GVR Report cover Induced Pluripotent Stem Cells Production Market Size, Share & Trends Report

Induced Pluripotent Stem Cells Production Market Size, Share & Trends Analysis Report By Process, By Product, By Workflow, By Application, By End-use, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: Oct, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-4-68039-549-7
  • Format: Electronic (PDF)
  • Historical Data: 2017 - 2019
  • Number of Pages: 150

Report Overview

The induced pluripotent stem cells production market was valued at USD 948.29 million in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 8.0% from 2021 to 2028. Induced pluripotent stem cells have several advantages over Embryonic Stem Cells (ESCs), such as avoiding the stem cell-associated ethical implications and maximum flexibility in cell-based research applications. These advantages have offered induced pluripotent stem cells (iPSCs) significant momentum in recent years, creating a favorable market for entities operating in the market. The robust pipeline for iPSC-derived cell therapeutics coupled with emerging applications of iPSCs is anticipated to accelerate the market growth. As of 2021, the total number of iPSC clinical trials has risen to 54. For instance, Allele Biotechnology & Pharmaceuticals is developing a diabetics drug from iPSC-derived pancreatic beta cells.

Germany induced pluripotent stem cells production market size, by workflow, 2018 - 2028 (USD Million)

Moreover, a substantial number of companies and organizations are exploring the potential of iPSCs in cell therapeutics targeted at the treatment of different diseases, which, in turn, will stimulate market growth. Moreover, the rising popularity of regenerative medicines is further contributing to market growth. iPSCs are commonly used for the regeneration of tissue-specific cells for transplantation to patients of different injuries. In addition, researchers are showing interest in using iPSCs for ex-vivo expansion of various blood components. iPSCs are used for the production of red blood cells, which could be used for the generation of blood.

The COVID-19 pandemic has increased the iPSC-based research and development activities. In addition, researchers are keen to find new therapies and treatments to combat this pandemic. In this scenario, iPSCs are powerful research tools to produce normal different cell types relevant for SARS-CoV-2. Moreover, iPSCs are important to generate physiologically relevant human-cell models that can replicate the pathophysiology of COVID-19, thus aiding drug testing.

For instance, a research team at Newcastle University, U.K., has successfully developed a lung cell model from iPSCs that can be used to understand how SARS-CoV-2 infects the airways. High costs associated with iPSC production as well as tumorigenicity, immunogenicity, and heterogeneity may hamper the market growth. The iPS cells may exhibit chromosomal instability, loss of heterozygosity, copy number variant, and genetic instability over a while in in-vitro culture. Moreover, iPSCs are mainly produced and expanded with a feeder layer system, which can generate a high lot-to-lot variability, safety & regulatory concerns and affect the scalability of the process.

Process Insights

The manual iPSC production process segment dominated the global market in 2020 with a revenue share of 78.13%. The iPSC production process can be cost-effective and efficient by simply optimizing the manual steps routinely used to reprogram patient cells. The reprogramming of somatic cells into iPS cells is largely a manual process integrating several routinely used manual instruments/devices. The manual iPSC generation process demands skilled personnel to recognize appropriate colonies and carry out different generation workflows effectively. It also serves as a convenient method for producing various iPSC lines in parallel, which has led to the segment’s dominance.

The automated iPSC production process is expected to register the fastest CAGR from 2021 to 2028. Increasing demand for reproducible large-scale stem cell and differentiated progeny production, with minimum variation, propels the demand for automation platforms. Several countries have started initiatives for iPSC line collection to facilitate studies of numerous conditions, including diabetes and cardiovascular and neurodegenerative diseases.

Several of these initiatives plan to use automated systems to achieve their goal. For instance, various consortiums in Europe aim to develop iPSCs biobank for different diseases. The European Bank for induced Pluripotent Stem Cells (EBiSC) design a bank for more than 10,000 lines covering a wide range of disorders.

Workflow Insights

Cell culture was the dominant workflow segment in 2020 with a revenue share of more than 37% and is estimated to expand further at a steady CAGR over the forecast period. The studies of stem cell behavior and differentiation in development are complicated, expensive, and time-consuming, and thus, cell culture is a prominent workflow in generating iPSC. Traditional human-induced pluripotent stem cells culture technique requires the use of human or mouse fibroblast feeder layers, which is a time-consuming and labor-intensive process. Recently, researchers have developed a feeder-free culture for both hESC and hiPSC cell culture. These cultures include Matrigel, or extracellular matrix protein, such as vitronectin, to maintain hiPSCs and hESCs and removal of serum from human stem cell culture.

On the other hand, the reprogramming of iPSCs production market space has undergone various advancements in the past few years. The reprogramming of somatic cells into iPS cells has a high potential, enabling researchers to push forward groundbreaking research and discover the advanced generation of therapeutics.

Furthermore, the differentiation type is also expected to show significant growth in the coming years. Several companies are dedicated to providing different viable and cost-effective methods for iPSCs differentiation, which supports segment growth. For instance, Axol Biosciences offers a stem cell differentiation service, which supports the generation of multiple cell types from iPSCs. It directs the differentiation of iPSCs to cardiac, neural, immune, and other cell types.

Product Insights

The automated platforms segment is expected to register the fastest CAGR of 8.9% from 2021 to 2028. Automated platforms are known to produce more reliable iPSCs, minimizing human bias, while ensuring standardization of protocols. Moreover, it offers an ideal chance for reproducibility of cells, reduces cost, increases throughput, and provides the required adaptability to cultivate iPS cell lines.

The Instruments/devices accounted for the second-highest revenue share in 2020. The instruments/devices have the potential to help in iPSC generation by regulating the kinetics of reprogramming factor delivery. A substantial number of players are offering instruments/devices under this segment. For instance, Lonza offers Nucleofector transfection technology for efficient transfection of neurons, stem cells, primary cells, and cell lines. The company offers 4-D Nucleofector X Unit and 4D- Nucleofector Y Unit. 4-D Nucleofector X Unit helps with the nucleofection process of different cell numbers in different formats.

Application Insights

The drug development & discovery segment accounted for the largest revenue share of 42.86% of the global induced pluripotent stem cells generation market in 2020. iPSCs have broad applications in efficacy and safety evaluation during the drug development process. The segment growth is also attributed to the fact that disease-specific iPSCs can retain the patient’s genetic information, which has contributed to novel drug discovery pathways, including assessment of drug sensitivity, screening of therapeutic drugs, and the pathogenic mechanism.

Moreover, iPSCs allow in vitro differentiation into various types of cells that constitute the organs and tissues. Currently, commercially usable iPSC-derived products include hepatocytes, cardiomyocytes, islet cells, vascular endothelial cells, and neurons, which are being studied to explain the mechanisms of human-specific adverse events and toxicity screening during drug exploration.

The regenerative medicine segment is expected to witness the fastest CAGR over the forecast period owing to the ability of iPSCs to propagate indefinitely. In addition, the development and launch of new platforms are contributing to the segment growth. For instance, in December 2020, REPROCELL launched a personalized iPSC generation service alongside a new B2C website to support the “Personal iPS” service. This service prepares and stores an individual’s iPSCs for the regenerative treatment of future injury or illness.

End-use Insights

Biotechnology & pharmaceutical companies dominated the market with a revenue share of more than 58% in 2020. Acknowledging the profitable opportunities posed by the market, biotechnology companies are focused on initiating new product development to strengthen their market presence. For instance, Fate Therapeutics is utilizing iPSC-based NK and T cells to treat immune and cancer diseases. Cynata Therapeutics Limited is developing an iPSC-based treatment for graft-versus-host disease. Semma Therapeutics is developing a treatment for type I diabetes containing cells derived from iPSCs that perform like pancreatic cells.

Global induced pluripotent stem cells production market share, by end-use, 2020 (%)

Recently, researchers have taken iPSCs from the lab to the clinics. iPSCs have been utilized in many clinical and research studies, including regenerative medicine, disease modeling, and drug toxicity/drug discovery studies. The utilization of iPSCs in regenerative medicine gives a great opportunity for the clinical translation of this technology. This is attributed to increasing research activities evaluating iPSCs efficiency and safety, which has contributed to the segment growth.

Furthermore, a rising number of strategic initiatives for research and technique for an innovative product from iPSCs is anticipated to drive the segment. For instance, in January 2019, New York Stem Cell Foundation Research Institute and Ngene Therapeutics Inc. entered into a partnership to develop the treatment of new diseases that leverage human stem cell research and novel gene-editing techniques.

Regional Insights

North America dominated the market with a revenue share of more than 52% in 2020 The robust business model in the U.S. and Canada contributed to the market growth in the region. Moreover, organizations are investing in research programs related to iPSCs. For instance, the California Institute for Regenerative Medicine (CIRM) supports research institutes by granting funds for the research on iPSCs and their translation into clinical applications. In addition, the National Health Institute (NIH) has started the Regenerative Medicine Program (RPM). The goal of this program is to develop resources to catalyze the therapeutic use of iPSCs. The RPM also supports the distribution of iPS cell lines for clinical and laboratory research.

Europe is expected to witness steady growth over the forecast period. The development of the EBiSC accelerates the research activities about iPSCs in this region. The EBiSC aims to deliver disease-relevant, quality-controlled, research-grade iPS cell lines, data, and cell services. Moreover, it is a non-profit iPS cell lines bank for industry and academics to deliver consistent, high-grade tools for innovative medicine development.

Companies are entering into agreements for expanding their iPSC-derived therapies, which, in turn, will drive the research activities in the region. In June 2021, Neurophth Therapeutics formed a strategic partnership with Hopstem Biotechnology to develop human iPSC-derived therapies for the treatment of ocular diseases. Under this strategic partnership, Hopstem Biotechnology received upfront and milestone payment for the development of a candidate cell product for retinal degenerative disease.

Key Companies & Market Share Insights

Key players are focused on the expansion of their offerings through substantial R&D and improving their product portfolio through alliances and partnerships with other major players. For instance, in January 2021, Evotec SE received USD 6 million from Bristol Myers Co. for their iPS cell-based neuroscience partnership.

This partnership is expected to help identify disease-modifying treatments for a wide range of neurogenerative disorders. In October 2020, Axol Biosciences introduced Multi-Electrode Array (MEA) screening for human iPSC-derived cells to expand its service offering. Some of the key participants operating in the global induced pluripotent stem cells production market include:

  • Lonza

  • Axol Biosciences Ltd.

  • Evotec

  • Hitachi Ltd.

  • Merck KGaA

  • REPROCELL, Inc.

  • Fate Therapeutics

  • Thermo Fisher Scientific, Inc.

  • StemCellFactory III

  • Applied StemCell, Inc.

Induced Pluripotent Stem Cells Production Market Report Scope

Report Attribute

Details

Market size value in 2021

USD 1,023.41 million

Revenue forecast in 2028

USD 1.76 billion

Growth rate

CAGR of 8.0% from 2021 to 2028

Base year for estimation

2020

Historical data

2017 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Process, product, workflow, application, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; Germany; U.K.; Italy; France; Spain; China; Japan; India; Brazil; Mexico; South Africa; Saudi Arabia

Key companies profiled

Lonza; Axol Biosciences Ltd.; Evotec; Hitachi Ltd.; Merck KGaA; REPROCELL Inc.; Fate Therapeutics; Thermo Fisher Scientific, Inc.; StemCellFactory III; Applied StemCell Inc.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options

 

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global induced pluripotent stem cells production market report on the basis of process, product, workflow, application, end-use, and region:

  • Process Outlook (Revenue, USD Million, 2017 - 2028)

    • Manual

    • Automated

  • Product Outlook (Revenue, USD Million, 2017 - 2028)

    • Instruments/Devices

    • Automated Platforms

    • Consumables & Kits

      • Media

      • Kits

      • Others

    • Services

  • Workflow Outlook (Revenue, USD Million, 2017 - 2028)

    • Reprogramming

    • Cell Culture

    • Cell Characterization/Analysis

    • Engineering

    • Others

  • Application Outlook (Revenue, USD Million, 2017 - 2028)

    • Drug Development and Discovery

    • Regenerative Medicine

    • Toxicology Studies

    • Others

  • End-use Outlook (Revenue, USD Million, 2017 - 2028)

    • Research & Academic Institutes

    • Biotechnology & Pharmaceutical Companies

    • Hospitals & clinics

  • Regional Outlook (Revenue, USD Million, 2017 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

      • France

      • Italy

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

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