REPORT SCOPE
INTRODUCTION
STUDY GOALS AND OBJECTIVES
BCC’s goal in conducting this study was to determine the current status of the global marketplace for stem cell therapies utilized in oncology settings and to assess this niche marketplace’s growth potential for the 5–year period from 2010 through 2015.
At present, stem cell based therapies in oncology are primarily of the hematopoietic variety, although at the research level there is significant development with embryonic, pluripotent and other stem cell therapies. Conservatively speaking there are, presently, no FDA approved stem cell biologics, however there are a few FDA approved therapies that are utilized adjunctively as part of an oncology regimen. These therapies have either a tissue regenerative effect, a tissue protective effect, or an anti–cancer effect and are stem or progenitor cell based depending on which theory of cellular biology is employed. In 2009 President Obama issued executive order 13505, which further empowered new stem cell lines, and ultimately gives scientists larger pools of new data to explore, and brightens both the near term and long term future of stem cell research.
The majority of the revenues reflected in this report are based on the industrial research from incorporated entities providing second– and third–party research where the key data is excerpted from public sources such as annual reports, press releases, and other key public data, as it relates to a conservative definition of stem cell based therapeutics. Generally speaking, research at this level is not profitable, so the revenues reflected in this report represent some of the more innovative companies and organizations with the savvy to produce revenue streams in the millions of dollars range at a time when most organizations are having great difficulty keeping pace.
Our key objective with this report is to produce an intensive analysis of the current stem cell therapeutics oncology market in cancers such as multiple myeloma, leukemia, lymphoma, prostate, breast and lung cancers, and to explore the future direction of these markets. These are the primary cancers being studied for applications relating to stem cell based therapies. We have included a section on natural derived products with antitumor effects that are part of a stem cell therapeutic–based regimen.
We have specifically excluded any analysis of non–oncology uses of stem cells, stem cells in diagnostics, or any use of stem cells that are outside the scope of anti–tumor therapeutics, protection of healthy tissues in oncology settings, or healthy tissue development in individuals with cancer. Also our selection of stem cell based therapeutics has been carefully selected to include therapeutics that are denoted in primary sources as stem cell therapeutics, not those of progenitor cells, or of growth factors, proteins, cell mobilizers that are later in cell development cycle than stem cells. There will be further discussion of this in Chapter Four
REASONS FOR DOING THIS STUDY
Malignant tumors, particularly those that are advanced, often are incurable and recurrent. Their etiology is based on a host of factors ranging from genetics, radiation exposure, to a chemical and/or biological carcinogen, or any combination of the above. To further complicate treatment, there are issues of drug–resistance, proper early diagnosis, and our treatments of the disease doing less harm than the cancer itself in humans with these often invasive neoplasms. It is estimated that nearly 1 out of 2 men and 1 out of 3 women at some point in their lifetime will have a form of cancer. To further complicate matters, there is good statistical source material that denotes as much as a 50% death rate attributed to stem cell transplants in oncology settings due to the side effects of the transplant including graft vs. host disease being a key issue.
Nonetheless, as cancer is presently incurable in its advanced state, biologics hold a fantastic amount of potential and a growing market share in the oncology therapeutics marketplace and stem cells, should we resolve the regulatory and safety issues. As such, BCC was particularly interested in examining the oncology market of the stem cell therapies in all venues that they present.
INTENDED AUDIENCE
This report was prepared as a study of the global oncolytic stem cell therapeutic marketplace for use in humans.
Information is presented on the oncology industry in general including a specific focus on the various market segments including autologous or allogeneic, stem cell transplants, therapeutics that produce healthy stem cells or inhibit tumor stem cells, both alone and in adjunctive settings.
This study will be of significant interest to hospitals, pharmacies, pharmaceutical companies, biopharmaceutical researchers, pharmaceutical company marketing executives, contract research organizations (CROs), chemists, physicians, nurses, physician assistants, pharmaceutical directors, product managers and representatives, all manner of institutional directors ranging from nursing homes and schools, to those in long term care situations both public and private. It will also be of interest to investment bankers in the biotechnology and pharmaceutical sectors, insurance executives and oncology product marketing managers alike.
SCOPE OF REPORT
This study examines the human applications both marketed and in development of anti–cancer and tissue protective therapies and stem cell therapies for oncology conditions. BCC extensively analyzes each market segment, presents its current market status and presents various forecasts for growth over the next 5 years. Other factors such as Food and Drug Administration (FDA) restrictions, government legislation, a cancer’s drug resistance to therapeutics, and/or natural and alternative remedies are also highlighted, where they meet the criteria of what this report is defining as a stem cell based therapeutic. Our financial and sales analysis focuses on the available figures from 2007 through 2009 with estimates for the years 2010 through 2015, including compound annual growth rates (CAGRs).
METHODOLOGY
Through an extensive industry survey BCC was able to compile data to present our analysis of the oncology stem cell based therapeutics, by market segment. Research included online database searches of industry specific data sources coupled with financial, trade, government, and marketing database sources as well as interviews via correspondence or telephone with independent sources comprising companies, government agencies, and academic experts.
INFORMATION SOURCES
Of the companies and agencies surveyed, the majority were pharmaceutical or compound manufacturers. Additional information was supplied by known industry or trade sources.
ANALYST CREDENTIALS
Michael Delander is a biotechnology research consultant with more than 15 years of research experience. Michael has been consulting with venture capital based start–ups and larger industry alike since 2003, and has focused on in–depth research in a wide range of medical therapeutics in early development. His key published work is located in national and international organizations including the National Library of Medicine, the University of California as well as numerous Ivy–league libraries..
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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 medical, 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 of a speculative nature. BCC assumes no responsibility for any loss or damage that might result from reliance on the reported information or from its use.
