Induced Pluripotent Stem Cells Production Market Size, Share & Trends Analysis Report By Process, By Workflow (Cell Culture), By Product, By Application (Regenerative Medicine), By End-user, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global induced pluripotent stem cells production market size was valued at USD 1.26 billion in 2021 and is expected to witness a compound annual growth rate (CAGR) of 9.2% from 2022 to 2030. The potential of stem cell-based therapies, increasing capital investments for stem cell-based research, the growing incidence of cancer, and multiple advantages of induced pluripotent stem cells (iPSCs) over Embryonic Stem Cells (ESCs) are driving the market growth significantly. The increase in research activities during the COVID-19 pandemic also boosted iPSCs-based research activities. The continuous strive by scientists to develop novel treatment and therapies to manage the SARS CoV-2 infection have driven the demand for iPSCs as research tools. In addition, as induced pluripotent stem cells are capable of generating physiologically similar organ models or organoids, these cells can be used to understand the pathophysiology of the virus infection in humans. 

For example, in a October 2022 published article, researchers from Japan tried to understand the role of salivary glands during COVID-19 infection. The researchers used human iPSCs to generate Human Induced Salivary Glands (hiSGs) to assess the role of salivary glands as virus reservoirs. As per the authors of this research article, hiSGs can prove to be a promising in-vitro model for future investigation. This further aid the understanding of SARS CoV-2 infection spread, thereby driving the demand for induced pluripotent stem cells as a powerful research tool in the future.

The increase in the number of induced pluripotent stem cells based research studies is expanding the market growth drastically. Currently, there are more than 120 clinical trials underway which utilize iPSCs for disease intervention or the generation of iPSCs products. In addition, the advantages offered by induced pluripotent stem cells such as the elimination of animal models and flexibility of ethical implications associated with embryonic stem cells further propel the market growth. This has created a favorable market for iPSCs-based therapeutics from many business entities.

A significant number of companies and research organizations are discovering the therapeutic potency of stem cell products and targeting diseases with cell-based therapeutics. For example, in June 2021 Novo Nordisk A/S announced a global collaborative effort with Heartseed Inc., an iPSC-producing startup in Japan. Through this collaboration, the company develops, manufactures, and commercializes HS-001, which are purified cardiomyocytes derived from iPSCs. HS-001 is an investigated cell therapy for heart failure.

The manufacturing process for the production of induced pluripotent stem cells is relatively long. The induced pluripotent stem cells may exhibit loss of heterozygosity, chromosomal instability, and genetic instability over a cultured in-vitro. Furthermore, the high costs associated with iPSC production as well as immunogenicity and heterogeneity issues also make a negative impact on market demand.

Despite the potential applications of clinical-grade autologous iPSC therapies, certain challenges and limitations still persist. The primary challenge includes the reprogramming method that is completed using retroviruses which elevates the safety issues along with permanent integration of the transgene and change of copy number into the genome of iPSC. This affects the therapeutic applications of iPSCs and hinders market growth. However, the technological advancements and increased capital investments for incorporating automation in iPSCs production, understanding the functionality using omics-based data, and robust therapy product pipeline will boost the growth and present new opportunities in the induced pluripotent stem cells production market.

Process Insights

Based on process, the manual iPSC production segment held the largest market revenue share of 77.4% in 2021. The manual iPSC production process begins with the introduction of genes/transcription factors into rising somatic cells, a reprogramming step & selection of iPSC colonies, expansion, and passaging of iPSCs. Companies with expertise in tissue procurement, gene introduction, RNA reprogramming, and cell culture and expansion drive revenue generation in this segment. For example, REPROCELL, Inc. a Japan-based company, provides GMP iPSCs manufacturing services.  The company offers to generate the GMP master cell bank of iPSCs via manufacturing processes which is consistent with global regulatory guidelines.

On the other hand, the automated iPSC production process is estimated to exhibit the fastest CAGR during the forecast period. The increasing demand for stem cell-based therapies requires scaling up. This demand for generating large-scale induced pluripotent stem cells (iPSCs) in a reproducible manner with minimum alterations is propelling the adoption of automated production platforms. Most companies working on iPSCs-based therapies rely on lines of allogenic cells that are taken from multiple donors. These cells are then created into off-the-shelf products on a large scale which can be used for the treatment of patients affected with the same diseases. 

Workflow Insights

The cell culture segment dominated the market and accounted for the largest revenue share of 37.2% in 2021. Cell culture workflow is inclusive of revenues generated from iPSC harvest products, expansion products, and differentiation products; thus contributing to the market relevance of this segment. Cell culture plays a pivotal role in various stages of induced pluripotent stem cells (iPSCs) generation and continuous investments by key players operating in this market globally have made an important contribution to the segment’s revenue generation. For example, in August 2021, HebeCell Corp. announced that it has raised USD 53 million in financing to advance its R&D program, clinical operations, and commercialization for off-the-shelf pluripotent stem cell-CAR-NK products. Additionally, costs associated with cell culture matrices, media, and regular maintenance of these cells add up to the revenue generated by this segment.

Along with cell culture, reprogramming is also witnessing various advancements in the iPSCs production market. In recent years, researchers have developed clinically important reprogramming techniques such as the silencing of retroviruses in the human genome. The silencing of retroviruses in the human genome is one of the most important steps in the reprogramming process. Gaining a better understanding of the underlying molecular mechanisms to reprogram iPSCs has witnessed significant traction among research professionals.

Product Insights

Based on product, the consumables and kits segment held the largest revenue share in the market in 2021. The never-ceasing research and development activities in the iPSCs space are driving the demand for various consumables & kits. Multiple induced pluripotent stem cells (iPSCs) kits such as reprogramming kits, differentiation kits, and generation kits along with a selection of media & other consumables by key players are allowing end-users to utilize these products as per intended application. In addition, the utility of kits and media during toxicology testing is further propelling the growth of this product segment.

Automated platforms are anticipated to register the fastest CAGR in the upcoming years. The demand for stem cell products, the scaling up of clinical phase iPSC therapies, and regulatory level quality control will drive this segment’s growth rate. The automated platforms provide reproducible & reliable results, reduce labor dependence, and provide well-maintained conditions of manufacturing, and standardization of protocols while eliminating human biases. For instance, Hitachi Ltd. offers an automated equipment for iPSCs culture with an aim to spread regenerative medicines. Many other companies are also offering such automated platforms to increase throughput, decrease operational costs and increase adaptability for iPSCs production.

Application Insights

In 2021, the drug development and discovery segment generated the highest revenue of USD 546.4 million in the market. As the world is witnessing a rise in chronic diseases, The Partnership to Fight Chronic Disease (PFCD) estimated that more than 130 million Americans are affected with chronic diseases like diabetes, asthma, heart problems, and cancer. PFCD also stated that more than 1 in 2 American adults lives with one chronic disease and about 1 in 3 suffers from two or more chronic diseases. Thus, the prevalence of diseased conditions is driving the demand for disease understanding, and induced pluripotent stem cells are widely used in disease modeling leading to the development & discovery of innovative treatment plans. For instance, market players like Evotec SE have built iPSC infrastructure that serves as a platform for high throughput, reproducible, and robust drug screening.

The regenerative medicine segment is estimated to observe the fastest growth during 2022-2030. Vast applications and robust product pipelines by companies are expected to attribute the segment’s growth. In addition, iPSCs can be mediated for disease-specific therapies and provide greater and safer drug development platforms. Also, iPSC-derived organoids and organs are recently being analyzed for both disease modeling and regenerative therapy. In disease modeling, induced pluripotent stem cells enable drug discovery for innovative therapeutics, and in regenerative therapy, iPSCs are proceeding with clinical trials. For example, in April 2022, Editas Medicine, Inc. announced its preclinical data (both in-vitro & in-vivo) for tumor killing capability of its NK cell therapy derived from induced pluripotent stem cells (iPSCs).

End-user Insights

Based on end-user, the biotechnology and pharmaceutical companies segment dominated the market and accounted for a revenue share of 59.3% in 2021. The availability and adoption of various kits, consumables, and instruments along with iPSCs products are driving the revenue generation in this segment. To utilize the market opportunity of the stem cell-based therapy market, biotechnology and pharmaceutical companies are boosting new product developments via intensive R&D efforts. For example, in October 2022, Fate Therapeutics announced that it will be presenting its preclinical and clinical data of multiple iPSC product platforms at Society for Immunotherapy of Cancer (SITC) meeting to be held in November 2022. This demonstrates the robust induced pluripotent stem cells (iPSCs) product pipeline in the market, further fueling the growth.

However, it is expected that research and academic institutes will exhibit the fastest growth rate. iPSCs have wide applications and thus are utilized in many research as well as clinical studies. The increasing utilization of iPSCs in regenerative studies provides favorable prospects for translating this technology into clinical use. For instance, in March 2022, researchers from Indiana University in collaboration with other institutions investigated the use of human induced pluripotent stem cells for the regeneration of visual acuity among diabetes patients. Furthermore, growing research setting to evaluate the safety and efficacy of iPSC-based treatments will drive market growth.  

Regional Insights

North America held the largest revenue share of 59.3% in 2021. The growing incidence of chronic diseases in this region, developed healthcare infrastructure, funds from private & government initiatives, and strategic business models are driving the revenue generation in the marketspace. In addition, North America is also observing the highest number of clinical trials for iPSCs. Currently, there are more than 58 clinical trials that are underway in this region. Moreover, institutes like NIH, California Institute for Regenerative Medicine (CIRM), National Institute of Neurological Disorders and Stroke (NINDS), and many more support induced pluripotent stem cells (iPSCs) related research activities.

Asia Pacific (APAC) will register the fastest CAGR of 10.37% in the market. Key factors such as intensive low-cost driven stem cell-based research, growing economies, betterment in healthcare plans, and the rising awareness of the potential of personalized treatments will drive revenue generation during the forecasted period. Moreover, the presence of multiple start-ups, academic universities, collaborative efforts by international companies, and new product/service launches in this region will contribute to APAC’s growth. For instance, Japanese firms, REPROCELL, Inc. and JTB Corp announced a business alliance in October 2022. Both companies will cooperatively begin marketing the “Personal iPS” service to customers in Japan as well overseas. This service was launched by REPROCELL, Inc. in December 2020.     

Key Companies & Market Share Insights

In the induced pluripotent stem cells (iPSCs) production marketspace, key players are continuously expanding their product offerings by providing innovative & breakthrough technologies. Significant investments into R&D to provide disruptive products, business collaborations to expand the customer base, and strategic initiatives like partnership & acquisition to maintain market presence are driving the competition as well as fueling the growth dynamics. For example, in July 2021, SCM Lifescience Co. Ltd., a South Korea based cell therapy developing company announced that it has in-license a diabetes drug from the US-based Allele Biotechnology and Pharmaceuticals, Inc. The deal is valued at USD 0.75 million, and the diabetes drug is a pancreatic beta cell therapy derived from iPSCs. Some of the prominent players in the induced pluripotent stem cells production market include:

• Lonza

• Axol Biosciences Ltd.

• Evotec SE

• Hitachi Ltd.

• Merck KGaA

• REPROCELLS, Inc.

• Fate Therapeutics

• Thermo Fisher Scientific, Inc.

• StemCellsFactory III

• Applied StemCells, Inc.

Induced Pluripotent Stem Cells Production Market Report Scope

Global Induced Pluripotent Stem Cells Production Market Segmentation

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 2018 to 2030. For this report, Grand View Research has segmented the global induced pluripotent stem cells production market report based on process, workflow, product, application, end-user, and region:

• Process Outlook (Revenue, USD Million, 2018 - 2030)

  • Manual iPSC Production Process

  • Automated iPSC Production Process

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)

  • Reprogramming

  • Cell Culture

  • Cell Characterization / Analysis

  • Engineering

  • Others

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments/ Devices

  • Automated Platforms

  • Consumables & Kits

    • Media

    • Kits

    • Others

  • Services

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Drug Development & Discovery

  • Regenerative Medicine

  • Toxicology Studies

  • Others

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Research & Academic Institutes

  • Biotechnology & Pharmaceutical Companies

  • Hospitals & Clinics

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE