The total worldwide market for MS disease-modifying therapies is expected to grow at an 8.1% compound annual growth rate (CAGR) from 2010 through 2015, with sales reaching nearly $16.7 billion by the end of 2015, from $11.3 billion in 2010.From 2010 through 2015, the overall small molecule MS disease-modifying drug market is expected to grow rapidly. This segment is worth an estimated $3.6 billion in 2010 and is projected to increase at a 17.4% compound annual growth rate (CAGR) to reach $7.9 billion in 2015.Biologics represent the largest class of MS disease-modifying therapies by sales and by number of approved therapies. This sector is valued at $7.8 billion in 2010 and is expected to increase at a 2.5% compound annual growth rate (CAGR) to reach a value of $8.8 billion in 2015.  INTRODUCTIONSTUDY 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. REASO

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Multiple Sclerosis (MS) Drugs and Biologics: Technologies and
Global Markets
Published on September 2010
Report Summary
The total worldwide market for MS disease-modifying therapies is expected to grow at an 8.1% compound annual growth rate (CAGR)
from 2010 through 2015, with sales reaching nearly $16.7 billion by the end of 2015, from $11.3 billion in 2010.
From 2010 through 2015, the overall small molecule MS disease-modifying drug market is expected to grow rapidly. This segment is
worth an estimated $3.6 billion in 2010 and is projected to increase at a 17.4% compound annual growth rate (CAGR) to reach $7.9
billion in 2015.
Biologics represent the largest class of MS disease-modifying therapies by sales and by number of approved therapies. This sector is
valued at $7.8 billion in 2010 and is expected to increase at a 2.5% compound annual growth rate (CAGR) to reach a value of $8.8
billion in 2015.
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
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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
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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 July 2010. 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.
Table of Content
CHAPTER ONE: INTRODUCTION STUDY GOALS AND OBJECTIVES REASONS FOR DOING THIS STUDY INTENDED
AUDIENCE SCOPE OF REPORT METHODOLOGY INFORMATION SOURCES AUTHOR’S CREDENTIALS RELATED BCC
REPORTS BCC ONLINE SERVICES DISCLAIMER CHAPTER TWO: SUMMARY SUMMARY SUMMARY TABLE GLOBAL
MARKET FOR MS DISEASEMODIFYING PRODUCTS, THROUGH 2015 ($ MILLIONS) SUMMARY FIGURE GLOBAL MARKET
FOR THERAPIES TREATING MS, 2008-2015 ($ MILLIONS) CHAPTER THREE: OVERVIEW DISEASE CHARACTERISTICS
HISTORY AND DISCOVERY OF MS SYMPTOMS OF MS PREVALENCE AND INCIDENCE OF MS TABLE 1 MS STATISTICS
FROM AROUND THE WORLD, 2008 DIAGNOSIS OF MS DIAGNOSIS OF MS (CONTINUED) TYPES OF MS PROGNOSIS
TREATMENTS FOR MS TYPES OF MS THERAPIES TABLE 2 CURRENTLY APPROVED MS THERAPIES ON THE MARKET
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TABLE 3 FEATURES OF SMALL MOLECULE VERSUS BIOLOGIC MS DISEASE-MODIFYING THERAPIES TABLE 3
(CONTINUED) TABLE 4 WHOLESALE ACQUISITION COST OF SELECTED THERAPIES FOR MS, 2009 ($) TARGETS OF MS
THERAPIES VLA-4 (CD49D AND CD29) S1P CD20 IL-2 (CD25, CD122, AND CD132) CD52 MYELIN BASIC PROTEIN-REACTIVE
T-CELLS SIDE EFFECTS OF MS THERAPIES TABLE 5 COMPARISON OF SIDE EFFECT PROFILES OF MARKETED AND
LATE-CLINICAL STAGE THERAPIES FOR MS MS THERAPIES IN CLINICAL DEVELOPMENT TABLE 6 MS THERAPIES IN
CLINICAL TRIALS, ORDERED BY PHASE TABLE 6 (CONTINUED) TABLE 6 (CONTINUED) TABLE 7 MS THERAPIES IN
DEVELOPMENT, BY PHASE (NUMBER/%) FIGURE 1 MS THERAPIES IN ACTIVE CLINICAL TRIALS BY PRIMARY TARGET
(NUMBER) FIGURE 1 (CONTINUED) TABLE 8 COMPANIES WITH MORE THAN ONE MS THERAPY IN ACTIVE CLINICAL
TRIALS OR ON THE MARKET* CLINICAL TRIAL EFFICACY OUTCOME MEASUREMENTS IN MS STUDIES Relapse Rate EDSS
Gadolinium-Enhanced (GdE) Lesions on MRI TABLE 9 EFFICACY RESULTS OF MS DISEASE-MODIFYING THERAPIES
CHAPTER FOUR: TECHNOLOGY OVERVIEW TABLE 10 GLOBAL MARKET FOR MS DISEASE-MODIFYING THERAPIES BY
CLASS, THROUGH 2015 ($ MILLIONS) TABLE 11 GLOBAL SALES OF MS DISEASE-MODIFYING THERAPIES BY
FORMULATION, THROUGH 2015 ($ MILLIONS) TABLE 12 ADMINISTRATION PROFILES OF THERAPIES APPROVED TO
TREAT MS CHAPTER FIVE: PATENT EVALUATION PATENT LENGTH AND MARKET EXCLUSIVITY ORPHAN DRUG
EXCLUSIVITY REBIF AND AVONEX’S ORPHAN DRUG MARKETING EXCLUSIVITY TABLE 13 U.S. PATENT EXPIRATION
DATES OF THERAPIES FOR MS ON THE MARKET OR IN PHASE III DEVELOPMENT TABLE 13 (CONTINUED) BIOGEN IDEC
AND THE INTERFERON BETA PATENTS SMALL MOLECULE MS DISEASE-MODIFYING PRODUCTS AND GENERIC DRUGS
CHAPTER SIX: SMALL MOLECULE MS DRUGS MARKET OVERVIEW TABLE 14 GLOBAL MARKET FOR SMALL MOLECULE MS
DISEASEMODIFYING DRUGS BY INDIVIDUAL DRUG, THROUGH 2015 ($ MILLIONS) SMALL MOLECULE MS
DISEASE-MODIFYING DRUGS COPAXONE (GLATIRAMER ACETATE, COPOLYMER 1) TABLE 15 COPAXONE PIVOTAL
STUDY RESULTS Copaxone (Continued) TABLE 16 GLOBAL MARKET FOR COPAXONE BY REGION,THROUGH 2015 ($
MILLIONS) NOVANTRONE (MITOXANTRONE) Novantrone (Mitoxantrone) (Continued) TABLE 17 GLOBAL MARKET FOR
NOVANTRONE BY REGION,THROUGH 2015 ($ MILLIONS) M356 (GLATIRAMER ACETATE) M356 (Glatiramer Acetate)
(Continued) GILENIA (FINGOLIMOD, FTY720) Gilenia (Fingolimod, FTY720) (Continued) TABLE 18 GILENIA PIVOTAL PHASE III
STUDY RESULTS Gilenia (Fingolimod, FTY720) (Continued) TABLE 19 GLOBAL MARKET FOR GILENIA BY REGION, THROUGH
2015 ($ MILLIONS) LAQUINIMOD (ABR-215062) TABLE 20 LAQUINIMOD PIVOTAL PHASE III STUDIES Laquinimod
(ABR-215062) (Continued) TABLE 21 GLOBAL MARKET FOR LAQUINIMOD BY REGION,THROUGH 2015 ($ MILLIONS)
MYLINAX, MOVECTRO (ORAL CLADRIBINE) Mylinax, Movectro (Oral Cladribine) (Continued) Mylinax, Movectro (Oral Cladribine)
(Continued) Mylinax, Movectro (Oral Cladribine) (Continued) TABLE 22 GLOBAL MARKET FOR MYLINAX, BY REGION, THROUGH
2015 ($ MILLIONS) TERIFLUNOMIDE (HMR1726) TABLE 23 GLOBAL MARKET FOR TERIFUNOMIDE BY REGION,THROUGH
2015 ($ MILLIONS) BG-12 (DIMETHYL FUMARATE, BG00012) TABLE 24 GLOBAL MARKET FOR BG-12 BY REGION, THROUGH
2015 ($ MILLIONS) FIRATEGRAST (SB683699, T-0047)BAF312 ONO-4641 ACT-128800 MASITINIB PLENEVA (BGC20-0134)
TRIMESTA (ESTRIOL) KETAS (MN-166, AV-411, IBUDILAST) TABLE 25 MN-166 PHASE II STUDY RESULTS ELND002 PI-2301
CS-0777 CDP323 (UCB-323) DIRUCOTIDE (MBP8298) CHAPTER SEVEN: BIOLOGICS FOR MS OVERVIEW TABLE 26
BIOLOGICS FOR MS BY CLASS TABLE 27 GLOBAL MARKET FOR BIOLOGIC FOR MS BY INDIVIDUAL DRUG, THROUGH 2015
($ MILLIONS) MABS ANTIBODIES FOR MSTABLE 28 BENEFITS AND CHARACTERISTICS OF MABS TABLE 29 SELECTED
ANTIBODIES IN DEVELOPMENT FOR MS TYSABRI (NATALIZUMAB) TABLE 30 TYSABRI SENTINEL AND AFFIRM STUDY
RESULTS Tysabri (Natalizumab) (Continued) Tysabri (Natalizumab) (Continued) TABLE 31 GLOBAL MARKET FOR TYSABRI BY
REGION, THROUGH 2015 ($ MILLIONS) CAMPATH/MABCAMPATH (ALEMTUZUMAB) Campath/MabCampath (Alemtuzumab)
(Continued) TABLE 32 ALEMTUZUMAB PHASE II STUDY RESULTS Campath/MabCampath (Alemtuzumab) (Continued) TABLE 33
GLOBAL MARKET FOR CAMPATH IN MS BY REGION, THROUGH 2015 ($ MILLIONS) ZENAPAX (DACLIZUMAB) TABLE 34
DACLIZUMAB CHOICE STUDY RESULTS Zenapax (Daclizumab) (Continued) TABLE 35 GLOBAL MARKET FOR DACLIZUMAB IN
MS BY REGION, THROUGH 2015 ($ MILLIONS) RITUXAN, MABTHERA (RITUXIMAB) Rituxan, MabThera (Rituximab) (Continued)
OCRELIZUMAB (RG1594, PRO70769) ARZERRA (OFATUMUMAB) AIN457 LY2127399 ABT-874 BIIB033 ANTI-CD100 MAB
USTEKINUMAB (CNTO1275) INTERFERON BETAS INTERFERON BETAS (CONTINUED) TABLE 36 GLOBAL MARKET FOR
INTERFERON BETAS IN MS BY REGION, THROUGH 2015 ($ MILLIONS) BETASERON, BETAFERON (INTERFERON
BETA-1B,BAY86-5046) TABLE 37 TWO-YEAR BETASERON RRMS STUDY RESULTS TABLE 38 THREE-YEAR BETASERON
RRMS STUDY RESULTS TABLE 39 GLOBAL MARKET FOR BETASERON BY REGION, THROUGH 2015 ($ MILLIONS) AVONEX
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(INTERFERON BETA-1A) TABLE 40 AVONEX PIVOTAL PHASE III STUDY RESULTS TABLE 41 GLOBAL MARKET FOR AVONEX
BY REGION, THROUGH 2015 ($ MILLIONS) REBIF (INTERFERON BETA-1A) Rebif (Interferon Beta-1A) (Continued) TABLE 42
GLOBAL MARKET FOR REBIF BY REGION, THROUGH 2015 ($ MILLIONS) EXTAVIA (INTERFERON BETA-1B) Extavia
(Interferon Beta-1b) (Continued) TABLE 43 GLOBAL MARKET FOR EXTAVIA BY REGION, THROUGH 2015 ($ MILLIONS)
CINNOVEX (INTERFERON BETA-1A) BIFERONEX (INTERFERON BETA-1A) Biferonex (Interferon Beta-1a) (Continued) PEG
INTERFERON BETA-1A, BIIB017) TV-1390 THERAPEUTIC VACCINES TOVAXIN ATX-MS-1467 RTL1000 BHT-3009 NEUROVAX
XTOLL (CHAPERONIN 10, CPN10) XToll (Chaperonin 10, Cpn10) (Continued) NTX-488 (PROLACTIN) ATL1102 (FORMERLY
TV-1102) ATL1102 (formerly TV-1102) (Continued) CHAPTER EIGHT: DISEASE APPLICATIONS OVERVIEW TABLE 44 LABELS
OF APPROVED DISEASE-MODIFYING THERAPIES FOR MS TABLE 44 (CONTINUED) MS SUBGROUPS RRMS SPMS PPMS
PPMS (Continued) PRMS THE MARKET FOR MS THERAPIES BY MS DISEASE SUBGROUP CLASSIFICATION CHAPTER NINE:
MAJOR COMPANIES AND MARKET SHARE MARKET SHARE TABLE 45 FORECASTED SALES AND MARKET SHARE OF
COMPANIES WITH AGENTS FOR MS ON THE MARKET, 2010 AND 2015 ($ MILLIONS/%) COMPANY PROFILES AB SCIENCE
AB Science USA ABBOTT LABORATORIES ACTELION ACTIVE BIOTECH ADEONA PHARMACEUTICALS ANTISENSE
THERAPEUTICS APITOPE ARTIELLE IMMUNOTHERAPEUTICS BAYER AG Bayer (U.S. Location) BIOGEN IDEC BTG CBIO
CINNAGEN DAIICHI SANKYO ELAN ELI LILLY FAST FORWARD, LLC FIVE PRIME THERAPEUTICS GENMAB Genmab (U.S.
Location) GENZYME GLAXOSMITHKLINE GlaxoSmithKline (U.S. Location) MEDICINOVA MERCK KGAA (MERCK SERONO)
MITSUBISHI TANABE PHARMA MOMENTA PHARMACEUTICALSNOVARTIS ONO PHARMA OPEXA THERAPEUTICS
PEPTIMMUNE PFIZER ROCHE SANOFI-AVENTIS STEM CELL THERAPEUTICS TEVA PHARMACEUTICAL INDUSTRIES
CHAPTER TEN: INTERNATIONAL ASPECTS AND REGULATORY ISSUES MARKET BY REGION TABLE 46 GLOBAL
FORECAST FOR MS DISEASE-MODIFYING THERAPIES BY REGION, THROUGH 2015 ($ MILLIONS) MARKET BY REGION
(CONTINUED) UNITED STATES The FDA Modernization Act of 1997 Fast-Track Status Special Protocol Assessments New
Surveillance and Safety Requirements Approvable Letters Consumer Confidence Medicare Other Healthcare Changes EUROPEAN
UNION New Drug Approvals and Innovation Drug Reimbursement and Reference Pricing Relocation of R&D JAPAN New Drug
Approvals Regulatory Climate Relationship between Academia and Industry CHAPTER ELEVEN: FUTURE DIRECTIONS THE
ROLE OF BIOMARKERS AND PHARMACOGENOMICS COMBINATION THERAPIES THE EFFECT OF GENERIC MS THERAPIES
ON PRICE THE EFFECT OF GENERIC MS THERAPIES ON PRICE (CONTINUED)
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