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Fast growth MAb market to offer great rewards to a select few over 2009-15

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Fast growth MAb market to offer great rewards to a select few over 2009-15

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In a new report entitled Monoclonal Antibodies: 2010, Datamonitor predicts that the MAb sector will record a near double-digit growth rate over 2009-15, making it the fastest growing molecule type segment in the prescription pharmaceutical industry. With total sales derived by a select band of blockbuster products, the MAb sector is a tough market to break in to, but one that offers high rewards.

The dynamics of the therapeutic monoclonal antibody (MAb) market have changed significantly since the launch of Johnson & Johnson's murine (mouse) MAb OrthoClone OKT3 (muromonab) for organ transplant rejection 25 years ago.

Following initial disappointments, due mainly to immunogenicity issues associated with murine MAbs, this market sector has delivered consistently high year-on-year growth rates, with total MAb sales (based on company-reported information) recording a CAGR of 29.7% over 2003-09 and surpassing the $36 billion mark in 2009. Furthermore, despite being a smaller sector than both small molecules and therapeutic proteins, MAbs currently represent the fastest-growing segment within the global pharmaceutical industry.

The evolution of antibody technology (away from murine toward more human content) has acted as a major growth driver behind this trend, distancing today's blockbuster products from the murine MAbs that were the primary focus of early-stage antibody development. Chimeric and humanized MAbs currently dominate the market, but this technology evolution is continuing.

Five key products account for the bulk of MAb sales

To date, the MAb market has been shaped by five key products: Roche (Genentech)/Chugai's anticancer MAb trio of Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab); Abbott/Eisai's Humira (adalimumab) and Johnson & Johnson/Merck & Co./Mitsubishi Tanabe's Remicade (infliximab). Dubbed the 'Big 5', these products generated over $21 billion in sales over 2003-09, with combined sales in 2009 that accounted for over three-quarters of the global MAb market. Their success can be attributed to some common characteristics: they are all first-to-market MAbs addressing novel protein targets (with the exception of second-to-market Humira), and each addresses disease areas with high unmet need.

A new Datamonitor report, Monoclonal Antibodies: 2010 (October 2010) anticipates that while global sales of small molecules will decline at a CAGR of -0.5% over 2009-15 and therapeutic proteins will see relatively slow growth, the fast growth MAb sector will maintain its trajectory over this period, recording a near double-digit CAGR of 9.5% to reach global sales of $62.7 billion by 2015.

While the Big 5 will comprise the bulk of the global MAb market's sales, Datamonitor has identified an emerging group of seven therapies which, combined, are forecast to record a sales growth contribution over 2009-15 that will match that of the Big 5. However, while Datamonitor predicts that a total of 31 late-stage pipeline MAbs currently in development (or registration) will reach the market over the next six years, the MAb market will continue to be dominated by a select band of products. The Big 5 will command around 60% of the forecast global MAb market by 2015, leaving the remaining 40% shared between 55 other therapies.

Prolia and Benlysta are set to make a significant contribution

Two highly anticipated and well-publicized MAbs of particular interest to the sector are the recently launched Prolia (denosumab; Amgen) and the Phase III candidate Benlysta (belimumab; GlaxoSmithKline), both of which will boost the global MAb market over the coming six years. Perhaps more significantly, they will also be key growth drivers for companies that, to date, have achieved only moderate commercial success in the MAb sector.

Recently launched for the treatment of osteoporosis and approved to treat bone loss in cancer patients undergoing hormone ablation therapy, the fully human MAb Prolia (developed by Amgen and co-marketed with GlaxoSmithKline and with Daiichi Sankyo when launched in Japan) is forecast to surpass $1.5 billion in sales by 2015. Widely regarded as Amgen’s 'white knight' product, the future commercial performance of the MAb is of key strategic importance to the US biotech, with the product expected to return the company to growth following the declining sales of its key anemia treatments, the therapeutic proteins Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).

Benlysta, which is being prepared for filing (anticipated this year), is a fully human MAb being developed by GlaxoSmithKline and US biotech company Human Genome Sciences. Datamonitor expects sales of Benlysta, which is a potential systemic lupus erythematosus treatment, to reach near blockbuster levels by 2015. The MAb is a key growth driver for GlaxoSmithKline and, if approved, will add to the company's burgeoning MAb interests following the launch of the chronic lymphocytic leukemia therapy Arzerra (ofatumumab) in 2009.

Despite these two high climbers, sales from products sourced from MAb pioneer Genentech (now wholly owned by Roche) will continue to provide the bulk of the global MAb market. Along with sales from Chugai (the majority-owned Japanese arm of Roche's pharmaceutical empire) Roche is expected to command over 40% of the $62.7 billion MAb market by 2015, driven by the continued success of its anticancer trio of Avastin, Herceptin and Rituxan.

The MAb sector will provide the highest growth across the entire industry

There is more to the MAb sector's predicted strong growth than simply these promising new products. Datamonitor's research shows that the small molecule expiry portfolio (products that have lost or are set to lose patent protection over the period 2009-15), will contract by -$100 billion due to severe sales erosion caused by generics. In contrast, the MAb sector is forecast to deliver sales growth across all stages of the product lifecycle. Most significantly, Datamonitor expects sales from expiry MAb products to deliver a positive sales growth over the coming six years.

There are three points to consider when comparing the MAb expiry portfolio with the small molecule portfolio. Firstly, the MAb expiry portfolio is low populated. Given the respective market sizes of small molecules and MAbs, and the relative infancy of the MAb sector (in comparison to the small molecule sector) Datamonitor has identified only a very small number of MAbs that are expected to lose patent protection over the coming six years.

Secondly, the major MAb brands that are set to see their primary patent expire over the coming six years have other competitive forces impacting their projected sales performances, namely competition from second-generation MAb products, and competition from small molecule targeted therapies.

Thirdly, and perhaps most telling for the comparison with small molecules, is the current lack of a clear regulatory framework for the approval of a 'biosimilar MAb'. Although Datamonitor anticipates that such a framework will be approved by regulatory bodies and put in place in the very near future, Datamonitor does not expect the introduction of a biosimilar MAb to erode sales of target branded prescription MAbs to the same extent that the entry of a generic small molecule drug erodes sales of its target branded prescription drug.

MAbs offer a means to offset expiry decline

The protection from severe biosimilar erosion offers a great means for those players with large expiry portfolios to offset decline. Indeed, according to Datamonitor research, over 2009-15 the dominant MAb player Roche will perform the strongest, with other marketing companies attached to the Big 5 (Johnson & Johnson, Merck & Co. and Abbott) also predicted to deliver a net increase in sales out to 2015.

Furthermore, both GlaxoSmithKline with its highly anticipated Benlysta launch, and Novartis, which has considerable MAb interests (through licensing agreements with Genentech), are emerging as significant forces in the MAb market, and are expected to deliver net sales growth, despite both having significant small molecule expiry portfolios. Although it must be remembered that non-MAb therapies contribute to the major pharmaceutical players' sales growth, it is striking that only one of the companies highlighted in Datamonitor's report with a positive net sales growth forecast has not been identified as a key player in the MAb market.

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