3D Cell Cultures: Technologies and Global Markets

Report Scope:

The scope of the report encompasses the major types of 3D cell culture that are being used by industry, academic researchers, government labs, and independent research groups. This includes the main inputs such as cell lines, media, sera, reagents, software, and instrumentation. It analyzes the current market status, examines future market drivers, and presents forecasts of growth over the next five years. The previous edition had a separate section on patent analysis. Here patents have been included by type of technology instead.

The market structure has been re-organized for this edition. Also, more research was done on base case data for different product areas. The greater emphasis is on the different products used for 3D cell culture, but the report also investigates the market in terms of types of applications, end users and geographic regions.

Report Includes:

- 79 tables
- An overview of the global markets and technologies for 3D cell cultures
- Estimation of the market size and analyses of global market trends with estimated data from 2020 to 2024, and projections of compound annual growth rates (CAGRs) through 2025
- Information on analytical systems used in tissue and cell culture, cellomics and human cancer model initiative (HCMI)
- Details about assay development for mesenchymal stem cells, In Vitro testing of adventitious agents and description of assays and assay kits
- A look at the main classes of models for researching cancer and other diseases, benefits of 3D models to cancer research and description of 3D engineered scaffolds
- Analysis of the markets dynamics, specifically growth drivers, restraints, and opportunities and discussion on the impact of COVID-19 on the world of cell culture
- Insights into U.S. regulatory status of bioprinted products; basic guidance for the regulation of biologics, regenerative medicine and xenotransplants
- Relevant patent analysis, including recent activity and a list of key patents
- Market share analysis of the major players in the industry and their comprehensive company profiles including Agilent Technologies, BioVision Inc., Cell Applications Inc., Envisiontec Inc., Mitra Biotech Inc., Promega Corp. and Thermo Fisher Scientific

Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing the Study
Scope of Report
Intended Audience
Methodology and Information Sources
Analysts Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary
New Applications Identified Since 2015 Report
Changes from 2015 Report
Changes from 2017 Report
New Applications Since 2017
Changes Since 2017
Chapter 3 Highlights and Issues
An Opening Comment on an Amazing Industry
Industry Issues
In Vitro versus In Vivo
The Research Chain for 2D and 3D Cell Culture
Best Practices
Genomics Forcing the Hand of the FDA
Leachables and Extractables
Broad Issues
Research Talent Shortages
The Shifting International Picture
Pace and Diversification of Innovation
A Comment on the "Other" Areas of Cell Culture
Omics Everywhere
Is 2020 a Watershed Year for the Cell Culture Industry?
Preliminary Market Analysis
Cell Culture Market Growth Rate Estimates
Assessing Large-Scale Media Consumption Needs
Modeling Future Growth in Biopharmaceuticals
Base Case for the Cell Culture Market
Challenges in Projecting Sales and Growth
Cell Culture Media Market Estimates
Cell and Gene Therapy Bioprocessing Segment
Evaluating Media Consumption for Biosimilars
What About CDMOs?
Internal Cell Culture Resources
Drug Development Costs: What to Believe?
Is There Too Much Concentration of Ownership in Biotechnology?
Characterizing Innovation in 3D Cell Culture
Bioprinting Strategic Roadmap
Impact of COVID-19 on the World of Cell Culture
Clinical Trials on COVID-19
Chapter 4 Tissue and Cell Culture: Technology and Product Background
Where did Tissue and Cell Culture Start?
History and Early Applications
Invention of Tissue Culture
Development of Sustained Cell Lines
First Cell Culture Flask and Rigorous Techniques
Lindbergh: The Cell Culture Equipment Pioneer
Establishing Continuous Cell Lines
Key Developments in Equipment
Terminology and Concepts
Tissue and Cell Culture Industry
Cell Types
Tissue Culture and Cell Culture Definitions
Cell Lines
Care and Growth of Cell Culture Systems
Media, Sera and Reagents
Gels and Scaffolds
Microplates/Microtiter Plates
Bioanalytical Instruments
Bioanalytical Imaging
Other Equipment for Cell Culture
Adherent Approaches
Traditional Roller Bottles
Other Systems
Information Technology: Software and Services for the Cell Culture Research Market
Software for the Research Market in Cell Culture
Software-Related Support Services
Bioprocessing Consumables for Cell Culture
Microcarriers for Large-Scale 3D Culture
Sera for Large-Scale 3D Culture
Media for Large-Scale 3D Culture
Bioreactor Bags for Large-Scale 3D Culture
Bioprocessing Equipment
Analytical Equipment for Bioprocessing
Automation Systems for Bioprocessing
Support Equipment for Bioprocessing
Aspects of Large-Scale Manufacturing of Biopharmaceuticals and Vaccines
Suspension Proteins and Monoclonal Antibodies
Adherent-Cell-Based Therapies and Vaccines
Small-Scale Adherent to Make Somatic Cells, Stem Cells and Tissues
Vaccine Development as a Catalyst
Vaccines Developed Using Human Cell Strains
Exosome Manufacturing
Viral Vector Manufacturing
Lentivirus Manufacturing
Plasmid Manufacturing
Cell Culture End Users
Cell Culture Applications
Drug Discovery
Clinical Development
Basic Research
Bioprocessing Development
Regional Markets
The Americas
Rest of the World
Chapter 5 Assays, Imaging and Analysis
Assay Development for Mesenchymal Stem Cells
In Vitro Testing of Adventitious Agents
Assays and Assay Kits
Cell-Based Assays: Overview and Newer Developments
Cells Used in Cell-Based Assays
Notes on 3D Cell-Based Assays
Kinetic Metabolism Assays
Cell Proliferation
Viability and Cytotoxicity
Permeability Assays for Cell Viability and Survival
Cell Invasion
Cell Signaling and Communication
Cell Death Assays
Imaging Technology
Imaging Assays
Fluorescence as a Driver of Screening
Analytical Systems Used in Tissue and Cell Culture
Understanding "Cellomics"
HCS Support of 3D Cell Culture
NGS Discovery Pools
Multiplex Assays
Predictive Toxicology
Neuro Safety
The Omics Invasion
Chapter 6 Regulation and Standardization
U.S. Regulatory Status of Bioprinted Products
Basic Guidance for the Regulation of Biologics
Guidance for Regenerative Medicine
Guidance for Xenotransplants
Guidance for Regenerative Medicine: Emergency Approval
Regulating Bioprinted Products
Chapter 7 3D Models for Cancer
Disease Modeling
Main Classes of Models for Researching Cancer and Other Diseases
Cell Lines
Spheroids and Organoids
Genetically Engineered Mouse Model (GEMM)
Patient-Derived Tumor Xenografts (PDXs)
Overview: Cancer at the Cellular Level
In Vivo (Animal) Testing Standard
Empire of the Mouse
Humanized Mice
2D Culture
3D Requirements
Cell Number and Viability
Migration and Invasion
Unmet Needs: Angiogenesis and Immune System Evasion
Benefits of 3D Models to Cancer Research
Greater Distinction in Cell Morphology and Proliferation
Greater Gene Expression and Cell Behavior
Better Models of Cell Migration and Invasion
Cell Heterogeneity
Breast Cancer as a Driver of 3D Cultures
Structure, Polarity and Apoptosis
Melanoma as a Driver of 3D Cultures
Moving to Spheroid Configurations
3D Systems in Cancer Research
Multicellular Tumor Spheroids
Multilayered Cell Cultures
3D Engineered Scaffolds
Natural Materials
Synthetic Materials
Human Cancer Model Initiative (HCMI)
Next-Generation Human Cancer Models
Drug Sensitivity and Resistance
Altered Signaling and Sensitivity
Drug Resistance
Cellular Signaling
Cellular Signaling Mediated by Integrins
Drug Screening
Approaches and Endpoints
Spheroid Applications
Metastasis via 3D Cell Migration Model
Metastasis via Lung-on-Chip
Cancer Metabolism
Future Horizons
Cancer-Associated Fibroblasts
Cancer Stem Cells
Combination Therapies
Biologics Development
Tumor Recurrence
Patient-Derived Cells
Patient-Derived Tumor Xenografts (PDXs)
Evolution of PDX Platforms
Chapter 8 Landscape for Toxicology and Drug Safety Testing
Cardiovascular Toxicity
Toxicology Background
Testing for Adverse Effects on the Skin
New Assessment Methodologies Impact on 3D Cell Culture
Toxicology Testing in Cosmetics
Updated Regulatory Requirements
Efficacy of Cosmetics and Cosmeceuticals
Aspects of Cosmetic Toxicity Testing
Skin Irritation
Skin Corrosion
Skin Sensitization
Eye Irritation
Acute Systemic Toxicity
Acute Toxicity Testing
Cytotoxicity Assays for Acute Toxicity Testing
Chronic and Repeated Dose Toxicity
Carcinogenicity and Genotoxicity
In Vitro Methods: Background and Recent Developments
Regulatory versus Drug Development Applications
Efforts to Reduce False Positives
Recent Innovations in Screening
Future Challenge: Non-genotoxic Carcinogens
Reproductive and Developmental Toxicity
Following the Reproductive Cycle
Development and Reproductive Tox Testing Types
Zebrafish Model for Developmental Toxicity Screening
Combination of Zebrafish and Stem Cells
Biomedical Frontiers: Male Testis
Endocrine Disruptor Screening
Environmental Toxicology Impacts In Vitro Methods
High-Production Volume Chemicals
ToxCast and Tox 21 Initiatives
Future Challenge: Thyroid Disruption
BG1 Assay
Toxicokinetics and ADME
In Vitro Developments
Pharmacokinetics of Low Turnover Compounds
Organotypic Models
3D Models for Skin
3D Corneal System
Absorption Barrier Models
Blood-Brain Barrier
Real Architecture for 3D Tissue Barriers and Extracellular Matrix
Liver Toxicity
Uniqueness and Complexity of Liver
Liver as a Key Driver for 3D Innovation
In Vitro Liver Applications
In Vivo Liver Function and Structure
Liver Metabolism
In Vitro Liver Models
Cocultures of Hepatocytes and Macrophages
3D Liver Models
Bioprinted Liver Tissue
Detected Hepatosphere Structures and Functionality
Ideal Criteria
Drug Resistance
Transporter Studies
Achieving Heterotypic Cell-Cell Contacts
Unmet Needs and Future Drivers of Innovation
Morphogen Signaling
Multi-donor Liver Cells
Kidney Toxicity Applications
Future Challenge: Stem-Cell Derived Kidney Cells
Bioprinted Kidney Tissue
Pancreatic Toxicology Applications
Cardiovascular Toxicity
Commercial Avenue
Collaboration with Regulators
Cardiovascular Drug Discovery
Microelectrode Arrays (MEAs) Based on Impedance
Surrogate for Aortic Ring Assay via Bioprinted Magnetics
Vasodilator Activity
3D Engineered Heart Tissues
Chapter 9 Stem Cell Landscape
A History of Stem Cells
Major and Minor Research Areas for Stem Cells
3D Stem Cell Culture Systems
Plate or Culture Dish
Spinner Flask and Rotating Wall Vessel
Perfusion Bioreactor and Microcarrier Systems
Microfluidics and Stem Cells
Short Review of Stem Cell Biology
Growth, Structure and Morphology of Stem Cells
Stem Cell Differentiation
Stem Cell Differentiation versus Proliferation
Extracellular Matrix and Stem Cells
Soluble Factors
Manufacturing Stem Cells
Controlling Embryoid Body Formation
Forced Aggregation Cultures
Hanging-Drop Approach
Stem Cell Markers for High-Throughput Screening
Teratomas and the Teratoma Assay
Fujifilm (Cellular Dynamics Inc.)
Stem Cell Research Breakthroughs
Stem Cells for Neuroscience Discovery and Development
Example: Alzheimers Research
Background: B-Amyloid Cascade Hypothesis
Human iPSC-Derived Models
New 3D Model
Other Advantages of 3D
Envisioned Applications
Other 3D Neuro Applications
Stem Cells for Cardiovascular Discovery
Stem Cells for the Development of Regenerative Medicine
Background: Allogenic versus Autologous
Induced Pluripotent Stem Cells (IPS)
Chapter 10 Regenerative Medicine: Organ Transplants and Skin Substitutes
Regenerative Medicine
Need for Organ Transplants
Applications in Regenerative Medicine
Investments in Regenerative Medicine
Skin Substitutes Industry
Tissue Culture Allograft and Autograft Products
Tissue Engineering in Regenerative Medicine
Chapter 11 Company Profiles

List Of Tables

Summary Table : Global Market for Cell Culture, by Segment, Through 2025
Table 1 : Dimensionality of Cell Culture
Table 2 : WHO R&D Roadmap of Priority Infectious Diseases
Table 3 : 3D Bioprinting Roadmap
Table 4 : Selected Online Prices for Bioreactors
Table 5 : Current Clinical Trials on Remdesivir
Table 6 : Tissue Types
Table 7 : Cell Types Based on Developmental Origin
Table 8 : Leading Cell Line Suppliers, April 2020
Table 9 : Commonly Used Transformed Cells Lines
Table 10 : Major Primary Cell Lines
Table 11 : Leading Primary Cell Suppliers, April 2020
Table 12 : Main Types of Stem Cells
Table 13 : Stem Cell Services
Table 14 : Areas of Interest in 3D Spheroid Research
Table 15 : Global Market for Cell Culture Consumables in Research, Through 2025
Table 16 : Selected Nanoparticle Products Used in Life Science Research
Table 17 : Results of Liver-Chip Drugs Halted in Previous Clinical Trials Based on Animal Studies
Table 18 : Companies and Universities Involved in the Organ-on-a-Chip Industry
Table 19 : Global Market for Cell Culture Equipment, by Type, Through 2025
Table 20 : Microfluidics Companies
Table 21 : Selected Recent Patents Issued on Microfluidic Devices Related to Cell Culture Applications
Table 22 : Selected Papers Published on Recent Microfluidic Advances in Cell Culture
Table 23 : High-Content Screening Suppliers and Key Attributes, April 2020
Table 24 : Selected Patents Issued Related to Flow Cytometers
Table 25 : Thermo Fisher Imaging Products
Table 26 : Publicly Disclosed Funding of Bioprinting Companies, 2017-2020*
Table 27 : Bioprinting Company Deals and Strategic Partnerships, 2019 and 2020
Table 28 : Bioprinting Modalities
Table 29 : Maintaining Cell Viability During Printing
Table 30 : Bioprinting Instrument Industry
Table 31 : Biomaterial Components
Table 32 : Bioink Types
Table 33 : Classes of Matrix Bioink Hydrogels
Table 34 : Matrix Bioink Selection Criteria
Table 35 : Selected Bioink Companies, 2020
Table 36 : Projected Unit Sales of Research Bioreactors, <10 Liters, 2020
Table 37 : Leading Bioreactor Suppliers, 2020
Table 38 : Label-Free Technologies and Suppliers, April 2020
Table 39 : Global Market for Software and Services for Cell Culture Research, Through 2025
Table 40 : Global Market for Bioprocessing Consumables for Cell Culture, Through 2025
Table 41 : Global Market for Cell Culture Bioprocessing Equipment, by Type, Through 2025
Table 42 : Global Market for Software for Cell Culture in Bioprocessing, Through 2025
Table 43 : Developmental Issues Facing the Commercialization of Exosomes
Table 44 : Companies Working on Exosome Products
Table 45 : Global Market for Cell Culture, by End User, Through 2025
Table 46 : Global Market for Cell Culture, by Application, Through 2025
Table 47 : Global Market for Cell Culture, by Region, Through 2025
Table 48 : Typical Assay Endpoints and Tests
Table 49 : U.S. Patents on Assays Systems, 2019 and 2020
Table 50 : Selected U.S. Patents on Assay Imaging, 2019 and 2020
Table 51 : Recently Issued U.S. Patents on Cellomics, 2017-2019
Table 52 : Toxicology Issues That Need to Be Addressed for FDA-Regulated Products
Table 53 : Overview of Federal Regulation of the Cell Culture Markets
Table 54 : FDA List of Cell, Biologic and Tissue Products Regulated Under CBER and CDRH
Table 55 : FDA Talking Point Recommendations for Regenerative Medicine Advanced Therapies (RMATs)
Table 56 : U.S. Regulatory Considerations
Table 57 : Main Types of Models for Researching Cancer and Other Diseases
Table 58 : Goals of Funding Opportunity Announcement RFA-CA-19-055
Table 59 : Common 3D Assays
Table 60 : 3D Tumor Models Developed for Drug Discovery, June 2017
Table 61 : Summary of the Benefits and Advantages of EV3D
Table 62 : ECVAM List of Current Activities, 2020
Table 63 : In Vitro Testing in Cosmetics, by Test Class
Table 64 : In Vitro and In Vivo Assays in the Tier 1 Screening Battery, January 2014
Table 65 : Timeline of Key Developments in Stem Cell Research, 1978-2006
Table 66 : Major and Minor Research Areas in Stem Cells
Table 67 : Stem Cell Usage in Research
Table 68 : Recent U.S. Patents Granted on Stem Cell Technologies
Table 69 : Papers Published on Selected Stem Cell Research Trends
Table 70 : Comparison of the Number of Citations in the Literature on Cell Culture versus Stem Cell Culture
Table 71 : Number of Organ Transplants Performed in the United States, 2018 and 2019
Table 72 : Total Global Financing of Regenerative Medicine
Table 73 : Total Financing of Regenerative Medicine, by Therapeutic Area
Table 74 : Leading Tissue Products and Suppliers, April 2020
Table 75 : Printed Tissue and Organs: Commercialization Timeframe
Table 76 : Tissue/Organ Complexity
Table 77 : New Bioassay Kits Introduced by BioVision
Table 78 : Partial List of Specialty Media Formulations Sold by Cell Applications Inc.

List Of Figures

Summary Figure : Global Market for Cell Culture, by Segment, 2020-2025
Figure 1 : Research Chain for Cell Culture
Figure 2 : A Model for The Evolution of FDA Regulation
Figure 3 : An Innovation Matrix
Figure 4 : Bioprinting Strategic Roadmap
Figure 5 : Gastrointestinal Organotype Cultures
Figure 6 : iCELLis Nanoreactor: Example of Commercial 2D Cell Culture Systems
Figure 7 : Prototype of 3D Model Lung-on-a-Chip from Wake Forest
Figure 8 : Recent Photos of the HepaChip
Figure 9 : Recent Photos of the HepaChip-MWP
Figure 10 : University of Toronto Handheld Bioprinting Device
Figure 11 : Collaborative Experiment Conducted by American, Russian and Israeli Scientists
Figure 12 : Smart Marbles Concept for Quantifying Process Heterogeneity
Figure 13 : Porcine Intestinal Organoids
Figure 14 : Diagram of the Components of a Predictive Toxicology System
Figure 15 : Gleasons Pattern
Figure 16 : Diagram of PDXs, Cell Lines and Organoid/Spheroid Xenografts
Figure 17 : Cell Heterogeneity and Its Function
Figure 18 : Electron Micrograph of Porous Microcarrier for Stem Cell Production
Figure 19 : Photograph of Apligraf

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