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

NEW YORK, Sept, 23 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

http://www.reportlinker.com/p0298009/Multiple-Sclerosis-MS-Drugs-and-Biologics-Technologies-and-Global-Markets.html

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 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 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.

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 DISEASE MODIFYING 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

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 DISEASE MODIFYING 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 TERIFLUNOMIDE 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 MS

TABLE 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 (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 PHARMACEUTICALS

NOVARTIS

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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