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Biologics Contract Manufacturing Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Service(s) Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Re

Publisher Roots Analysis
Published Sep 24, 2025
Length 799 Pages
SKU # ROAL20418502

Description

Biologics Contract Manufacturing Market: Overview

As per Roots Analysis, the global biologics contract manufacturing market is estimated to grow from USD 23.8 billion in the current year to USD 55.0 billion by 2035, at a CAGR of 8.8% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Service Offered
  • API Manufacturing
  • FDF Manufacturing
Type of Biologic Manufactured
  • Antibodies
  • Cell Therapies
  • Vaccines
  • Other Biologics
Type of Expression System Used
  • Mammalian
  • Microbial
  • Others
Scale of Operation
  • Preclinical / Clincal
  • Commercial
Company Size
  • Small
  • Mid-sized
  • Large and Very Large
Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Middle East and North Africa
  • Latin America
Biologics Contract Manufacturing Market: Growth and Trends

The biologics contract manufacturing sector has seen significant growth in recent years due to the several benefits offered by biological products, such as specificity, efficacy and safety. It is worth mentioning that the biopharmaceutical industry has witnessed a shift from small-molecule drugs to complex biologics like monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars. In fact, the USFDA approved over 50 biological products (including monoclonal antibodies and recombinant proteins) in 2024. This growing pipeline of new therapies, coupled with the increasing number of biologics approvals, drives the demand for external manufacturing capacity.

Despite the success of biopharmaceutical products, producing biologics is technically challenging and requires significant capital investment in specialized facilities, equipment, and expertise, such as long development timelines, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers for comprehensive solutions, encompassing bioprocess development and optimization. With outsourcing becoming increasingly recognized as a practical and advantageous business model in this sector, substantial market growth for biologics contract manufacturing is expected throughout the forecast period.

Biologics Contract Manufacturing Market: Key Insights

The report delves into the current state of the biologics contract manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
  • Currently, more than 305 contract manufacturing organizations (CMOs) are engaged in the production of biologics; over 90% of such players provide FDF manufacturing services.
  • Around 70% of the stakeholders operate at all scales of operation to cater to the diverse needs of customers; notably, mammalian cell-based expression systems have emerged as a popular choice among CMOs.
  • The competition among service providers that claim to be focused on the niche and upcoming drug classes is fierce; it is primarily influenced by the success of several blockbuster therapies in the recent past.
  • In the past decade, a shift in trend has been observed in the biopharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.
  • Over the last five years, more than 695 deals have been inked by biologics CMOs; most of the collaborations were inked for the manufacturing of vaccines, antibodies and cell therapies.
  • In order to maintain a competitive edge and establish themselves as one-stop-shops, players are expanding their existing capabilities and service portfolios; the domain has witnessed over 135 mergers and acquisitions.
  • Considering the enormous opportunities associated with biologics contract manufacturing, investors have actively extended funds, amounting to USD 7.5 billion, across more than 90 funding instances in the past eight years.
  • Driven by the growing demand, CMOs have made elaborate investments to expand their existing capacities and capabilities, primarily for niche biologics; this trend is most pronounced in the US and China.
  • More than 215 initiatives were undertaken by big pharma players; more than 80% of such initiatives were focused on partnerships and expansions.
  • Though the existing installed capacity is sufficient to meet the current annual demand for biologics, we anticipate that CMOs are likely to invest in installing incremental capacity to meet the long-term demand.
  • The global installed biopharmaceutical contract manufacturing capacity is spread across various geographies; notably, large players account for 80% of the total capacity.
  • With the growing pipeline of biologics and the increased preference for outsourcing, the biopharmaceutical contract manufacturing services market is anticipated to witness steady growth in the foreseen future.
  • As more developers outsource various aspects of their respective manufacturing operations, we expect the biologics CMOs market to grow at an annualized rate of 8.8% in the coming decade.
Biologics Contract Manufacturing Market: Key Segments

Contract Manufacturing Market for API is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of service(s) offered, the market is segmented into API and FDF. It is worth highlighting that majority of the current biologics contract manufacturing market is captured by APIs. This can be attributed to the fact that manufacturing of biopharmaceuticals API demand significant capital investments, which include facility costs (development and maintenance), material costs, labor costs and a number of other ancillary expenses. Therefore, stakeholders rely on the expertise of CMOs for API production.

Cell Therapies is the Fastest Growing Segment of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, vaccines and other biologics. It is worth highlighting the antibodies capture the maximum share within the biopharmaceutical contract manufacturing market. This can be attributed to the fact that more than 100 antibodies have been approved across the globe and an increasing number of clinical trials related to antibodies are also underway.

Mammalian Expression System is Expected to Capture the Highest Share of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of expression system used, the market is segmented into mammalian, microbial and others. It is worth highlighting that currently, the market is likely to be driven by revenues generated through biopharmaceutical projects employing mammalian expression systems. This can be attributed to the higher usage of such systems owing to their high protein yielding ability, enhanced folding and post-translational modifications, and improved batch-to-batch uniformity.

By Scale of Operation, Commercial Scale is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. The commercial scale manufacturing segment is projected to be the primary driver of the overall market. Further, it is worth highlighting that the biologics manufacturing market at preclinical / clinical scale is likely to grow at a relatively higher CAGR.

Large and Very Large Companies Hold Maximum Share within the Biologics Manufacturing Market

Based on company size, the market is segmented into small companies, mid-sized, and large and very large companies. While large and very large companies account for a relatively higher market share, it is worth highlighting that the biologics contract manufacturing market for small companies is likely to witness substantial market growth in the coming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. It is worth highlighting that over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Biologics Contract Manufacturing Market
  • AGC Biologics
  • Boehringer Ingelheim
  • Catalent
  • Cell Therapies
  • Charles River Laboratories
  • FUJIFILM Diosynth Biotechnologies
  • KBI Biopharma
  • Kemwell Biopharma
  • Lonza
  • Miltenyi Biotec
  • Minaris Regenerative Medicine
  • Samsung Biologics
  • Sandoz
  • Vetter Pharma
  • Wuxi Biologics
Primary Research Overview
  • The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:
  • Chief Executive Officer, Company A
  • Chief Executive Officer and Co-Founder, Company B
  • Chief Technical Officer, Cell and Gene Therapy, Company C
  • President, Company D
  • Senior Director, Global Strategic Marketing, Company E
  • Senior Director of Commercial Strategy and Market Insights, Company F
  • Global Head of Sales and Marketing and Head of Business Development (Germany), Company G
  • Business Development Manager, Company H
  • Manager Marketing and Sales, Company I
Biologics Contract Manufacturing Market: Research Coverage
  • Market Sizing and Opportunity Analysis: The report features a thorough analysis of the global biologics contract manufacturing market, in terms of the key market segments, including [A] type of service(s) offered, [B] type of biologic manufactured, [C] type of expression system used, [D] scale of operation, [E] company size and [F] key geographical regions.
  • Market Landscape: An in-depth assessment of the companies involved in biologics contract manufacturing market, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of service offered, [E] type of biologic manufactured, [F] scale of operation, [G] type of expression systems used, [H] type of bioreactor used and [I] mode of operation of bioreactor.
  • Regional Capability Analysis: A comprehensive analysis of biopharmaceutical manufacturing facilities established across the key geographical regions, such as [A] North America [B] Europe [C] Asia-Pacific, and [D] rest of the world.
  • Company Profiles: Detailed profiles of key service providers across North America, Europe and Asia-Pacific engaged in the biologics contract manufacturing market, focused on parameters such as [A] company overview, [B] financial information (if available), [C] service portfolio, [D] manufacturing facilities and [E] recent developments and an informed future outlook.
  • Case Study - Niche Pharmaceutical Sectors: A comprehensive evaluation of the primary enablers within this industry, highlighting specific niche products such as [A] antibody-drug conjugates (ADCs), [B] bispecific antibodies, [C] cell therapies, [D] gene therapies, and [E] viral vectors.
  • Case Study – In-house Manufacturing: A detailed review of various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a biologics CMO.
  • Make Versus Buy Framework: An elaborate study of the various biopharmaceutical-focused manufacturing initiatives undertaken by top big pharma players, highlighting trends across various parameters, such as [A] number of initiatives, [B] year of initiative, [C] purpose of initiative, [D] type of initiative, [E] scale of operation and [F] type of biologic manufactured.
  • Partnerships and Collaborations: An in-depth analysis of the recent collaborations within the biologics contract manufacturing market, based on several relevant parameters, such as [A] year of partnership, [B] type of partnership, [C] type of biologic manufactured, [D] therapeutic area, [E] most active players and [F] regional distribution of partnership activity that have taken place in this industry.
  • Mergers and Acquisitions: A detailed analysis of the various mergers and acquisitions that have taken place within this industry, based on several relevant parameters, [A] such as year of agreement, [B] type of deal, [C] geographical location of companies, [D] type of acquisition, [E] type of biologic manufactured and [F] key value drivers.
  • Recent Expansions: A detailed analysis of expansion initiatives undertaken by biologics CMO, during the period along with information on several relevant parameters, such as [A] year of expansion, [B] purpose of expansion, [C] type of biologic manufactured and [D] location of expanded facility.
  • Recent Developments: An analysis of the recent developments within the biologics contract manufacturing market, highlighting information on the [A] funding investments made and [B] information on the technology advancements related to biomanufacturing.
  • Capacity Analysis: An estimate of the overall installed capacity for the manufacturing of biopharmaceuticals, highlighting the distribution of the available capacity, based on [A] size of manufacturer, [B]type of expression system used and [C] geography.
  • Demand Analysis: An informed estimate of the annual demand for biologics, based on various relevant parameters, such as [A] target patient population, [B] dosing frequency and [C] dose strength.
  • Total Cost of Ownership: A detailed analysis of the total cost of ownership for biologics CMO.
  • SWOT Analysis: A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT analysis, which are likely to impact the industry’s evolution.
  • Case Study – Virtual Pharmaceutical Companies: A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry.
Key Questions Answered in this Report
  • How many companies are currently engaged in this market?
  • Which are the leading companies in this market?
  • What factors are likely to influence the evolution of this market?
  • What is the current and future market size?
  • What is the CAGR of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?
Reasons to Buy this Report
  • The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
  • Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
  • The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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Table of Contents

799 Pages
1. Preface
1.1. Biopharmaceutical Contract Manufacturing Market Overview
1.2. Key Market Insights
1.3. Scope Of The Report
1.4. Research Methodology
1.5. Key Questions Answered
1.6. Chapter Outlines
2. Research Methodology
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. Covid Impact / Related Factors
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation
3. Economic And Other Project Specific Considerations 
3.1. Chapter Overview
3.2. Market Dynamics
3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current And Forecasted Estimates
3.2.2. Currency Coverage
3.2.2.1. Overview Of Major Currencies Affecting The Market
3.2.2.2. Impact Of Currency Fluctuations On The Industry
3.2.3. Foreign Exchange Impact
3.2.3.1. Evaluation Of Foreign Exchange Rates And Their Impact On Market
3.2.3.2. Strategies For Mitigating Foreign Exchange Risk
3.2.4. Recession
3.2.4.1. Historical Analysis Of Past Recessions And Lessons Learnt
3.2.4.2. Assessment Of Current Economic Conditions And Potential Impact On The Market
3.2.5. Inflation
3.2.5.1. Measurement And Analysis Of Inflationary Pressures In The Economy
3.2.5.2. Potential Impact Of Inflation On The Market Evolution
4. Executive Summary
5. Introduction
5.1. Chapter Overview
5.2. Overview Of Biopharmaceuticals
5.3. Expression Systems For Biopharmaceuticals
5.3.1. Insect Expression Systems
5.3.2. Mammalian Expression Systems
5.3.3. Microbial Expression Systems
5.3.3.1. Bacterial Expression Systems
5.3.3.2. Fungal Expression Systems
5.3.3.3. Yeast Expression Systems
5.3.4. Plant Expression Systems
5.3.5. Mammalian Versus Microbial Expression Systems
5.4. Manufacturing Process Of Biopharmaceuticals
5.4.1. Upstream Processing
5.4.2. Fermentation
5.4.3. Downstream Processing
5.5. Overview Of Contract Manufacturing
5.6. Need For Outsourcing Biopharmaceutical Manufacturing Operations
5.6.1. Commonly Outsourced Manufacturing Operations For Biopharmaceuticals
5.6.2. Advantages Of Outsourcing Biopharmaceutical Manufacturing Operations
5.6.3. Risks And Challenges Associated With Outsourcing Biopharmaceutical Manufacturing Operations
5.7. Key Considerations While Selecting A Contract Manufacturing Partner
5.8. Future Perspectives
 
6. Market Landscape
6.1. Chapter Overview
6.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
6.2.1. Analysis By Year Of Establishment
6.2.2. Analysis By Company Size
6.2.3. Analysis By Location Of Headquarters
6.2.4. Analysis By Type Of Service Offered
6.2.5. Analysis By Type Of Biologic Manufactured
6.2.6. Analysis By Scale Of Operation
6.2.7. Analysis By Type Of Expression System Used
6.2.8. Analysis By Type Of Bioreactor Used
6.2.9. Analysis By Mode Of Operation Of Bioreactor
7. Regional Capability Analysis
7.1. Chapter Overview
7.2. Key Assumptions And Parameter
7.3. Overview Of Biopharmaceutical Contract Manufacturing Facilities
7.3.1. Analysis By Type Of Service Offered
7.3.2. Analysis By Scale Of Operation
7.4. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities In North America
7.5. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities In Europe
7.6. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities In Asia-pacific
7.7. Regional Capability Analysis: Biopharmaceutical Contract Manufacturing Facilities In Rest Of The World
8. Biopharmaceutical Contract Manufacturing In North America
8.1. Chapter Overview
8.2. Biopharmaceutical Contract Manufacturing In The Us: Regulatory Scenario
8.3. Leading Biopharmaceutical Cmos In North America
8.3.1. Agc Biologics
8.3.1.1. Company Overview
8.3.1.2. Service Portfolio
8.3.1.2.1. Process Development
8.3.1.2.2. Cgmp Manufacturing
8.3.1.2.3. Quality And Regulatory Services
8.3.1.2.4. Process Validation
8.3.1.3. Financial Information
8.3.1.4. Manufacturing Facilities
8.3.1.5. Recent Developments And Future Outlook
8.3.2. Catalent
8.3.2.1. Company Overview
8.3.2.2. Service Portfolio
8.3.2.2.1. Cell Line Development
8.3.2.2.2. Biomanufacturing
8.3.2.2.3. Adcs And Bioconjugates Manufacturing
8.3.2.2.4. Biosimilars Development And Manufacturing
8.3.2.2.5. Fill / Finish Solutions And Delivery Services
8.3.2.2.6. Analytical Services
8.3.2.3. Clinical Supply Services
8.3.2.4. Financial Information
8.3.2.5. Manufacturing Facilities
8.3.2.6. Recent Developments And Future Outlook
8.3.3. Fujifilm Diosynth Biotechnologies
8.3.3.1. Company Overview
8.3.3.2. Service Portfolio
8.3.3.2.1. Strain Development
8.3.3.2.2. Process Development
8.3.3.2.3. Cgmp Manufacturing
8.3.3.2.4. Analytical Solutions
8.3.3.3. Financial Information
8.3.3.4. Manufacturing Facilities
8.3.3.5. Recent Developments And Future Outlook
8.3.4. Kbi Biopharma
8.3.4.1. Company Overview
8.3.4.2. Service Portfolio
8.3.4.2.1. Process Development
8.3.4.2.2. Analytical Development
8.3.4.2.3. Gmp Manufacturing
8.3.4.2.4. Clinical Cell Therapy Support
8.3.4.3. Manufacturing Facilities
8.3.4.4. Recent Developments And Future Outlook
8.3.5. Charles River Laboratories
8.3.5.1. Company Overview
8.3.5.2. Service Portfolio
8.3.5.2.1. Cell Sourcing
8.3.5.2.2. Cell And Gene Therapy Solutions
8.3.5.2.3. Biologics Testing Solutions
8.3.5.2.4. Avian Vaccine Services
8.3.5.2.5. Qc Microbial Solutions
8.3.5.2.6. Scientific And Regulatory Advisory Services
8.3.5.3. Financial Information
8.3.5.4. Manufacturing Facilities
8.3.5.5. Recent Developments And Future Outlook
8.4. Other Leading Biopharmaceutical Cmos In North America
8.4.1. Cytiva
8.4.1.1. Company Overview
8.4.2. Patheon
8.4.2.1. Company Overview
8.4.3. Piramal Pharma Solutions
8.4.3.1. Company Overview
9. Biopharmaceutical Contract Manufacturing In Europe
9.1. Chapter Overview
9.2. Biopharmaceutical Contract Manufacturing In Europe: Regulatory Scenario
9.2.1. Ema’s Cgmp Regulations
9.3. Leading Biopharmaceutical Cmos In Europe
9.3.1. Boehringer Ingelheim (Bioxcellence)
9.3.1.1. Company Overview
9.3.1.2. Service Portfolio
9.3.1.2.1. Process Development
9.3.1.2.1.1. Expression Systems
9.3.1.2.1.2. Upstream Technology
9.3.1.2.1.3. Downstream Technology
9.3.1.2.1.4. Other Process Development Services
9.3.1.2.2. Quality Assurance
9.3.1.2.3. Fill / Finish Services
9.3.1.3. Financial Information
9.3.1.4. Manufacturing Facilities
9.3.1.5. Recent Developments And Future Outlook
9.3.2. Lonza
9.3.2.1. Company Overview
9.3.2.2. Service Portfolio
9.3.2.3. Manufacturing Services
9.3.2.4. Financial Information
9.3.2.5. Manufacturing Facilities
9.3.2.6. Recent Developments And Future Outlook
9.3.3. Sandoz
9.3.3.1. Company Overview
9.3.3.2. Service Portfolio
9.3.3.3. Financial Information
9.3.3.4. Manufacturing Facilities
9.3.3.5. Recent Developments And Future Outlook
9.3.4. Vetter Pharma
9.3.4.1. Company Overview
9.3.4.2. Service Portfolio
9.3.4.3. Manufacturing Facilities
9.3.4.4. Recent Developments And Future Outlook
9.3.5. Miltenyi Biotec
9.3.5.1. Company Overview
9.3.5.2. Service Portfolio
9.3.5.3. Manufacturing Facilities
9.3.5.4. Recent Developments And Future Outlook
9.4. Other Leading Biopharmaceutical Cmos In Europe
9.4.1. Novasep
9.4.1.1. Company Overview
9.4.2. Olon
9.4.2.1. Company Overview
9.4.3. Rentschler Biopharma
9.4.3.1. Company Overview
10. Biopharmaceutical Contract Manufacturing In Asia-pacific And Rest Of The World
10.1. Chapter Overview
10.2. Biopharmaceutical Contract Manufacturing In China
10.2.1. Biopharmaceutical Contract manufacturing In China: Regulatory Scenario
10.3. Leading Biopharmaceutical Cmos In China
10.3.1. Wuxi Biologics
10.3.1.1. Company Overview
10.3.1.2. Service Portfolio
10.3.1.2.1. Discovery Services
10.3.1.2.2. Development Services
10.3.1.2.3. Testing Services
10.3.1.2.4. Clinical Manufacturing Services
10.3.1.3. Financial Information
10.3.1.4. Manufacturing Facilities
10.3.1.5. Recent Developments And Future Outlook
10.4. Biopharmaceutical Contract Manufacturing In India
10.4.1. Biopharmaceutical Contract Manufacturing In India: Regulatory Scenario
10.5. Leading Biopharmaceutical Cmos In India
10.5.1. Kemwell Biopharma
10.5.1.1. Company Overview
10.5.1.2. Service Portfolio
10.5.1.2.1. Development Services For Biopharmaceuticals
10.5.1.2.2. Manufacturing Services For Biopharmaceuticals
10.5.1.3. Manufacturing Facilities
10.5.1.4. Recent Developments And Future Outlook
10.6. Biopharmaceutical Contract Manufacturing In Japan
10.6.1. Biopharmaceutical Contract Manufacturing In Japan: Regulatory Scenario
10.7. Leading Biopharmaceutical Cmos In Japan
10.7.1. Minaris Regenerative Medicine
10.7.1.1. Company Overview
10.7.1.2. Service Portfolio
10.7.1.2.1. Manufacturing Development Services
10.7.1.2.2. Gmp Manufacturing
10.7.1.3. Manufacturing Facilities
10.7.1.4. Recent Developments And Future Outlook
10.8. Biopharmaceutical Contract Manufacturing In South Korea
10.8.1. Biopharmaceutical Contract Manufacturing In South Korea: Regulatory Scenario
10.9. Leading Biopharmaceutical Cmos In South Korea
10.9.1. Samsung Biologics
10.9.1.1. Company Overview
10.9.1.2. Service Portfolio
10.9.1.2.1. Process Development
10.9.1.2.2. Analytical Services
10.9.1.2.3. Cgmp Manufacturing Services
10.9.1.2.4. Aseptic Fill / Finish Services
10.9.1.2.5. Quality Services
10.9.1.3. Financial Information
10.9.1.4. Manufacturing Facilities
10.9.1.5. Recent Developments And Future Outlook
10.10. Biopharmaceutical Contract Manufacturing In Australia
10.10.1. Biopharmaceutical Contract Manufacturing In Australia: Regulatory Scenario
10.11. Leading Biopharmaceutical Cmos In Australia
10.11.1. Cell Therapies
10.11.1.1. Company Overview
10.11.1.2. Service Portfolio
10.11.1.3. Manufacturing Facilities
10.11.1.4. Recent Developments And Future Outlook
10.12. Other Leading Biopharmaceutical Cmos In Asia-pacific And Rest Of The World
10.12.1. Acurabio (Formerly Known As Luina Bio)
10.12.1.1. Company Overview
10.12.2. Celltrion
10.12.2.1. Company Overview
10.12.3. Takara Bio
10.12.3.1. Company Overview
11. Niche Biopharmaceutical Sectors
11.1. Chapter Overview
11.2. Bispecific Antibodies
11.2.1. Approved And Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
11.2.2. Bispecific Antibodies: Pipeline Analysis
11.2.2.1. Analysis By Phase Of Development
11.2.2.2. Analysis By Target Indication
11.2.3. Bispecific Antibody Therapeutics: Technology Platforms
11.2.4. Key Considerations For Manufacturing And Associated Challenges
11.2.5. Role Of Cmos In Offering Services For Bispecific Antibodies
11.2.5.1. Cmos Offering Services For Bispecific Antibodies
11.3. Antibody Drug Conjugates (Adcs)
11.3.1. Components Of Adcs
11.3.1.1. Antibody
11.3.1.2. Cytotoxin
11.3.1.3. Linker
11.3.2. Antibody Drug Conjugates (Adcs): Pipeline Analysis
11.3.2.1. Analysis By Status Of Development
11.3.2.2. Analysis By Target Disease Indication
11.3.2.3. Most Active Players: Analysis By Number Of Therapies
11.3.3. Antibody Drug Conjugate Developers
11.3.4. Manufacturing Process
11.4. Cell Therapies
11.4.1. Cell Therapies: Overall Market Landscape
11.4.2. Overview Of Cell Therapy Manufacturing
11.4.2.1. Cell Therapy Manufacturing Models
11.4.2.1.1. Centralized Manufacturing
11.4.2.1.2. Decentralized Manufacturing
11.4.3. Key Challenges For Manufacturing Cell Therapies
11.4.4. Key Factors Impacting Cell Therapy Manufacturing
11.4.4.1. Characterization
11.4.4.2. Cost Of Goods
11.4.4.3. Automation Of Cell Therapy Manufacturing
11.4.5. Cell Therapies: Pipeline Analysis
11.4.5.1. Analysis By Type Of Cell Manufactured
11.4.6. Stem Cell Therapies: Analysis By Phase Of Development
11.4.7. T-cell Therapies: Analysis By Phase Of Development
11.4.8. Role Of Cmos In Offering Services For Cell Therapies
11.4.8.1. Cmos Offering Services For Cell Therapies
11.5. Gene Therapies 
11.5.1. Gene Therapies: Pipeline Analysis
11.5.1.1. Analysis By Stage Of Development
11.5.1.2. Analysis By Phase Of Development
11.5.1.3. Analysis By Type Of Vector Used
11.5.1.3.1. Clinical Pipeline
11.5.1.3.2. Preclinical Pipeline
11.5.1.4. Analysis By Therapeutic Area
11.5.1.4.1. Clinical And Commercial Pipeline
11.5.1.4.2. Preclinical Pipeline
11.5.2. Role Of Cmos In Offering Services For Gene Therapies
11.5.2.1. Cmos Offering Services For Gene Therapies
11.6. Viral Vectors 
11.6.1. Viral Vectors: Pipeline Analysis
11.6.1.1. Analysis By Location Of Viral Vectors Manufacturing Facilities
11.6.1.2. Analysis By Type Of Viral Vector Manufactured
11.6.2. Role Of Cmos In Offering Services For Viral Vectors
11.6.2.1. Cmos Offering Services For Viral Vectors
11.7. Plasmid Dna
11.7.1. Plasmid Dna: Pipeline Analysis
11.7.1.1. Analysis By Location Of Manufacturing Facilities
11.7.2. Role Of Cmos In Offering Services For Plasmid Dna
11.7.2.1. Cmos Offering Services For Plasmid Dna
12. Case Study: Outsourcing Of Biosimilars
12.1. Chapter Overview
12.2. Overview Of Biosimilars
12.3. Development Stages Of Biosimilars
12.4. Regulatory Requirements For Licensing Of Biosimilars
12.5. Need For Outsourcing Manufacturing Operations
12.6. Impact Of Biosimilars On The Global Contract Manufacturing Market
12.6.1. Biosimilars: Historical Trend Of Fda Approvals
12.7. Biosimilars Contract Manufacturing Service Providers
12.8. Challenges Associated With Outsourcing Of Biosimilar Manufacturing Operations
13. Case Study: Comparison Of Small And Large Molecule Drugs / Therapies
13.1. Chapter Overview
13.2. Small Molecule And Large Molecule Drugs / Therapies
13.2.1. Comparison Of General Characteristics
13.2.2. Comparison Of Key Specifications
13.2.3. Comparison Of Manufacturing Process
13.2.4. Comparison Of Key Manufacturing Challenges
14. Case Study: In-house Manufacturing
14.1. Chapter Overview
14.2. In-house Manufacturing
14.2.1. Benefits Associated With In-house Manufacturing
14.2.2. Risks Associated With In-house Manufacturing
14.3. Outsourcing Trends In The Biopharmaceutical Industry
14.3.1. Types Of Outsourcing Partners
14.4. Manufacturing Approaches Used For Approved Biologics
14.5. Choosing The Right Strategy: In-house Manufacturing Versus Outsourcing
15. Make Versus Buy Decision Making Framework
15.1. Chapter Overview
15.2. Key Assumptions And Parameters
15.3. Biopharmaceutical Contract Manufacturers: Make Versus Buy Decision Making
15.3.1. Scenario 1
15.3.2. Scenario 2
15.3.3. Scenario 3
15.3.4. Scenario 4
15.4. Conclusion
16. Big Pharma Initiatives
16.1. Chapter Overview
16.2. Biopharmaceutical Related Initiatives By Big Pharmaceutical Players
16.2.1. Analysis By Number Of Initiatives
16.2.2. Analysis By Year Of Initiative
16.2.3. Analysis By Purpose Of Initiative
16.2.4. Analysis By Type Of Initiative
16.2.4.1. Analysis By Type Of Partnership
16.2.4.2. Analysis By Type Of Expansion
16.2.5. Analysis By Scale Of Operation
16.2.6. Analysis By Type Of Biologic Manufactured
16.2.7. Analysis Of Big Pharma Players By Year Of Initiative
16.2.8. Analysis Of Big Pharma Players By Purpose Of Initiative
16.2.9. Analysis By Year And Type Of Initiative
16.2.10. Analysis Of Big Pharma Players By Region Of Expansion
16.2.11. Analysis Of Big Pharma Players By Type Of Biologic Manufactured
17. Partnerships And Collaborations
17.1. Chapter Overview
17.2. Partnership Models
17.3. Biopharmaceutical Contract Manufacturing: Partnerships And Collaborations
17.3.1. Analysis By Year Of Partnership
17.3.2. Analysis By Type Of Partnership
17.3.3. Analysis By Year And Type Of Partnership
17.3.4. Analysis By Type Of Biologic Manufactured
17.3.5. Analysis By Year Of Partnership And Type Of Biologic Manufactured
17.3.6. Analysis By Type Of Partnership And Type Of Biologic Manufactured
17.3.7. Analysis By Scale Of Operation
17.3.8. Analysis By Therapeutic Area
17.3.9. Most Active Players: Analysis By Number Of Partnerships
17.3.10. Analysis By Geography
17.3.10.1. Local And International Agreements
17.3.10.2. Intracontinental And Intercontinental Agreements
18. Mergers And Acquisitions
18.1. Chapter Overview 
18.2. Merger And Acquisition Models
18.3. Biopharmaceutical Contract Manufacturing: Mergers And Acquisitions
18.3.1. Cumulative Year-wise Trend Of Mergers And Acquisitions
18.3.2. Analysis By Type Of Acquisition
18.3.3. Analysis By Geography
18.3.3.1. Local And International Mergers And Acquisitions
18.3.3.2. Intracontinental And Intercontinental Mergers And Acquisitions
18.3.3.3. Year-wise Trend In North America, Europe And Asia-pacific
18.3.4. Most Active Acquirers: Analysis By Number Of Acquisitions
18.3.5. Analysis By Key Value Drivers
18.3.6. Analysis By Year Of Acquisition And Key Value Drivers
18.3.7. Analysis By Type Of Biologic Manufactured
18.3.8. Analysis By Key Value Drivers And Type Of Biologic Manufactured
18.4. Key Acquisitions: Deal Multiples
18.4.1. Year-wise Trend Of Deal Multiple Amount
19. Recent Expansions
19.1. Chapter Overview
19.2. Biopharmaceutical Contract Manufacturing: Recent Expansions
19.2.1. Analysis By Year Of Expansion
19.2.2. Analysis By Purpose Of Expansion
19.2.3. Analysis By Year And Purpose Of Expansion
19.2.4. Analysis By Type Of Biologic Manufactured
19.2.5. Analysis By Purpose Of Expansion And Type Of Biologic Manufactured
19.2.6. Analysis By Location Of Expanded Facility
19.2.7. Most Active Players: Analysis By Number Of Recent Expansions
19.2.8. Analysis By Purpose Of Expansion And Location Of Expanded Facility
19.2.9. Analysis By Amount Invested
19.2.10. Recent Expansions: Scenarios
20. Recent Developments
20.1. Chapter Overview
20.2. Types Of Funding
20.3. Biopharmaceutical Contract Manufacturing: Funding And Investment Analysis
20.3.1. Analysis By Year Of Funding
20.3.2. Analysis By Amount Invested
20.3.3. Analysis By Type Of Funding
20.3.4. Analysis By Year And Type Of Funding 
20.3.5. Analysis Of Funding Instances And Amount Invested By Geography (Continent)
20.3.6. Analysis Of Funding Instances And Amount Invested By Geography (Country)
20.3.7. Most Active Players: Analysis By Number Of Funding Instances
20.3.8. Most Active Players: Analysis By Total Amount Raised 
20.3.9. Leading Investors: Analysis By Number Of Funding Instances 
20.3.10. Leading Investors: Analysis By Total Amount Raised 
20.4. Technological Advancements
20.4.1. Single-use Technology
20.4.2. Process Analytical Technology (Pat)
20.4.3. Continuous Processing
20.4.4. Quality By Design (Qbd) In Bio-processing
20.4.5. Modular / Podular Biopharma Facilities
21. Capacity Analysis
21.1. Chapter Overview
21.2. Key Assumptions And Methodology
21.3. Biopharmaceutical Contract Manufacturing: Global Installed Capacity
21.3.1. Analysis By Company Size
21.3.2. Analysis By Type Of Expression System Used
21.3.3. Analysis By Geography
21.3.3.1. Analysis Of Biopharmaceutical Contract Manufacturing Capacity In North America
21.3.3.2. Analysis Of Biopharmaceutical Contract Manufacturing Capacity In Europe
21.3.3.3. Analysis Of Biopharmaceutical Contract Manufacturing Capacity In Asia-pacific
21.3.3.4. Analysis Of Biopharmaceutical Contract Manufacturing Capacity In Rest Of The World
21.4. Concluding Remarks
22. Demand Analysis
22.1. Chapter Overview
22.2. Key Assumptions And Methodology
22.3. Global Demand For Biopharmaceuticals
22.4. Global Demand For Emerging Novel Biologics
22.4.1. Global Demand For Adc Therapeutics
22.4.2. Global Demand For Cell Therapy Manufacturing
23. Total Cost Of Ownership For Biopharmaceutical Contract Manufacturing Organizations 
23.1. Chapter Overview 
23.2. Key Parameters 
23.3. Assumptions And Methodology 
23.4. Total Cost Of Ownership (Sample Dataset) 
23.5. Total Cost Of Ownership For Mid-sized Biopharmaceutical Contract Manufacturing Organizations, Y0-y20
23.5.1. Total Cost Of Ownership For Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis By Capex, Y0 
23.5.2. Total Cost Of Ownership For Mid-sized Biopharmaceutical Contract Manufacturing Organizations: Analysis By Opex, Y1-y20
23.6. Total Cost Of Ownership For Large / Very Large Biopharmaceutical Contract Manufacturing Organizations, Y0-y20
23.6.1. Total Cost Of Ownership For Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis By Capex, Y0 
23.6.2. Total Cost Of Ownership For Large / Very Large Biopharmaceutical Contract Manufacturing Organizations: Analysis By Opex, Y1-y20
24. Global Biopharmaceutical Contract Manufacturing Market
24.1. Chapter Overview
24.2. Assumptions And Methodology
24.3. Global Biopharmaceutical Contract Manufacturing Market, Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
24.3.1. Scenario Analysis
24.3.1.1. Conservative Scenario
24.3.1.2. Optimistic Scenario
24.4. Key Market Segmentations
25. Biopharmaceutical Contract Manufacturing Market, By Type Of Service Offered
25.1. Chapter Overview
25.2. Key Assumptions And Methodology
25.3. Biopharmaceutical Contract Manufacturing Market: distribution By Type Of Service Offered, 2018, Current Year And 2035
25.3.1. Api Manufacturing: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
25.3.2. Fdf Manufacturing: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
25.4. Data Triangulation And Validation
26. Biopharmaceutical Contract Manufacturing Market, By Type Of Biologic Manufactured
26.1. Chapter Overview
26.2. Key Assumptions And Methodology
26.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Type Of Biologic Manufactured, 2018, Current Year And 2035
26.3.1. Antibodies: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
26.3.2. Cell Therapies: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
26.3.3. Vaccines: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
26.3.4. Other Biologics: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
26.4. Data Triangulation And Validation
27. Biopharmaceutical Contract Manufacturing Market, By Type Of Expression System Used
27.1. Chapter Overview
27.2. Key Assumptions And Methodology
27.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Type Of Expression System Used, 2018, Current Year And 2035
27.3.1. Mammalian Expression Systems: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
27.3.2. Microbial Expression Systems: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
27.3.3. Other Expression Systems: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
27.4. Data Triangulation And Validation
28. Biopharmaceutical Contract Manufacturing Market, By Scale Of Operation
28.1. Chapter Overview
28.2. Key Assumptions And Methodology
28.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Scale Of Operation, 2018, Current Year And 2035
28.3.1. Preclinical / Clinical Operations: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
28.3.2. Commercial Operations: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
28.4. Data Triangulation And Validation
29. Biopharmaceutical Contract Manufacturing Market, By Company Size
29.1. Chapter Overview
29.2. Key Assumptions And Methodology
29.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Company Size, 2018, Current Year And 2035
29.3.1. Small Companies: Historical Trends (Since 2018) And forecasted Estimates (Till 2035)
29.3.2. Mid-sized Companies: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
29.3.3. Large And Very Large Companies: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
29.4. Data Triangulation And Validation
30. Biopharmaceutical Contract Manufacturing Market, By Geography
30.1. Chapter Overview
30.2. Key Assumptions And Methodology
30.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Geography, 2018, Current Year And 2035
30.3.1. North America: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.1.1. Us: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.1.2. Canada: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2. Europe: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.1. Italy: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.2. Germany: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.3. France: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.4. Spain: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.5. Uk: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.2.6. Rest Of Europe: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3. Asia-pacific: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3.1. China: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3.2. India: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3.3. South Korea: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3.4. Japan: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.3.5. Rest Of Asia-pacific: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.4. Latin America: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.3.5. Middle East And North Africa: Historical Trends (Since 2018) And Forecasted Estimates (Till 2035)
30.4. Data Triangulation And Validation
31. Biopharmaceutical Contract Manufacturing Market, By Leading Players
31.1. Chapter Overview
31.2. Key Assumptions And Methodology
31.3. Biopharmaceutical Contract Manufacturing Market: Distribution By Leading Players
31.4. Data Triangulation And Validation
32. Case Study: Virtual Pharmaceutical Companies
32.1. Chapter Overview
32.2. Historical Evolution Of The Virtual Business Model
32.3. Virtual Pharmaceutical Companies As A Subset Of The Overall Biopharmaceutical Industry
32.4. Advantages Associated With Outsourcing Operations To Virtual Service Providers
32.5. Key Challenges Associated With Outsourcing Operations To Virtual Service Providers
33. Swot Analysis 
33.1. Chapter Overview
33.2. Strengths
33.3. Weaknesses
33.4. Opportunities
33.5. Threats
33.6. Comparison Of Swot Factors
33.7. Conclusion
34. Future Of The Biopharmaceutical Cmo Market
34.1. Chapter Overview
34.2. Outsourcing Activities To Witness Significant Growth In The Coming Years
34.3. Shift From One-time Contracts To Strategic Partnerships
34.4. Integration / Adoption Of New And Innovative Technologies
34.4.1. Single-use Bioreactors
34.4.2. Novel Bioprocess Techniques
34.4.3. Bioprocess Automation
34.5. Focus On Niche Therapeutic Areas
34.6. Growing Biosimilars Market To Contribute To The Growth Of The Contract Services Segment
34.7. Capability Expansion By Cmos To Become One-stop-shops
34.8. Offshoring Outsourcing Activities To Maximize Profits And Expand Existing Capacities
34.9. Increase In Financial Inflow And Outsourcing Budgets
34.10. Challenges Faced By Sponsors And Service Providers
34.10.1. Concerns Related To Single-use Systems
34.10.2. Issues Related To Capacity Fluctuations
34.11. Concluding Remarks
35. Conclusion
36. Executive Insights
36.1. Chapter Overview
36.2. Company A
36.2.1. Company Snapshot
36.2.2. Interview Transcript: Chief Executive Officer
36.3. Company B
36.3.1. Company Snapshot
36.3.2. Interview Transcript: Chief Executive Officer And Co-founder
36.4. Company C
36.4.1. Company Snapshot
36.4.2. Interview Transcript: Chief Technical Officer, Cell And Gene Therapy
36.5. Company D
36.5.1. Company Snapshot
36.5.2. Interview Transcript: President And Chief Operating Officer
36.6. Company E
36.6.1. Company Snapshot
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