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U.S. Autoimmune Disorders Markets for Biologics

Published by: Frost & Sullivan

Published: Sep. 15, 2004


Table of Contents



1. Executive Summary

        1. Executive Summary

                1. Executive Summary



2. Total Market

        1. Overview

                1. Introduction

                2. Report Scope and Segmentation

                3. Market Engineering Analysis

        2. Forecasts and Trends

                1. Overall Trends

                2. Forecast Assumptions

                3. Market Analysis and Forecasts

                4. Competitive Overview

        3. Frost & Sullivan Awards

                1. Introduction

                2. Product Innovation Award

                3. Marketing Strategy Leadership

                4. Customer Value Leadership Award

                5. Growth Strategy Leadership



3. Rheumatoid Arthritis Market

        1. Overview

                1. Introduction

                2. Market Engineering Analysis

                3. Challenges

                a. Dearth of Awareness Reduces the Number of Patients Treated

                b. Low Treatment Cost Therapies Challenge Penetration

                c. Physician Education Holds the Key to Market Penetration

                d. Reimbursement Issues with Managed Care Retards Expansion

                e. Over-the-Counter Medications Consume Prescription Sales

        2. Revenue Analysis And Market Size

                1. Revenue Forecasts for Biologics

        3. Market Trends

                1. Market Drivers

                a. Aggressive Marketing by Pharmaceutical Companies Drives Market

                b. Advent of Newer Biologics Helps Market Expansion

                c. Publicity and DTC Advertising Increase the Number of Patients Visiting the Doctor

                d. Rheumatoid Arthritis is Poised for Rapid Growth as Baby Boomers Grow Older

                e. Educational Programs by the Arthritis Foundation and the Government Augments Patient Awareness

                2. Market Restraints

                a. Delay by Primary Care Physicians in Referring Arthritis Patients to Rheumatologists Curbs Patients Confidence in Anti-arthritis Drugs

                b. Fierce Competition Augments Spread Ebbing Profitability

                c. Reimbursement Issues for High Cost Treatment by Managed Care Curbs Revenue Generation

                d. Availability of OTC Drugs Influences the Market Penetration of Biologics and Hence Impacts Revenue Generation

        4. Competitive Analysis

                1. Market Share Analysis



4. Psoriasis Market

        1. Overview

                1. Introduction

                2. Market Engineering Analysis

                3. Biologics for Psoriasis

                4. Challenges

                a. Initial Teething Problems of New Forms of Therapy Likely to Delay Acceptance

                b. Difficulty in Promoting the Benefits of Newly Approved Drugs to Physicians and Patients Limits Market Potential

                c. Reimbursement Issues Expected to Limit Acceptance initially

                d. Small companies may battle to successfully commercialize a new product, which could limit revenue growth.

        2. Revenue Analysis and Market Size

                1. Revenue Forecast for Biologics

        3. Market Trends

                1. Market Drivers

                a. Psoriasis is a Large Untapped Market Waiting to be Penetrated

                b. Increase inTreatment Options Available to Patients and Physicians Boosts Revenue

                c. Higher Prices Likely to Boost Revenues

                d. Increased Disease Awareness through DTC Advertising Leads to Increased Market Revenues

                2. Market Restraints

                a. The Unavailability of Long-term Clinical Data Likely to Slow Market Growth of New Products

                b. Severe Side Effects Profile of Existing Drugs have Alienated Patients

                c. The Non-life Threatening Status of Psoriasis is Increasing the Barriers to Entry for New Drugs

                d. Improper Diagnosis of the Severity of the Disease by Physicians Restricts Revenues

                e. High cost of new products may limit market potential

                f. Mode of Administration Anticipated to Limit the Appeal of Certain Drugs

                g. Reluctance of Health Insurers to Reimburse Patients for New Drugs Likely to Stunt Growth

        4. Competitive Analysis

                1. Market Share Analysis



5. Multiple Sclerosis Market

        1. Overview

                1. Introduction

                2. Market Engineering Analysis

                3. Biologics for Multiple Sclerosis

                4. Challenges

                a. Limited RRMS Indication and Lack of Proven Medical Benefits in other Disease Types Limits Market Penetration Potential

                b. Complex Nature of the Disease Contributes to Either Poor Diagnosis or Misdiagnosis

                c. Medication Side Effects Contribute to Compliance Problems and Acceptance of MS Drug Therapy

                d. Time-consuming Reconstitution Process, Required Dosing Frequency, and Patient Resistance to Needles Hampers Patient Acceptance and Compliance with MS Drug Therapy

        2. Revenue Analysis and Market Size

                1. Revenue Forecast for Biologics

        3. Market Trends

                1. Market Drivers

                a. Increased Prices for MS Drugs are Expected to Drive Market Revenue Growth

                b. Increasing Number of Newly Diagnosed Patients Fuels New Patient Demand for MS Drugs

                c. Increasing Patient Compliance and Acceptance of Biologics as a First Line of Therapy Spurs Demand

                d. Increases in Medication Dosing and Combination Therapies Contributes to Market Revenue Growth

                2. Market Restraints

                a. High Cost of MS Medications and Low Willingness to Pay on the Part of Some Health Insurance Providers Adversely Affects Market Penetration in the Non-insured and Under-insured Patient Segments

                b. Lack of Complete MS Remission and Clinically Evident Patient Benefits Leads to Lower Compliance Rates

                c. Contraindications Limit Access in Some Patient Segments

        4. Competitive Analysis

                1. Market Share Analysis



6. Inflammatory Bowel Diseases Market

        1. Overview

                1. Introduction

                2. Market Engineering Analysis

                3. Biologics for Crohn's Disease and Ulcerative Colitis

                4. Challenges

                a. Long Clinical Trials and Stringent Regulatory Requirements Delays the Entry of New Products into the Marke

                b. Difficulty in Diagnosing the IBD Masks the Actual Demand in this Market

                c. Difficulty in Enrolling the Right Patients Influences Clinical Trials Posing a Challenge for New Product Entry and Supplementary Approvals for other Indications

        2. Market Trends

                1. Market Drivers

                a. Unmet Medical Need for this Critical Health Condition is One of the Key Drivers for Market Growth

                b. Patients with Crohn's Disease Experience Periods of Relapse and Remission Lasting Months to Years Generating Demand for Treatment during the Patient's Lifetime

                c. Safety Profile of the Existing Biologic for Crohn's Disease Coerces Usage

                d. A Significant Number of Patients Suffering From Inflammatory Bowel Disease Spurs Demand for the Drugs

                2. Market Restraints

                a. Reimbursement Issues Likely to Restrict Profitability

                b. Regulatory Issues Likely to Curb Revenues

                c. Low Efficacy Anticipated to Hinder Acceptance

                d. Fierce Competition Expected to Confine Revenues

        3. Revenue Analysis And Market Size

                1. Revenue Forecasts for Biologics

        4. Competitive Analysis

                1. Market Share Analysis



7. Other Emerging Autoimmune Disorders Markets

        1. Overview

                1. Overview



8. Appendix

        1. Decision Support Database

                1. Arthritis Prevalence - World

                2. Biotech Private Investment

                3. Total Healthcare Expenditure

                4. Total Population

                5. USPTO Biotech Patent

Abstract

Biologics for Autoimmune Disorders Hold Immense Market Potential

Growing diagnosis of numerous autoimmune diseases - over sixty have already been identified - is increasing the demand for drugs to treat such disorders. However, biologics are presently available only for diseases such as rheumatoid arthritis, multiple sclerosis and psoriasis while treatment options for illnesses such as Sjogren’s syndrome, Uvetis, Scleroderma, and Fibromyalgia are under development. An upward trend in market growth is expected once these drugs, which are in advanced stages of clinical trial, are introduced.

Frost & Sullivan’s recent study analyzes the U.S. autoimmune disorders markets for biologics. It focuses specifically on drugs for rheumatoid arthritis, multiple sclerosis, psoriasis, and inflammatory bowel disease. The research also provides a comprehensive overview of market size, growth patterns, and revenue forecast while also providing details on biologic drugs in the pipeline.

Biologics for Rheumatoid Arthritis and Psoriasis in High Demand

Nearly 2.1 million people in the United States suffer from rheumatoid arthritis, 7 million from psoriasis, more than 400,000 from multiple sclerosis and these numbers continue to increase. A corresponding increase in the demand for treatment drugs is pushing biotech and pharmaceuticals companies to develop appropriate biologics. Rheumatoid arthritis drugs have the maximum demand with nearly seven drugs in various stages of advanced clinical trials. "Biologics for treatment of psoriasis is another potential multi billion dollar market," says the analyst of this research. "Three approved drugs - Enbrel, Raptiva, and Amevive - are already available in the market with many more in the pipeline and advanced stages of clinical trials."

Increasing FDA Approval and New Medicare Legislations Aid Market Growth

Nearly thirty drugs are in the advanced stages of clinical trials presently. End users are expected to benefit significantly from these since the Food and Drug Administration (FDA) is increasing approval of pipeline biologics. The recent Medicare Prescription Drug and Modernization Act favoring biotech medicines is also advantageous for quicker commercialization of these drugs. This legislation guarantees reimbursement to industry participants involved in the development of drugs for various disorders besides ensuring availability of these drugs to patients needing them the most such as senior citizens and disabled persons.

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