ADCC 2014 2017 market report_201312
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This document outlines the ADCC (antibody-dependent cell-mediated cytotoxicity) assay market. It notes that biologics such as monoclonal antibodies will make up 7 of the top 10 pharmaceuticals by 2016. There are currently over 500 monoclonal antibodies and 900 biosimilars/biobetters in development globally. ADCC assays are required by regulatory agencies to characterize biologics and are used throughout the development and manufacturing process. The document predicts the ADCC assay market size to be over $150 million in Korea and China alone by 2015 based on the large biologics pipeline and manufacturing volume in those regions. It concludes by providing contact information for ADCC assay services.
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Oncogene inhibitors market & pipeline insight 2015
" Oncogene Inhibitors Market & Pipeline Insight 2015" Report Highlight:
Global Oncogene Inhibitors Market Overview
Oncogene Inhibitors Pipeline by Company, Indication & Phase
Oncogene Inhibitors Pipeline: 185 Drugs
Majority Oncogene Inhibitors in Preclinical Phase: 105 Drugs
Proto Oncogene Protein c met Inhibitors Pipeline: 42 Drugs
Proto Oncogene Protein c-akt Inhibitors: 39 Drugs
Marketed Oncogene Inhibitors: 22 Drugs
Marketed Proto-Oncogene Protein c-bcl-2 Inhibitors: 8 Drugs
High-Growth Diagnostic Testing Markets
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Global monoclonal antibodies market report 2017
McAbs has high targeting ability and can directly reach the diseased cells. Now McAbs are widely used in clinical practice with the unique advantages of reducing the damage of normal cells side effects.
The market share monoclonal antibody in global biopharmaceuticals has increased from 10% in 2000 to 42% in 2016.
It is the largest and fastest growing fine industry in the modern biopharmaceutical industry.
According to Chlue Research, the total sales of 52 kinds of McAbs approved by FDA were up to 99 billion US dollars in 2016, up 15% from 2015.
Content
McAbs Market
Biosimilars
Antineoplastic drugs
Autoimmune diseases
Ophthalmic remedy
PD-1 and PD-L1 McAbs
McAbs approved by FDA
Download Oncogene inhibitors market & pipeline insight 2015
\" Oncogene Inhibitors Market & Pipeline Insight 2015\" Report Highlight:
Global Oncogene Inhibitors Market Overview
Oncogene Inhibitors Pipeline by Company, Indication & Phase
Oncogene Inhibitors Pipeline: 185 Drugs
Majority Oncogene Inhibitors in Preclinical Phase: 105 Drugs
Proto Oncogene Protein c met Inhibitors Pipeline: 42 Drugs
Proto Oncogene Protein c-akt Inhibitors: 39 Drugs
Marketed Oncogene Inhibitors: 22 Drugs
Marketed Proto-Oncogene Protein c-bcl-2 Inhibitors: 8 Drugs
Oncogene inhibitors market & pipeline insight 2015
" Oncogene Inhibitors Market & Pipeline Insight 2015" Report Highlight:
Global Oncogene Inhibitors Market Overview
Oncogene Inhibitors Pipeline by Company, Indication & Phase
Oncogene Inhibitors Pipeline: 185 Drugs
Majority Oncogene Inhibitors in Preclinical Phase: 105 Drugs
Proto Oncogene Protein c met Inhibitors Pipeline: 42 Drugs
Proto Oncogene Protein c-akt Inhibitors: 39 Drugs
Marketed Oncogene Inhibitors: 22 Drugs
Marketed Proto-Oncogene Protein c-bcl-2 Inhibitors: 8 Drugs
Download Global biosimilars market regulations & pipeline insight
“Global Biosimilars Market Regulations & Pipeline Insight 2014” Report Highlights:
Market Overview
Detailed Regulatory Pathways For 12 Countries/Regions
Global Biosimilars Pipeline by Phase, Indication, Company & Country
Biosimilars Pipeline: 276 in Development Phase
Majority Biosimilars in Preclinical Phase: 76 Biosimilars
Marketed Biosimilars by Indication, Company & Country: 113 Biosimilars
UK Coagulation Testing Market: Innovative Technologies and Emerging Business ...
This report provides an in-depth analysis of the UK coagulation testing market over the next ten years, including forecasts for test volumes, instrument and reagent sales, and market shares of major suppliers. It reviews 40 routine coagulation tests and nearly 50 leading analyzers, and identifies opportunities for suppliers in automated technologies, point-of-care testing, and emerging applications. The 409-page report is available for single-user purchase at US$5400 from the provided website.
Basic cGMP
The document discusses key aspects of current good manufacturing practices (cGMP) for pharmaceuticals. It defines cGMP and explains that the "C" stands for "current," meaning manufacturers must use up-to-date technologies and systems. cGMP covers all aspects of production from facilities, equipment, personnel, packaging, quality control, and documentation. Following cGMP is important because it helps ensure the quality, safety and effectiveness of drugs. Historical incidents like the thalidomide tragedy and Tylenol tampering case demonstrate how non-compliance with GMP can put patients' lives at risk.
Tracking cmo investments in biologics
- Biologics manufacturing is growing rapidly due to increased biologics sales and pipeline products. Biologics are projected to exceed $390 billion by 2020 and nearly reach parity with small molecules.
- Many CMOs are expanding biologics manufacturing capacity through new facilities and production trains featuring single-use technologies and larger bioreactors up to 2000L. Locations include the US, Europe, and Asia.
- Emerging biologics modalities like cell and gene therapies are driving additional manufacturing capacity investments in viral vector production and cell therapy services.
Pro tech med narrated2plus
This document provides an overview of Advanced Preservation Technologies, LLC, a new technology development company. It describes two exclusive licenses the company has obtained - one from NASA for a preservative used in the space program, and one being negotiated from a major university for a biopolymer that preserves samples for extended periods of time. The document outlines current and potential applications of the technologies, including preserving urine, blood, and other samples without refrigeration. Financial projections through year 5 anticipate growing revenue from sales of urine and blood tubes as production and customers increase. Key leadership is introduced, along with their relevant experience.
Canasita: Enabling Bioscience Processors
The business plan outlines an opportunity in the US healthcare market for point-of-care diagnostic solutions. Specifically, it aims to develop a biosensor using cytochrome P450 enzymes to enable quick diagnosis and drug monitoring. This would help address delays in prognosis and high costs associated with traditional lab tests. The plan is to launch solutions first for clinical trials and blood analysis, followed by urine analysis. Financial projections estimate capturing 3-5% of relevant markets by 2017 and achieving profitability, with research and development comprising 20% of expenses as new solutions are developed to address pain points in geriatric care and diagnostics.
2013 US Hospital Coagulation Testing Market
This 411-page report from January 2013 analyzes the US hospital coagulation testing market. It provides volume and sales forecasts for 40 coagulation procedures performed in US hospitals through 2018. It reviews current instrumentation technologies and compares leading analyzers. It also profiles major suppliers of reagents and instruments, and identifies business opportunities in the market. The report is available for $6,300 for a single-user license and its table of contents covers topics like coagulation tests, instrumentation, technologies, the US market structure and size, and competitive assessments of major companies.
BSI-July-2016-Raj Gunashekar
The document discusses the new National Intellectual Property Rights Policy that was approved by the Cabinet and examines whether the revised norms have improved the clinical research environment in India; it also explores strategies that life sciences startups employ to de-risk themselves and features an upcoming Biotechnology Ignition Grant application workshop at the Centre for Cellular and Molecular Platforms.
US Coagulation Testing Market: Innovative Technologies and Emerging Business ...
This 424-page report provides a comprehensive analysis of the US coagulation testing market, including major issues, trends, forecasts, and business opportunities. It reviews 40 coagulation procedures, placement estimates for automated systems, a comparison of 50 leading analyzers, and forecasts for reagent and instrument sales. The report also profiles major suppliers and provides strategic recommendations for players in the market.
Innovative Clinical Chemistry and Immunodiagnostic Technologies and Emerging ...
This unique 1,115-page report contains 450 tables, and provides sales and market shares of leading reagent and instrument suppliers, as well as test volume and sales forecasts for 100 chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays, calibrators and controls. Available by country and section.This unique worldwide market intelligence and technology assessment report will help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective strategic responses. The report explores future trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; provides estimates of the specimen, test and sales volumes, as well as major suppliers’ sales and market shares; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities emerging during the next ten years.The clinical chemistry and immunodiagnostics markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition. Some segments, like routine chemistry, begin to resemble commodity markets, where product positioning and cost per test are more critical than underlying technology. This evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices, controls, and calibrators.
Future of red biotechnology in china
"Description:
Red biotechnology (RB) refers to the biotechnology applied in pharmaceutical production and it has become the most important part in biotechnology industry. About 60% of achievements in biotechnology in the world are applied in production of bio-pharmaceuticals. At present, RB products mainly include gene recombinant drugs, blood products, vaccines, diagnostic reagents, etc. What is the current production situation of different RB products in China?
Driven by its substantial environmental or economic benefits, China’s RB industry has witnessed fast development and has played an increasingly important role in Chinese economic growth. However, the overall development of China’s RB industry remains in growth stage, and still has an enormous gap compared with developed countries. What is the future trend of Chinese RB industry development? What are the relevant supporting policies on Chinese RB industry? What have been the popular cutting-edge technologies in China in recent years? Where are the investment opportunities and what is the investment mode in China?
What is covered in this report?
- Overview of China’s red biotechnology;
- Detailed analysis of each sub-categories of red biotechnologies in China: gene recombinant drugs, blood products, vaccines, diagnostic reagent, etc., in terms of market data, major players, technical suppliers, technologies or R&D situations;
- Future prospects of each category of red biotechnologies, with key influencing factors and commercial opportunities
- Profiles of major players and research institutes
- Related policies and regulations
What benefits will you get?
- Gain a clear understanding about the industry landscape and latest developments in R&D, production, technology advancement and future trends in China’s red biotechnology;
- Keep informed of the precise development situation of key RB products with basic data and latest info;
- Gain reasonable and constructive suggestions on market opportunities in China’s RB fields;
- Figure out, current trend and future growth prospect of red biotechnology in China;
- Know more about how innovative players and research groups are carrying out innovation, collaboration and achieving commercial success in China.
"
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Oncogene inhibitors market & pipeline insight 2015
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Download Oncogene inhibitors market & pipeline insight 2015
Oncogene inhibitors market & pipeline insight 2015
Oncogene inhibitors market & pipeline insight 2015
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Download Global biosimilars market regulations & pipeline insight
UK Coagulation Testing Market: Innovative Technologies and Emerging Business ...
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ADCC 2014 2017 market report_201312
- 2. Outline Mab/BioSimilar Market ADCC Assay Brief ADCC Service Market 2
- 3. Biologics in BioPharma Market By 2016, 7 of the top 10 pharmaceuticals worldwide will be biologics. Source: Evaluate Pharma, Sandoz analysis 3
- 4. Therapeutic mAbs drive BioPharma Market 4
- 5. Current New mAbs Pipeline In total, > 574 mAbs 5
- 6. Global BioSimilars Market Scenario Source: 2013 Annual Reports, SEC Filings, Market Analysis 6
- 7. Top Reference Products with BioSimilars in Development 2013 *As of July,2013 Source: PhRMA reports 7
- 8. Current BioSimilars Pipeline As of June 2013, including 514 candidate biosimilars and 402 biobetters, a total of 916 products in development concerning >140 mabs and proteins that are currently approved in the United States. Source: BII pipeline database 8
- 9. Current BioSimilars Pipeline *Companies with largest biosimilar portfolios **Geographic distribution of products by company ***Geographic distribution of companies *As of June,2013 Source: BII pipeline database 9
- 10. # of mAbs/biosimilars in 2015 Biosimilars launched date: In 2015, around 55 on market Approved mAb drugs on the market: So far, total 53, around 58 in 2015 Source: SameDan Ltd, Winter 2012 10
- 11. Bioassay/ADCC Required in Regulation Fingerprint mAbs/fusion proteins as ICH, US-FDA, EMA etc. recommend. 11
- 12. Mechanism of Action (MOA) for mAb Nature Review. Drug Discovery. Volume 10, Feb 2011-101 12
- 13. What is ADCC? 13
- 14. When is ADCC needed? Starting from phase I and even earlier, ADCC assay should be performed for biologics potency assessment. 14
- 15. What is ADCC for? MAbs/Biosimilars/Biobetters discovery research High-throughput screening Characterization and process development of therapeutic molecules Batch/lot or quality control release testing of clinical product Stability testing In-vitro detection of neutralizing antibodies If significant changes to process, facility transfers, line-extensions 15
- 17. Major Players in ADCC Assay 17
- 18. ADCC Market Prediction Current ADCC assay in industry: $16K -- $25K, averagely $20K per assay Scenario 1 – mAbs/biosimilar pre-approval Averagely, at least 10 times of ADCC assay for one candidate each year Currently, # of new mAb entities in pipeline is > 514, # of biosimilars/biobetters in pipeline is around 916. 25% of pipeline is in Japan/Korea/China. Market size: (514+916)*10*$20K *25%= $71.5M 18
- 19. ADCC Market Prediction Scenario 2 – mAbs/biosimilar manufacturing Post-Approval 2-1. The manufacturing volume reaches to 5*10^7 L in Korea/China in 2015. 500L20,000L/bioreactor, averagely 10,000L/batch. Market size in Korea/China: 5*10^7/10,000*$20K = $100M 2-2. Revenue of mAbs drug in 2015 is around $86B globally. 5% of cost for QC. 2% of QC cost for ADCC. 70% of mAbs manufactured in Korea/China. Market size in Korea/China: $86B*5%*5%*70% = $60M 19
- 20. ADCC Market Prediction Scenario 2 – mAbs/biosimilar manufacturing Post-Approval 2-3. Averagely, 1 time of ADCC assay per drug per week. Totally around 113 mAbs/ biosimilars on the market in 2015. 70% of biologics manufactured in Korea/China. Market size in Korea/China: 113*1*52*70%*$20K = $83M Totally, $71.5M + ($100M+$60M+$83M)/3 = $152.5M ADCC Service Contact: cn.linkedin.com/in/jasonsoung/ 20