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Biologics Outsourcing Global Market

  • ID: 4719965
  • Report
  • Region: Global
  • 572 Pages
  • IQ4I Research & Consultancy Pvt. Ltd
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until Dec 31st 2019
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In 2017, 7 out of 10 Blockbuster Drugs were Biologics Outnumbering Small Molecule Drugs

FEATURED COMPANIES

  • 3P Biopharmaceuticals
  • Biomeostasis
  • Cytovance biologics
  • JHL biotech
  • Noble Life Sciences
  • SMC Laboratories, Inc.
  • MORE

The biologics outsourcing global market is expected to grow at double digit CAGR to reach $87.6 billion by 2027.

Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids made from natural sources such as human, animal or micro organisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies and gene therapies. Like small molecule drugs, these drugs are intended for treatment of diseases and medical conditions.

However, Biologics bring into picture higher range of specificity in treating a disease condition as the biologic entities like monoclonal antibodies and recombinant proteins target specific areas in the molecular mechanism of disease action.

Although biologics are much costlier than small molecule drugs, these classes of drugs prove to be highly beneficial for the patient and also bring about 40% higher profits to the manufacturers when compared to small molecule drug treatments. Due to the increasing demand for biologics drugs and increased regulatory approvals for these drugs, there is huge demand for biologics manufacture and testing at various levels of clinical studies as well as commercial supply.

The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing this piece of work to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs).

These organizations bridge the gap between demand and supply and ensure the drug discovery process gets much faster and convenient thus bringing life saving drugs to the market to reach the needy patients.

In 2017, 7 out of 10 blockbuster drugs were biologics outnumbering small molecule drugs. Some of the top selling biologics in 2017 includes Humira ($18.4 billion), Rituxan ($9.2 billion), Enbrel ($7.9 billion), and Herceptin ($7.4 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologics development starting preclinical stage to commercial manufacturing.

The high complexity of biologics development and manufacture requiring huge technical expertise is prompting major biopharma companies turn to outsourcing as a viable option. Various stages of biological development require different types of services as listed below.

Discovery services- Includes lead identification and validation for identifying possible drug candidates targeting specific diseases. The process further involves steps such as target validation, screening preparation, hit generation and lead selection, lead optimization and characterization and finally lead selection.

Preclinical development services- Involves in-vitro and in-vivo studies of the biologic drug candidates before testing them on humans to test the safety, efficacy and biological functionality against the disease target. Preclinical services include cell line engineering, process development, product analytical characterization, cGMP cell banking, cell line characterization, animal model assay development and testing services.

Clinical development- Clinical development includes testing potential drug candidates on humans in phase I, II and II trials. Services at this stage include cGMP grade clinical supply of biologics such as MAb, or recombinant protein, stability testing, fill/finish and regulatory support.

Commercialization- Once the drug has passed all the necessary approvals, the manufacture, marketing and sale of commercial quantities is performed. Outsourcing partners here manufacture the commercial supply for product launch and sale.

Note: Product cover images may vary from those shown
2 of 5

FEATURED COMPANIES

  • 3P Biopharmaceuticals
  • Biomeostasis
  • Cytovance biologics
  • JHL biotech
  • Noble Life Sciences
  • SMC Laboratories, Inc.
  • MORE

1 Biologics Outsourcing Global Market
1.1 Introduction
1.2 Landscape Of Biologics Market
1.3 Biologics Global Market
1.4 Top Destination For Biologics Outsourcing
1.4.1 China Biologics Outsourcing Market
1.4.2 China Vs India - Biologics Market
1.4.3 Regulations And Government Initiatives
1.4.4 Capabilities And Technologies

2 Market Analysis
2.1 Introduction
2.2 Factors Influencing Market
2.2.1 Drivers And Opportunities
2.2.1.1 Increased Investment In R&D By Pharmaceutical Companies Is Increasing The Outsourcing
2.2.1.2 Adoption Of Biological Therapies In Disease Management
2.2.1.3 Successful Collaboration And Low Cost For Outsourcing
2.2.1.4 Increasing Biologics Approvals In The Past Year
2.2.1.5 Increasing Chronic And Autoimmune Illnesses
2.2.1.6 Increasing Number Of Branded Drugs Going Off-Patent Creates A
Scope For Biosimilars
2.2.1.7 Requirement Of Novel Biologics Therapeutics For Rare Diseases
2.2.1.8 Increasing Demand For Antibody Conjugates And Bispecific Antibodies
2.2.1.9 Advanced Technologies For Screening, Cell Line Engineering And Bioprocessing
2.2.1.10 Pharma Companies Restricting Their Global Presence, Reducing Manpower,
Lack Of Facilities For Discovery And Manufacturing Of Biologics
2.2.2 Restraints And Threats
2.2.2.1 Intense Complexities In Handling Biologics
2.2.2.2 Requirement Of Highly Skilled Technicians
2.2.2.3 High Cost Of Drug Development Process
2.2.2.4 Challenges In Oral Formulations With Biologics
2.2.2.5 Stringent Regulatory Frameworks
2.2.2.6 High Capital And Technical Requirements To Obtain Gmp Certifications
2.2.2.7 Limited Ip Protection In Developing Regions
2.2.2.8 High Chances Of End Stage Failure Of Drug
2.2.2.9 Conflict Of Interest Between Pharmaceutical Company And Cro

3 Biologics Outsourcing Global Market, Market Analysis
3.1 Introduction
3.2 Discovery And Pre-Clinical Development Process
3.3 Biologics Outsourcing Global Market, By Product Type
3.3.1 Antibody
3.3.1.1 Monoclonal Antibody
3.3.1.2 Bispecific Antibody
3.3.1.3 Antibody Drug Conjugates
3.3.1.4 Others
3.3.2 Recombinant Protein
3.3.2.1 Fusion Proteins
3.3.2.2 Hormones
3.3.2.3 Recombinant Enzymes
3.3.2.4 Others
3.3.3 Vaccines
3.3.4 Others
3.3.4.1 Gene Therapy
3.3.4.2 Cell Therapy
3.3.4.3 Others
3.4 Market Share Analysis
3.5 Company Developments
3.5.1 Agreements, Partnerships & Collaborations
3.5.2 New Service Launch
3.5.3 Expansion
3.5.4 Acquisitions
3.5.5 Other Developments
3.6 Service Cost Analysis
3.6.1 Antibody Production Service Costs
3.6.2 Custom Monoclonal Antibody Production Service Costs
3.6.3 Custom Polyclonal Antibody Production Service Costs
3.6.4 Protein Production Service Costs
3.6.5 Additional Antibody And Protein Services
3.6.6 Gene Editting Services
3.6.7 Car-T/Nk Platform Services

4 Biologics Outsourcing Global Market –  Animal Model Services
4.1 Introduction
4.1.1 Market Dynamics
4.1.2 Comparison Matrix Of Animal Models And Applications
4.1.3 Small Animal Models
4.1.4 Large Animal Models
4.2 Ethics And Regulations
4.3 Alternatives To Animal Models
4.4 Overview Of Applications Of Animal Models
4.5 Animal Model Services Global Market, By Molecule
4.6 Animal Models Services Regional Market
4.7 Animal Model Services Market, By Speices
4.8 Animal Model Services Global Market, By Application
4.9 Market Share Analysis
4.10 Competitive Landscape
4.11 Company Developments

5 Biologics Outsourcing Global Market - Biomanufacturing
5.1 Introduction
5.2 Market Dynamics
5.3 In House Vs Cmo Capacity
5.4 Contract Biomanufacturing, By Process
5.4.1 Biomanufacturing By Mammalian Cell Culture
5.4.2 Biomanufacturing By Microbial Cell Culture
5.4.3 Biomanufacturing By Other Cell Culture
5.5 Contract Biomanufacturing Global Market, By End Users
5.5.1 Contract Biomanufacturing Of Diagnostics
5.5.2 Contract Biomanufacturing Of Research Reagents
5.5.3 Contract Biomanufacturing Of Therapeutics
5.6 Competitive Landscape
5.6.1 Capacity Comparison
5.6.2 Contract Manufacturing Global Market Share, By Leading Players
5.7 Company Developments
5.7.1 Merger And Acquisition By Cmos
5.7.2 Collaborations
5.7.3 Capacity Expansions

6 Biologics Outsourcing Global Market - Cell Line Development
6.1 Introduction
6.1.1 Market Dynamics
6.2 Cell Line Development
6.2.1 Cell Line Construction
6.2.2 Host Cell Line Engineering
6.2.3 Expression System
6.2.4 Transient Gene Expression
6.2.5 Stable Cell Line Development
6.2.6 Screening
6.2.7 Upstream Process Development
6.3 Host Cell Lines
6.4 Cell Line Development Services Market, By Expression System
6.4.1 Microbial Expression Systems
6.4.2 Mammalian Expression System
6.4.3 Others
6.5 Cell Line Development Services, By Cell Type
6.5.1 Cho
6.5.2 Murine/Mouse Myeloma
6.5.3 Baby Hamster Kidney (BHK) Cells
6.5.4 Hybridoma
6.5.5 Human Embryonic Kidney (HEK) Cells
6.5.6 Human Embryonic Retinal Cells (Per.C6)
6.5.7 Others
6.6 Cell Line Development Services, By Applications
6.6.1 Research
6.6.2 Bioproduction
6.6.3 Diagnostics
6.7 Key Developments
6.8 Market Share Analysis

7 Company Profiles
7.1 Abzena Plc
7.1.1 Overview
7.1.2 Financials
7.1.3 Service Portfolio
7.1.4 Key Developments
7.1.5 Swot Analysis
7.2 Adimab Llc.
7.2.1 Overview
7.2.2 Financials
7.2.3 Service Portfolio
7.2.4 Key Developments
7.2.5 Swot Analysis
7.3 Albany Molecular Research, Inc
7.3.1 Overview
7.3.2 Financials
7.3.3 Service Portfolio
7.3.4 Key Developments
7.3.5 Swot Analysis
7.4 Beijing Vital Star Biotechnology Co. Ltd.
7.4.1 Overview
7.4.2 Financials
7.4.3 Service Portfolio
7.4.4 Key Developments
7.4.5 Swot Analysis
7.5 Boehringer Ingelheim
7.5.1 Overview
7.5.2 Financials
7.5.3 Service Portfolio
7.5.4 Key Developments
7.5.5 Swot Analysis
7.6 Catalent Inc.
7.6.1 Overview
7.6.2 Financials
7.6.3 Service Portfolio
7.6.4 Key Developments
7.6.5 Swot Analysis
7.7 Charles River Laboratories
7.7.1 Overview
7.7.2 Financials
7.7.3 Service Portfolio
7.7.4 Key Developments
7.7.5 Swot Analysis
7.8 Crown Biosciences (JSR)
7.8.1 Overview
7.8.2 Financials
7.8.3 Service Portfolio
7.8.4 Key Developments
7.8.5 Swot Analysis
7.9 Genoway
7.9.1 Overview
7.9.2 Financials
7.9.3 Service Portfolio
7.9.4 Key Developments
7.9.5 Swot Analysis
7.10 Genscript Biotech Corporation
7.10.1 Overview
7.10.2 Financials
7.10.3 Service Portfolio
7.10.4 Key Developments
7.10.5 Swot Analysis
7.11 GL Biochem
7.11.1 Overview
7.11.2 Financials
7.11.3 Service Portfolio
7.11.4 Key Developments
7.11.5 Swot Analysis
7.12 Horizon Discovery Group, Plc
7.12.1 Overview
7.12.2 Financials
7.12.3 Service Portfolio
7.12.4 Key Developments
7.12.5 Swot Analysis
7.13 Jackson Laboratory
7.13.1 Overview
7.13.2 Financials
7.13.3 Service Portfolio
7.13.4 Key Developments
7.13.5 Swot Analysis
7.14 Samsung Biologics
7.14.1 Overview
7.14.2 Financials
7.14.3 Service Portfolio
7.14.4 Key Developments
7.14.5 Swot Analysis
7.15 JHL Biotech Inc.
7.15.1 Overview
7.15.2 Financials
7.15.3 Service Portfolio
7.15.4 Key Developments
7.15.5 Swot Analysis
7.16 Joinn Laboratories Co. Ltd
7.16.1 Overview
7.16.2 Financials
7.16.3 Service Portfolio
7.16.4 Key Developments
7.16.5 Swot Analysis
7.17 Lonza Group
7.17.1 Overview
7.17.2 Financials
7.17.3 Service Portfolio
7.17.4 Key Developments
7.17.5 Swot Analysis
7.18 Merck KGaA
7.18.1 Overview
7.18.2 Financials
7.18.3 Product Portfolio
7.18.4 Key Developments
7.18.5 Swot Analysis
7.19 Patheon N.V. (Thermofisher Scientific)
7.19.1 Overview
7.19.2 Financials
7.19.3 Service Portfolio
7.19.4 Key Developments
7.19.5 Swot Analysis
7.20 Pharmalegacy Laboratories
7.20.1 Overview
7.20.2 Financials
7.20.3 Service Portfolio
7.20.4 Key Developments
7.20.5 Swot Analysis
7.21 Pharmaron
7.21.1 Overview
7.21.2 Financials
7.21.3 Service Portfolio
7.21.4 Key Developments
7.21.5 Swot Analysis
7.22 Prosci Inc.
7.22.1 Overview
7.22.2 Financials
7.22.3 Service Portfolio
7.22.4 Key Developments
7.22.5 Swot Analysis
7.23 Proteogenix
7.23.1 Overview
7.23.2 Financials
7.23.3 Service Portfolio
7.23.4 Key Developments
7.23.5 Swot Analysis
7.24 Psychogenics, Inc
7.24.1 Overview
7.24.2 Financials
7.24.3 Service Portfolio
7.24.4 Key Developments
7.24.5 Swot Analysis
7.25 JSR Life Sciences (Selexis SA)
7.25.1 Overview
7.25.2 Financials
7.25.3 Service Portfolio
7.25.4 Key Developments
7.25.5 Swot Analysis
7.26 Shanghai Medicilon
7.26.1 Overview
7.26.2 Financials
7.26.3 Service Portfolio
7.26.4 Key Developments
7.26.5 Swot Analysis
7.27 Shangpharma Corporation /Shanghai Chempartner
7.27.1 Overview
7.27.2 Financials
7.27.3 Service Portfolio
7.27.4 Key Developments
7.27.5 Swot Analysis
7.28 Sino Biological
7.28.1 Overview
7.28.2 Financials
7.28.3 Service Portfolio
7.28.4 Key Developments
7.28.5 Swot Analysis
7.29 Sundia Meditech Co., Ltd.
7.29.1 Overview
7.29.2 Financials
7.29.3 Service Portfolio
7.29.4 Key Developments
7.29.5 Swot Analysis
7.30 Syngene International
7.30.1 Overview
7.30.2 Financials
7.30.3 Service Portfolio
7.30.4 Key Developments
7.30.5 Swot Analysis
7.31 Taconic Biosciences
7.31.1 Overview
7.31.2 Financials
7.31.3 Service Portfolio
7.31.4 Key Developments
7.31.5 Swot Analysis
7.32 Viva Biotech Ltd.
7.32.1 Overview
7.32.2 Financials
7.32.3 Service Portfolio
7.32.4 Key Developments
7.32.5 Swot Analysis
7.33 Wuxi Biologics (Wuxi Apptec)
7.33.1 Overview
7.33.2 Financials
7.33.3 Service Portfolio
7.33.4 Key Developments
7.33.5 Swot Analysis

List Of Tables

Table 1 Highlights Of The Revised Guidelines
Table 2 Biologics Outsourcing Global Market Revenue, By Region (2017-2027) ($Bn)
Table 3 Biologics Outsourcing Global Market Revenue, By Product (2017-2027) ($Bn)
Table 4 List Of Biologics Approved (2012-2018)
Table 5 Biologics Outsourcing Global Market Revenue, By Phase (2017-2027) ($Bn)
Table 6 Antibody Outsourcing Global Market Revenue, By Product Type (2017-2027) ($Bn)
Table 7 Others Global Market Revenue, By Product Type (2017-2027) ($Bn)
Table 8 Biologics Outsourcing Global Market Revenue, By End Users (2017-2027) ($Bn)
Table 9 Agreements, Partnership & Collaboartion (2017-2018)
Table 10 New Service Launch (2017-2018)
Table 11 Expansion (2017-2018)
Table 12 Acquisitions (2017-2018)
Table 13 Other Developments (2017-2018)
Table 14 Service Comparison Matrix Of The Company Based On Biologics Type
Table 15 Comparison Matrix Of Animal Models And Applications
Table 16 Major Types Of Genetically Engineered And Transplantation Animal Models
Table 17 Typical Preclinical Issues Of Biologics
Table 18 Animal Model Service Global Market, By Molecule ($Mn)
Table 19 Animal Model Service Global Market, By Region ($Mn)
Table 20 Animal Model Service Global Market By Type Of Animal Species ($Mn)
Table 21 Animal Model Service Global Market By Application ($Mn)
Table 22 Animal Model Service Cost (Development Of Transgenic Mouse)
Table 23 Animal Model Service Cost (Based On Disease Models)
Table 24 Animal Model Service Cost (Imaging Service Cost)
Table 25 Comparison Matrix Of Animal Model Service Companies And Models In Respective Therapeutic Areas
Table 26 Comparison Matrix Of Animal Model Service Companies And Models In Respective Immunology/Inflammation Therapeutic Areas
Table 27 Comparison Matrix Of Animal Model Service Companies And Models In Respective Fibrosis Therapeutic Areas
Table 28 Company Developments
Table 29 Capacity Comparison Of Contract Manufacturing Organizations V’S In-House Capacities (L)
Table 30 Contract Manufacturing Organizations Capacity, By Process (L)
Table 31 Drugs Synthesized In Microbial Cell Culture
Table 32 Biomanufacturing Outsourcing Global Market By End Users 2017-2027 ($Bn)
Table 33 Selected Fda Approved Therapeutic Peptides And Proteins
Table 34 Biomanufacturing Outsourcing Global Market By Region 2017-2027 ($Bn)
Table 35 Company Comparison Matrix, By Manufacturing Capability
Table 36 Mergers And Acquisitions (2017-2018)
Table 37 Collaborations (2017-2018)
Table 38 Capacity Expansions (2017-2018)
Table 39 Cell Line Development Services Market, By Region, (2017-2027) ($Mn)
Table 40 Approved Biologics And Cell Line Type (2012-2018)
Table 41 Number Of Approved Biologics By Cell Line Type (2012-2018)
Table 42 Cell Line Development Services Market, By Expression System, (2017-2027) ($Mn)
Table 43 Cell Line Development Services Market, By Cell Type, (2017-2027) ($Mn)
Table 44 Cell Line Type Of Some Approved Biologics Modalities And Cell Line Type
Table 45 Cell Line Development Services Market, By Application, (2017-2027) ($Mn)
Table 46 Cell Line Development Technologies
Table 47 Cell Line Development Services Cost
Table 48 Key Developments (2017-2018)
Table 49 Comparison Matrix Of Cell Line Development Players And Services Offered
Table 50 Abzena Plc: Total Revenue And R&D Expenses (2016-2018) ($Mn)
Table 51 Abzena Plc: Total Revenue, By Segment, (2016-2018) ($Mn)
Table 52 Abzena Plc: Total Revenue, By Geography, (2016-2018) ($Mn)
Table 53 Boehringer Ingelheim: Total Revenue And R&D Expenses, (2015-2017) ($Mn)
Table 54 Boehringer Ingelheim: Total Revenue, By Segments, (2015-2017) ($Mn)
Table 55 Boehringer Ingelheim: Total Revenue, By Geography, (2015-2017) ($Mn)
Table 56 Catalent Inc: Total Revenue And R&D Expenses (2016-2018) ($Mn)
Table 57 Catalent Inc: Total Revenue, By Segment, (2016-2018) ($Mn)
Table 58 Charles River Laboratories: Total Revenue And R&D Expenses, (2016-2018(Q3)) ($Mn)
Table 59 Charles River Laboratories: Total Revenue, By Segments, (2016-2018(Q3)) ($Mn)
Table 60 Charles River Laboratories: Total Revenue, By Geography, (2016-2018(Q3)) ($Mn)
Table 61 Genoway: Total Revenue And R&D Expenses (2016-2018(H1)) ($Mn)
Table 62 Genscript Biotech Corporation: Total Revenue And R&D Expenses, (2016-2018(Q3)) ($Mn)
Table 63 Genscript Biotech Corporation: Total Revenue, By Segments, (2016-2018(Q3)) ($Mn)
Table 64 Genscript Biotech Corporation: Total Revenue, By Geography, (2016-2018(Q3)) ($Mn)
Table 65 Horizon Discovery Group: Total Revenue And R&D Expenses, (2016-2018(H1) ($Mn)
Table 66 Horizon Discovery Group: Total Revenue, By Segments, (2016-2018(H1)) ($Mn)
Table 67 Horizon Discovery Group: Total Revenue, By Geography, (2016-2018(H1)) ($Mn)
Table 68 Jackson Laboratory: Total Revenue And R & D Expenses, (2015-2017) ($Mn)
Table 69 Samsung Biologics Co., Ltd: Total Revenue ($Mn)
Table 70 Samsung Biologics: Total Revenue, By Geography (2016-2018(H1)) ($Mn)
Table 71 JHL Biotech: Total Revenue And R & D Expenses (2015-2017) ($Mn)
Table 72 Lonza Group: Total Revenue & R&D Expenses (2016-2018 (H1)) ($Mn)
Table 73 Lonza Group: Total Revenue, By Segment, (2016-2018(H1)) ($Mn)
Table 74 Lonza Group: Total Revenue, By Geography (2016-2018(H1)) ($Mn)
Table 75 Merck KGaA: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
Table 76 Merck KGaA: Total Revenue, By Segments, (2016-2018(H1)) ($Mn)
Table 77 Merck KGaA: Total Revenue, By Geography, (2016-2018 (H1)) ($Mn)
Table 78 Patheon (Thermofisher Scientific): Total Revenue And R&D Expenses (2016-2018 (Q3)) ($Mn)
Table 79 Patheon (Thermofisher Scientific): Total Revenue, By Segment, (2016-2018(Q3)) ($Mn)
Table 80 Syngene International: Total Revenue And R&D Expenses, (2016-2018 (H1)) ($Mn)
Table 81 Syngene International: Total Revenue, By Geography, ((2016-2018 (H1)) ($Mn)
Table 82 Wuxi Biologics: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)

List Of Figures

Figure 1 Top Selling Drugs And Approvals, Small Molecules V’S Biologics, 2013-2017
Figure 2 Top 30 Biologics Patent Expiry, 2013-2038 And Rise Of Biosimilars
Figure 3 Biologics Revenue Generation In Non-Traditional Therapies (2016 Vs 2017)
Figure 4 Outlook Of Biologics Global Market (2017-2027)
Figure 5 Outlook Of China Biologics And Biologics Outsourcing Market (2017-2027)
Figure 6 China Vs India
Figure 7 Market Dynamics
Figure 8 Biologics Outsourcing Global Market Revenue, By Region (2017-2027) ($Bn)
Figure 9 Biologics Outsourcing Global Market Share, By Product, (2018 V’S 2027) (%) 
Figure 10 Discovery Biologics Outsourcing Market Share, By Services 2018 (%)
Figure 11 Discovery Biologics Outsourcing Market, By Service Type, 2018 ($Mn)
Figure 12 Biologics Outsourcing Global Market Revenue, By Phase (2018 V’S 2027) ($Bn)
Figure 13 Antibody Outsourcing Global Market Revenue, By Product Type, (2018 V’S 2027) ($Bn)
Figure 14 Others Global Market Revenue, By Product Type, (2018 V’S 2025) ($Bn)
Figure 15 Biologics Outsourcing Global Market Revenue, By End-Users (2018 V’S 2027) ($Bn)
Figure 16 Biologics Outsourcing Global Market Share Analysis, By Major Players, 2018
Figure 17 Recent Deals In Biologics Outsourcing
Figure 18 Genome Comparison
Figure 19 Drot: Animal Models
Figure 20 Animal Profiles
Figure 21 Common Animal Models
Figure 22 Advantages And Disadvantages Of Rodent Models
Figure 23 Advantages And Disadvantages Of Nhp
Figure 24 Principles Of 3Rs
Figure 25 Percentage Of Animals Used In Different Stages Of Pharmaceutical Development
Figure 26 Animal Model Service Global Market, By Molecule ($Mn)
Figure 27 Animal Model Service Global Market, By Region ($Mn)
Figure 28 Animal Model Service Global Market, By Type Of Animal Species ($Mn, %)
Figure 29 Animal Model Service Global Market Revenue And Share, By Application ($Mn, %(2018))
Figure 30 Animal Model Services Global Market Share Analysis, 2018 (%)
Figure 31 Company Developments
Figure 32 Market Dynamics Of Contract Biomanufacturing Global Market
Figure 33 Global Manufacturing Capacity, Cgmp V’S Non-Cgmp, Inhouse V’S Cmo, 2017-2027
Figure 34 Capacity Utilization Of Contract Manufacturing Organizations, By Stage (L)
Figure 35 Capacity Comparison Of Mammalian, Microbial And Other Culture Systems (L)
Figure 36 Bio-Manufacturing Outsourcing Global Market, By End Users ($Bn)
Figure 37 Adc Pipeline For Cancer 2018
Figure 38 Outlook Of Biologics Cmo Global Market Share, By Region (%) And Manufacturing In Metric Tons, 2018
Figure 39 Capacity Composition Of Top 10 Contract Manufacturing Organizations (L)
Figure 40 Market Share Analysis By Contract Manufacturing Major Players, 2018
Figure 41 Key Deals (2017-2018)
Figure 42 Market Dynamics Of Cell Line Development
Figure 43 Cell Line Development Services Market, By Region, (2018 Vs 2027) ($Mn)
Figure 44 Number Of Approved Biologics By Cell Line Type (2012-2018)
Figure 45 Cell Line Development Services Market, By Expression System, (2018 V’S 2027) ($Mn)
Figure 46 Expression Systems Of Some Approved Biologics
Figure 47 Cell Line Development Services Market, By Cell Type, (2018 Vs 2027) ($Mn)
Figure 48 Cell Line Type Of Some Approved Biologics
Figure 49 Cell Line Type Of Some Approved Biologics Modalities And Cell Line Type
Figure 50 Cell Line Development Services Market, By Application, (2018 V’S 2027) ($Mn)
Figure 51 Key Developments Of Cell Line Development Market Players, 2017-2018
Figure 52 Market Share Analysis, By Cell Line Development Major Players (2018)
Figure 53 Overview: Abzena Plc
Figure 54 Swot: Abzena Plc
Figure 55 Swot: Adimab Llc
Figure 56 Swot: Albany Molecular Research, Inc
Figure 57 Swot: Beijing Vital Star Biotechnology Co. Ltd.
Figure 58 Boehringer Ingelheim Revenue Overview
Figure 59 Swot: Boehringer Ingelheim
Figure 60 Overview: Catalent Inc.
Figure 61 Swot: Catalent Inc.
Figure 62 Overview: Charles River Laboratories
Figure 63 Swot: Charles River Laboratories
Figure 64 Swot: Crown Biosciences
Figure 65 Overview: Genoway
Figure 66 Swot: Genoway
Figure 67 Overview: Genscript Biotech Corporation
Figure 68 Swot: Genscript Biosciences Corporation
Figure 69 Swot: GL Biochem
Figure 70 Overview: Horizon Discovery Group, Plc
Figure 71 Swot: Horizon Discovery Group, Plc
Figure 72 Overview: Jackson Laboratory
Figure 73 Swot: Jackson Laboratory
Figure 74 Overview: Samsung Biologics
Figure 75 Swot: Samsung Biologics
Figure 76 Overview: JHL Biotech
Figure 77 Swot: JHL Biotech Inc.
Figure 78 Swot: Joinn Laboratories Co. Ltd
Figure 79 Overview: Lonza Group
Figure 80 Swot: Lonza Group
Figure 81 Overview: Merck Kgaa
Figure 82 Swot: Merck Kgaa
Figure 83 Overview: Patheon (Thermofisher Scientific)
Figure 84 Swot: Thermo Fisher Scientific
Figure 85 Swot: Pharmalegacy
Figure 86 Swot: Pharmaron
Figure 87 Swot: Prosci. Inc.
Figure 88 Swot: Proteogenix
Figure 89 Swot: Psycogenics Inc
Figure 90 Swot: Jsr Life Sciences (Selexis SA)
Figure 91 Swot: Shanghai Medicilon
Figure 92 Swot: Shanghai Chempartner
Figure 93 Swot: Sino Biological
Figure 94 Swot: Sundia Meditech Company Ltd
Figure 95 Swot: Syngene International
Figure 96 Swot: Taconic Biosciences
Figure 97 Swot: Viva Biotech Ltd
Figure 98 Swot: Wuxi Biologics

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • 3P Biopharmaceuticals
  • Biomeostasis
  • Cytovance biologics
  • JHL biotech
  • Noble Life Sciences
  • SMC Laboratories, Inc.
  • MORE

Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids made from natural sources such as human, animal or micro organisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies and gene therapies.

Like small molecule drugs, these drugs are intended for treatment of diseases and medical conditions.

However, Biologics bring into picture higher specificity in treating a disease condition as the biologic entities like monoclonal antibodies and recombinant proteins target specific areas in their molecular mechanism of disease action.

Although biologics are much costlier than small molecule drugs, this classe of drugs prove to be highly beneficial for the patients and also bring about 40% higher profits to the manufacturers when compared to small molecule drug treatments. Due to the increasing demand for biologics drugs and increased regulatory approvals for these drugs, there is huge demand for biologics manufacturing and testing at various levels of clinical studies as well as commercial supply.

The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing this piece of work to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). These organizations bridge the gap between demand and supply and ensure the drug discovery process gets much faster and convenient thus bringing life saving drugs to the market to reach the needy patients.

In 2017, seven out of 10 blockbuster drugs were biologics outnumbering small molecule drugs. Some of the top selling biologics in 2017 includes Humira ($18.4 billion), Rituxan ($9.2 billion), Enbrel ($7.9 billion), and Herceptin ($7.4 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologics development starting preclinical stage to commercial manufacturing.

The high complexity of biologics development and manufacture requiring huge technical expertise is prompting major biopharma companies turn to outsourcing as a viable option. Various stages of biological development require different types of services as listed below.

Discovery services- Includes lead identification and validation for identifying possible drug candidates targeting specific diseases. The process further involves steps such as target validation, screening preparation, hit generation and lead selection, lead optimization and characterization and finally lead selection.

Preclinical development services- Involves in-vitro and in-vivo studies of the biologic drug candidates before testing them on humans to test the safety, efficacy and biological functionality against the disease target. Preclinical services include cell line engineering, process development, product analytical characterization, cGMP cell banking, cell line characterization, animal model assay development and testing services.

Clinical development- Clinical development includes testing potential drug candidates on humans in phase I, II and II trials. Services at this stage include cGMP grade clinical supply of biologics such as MAb, or recombinant protein, stability testing, fill/finish and regulatory support. 

Commercialization- Once the drug has passed all the necessary approvals, the manufacture, marketing and sale of commercial quantities is performed. Outsourcing partners here manufacture the commercial supply for product launch and sale.

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  • 3P Biopharmaceuticals
  • Abbvie Contract Manufacturing
  • Abeomics
  • Abgenex
  • Abzena
  • Aginko Research
  • Ajinomoto Biopharma services
  • Altasciences
  • American Preclinical Services
  • Amplia PharmaTek Inc
  • ANS Biotech
  • Applied stem cell
  • Aragen Biosciences (GVK Bioscience)
  • Artimmune SAS
  • ATCC
  • Athena Discovery, Inc
  • ATUM
  • Avastus Preclinical services
  • Avid Bioservices
  • Batavia Biosciences
  • Berkeley Lights
  • Binex
  • Biogen
  • Biologics International Group
  • Biomedcode
  • Biomeostasis
  • Biomere
  • Biomodels LLC.
  • Bioqual
  • Biospective Inc.
  • Boehringer Ingelheim
  • Bolder BioPATH, Inc.
  • BTS Research
  • Burleson Research Technologies, Inc
  • C & M Biolabs
  • CARE Research, LLC
  • Catalent
  • Celltrion
  • Celonic
  • Cevec Pharmaceuticals GmbH
  • Charles River Laboratories
  • Clintox Bioservices
  • CMC
  • Cobra Biologics
  • Creative Animodel
  • Crown Bioscience
  • Cytovance biologics
  • Eirgenix
  • Envigo
  • Eurofins (Advinus)
  • Evotec
  • Exonbio
  • Explora BioLabs
  • Fujifilm Diosynth Biotechnologies
  • Fusion antibodies
  • Genecopoeia
  • Glycotope
  • Goodwin Biotechnology
  • GVK Biosciences (Aragen Biosciences)
  • Hera BioLabs
  • Horizon Discovery
  • IBT Bioservices
  • Inno biologics
  • Intas pharmaceuticals
  • Intestinal Biotech Development
  • InTouch BioSolutions LLC
  • Invitek Inc.
  • ITR Laboratories Canada Inc.
  • Jackson Laboratory
  • JHL biotech
  • JSR Life Sciences (KBI biopharma, Selexis, Crown Biosciences)
  • Jubilant Biosys
  • KCI Biotech (SUZHOU), Inc.
  • Kemwell Biopharma
  • LabCorp (Covance Inc)
  • Lake Pharma
  • Lancaster
  • LFB Biomanufacturing
  • Lonza
  • Luina Bio
  • Mabplex
  • MD Biosciences Inc.
  • Melior Discovery Inc.
  • Menarini Biotech s.r.l
  • Merck KGaA
  • Merk KGaA
  • Miltenyi biotech GmbH
  • Molecular Devices
  • MuriGenics
  • NeuroSolutions Ltd
  • Noble Life Sciences
  • Oxford genetics
  • Paragon Bioservices
  • Pharma Models
  • Company
  • Pharmacelsus GmbH
  • PharmaLegacy laboratories
  • Pharmaseed
  • Proteogenix
  • Px Therapeutics
  • Radiant Research Services Pvt Ltd.
  • Renovo Neural, Inc.
  • Rentschler Biotechnologie
  • Samsung biologics
  • Sandoz GmbH
  • Scripps laboratories
  • SGI-DNA
  • Shanghai Medicilon
  • Sinclair BioResearch
  • Sinclair Research
  • SMC Laboratories, Inc.
  • SMC Laboratories, Inc.
  • SoBran
  • SRI International
  • Suven Life Sciences
  • SYNCROSOME
  • Syngene
  • Taconic Biosciences
  • TCG Lifesciences
  • Texcell
  • Therapure Biomanufacturing
  • Therapure Biopharma
  • Thermo Fisher (Patheon)
  • Thermo Fisher Scientific (Patheon N.V)
  • TNO
  • Toxindia Contractual research organisation
  • Toyobo GMP group
  • TransCure bioServices
  • TransGenic Inc.
  • TransGenic.Inc
  • Trenzyme
  • Tribiosciences
  • Trinity Bioactives Limited
  • UGA Biopharma
  • Vifor pharma Ltd
  • Waisman clinical biomanufacturing
  • William Harvey Research Limited
  • Woodland Biosciences
  • Wuxi AppTec
Note: Product cover images may vary from those shown
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