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 Presentation Transcript

  • 1. ADCC Market Dec., 2013
  • 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
  • 16. Classic ADCC Assays 16
  • 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
  • 21. Move together, Win together. 21