登录  
 加关注
查看详情
   显示下一条  |  关闭
温馨提示!由于新浪微博认证机制调整,您的新浪微博帐号绑定已过期,请重新绑定!立即重新绑定新浪微博》  |  关闭

青山妩媚

新的一年,新的心情,新的挑战,新的起点...

 
 
 

日志

 
 

Antibody Drug Marketing 抗體藥物全球市場分析  

2008-07-26 14:27:06|  分类: 個人作品 |  标签: |举报 |字号 订阅

  下载LOFTER 我的照片书  |

                                      Antibody  Drug  Marketing

Antibody Drug Introduction:

The discovery of hybridoma technology by Milstein and Kohler in 1975 allowed researchers to isolate specifically defined monoclonal antibodies (MAbs). MAbs mimic the body's immune system with the antibody working as the drug molecule, which make the cancer cell more visible to the immune system, block growth signals, deliver radiation to cancer cells, and slip powerful drugs into cancer cells. For high specificity, diversity and directionality, MAbs are thus important tools for medicine as extremely targeted therapies for treating patients with severe diseases-especially autoimmune conditions and cancers.

 

The first generation of antibody drug is derived from animal antiserum for infectious disease. The second generation lied on hybridoma technology. MuromonabCD3 (hoclone OKT3) sponsored by Ortho company, the first therapeutic monoclonal antibody, a murine antibody used in transplantation rejection, was proved by US FDA in 1986. That appeared to herald the dawn of a new treatment paradigm. But progress was at a snail's pace into the 1990s, until a host of new engineered antibodies (Rituxan) achieved FDA approval. A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. Recombinant antibody therapeutics are moving to a next generation of products with Transgenic Animal/Plant Technologies in US.

Market Size:

The market for therapeutic monoclonal antibodies (mAbs) is one of the most dynamic sectors within the pharmaceutical industry. MAbs currently generate global revenues of around $27 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux. According to the U.S. pharmaceutical industry association report showed that MAbs were the first biotechnology products accounted for 31 per cent in global sales. Monoclonal antibodies are a high-performance segment of the pharmaceutical market, promising a 2007–13 CAGR of 10.9 per cent, a three-fold revenue premium over small molecules and immunity from material generic threat for the foreseeable future.

Up to 2006, there are 24 MAbs proved by FDA. Today the number is 53, and there are more than 190 companies plus partners developing more than 430 antibody based oncology drugs in more than 770 developmental projects.      

 

Market Growth:

             

 Fig. 1.     Global sales of MAbs from 1997 to 2007

 

          y = -0.005x4 + 0.142x3 - 0.923x2 + 2.646x - 1.754            (1)
          R² = 0.997  x= year-1996

According to previous reports on global sales of MAbs, I make a dispersed plot up by Excel. From that, we can find that the global market for Mabs Therapeutics reached a total of $24 billion in 2007. In 2005, the antibodies market was valued at an estimated US$14 billion, accounting for over 24 percent of the total protein therapeutics market. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs. That's by far the fastest-growing segment of the industry.  Industry participants forecast of the market vary widely, however, a consensus is emerging that the market should reach US$34 billion by the end of the decade, driven by technological evolution from chimeric and humanized to fully human antibodies.

 

Calculating by fitting formula (1), the global market for mAbs will reach $50.1 billion in 2014, which is consistent with the prediction by Datamonitor.

 

The overall prescription pharmaceutical market is expected to face a decline in sales over 2011 to 2012 as a result of the 'patent cliff'. The patent cliff will impact the small molecule market, in contrast, the mAb market segment will continue to record robust growth. Over the forecast period monoclonal antibodies are predicted to enjoy double-digit growth while small molecule drugs face declining growth rates. The main barrier to sales growth for small molecules is exposure to material generic competition, which will have no effect on mAbs out to 2013.

 

Monoclonal antibody therapies have been posting the fastest growth within the protein therapeutics market easily outstripping the growth rate of 0.6% in the more traditional, small molecules market. mAbs currently command a three-fold average revenue per product premium over small molecules. Positive factors supporting this premium include a higher demand due to addressing therapy areas of high unmet need and lower competitive intensity due to accessing novel target space.

 

Main Players:

Traditionally, MAB have been produced as native molecules in murine hybridoma lines. However, there has been considerable interest in development of recombinant DNA expression of MAB. The development focus of the industry is moving away from murine and chimeric antibodies, to humanized and, in particular, fully human technologies.

 

High speciality, high technology, High cost, high venture, high price, high return, Even in the best of situations there always is an element of risk. However in this instance it turned out to be a good choice. Many of the leading pharmaceutical companies have entered the MAb sector. The activities of the leading biopharmaceutical/ biotechnological companies with antibody-based drug products currently on the market are shown in following.

  Tab. 1  Core technology and advantages of main players in MAbs market.

  

 

 

 

In addition, at Human Genome Sciences (www. humangenomesciences.com), several antibodies have progressed to the stage of clinical development for treatments of autoimmune diseases (LymphoStat-B), cancer (HGS-ETR1, HGS-ETR2, and HGS-TR2J), and infectious diseases (ABthrax, CCR5 mAb004).

Tab. 2  Therapeutic MAbs approved by the US FDA before 2005

 

 Tab. 3 Therapeutic MAbs approved by the US FDA currently

 

 

 Tab. 4  US Sales of Monoclonal Antibodies, Cancer Indications 2000-2006 ($m)

 

 

Tab. 5  Global Sales of Raptiva 2003-2006 ($m) --- Genentech

 

 

Tab. 6  Global Sales of Xolair 2003-2006 ($m)---- Genentech

 

Market share:

Oncology products will continue to dominate the market. However, sales of arthritis, immune and inflammatory disorders (AIID) products are forecast to grow strongly and account for 40.1% of the market by 2010.

 

    Fig. 2 Monoclonal Antibody Market Share by Therapeutic Category (2005)

 

 

 

An insightful method for quantifying the impact of expiries (and consequently generic competition) is to divide products in the PharmaVitae forecast sales database into three classes; ‘launch’ (products launching between 2007 and 2012), ‘expiry’ (products expiring between 2007 and 2012) and ‘core’ (products neither launching nor expiring between 2007 and 2012). This analysis is summarized graphically in Figure 3. Having assigned the 1,000+ products to one of these three classes we can now measure the total change in annual sales between 2007 and 2012 for all new launches in the PharmaVitae universe—this value is +$61,472m. This corresponds to a total increase of +13.2% in 2012 sales over 2007 and a 2007–12 CAGR of 2.5% due to new launches. In a similar manner we can calculate the total change in annual sales between 2007 and 2012 for all ‘core’ products, which is equal to +$58,929m corresponding to a total increase of +12.7% in 2012 sales over 2007 and a 2007–12 CAGR of 2.4% due to expanding sales of ‘core’ products.

 

 Fig. 4 Competitive dynamics of current marketed drugs, 2004-5

 

 

 Fig. 5 marketed monoclonal antibodies, 2006

 

Fig. 6 Therapy area analysis of forecasted monoclonal antibody sales ($m), 2004-11

 

Fig. 7 Comparison of therapeutic mAb sales trajectories in 2002 (yellow) and 2008 (blue) in terms of technological focus. Despite the undisputed leadership of chimeric mAbs, the contribution of humanized and fully human products to total market size will significantly rise. Source: Datamonitor.

Fig. 8 Market share by MAbs produced in different areas

 

Fig. 9 Leaders in the Monoclonal Antibody Therapy Market, 2005 Market Share

 

To date, five top MAbs account for over 80 percent of the total therapeutics market, including Avastin/Herceptin/Rituxan of Roche & Genetech (NYSE:  DNA), Humira of Abbott (NYSE:  ABT), and Remicade of J&J/Schering (NYSE:  JNJ). To 2012, Biogen (Nasdaq:  BIIB), Amgen (Nasdaq:  AMGN) and UCB (Brussels Stock Exchange: UCB.BR) will play into the game.

 

 

Strategies:

Position

Though the price of Rituxan is about $3000/400mg, it is pinup. The global production capacity is lack. At present, the global mammalian cell culture capacity is estimated at 400 to 500 thousand liters. That is mainly controlled by three companies, such as Genentech, Boehringer Ingelheim and Lonza Biologics, whose production capacity is saturated. Antibody processing is a complex field, demanding an understanding of bioengineering, equipment design, cell genetics, and cell culture technology. As demands for large-scale antibody production levels become more intense, companies are pursuing these disciplines from a variety of perspectives.

Alliances between pharmaceutical and biotech companies are a key driver of the current mAb market. According to Guangli’s report on Jul 24, we will mainly provide large-scale mammalian cells culture for other pharmaceutical company. Our capacity will be 2×10L and 2×5L at end of Q4 this year. At time of the technology maturing and a broad array of promising drugs filling the pipeline, we should shift from a technology development model to become a product firm.

 

 

Marketing Mix:

Because our platform has not been completely established, please forgive me for not analysing that exactly and minutely.

 

    Product:  Service for large-scale mammalian cells culture; MAbs;

         Place:  Global market; pharmaceutical companies;

 Promotion:  Advertising in print media, Internet Web Sites, cable television, Email, face-to-face interaction, DM flyers, tradeshow, professional publications, or as some tradeshows contractor; sales promotion in the form of introductory rebates, technology trade shows; public relations efforts to news media and sponsorship of world events.

          Price:   no

 

 

 

 

 

 

 

 

 

 

                                              Analyser:  Jason Soung

                                                        2008-7-25

  评论这张
 
阅读(725)| 评论(0)

历史上的今天

评论

<#--最新日志,群博日志--> <#--推荐日志--> <#--引用记录--> <#--博主推荐--> <#--随机阅读--> <#--首页推荐--> <#--历史上的今天--> <#--被推荐日志--> <#--上一篇,下一篇--> <#-- 热度 --> <#-- 网易新闻广告 --> <#--右边模块结构--> <#--评论模块结构--> <#--引用模块结构--> <#--博主发起的投票-->
 
 
 
 
 
 
 
 
 
 
 
 
 
 

页脚

网易公司版权所有 ©1997-2018