Market and R&D Analysis of Recombinant Protein Drugs

Background 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. Global Market Share

Recombinant Protein Recombinant Monoclonal Antibody Recombinant Vaccine Background

Golden Age for Recombinant Protein Drug Background Global Prescription Drug Market

Background Global Market Share

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).

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.

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

Production system selection Vector construction Parameter optimization Bacteria Expressio n System Yeast Expressio n System Insect Expressio n System Mammalian Expression System Advantages of Market & Research Separation and purification Activity test …

Unlike small molecular chemicals, the biosimilar drug is difficult to guarantee exactly the same as the original. VS 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. Advantages of Market & Research

Recombinant Drug Hormone peptide drugs Human hematopoietic factor Human cytokines Human plasma protein factor Human bone formation protein Recombinant enzyme Fusion protein Exogenous recombinant proteins Recombinant Drug Classification

Hormone peptide InsulinGHFSH Hematopoietic factor erythropoietin GM-CSF Other related factors Recombinant Drug Classification

Cytokines Interferon-αInterferon-βOthers Plasma Protein Factor Factor VIIIFactor VIIFactor IXtPA C-reactive protein ATryn Recombinant Drug Classification

Recombinant Drug Hormone peptide drugs Human hematopoietic factor Human cytokines Human plasma protein factor Human bone formation protein Recombinant enzyme Fusion protein Exogenous recombinant proteins Recombinant Drug Classification

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

Research and Development Trends Production host and production yield Genetically engineering and post-translational modifications of recombinant drugs Administration approaches change 01

Insufficient production capacity High price Research and Development Trends

Insulin Growth hormone Interferon-β Interleukin …  Mammalian Expression System  CHO  BHK  NSO  HEK293  …  Mammalian Expression System Problem  Production yield  Serum-free media  Cell apoptosis delay  Glycosylation improvement  … Research and Development Trends E.coli ExpressionE.coli Expression System

 Breakthrough  "humanized" Pichia pastoris  plant expression system (molecular culture ) Research and Development Trends

Production host and production yield Genetically engineering and post-translational modifications of recombinant drugs Administration approaches change 02

Research and Development Trends

Production host and production yield Genetically engineering and post-translational modifications of recombinant drugs Administration approaches change 03

Research and Development Trends IV: Intravenous IM: Intramuscular SC: Subcutaneous

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

Other therapeutic drugs or methods challenge the market share of recombinant drugs Effect of Biosimilar drugs on recombinant drug market Clinical safety risk 01 Problems and Challenges

Antibody Drug Aptamer Drug

Other therapeutic drugs or methods challenge the market share of recombinant drugs Effect of Biosimilar drugs on recombinant drug market Clinical safety risk 02 Problems and Challenges

VS Safe Effective Same Active Ingredients GENERIC $ Safe Effective Same Active Ingredients BRAND $$$

Other therapeutic drugs or methods challenge the market share of recombinant drugs Effect of Biosimilar drugs on recombinant drug market Clinical safety risk 03 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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