复合治疗药物:学名药和生技仿制药的机会 是由出版商Espicom Business Intelligence在2011年10月所出版的。
这份英文市场调查报告书包含Pages: 108 价格从美金1740起跳。
复合治疗药物市场2010年达到超过700亿美元的销售额。2010年销售最好的复合治疗药物是Enbrel的Amgen，Pfizer，武田药品工业的销售额为78亿5,000万美金。Johnson & Johson及Merck & Co的Remicade为第二名，销售额为75亿8,100万美元。
本报告提供具有复合适应性的有力药物依各产品介绍，各种的作用机制，核准趋势，生命周期开发，市场上竞争趋势，专利等汇整数据，为您概述为以下内容。
序文
摘要整理
概要
- 生命周期开发与新适应症
- 潜在的额外收入的认识
- Rituximab:从癌症到免疫疾病的复合适应症
- Sildenafil:活性成分，品牌化的适应症
- 学名药和生技仿制药的机会
产品分析
- 抗代谢药
- 单株抗体
- Rituxan/MabThera
- Herceptin
- Erbitux
- Avastin
- 蛋白激酶抑制剂
- Glivec
- Tarceva
- Sutent
- Nexavar
- 其他的抗癌药物
- 免疫抑制剂
- Enbrel
- Remicade
- Humira
- Cimzia
- Actemra
- Afinitor/Zortress
- Tysabri
- 神经系统
- Lyrica
- Seroquel
- Abilify
- Cymbalta
- 其他
情报来源
名录
图表
Abstract
Targeting multiple conditions is likely to increase a drug's potential target
audience and result in large financial returns for the developing company.
With annual sales counted in billions of dollars, these blockbuster drugs are
undoubtedly attractive to companies developing generics and biosimilars.
The logic is simple: more indications result in a larger number of potential
patients and, consequently, greater revenue opportunities. Obviously this
logic only works if there is unmet clinical need and efficacy is demonstrated
in each indication, so the number of drugs approved for multiple indications
is relatively small. But where multiple indications are approved, annual sales
can be counted in billions of dollars. The trend for developing products for
multiple indications has been particularly evident in biological
pharmaceuticals and has resulted in multi-billion dollar sales over a number
of years. The commercial costs of developing biosimilars are great. Better,
then to have the possibility of multiple revenue streams.
Use this new report to easily answer key business questions, such as:
- What is the latest position on extrapolating biosimilar approvals to other
indications, and what impact could this have on the sector?
- How is Big Pharma's attitude changing as the biosimilar market develops?
- Remicade (infliximab) generated sales of US$7.9 billion in 2010 and is
indicated for 7 conditions - what are they?
- Which companies are known to be developing biosimilar versions of
Pfizer/Takeda's Enbrel (etanercept)?
- How might new branded development in the multi-kinase sector affect the
biosimilar development of Bayer's Nexavar (sorafenib)?
- What revenue generating lifecycle developments will offset the challenge
of generic competition for Roche's Xeloda (capecitabine)?
Assessing additional sales potential from a valuable product fit
The multi-therapy drugs included in this report realised total sales in excess
of US$70 billion in 2010. It is, therefore, hardly surprising that many are
being targeted by generic companies for the development of either traditional
bioequivalent generics, or as targets for the next wave of biosimilars.
The top selling multi-therapy drug in 2010 was Enbrel (etanercept), with sales
reported separately by Amgen, Pfizer and Takeda amounting to a total of
US$7,850 million. Remicade (infliximab) was a close second, with sales
reported by Johnson & Johnson and Merck & Co totalling US$7,581 million in
2010. In third place was Abbott's Humira (adalimumab), with sales of US$6,738
million; while Roche reported global sales of Rituxan/MabThera (rituximab)
worth US$6,094 million in 2010.
While the top five in terms of sales in 2010 were biologicals, a number of
small molecule multi-therapy drugs have established a place among the market
leaders and are worthy of attention as they will not face the same regulatory
obstacles of biosimilars. These include AstraZeneca's Seroquel franchise, with
revenue of US$5,302 million; Otsuka/Bristol-Myers Squibb's Abilify
(aripiprazole) with sales reported by Otsuka amounting to US$4,266 million;
and Novartis' Glivec/Gleevec (imatinib) with sales of US$4,265 million.
Generic and biosimilar opportunities: high risk, high reward?
With annual sales counted in billions of dollars, these blockbuster drugs are
undoubtedly attractive to companies developing generics and biosimilars.
Competition is often fierce for bioequivalent generics of the big sellers.
Consequently, companies are likely to be vying for a relatively small slice of
the market. Nonetheless, when branded sales are counted in billions of
dollars, companies could still make a significant return even with generic
price erosion.
The market for biosimilars is inherently different to the traditional generics
market. Market acceptance remains a big challenge and the take up of
biosimilars in Europe to date has been relatively slow. Not only will
companies need to convince healthcare providers that biosimilar drugs are as
good as the originator products, they will also have to compete with the
originator companies who are less likely to exit the market than if faced with
a flood of bioequivalent generics.
Biosimilar approval for multiple indications: extrapolation or additional trials?
One question that has yet to be fully answered with regard to multi-therapy
drugs is whether biosimilar approval for one indication will automatically
lead to approval for all indications associated with the reference product.
In the EU - so often the leading player in biosimilar regulation - the current
position seems a little vague. In November 2010, the EMA discussed
extrapolation in its draft guideline on similar medicinal products containing
monoclonal antibodies (Mabs: EMA/CHMP/BMWP/403543/2010). The guideline
suggested the possibility of extrapolation of clinical efficacy and safety
data to other indications of the reference Mab, based on the overall evidence
of biosimilarity. However, the reality is unlikely to be simple, particularly
when the reference product is approved in unrelated indications.
The final guideline has yet to be published and a year later the subject of
extrapolation remains a major topic of discussion. In the meantime, companies
are hedging their bets and conducting comparative studies of their biosimilar
Mabs in more than one indication.
About the Author
The report has been researched and written by Espicom Senior Analyst, Karen
Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis
experience. Her recent studies include
Table of Contents
FOREWORD
EXECUTIVE SUMMARY
OVERVIEW
- Lifecycle Development and New Indications
- Realising Additional Sales Potential
- Rituximab: Multiple Indications from Oncology to Immunology
- Sildenafil: One Active Ingredient, Two Distinctly Branded Indications
- Generic and Biosimilar Opportunities
- Biosimilar Approval for Multiple Indications: Extrapolation or
Additional Trials?
- US Patent Expiries
PRODUCT ANALYSIS
- ANTI-METABOLITES
- Alimta (pemetrexed)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Xeloda (capecitabine)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Colorectal Cancer
- Breast Cancer
- Gastric Cancer
- Patents
- Generic Company Activity
- Market Outlook
- MONOCLONAL ANTIBODIES
- Rituxan/MabThera (rituximab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Biosimilar Activity
- Market Outlook
- Herceptin (trastuzumab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Breast Cancer
- Gastric Cancer
- Patents
- Biosimilar Activity
- Market Outlook
- Erbitux (cetuximab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Biosimilar Activity
- Market Outlook
- Avastin (bevacizumab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Biosimilar Potential
- Market Outlook
- PROTEIN KINASE INHIBITORS
- Glivec (imatinib)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Tarceva (erlotinib)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Sutent (sunitinib)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Nexavar (sorafenib)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- OTHER ANTINEOPLASTIC AGENTS
- Velcade (bortezomib)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- IMMUNOSUPPRESSANTS
- Enbrel (etanercept)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Biosimilar Activity
- Merck & Co
- Avesthagen
- Protalix BioTherapeutics
- Simcere
- Market Outlook
- Remicade (infliximab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Biosimilar Activity
- Market Outlook
- Humira (adalimumab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Biosimilar Activity
- Market Outlook
- Cimzia (certolizumab pegol)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Biosimilar Potential
- Market Outlook
- Actemra (tocilizumab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Biosimilar Potential
- Market Outlook
- Afinitor/Zortress (everolimus)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Renal Cell Carcinoma
- Breast Cancer
- Patents
- Generic Company Activity
- Market Outlook
- Tysabri (natalizumab)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Market Outlook
- NERVOUS SYSTEM
- Lyrica (pregabalin)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Seroquel (quetiapine)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Seroquel XR
- Seroquel IR
- Market Outlook
- Abilify (aripiprazole)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- Cymbalta (duloxetine)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
- OTHER
- Viagra & Revatio (sildenafil)
- Mode of Action
- Approvals
- Lifecycle Development
- Competition within the Marketplace
- Patents
- Generic Company Activity
- Market Outlook
SOURCES
DIRECTORY
INDEX
List of Tables
- Summary of Drugs and Indications
- Drug Sales, 2010 (US$ Million)
- Drugs by US Patent Expiry
- Alimta US Patents
- Tentative ANDA Approval for Pemetrexed
- Alimta Sales 2009-2016 (US$ Million)
- Xeloda US Patents
- Xeloda Sales, 2009-2016 (SFr & US$ Million)
- Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million)
- Herceptin US Patents
- Herceptin Sales, 2009-2016 (CHF & US$ Million)
- Erbitux Sales by Company, 2009-2016 (EUR & US$ Million)
- Avastin Sales by Company, 2009-2016
- Glivec US Patents
- Glivec/Gleevec Sales, 2009-2016 (US$ Million)
- Tarceva US Patents
- Tarceva Sales, 2009-2016 (SFr & US$ Million)
- Product US Patents
- Sutent Sales, 2009-2016 (US$ Million)
- Product US Patents
- Nexavar Sales, 2009-2016 (EUR & US$ Million)
- Velcade US Patents
- Velcade Sales by Company, 2009-2016 (US$ Million)
- Enbrel US Patents
- Enbrel Sales by Company, 2009-2016 (US$ Million)
- Remicade US Patents
- Remicade Sales by Company, 2009-2016 (US$ Million)
- Humira US Patents
- Humira Sales by Company, 2009-2016 (US$ Million)
- Cimzia Sales, 2009-2016 (US$ Million)
- Actemra/RoActemra Sales by Company, 2009-2016
- Afinitor/Zortress US Patents
- Afinitor/Zortress Sales, 2009-2016 (US$ Million)
- Tysabri Sales by Company, 2009-2016 (US$ Million)
- Lyrica US Patents
- FDA Tentative ANDA Approvals for Pregabalin
- Lyrica Sales, 2009-2016 (US$ Million)
- Seroquel US Patents
- FDA Tentative ANDA Approvals for Quetiapine XR
- FDA Tentative ANDA Approvals for Quetiapine IR
- Seroquel Sales, 2009-2016 (US$ Million)
- Abilify US Patents
- Abilify Sales by Company, 2009-2016 (\ Billion & US$ Million)
- Cymbalta US Patents
- FDA Tentative ANDA Approvals for Duloxetine
- Cymbalta Sales, 2009-2016 (US$ Million)
- Viagra & Revatio US Patents
- EU Marketing Authorisations for Generic Sildenafil
- FDA Tentative ANDA Approvals for Sildenafil
- Viagra/Revatio Sales, 2009-2016 (US$ Million)
List of Figures
- Product US Patents
- Nexavar Sales, 2009-2016 (EUR & US$ Million)
- Velcade US Patents
- Velcade Sales by Company, 2009-2016 (US$ Million)
- Enbrel US Patents
- Enbrel Sales by Company, 2009-2016 (US$ Million)
- Remicade US Patents
- Remicade Sales by Company, 2009-2016 (US$ Million)
- Humira US Patents
- Humira Sales by Company, 2009-2016 (US$ Million)
- Cimzia Sales, 2009-2016 (US$ Million)
- Actemra/RoActemra Sales by Company, 2009-2016
- Afinitor/Zortress US Patents
- Afinitor/Zortress Sales, 2009-2016 (US$ Million)
- Tysabri Sales by Company, 2009-2016 (US$ Million)
- Lyrica US Patents
- FDA Tentative ANDA Approvals for Pregabalin
- Lyrica Sales, 2009-2016 (US$ Million)
- Seroquel US Patents
- FDA Tentative ANDA Approvals for Quetiapine XR
- FDA Tentative ANDA Approvals for Quetiapine IR
- Seroquel Sales, 2009-2016 (US$ Million)
- Abilify US Patents
- Abilify Sales by Company, 2009-2016 (\ Billion & US$ Million)
- Cymbalta US Patents
- FDA Tentative ANDA Approvals for Duloxetine
- Cymbalta Sales, 2009-2016 (US$ Million)
- Viagra & Revatio US Patents
- EU Marketing Authorisations for Generic Sildenafil
- FDA Tentative ANDA Approvals for Sildenafil
- Viagra/Revatio Sales, 2009-2016 (US$ Million)
- Product US Patents
- Nexavar Sales, 2009-2016 (EUR & US$ Million)
- Velcade US Patents
- Velcade Sales by Company, 2009-2016 (US$ Million)
- Enbrel US Patents
- Enbrel Sales by Company, 2009-2016 (US$ Million)
- Remicade US Patents
- Remicade Sales by Company, 2009-2016 (US$ Million)
- Humira US Patents
- Humira Sales by Company, 2009-2016 (US$ Million)
- Cimzia Sales, 2009-2016 (US$ Million)
- Actemra/RoActemra Sales by Company, 2009-2016
- Afinitor/Zortress US Patents
- Afinitor/Zortress Sales, 2009-2016 (US$ Million)
- Tysabri Sales by Company, 2009-2016 (US$ Million)
- Lyrica US Patents
- FDA Tentative ANDA Approvals for Pregabalin
- Lyrica Sales, 2009-2016 (US$ Million)
- Seroquel US Patents
- FDA Tentative ANDA Approvals for Quetiapine XR
- FDA Tentative ANDA Approvals for Quetiapine IR
- Seroquel Sales, 2009-2016 (US$ Million)
- Abilify US Patents
- Abilify Sales by Company, 2009-2016 (\ Billion & US$ Million)
- Cymbalta US Patents
- FDA Tentative ANDA Approvals for Duloxetine
- Cymbalta Sales, 2009-2016 (US$ Million)
- Viagra & Revatio US Patents
- EU Marketing Authorisations for Generic Sildenafil
- FDA Tentative ANDA Approvals for Sildenafil
- Viagra/Revatio Sales, 2009-2016 (US$ Million)
- Alimta Sales Trend 2007-2016
- Xeloda Sales Trend, 2007-2016
- Rituxan/MabThera Sales Trend, 2007-2016
- Herceptin Sales Trend, 2007-2016
- Erbitux Sales Trend, 2007-2016
- Avastin Sales Trend, 2007-2016
- Glivec/Gleevec Sales Trend, 2007-2016
- Tarceva Sales Trend, 2007-2016
- Sutent Sales Trend, 2007-2016
- Nexavar Sales Trend, 2007-2016
- Velcade Sales Trend, 2007-2016
- Enbrel Sales Trend, 2007-2016
- Remicade Sales Trend, 2007-2016
- Humira Sales Trend, 2007-2016
- Cimzia Sales Trend, 2008-2016
- Actemra/RoActemra Sales Trend, 2008-2016
- Afinitor/Zortress Sales Trend, 2009-2016
- Tysabri Sales Trend, 2007-2016
- Lyrica Sales Trend, 2007-2016
- Seroquel Sales Trend, 2007-2016
- BMS Abilify Sales Trend, 2007-2016
- Otsuka Abilify Sales Trend, 2007-2016
- Cymbalta Sales Trend, 2007-2016
- Viagra/Revatio Sales Trend, 2007-2016
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