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U.S. Biotechnology - Therapeutic Monoclonal Antibodies Market

Frost & Sullivan
May 13, 2008
185 Pages - SKU: MC1782218

Abstract Table of Contents Related Reports

Countries covered: United States

This Frost & Sullivan research service titled U.S. Biotechnology - Therapeutic Monoclonal Antibodies Market provides an overview of therapeutic monoclonal antibodies and provides market forecasts, along with a complete analysis of key market drivers, restraints, and challenges and other market dynamics. In this research, Frost & Sullivan's expert analysts thoroughly examine the following therapeutic application segments: oncology, autoimmune and inflammatory disorders, organ transplantation, infectious diseases, cardiovascular disorders, and others (paroxysmal nocturnal hemoglobinuria, age-related macular degeneration, osteoporosis, and Alzheimer's disease). For each of the segments, both prescription products on the market and the clinical development pipeline are discussed.

Unmet Treatment Needs Fuel Demand for Therapeutic Monoclonal Antibodies

The U.S. therapeutic monoclonal antibodies market has taken a tremendous leap forward in recent years, and growth in this sector has surpassed that of others in the pharmaceutical marketplace with revenues almost doubling since 2004. The ineffectiveness of traditional medical approaches, technological advances in the sector and the lack of generic competition have created opportunities for growth. There are still high unmet needs associated with the treatment of diseases such as cancer, autoimmune and inflammatory disorders, organ transplantation, and infectious diseases, with many conventional therapies in these areas limited by characteristics such as adverse side effects.

Monoclonal antibodies provide an ideal solution for both diseases underserved by current standard treatments and those that currently do not have FDA approved treatments. "Advantages such as low levels of toxicity and the targeted nature of monoclonal antibodies make them useful therapies for the treatment of hard to treat diseases," notes the analyst of this research study. "Monoclonal antibodies bind with great specificity, allowing them to target disease causing cells with minimal damage to healthy tissue."

Technological Innovations and Lack of Marketed Generics Provide Solid Growth Opportunity

Both the rollout of many new products and the expansion of therapeutic indications for existing products have helped drive growth in the therapeutic monoclonal antibodies market. Currently there are 21 products in the U.S. market. By 2014 another 16 are expected to receive FDA approval, increasing the total numbers to thirty seven. At present, there are no generic monoclonal antibodies in the marketplace. In addition, the approval process has been relatively speedy for the new therapeutic monoclonal antibodies when compared to conventional pharmaceuticals, expanding the patient customer base and enabling a wider reach for these products.

Researchers are also focusing to achieve rapid production of monoclonal antibodies and working on increasing drug potency to provide enhanced therapeutic effects. "Intensive research into the immune system, molecular biology and genetic engineering has enabled efficiency in the manufacture and design of monoclonal antibodies, representing an enormous step forward," notes the analyst. "Prominent advancements include transgenic animals and phage display libraries which are used in the manufacture of fully human monoclonal antibodies." In addition, some companies are replacing the full-length antibody with mAb fragments which allows for better penetration into diseased tissues. Another new trend in the market is the development of mAbs to be used in conjunction with certain vaccines in the belief that the monoclonal antibodies would act to boost the immune system, increasing the response of the vaccine. This technique is being used in several vaccines that are in clinical development. With all these developments, the use of monoclonal antibodies is making headway in the pharmaceutical marketplace, widening its scope for the future.

1. Executive Summary: 1. Executive Summary
2. Market Introduction: 1. Research Scope and Methodology; 2. Market Overview; 3. Product Analysis; 4. Pipeline Analysis
3. Competitive Analysis: 1. Competitive Analysis; 2. Forecasts and Trends; 3. Market Share Analysis
4. Decision Support Databases: 1. Oncology Databases; 2. Autoimmune and Inflammatory Disorders Databases; 3. Organ Transplant Databases; 4. Cardiovascular Databases; 5. Other Indications Databases
List of Figures
Chapter 2: Therapeutic Monoclonal Antibodies Market: Paroxysmal Nocturnal Hemoglobinuria Patient Population Forecasts by Gender (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Major Market Challenges (U.S.), 2008-2014; Therapeutic Monoclonal Antibodies Market: Market Drivers Ranked in Order of Impact (U.S.), 2008-2014; Therapeutic Monoclonal Antibodies Market: Market Restraints Ranked in Order of Impact (U.S.), 2008-2014; Therapeutic Monoclonal Antibodies Market: Product Analysis - Oncology (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Product Analysis - Autoimmune and Inflammatory Disorders (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Product Analysis - Organ Transplantation (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Product Analysis - Cardiovascular Disorders (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Product Analysis - Infectious Diseases (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Product Analysis - Other Indications (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Oncology Phase III Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Oncology Phase II Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Oncology Phase I and Selected Pre-Clinical Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Autoimmune and Inflammatory Disorders Phase III Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Autoimmune and Inflammatory Disorders Phase II and I Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Organ Transplantation Selected Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Cardiovascular Disorders Selected Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Infectious Diseases Selected Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Other Indications Selected Pipeline (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Marketed Product Pipeline for Additional Indications - Oncology (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Marketed Product Pipeline for Additional Indications - Autoimmune and Inflammatory Disorders (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Marketed Product Pipeline for Additional Indications - Organ Transplantation (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Marketed Product Pipeline for Additional Indications - Cardiovascular Disorders (U.S.), 2008; Therapeutic Monoclonal Antibodies Market: Marketed Product Pipeline for Additional Indications - Other Indications (U.S.), 2008
Chapter 3: Therapeutic Monoclonal Antibodies Market: Competitive Structure (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Revenue Forecasts by Segment (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Oncology Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Oncology Revenue Forecasts by Product (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Autoimmune and Inflammatory Disorders Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Autoimmune and Inflammatory Disorders Revenue Forecasts by Product (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Organ Transplantation Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Cardiovascular Disorders Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Infectious Diseases Revenue Forecasts (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Infectious Diseases Revenue Forecasts by Product (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Other Indications Revenue Forecasts (U.S.), 2006-2014; Therapeutic Monoclonal Antibodies Market: Other Indications Revenue Forecasts by Product (U.S.), 2004-2014; Therapeutic Monoclonal Antibodies Market: Company Market Share by Revenues (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Company Market Share by Revenues (U.S.), 2014; Therapeutic Monoclonal Antibodies Market: Product Market Share by Revenues (U.S.), 2007; Therapeutic Monoclonal Antibodies Market: Total Product Market Share by Revenues (U.S.), 2014

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