The remarkable variety in which these antibodies may be used has had some analysts hailing this technology as the medicine of the future. Monoclonal antibodies are effective in a broad range of diseases including autoimmune, cardiovascular and infectious diseases, cancer and inflammation.
Market drivers for this sector are seen as more important than other sectors of the pharmaceutical industry partly because they are seen as one of the main indicators of the direction drug treatments are shaping towards.
Currently the limited efficacy of conventional therapies combined with serious side effects, has increased demand for monoclonal (mAbs). One of the great advantages of this therapy is its low or negligible toxicity. Indeed, another one is that the antibody itself may be used as a weapon or the antibody may serve as the vehicle to deliver a drug.
Indeed, beyond fully human antibodies, conjugated antibodies (linked to small molecule drugs, toxins, or radioactive payloads) have shown strong theoretical potential, particularly in the treatment of cancers.
According to a soon-to-be-released updated report: "RC-088Z Dynamic Antibody Industry," from Business Communications Company, the worldwide market for therapeutic and diagnostic antibodies is estimated at $15 billion in 2005.
With the rollout of more than a dozen new therapeutic monoclonal antibody products and expanded indications for existing products expected during the forecast period, the market is expected to rise at an average annual growth rate (AAGR) of 11.5 per cent to nearly $26 billion in 2010.
The current market has a wealth of products that are jostling for key position. The market leaders include Roche/Genentech's Rituxan/MabThera (rituximab) and Johnson & Johnson's Remicade (infliximab).
Now, more recently launched humanised antibodies, including Roche/Genentech's Avastin (bevacizumab) and Herceptin (trastuzumab) and Bristol-Myers Squibb's Erbitux (cetuximab), are also starting to make a real commercial impact, along with the first fully human antibody, Abbott's Humira (adalimumab).
As of May 2005, there were 18 therapeutic monoclonal antibody products on the US market. Worldwide, there were an estimated 500 monoclonal antibody products in development by more than 200 companies for the treatment of virtually every debilitating disease. Approximately 80 of these monoclonal antibody products are in clinical trials.
Two notable novel monoclonal antibody drugs include, ImClone/BMS/Merck KGaA's Erbitux (for cancer), which has received FDA approval and Biogen Idec/Elan's Antegren (for multiple sclerosis). Antegren received FDA priority review in July 2004 and is expected to launch in early 2005.
GlaxoSmithKline'sRANK monoclonal antibodies are a new therapy that inhibits the receptor activator of nuclear factor Kappa B (RANK) ligand in oesteoporosis.
Genmab recently granted Serono exclusive worldwide rights to develop and market Genmab's HuMax-TAC, a human antibody targeting the TAC antigen also known as CD25, or the interleukin-2 receptor alpha subunit (IL-2Ra) - which is overexpressed by activated T-cells.
The report stated that therapeutic antibodies currently dominate the market and are projected to have an AAGR of 11.4 per cent, reaching $25.7 billion in 2010. The therapeutic monoclonal antibody market is projected to have an AAGR of approximately 12.4 per cent through 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 approximately 4 per cent.
The report also predicted the diagnostic imaging market, though small, would do well, with average annual growth approaching 17 per cent reaching $147 million in 2010.