zum MOR Potential :-)
ipollit : zum MOR Potential :-)
Finding the Opportunities in Therapeutic Monoclonal Antibodies
[Published: 28 May 2004 Source: Frost & Sullivan]
By Raju Adhikari, Pharmaceutical-Biotechnology Analyst, Healthcare Practice
Monoclonal antibodies (mAbs) have come a long way from the time of development to their use in therapeutics. mAbs were quick to win acceptance as research and diagnostic aids, but realising therapeutic potential proved to be much more challenging. By 1990, plagued by costly production problems and disappointing results in initial clinical studies, it appeared that mAbs had failed to live up to their theoretical potential. However, with genetic engineering advances combined with more focused targets, the potential of therapeutic mAbs has been realised once again. Following the success of recombinant proteins, therapeutic mAbs now represent the second wave of innovation created by the biotechnology industry in the past twenty years.
Monoclonal antibodies are antibodies secreted by a hybridoma clone, each such clone being derived from a single B cell (lymphocyte) that produces a specific antibody. The initial technology for producing monoclonal antibodies was developed by Kohler and Milstein (Nature 1975 256 (5517): 495-7). mAbs are produced by immunising an animal by injection of an antigen to stimulate the production of antibodies targeted against the immunogen. The antibody forming cells are isolated from the animal?s spleen. MAbs are then produced by fusing single antibody-forming cells to tumor cells (immortal cells) grown in culture. The resulting cell is called a hybridoma. Each hybridoma produces relatively large quantities of identical antibody molecules. By allowing the hybridoma to multiply in culture, it is possible to produce a population of cells, each of which produces identical antibody molecules. These antibodies are the "monoclonal antibodies" because they are produced by the identical offspring of a single, cloned antibody-producing cell. Once a monoclonal antibody is made, it can be used as a specific probe to track down and purify the specific protein that induced its formation. It may be produced in large quantities, usually for use against a specific antigen, for diagnostic and potentially for therapeutic use. This potential has been realised and mAbs have been developed into therapeutics and many are now being studied in clinical trials to determine their effectiveness mainly in indication detection, diagnosis, and treatment.
Setting no Limits
What makes them blockbuster potential drug is their specificity against antigen. The specificity of mAbs has tremendous clinical value and makes them very attractive therapeutics. The focus, which was once dominated by their use in oncology, has now broadened to encompass additional disease areas. In 1994, the first therapeutic mAb was launched in Europe and since then, nine further mAbs have become commercially available in the European Union targeting a variety of therapeutic areas. Globally, there are 17 FDA approved therapeutic mAbs so far. It is likely that the rest will also be approved by the EU in the next two to three years.
mAbs are now a major component of the pharmaceutical pipeline. Of the estimated 370 biotechnology-based drugs in development in 2000, approximately 70 were mAbs, second only to therapeutic vaccines. There are currently 132 mAb products in development. Majority of the products are either humanized (42%) mAbs or fully human (28%) mAbs. The US NIH estimates 16 new therapeutic mAbs will be approved between now and 2008. A healthy future is anticipated for novel mAbs based therapies.
Frost & Sullivan estimates that global therapeutic mAb market in 2003 was 7.6 USD billion and this represents healthy growth of approximately 40% from 2002 figures of 5.5 USD billion. Chimeric mAbs take the biggest share of the market (approximately 45%) followed by humanised mAbs, which have approximately 25-30% of the market share. Of the available therapeutic mAbs, the best seller is Johnson & Johnson/Schering-Plough?s Remicade (Rheumatoid Arthritis), with sales worth 1.6 USD billion in 2002. This was also the fastest-growing product in 2002, with sales increasing by almost 85%.
Probing the Future
Therapeutic mAb is a fast growing market. The growth of the market is predicted to be dominated by chimeric mAbs (Remicade and Rituxan) taking market share of almost 50% in 2008. The number of approved humanised and human antibodies will also significantly increase, with sales forecast to reach $5 billion (approximately 30% market share) for humanised mAbs and $2 billion (approximately 10% market share) for human mAbs by 2008. In terms of the indication markets, oncology and arthritis, immune and inflammatory disorders will likely to be research and commercial focus during the next 4-5 years. With recent FDA approvals of Erbitux (colorectal cancer; Imclone Systems) and Avastin (colorectal cancer, Genentech), oncology will remain the driving income earner with forecast sales of approximately $7 billion in 2008. Arthritis, immune and inflammatory disorders indication will be the next largest income earners, with sales reaching over $6 billion by 2008.
The success of new mAb products depends on the technology used to develop products and financial resources to test products in clinical trials. Companies cannot succeed in the monoclonal antibody business without investing in technology to develop safe and effective products and it certainly is a market that is long on potential. The pharmaceutical and biotechnology industry needs to continue to evolve towards technology integration and market expansions. The success of mAb market will depend on five key factors: a. innovative molecular engineering; b. shorter development times; c. higher success rates; d. robust and efficient IP protection; d. development of cost-effective manufacturing. It is up to the pharmaceutical and biotechnology companies to design their business strategies taking into consideration these factors in order to win the mAb race.
wenn ich das richtig sehe, soll der Markt 2008 auf 13-20 Mrd USD wachsen... man stelle sich mal vor der AK IDEC-C2B8 Anti-CD20 und der AK Bevacizumab rhuMAb-VEGF IgG1 käme aus dem Hause von Morphosys, genauso wie auch 1D09C3 Anti-MHCII, MOR 101 Fab Anti-CD54, MOR102 IgG4 Anti-CD54, MOR202 Anti-CD38... was würde das für MOR im Optimalfall bedeuten? Hinter dem unscheinbaren IDEC-C2B8 verbirgt sich Rituxan und hinter Bevacizumab Avastin... diese zwei Medikamente können zusammen nach sehr optimistischen Schätzungen an die 10 Mrd USD Umsatz generieren. Kämen diese beiden AKs von MOR, so würden sie etwa 5% davon erhalten, ohne dass dies weitere Kosten verursacht... macht einen Gewinn von schlappen 500 Mio USD. Okay dies wäre wohl ein wenig des Guten zuviel... aber es vermittelt vielleicht ein wenig davon, was sich hinter den zahlreichen bekannten oder unbekannten MOR-AKs mit kryptischen Namen für Potential verbergen kann...
soviel zur MOR-Phantasie ;-)
ecki : Der deutschen Sprache bist du mächtig, Mr.? ?
ipollit postet hier einen Artikel ganz allgemein über Marktchancen von AK-Medikamenten und das Gesamtmarktpotential. Das kann wohl kaum pushen von Mor sein?
In diesem Markt hat Morphosys viele Eisen im Feuer. Keines davon ist irgendwie "durch". Ja noch nicht ein eiziger AK ist bisher in der Klinik. Es ist sogar davon auszugehen, das ein großer Anteil der aktuellen Produktkandidaten bei den Kooperationspartnern auf der Strecke bleibt. Aber Morphosys bewegt sich eben in diesem Markt. Das ist Fakt und kein pushen.
Aber gerade durch die Vielzahl der Kandidaten gibts eben ein wahrscheinlich nur durch dich zu leugnendes Potential.
Natürlich werden wir 2010 mehr wissen. Da wird der Kurs dann auch einiges höher stehen als heute. ;-)