Dublin, Jan. 11, 2019 (GLOBE NEWSWIRE) -- The "Biologics Outsourcing Global Market" report has been added to ResearchAndMarkets.com's offering.
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.
Key Topics Covered:
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
- Abzena Plc
- Adimab Llc.
- Albany Molecular Research, Inc
- Beijing Vital Star Biotechnology Co. Ltd.
- Boehringer Ingelheim
- Catalent Inc.
- Charles River Laboratories
- Crown Biosciences (JSR)
- Genoway
- Genscript Biotech Corporation
- GL Biochem
- Horizon Discovery Group, Plc
- Jackson Laboratory
- Samsung Biologics
- JHL Biotech Inc.
- Joinn Laboratories Co. Ltd
- Lonza Group
- Merck KGaA
- Patheon N.V. (Thermofisher Scientific)
- Pharmalegacy Laboratories
- Pharmaron
- Prosci Inc.
- Proteogenix
- Psychogenics, Inc
- JSR Life Sciences (Selexis SA)
- Shanghai Medicilon
- Shangpharma Corporation /Shanghai Chempartner
- Sino Biological
- Sundia Meditech Co., Ltd.
- Syngene International
- Taconic Biosciences
- Viva Biotech Ltd.
- Wuxi Biologics (Wuxi Apptec)
Companies Mentioned
- 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
For more information about this report visit https://www.researchandmarkets.com/research/2d8jbq/global_biologics?w=12
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.