Forecast
Period
|
2026-2030
|
Market
Size (2024)
|
USD 208.58 Million
|
CAGR
(2025-2030)
|
5.72%
|
Fastest
Growing Segment
|
Human
|
Largest
Market
|
South
India
|
Market
Size (2030)
|
USD
287.94 Million
|
Market Overview
India
Monoclonal Antibodies Market was valued at USD
208.58 Million in 2024 and is expected to reach USD 287.94 Million by 2030
with a CAGR of 5.72% during the forecast period. Monoclonal antibodies (mAbs) are
laboratory-engineered molecules that replicate the immune system's ability to
combat harmful pathogens like bacteria, viruses, and other foreign substances.
These molecules are specifically designed to target and bind to distinct
antigens or proteins with high precision. mAbs are a key class of
biopharmaceuticals used for a variety of medical purposes, including disease
diagnosis and treatment. In India, the monoclonal antibodies market is
witnessing significant expansion, fueled by advancements in biotechnology,
growing healthcare demands, and an increased focus on treating chronic diseases
and cancer. As the need for targeted therapies continues to rise, mAbs are
gaining traction for their ability to provide highly specific and effective
treatments for a range of medical conditions, including cancer, autoimmune
disorders, and infectious diseases.
The
rise of biosimilars developed by Indian pharmaceutical companies has made mAb
treatments more affordable and accessible, presenting substantial opportunities
for market growth. India is also becoming a key hub for clinical trials, with
numerous global pharmaceutical companies conducting monoclonal antibody
studies, attracted by the country's large patient population and cost-effective
advantages. Many Indian pharmaceutical companies are forming partnerships with
international players to advance the development and distribution of monoclonal
antibody products, which expands their portfolios and broadens access to global
markets. Despite the affordability gains brought about by biosimilars, the
overall cost of monoclonal antibody therapies remains high, which limits access
for many patients. Additionally, stringent regulatory frameworks and market
entry barriers can slow the approval and commercialization of new mAb
treatments in India. The monoclonal antibodies market in India is
well-positioned for strong growth, driven by the increasing demand for targeted
therapies, advances in biotechnology, and government support for the
biosimilars sector. However, overcoming challenges related to cost and
regulatory hurdles will be crucial in ensuring broader access to these
therapies. The market is set to benefit from the ongoing development of
biosimilars, improved healthcare infrastructure, and a growing focus on
precision medicine.
Key Market Drivers
Growing Prevalence of Chronic
Diseases
The
rising prevalence of chronic diseases in India is a key factor driving the
growth of the monoclonal antibodies (mAb) market. Conditions such as cancer,
cardiovascular diseases, autoimmune disorders, and diabetes are becoming
increasingly common, largely due to changes in lifestyle, an aging population,
and environmental factors. According to recent data from the Longitudinal
Ageing Survey in India (LASI), 21% of the elderly population suffers from at
least one chronic condition, with urban areas exhibiting a higher prevalence
(29%) compared to rural areas (17%). Hypertension and diabetes are the most
widespread, accounting for approximately 68% of chronic diseases among the
elderly. Additionally, cardiovascular diseases impact 37% of individuals aged
75 and older, with bone/joint diseases and chronic lung diseases also emerging
as significant health concerns. As these conditions affect a growing
segment of the population, the demand for advanced treatments such as
monoclonal antibodies are rising. mAbs are particularly effective for treating
chronic diseases due to their ability to provide targeted therapies that
address the root causes of these conditions with precision. This makes them
especially valuable for managing complex, long-term illnesses like cancer and
autoimmune disorders, which require continuous treatment and specialized care.
The
increasing burden of chronic diseases has led to a greater emphasis on
innovative therapies, further driving the demand for monoclonal antibodies. As
the need for more effective and specialized treatments intensifies, the market
for mAbs is expected to expand, presenting significant opportunities for
pharmaceutical companies to develop and bring new mAb-based therapies to the
market.
Growing Demand for Targeted
Therapies
The
rising demand for targeted therapies is a key driver of the monoclonal
antibodies (mAb) market in India. As the healthcare sector evolves toward
precision medicine, there is a growing preference for treatments that directly
address the root causes of diseases, rather than simply alleviating symptoms.
Monoclonal antibodies, known for their ability to specifically target
particular molecules or cells associated with various conditions, are leading
this transformation. According to the Indian Council of Medical Research
(ICMR), for every two women diagnosed with breast cancer, one woman dies from
the disease in India. Additionally, approximately 2,500 individuals die each
day from tobacco-related illnesses. Cancers of the oral cavity and lungs in
men, and cervix and breast cancer in women, account for more than 50% of
cancer-related deaths in India. Targeted therapies are particularly in
demand for treating complex diseases such as cancer, autoimmune disorders, and
chronic conditions. For example, mAbs can be engineered to bind to specific
antigens on cancer cells, effectively targeting tumors with minimal damage to
surrounding healthy tissue. This precision not only enhances the effectiveness
of treatment but also minimizes side effects, making mAbs an appealing option
for both patients and healthcare providers.
As
both patients and medical professionals increasingly seek treatments with
better outcomes and fewer side effects, the demand for monoclonal antibodies
continues to grow. This shift toward precision and personalized medicine
further propels the expansion of the market, prompting pharmaceutical companies
to focus on developing and commercializing new mAb-based therapies for a wide
range of diseases.
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Key Market Challenges
Quality Assurance and
Manufacturing
The
production of mAbs involves complex biotechnological processes, including cell
culture, purification, and formulation. Ensuring consistency and quality
throughout these processes is challenging. Setting up and maintaining
facilities for mAb manufacturing requires substantial investments in
infrastructure, equipment, and skilled personnel. Ensuring compliance with Good
Manufacturing Practices (GMP) standards is essential. The mAb manufacturing
process is subject to strict regulatory oversight to guarantee product safety
and efficacy. Compliance with evolving regulatory requirements can be demanding
and resource intensive. Managing the supply chain for critical raw materials
and reagents needed for mAb production is a challenge, particularly during
disruptions such as the COVID-19 pandemic. Skilled professionals in
bioprocessing, quality control, and regulatory affairs are needed for
successful mAb manufacturing. A shortage of trained personnel can be a
challenge. Maintaining sterility and preventing contamination in bioreactors
and downstream processing is critical. Even minor contamination incidents can
result in production losses and quality issues. Transitioning from
laboratory-scale production to commercial-scale manufacturing presents
challenges in terms of process scalability, efficiency, and consistency.
Cost and Affordability
The
development and manufacturing of mAbs involve complex and resource-intensive
processes, contributing to high production costs. This cost burden can be
passed on to patients, making mAb therapies expensive. Patients, healthcare
providers, and healthcare systems in India are often price sensitive. The high
cost of mAbs may limit their adoption, especially in a healthcare market where
affordability is a critical factor. Health insurance coverage for mAbs may be
limited, which means that many patients must pay for these treatments out of
pocket. Affordability can be a major concern in such cases.
Even
if patients have health insurance, copayments, deductibles, and other
out-of-pocket expenses for mAbs can be substantial. High costs can discourage
patients from pursuing these therapies. The high cost of mAbs can create
disparities in healthcare access, making it difficult for marginalized or poor
populations to benefit from these therapies. High costs can limit market
penetration, which affects the adoption of mAbs. A smaller patient pool can
impact the commercial success of these therapies. The affordability of mAbs can
impact patient compliance. Patients who cannot afford these treatments may not
adhere to their prescribed regimens, leading to suboptimal outcomes. In rural
areas with limited healthcare infrastructure, affordability issues may exacerbate
disparities in access to mAb therapies.
Key Market Trends
Rising Focus on Biosimilars
Biosimilars
are biologic products that closely resemble an already approved reference
product, typically offered at a lower cost than the original branded versions.
This trend is particularly significant in India, where the ability to produce
high-quality, affordable biosimilars is expanding access to treatments,
particularly for low- and middle-income populations. A study commissioned by
the Department of Pharmaceuticals has projected that by 2030, patents for 24
major drugs, including globally recognized products such as Humira
(adalimumab), Keytruda (pembrolizumab), Opdivo (nivolumab), Ibrance
(palbociclib), and Symbicort (budesonide), will expire, unlocking a market
worth over USD 250 billion. As more than 20 drugs, collectively valued at USD 250
billion in annual sales, are poised to go off-patent, Indian companies are
expected to step in with generic and biosimilar alternatives.
India's
regulatory framework has become more conducive to biosimilar development, with
the Central Drugs Standard Control Organisation (CDSCO) streamlining approval
processes. Government support for biosimilar research and development has
significantly contributed to the rapid expansion of this market segment.
Initially, biosimilars in India were focused on oncology and immunology, but
their application is increasingly expanding to other therapeutic areas,
including rheumatology, diabetes, and dermatology. This broader range of uses
is further fueling demand. For instance, in March 2024, Aurobindo Pharma Ltd
announced that its wholly owned subsidiary, CuraTeQ Biologics Pvt Ltd,
demonstrated positive Phase-1 trial results for its Omalizumab biosimilar
(BP11), comparing favorably to the reference product Xolair sourced from the US
and EU. Omalizumab is a monoclonal antibody used to treat asthma and hives.
India's
leadership in biosimilar production is not just catering to domestic demand but
also positioning the country as a major player in international markets,
including Europe, the U.S., and emerging markets, opening up significant growth
opportunities. As the adoption of biosimilars continues to rise, their
affordability, accessibility, and effectiveness will be crucial factors in
shaping the future of the mAb market in India, making them a central element in
market growth and innovation.
Segmental Insights
Type Insights
Based
on Type, the Human emerged as the fastest growing segment
in the Indian market for Monoclonal Antibodies during the forecast period. Fully human monoclonal antibodies (mAbs)
are engineered to target specific molecules or cells involved in disease
processes with a high degree of precision. This targeted approach enables more
effective treatments, especially for complex conditions like cancer, autoimmune
disorders, and infectious diseases. By focusing exclusively on the relevant
disease-causing factors, human mAbs deliver superior therapeutic outcomes
compared to other types, such as murine or chimeric mAbs. Since human mAbs are
derived entirely from human sources, they are less likely to trigger immune
reactions, making them safer and better tolerated by patients, which enhances
their appeal in clinical settings.
Advances
in biotechnology, including the use of transgenic mice and phage display
techniques, have facilitated the development of high-quality fully human
antibodies, increasing their availability and cost-effectiveness. These
innovations are contributing to the rapid expansion of the human mAb market.
Regulatory agencies, such as the U.S. FDA and the EMA, are increasingly
favorable towards fully human mAbs, offering faster approval processes due to
their lower immunogenicity and superior safety profile. This regulatory
confidence is fostering further investment and development in human mAbs. As
the healthcare sector moves towards personalized medicine, human mAbs are
becoming central to this shift, offering highly targeted therapies tailored to
an individual's genetic profile or specific disease mechanisms. This aligns
with the growing demand for treatments that are more precise, effective, and
have fewer side effects. While initially used primarily in oncology, the
applications of human mAbs are now expanding into areas like autoimmune
disorders, infections, and neurological conditions. This broadening of
therapeutic uses is significantly increasing their market potential and growth
opportunities.
Application Insights
Based
on Application, Cancer emerged as the dominating segment in the Indian market
for Monoclonal Antibodies in 2024. India has experienced an increase in cancer
diagnoses, with a growing number of cases each year. Common types of cancer,
including breast cancer, lung cancer, colorectal cancer, and head and neck
cancers, are becoming more widespread, driving demand for advanced treatments
like monoclonal antibodies. Breast cancer is the most prevalent cancer among
women in India, representing 28.2% of all female cancers, with approximately
216,108 new cases estimated in 2022. Monoclonal antibodies have proven
highly effective in cancer treatment, particularly by modulating the immune
system and targeting tumor cells. These therapies have become a standard
approach for various cancers, offering better survival rates and quality of
life compared to traditional treatments like chemotherapy and radiation. Both
international and Indian pharmaceutical companies are making significant
investments in the development of mAb-based cancer therapies. The emphasis on
innovative, targeted cancer treatments is driving growth in the oncology
sector. As India’s healthcare infrastructure improves, and the cost of
monoclonal antibodies decreases partly due to the rise of biosimilars—oncology
continues to be the largest and fastest-growing therapeutic area for mAb
treatments.

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Regional Insights
Based
on Region, South India emerged as the dominant region in the Indian market for Monoclonal
Antibodies in 2024. The Southern states of Tamil Nadu, Karnataka, Andhra
Pradesh, and Kerala are recognized for their advanced healthcare
infrastructure, including specialized cancer centers, hospitals, and research
facilities. This well-established infrastructure makes the region an ideal hub
for the administration and expansion of monoclonal antibody therapies. Cities
like Hyderabad, often called "Genome Valley," and Bengaluru are home
to numerous pharmaceutical and biotech companies, known for their strong R&D
capabilities in monoclonal antibody development and production. The presence of
major players in the pharmaceutical and biosimilar industries has bolstered the
South's leadership in the mAb market. Furthermore, the South leads in the
number of clinical trials related to monoclonal antibodies, with its healthcare
institutions equipped to handle emerging treatments, fostering both research
activity and adoption of new therapies. The region also benefits from extensive
government initiatives aimed at improving healthcare access and advancing
cutting-edge treatments, such as monoclonal antibodies for cancer and other
complex diseases. Additionally, Southern India is home to top-tier medical and
pharmaceutical universities that produce a highly skilled workforce in fields like
biotechnology and molecular biology, supporting the region's growing
pharmaceutical sector and further fueling the mAb market's expansion.
Recent Development
- In
October 2024, the Serum Institute of India received approval from the Subject
Expert Committee (SEC) under the Central Drug Standard Control Organisation
(CDSCO) to proceed with a Phase III clinical trial of a dengue monoclonal
antibody in children aged 5 years and older, as well as adults with dengue.
This approval followed the submission of their proposal for the Phase III
trial, titled "A Phase III, double-blind, randomized, placebo-controlled,
multicentric study of dengue monoclonal antibody in children ≥ 5 years and
adults with dengue" (protocol number: Dengue-mAb-03 version 1.0, dated
July 4, 2024), along with the results from the Phase II study.
- In
September 2024, Indian Immunologicals, a subsidiary of the National Dairy
Development Board (NDDB), announced the development of a bivalent monoclonal
antibody with support from the National Biopharma Mission, the Department of
Biotechnology (DBT), and the Biotechnology Industry Research Assistance Council
(BIRAC). This fully human monoclonal antibody holds the potential to transform
rabies management by providing an exceptionally effective and targeted
treatment for post-exposure prophylaxis.
- In
June 2024, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, received
approval from the European Medicines Agency (EMA) to produce biosimilar
Bevacizumab at its state-of-the-art, multi-product monoclonal antibody (mAb)
drug substance facility in Bengaluru. This facility had previously been
approved for the production of biosimilar Trastuzumab in September 2022. The
company also announced that the EMA has renewed its Good Manufacturing Practice
(GMP) Certificates of Compliance for both its biosimilars manufacturing
facility in Bengaluru and its insulin facility in Malaysia, following routine
GMP inspections. These certificates were issued by the Health Products
Regulatory Authority (HPRA) in Ireland, on behalf of the EMA.
- In
March 2024, Roche Pharma India introduced Vabysmo (faricimab) for the treatment
of neovascular or "wet" age-related macular degeneration (nAMD) and
diabetic macular edema (DME) in India. This launch marks Roche's entry into the
ophthalmology market. Neovascular AMD and DME are among the primary causes of
vision loss globally. Vabysmo is the first and only dual-pathway inhibitor,
specifically designed to target and block two disease pathways associated with
several vision-threatening retinal conditions.
Key Market Players
- Dr. Reddy's Laboratories Ltd.
- Bristol Myers Squibb India Pvt. Ltd.
- Roche India Pvt. Ltd.
- Intas Pharmaceuticals Limited
- Merck India
- Eli Lilly, and Company (India) Private
Limited
- Biocon Limited
- AstraZeneca India Pvt. Ltd.
- Pfizer Limited
By
Type
|
By
Application
|
By
Production
|
By
Biomanufacturing
|
By
End User
|
By Region
|
- Murine
- Chimeric
- Humanized
- Human
|
- Cancer
- Cardiac/Cardiovascular
- Neurological
- Others
|
|
|
- Hospitals
- Research Laboratories
- Others
|
- West India
- North India
- South India
- East India
|
Report Scope:
In this report, the India Monoclonal Antibodies Market
has been segmented into the following categories, in addition to the industry
trends which have also been detailed below:
- India Monoclonal Antibodies Market, By Type:
o Murine
o Chimeric
o Humanized
o Human
- India Monoclonal Antibodies Market, By Application:
o Cancer
o Cardiac/Cardiovascular
o Neurological
o Others
- India Monoclonal Antibodies Market, By Production:
o In vitro
o In vivo
- India Monoclonal Antibodies Market, By Biomanufacturing:
o Originator
o CMO
- India Monoclonal Antibodies Market, By End User:
o Hospitals
o Research Laboratories
o Others
- India Monoclonal Antibodies Market, By Region:
o West India
o North India
o South India
o East India
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the India Monoclonal
Antibodies Market.
Available Customizations:
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given market data, TechSci 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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