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

1. ADCC Market
Dec., 2013

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