.
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