ADCC Market

Dec., 2013

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Outline

Mab/BioSimilar Market

ADCC Assay Brief

ADCC Service Market

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Biologics in BioPharma Market

Source: Evaluate Pharma, Sandoz analysis

By 2016, 7 of the top 10 pharmaceuticals worldwide will be biologics.

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Therapeutic mAbs drive BioPharma Market

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Current New mAbs Pipeline

In total, > 574 mAbs

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Global BioSimilars Market Scenario

Source: 2013 Annual Reports, SEC Filings, Market Analysis

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Top Reference Products with BioSimilars in Development 2013

*As of July,2013

Source: PhRMA reports

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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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***Geographic distribution of companies

**Geographic distribution of products by company *Companies with largest biosimilar portfolios

*As of June,2013Source: BII pipeline database

Current BioSimilars Pipeline

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# 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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Bioassay/ADCC Required in Regulation

Fingerprint mAbs/fusion proteins as ICH, US-FDA, EMA etc. recommend.

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Mechanism of Action (MOA) for mAb

Nature Review. Drug Discovery. Volume 10, Feb 2011-101

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What is ADCC?

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When is ADCC needed?

Starting from phase I and even earlier, ADCC assay should be performed for biologics potency assessment.

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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

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Classic ADCC Assays

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Major Players in ADCC Assay

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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 yearCurrently, # 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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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. 500L-20,000L/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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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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Move together, Win together.