Market and R&D Analysis of Recombinant Protein Drugs

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Market and RD Analysis of Recombinant Protein
Drugs
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Background
Global Market Share

• The global biotechnology market is expected to
  grow at a compound annual growth rate of 12.3.
  By 2020, the market size will be 606.8 billion.

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Background
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Background
Golden Age for Recombinant Protein Drug
Global Prescription Drug Market
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Background
Global Market Share
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Background

• The United States ranks first of new drugs listed
• Free drug price environment
• Doctors high acceptance of new drugs
• Europe takes the lead in approving the listing of
  recombinant human antithrombin (GTC
  biotherapeutic company), which is produced by
  transgenic animals (sheep).

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Advantages of Market Research

• Recombinant protein is effective and plays an
  irreplaceable role in the treatment of certain
  diseases.
• Most recombinant protein drugs applies to
  diseases due to a single gene or a simple cause
  of lack of one protein or protein function
  losing.
• Recombinant protein drugs have higher price due
  to higher technical barriers and financial
  barriers.

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Advantages of Market Research
Phosphorylation
Methylation
Acetylation
Amidation
Sulfation
Correctly folded
PTMs
Sumoylation
Hydroxylation
Formylation
Nitration
Palmitoylation
Glycosylation
Incorrectly
Ubiquitination
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Advantages of Market Research

• Production system selection
• Vector construction
• Parameter optimization

Separation and purification Activity test
Insect Expression System
Mammalian Expression System
Yeast Expression System
Bacteria Expression System
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Advantages of Market Research
Unlike small molecular chemicals, the biosimilar
drug is difficult to guarantee exactly the same
as the original.
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Advantages of Market Research

• Targeted at major diseases area
• No substituted product
• Relatively few approval drugs
• Significantly greater safety than
• small molecules
• Higher approval rate
• Shorter clinical trial period
• Extended patent protection time
• Longer exclusive sales time.

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Recombinant Drug Classification
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Recombinant Drug Classification
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Recombinant Drug Classification
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Recombinant Drug Classification
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Research and Development Trends

• Production host and production yield
• Genetically engineering and post-translational
• modifications of recombinant drugs
• Administration approaches change

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Research and Development Trends

• Production host and production yield
• Genetically engineering and post-translational
• modifications of recombinant drugs
• Administration approaches change

01
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Research and Development Trends
Insufficient production capacity
High price
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Research and Development Trends

• Mammalian Expression System
• CHO
• BHK
• NSO
• HEK293

E.coli Expression System

• Insulin
• Growth hormone
• Interferon-ß
• Interleukin

• Mammalian Expression System Problem
• Production yield
• Serum-free media
• Cell apoptosis delay
• Glycosylation improvement

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Research and Development Trends

• Breakthrough
• "humanized" Pichia pastoris
• plant expression system (molecular culture)

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Research and Development Trends

• Production host and production yield
• Genetically engineering and post-translational
• modifications of recombinant drugs
• Administration approaches change

02
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Research and Development Trends
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Research and Development Trends
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Research and Development Trends
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Research and Development Trends

• Production host and production yield
• Genetically engineering and post-translational
• modifications of recombinant drugs
• Administration approaches change

03
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Research and Development Trends
IV Intravenous IM Intramuscular SC
Subcutaneous
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Problems and Challenges

• Other therapeutic drugs or methods challenge the
  market share of recombinant drugs
• Effect of Biosimilar drugs on recombinant drug
  market
• Clinical safety risk

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Problems and Challenges

• Other therapeutic drugs or methods challenge the
  market share of recombinant drugs
• Effect of Biosimilar drugs on recombinant drug
  market
• Clinical safety risk

01
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Problems and Challenges
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Problems and Challenges
Antibody Drug
Aptamer Drug
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Problems and Challenges

• Other therapeutic drugs or methods challenge the
  market share of recombinant drugs
• Effect of Biosimilar drugs on recombinant drug
  market
• Clinical safety risk

02
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Problems and Challenges

BRAND
Safe Effective Same Active Ingredients
Safe Effective Same Active Ingredients
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Problems and Challenges

• Other therapeutic drugs or methods challenge the
  market share of recombinant drugs
• Effect of Biosimilar drugs on recombinant drug
  market
• Clinical safety risk

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Problems and Challenges

• The function of the recombinant drug is not
  unique.
• Effect degree is difficult to precisely control

Side Effect
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