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Regenerative Medicines: Bone and Joint Applications

  • May 2015
  • 309 pages
  • BCC Research
Report ID: 157460

Summary

Table of Contents

This BCC Research report focuses on the bone- and joint-related applications of and markets for the various categories of regenerative medicine products currently available and projected to be introduced during the five-year forecast period from 2015 through 2020.

Use this report to:
- Learn about leading bone and joint diseases and disorders applicable to regenerative technologies.
- Analyze the regenerative products used to treat bone and joint disorders.
- Receive information about the regulatory issues affecting regenerative medicine products.
- Review the profiles of leading and emerging companies in the bone and joint regenerative medicine markets.

Highlights
- The U.S. market for regenerative medicine products used in bone and joint applications is expected to grow at a compound annual growth rate (CAGR) of 6.8% from $2.9 billion in 2015 to nearly $4.1 billion in 2020.
- Bone replacement/grafting as a segment will grow from nearly $2.1 billion in 2015 to nearly $2.8 billion in 2020 at 5.9% CAGR for the period 2015-2020.
- Cell therapy/tissue engineering/cartilage as a segment will grow from $255 million in 2015 to $460 million by 2020, increasing at a CAGR of 12.5% for the period 2015-2020.

Introduction & Scope

INTRODUCTION
Regenerative medicine in orthopedic applications is a $2.9 billion per year niche sector in America’s $3.1 trillion per year healthcare system. However, it is a sector of
immense interest in terms of technical, medical and investment possibilities. The best analogy to the current state of regenerative therapies in the bone and joint healing
sector is the nascency of the microprocessors business back in 1971. At that time, microprocessors (namely Intel’s 4004), and related innovations, were just an infinitesimal segment of electronic component sales, but this innovation came to dominate the economy. The regenerative therapies sector, particularly areas such as cell therapy, genetic engineering and stem cell-derived products is in a comparable position today. A good example is Bluebird Bio, which received FDA designated breakthrough therapy status in February 2015 for one of the company’s gene therapies.

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 $2.9 billion in economic activity in 2015, of which venture capital and R&D funding accounts for about $200 million. 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 and even since the most recent edition in 2013. Innumerable buyouts, consolidations, product abandonments, new firms and a few bankruptcies, too, have occurred in just the last several years. These changes are reflected in the Company Profiles section of this report. In addition, intensive R&D efforts at universities, the National Institutes of Health, the National Science Foundation and at FDA centers that focus on cutting-edge technology underscore the importance of this industry.

Regenerative therapies have the potential to improve medical outcomes, enhance quality of life and reduce overall healthcare costs. A key objective 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 and are briefly covered to underscore the
larger importance of regenerative therapies. 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, Duchene muscular dystrophy, heart disease, and vision and hearing loss.

OBJECTIVES AND GOALS OF STUDY
This report focuses on the bone- and joint-related applications of and markets for the various categories of regenerative medicine products currently available and projected
to be introduced during the five-year forecast period from 2015 through 2020. Market drivers discussed include the status of R&D and what is likely to issue from R&D in the
way of actual products and therapies. Other market drivers include the incidence, and rate of growth, of 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 nonautograft 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. Developmental and clinical stage companies are well covered.

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 for 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.

STUDY SCOPE AND FORMAT
The U.S. has been the main regenerative medicine market in terms of R&D innovation, patents and product sales often accounting for as much as half of the market
depending on the product niche; hence, the scope of the study is mainly the U.S., although worldwide developments are discussed and measurements provided 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 application 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 estimates for the revenues of the leading companies and a concise description 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 2014. Data for 2015 are estimated and
2020 is the forecast terminal year. Sales data are estimated in nominal current dollars, unadjusted for inflation. Information to prepare this study was derived from market
intelligence provided by leading companies involved in the regenerative medicine market. Data were accessed from government agencies such as the SEC and regulatory bodies (FDA, EMA) that monitor and/or regulate medical devices. Searches of secondary material such as company annual reports and 10Ks, medical journal articles, prospectus assessments, government resources and data from healthcare institutions were conducted. In addition, the study author attended the 2015 Third Annual Alliance for Regenerative Medicine Investor’s Conference in New York in order to conduct primary interviews with industry contacts.

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