iPSC Characterization Kit Market Size, Share & Trends Analysis Report By Type (Alkaline Phosphatase Staining Assay, Pluripotency Markers (Protein), Pluripotency Markers (mRNA)), By Application, By Region, And By Segment Forecasts, 2024-2031

Report Id: 1418 Pages: 185 Last Updated: 22 February 2024 Format: PDF / PPT / Excel / Power BI
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The iPSC Characterization Kit Market Size is predicted to grow at an 15.54 % CAGR during the forecast period for 2024-2031.

Key Industry Insights & Findings from the Report:

  • The advent of the iPSC characterization kit market arose for technological innovation, regulatory support, and collaborative partnerships that propel stem cell research forward.
  • The increasing applications in research and therapy are expected to drive this market’s growth.
  • North America dominated the market and accounted for a global revenue share in 2023.
  • One of the significant concerns restraining industry growth is the high cost associated with stem cell therapy.

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A variety of delicate instruments are included in the iPSC characterization kit (induced pluripotent stem cell) for the phenotypic evaluation of the pluripotent state of human embryonic stem & induced pluripotent stem cells. Compared to embryonic stem cells (ESCs), induced pluripotent stem cells have several advantages, including avoiding the ethical concerns surrounding stem cells and offering the most significant degree of versatility for use in cell-based research. In recent years, these benefits have given induced pluripotent stem cells (iPSCs) a considerable boost, establishing a promising market for iPSC characterization kits. The strong pipeline for cell therapies derived from iPSCs and new iPSC applications is expected to accelerate market growth. Furthermore, the demand for iPSC characterization kits is expanding as a result of an increase in the prevalence of chronic diseases.

Additionally, induced pluripotent stem cells can be used to treat chronic diseases like diabetes, cancer, cancer, and heart disease, hence driving the iPSC characterization kit market. According to the Partnership to Fight Chronic Disorder (PFCD) survey, out of 133 million Americans, 45% of the population had at least one chronic disorder. In addition, it was calculated that chronic diseases account for 7 out of 10 deaths in the USA or roughly 1.7 million deaths, and that induced pluripotent stem cell therapy can prevent these deaths. Hence, the increased demand for induced pluripotent stem cell therapy is being driven by this surge in the prevalence of chronic disorders, which aids in the iPSC characterization kit market expansion.

Competitive Landscape

Some Major Key Players In The iPSC Characterization Kit Market:

  • Merck KGaA,
  • Takara Bio,
  • Thermo Fisher Scientific,
  • BD Biosciences,
  • Applied StemCell,
  • Amsbio,
  • Bio-Techne,
  • ALSTEM,
  • STEMCELL Technologies,
  • System Biosciences,
  • Applied Biological Materials,
  • Creative Bioarray,
  • Elixirgen Scientific
  • Miltenyi Biotec.

Market Segmentation:

The iPSC characterization kit market is segmented by type and application. Based on the type, the market is segmented into alkaline phosphatase staining assay, pluripotency markers (protein) and pluripotency markers (mRNA). Based on the application, the market is segmented into cancer research center, pathology laboratory, academic and research, contract research organizations and others.

Based On The Type, The Alkaline Phosphatase Staining Assay Category Is Accounted As A Major Contributor To The iPSC Characterization Kit Market.

The alkaline phosphatase staining assay category dominated the market in 2021. It is a stem cell imaging product used to stain pluripotent stem cells (PSCs) differentially. Over two hours, the dye diffuses out and acts as a cell-permeable fluorescent substrate for alkaline phosphatase (AP) that is non-toxic to cells. A high signal above the background enables the identification of pluripotent stem cells. Since it preserves stem cell viability, the alkaline phosphatase live stain is perfect for colony screening in the early stages of the reprogramming procedure. It can also be employed as a negative selection method to spot undifferentiated cells in advanced phases.

The Contract Research Organizations Category Witnessed Growth At A Rapid Rate.

The contract research organizations category dominated the market in 2021 due to the expanding emphasis on stem cell cytology and pathophysiology research and the expansion of public-private funding to assist the development and commercialization of stem cell products. A corporation that supports the pharmaceutical, biotechnology, and medical device sectors by contracting out research activities is known as a contract research organization (CRO). A CRO might offer commercialization, clinical trial management, pharmacovigilance, clinical development, outcomes research, and real-world evidence, among other services.

The North American iPSC Characterization Kit Market Holds A Signification Revenue Share.

The North American iPSC characterization kit market is expected to register the highest market share. Vital industry players are well represented in the area, and significant private and public financing for research institutes is a key factor in this situation. In addition, developing the iPSC characterization kit market is aided by a robust infrastructure for R&D and application scenarios, including tissue engineering and toxicity screening. It is projected that the region will maintain its dominance. In addition, Asia Pacific is projected to increase in the global iPSC characterization kit market. Induced pluripotent stem cell use is anticipated to be fueled by substantial market expansion in nations like Japan and China, as well as growing interest in regenerative medicine in the area, which will further fuel the growth of the iPSC characterization kit market. Although there isn't a clear legislative framework for the iPSC business, regional governments are making concerted attempts to change that. Those efforts are anticipated to support the development of the iPSC characterization kit market.

Recent Developments:

  • In August 2021, Fate Therapeutics officially declared that FT819 had been successful in treating its first patient in a clinical trial. FT819, which is a CAR-T cell treatment, was made utilizing iPSCs. 
  • In May 2022, Sernova and Evotec discussed a strategic treaty to develop an IPSC-based beta substitute therapy for type 1 and 2 diabetes.
  • In July 2021, SCM Lifescience Co. Ltd., a South Korea-based cell therapy developing firm, pronounced that it had in-license a diabetes drug from Allele Biotechnology and Pharmaceuticals, Inc., which is a pancreatic beta cell therapy extracted from IPSCs, and the deal has been signed at a valuation of US$ 0.75 million.

iPSC Characterization Kit Market Report Scope

Report Attribute Specifications
Growth Rate CAGR CAGR of 15.54 % from 2024 to 2031
Quantitative Units Representation of revenue in US$ Million and CAGR from 2024 to 2031
Historic Year 2019 to 2023
Forecast Year 2024-2031
Report Coverage The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends
Segments Covered Type, Application
Regional Scope North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Country Scope U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico ;The UK; France; Italy; Spain; China; Japan; India; South Korea; South East Asia; South Korea; South East Asia
Competitive Landscape Merck KGaA, Takara Bio, Thermo Fisher Scientific, BD Biosciences, Applied StemCell, Amsbio, Bio-Techne, ALSTEM, STEMCELL Technologies, System Biosciences, Applied Biological Materials, Creative Bioarray, Elixirgen Scientific and Miltenyi Biotec.
Customization Scope Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape.
Pricing And Available Payment Methods Explore pricing alternatives that are customized to your particular study requirements.

Segmentation of iPSC Characterization Kit Market-

By Type-

  • Alkaline Phosphatase Staining Assay
  • Pluripotency Markers (Protein)
  • Pluripotency Markers (mRNA)

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By Application-

  • Cancer Research Center
  • Pathology Laboratory
  • Academic and Research
  • Contract Research Organizations
  • Others

By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • South East Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of Middle East and Africa

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Research Design and Approach

This study employed a multi-step, mixed-method research approach that integrates:

  • Secondary research
  • Primary research
  • Data triangulation
  • Hybrid top-down and bottom-up modelling
  • Forecasting and scenario analysis

This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.

Secondary Research

Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.

Sources Consulted

Secondary data for the market study was gathered from multiple credible sources, including:

  • Government databases, regulatory bodies, and public institutions
  • International organizations (WHO, OECD, IMF, World Bank, etc.)
  • Commercial and paid databases
  • Industry associations, trade publications, and technical journals
  • Company annual reports, investor presentations, press releases, and SEC filings
  • Academic research papers, patents, and scientific literature
  • Previous market research publications and syndicated reports

These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.

Secondary Research

Primary Research

Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.

Stakeholders Interviewed

Primary interviews for this study involved:

  • Manufacturers and suppliers in the market value chain
  • Distributors, channel partners, and integrators
  • End-users / customers (e.g., hospitals, labs, enterprises, consumers, etc., depending on the market)
  • Industry experts, technology specialists, consultants, and regulatory professionals
  • Senior executives (CEOs, CTOs, VPs, Directors) and product managers

Interview Process

Interviews were conducted via:

  • Structured and semi-structured questionnaires
  • Telephonic and video interactions
  • Email correspondences
  • Expert consultation sessions

Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.

Data Processing, Normalization, and Validation

All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.

The data validation process included:

  • Standardization of units (currency conversions, volume units, inflation adjustments)
  • Cross-verification of data points across multiple secondary sources
  • Normalization of inconsistent datasets
  • Identification and resolution of data gaps
  • Outlier detection and removal through algorithmic and manual checks
  • Plausibility and coherence checks across segments and geographies

This ensured that the dataset used for modelling was clean, robust, and reliable.

Market Size Estimation and Data Triangulation

Bottom-Up Approach

The bottom-up approach involved aggregating segment-level data, such as:

  • Company revenues
  • Product-level sales
  • Installed base/usage volumes
  • Adoption and penetration rates
  • Pricing analysis

This method was primarily used when detailed micro-level market data were available.

Bottom Up Approach

Top-Down Approach

The top-down approach used macro-level indicators:

  • Parent market benchmarks
  • Global/regional industry trends
  • Economic indicators (GDP, demographics, spending patterns)
  • Penetration and usage ratios

This approach was used for segments where granular data were limited or inconsistent.

Hybrid Triangulation Approach

To ensure accuracy, a triangulated hybrid model was used. This included:

  • Reconciling top-down and bottom-up estimates
  • Cross-checking revenues, volumes, and pricing assumptions
  • Incorporating expert insights to validate segment splits and adoption rates

This multi-angle validation yielded the final market size.

Forecasting Framework and Scenario Modelling

Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.

Forecasting Methods

  • Time-series modelling
  • S-curve and diffusion models (for emerging technologies)
  • Driver-based forecasting (GDP, disposable income, adoption rates, regulatory changes)
  • Price elasticity models
  • Market maturity and lifecycle-based projections

Scenario Analysis

Given inherent uncertainties, three scenarios were constructed:

  • Base-Case Scenario: Expected trajectory under current conditions
  • Optimistic Scenario: High adoption, favourable regulation, strong economic tailwinds
  • Conservative Scenario: Slow adoption, regulatory delays, economic constraints

Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.

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Frequently Asked Questions

The iPSC Characterization Kit Market is predicted to grow at a 15.54 % CAGR during the forecast period for 2024-2031.

Merck KGaA, Takara Bio, Thermo Fisher Scientific, BD Biosciences, Applied StemCell, Amsbio, Bio-Techne, ALSTEM, STEMCELL Technologies, Others
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