Forecast
Period
|
2025-2029
|
Market
Size (2023)
|
USD
9.34 Billion
|
Market
Size (2029)
|
USD
12.78 Billion
|
CAGR
(2024-2029)
|
5.85%
|
Fastest
Growing Segment
|
Secondary
Antibodies
|
Largest
Market
|
North
America
|
Market Overview
Global Polyclonal Antibodies
Market was valued at USD 9.34 Billion in
2023 and is anticipated to project impressive growth in the forecast period
with a CAGR of 5.85% through 2029. This is mainly attributed to the growing
prevalence of infectious and chronic diseases such as cancer across the globe,
increasing technological advancements in antibody-based drugs, and the rising
R&D activities in the biopharmaceutical industry. As compared to
monoclonal antibodies, the manufacturing cost of polyclonal antibodies is less.
Polyclonal antibodies (pAbs) are widely used in qualitative and quantitative
biological analysis and various diagnostic testing. The COVID-19 pandemic
significantly impacted the polyclonal antibody market. Various firms are
working towards establishing pAbs-based in-house products that are used for
treating individuals suffering from COVID-19. The rising acceptance of standard
laboratory tests, such as western blot analysis, microarray assays, cell
imaging, and immunohistochemical, is projected to propel polyclonal antibody
market growth. For instance, GenScript, a U.S.-based biotechnology company,
offers tailored pAbs that are appropriate for several assays type, such as
CHiP, sandwich ELISA, Immunoprecipitation, Western Blot, IHC, IF, and Flow
Cytometry. According to an article published in April 2021, a
human-derived antibody, SAB-185 developed by SAB Biotherapeutics, Inc., has
been tested in a Phase 2/3 trial that is enrolled in non-hospitalized
individuals with mild or moderate COVID-19 infections. Hence, these initiatives
showcased the rise of demand for the pAbs during the pandemic period.
According to a report published by WHO in February
2022, approximately 10 million deaths were reported in the year 2020, among
which, the most common cancers include lung, breast, rectum & colon, and
prostate cancer. As per the article released by the American
Cancer Society in January 2023, nearly 59,610 fresh leukemia cases (of all
kinds) and 23,710 deaths caused due to leukemia (of all kinds) in the U.S.
Polyclonal antibody treatment is widely used to treat various cancers including
lymphoma, leukemia, solid tumor, and many more. For instance, in August 2021,
the Cancer Prevention & Research Institute of Texas was funded with USD
250,000, for Antibody like Therapeutics which would Target Polyclonal T Cells
to CMV-Positive Glioblastomas. Thus, the increasing prevalence of cancer is
expected to create huge opportunities to propel the upsurge of the market.
According to an article published by the National
Library of Medicine in May 2018, the rabbit model was adopted initially to
study polyclonal antibody reactions and supported the immunogenicity associated
with DNA immunization as an innovative immunization technique. The rabbit model has been used significantly in the development of the HIV
vaccine. Rabbits have a number of benefits over other small animals, such as
mouse or rat, including, ease in inducing high-titer, high-affinity epitope-specific
Abs that respond to nearly all kinds of antigens and minimal non-specific
responses. Government organizations around the world are
increasingly recognizing the potential of the pAbs, and are taking initiatives
to support its growth. These initiatives are aimed at promoting research and
development, improving healthcare infrastructure, and providing funding for the
development of new and innovative products. In September 2021, Regeneron
Pharmaceuticals, Inc. announced their collaboration with the U.S. government,
i.e., the Department of Defense (DOD) and the Department of Health and Human
Services (HHS) for buying doses of REGEN-COV (casirivimab and imdevimab)
antibody cocktail that is used in treating COVID infected patients in various
hospitals.
Key Market Drivers
Increasing Prevalence Of Chronic And Infectious
Diseases
The increasing prevalence of chronic and infectious
diseases is a significant driver behind the growth of the Polyclonal Antibodies
Market. Polyclonal antibodies are a crucial component in the diagnosis,
treatment, and prevention of a wide range of medical conditions, making them
essential tools in modern healthcare. In the context of chronic diseases, such
as cancer, autoimmune disorders, and cardiovascular diseases, polyclonal
antibodies play a vital role in targeted therapy. As the global population continues
to age and lifestyles evolve, the incidence of these conditions is on the rise.
Polyclonal antibodies offer a versatile and effective approach to managing
these diseases, often used in conjunction with other treatment modalities.
Infectious diseases represent another compelling
driver. The ongoing emergence of new pathogens and the re-emergence of existing
ones highlight the constant threat posed by infectious diseases. Polyclonal
antibodies are crucial in the development of serological tests for disease
detection, as well as in the treatment of infections. The global fight against
pandemics like COVID-19 has also spotlighted the importance of polyclonal
antibodies in the form of convalescent plasma therapy. Advancements in biotechnology
have made it more feasible to produce polyclonal antibodies on a larger scale.
These innovations, along with improved purification methods, have enhanced the
availability and quality of polyclonal antibodies, making them more accessible
and reliable for diagnostics and therapy. The biopharmaceutical
industry's growth has significantly contributed to the expansion of the
Polyclonal Antibodies Market. As more biopharmaceutical companies engage in the
development of biologics and antibody-based therapeutics, the demand for
polyclonal antibodies has increased. These antibodies are valuable for
research, drug development, and manufacturing processes.
As the prevalence of chronic and infectious
diseases continues to grow, and with ongoing advancements in technology and
biopharmaceutical research, the demand for polyclonal antibodies is expected to
remain strong. They are likely to remain a cornerstone in the arsenal of tools
used to combat, diagnose, and treat a wide spectrum of diseases, reaffirming
their essential role in modern medicine.
Increasing Biopharmaceutical R&D Activities
The increasing activities in biopharmaceutical
research and development (R&D) are playing a pivotal role in driving the
growth of the Polyclonal Antibodies Market. Polyclonal antibodies have become
indispensable tools in the field of biopharmaceuticals, and their demand is
intricately linked to the expansion of this industry. Biopharmaceutical R&D
encompasses the discovery and development of biologic drugs, which includes
monoclonal antibodies, vaccines, and therapeutic proteins, among others. In
this context, polyclonal antibodies serve several crucial functions: Polyclonal
antibodies are essential in the initial stages of drug discovery and
validation. They are used to assess target proteins, which can be potential
drug candidates. By binding to specific proteins, polyclonal antibodies aid in
the identification and characterization of drug targets, accelerating the
R&D process. As biopharmaceuticals are developed and manufactured, they
undergo rigorous quality control processes. Polyclonal antibodies are employed
in these processes to confirm the quality, purity, and consistency of biologic
drugs. Polyclonal antibodies are used in pre-clinical and clinical studies to
evaluate drug safety and efficacy. They are vital in assessing how well a drug
interacts with the body's immune system, which is critical for
biopharmaceutical R&D. In biopharmaceutical R&D, polyclonal antibodies
are pivotal in the development of diagnostic assays, which are used to detect
and measure specific biomarkers or disease indicators. These assays are
instrumental in patient screening, disease diagnosis, and monitoring.
As the biopharmaceutical industry continues to
expand, driven by the demand for innovative and targeted therapies, the need
for polyclonal antibodies grows in parallel. Advancements in
biotechnology have facilitated the development of more advanced and specialized
polyclonal antibodies tailored to specific applications. The pursuit of
personalized medicine, coupled with the development of novel biologics, has
further increased the demand for polyclonal antibodies in biopharmaceutical
R&D. These antibodies are instrumental in validating and optimizing
biologic drug candidates for patient-specific treatment approaches. In
conclusion, the increasing biopharmaceutical R&D activities are driving the
Polyclonal Antibodies Market by elevating their significance in drug discovery,
development, and quality control. As the biopharmaceutical sector continues to
thrive and innovate, the demand for polyclonal antibodies is expected to remain
on an upward trajectory, solidifying their role in advancing modern medicine
and healthcare.
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Key Market Challenges
Competition from monoclonal antibodies
Competition from monoclonal antibodies presents a
notable challenge for the Polyclonal Antibodies Market. Monoclonal antibodies,
which are engineered to target a single antigen with high specificity, often
offer advantages in terms of precision and reduced side effects compared to
polyclonal antibodies. Consequently, in certain therapeutic and diagnostic
applications, monoclonal antibodies have gained prominence.
The challenge for polyclonal antibodies lies in
convincing healthcare providers and pharmaceutical companies of their unique
benefits, such as broader antigen recognition, which can be advantageous in
some clinical contexts. To address this challenge, manufacturers of polyclonal
antibodies need to demonstrate their effectiveness, safety, and
cost-efficiency, emphasizing the situations where they offer superior
performance to monoclonal antibodies.
Complex production processes
Complex production processes are a challenge for
the Polyclonal Antibodies Market. Producing polyclonal antibodies involves
immunizing animals, typically rabbits or goats, and then purifying the
antibodies from their blood. This process is more intricate and time-consuming
compared to monoclonal antibody production, which uses cell lines. Ensuring consistent quality and specificity in polyclonal
antibodies can be challenging due to the variability inherent in animal
responses.
The complex production processes not only increase
manufacturing costs but also make scaling up production and maintaining
batch-to-batch consistency difficult. This presents challenges for meeting the
growing demand for polyclonal antibodies and necessitates continuous efforts to
streamline and standardize production methods.
Quality control and standardization
Quality control and standardization pose
significant challenges for the Polyclonal Antibodies Market. Polyclonal
antibodies exhibit inherent batch-to-batch variability due to variations in the
immune response of the host animals. This makes maintaining consistent antibody
quality and specificity challenging, especially when they are used in
diagnostics or therapies where accuracy and reliability are critical. Ensuring
that each batch meets stringent quality standards necessitates rigorous testing
and validation, increasing production costs and time. To address these
challenges, the industry must invest in advanced purification techniques,
analytical methods, and robust quality control protocols to enhance the
reliability and consistency of polyclonal antibodies, thus increasing their
competitiveness in the market.
High production costs
High production costs present a notable challenge
for the Polyclonal Antibodies Market. The production of polyclonal antibodies
involves complex processes, including immunizing animals, maintaining animal
colonies, and purifying antibodies. These steps are labor-intensive, require
specialized facilities, and involve ethical considerations regarding animal
welfare. Consequently, the costs associated with polyclonal antibody production
can be considerably higher than those for monoclonal antibodies, which are
generated using cell lines and bioreactors. These high production costs can
limit the accessibility of polyclonal antibodies for research, diagnostics, and
therapeutic applications, particularly in resource-constrained settings,
hindering their widespread adoption and market competitiveness.
Key Market Trends
Personalized medicine applications
Personalized medicine applications are emerging as
a significant trend in the Polyclonal Antibodies Market. Polyclonal antibodies,
with their capacity to recognize a broad spectrum of antigens, are being
harnessed to develop patient-specific therapies and diagnostic tools. This
trend aligns with the growing focus on tailoring healthcare to individual
genetic and molecular profiles. Polyclonal antibodies, often used to target
multiple antigens simultaneously, offer a more comprehensive approach in identifying
and treating complex diseases. In this era of precision medicine, personalized
therapies using polyclonal antibodies can provide more effective,
patient-centric treatment options, thus driving the growth of the market as
healthcare becomes increasingly tailored to individual needs.
Growth in biotech and
pharma collaborations
The trend of increased
collaboration between the biotechnology and pharmaceutical sectors is driving
the Polyclonal Antibodies Market. Biotech and pharma companies are recognizing
the versatility and utility of polyclonal antibodies in various applications,
such as drug development, diagnostics, and targeted therapies. These
collaborative efforts aim to leverage the advantages of polyclonal antibodies
in terms of their broad antigen recognition and versatility. Partnerships
facilitate the development of novel polyclonal antibody-based products and
solutions, ultimately expanding their market presence. As a result, the
Polyclonal Antibodies Market benefits from the combined expertise and resources
of these sectors, accelerating research and innovation in antibody-based
products and services.
Advancements in antibody
engineering
Advancements in antibody
engineering are shaping the trend in the Polyclonal Antibodies Market.
Traditionally, polyclonal antibodies were obtained from animal hosts, resulting
in inherent variability. However, recent innovations in antibody engineering and
recombinant DNA technology allow for the production of recombinant polyclonal
antibodies. These engineered polyclonals offer improved specificity,
consistency, and versatility. They can be tailored for various applications,
including diagnostics, therapeutics, and research. This trend is driving the
adoption of recombinant polyclonal antibodies as more reliable and
cost-effective alternatives to traditional polyclonals, addressing concerns
related to batch-to-batch variability and animal welfare. These advancements
are poised to reshape the Polyclonal Antibodies Market in the coming years.
Expanding diagnostic and
therapeutic uses
The trend of expanding
diagnostic and therapeutic uses is driving the Polyclonal Antibodies Market.
Polyclonal antibodies are finding application in a widening array of medical
fields, ranging from cancer diagnostics to infectious disease treatments. The
versatility of these antibodies in targeting multiple antigens makes them
valuable in developing diverse diagnostic assays, personalized medicine, and
novel immunotherapies. As the understanding of disease mechanisms and
biomarkers deepens, the Polyclonal Antibodies Market is poised to grow by
providing essential tools for healthcare providers and researchers. The
expanding applications of polyclonal antibodies reflect their adaptability to
meet evolving diagnostic and therapeutic needs in a dynamic healthcare
landscape.
Targeted immunotherapies
Targeted immunotherapies
are a significant trend in the Polyclonal Antibodies Market. Polyclonal
antibodies are being increasingly utilized to develop targeted immunotherapies,
particularly for cancer treatment. These therapies harness the immune system's
power to identify and destroy cancer cells. Polyclonal antibodies, with their
broader antigen recognition, offer advantages in creating personalized immune
responses against tumors. By developing polyclonal antibody-based
immunotherapies, healthcare providers can offer more effective,
patient-specific treatment options, reducing side effects and improving
therapeutic outcomes. This trend aligns with the growing interest in
immunotherapies, positioning polyclonal antibodies as key players in the
rapidly evolving landscape of cancer treatment and beyond, thus driving the
market's growth.
Segmental Insights
Product Insights
Based on the product, the secondary antibodies
segment dominated the market. Secondary Abs bind to primary Abs that are raised
against the target antigen and amplify the signal through various detection
methods including ELISA, Western blotting, and Immunohistochemistry. In
addition, secondary Abs are typically produced by immunizing host animals, such
as rabbits, goats, or mice along with the immunoglobulin (Ig) of the same
species as the primary antibody. Thus, this leads to the production of
polyclonal secondary Abs that can recognize multiple epitopes on primary Abs,
henceforth increasing the sensitivity and specificity of the assay.
The primary antibodies
segment is expected to grow at the fastest CAGR during the forecast period. The
increasing adoption of primary antibodies based (pAb-based) assays in clinical
diagnostics, and rising demand for high-quality & diverse primary Abs are
the factors contributing to the growth of the segment. Primary Abs are
essential reagents for various clinical assays, including Western Blotting,
ELISA, and Immunohistochemistry for the identification of disease biomarkers.
Thus, as the demand for personalized medicine and biomarker-based diagnostics
continues to grow, the primary antibody segment in the pAbs market is expected
to grow further.
Application Insights
Based on application, the diagnostics segment dominates the market for
polyclonal antibodies in 2023 and the same is anticipated to have the highest
CAGR from 2025-2029. pAbs are an ideal reagent in hemagglutination reactions
and diagnostics assay due to their capability to identify the epitopes of
targeted molecules. pAbs are relatively inexpensive to produce as
compared to mAbs, as they can be produced by immunizing animals such as
rabbits, goats, or mice, with the target antigen that would stimulate a
polyclonal antibody response. In addition, the polyclonal antibody used in
applications such as ELISA, Western Blot, and many others, are less likely to
produce false negatives due to their ability to recognize multiple epitopes on
the targeted antigen. Biomedical research is projected to show significant
growth during 2025-2029. This growth is due to their versatile nature, easy
producibility, diverse range of binding specificities, and the ability to
detect a wide range of biomolecules. In addition, as per the article published
in January 2023 by ScienceDaily, scientists have developed a machine learning
approach using AI technology to accelerate the production of new highly
specific antibody drugs against diseases such as cancer, rheumatoid arthritis,
and COVID-19. In June 2021, Rapid Novor designed the
first-of-its-kind sequencing technology, namely, REpAb, used for identifying
sequences in pAbs utilized during drug discovery processes. Such technological
advancements are expected to increase the demand for biomedical research during
the forecast period.
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Regional Insights
Based on region, North America's dominance in the Polyclonal
Antibodies Market can be attributed to several key factors. The region boasts
advanced healthcare infrastructure, a strong biotechnology sector, and
extensive pharmaceutical research and development activities. North America's aging population and high prevalence of chronic and infectious
diseases drive the demand for polyclonal antibodies in diagnostics, therapies,
and research. Access to healthcare, insurance coverage, and healthcare
expenditure levels are comparatively high, facilitating greater utilization of
these antibodies. The region's regulatory environment and
intellectual property protection encourage innovation, making it a hub for
biopharmaceutical and antibody-based therapeutic developments. These factors
collectively position North America as a leader in the Polyclonal Antibodies
Market.
Recent Developments
- In July 2022, GigaGen Inc. released a peer-reviewed study in the International Pathogens publication, unveiling their breakthrough recombinant polyclonal product, GIGA-2050, designed to combat SARS-CoV-2. The article detailed the company's meticulous adherence to Good Manufacturing Practice (GMP) standards in the production process and underscored the Investigational New Drug (IND)-enabling research conducted on this innovative class of medications. GigaGen's pioneering work in developing recombinant polyclonal antibodies represents a significant advancement in therapeutic strategies against infectious diseases, showcasing their commitment to scientific excellence and addressing critical global health challenges with cutting-edge medical solutions.
Key Market Players
- Thermo Fisher Scientific Inc
- Merck KGAA
- Abcam Plc
- Proteogenex Inc
- Proteintech Group, Inc
- Bio-Rad Laboratories Inc
- BPS Bioscience, Inc
- R&D Systems, Inc
- Agilent Technologies, Inc.
- Cusabio Technology LLC
By Product
|
By Application
|
By Source
|
By End user
|
By Region
|
- Primary Antibodies
- Secondary Antibodies
|
- Biomedical Research Diagnostics
|
- Rabbits
- Goats
- Sheep
- Mouse
- Others
|
- Pharmaceutical & Biotechnology Companies
- Hospitals & Diagnostic Centers
- Academic & Research Center
|
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Polyclonal Antibodies
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Polyclonal Antibodies Market, By Product:
o Primary Antibodies
o Secondary Antibodies
- Polyclonal Antibodies Market, By Application:
o Biomedical Research
o Diagnostics
- Polyclonal Antibodies Market, By Source:
o Rabbits
o Goats
o Sheep
o Mouse
o Others
- Polyclonal Antibodies Market, By End user:
o Pharmaceutical &
Biotechnology Companies
o Hospitals & Diagnostic
Centres
o Academic & Research
Centre
- Polyclonal Antibodies Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the
Polyclonal Antibodies Market.
Available Customizations:
Global Polyclonal Antibodies market report
with the given market data, Tech Sci Research offers customizations according
to a company's specific needs. The following customization options are
available for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
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