Biologics Outsourcing Market, 2028 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Biologics Outsourcing Global Market - Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

The biologics outsourcing global market is expected to grow at low teen CAGR to reach $87.5 billion by 2028

Biologics are the therapeutic entities composed of sugars, proteins, or nucleic acids and made from natural sources such as human, animal or microorganisms. Biologics also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (for transplantation), cell and gene therapeutics. Similar to the conventional therapeutics, these drugs help in treating several diseases but are highly specific and more efficient in their disease healing mechanisms. The biologic entities like monoclonal antibodies and recombinant proteins target specific areas during their molecular mechanism of disease curing.

In 2019, seven out of the 10 blockbuster drugs were biologics, outnumbering small molecule drugs. Some of the top-selling biologics in 2019 include Humira ($19.1 billion), Keytruda ($11.0 billion), Avastin ($7.28 billion) and Opdivo ($7.20 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologic development starting from the preclinical stage to commercial manufacturing.

The high complexity associated with development and manufacturing of biologics and requirement of specialized equipments and skills for biomanufacturing is prompting the biopharma companies to turn to outsourcing as a viable option. Thus the CMO's offering quality compliant, rapid bioproduction and supply services, scalable and flexible capacities with stable capabilities at competitive costs will become an integral part of the biopharmaceutical company.

The report specifically emphasizes on the rapidly evolving and high growth potential biologics contract manufacturing services market and cell line development services market. Biologics contract biomanufacturing services global market is expected to reach $57.1 billion by 2028 growing at a low teen CAGR from 2020 to 2028. The cell line development service global market is expected to reach $1,702.2 million by 2028 growing at a double digit CAGR from 2020 to 2028.

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.

Key Topics Covered:

1 Biologics Outsourcing Global Market

1.1 Introduction

1.2 Landscape of Biologics Market

1.3 Rise of Biosimilars

1.4 Biosimilars Global Market, by Region

1.5 Biologics Global Market

1.6 Top Destination for Biologics Outsourcing

1.6.1 China Biologics Outsourcing Market

1.6.2 India Biologics Outsourcing Market

1.6.3 China Vs India - Biologics Market

1.6.4 Regulations and Government Initiatives

1.6.5 Capabilities and Technologies

2 Market Analysis

2.1 Introduction

2.2 Factors Influencing Market

2.2.1 Drivers and Opportunities

2.2.1.1 Increasing Trend of Outsourcing

2.2.1.2 Advanced Bioprocessing Capabilities of Bioservice Providers

2.2.1.3 Emergence of Next Generation Biologics

2.2.1.4 Escalating Approvals and Uptake of Biosimilars

2.2.1.5 Increasing Approvals and Adoption of Biologics

2.2.1.6 Increasing R&D Expenditures

2.2.1.7 Increasing Prevalence of Chronic, Communicable and Autoimmune Diseases

2.2.1.8 Development of Personalized and Orphan Indication Therapies

2.2.2 Restraints and Threats

2.2.2.1 Increasing Focus on In-House Biologics Manufacturing

2.2.2.2 Huge Capital Investments for Capacity and Capability Development

2.2.2.3 Compliance With Stringent Regulatory Guidelines

2.2.2.4 Concerns About Ip Protection

1.2.2.5 Competition and Trend of Outsourcing of Low Volume Biologics

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

3.3.2 Recombinant Protein

3.3.3 Fusion Proteins

3.3.3.1 Hormones

3.3.3.2 Recombinant Enzymes

3.3.3.3 Others (Cytokines, Peptides)

3.3.4 Vaccines

3.3.5 Gene Therapy

3.3.6 Cell Therapy

3.4 Biologics Outsourcing Global Market, by Endusers

3.4.1 Therapeutics

3.4.2 Diagnostics

3.4.3 Research

3.5 Bioanalytical Testing Services

3.6 Market Share Analysis

3.7 Company Developments

3.8 Service Cost Analysis

3.8.1 Antibody Production Service Costs

3.8.2 Custom Monoclonal Antibody Production Service Costs

3.8.3 Custom Polyclonal Antibody Production Service Costs

3.8.4 Protein Production Service Costs

3.8.5 Additional Antibody and Protein Services

3.8.6 Gene Editting Services

3.8.7 Car-T/Nk Platform Services

4 Biologics Outsourcing Global Market - Biomanufacturing

4.1 Introduction

4.2 Market Dynamics

4.3 in House Vs Cmo Capacity

4.3.1 Global Biomanufacturing Capacity

4.3.2 Biologics Contract Manufacturing Organizations, by Phase

4.4 Contract Biomanufacturing, by Process

4.4.1 Biomanufacturing by Mammalian Cell Culture

4.4.2 Mammalian Cell Culture Biomanufacturing V/S Microbial and Other Cell Cultures

4.4.3 Biomanufacturing by Microbial Cell Culture

4.4.4 Biomanufacturing by Other Cell Culture

4.5 Contract Biomanufacturing Global Market, by End-users

4.5.1 Contract Biomanufacturing of Diagnostics

4.5.2 Contract Biomanufacturing of Research Reagents

4.5.3 Contract Biomanufacturing of Therapeutics

4.6 Biomanufacturing Outsourcing Global Market, by Region

4.7 Contract Biomanufacturing Capacity Penetration

4.8 Competitive Landscape

4.8.1 Capacity Comparison

4.8.2 Contract Manufacturing Global Market Share, by Leading Players

4.8.3 Company Developments

5 Biologics Outsourcing Global Market - Cell Line Development

5.1 Introduction

5.1.1 Market Dynamics

5.2 Cell Line Development

5.2.1 Cell Line Construction

5.2.2 Host Cell Line Engineering

5.2.3 Expression System

5.2.4 Transient Gene Expression

5.2.5 Stable Cell Line Development

5.2.6 Screening

5.2.7 Upstream Process Development

5.3 Host Cell Lines

5.4 Cell Line Development Services Market, by Expression System

5.4.1 Microbial Expression Systems

5.4.2 Mammalian Expression System

5.4.3 Others (Insect and Plant Cell)

5.5 Cell Line Development Services, by Cell Type

5.5.1 Cho

5.5.2 Murine/Mouse Myeloma

5.5.3 Baby Hamster Kidney (Bhk) Cells

5.5.4 Hybridoma

5.5.5 Human Embryonic Kidney (Hek) Cells

5.5.6 Human Embryonic Retinal Cells (Per.C6)

5.5.7 Others (E.Coli, Yeast, Insect Cell, Ht-1080, Hela Cell Line, Cap, Hkb-11, Huh-7)

5.6 Cell Line Development Services, by Applications

5.6.1 Research

5.6.2 Bioproduction

5.6.3 Diagnostics

5.7 Cell Banking Services

5.8 Cell Line Characterization Services

5.9 Market Share Analysis

5.10 Key Developments

5.10.1 Agreements

5.10.2 New Technology, Product and Service Launch

5.10.3 Expansion

5.10.4 Other Developments

6 Company Profiles

6.1 Abbvie Inc.

6.1.1 Overview

6.1.2 Financials

6.1.3 Service Portfolio

6.1.4 Key Developments

6.1.5 SWOT Analysis

6.2 Abzena plc

6.3 AGC Inc.

6.4 Albany Molecular Research, Inc.

6.5 Boehringer Ingelheim International GmbH

6.6 Catalent Inc.

6.7 Charles River Laboratories

6.8 Cognate Bioservices Inc. (Cobra Biologics)

6.9 Envigo

6.10 Eurofins Scientific S.E.

6.11 Fujifilm Holdings Corporation (Fujifilm Diosynth Biotechnologies)

6.12 Genscript Biotech Corporation

6.13 Intertek Group plc

6.14 Iqvia Holdings Inc.

6.15 JSR Corporation

6.16 Laboratory Corp of America Holdings

6.17 Lonza Group Ltd.

6.18 Merck Kga

6.19 Rentschler Biopharma Se

6.20 Samsung Biologics Co. Ltd.

6.21 Sartorius Group

6.22 SGS Sa

6.23 Syngene International Ltd.

6.24 Thermo Fisher Scientific Inc.

6.25 Wuxi Apptec Co. Ltd.

6.26 Wuxi Biologics (Cayman) Inc.

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