Antibody Drugs: Technologies and Global Markets
The global market for therapeutic monoclonal antibodies (mAbs) was estimated at $44.6 billion in 2011. With the rollout of at least eight new therapeutic mAb products and expanded indications for existing products expected during the forecast period, the global mAb market is expected to rise at a compound annual growth rate (CAGR) of 5.3% to nearly $58 billion in 2016.
This report analyzes and assesses therapeutic applications of mAbs in human medicine. Covered in this report are mAbs exclusively, including the combination of mAbs when they are attached to a cytotoxic agent such as with ADCs.
Excluded from this report are diagnostic uses of mAbs (such as for imaging purposes) and therapeutic antibodies for veterinary use. Also excluded are research applications of mAbs.
The scope of the study is global. The “Overview” section provides a discussion of the importance and advantages of antibody-based products, valuation of antibody product sales, patent issues and differences in applicability of mAbs products versus polyclonal antibodies (pAbs), and other competing agents such as small molecule therapeutics.
The “Technology and Technical Issues” section discusses new directions in antibody research, the types of antibodies used as therapeutics, the challenges in antibody production, and other approaches—in particular transgenic sources—of antibody production.
The “Products” section provides a synopsis of more than 60 mAb drugs, including those currently marketed and those in late-stage development. Comparative product and sales analyses are provided for individual products. Tables include current and forecasted sales by individual product, sales by target and technology (for mAb-based drugs), as well as global market size and growth estimates for therapeutic mAbs.
The “Applications” section provides an overview of the leading indications for available and emerging antibody-based therapeutics. These include selected indications for autoimmune diseases (specifically rheumatoid arthritis, psoriasis, and Crohn’s disease), cancer indications (specifically the most common solid tumor types, leukemias, and lymphomas) cardiovascular diseases, infectious diseases, ophthalmic indications, and respiratory diseases.
The “Industry Structure” section provides an overview of the antibody industry as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.
The “Company Profiles” section emphasizes companies that lead the biotechnology and pharmaceutical industry in the research and development of antibody drugs and the innovative products that those companies have launched or have in development.
Esther Bosklopper has been an analyst working in the biotechnology and pharmaceutical industry and other life sciences industries for more than six years. She holds a degree from the University of California, Davis.
- The global market for monoclonal therapeutic and diagnostic antibodies increased from $26 billion in 2006 to an estimated $31 billion by the end of 2007. It should reach $56 billion by 2012, a compound annual growth rate (CAGR) of 13%.
- In 2007, the U.S. Food and Drug Administration approved 21 therapeutic monoclonal antibodies for therapeutic use under a drug approval review.
- Monoclonal antibodies are a significant part of effective medical treatment and of financial deals within the biotechnology and pharmaceutical sectors of the economy.
The worldwide market for therapeutic and diagnostic antibodies is estimated at $15 billion in 2005 and will rise at an average annual growth rate (AAGR) of 11.5% to nearly 26 billion in 2010.
Therapeutic antibodies dominate the market and are projected to have an AAGR of 11.4%, reaching $25.7 billion in 2010.
The therapeutic monoclonal antibody segment will rise at an AAGR of 12.4% while the therapeutic polyclonal market, driven more by volume and demand than innovation, is projected to see an AAGR of only 4%.
The diagnostic imaging market, though small, will experience an average annual growth near 17%, reaching $147 million in 2010.
As of May 2002, there were 11 therapeutic monoclonal antibody products on the U.S. market. Worldwide, there were an estimated 470 monoclonal antibody products in development by more than 200 companies for the treatment of virtually every debilitating disease. Approximately 70 of these monoclonal antibody products were in clinical trials. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), monoclonal antibody products represented approximately 20% of all products in development and 33% of all biotech products in development by its members.
The therapeutic monoclonal antibody market is projected to have an average annual growth rate (AAGR) of approximately 25% throughout the forecast period. The therapeutic polyclonal antibody market, which is driven more by volume and demand than innovation, is projected to see an AAGR of just less than 11%. The diagnostic imaging market, though small, will see average annual growth exceeding 28% throughout the forecast period.
Antibody-based drugs, in particular monoclonal antibody-based products, are on the brink of significant commercial growth. New developments are spurred in part by advances in technology that have now surmounted previous technical barriers to commercialization.
The information and analyses presented in this report on antibody-based drugs is an important asset in decision-making for managers involved in development, marketing, market research, product development, mergers and acquisitions, licensing, management, investment banking and deal creation, and to consultants to the pharmaceutical and biotechnology industry.
The study provides a comprehensive analysis of the current markets for antibody drugs and, in particular, the market potential of promising drugs and technologies under development.