REPORT SCOPE
INTRODUCTION
STUDY GOALS AND OBJECTIVES
BCC’s goal in conducting this study was to determine the current status of the market for disease-modifying multiple sclerosis (MS) drugs, biologics, and vaccines and to assess their growth potential over a 5-year period from 2010 through 2015.
MS is an autoimmune disease characterized by the body’s own immune system attacking itself and causing spots of demyelination (plaques) in the brain and spinal cord. Symptoms of MS vary widely depending on the severity of the disease and which nerve cells are attacked. Today there are currently eight disease-modifying therapies for MS approved throughout the world. Biologics represent the largest class of MS disease-modifying therapies by sales and by number of approved therapies accounting for six out of the eight approved MS disease-modifying products (Avonex, Betaseron, CinnoVex, Extavia, Rebif, and Tysabri). Of these biologics, five are beta interferon products. All of these approved MS agents are able to slow down the progression of the disease but none can reverse any nerve damage that occurs due to demyelination.
The initial 2004 Food and Drug Administration (FDA) approval of Biogen Idec’s and Elan’s Tysabri marked the approval of the first therapeutic for MS that may actually reverse some of the effects of MS. Other novel compounds in late-stage clinical testing, such as Novartis’ Gilenia (fingolimod, FTY720), Merck KGaA’s Mylinax (oral cladribine), and Genzyme’s Campath (alemtuzumab) have unique routes of administration and mechanisms of action that may also have a large effect on how MS is treated in the future. Finally, biosimilar versions of existing biologics and new molecular entities in late-stage clinical testing may also play a major role in shaping the market for MS products through 2015.
For each drug or biologic for MS on the market, all agents for MS in mid-to-late stages of clinical development, and some in earlier stages of development we have examined where these compounds stand in the development process, the major challenges to their regulatory approval or market success, their competitive profile, and, if applicable, their projected sales through 2015.
We were particularly interested in profiling small molecule drugs, therapeutic vaccines and other biologics targeting MS that are in Phase II or III clinical studies or those with unique mechanisms of action in earlier stages of development. We identify the leading MS treatments by formulation, by mechanism of action, and by geographic location. In some cases, we discuss notable compounds that failed in clinical testing, such as Roche and Biogen Idec’s Rituxan (rituximab), or that were pulled from the market due to adverse event or other issues. We also discuss the potential of some compounds that are being tested for other inflammatory or autoimmune disorders that could in the future potentially be tested as a treatment for or used off-label for MS.
Our main objective is to present a comprehensive analysis of the current market for MS disease-modifying products and to forecast this market’s future direction through 2015.
REASONS FOR DOING THIS STUDY
Disease-modifying agents to treat MS are currently one of the largest classes of pharmaceutical products by sales in the U.S. and throughout the world. Sales of these agents for MS have grown from less than $1 billion worldwide in 1999 to more than $10 billion in 2009. A period of dynamic growth in the MS disease-modifying product market is expected to continue with seven new agents with unique mechanisms of action or new formulations entering the market between 2010 and the end of 2015. Longer-acting formulations of existing MS products are also expected to have a positive effect on the market as well.
New approaches to treating MS are being pursued by pharmaceutical and biotech companies as many of them look to move beyond agents such as the interferons that primarily slow the progression of MS. These potential new disease-modifying agents with novel mechanisms of action or improved delivery systems will provide powerful new options for patients failing or intolerable to the currently prescribed treatments for MS.
INTENDED AUDIENCE
We have compiled detailed profiles of the MS disease-modifying products on the market in the U.S. and around the world. We discuss all disease-modifying products in the Phase I, II, and III stages of clinical development and some unique treatments in the preclinical stage of development as well. This study includes technical descriptions of these products, discussion of their individual efficacy and side effect profiles when possible, what stage of the disease they treat, the major companies focusing on their development, and international aspects affecting these products. We provide sales forecasts and the reasoning behind our forecasts for products that are on the market already or that may enter the market through 2015.
This study will be of interest to members of the pharmaceutical, healthcare, and biotechnology industries. It will also be a valuable resource for investors that invest in the pharmaceutical sector. It is written in such a way as to be accessible to an investor or businessperson while maintaining a high level of technical detail.
SCOPE OF REPORT
At the beginning of 2010, there were eight disease-modifying agents for MS actively being sold on the worldwide market. The emphasis of this report is on these products and the more than 33 products for MS in various stages of clinical development.
Special focus is placed on how new products and technologies will affect current market leaders in the MS treatment sector. Profiles are provided of companies projected to have disease-modifying products on the market during the forecast period and on companies with rich or interesting pipelines.
Included in this report are forecasts for sales by product, company, geographic region, formulation, and indication (if possible) from 2010 through 2015, including supporting analyses for projections.
Market trends are assessed based on projected sales of new products being introduced, competitive advantages of emerging products as well as other factors such as increases in the diagnosis of MS in parts of the world.
The study is arranged to offer an overview of the MS disease-modifying product market, including regulatory issues, and accompanied by detailed analyses and forecasts by product. Profiles of the many emerging competitors in this sector provide a comprehensive assessment of the various products and technologies entering this market as well as marketing strategies being used to gain a competitive edge.
METHODOLOGY
The market assessments in this report have been assembled based on publicly available information through 2010-07-15. The base year for the report for forecasting purposes is 2010 and forecast data is provided through 2015. Market figures are based on current dollars, and inflation (outside of its effects on drug pricing) is not computed into the projected forecast figures. Interviews with industry professionals were also used to adjust market size estimates as well as to formulate market projections.
MS disease-modifying product development is still evolving as new immunomodulatory treatments are discovered, and other targets prove to be futile in development. The reader is cautioned to use the report data primarily as a guide to assess trends, developments, and challenges that the industry faces.
INFORMATION SOURCES
The information contained in this report has been assembled from both primary and secondary data sources. Primary research was conducted via in-person, telephone, and email correspondences with selected industry professionals, company executives, research scientists, and laboratory heads to discover the most recent developments in the MS disease-modifying space. Secondary data was collected via a comprehensive search of scientific peer-reviewed literature, presentations at medical conferences clinical trial reports, databases such as PubMed, industry trade media, company websites, annual reports, and industry press releases.
AUTHOR’S CREDENTIALS
Brian Lawler has more than 4 years of experience working as an analyst covering the pharmaceutical and biotechnology industries. Trained at the University of Southern California, he holds a B.A. degree in economics.
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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.
