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Multiple Sclerosis (MS) Drugs and Biologics : Technologies and Global Markets

  • June 2014
  • 129 pages
  • BCC Research
Report ID: 2212017

Summary

Table of Contents

This BCC Research study offers an overview of the multiple sclerosis (MS) disease-modifying product market, including regulatory issues accompanied by detailed analyses and forecasts by product. Its 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 2018. Special focus is placed on how new products and technologies will affect current market leaders in the MS treatment sector. 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.

Use this report to:
- Receive a comprehensive analysis of the current market for MS disease-modifying products and the market's future direction.
- Receive information on various types of MS therapies.
- Receive information about international aspects and regulatory issues of the industry.
- Receive administration profiles of therapies approved to treat MS.

Highlights
- The global market for Multiple Sclerosis (MS) disease-modifying products reached $10.1 billion in 2012 and nearly $10.9 billion in 2013. This market is expected to grow to nearly $14.2 billion in 2018 with a compound annual growth rate (CAGR) of 5.4% over the five-year period from 2013 to 2018.
- Biologics, as a segment, reached $6.3 billion in 2013. The segment is expected to decline to nearly $5.3 billion in 2018, with a CAGR of -3.5% over the five-year period from 2013 to 2018.
- Small molecules, as a segment, reached nearly $4.6 billion in 2013. The segment is projected to grow to nearly $8.9 billion in 2018, with a CAGR of 14.2% over the five-year period from 2013 to 2018.

INTRODUCTION

STUDY GOALS AND OBJECTIVES
BCC Research’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 five-year period from 2013 through 2018. 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.

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 2018.

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 around $11 billion in 2013. 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 2018.

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
The emphasis of this report is on these products and about 39 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.

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 July 2013. The base year for the report for forecasting purposes is 2013 and forecast data is provided through 2018. Market figures are based on current dollars, and inflation (outside of its effects on drug pricing) is not computed
into the projected forecast figures. 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.

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