美國的治療用單細胞繁殖抗體市場

Abstract

Dearth of Reliable Conventional Therapies for Serious/Long-term Illnesses Boosts Markets for Therapeutic mAbs

The shortage of reliable conventional therapies for critical illnesses is propelling demand for monoclonal antibodies (mAbs), which work closely with the bodys natural biomedical systems. Estimates indicate that more than two-thirds of therapeutic mAbs are used for transplant rejection, cancer, and autoimmune and infectious diseases. Sales in the billion dollar range and growing investments in mAb development, underline the clinical credibility of the therapy for serious long-term conditions such as non-hodgkins disease, psoriasis, allergic asthma, rheumatoid arthritis, and Crohns disease. To increase awareness on the benefits of mAbs, it is necessary to allot a large budget, while also implementing well designed communication strategies.

This Frost & Sullivan research service provides an overview of and an outlook for the therapeutic mAb market in United States, detailing revenue forecasts by region and segments as well as providing market share analyses. It looks into the major market sectors for therapeutic mAbs such as oncology, auto-immune and inflammatory disorders, cardiovascular disorders, organ transplants, and infectious diseases. This information is valuable to both large and small market participants seeking to position themselves for maximum return on investment.

High Specificity mAbs Provides Attractive Therapeutic Solutions

mAbs, particularly the human type, have a high binding capacity and specificity that make them suitable for targeted attacks on tumor cells, infectious agents, infected cells, and other human biomaterials related to diseases. It can target any antigen or molecule in the human body. "Unlike the traditional drugs, mAbs can prevent the disease-causing target cells from spreading without damaging the healthy cells in the adjacent tissues," points out the analyst of the research. "They attack specific antigens (within cells, tissues and organs) and do not have off-target effects, thus eliminating side-effects. "Due to this characteristic, mAbs offer high commercial viability and are successfully used in clinical applications.

Broadening Indication Range of Therapeutic mAbs Attract New Patient Groups

With the initial approval being rather cautious, mAbs are often restricted to a single indication comprising smaller patient population. However, companies are extending their indications domain within the same disease area, eventually covering different sets of patients. "Enterprises are increasingly conducting research on pipeline products to develop successful multi-target indications, in almost the same amount of time earlier consumed to develop a single product indication," notes the analyst.

To enhance this product development, big pharmaceutical companies are developing alliances with smaller biotech companies in mAb research for specific products and technologies. These alliances can balance the small biotech companies capabilities in mAb generation and optimization, along with their process technology and early clinical skills, with the superior drug development capabilities and domestic and global reach of the big pharmaceutical companies.

Table of Contents

1. Executive Summary

2. Objectives and Scope

• 1. Objectives and Scope
  • 1. Objectives
  • 2. Scope

3. Introduction to Monoclonal Antibodies

• 1. Monoclonal Antibodies Market Overview
  • 1. Introduction
  • 2. Structure of Antibodies
  • 3. Typical Problems with Murine mAbs
  • 4. The Role of Hybridoma Clone
  • 5. Medical Utility of mAbs
  • 6. Market Overview
• 2. Evolution and Technology Trends
  • 1. Introduction
  • 2. Early Murine mAbs
  • 3. Chimeric mAbs
  • 4. Humanized mAbs
  • 5. Fully Human mAbs
  • 6. Phage Display of Human mAbs
  • 7. Monoclonal Antibodies as Carriers
  • 8. Naked Monoclonal Antibodies
  • 9. Conjugated Monoclonal Antibodies
• 3. Future of Monoclonal Antibodies
  • 1. The Foundation for Optimistic Future
  • 2. Return on Investment and Future

4. Industry Challenges

• 1. Challenges Affecting the US Therapeutic Monoclonal Antibodies Market
  • 1. Introduction
  • 2. Increasing Costs and Complexities of Clinical Trials
  • 3. Long-Term Safety and Efficacy
  • 4. High Cost of mAbs
  • 5. Restricted Government Healthcare Spending
  • 6. Complexities of Registration Processes
  • 7. Production Capacity Crunch
  • 8. Identify New Targets or Access Validated Targets
  • 9. Small Molecule Drugs
  • 10. Second Line to First Line Therapy
  • 11. Production Challenges of Humanized and Human mAbs

5. Pipeline Analysis

• 1. Overview of the mAbs Pipeline
  • 1. Introduction
  • 2. Therapeutic mAbs in Oncology
  • 3. Therapeutic mAbs in Autoimmune and Inflammatory Disorders
  • 4. Therapeutic mAbs in Organ Transplants
  • 5. Therapeutic mAbs in Cardiovascular Disorders
  • 6. Therapeutic mAbs in Infectious Diseases
  • 7. Therapeutic mAbs in Miscellaneous Indications
  • 8. Participants in mAB Development and/or Marketing

6. Total US Therapeutic Monoclonal Antibodies Market

• 1. Market Dynamics
  • 1. Introduction
  • 2. Market Engineering Measurement
  • 3. Market Drivers
    • a. Paucity of Reliable Conventional Therapies in Serious and/or Long-term Illnesses Propels the Market for Therapeutic mAbs
    • b. Highly Specific Actions of mAbs Make Them Attractive as Therapeutics and Drive Market Expansion
    • c. Improved Safety and Tolerance Profiles of mAbs Expand Their Applications
    • d.Widening Indication Range of Therapeutic mAbs Adds New Patient Groups
    • e.Evolution of Therapeutic mAbs from Murine and Chimeric to Humanized and Human Forms Limits Immunogenicity While Expanding Usage
    • f. Market Growth Impelled as Therapeutic Monoclonal Antibodies Improve Survival Rates Much Better than Small-molecule Drugs
    • g. Strategic Partnerships of Big Pharma With mAb Developers Boost Market Performance
    • h. Mainly Long-term Illnesses Needing Constant Therapeutic Intervention Maintains Therapeutic mAbs Demand
  • 4. Market Restraints
    • a. High Cost of Therapeutic mAbs Delays Demand and Growth
    • b. Paucity of Validated Targets Restricts Patient Numbers and Curbs Market Potential
    • c. Robust Competition from Optional Therapies Curtails mAb Acceptance
    • d.Lack of Large Databases of Long-term Safety Curbs Demand
    • e.Need for Comparative Studies of mAbs with Optional Therapies Discourages Uptake
    • f. High Risks of Product Development Contain mAbs Market Expansion
• 2. Market Forecasts
  • 1. Forecast Assumptions
  • 2. Total Revenue Forecasts
  • 3. Segment-wise Revenue Forecasts
  • 4. Issue of Pricing and Reimbursements
• 3. Frost and Sullivan Awards
  • 1. Technology Excellence Award
  • 2. Entrepreneurial Company Award
  • 3. Competitive Strategy Leadership Award
  • 4. Growth Strategy Leadership Award
  • 5. Industry Innovation and Advancement Award
  • 6. Technology Innovation Award

7. Competitive Analysis

• 1. Competitive Structure
  • 1. Competitive Factors
  • 2. Companies in Therapeutic mAbs Research
  • 3. Companies in Marketing and Sales of Therapeutic mAbs
  • 4. The Dynamism of Deals
  • 5. Market Share Analysis

8. US Therapeutic Monoclonal Antibodies for Use in Oncology

• 1. Overview
  • 1. Introduction
  • 2. Market Engineering Measurement
• 2. Market Forecasts
  • 1. Revenue Forecasts
• 3. Competitive Analysis
  • 1. Competitive Structure
  • 2. Market Share Analysis
  • 3. Competitive Factors

9. US Therapeutic Monoclonal Antibodies in Autoimmune and Inflammatory Disorders

• 1. Overview
  • 1. Introduction
  • 2. Market Engineering Measurement
• 2. Market Forecasts
  • 1. Revenue Forecasts
• 3. Competitive Analysis
  • 1. Competitive Structure
  • 2. Market Share Analysis
  • 3. Competitive Factors

10. US Therapeutic Monoclonal Antibodies for Use in Organ Transplants

• 1. Overview
  • 1. Introduction
  • 2. Market Engineering Measurement
• 2. Market Forecasts
  • 1. Revenue Forecasts
• 3. Competitive Analysis
  • 1. Competitive Structure
  • 2. Market Share Analysis

11. US Therapeutic Monoclonal Antibodies for Use in Cardiovascular Disorders

• 1. Overview
  • 1. Introduction
  • 2. Market Engineering Measurement
• 2. Market Forecasts
  • 1. Revenue Forecasts
• 3. Competitive Analysis
  • 1. Competitive Structure
  • 2. Market Share Analysis

12. US Therapeutic Monoclonal Antibodies for Use in Infectious Diseases

• 1. Overview
  • 1. Introduction
  • 2. Market Engineering Measurement
• 2. Market Forecasts
  • 1. Revenue Forecasts
• 3. Competitive Analysis
  • 1. Competitive Structure
  • 2. Market Share Analysis

13. Market Engineering Strategy for the US Therapeutic Monoclonal Antibodies Market

• 1. Strategic Recommendations
  • 1. Introduction
  • 2. Market Life Cycle
  • 3. Skills Required to be Successful - Strengths Pyramid
  • 4. Seven Ways to Growth
  • 5. Strategies for Success for mAb Industry Participants

14. Decision Support Databases

• 1. Oncology Databases
  • 1. Prostate Cancer
  • 2. Breast Cancer
  • 3. Bladder Cancer
  • 4. Colon Rectum Cancer
  • 5. Lung Cancer
  • 6. Stomach Cancer
  • 7. Liver Cancer
• 2. Autoimmune and Inflammatory Disorders Databases
  • 1. Arthritis
  • 2. Multiple Sclerosis
• 3. Organ Transplant Databases
  • 1. Major Organ Transplants
  • 2. Heart Transplants
  • 3. Kidney Transplants
  • 4. Pancreas Transplants
  • 5. Liver Transplants
  • 6. Lung Transplants
• 4. Cardiovascular Databases
  • 1. Cardiologists
  • 2. Hypertension
  • 3. Stroke
  • 4. Myocardial Infarction

List Of Figures

Chapter 3

• *
• Introduction to Monoclonal Antibodies
• *
• Therapeutic Monoclonal Antibodies Market:
• *
• Marketed Brands (US), 2005

Chapter 4

• Challenges Affecting the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Industry Challenges Ranked by Priority (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Impact of Industry Challenges (US), 2005-2012

Chapter 5

• Pipeline Analysis of the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Pipeline Marketed Brands New Oncology Indications (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs in Oncology (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline Marketed Brands New AIID Indications (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs in AIID (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs in Transplants (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs / Indications in Cardiology (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs in Infections (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Pipeline New mAbs in Other Indications (US), 2005

Chapter 6

• Analysis of the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Market Drivers Ranked by Priority (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Impact of Market Drivers (US), 2005-2012
• Therapeutic Monoclonal Antibodies Market:
• Market Restraints Ranked by Priority (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Impact of Market Restraints (US), 2005-2012
• Therapeutic Monoclonal Antibiotics Market:
• Revenue Forecasts (US), 2002-2012
• Therapeutic Monoclonal Antibiotics Market:
• Products Offered by Major Market Participants (US), 2005
• Therapeutic Monoclonal Antibiotics Market:
• Segment-wise Revenue Forecasts (US), 2002-2012
• Therapeutic Monoclonal Antibiotics Market:
• Prices and Costs of Marketed Brands (US), 2005

Chapter 7

• Competitive Analysis of the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Deals, Sample List (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Market Players Ranked in Order of Market Position (US), 2005

Chapter 8

• US Therapeutic Monoclonal Antibodies Market for Use in Oncology
• Oncology Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Oncology Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005
• Oncology Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005
• Oncology Therapeutic Monoclonal Antibodies Market:
• Market Players Ranked in Order of Market Position (US), 2005

Chapter 9

• US Therapeutic Monoclonal Antibodies Market for Use in Autoimmune and Inflammatory Diseases
• AIID Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• AIID Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005
• AIID Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005
• Oncology Therapeutic Monoclonal Antibodies Market:
• Market Players Ranked in Order of Market Position (US), 2005

Chapter 10

• US Therapeutic Monoclonal Antibodies Market for Use in Organ Transplants
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005

Chapter 11

• US Therapeutic Monoclonal Antibodies Market for Use in Cardiovascular Disorders
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005

Chapter 12

• US Therapeutic Monoclonal Antibodies Market for Use in Infectious Diseases
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Competitive Structure (US), 2005

List of Charts

Chapter 3

• Introduction to Monoclonal Antibodies
• Therapeutic Monoclonal Antibodies Market:
• Technical Classification (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Murine mAbs Structure (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Murine mAbs Brands (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Chimeric mAbs Structure (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Chimeric mAbs Brands (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Humanized mAbs Structure (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Humanized mAbs Brands (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Human mAbs Structure (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Human mAbs Brand (US), 2005

Chapter 5

• Pipeline Analysis of the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Segment-wise Number of Marketed Brands (US), 2005

Chapter 6

• Analysis of the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market: Key Market Engineering Measurements (US), 2005
• Therapeutic Monoclonal Antibiotics Market:
• Revenue Forecasts (US), 2002-2012
• Therapeutic Monoclonal Antibiotics Market:
• Segment-wise Revenue Forecasts (US), 2002-2012
• Therapeutic Monoclonal Antibodies Market:
• Segment-wise Contributions (US), 2002-2012
• Therapeutic Monoclonal Antibiotics Market:
• Contributions, Segment-wise (US), 2005
• Therapeutic Monoclonal Antibiotics Market:
• Contributions, Segment-wise (US), 2012

Chapter 8

• *
• US Therapeutic Monoclonal Antibodies Market for Use in Oncology
• *
• Oncology Therapeutic Monoclonal Antibodies Market:
• *
• Market Engineering Measurements (US), 2005
• *
• Oncology Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Oncology Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005

Chapter 9

• US Therapeutic Monoclonal Antibodies Market for Use in Autoimmune and Inflammatory Diseases
• AIID Therapeutic Monoclonal Antibodies Market:
• Market Engineering Measurements (US), 2005
• AIID Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• AIID Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005

Chapter 10

• US Therapeutic Monoclonal Antibodies Market for Use in Organ Transplants
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Market Engineering Measurements (US), 2005
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Organ Transplants Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005

Chapter 11

• US Therapeutic Monoclonal Antibodies Market for Use in Cardiovascular Disorders
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Market Engineering Measurements (US), 2005
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Cardiovascular Disorders Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005

Chapter 12

• US Therapeutic Monoclonal Antibodies Market for Use in Infectious Diseases
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Market Engineering Measurements (US), 2005
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Revenue Forecasts (US), 2002-2012
• Infectious Diseases Therapeutic Monoclonal Antibodies Market:
• Marketed Brands (US), 2005

Chapter 13

• Market Engineering Strategy for the US Therapeutic Monoclonal Antibodies Market
• Therapeutic Monoclonal Antibodies Market:
• Market Life-Cycle (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• Market Optimization (US), 2005
• Therapeutic Monoclonal Antibodies Market:
• McKinsey Growth Pyramid Model (US), 2005
• Therapeutics Monoclonal Antibodies Market:
• Strategic Recommendations for Growth (US), 2005