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Antibody Therapeutics: Product Development, Market Trends, and Strategic Issues, Revised Edition
Drug and Market Development Publishing, Oct 2006, Pages: 415
Several new developments have taken place in the Antibody Therapeutics in the last two years. These developments are primarily in the antibody market place and in clinical development areas as opposed to in the antibody discovery field as was observed in the early part of this decade. That the emphasis in the field has shifted from the discovery area towards product development is obvious by the fact that many of the companies are now involved in building product based collaborations and in some cases major antibody discovery companies have become attractive enough that some of those have been acquired by large pharma organizations.
While some of the recently introduced antibody products have already achieved blockbuster status in the marketplace, two new ones have been approved for marketing in 2006, which make a total of 20 approved antibody therapeutics available for the treatment of various diseases. It is important to emphasize that one of these two antibodies, Tysabri(R) of BiogenIdec (Cambridge, MA) and Elan Pharmaceuticals (Dublin, Ireland), was originally approved in 2004 but was withdrawn from the market in 2005 due to adverse effects in certain patient segments, and has recently been reintroduced in both US and European markets. The most recently approved antibody product is Lucentis™ of Genentech/Roche and Novartis. Lucentis™ was approved by the FDA in June 2006 and by the regulatory authorities of Switzerland.
This report provides an update on the current market environment including clinical study status, progresses made in the area of collaborations and partnerships, patent situation, and finally the market status. These developments are primarily in the antibody market place and in clinical development areas as opposed to in the antibody discovery field as was observed in the early part of this decade.
Key Points
- Sales of biotech protein therapeutics in 2005 reached $44.5 billion, while revenue from therapeutic antibodies was $13.6 billion. This constituted about 30.5% of the total recombinant protein product sales, up from only 13% in 2001.
- The antibody therapeutics market is expected to grow by about 30% annually reaching excess of $22 billion by 2007.
- Sales of therapeutic antibodies in 2005 increased by about 152%, 92% and 28% over that of 2002, 2003 and 2004, respectively. While most of the revenues were generated in 2002 from five antibodies, i.e., ReoPro(R), Rituxan(R), Remicade(R), Synagis(R) and Herceptin(R). Humira™ was added in the contributory list in 2003, with further addition of Avastin™ and Eritux™ in 2004 and 2005, respectively.
- Many new alliances involving several antibody and bio/pharmaceutical companies have been recorded, although the rate of such alliance formation involving discovery technology has slowed down somewhat over the previous periods. Several antibody companies with either antibody discovery or antibody modification platforms have undergone acquisition by big pharma.
- Companies with antibody modification technologies directed to generating higher antibody efficacy are becoming attractive partners for those focused in the development of antibodies as therapeutic products.
- The worldwide half yearly sales of Herceptin(R) during the first half of 2006 has grown to $1.45 billion, which is an increase of 105% over that in the same period in 2005. The US sales were up by 116% and the non-US sales were up by 98%. Further growth in the Herceptin(R) market is predicted and the annual peak sales is expected to be about $3 billion.
- The worldwide half yearly sales of Rituxan(R) during the first half of 2006 has grown to almost $1.9 billion, which is an increase of 16% overall over the same time period in 2005. The US sales were up 11% and the non-US sales were up by 22.6%. The annual peak sales are expected to be around $4 billion.
- Humira™, the first fully human recombinant antibody for the treatment of rheumatoid arthritis by Abbott Laboratories and CAT already became a blockbuster drug within the third year of its introduction into the market reaching sales of $1.4 billion in 2005. The worldwide half yearly sales of Humira™ during the first half of 2006 has grown to $883 million, which is an increase of 46% over that in the same period in 2005. The US sales were up by 42% and the non-US sales were up by 53%. Further growth in the Humira™ market is predicted and the annual peak sales is expected to be about $1.9 billion in 2006
- More remarkable is the market capitulation by Avastin™, the first anti-angiogenesis antibody developed by Genentech and marketed by Genentech and Roche. Avastin™'s worldwide sales grew to more than a billion dollar within the second year of its introduction in the market reaching sales of almost $1.3 billion in 2005. The drug is doing extremely well in the worldwide market thus generating $1.11 billion within the first six months of 2006. With such growth Avastin is expected to generate more than $2 billion revenue by the end of 2006.
Products Mentioned:
- Reopro
- Rituxan
- Herceptin
- Remicade
- Synagis
- Avastin
- Erbitux
- Xolair
- Raptiva
- Lucentis
- Tysabri
About the author:
Rathin C. Das, Ph.D., M.B.A. is the Chief Business Officer of the human antibody therapeutics company, Affitech AS of Oslo, Norway and President of its US subsidiary, Affitech USA, Inc. of Walnut Creek, CA. He has over 22 years of experience in the bio/pharmaceutical industry in research and development, technology and product licensing, business development and corporate management. Dr. Das is also the Editor of the biotechnology trade journal, the American Biotechnology Laboratory, and has published numerous articles and publications including the Antibody Therapeutics, Antibody Engineering and Display Technologies.
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