ADCC 2014 2017 market report_201312
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ADCC 2014 2017 market report_201312

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2014-2017 Asia market projection of ADCC service (pre-clinical and GMP complied)

2014-2017 Asia market projection of ADCC service (pre-clinical and GMP complied)

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    ADCC 2014 2017 market report_201312 ADCC 2014 2017 market report_201312 Presentation Transcript

    • ADCC Market Dec., 2013
    • Outline  Mab/BioSimilar Market  ADCC Assay Brief  ADCC Service Market 2
    • Biologics in BioPharma Market By 2016, 7 of the top 10 pharmaceuticals worldwide will be biologics. Source: Evaluate Pharma, Sandoz analysis 3
    • Therapeutic mAbs drive BioPharma Market 4
    • Current New mAbs Pipeline In total, > 574 mAbs 5
    • Global BioSimilars Market Scenario Source: 2013 Annual Reports, SEC Filings, Market Analysis 6
    • Top Reference Products with BioSimilars in Development 2013 *As of July,2013 Source: PhRMA reports 7
    • 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
    • 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
    • # 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
    • Bioassay/ADCC Required in Regulation Fingerprint mAbs/fusion proteins as ICH, US-FDA, EMA etc. recommend. 11
    • Mechanism of Action (MOA) for mAb Nature Review. Drug Discovery. Volume 10, Feb 2011-101 12
    • What is ADCC? 13
    • When is ADCC needed? Starting from phase I and even earlier, ADCC assay should be performed for biologics potency assessment. 14
    • 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
    • Classic ADCC Assays 16
    • Major Players in ADCC Assay 17
    • 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
    • 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
    • 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
    • Move together, Win together. 21