PEGylated Proteins Market

PEGylated Proteins Market Size by Protein Type (Colony-stimulating Factor, Interferons, Erythropoietin, Recombinant Factor VII and Others), By Application (Cancer, Autoimmune Diseases, Hepatitis, Multiple Sclerosis, Hemophilia, Gastrointestinal Disorders and Others), By End-user (Pharmaceutical & Biotechnology Companies, Contract Research Organizations and Academic & Research Institutes), Regions, Global Industry Analysis, Share, Growth, Trends, and Forecast 2023 to 2032

Base Year: 2022 Historical Data: 2019-21
  • Report ID: TBI-13891
  • Published Date: Dec, 2023
  • Pages: 238
  • Category: Healthcare
  • Format: PDF
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The global PEGylated Proteins market was valued at USD 1.31 billion in 2022 and is anticipated to grow at a CAGR of 11.17% from 2023 to 2032. Polyethylene glycol, or PEG, is a multipurpose polymer with many uses in biotechnology and pharmacology, among other industries. The covalent attachment of PEG chains to proteins, or PEGylation, has become a potent tactic for improving the therapeutic qualities of proteins. PEGylated proteins are controlled by this technique, which entails conjugating PEG molecules to particular locations on protein molecules. Because PEGylation addresses issues with stability, solubility, immunogenicity, and pharmacokinetics, it has completely changed the field of protein-based medicines.

Market Introduction:

Fundamentally, PEGylation is a technique that can alter proteins' pharmacokinetic and physicochemical characteristics, thus improving their safety and therapeutic efficacy. When PEG chains are connected to proteins, they create a barrier that prevents enzyme clearance and destruction. Moreover, this alteration confers a property, lowering immunogenicity and the possibility of reticuloendothelial system clearance. Longer exposure to target tissues is made possible by PEGylated proteins' longer circulation times, which improves bioavailability and therapeutic results.

The process of PEGylation entails the difficult choice of PEG receptors and the adjustment of reaction conditions to attain the intended degree of modification while maintaining the integrity of the protein. The protein's size, structure, and attachment location greatly determine the pharmacokinetic and pharmacological characteristics of the final PEGylated product. Scientists and bioengineers use various methods, including enzymatic and chemical conjugation, to successfully phosphorylate proteins while maintaining their biological activity.

PEGylated Proteins Market Size

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Recent Development
  • In July 2022: Doxorubicin hydrochloride (Celdoxome pegylated liposomal) is recommended for approval by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in a favourable opinion. This medication is intended to treat patients with advanced ovarian cancer, progressive multiple myeloma, AIDS-related Kaposi's sarcoma, and metastatic breast cancer.
  • In November 2022: Nektar Therapeutics announced NKTR-288's initial preclinical data presentation for the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of NKTR-288, a new polyethylene glycol (PEG)-IFN-γ conjugate, is to alter IFN-γ's binding to its substrates and lengthen the signaling period of IFN-γ. Cytokine interferon-γ (IFN-γ) is known to trigger cellular antigen presentation and amplify the cytotoxic T-cell response specific to tumor antigens. It is being investigated for potential use in oncology and infectious illnesses, among other therapeutic domains.

Market Dynamics:

Drivers

Reduction of Immunogenicity - When developing and using protein-based therapies, immunogenicity—the capacity of a material to elicit an immune response—becomes extremely important. Proteins can cause the body to mount an immunological reaction, which can create antibodies that neutralize or eradicate the therapeutic protein. This immunological reaction may lessen the therapeutic patient's effectiveness and, in certain situations, cause negative symptoms in the patient. PEGylation is a common tactic to reduce immunogenic reactions linked to protein-based medicines. PEGylation is the process by which polyethylene glycol (PEG) chains bind covalently to the surface of proteins. This alteration is crucial in hiding immunogenic epitopes on the protein surface, which lessens the immune system's ability to recognize them. PEGylation can reduce the possibility of an immune response against the therapeutic protein by defining its immunogenic epitopes. This is the primary factor for the market growth and development.

Restraints:

Complex Manufacturing Processes - PEGylated protein production is an extremely complex process that requires multiple phases to maintain accuracy and control. Numerous difficulties arise in producing PEGylated proteins, which may affect the production process's scalability, reproducibility, and cost-effectiveness. It is difficult to scale up PEGylated Protein Synthesis from Laboratory to Commercial Scale because constant quality and purity are required. To guarantee the effectiveness and safety of the final product, large-scale production techniques must preserve the integrity of the PEG-protease conjugates. Producing PEGylated proteins can be extremely difficult because of the specific knowledge, tools, and raw materials needed for the production process. Maximizing production efficiency at the lowest possible cost is a major task for manufacturers. This factor is limiting the market growth and development.

Opportunities:

Diverse Applications in Oncology - Indeed, one of the main factors contributing to the market's expansion is using peptide-based proteins in oncology. This is mostly because PEGylation provides important advantages in cancer treatment. It has been demonstrated that PEGylation, the covalent bonding of polyethylene glycol (PEG) to therapeutic proteins or drug molecules, improves the pharmacokinetics of chemotherapy drugs. This improvement improves cancer treatments' overall efficacy and safety profile by increasing the accumulation of the medications in tumor tissues while minimizing systemic symptoms. Enhancing pharmacokinetic characteristics is one of PEGylated proteins' main benefits in oncology. PEG can prolong the half-life of a protein or medication molecule in the bloodstream by lowering proteolytic breakdown and renal clearance. Due to the increased permeability and resistance (EPR) effect, the therapeutic substance can accumulate more effectively within tumor tissues throughout this longer circulation period.

Regional segmentation analysis:

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America region emerged as the most prominent global PEGylated Proteins market, with a 42.0% market revenue share in 2022. U.S., Canada and Mexico are the key countries contributing towards the regional market growth and development. The regulatory landscape in North America, shaped by organizations like Health Canada and the U.S. Food and Drug Administration (FDA), is extremely important. Due to strict regulatory standards, patients and healthcare providers can feel confident knowing that PEGylated products are safe and effective. North America's significance in the worldwide market is fueled by the accepted market economy caused by the extended approval processes for novel therapies. North America's high healthcare costs make it easier for cutting-edge treatments like PEGylated proteins to be widely adopted. PEGylatеd treatments are accessible and affordable in the region because of the well-established health infrastructure. The regional market players also engage in various market strategies such as product innovation, product differentiation, mergers, acquisitions, partnerships, and strategic alliances to maintain their competitive edge.

North America Region PEGylated Proteins Market Share in 2022 - 42.0%

 

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  • In February 2022: Merck KGaA announced that it had paid USD 780 million to buy the CDMO Exelead. The company's lipid and mRNA capabilities have improved due to the acquisition. Exelead is a full-service biopharmaceutical CDMO focusing on PEGylated medicines and intricate formulations. Additionally, Merck KGaA declared that it will invest more than USD 485.67 (or EUR 500 million) to advance the technology in the following years.
Protein Type Segment Analysis

The protein type segment includes Colony-stimulating Factor (CSF), Interferons, Erythropoietin, Recombinant Factor VII and others. The Colony-stimulating Factor (CSF) segment dominated, with a market share of around 34% in 2022. Growth factors called CSF attach to receptor proteins to promote the development of hematopoietic stem cells into white blood cells (WBCs) and their proliferation. CSFs are used as a pharmacological agent to boost immune function in cancer patients receiving therapy who have low blood cell counts (neutropenia), which makes them vulnerable to infection. The biggest rise in this category can be attributable to the rising prevalence of various forms of cancer and the medications that are linked with them. PEGylated CSFs are essential parts of cancer treatment regimens because they can reduce neuropathy, a major side effect of chemotherapy. Their prolonged half-life, which results from PEGylation, makes them easier to administer and stimulates to their market dominance.

Application Segment Analysis

The application segment is bifurcated into cancer, autoimmune diseases, hepatitis, multiple sclerosis, hemophilia, gastrointestinal disorders and others. The cancer segment dominated, with a market share of around 38% in 2022. The prevalence of cancer is rising globally, and protein-based medicines are being used more frequently to treat cancer. The field of therapeutic pharmacology, particularly cancer therapy, benefits from the PEGylation process's gains in specificity, stability, and enhanced drug distribution. This method could be used to create more stable and non-immunogenic treatments. PEGylated proteins are widely used in cancer treatment; PEGylated liposomal formulations are especially well known. Because PEGylated CSFs can cause neuronia, a significant adverse effect of chemotherapy, they are crucial components of cancer treatment regimens. Due to PEGylation, they have a longer shelf life, which facilitates administration and increases their market dominance.   

End-user Segment Analysis

The end-user segment is bifurcated into pharmaceutical & biotechnology companies, contract research organizations and academic & research institutes. The pharmaceutical & biotechnology companies segment dominated, with a market share of around 44% in 2022. PEGylated protein development is driven by innovation in the pharmaceutical and biotechnology industries. Novel PEGylated formulations intended to add more unmedical nееds are frequently included in their broad pipelines. These businesses invest in state-of-the-art PEGylation technology, develop novel therapeutic indications, and carry out clinical trials to increase the range of applications for PEGylated proteins. The continuous development of non-glycemic PEGylated medicines demonstrates their dedication to foster the segment growth and development.

Some of the Key Market Players:
  • Thermo Fisher Scientific, Inc.
  • Abcam plc.
  • Enzon Pharmaceuticals, Inc.
  • Merck KGaA
  • Celares GmbH
  • Profacgen
  • Creative PEGworks
  • NOF America Corp.
  • Aurigene Pharmaceutical Services Ltd.
  • Laysan Bio, Inc.

Report Description:

Attribute Description
Market Size Revenue (USD Billion)
Market size value in 2022 USD 1.31 Billion
Market size value in 2032 USD 3.78 Billion
CAGR (2023 to 2032) 11.17%
Historical data 2019-2021
Base Year 2022
Forecast 2023-2032
Region The regions analyzed for the market are Asia Pacific, Europe, South America, North America, and Middle East & Africa. Furthermore, the regions are further analyzed at the country level.
Segments Protein Type, Application, End-user

Frequesntly Asked Questions

As per The Brainy Insights, the size of the PEGylated proteins market was valued at 1.31 billion in 2022 to USD 3.78 billion by 2032.

The global PEGylated proteins market is growing at a CAGR of 11.17% during the forecast period 2023-2032.

North America region became the largest market for PEGylated proteins.

The rising patient awareness regarding biologics is influencing the market's growth.

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This study forecasts revenue at global, regional, and country levels from 2019 to 2032. The Brainy Insights has segmented the global PEGylated proteins market based on below-mentioned segments:

Global PEGylated Proteins Market by Protein Type:

  • Colony-stimulating Factor
  • Interferons
  • Erythropoietin
  • Recombinant Factor VII
  • Others

Global PEGylated Proteins Market by Application:

  • Cancer
  • Autoimmune Diseases
  • Hepatitis
  • Multiple Sclerosis
  • Hemophilia
  • Gastrointestinal Disorders
  • Others

Global PEGylated Proteins Market by End-user:

  • Pharmaceutical & Biotechnology Companies
  • Contract Research Organizations
  • Academic & Research Institutes

Global PEGylated Proteins Market by Region:

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
  • Asia-Pacific
    • Japan
    • China
    • India
  • South America
    • Brazil
  • Middle East and Africa  
    • UAE
    • South Africa

Methodology

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Our research reports feature both; quantitative and qualitative aspects for any market. Qualitative information for any market research process are fundamental because they reveal the customer needs and wants, usage and consumption for any product/service related to a specific industry. This in turn aids the marketers/investors in knowing certain perceptions of the customers. Qualitative research can enlighten about the different product concepts and designs along with unique service offering that in turn, helps define marketing problems and generate opportunities. On the other hand, quantitative research engages with the data collection process through interviews, e-mail interactions, surveys and pilot studies. Quantitative aspects for the market research are useful to validate the hypotheses generated during qualitative research method, explore empirical patterns in the data with the help of statistical tools, and finally make the market estimations.

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Our research methodology encompasses an idyllic combination of primary and secondary initiatives. Key phases involved in this process are listed below:

MARKET RESEARCH PROCESS

Data Procurement:

The phase involves the gathering and collecting of market data and its related information with the help of different sources & research procedures.

The data procurement stage involves in data gathering and collecting through various data sources.

This stage involves in extensive research. These data sources includes:

Purchased Database: Purchased databases play a crucial role in estimating the market sizes irrespective of the domain. Our purchased database includes:

  • The organizational databases such as D&B Hoovers, and Bloomberg that helps us to identify the competitive scenario of the key market players/organizations along with the financial information.
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Primary Research: The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. Primary research mainly involves in telephonic interviews, E-mail interactions and face-to-face interviews with the raw material providers, manufacturers/producers, distributors, & independent consultants. The interviews that we conduct provides valuable data on market size and industry growth trends prevailing in the market. Our organization also conducts surveys with the various industry experts in order to gain overall insights of the industry/market. For instance, in healthcare industry we conduct surveys with the pharmacists, doctors, surgeons and nurses in order to gain insights and key information of a medical product/device/equipment which the customers are going to usage. Surveys are conducted in the form of questionnaire designed by our own analyst team. Surveys plays an important role in primary research because surveys helps us to identify the key target audiences of the market. Additionally, surveys helps to identify the key target audience engaged with the market. Our survey team conducts the survey by targeting the key audience, thus gaining insights from them. Based on the perspectives of the customers, this information is utilized to formulate market strategies. Moreover, market surveys helps us to understand the current competitive situation of the industry. To be precise, our survey process typically involve with the 360 analysis of the market. This analytical process begins by identifying the prospective customers for a product or service related to the market/industry to obtain data on how a product/service could fit into customers’ lives.

Secondary Research: The secondary data sources includes information published by the on-profit organizations such as World bank, WHO, company fillings, investor presentations, annual reports, national government documents, statistical databases, blogs, articles, white papers and others. From the annual report, we analyse a company’s revenue to understand the key segment and market share of that organization in a particular region. We analyse the company websites and adopt the product mapping technique which is important for deriving the segment revenue. In the product mapping method, we select and categorize the products offered by the companies catering to domain specific market, deduce the product revenue for each of the companies so as to get overall estimation of the market size. We also source data and analyses trends based on information received from supply side and demand side intermediaries in the value chain. The supply side denotes the data gathered from supplier, distributor, wholesaler and the demand side illustrates the data gathered from the end customers for respective market domain.

The supply side for a domain specific market is analysed by:

  • Estimating and projecting penetration rates through analysing product attributes, availability of internal and external substitutes, followed by pricing analysis of the product.
  • Experiential assessment of year-on-year sales of the product by conducting interviews.

The demand side for the market is estimated through:

  • Evaluating the penetration level and usage rates of the product.
  • Referring to the historical data to determine the growth rate and evaluate the industry trends

In-house Library: Apart from these third-party sources, we have our in-house library of qualitative and quantitative information. Our in-house database includes market data for various industry and domains. These data are updated on regular basis as per the changing market scenario. Our library includes, historic databases, internal audit reports and archives.

Sometimes there are instances where there is no metadata or raw data available for any domain specific market. For those cases, we use our expertise to forecast and estimate the market size in order to generate comprehensive data sets. Our analyst team adopt a robust research technique in order to produce the estimates:

  • Applying demographic along with psychographic segmentation for market evaluation
  • Determining the Micro and Macro-economic indicators for each region 
  • Examining the industry indicators prevailing in the market. 

Data Synthesis: This stage involves the analysis & mapping of all the information obtained from the previous step. It also involves in scrutinizing the data for any discrepancy observed while data gathering related to the market. The data is collected with consideration to the heterogeneity of sources. Robust scientific techniques are in place for synthesizing disparate data sets and provide the essential contextual information that can orient market strategies. The Brainy Insights has extensive experience in data synthesis where the data passes through various stages:

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  • Data Integration: Integrating multiple data streams is necessary to produce research studies that provide in-depth picture to the clients. These data streams come from multiple research studies and our in house database. After screening of the data, our analysts conduct creative integration of data sets, optimizing connections between integrated surveys and syndicated data sources. There are mainly 2 research approaches that we follow in order to integrate our data; top down approach and bottom up approach.

Market Deduction & Formulation: The final stage comprises of assigning data points at appropriate market spaces so as to deduce feasible conclusions. Analyst perspective & subject matter expert based holistic form of market sizing coupled with industry analysis also plays a crucial role in this stage.

This stage involves in finalization of the market size and numbers that we have collected from data integration step. With data interpolation, it is made sure that there is no gap in the market data. Successful trend analysis is done by our analysts using extrapolation techniques, which provide the best possible forecasts for the market.

Data Validation & Market Feedback: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helps us finalize data-points to be used for final calculations.

The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. The data validation interview and discussion panels are typically composed of the most experienced industry members. The participants include, however, are not limited to:

  • CXOs and VPs of leading companies’ specific to sector
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Moreover, we always validate our data and findings through primary respondents from all the major regions we are working on.

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