Over the last decade, biotech antibodies have provided some of the biggest breakthroughs in medicine. The list includes: Avastin, Herceptin, Rituxan and Erbitux for cancer; Enbrel, Humira, and Remicade for immune and inflammatory disorders.
A biopharmaceutical is defined as a medical drug (proteins including antibodies, nucleic acids, DNA, RNA or antisense oligonucleotides) which is produced using biotechnology. In the late 1990's, advances in manufacturing and processing revolutionized the production of biopharmaceuticals such as recombinant DNA technology and hybridoma technology. These technological advances have enabled the market place to open up and for smaller players to enter and capitalize on the growing need for targeted, personalized medicine.
The biopharmaceutical field represents a major opportunity for generic manufacturers with sufficient resources to survive the relatively high development costs and the technological demand. It is estimated that biosimilars, targeting the six leading biopharmaceutical products, could generate revenues in excess of $2 billion within 2-3 years. However, there are considerable challenges facing companies developing and marketing biopharmaceutical products.
Manufacturing problems will remain a significant hurdle for companies entering this field as the regulation of innovator biopharmaceutical products continues to evolve. The harmonization of regulatory processes among the three main national regulatory agencies in the EU, U.S. and Japan should make life simpler for biopharmaceutical companies seeking to establish a global presence for their products.
Biotherapeutics represent 7.5 percent of all drugs on the market. They account for approximately 10 percent of the total expenditure for marketed drugs and their use is growing at more than 20 percent per year. Biotechnology drug candidates account for around 32 percent of all pipeline research programs. In addition, biological drugs are administered in life-saving or end-stage applications, 74 percent more than chemically derived pharmaceuticals.
The biopharmaceutical market was estimated to be worth over $79 billion in 2007 with antibodies representing around $27 billion sales and protein products generating almost $52 billion. The biopharmaceutical market is growing at an annual rate of around 15% - far higher than pharmaceuticals (c. 6-7% per annum).
By 2020, the market is forecast to be worth over $200 billion driven by a shift in:
The usage from conventional drugs to biopharmaceutical products
The relatively high cost of biopharmaceutical products
The launch of biosimilars and a new generation of biotherapeutics
We here at Diteba, have already begun to feel this moevement as more and more interest is being directed our way to assist clients with developing methods and testing for new biopharmaceutical products. We are beginning to position ourselves to better serve this market with new analytical techniques and expertise to assist our clients in facing the challenges that lie ahead of them in developing these new proteins and peptide products.