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2012年生物制药的展望【中英对译】

Biomanufacturing Outlook
生物制药行业已开始与2012年乐观的理由。 Based on preliminary results from BioPlan Associates' 9th Annual Report and Survey of Biomanufacturing, biologics manufacturers and their vendors are spending more, demanding better technologies, and expressing greater optimism than at any time in the nine years we have been assessing this industry. 从BioPlan Associates的第九届年度报告和生物制造,生物制品制造商和他们的供应商调查的初步结果的基础上,花更多,更好的技术要求,并表示更加乐观,比在任何时间在9年中,我们一直在评估这个行业。 This year the BioPlan study finds substantial optimism, with a 37.3% of suppliers indicating that their company did either "better" or "much better" than expected in 2011. 今年的BioPlan研究发现相当乐观,与供应商表示,他们公司确实是“更好”或“更好”比预期在2011年的37.3%。 Even more relevant, 49.4% expect they will do "better" or "much better" in 2012. 更何况,49.4%预计他们将在2012年“更好”或“更好”。
Industry growth rates 工业增长率
Sales growth among vendors is a leading indicator of the overall performance of the bio/pharmaceutical industry because vendor sales are derived from demand for materials biologics production. 供应商之间的销售增长是一个生物/制药行业的整体表现的领先指标为原料的生物制剂生产的需求,因为供应商的销售所得。 If vendors are doing welll and are optimistic for the future, the bio/pharmaceutical industry is likely to follow. 如果厂商都在做welll和对未来感到乐观,生物技术/制药行业可能效仿。 Supplier respondents indicated that, on average, sales growth is currently at approximately 14% annually, up from 13.0% in 2010 and 14.1% in 2007. 供应商受访者表示,平均而言,销售额的增长,目前每年约14%,从13.0%,2010年和2007年的14.1%。

Biopharma's budget trends 生物制药的预算趋势

Figure 1: Average change in biomanufacturers' budgets (2009–2012). 图1:biomanufacturers的预算平均变化(2009-2012年)。 (Figure 1 is courtesy of the author) (图1为作者提供)

Budgets also are a good indicator of industry strength, and budget estimates for 2012 are up strongly in areas such as acquisition of new technologies, capital equipment, and personnel training and development. 预算产业的实力也是一个很好的指标,2012年的概算是强烈,如收购新技术,资本设备,人员培训和发展等领域。 Early results from the 2012 BioPlan survey projects increases in all 12 areas, except for outsourcing (see Figure 1). 从2012年BioPlan调查项目的早期结果增加在所有12个地区中,除了外包(见图1)。
Macro trends 宏观趋势
These overall trends are in large part resulting from global shifts that continue to drive the bio/pharmaceutical industry. 这些总的趋势是在继续推动生物/制药行业的全球变化造成大的一部分。 Below are trends we project in 2012 specifically relating to biomanufacturing. 下面是我们在2012年项目,特别是涉及到生物制造的发展趋势。
Internationalization. The bio/pharmaceutical industry continues to expand globally, driven by the need for prudent expansion of infrastructure, presence in new markets, and cost savings through outsourcing and offshoring, including R&D, which is traditionally performed in established high-technology regional clusters. 国际化。生物/制药业继续以扩大全球范围内,需要谨慎扩张的基础设施,在新的市场的存在,并节约成本通过外包和离岸外包,包括ŕ&ð,这是传统既定的高科技区域集群进行驱动。
Biomanufacturing capacity also is increasing outside established markets. 生物制造能力也日益成熟的市场之外。 Although the US and Western Europe remain the leaders in biopharmaceutical manufacturing capacity, more than 37% of bioreactor capacity is operating in other parts of the world, including nearly 10% in Japan and the Pacific Rim, 9% in China, and more than 8% in India (2). 虽然美国和西欧的领导人留在生物制药制造能力,超过37%的生物反应器能运行在其他世界各地,其中包括近10%,在日本和环太平洋地区,在中国的9%,超过8 %在印度(2)。 Western product developers also are joining with local companies, such as in the local manufacture of vaccines. 西方的产品开发也与当地的公司,如在本地生产的疫苗,加盟。 As more biopharmaceutical manufacturing is performed worldwide, product developers are working to standardize their products and manufacturing processes, which involves simplifying their manufacturing processes, so they can be reliably performed with consistent product produced even in facilities in lesser developed counties. 随着越来越多的生物制药是全球范围内进行,产品开发人员正在努力规范自己的产品和制造工艺,其中包括简化其生产流程,使他们能够可靠地进行一致的产品,即使在设施,在欠发达的县。
Single-use manufacturing. The trend toward more global standardized manufacturing is contributing to the adoption of single-use/disposable bioprocessing equipment, which allow the same manufacturing systems to be shipped and installed at multiple facilities. 单一用途的制造业,向全球的标准化生产的趋势正在推动通过single-use/disposable生物加工设备,其中允许相同的制造系统,运输和安装在多个设施。 Some companies, with major vaccine manufacturers among the leaders, are starting to think more in terms of selling full manufacturing and technology packages, including all needed equipment and technology transfer, not just finished end-products, to foreign countries that are seeking local manufacture of vaccines for domestic distribution. 有些企业,领导人之间的主要疫苗生产商,也开始想在销售完整的生产和技术的软件包,包括所有必需的设备和技术转移,不只是完成最终产品,到国外寻求本地生产方面的更多信息国内销售的疫苗。 Companies, such as GE and Biologics Modular, for example, are developing fully modular, drop-in-place-type, and equipment preinstalled or simply installed single-use bioprocessing-based facilities to address the interest for prepackaged biopharmaceutical manufacturing facilities. 公司,如GE和生物制品的模块化,例如,正在开发完全模块化,下降就地型,预装的设备或安装简单单使用生物加工为主的设施预先包装的生物制药生产设施,以解决利益。
单次使用的生物加工技术:在2011年,single-use/disposable生物处理系统,进一步提高临床前的研发和临床试验的生物制药生产中的霸主地位。 Single-use systems dominate noncommercial-scale biopharmaceutical manufacturing in most regions. 一次性使用的系统占据大部分地区的非商业规模的生物制药。 Single-use systems are increasingly being adopted for upstream manufacturing, such as adoption of single-use bioreactors and other upstream equipment. 单一用途的系统正越来越多地通过上游的制造业,如采用单一用途的生物反应器及其他上游设备,。 Despite dominance within precommercialization manufacturing segments, single-use systems remain a relatively small market compared with fixed stainless-steel equipment, capturing only approximately 10% of the overall bioreactor market. 尽管在precommercialization制造领域的优势,使用单系统仍然是一个相对较小的市场,与固定的不锈钢设备相比,捕捉只有大约10%的整体生物反应器市场。 Stainless steel remains the preference for commercial GMP manufacturing. 不锈钢仍然是商业GMP生产的偏爱。 In as short as 10 years (approximately about how long it takes a biopharmaceutical to reach the market), half or even more of new commercial biopharmaceutical manufacturing systems can be expected to be largely or fully single-use based. 在短短10年(约在一家生物制药,以达到市场需要多长时间),一半或新的商业生物制药生产系统,更可以预期,主要或完全单一使用基于。
Microbial manufacturing. Most industry attention in recent years, including blockbuster products and manufacturing technology development, has concentrated on recombinant proteins produced by mammalian cell culture. 大多数微生物制造。业界的关注,近年来,包括重磅产品和制造技术的发展,已集中在哺乳动物细胞培养生产重组蛋白。 Mammalian cell-culture capacity and facilities continue to dominate worldwide biopharmaceutical manufacturing (2). 哺乳动物细胞培养能力和设施,继续称霸全球的生物制药生产(2)。 Microbial manufacturing remains relatively stable with few new technologies, and few major bioprocessing equipment developers announcing novel devices. 微生物生产保持相对稳定,一些新的技术,以及一些主要的生物处理设备开发商宣布新型器件。 A confluence of trends, however, is contributing to increased use of microbial (ie, bacteria, yeasts, and other fungi) host cells for recombinant-protein manufacture. 合流的趋势,然而,有助于增加(即利用微生物,细菌,酵母菌和其他真菌)为宿主细胞重组蛋白制造。
Outsourcing. Companies of all sizes worldwide continue to increase their outsourcing, particularly R&D and manufacturing. 全球外包服务。各种规模的企业继续增加他们的外包,尤其是研发和制造。 These activities include increasing the use of CROs, particularly for high-throughput screening, lead identification, toxicological studies as well as greater use of CMOs for commercial manufacturing. 这些活动包括:增加CRO的使用,特别是高通量筛选,鉴定铅,毒理学研究,以及更大的CMOS用于商业化生产。 Based on the BioPlan annual survey that evaluates 24 outsourced activities, the primary outsourced activities include product-characterization testing, with 70% of biopharmaceutical companies outsourcing at least some of this activity. 基于对BioPlan的年度调查,评估外包活动24,外包的主要活动包括:产品的特性测试,有70%的外包至少这项活动的一些生物制药公司。 Other tasks routinely outsourced include validation services (69% of biomanufacturers cited), toxicity testing (65%), analytical testing/bioassays (61.1%), and fill–finish operations (60.0%). 经常外包的其他任务包括验证服务(69%biomanufacturers专利),毒性试验(65%),分析测试/生物测定(61.1%),填写完成操作(60.0%)。 Relatively few companies have outsourced all of their manufacturing, but nearly one-half of surveyed manufacturers expect to increase their budgets for biopharmaceutical CMO outsourcing. 相对较少的公司外包其生产的所有,但近一半的受访制造商之一,以增加他们的预算为生物制药奇美外包。
Overall bio/pharmaceutical trends 整体生物/制药趋势
These trends are, in large part, resulting from global shifts that continue to drive the bio/pharmaceutical industry. 这些趋势,在很大程度上,继续推动生物/制药行业的全球变化造成的。 Below are broad industry trends we project in 2012. 下面是广阔的行业发展趋势,我们预测在2012年。
Biopharmaceutical markets. The worldwide market for biopharmaceuticals continues to expand and at a more rapid rate than for pharmaceuticals in general. 生物制药市场。全球生物制药市场的不断扩大和更快速的速度比一般药品。 The world market for biopharmaceuticals is approximately $140 billion, with approximately $100 billion involving recombinant proteins and antibodies (2). 世界生物制药市场约140亿美元,约为100亿元,涉及重组蛋白和抗体(2)。 The market includes over 430 biopharmaceuticals, including over 300 recombinant proteins and antibodies that are approved in the US and/or Europe. 市场包含了超过430个,其中超过300个被批准在美国和/或欧洲的重组蛋白和抗体,生物制药,。 The biopharmaceutical market has been and is expected to continue to grow about 15–18% annually, well above overall economic growth rates. 生物制药市场一直预计将继续以每年增长15-18%左右,远高于整体经济增长率。 This steady overall growth rate is driving much current investment in biopharmaceutical R&D. 这种稳定的总体增长速度驾驶多目前在生物制药R&D投资

Table I: FDA full biopharmaceutical approvals in 2011.** 表一:FDA在2011年生物制药批准**。

Biopharmaceutical approvals. Despite increasing biopharmaceutical sales, the number and rate of biopharmaceutical approvals in the US has been relatively poor in the past few years (12 biopharmaceuticals entered the US market in 2011). 生物制药的批准。尽管越来越多的生物制药的销售,在美国的数量和生物制药的批准率在过去几年一直比较差(12生物制药于2011年进入美国市场)。 The 2011 approvals were even fewer in number than the relatively poor results in 2010 and 2009 (4). 2011年批准数量甚至少于2010年和2009年(4)相对较差的结果。 This weak showing for biopharmaceuticals is in contrast with FDA reporting in November 2011 near record overall pharmaceutical approvals. 这对于生物制药的疲弱表现是接近创纪录的整体药品批准FDA在2011年11月的报告对比。 The 2011 FDA biopharmaceutical approvals are listed in Table 1. 表1列出了2011年FDA生物制药批准。
Approval-related innovation and progress. The good news, particularly for patients and the healthcare system, is that 2011 FDA biopharmaceutical approvals involved genuine innovation and advances, with nearly all products being approved for either new indications for which no treatments were previously available or for indications for which the last product approval was granted well over a decade ago. 批准相关的创新和进步。好消息,特别是为患者和医疗保健制度,是2011年FDA生物制药批准无论新适应症的批准几乎所有的产品没有治疗以前或参与真正的创新和进步,最后的产品批准文被授予超过十年前的迹象。 A record number (ie, eight) products were approved with orphan designation. A记录编号(即八)产品被批准与孤儿称号。 Recombinant antibodies are a leading area for biopharmaceutical development. 重组抗体是生物制药发展的领先地区。 The large number of recombinant monoclonal antibody and recombinat monoclonal antibody-like products that many companies are relying on for future products may finally be starting to enter the market. 重组单克隆抗体和表达型重组单克隆抗体类产品,许多公司都在为未来的产品依靠大量可能终于开始进入市场。
Approval-related problems. Largely due to the limited markets for these orphan and other approved products, 2011 US approvals will not have as much industry economic impact as is likely needed in the long-term. 批准有关的问题,主要是由于这些孤儿和其他经批准的产品的市场有限,2011年美国批准不会有尽可能多的行业对经济的影响可能需要在长期的。 Only two of the twelve approvals are expected to eventually reach blockbuster sales levels of $1 billion or more per year. 只有两个十二批准,预计最终达到一鸣惊人的10亿美元或每年的销售水平。
Company and country approval trends: Illustrating the trend towards internationalization of manufacturing, a record number of four, or 33%, of newly-approved US biopharmaceuticals are manufactured outside the US—in the United Kingdom. 公司和国家批准的趋势,说明了对制造业的国际化趋势,四个记录数,或33%,新批准的美国生物制药生产以外的美国,在英国。 Germany, Mexico, and Italy. 德国,墨西哥和意大利。 These products include the first product manufactured in Latin America that received FDA approval—a scorpion venom antitoxin (equine immunoglobulin F(ab) fragments), Anascorp, manufactured by a Mexican company. 这些产品包括在拉丁美洲制造的第一个产品获得FDA批准的蝎毒抗毒素(马免疫球蛋白F(下的AB)片段),Anascorp,由墨西哥公司生产的。
Biosimilars (biobetters / biogenerics). With patents expiring for most established, successful, biopharmaceutical products, development of biosimilars is accelerating worldwide and will change the industry landscape. 历史最悠久的,成功的生物医药产品的专利到期的仿制药(biobetters /生物仿制药),生物仿制药的发展正在加速全球将改变产业的格局。 This emergence of biosimilars will likely involve the entrance of many new manufacturers. 这种生物仿制药的出现,可能会涉及到许多新的制造商的入口。 Most of this activity is targeted to introducing these products in the US and European markets, but many products are being developed by foreign companies, if only initially, for marketing in lesser-regulated domestic and international markets. 这项活动的最重要的是有针对性地引进这些产品在美国和欧洲市场,但外国公司正在开发的许多产品营销,如果只是初步的,较少管制的国内和国际市场。 There will likely be multiple biosimilars (as well as biobetters and biogenerics) for each currently successful biopharmaceutical. 有可能会多为每个目前成功的生物制药,生物仿制药(以及作为biobetters和生物仿制药)。 As a result, the number of biopharmaceuticals in the market and the number of biopharmaceutical manufacturing facilities will rapidly increase, perhaps doubling in the next five years. 因此,在市场上的生物制药和生物制药生产设施的数量将迅速增加,或许在未来五年翻一番。
Many biosimilar/biobetter/biogeneric developers are adopting state-of-the-art expression systems and other manufacturing platforms. 许多生物仿制药/ biobetter /生物仿制药开发,采用国家最先进的表达系统和其他制造业平台。 Biosimilars are competing with products being manufactured using 20-year-old technology. 生物仿制药的竞争与使用20岁的技术制造的产品。 Although biosimilar manufacturers will have technical advantages with newer technology, drug innovators of the the now biosimilars will have long off paid off manufacturing facilities. 虽然生物仿制药生产厂家将有新技术,现在生物仿制药将长期关闭还清的生产设施的药物创新的技术优势。 As a result, biosimilar/biobetter/biogeneric developers will have to compete on the basis of price and adopt aggressive cost-cutting technologies to effectively compete with the original biologic and other biosimilar manufacturers. 因此,生物仿制药/ biobetter /生物仿制药的开发将有竞争价格的基础上,采取积极的成本削减技术与原生物和其他生物仿制药制造商有效竞争。 Although over a dozen biosimilars have received European Union (EU) approval, no biologics have yet been approved as biosimilars by FDA. 虽然生物仿制药已收到了十几欧洲联盟(欧盟 )批准,任何生物制剂尚未被批准为生物仿制药通过FDA。 BioPlan analysis shows that biosimilar/biobetter companies are present in virtually every biotechnology-capable region, including Latin America, Korea, and other areas that have yet to be significantly involved in major Western biopharmaceutical markets (2). BioPlan分析表明,生物仿制药/ biobetter公司是目前几乎所有的生物技术能力的地区,包括拉丁美洲,韩国及其他地区尚未显着,在西方主要生物制药市场(2)参与。 For example, of the nearly 400 organizations involved in biosimilars/biobetters development, more than 30 companies are based in India and 14 in China. 例如,在生物仿制药/ biobetters发展所涉及的近400个团体,30多家公司总部设在印度和中国14。
The economy. The worldwide economic downturn in recent years continues to affect the biopharmaceutical industry. 经济。近年来全球经济衰退继续影响生物制药行业。 Yet, with continuing growth in its underlying sales revenue, the industry has managed to remain largely insulated from severe economic problems. 然而,在其底层的销售收入持续增长,行业管理,以保持从严重的经济问题主要是绝缘。 Financial issues continue to affect most companies, including the major international (ie, Big Pharma) companies that are the source for most biopharmaceutical R&D, with many having to deal with their most profitable products coming off patent. 财政问题继续影响到大多数公司,包括重大国际(例如,大型制药公司)公司是许多有对付他们最有利可图的产品专利,对于大多数的生物制药研发的源头。 Spurred, however, by their interest in new, profitable products, biopharmaceutical R&D continues to increase. 的带动下,然而,他们在新的,有利可图的产品的兴趣,生物制药研发的不断增加。 R&D invesment includes a record amount of more than $70 billion being invested by the pharmaceutical industry in R&D, about 90% sponsored by the largest international companies, with an increasing number and percentage of pharmaceuticals in the development pipeline being biopharmaceuticals versus chemically manufactured drugs). 研发invesment 1更多比$ 70被投资制药行业在研发,有关的最大的国际公司主办的90%,1增加的数量和药品比例的发展作为生物制药与化学制造毒品管道),亿创纪录金额。 Biopharmaceuticals provide more exclusivity, market monopolization, and are increasingly attractive to the Big Pharma-type companies. 生物制药提供了更多的排他性,垄断市场,越来越有吸引力的大型制药公司。
One important trend, however, is the internationalization of R&D. 然而,R&D国际化的一个重要趋势, Large international (ie, Big Pharma) companies continue their expansion and/or off-shoring of R&D. 国际大公司(例如,大型制药公司)继续他们的扩张和R&D /或离岸 Several companies have announced major, multimillion, investments in new R&D centers in China, such as Merck Serono's $225 million, four-year commitment in Beijing. 有几家公司已经宣布,数百万新的研发中心在中国的主要投资,如默克雪兰诺的$ 225亿美元,4年在北京的承诺。
Mergers and acquisitions. The trend for industry mergers, acquisitions, and other corporate consolidation at all scales continued in 2011. 兼并和收购。行业兼并,收购,并在各种规模的其他企业整合的趋势在2011年继续。 This is particularly evident among large international companies that continue merging and purging (ie, acquiring or merging companies and then downsizing the merged company). 继续合并和清除(即收购或合并的公司,然后缩编,合并后的公司)的国际大公司中,这一点尤为明显。 Some companies, such as Merck & Co., are moving from mergers/acquisitions in favor of more in-house and company-sponsored R&D. 一些公司,如默克公司正在兼并/收购有利于更多的内部和公司赞助的R&D The continuing trend of pharmaceutical mergers, combined with off-shoring of certain jobs and facilities, has resulted in relatively high bio/pharmaceutical industry unemployment rates in the US. 在相对 较高的生物/制药业在美国的失业率已导致医药并购相结合,与某些工作和设施的离岸趋势仍在继续。
Patent litigation. Patent-infringement suits can be expected to increase, particularly as a large number of biosimilars (and biobetters and biogenerics) approach filing in the US and other major markets. 可以预期增加,特别是作为一个生物仿制药的大量(biobetters和生物仿制药),在美国和其他主要市场的做法申请, 专利诉讼,专利侵权诉讼。 Major test cases, such as Classen Immunotherapies versus Biogen Idec , involve whether business methods patents include coverage of methods for determining the optimal dose of a therapeutic. 如Classen免疫疗法与Biogen Idec公司的重大考验案件,涉及商业方法专利是否包括覆盖的方法,确定了治疗的最佳剂量。 Biopharmaceutical companies may soon need to consider yet another type of patent, in addition to those for composition-of-matter (eg, sequences), formulations, uses, bioprocessing, and reference standards.
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