Good Manufacturing Practices (GMP) Cytokines Market Analysis and Forecast by Size, Share, Growth, Trends 2031

GMP Cytokines Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type (TNF, Interleukins, Growth Factors, and Others); Application (Cell and Gene Therapy, Tissue Engineered Products, and Others); and Geography

  • Report Code : TIPRE00008212
  • Category : Medical Device
  • No. of Pages : 150
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GMP Cytokines Market Trends, Share, and Growth (2021-2031)

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TheGMP Cytokines Market size is projected to reach US$ 350.2 million by 2031 from US$ 128.7 million in 2023. The market is expected to register a CAGR of 9.7% in 2023–2031. Technologically advanced GMP cytokines production is likely to remain a key GMP cytokines market trend.

GMP Cytokines Market Analysis

GMP cytokines utility in cancer therapy, use of cytokines as a potential biomarker for neonatal sepsis, and cytokines for stem cell therapy are the most influential factors responsible for market growth. Additionally, research & development (R&D) activities further drives the market growth during 2021-2031. Further, High Grade-GMP- cytokines production and optimization by the manufacturers will provide lucrative market opportunities in the coming years.

GMP Cytokines Market Overview

Cytokines are critically raw materials for T cell and NK cell therapy manufacturing. For example, PeproGMP Cytokines provide safety, purity, and simplified use in ex vivo manufacturing processes. Additionally, MACS GMP Cytokines offer a large variety of highly active and pure cytokines that perfectly meet the requirements for high-quality raw materials intended for cell manufacturing for cell-based therapies. Therefore, innovative product launches of GMP cytokines may act as an influential factor responsible for market growth.

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GMP Cytokines Market: Strategic Insights

gmp-cytokines-market
Market Size Value inUS$ 84.72 Million in 2019
Market Size Value byUS$ 158.13 Million by 2027
Growth rateCAGR of 8.1% from 2020-2027
Forecast Period2020-2027
Base Year2020
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GMP Cytokines Market Drivers and Opportunities

Rising Research & Development (R&D) Activities to Favor Market

Cytokines are used in clinical research, such as clinical cancer therapy. For example, cytokines stimulate the function, survival, and proliferation of Natural Killer (NK) and T Cells that mediate immune response against tumors.  For example, the MACS GMP Cytokine Portfolio offers ex-vivo cell culture in clinical research. Therefore, for rising clinical research for cytokines, manufacturers are developing high standards cytokines. For example, cytokines used for stem cell research should be low-endotoxin, free from microbes, animal products, and potential toxins. Also, cytokines have to be filtered for purity and tested for adequate biological activity. An example of such GMP cytokines is cytokines “T cell and NK cell” produced through ScaleReady manufacturing. GMP cytokines are critical raw materials for manufacturing T cell and NK cell therapy. The aforementioned factors positively influence the market growth of GMP cytokines during 2021-2031.

High Grade-GMP- Cytokines Production and Optimization by the Manufacturers– An Opportunity in GMP Cytokines Market

Currently, cytokines manufacturers are developing effective strategies for high throughput and effective optimization techniques. BioTechne is an example of such a manufacturer focussing on producing autologous T cell therapies targeting solid tumors cancers. The company seeks to develop innovative methods of cytokine supplementation, reduce cytokine waste, improve dose accuracy across lots, and decrease process risk. A feasibility study was done to monitor clinical effectiveness and optimization techniques for cytokines. Additionally, the company is pursuing to deliver process-fit activity for the residual cytokine products, eliminating GMP cytokine waste. Therefore, producing high Grade-GMP with effective process optimization will ultimately lead to a good quality manufacturing practices to deliver effective output will drive the market in the coming years.

GMP Cytokines Market Report Segmentation Analysis

Key segments that contributed to the derivation of the GMP cytokines market analysis are contaminants, technology, and food type.

  • Based on Type, the GMP cytokines market is divided into TNF, interleukins, growth factors, and others. The TNF segment held a larger market share in 2023.
  • In terms of application, the market is segmented into cell and gene therapy, tissue engineered products, and others. The cell and gene therapy segment dominated the market in 2023.

GMP Cytokines Market Share Analysis by Geography

The geographic scope of the GMP cytokines market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South America/South & Central America.

The GMP cytokines market in North America is significantly In North America, the GMP cytokines market is currently in the growth phase and experiencing exponential growth. In North America, the US accounts largest share for the GMP cytokines market. Presence of top biotechnology companies and innovative product launches are the most influential growth factors driving the North America region growth positively. Further, Asia Pacific will account highest CAGR for GMP cytokines market during 2021-2031.

GMP Cytokines Market Report Scope

GMP Cytokines Market News and Recent Developments

The GMP cytokines market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for innovations, business expansion, and strategies:

  • In March 2024, Synthekine Inc. an engineered cytokine therapeutics company announced releasing of Phase 1a/1b clinical trials of α/β biased IL-2 partial agonist, STK-012. (Source: Synthekine, Press Release)
  • In March 2022, Xenco, a clinical-stage biopharmaceutical company announced developing engineered antibodies and cytokines to treat cancer and autoimmune diseases and are preclinical data presented from XmAb Cytokine Programs at the American Association for Cancer Research (AACR) Annual Meeting 2022.
  • In July 2022, Sandoz announced US Food and Drug Administration (USFDA) for its Supplemental Biologics Licence Application (sBLA) for a high concentration formulation of 100mg/ml (HCF) of its biosimilar "Hyrimoz" (Adalimumab-adaz). The application includes the indications of the reference medicines Humira (adalimumab) not protected by orphan exclusivity, including the rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis arthritis, and other clinical conditions.

GMP Cytokines Market Report Coverage and Deliverables

The “GMP Cytokines Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering the following areas:

  • GMP Cytokines Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
  • Market dynamics such as drivers, restraints, and key opportunities
  • GMP Cytokines Market trends
  • Detailed PEST/Porter’s Five Forces and SWOT analysis
  • GMP Cytokines market analysis covering key market trends, Global and regional framework, major players, regulations, and recent market developments
  • GMP Cytokines Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
  • Detailed company profiles
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Type , and Application , and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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