|
Forecast Period
|
2026-2030
|
|
Market Size (2024)
|
USD 1.19 Billion
|
|
Market Size (2030)
|
USD 1.70 Billion
|
|
CAGR (2025-2030)
|
6.25%
|
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Fastest Growing Segment
|
Reagents and Kits
|
|
Largest Market
|
West India
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Market Overview
India Immunoassay Market was valued at USD 1.19 Billion in 2024 and is expected to reach USD 1.70 Billion by 2030 with a CAGR of 6.25% during the forecast period. The
immunoassay market refers to the global demand and supply for immunoassay
techniques, which are vital biochemical tests used to measure the presence or
concentration of substances in complex solutions. These tests leverage the
remarkable ability of antibodies or immunoglobulins to recognize and bind
specific macromolecules, even in the midst of intricate mixtures. Immunoassays
play a crucial role in diagnostics and research, finding applications in
various fields such as infectious diseases, endocrinology, and oncology.
The growth of
the immunoassay market is fueled by several factors. The rising
incidence of chronic and infectious diseases has created a significant demand
for accurate and efficient diagnostic tools. In
October 2023, a study from a tertiary care center in Bihar examined the use of
Indirect Immunofluorescence (IIF) and Line Immunoassay (LIA) in diagnosing
autoimmune diseases (ADs) in 98 patients. The speckled IIF pattern was most
commonly linked to systemic lupus erythematosus (SLE), with anti-U1-snRNP,
anti-SS-A/Ro60, and anti-SS-B/La being the most frequent autoantibodies
identified. IIF fluorescence patterns effectively predicted specific
antibodies, while LIA was suggested for IIF-positive cases with unclear or
atypical clinical presentations. Immunoassays provide reliable
results, aiding in the early detection and monitoring of diseases. Technological advancements in immunoassay products have improved their
sensitivity, specificity, and ease of use, making them indispensable in
clinical settings. The increasing availability and accessibility of
immunoassay products have contributed to their widespread adoption across
healthcare facilities and research institutions worldwide. As the immunoassay
market continues to expand, it is expected to drive advancements in diagnostic
capabilities, enhance patient care, and facilitate breakthroughs in various
fields of research.
Key Market Drivers
High Sensitivity
and Specificity of Immunoassays
The high
sensitivity and specificity of immunoassays are key factors driving the
significant growth of the immunoassay market in India. These advanced assays
have become increasingly prevalent in diagnostic laboratories due to their
exceptional ability to precisely detect and quantify specific molecules, even
in extremely low concentrations. This remarkable accuracy not only aids in the
early detection of diseases such as cancer and infectious diseases but also plays
a vital role in improving patient outcomes through timely intervention.
In a country
like India, with its vast population and high disease burden, the availability
of such highly precise diagnostic tools is invaluable. The ability of
immunoassays to provide reliable results with minimal chances of false
positives instills trust and confidence in healthcare providers and patients
alike. As a result, there has been a surge in demand for these diagnostic
tools, leading to the substantial growth of the immunoassay market in the
country. Looking ahead, as healthcare in India continues to evolve and expand,
the future of immunoassays appears promising. The increasing adoption of these
advanced diagnostic technologies is expected across various healthcare sectors
and diagnostic laboratories, further fueling the growth of the immunoassay
market. With their ability to revolutionize disease detection and management,
immunoassays are poised to play a crucial role in shaping the future of
healthcare in India.
Technological
Advancements in Immunoassay Instruments
In India,
remarkable technological advancements in immunoassay instruments have played a
pivotal role in bolstering the growth of the immunoassay market. With the surge
in the prevalence of chronic and infectious diseases, there has been a
significant increase in the demand for robust diagnostic solutions that can
effectively address these healthcare challenges. The advent of highly
sensitive, rapid, and compact immunoassay devices has been nothing short of
transformative. These modern instruments not only deliver precise results but
also enable early disease detection and management, thereby alleviating the
burden on healthcare systems. Manufacturers in the immunoassay
industry are increasingly focusing on combining automation and miniaturization
to enhance productivity and efficiency in laboratories. This innovative
approach is opening up new avenues for cutting-edge therapeutics research and
drug discovery, driving the industry towards groundbreaking advancements.
The Immunoassay platform in Mindray is equipped with the most advanced Chemiluminescence technology. Mindray Serum Automation Line (SAL) SAL-6000 & SAL-9000 is a high-performance integrated system connecting a Chemistry Analyzer seamlessly with a Chemiluminescence Immunoassay analyzer. With a patented automatic serum analysis design, the SAL series not only helps you optimize the management of lab space and manpower but also offers highly reliable test results. The Immunoassay platform in Mindray is equipped with the most advanced Chemiluminescence technology which have very high sensitivity, specificity, and a wide assay menu.
Equally
important is the rise of point-of-care (POC) testing in India. The development
of POC immunoassay systems has revolutionized diagnostics by making them more
accessible, even in remote locations that have limited healthcare
infrastructure. This accessibility is proving to be a game-changer, as it
enables timely and accurate diagnosis, paving the way for effective treatment
and improved patient outcomes.
The Indian
government's unwavering commitment to strengthening healthcare services,
coupled with the growing awareness about the benefits of personalized medicine
and preventive healthcare, is further fueling the surge in the immunoassay
market. This collaborative effort is ensuring that the latest advancements in immunoassay
instruments reach every corner of the country, benefiting a larger population
and improving overall healthcare outcomes. These technological advancements in
immunoassay instruments are acting as key growth accelerators in the Indian
immunoassay market, driving innovation, improving accessibility, and ultimately
transforming the landscape of healthcare in the country.
Increasing
Prevalence of Chronic and Infectious Diseases
In India, the
surge of chronic and infectious diseases, such as cardiovascular disease,
diabetes, cancer, tuberculosis, and hepatitis, has significantly driven the
growth of the immunoassay market. These diseases have posed a formidable
challenge to the healthcare system, necessitating the development and adoption
of improved diagnostic techniques. In response to this growing need,
immunoassays have emerged as a vital tool, offering fast, accurate, and
cost-effective detection of various diseases. Their ability to provide reliable
results has made them increasingly prominent in the Indian healthcare
landscape.
According to National Library of Medicine, about 21% of the elderly in India reportedly have at least one chronic disease. Seventeen percent elderly in rural areas and 29% in urban areas suffer from a chronic disease. Hypertension and diabetes account for about 68% of all chronic diseases. The rise in health awareness among the population and the Indian government's
focus on improving healthcare infrastructure have played a crucial role in the
widespread adoption of immunoassays. The establishment of advanced diagnostic
centers equipped with state-of-the-art technologies has further accelerated
their usage.
India's
considerable population also presents a significant patient pool, intensifying
the demand for efficient and reliable diagnostic methods. As a result, the
immunoassay market has witnessed rapid expansion, becoming an indispensable
component in India's fight against the escalating burden of chronic and
infectious diseases. The continued growth and advancement of the immunoassay
market in India underscore the importance of these diagnostic tools in
addressing the healthcare challenges faced by the nation. By facilitating early
and accurate detection, immunoassays contribute to improved patient outcomes
and the overall well-being of the population.
Increasing Incidence
of Cancer
The increasing
incidence of cancer in India is a significant driving force for the growth of
the immunoassay market. Immunoassays, a bioanalytical method used to detect the
presence and concentration of proteins in a sample, play a vital role in cancer
diagnosis, patient monitoring, and therapy selection. As the number of cancer
cases continues to rise, the demand for accurate, reliable, and quick
diagnostic methods has soared, fueling the expansion of the immunoassay market
in India.
India, with
its burgeoning population and a rising middle-class, presents a vast patient
pool and a growing demand for advanced healthcare infrastructure. With the
growing awareness about the importance of early detection of cancer, there has
been a surge in routine screenings, further increasing the need for
immunoassays. The government's efforts to improve healthcare
infrastructure and make cutting-edge diagnostic tools accessible to larger
segments of the population have also contributed to the growth of the
immunoassay market in the country. The rise of local immunoassay
manufacturers focusing on cost-effective solutions suitable for the Indian
market has made these essential diagnostic tools more accessible to healthcare
facilities across the nation, catalyzing the industry's expansion. This
combination of factors underscores how the escalating cancer incidence in India
directly propels the growth of the immunoassay market, creating opportunities
for innovation and advancements in cancer diagnostics and treatment.
Key Market Challenges
Stringent
Regulatory Scenario for Approval of Immunoassays
The stringent
regulatory environment for the approval of immunoassays in India is a
significant hindrance to market growth. Obtaining approval for new assays
requires a rigorous, time-consuming process that involves a thorough review of
clinical efficacy, safety, and quality. The Central Drugs Standard Control
Organization (CDSCO), the national regulatory body for pharmaceuticals and
medical devices, mandates strict adherence to these parameters. This regulatory
scrutiny, albeit necessary to maintain high standards of healthcare and ensure
patient safety, often results in substantial delays in bringing new products to
the market. Given the rapidly evolving nature of diseases and the resultant
demand for advanced diagnostic tools, these delays could prove costly for both
patients and manufacturers. Timely access to innovative immunoassays can have a
significant impact on disease diagnosis and treatment outcomes. However, the
stringent regulatory requirements and the associated lengthy approval process
may discourage companies from investing in the development of new immunoassays
in India.
In addition to
delays, the high costs associated with compliance with these regulatory norms
further strain the resources of manufacturers. Small and medium-sized
companies, in particular, may find it challenging to navigate the complex and
expensive regulatory landscape. In an environment where innovation and speed
are essential, these challenges pose a barrier to the growth and development of
the immunoassay market in India. Efforts to streamline the regulatory approval
process and reduce the burden on manufacturers while maintaining high standards
of safety and efficacy are crucial. Balancing the need for stringent regulation
with the facilitation of timely access to innovative immunoassays is vital for
the growth and advancement of healthcare in India.
Complexity of
Procedures
The growth of
immunoassay techniques in India is currently being hindered by the complexity
of the procedures involved. Immunoassays, despite their diverse applications in
diagnostic and therapeutic settings, are often characterized by intricate
protocols and require a high level of expertise to perform accurately. This
complexity is a significant barrier, especially in a country like India, where
resources and specialized training can be limited. Coupled with this, the lack
of standardized procedures and the need for advanced laboratory infrastructure
to execute these tests further exacerbate the challenge. Equally significant is
the time-consuming nature of these assays, limiting their use in time-sensitive
diagnostics. The cost implications of these complex procedures
cannot be overlooked. The expenses associated with procuring sophisticated
reagents and maintaining the necessary equipment can be prohibitive, thereby
limiting the widespread adoption of immunoassay techniques. These factors
combined are slowing the growth of immunoassay in India, calling for urgent
simplification of procedures and training of personnel to unlock the full potential
of this powerful tool in healthcare.
Key Market Trends
Increased
Patient Awareness
The growth of
immunoassay testing in India is significantly influenced by the increasing
awareness among patients regarding advancements in diagnostic techniques.
Immunoassays, which provide fast and accurate results, are becoming the
preferred diagnostic method for numerous conditions, including infectious
diseases, endocrine disorders, and oncological conditions. As the Indian
population gains knowledge about these modern diagnostic tools through health
education initiatives, online platforms, and patient-doctor interactions, the
demand for immunoassay testing is surging.
One of the key
factors driving this demand is the rise in lifestyle diseases, such as diabetes
and cardiovascular ailments. As patients recognize the importance of early and
precise diagnosis for effective treatment, they are increasingly turning to
immunoassays for accurate and timely results.Public and private companies are boosting the India immunoassay demand by initiatives such as, In
March 2024, Fapon, a global leader in life sciences, reaffirmed its commitment
to advancing the Indian IVD industry at Medical Fair India 2024, held from
March 13 to 15 in Mumbai. As one of the premier medical trade fairs in India,
the event served as a key platform for Fapon to showcase its innovative IVD
technologies and comprehensive solutions designed for IVD manufacturers.
At the
fair, Fapon introduced a range of novel IVD products, technologies, and
solutions tailored to the Indian market, including new biomarkers, blockers,
bulk reagents, assays, and instrument platforms, all aimed at meeting the
evolving needs of the local healthcare sector. This trend is further fueled by
the Indian government's efforts to enhance healthcare infrastructure and ensure
the accessibility of sophisticated diagnostic services, even in rural areas.
These initiatives are playing a crucial role in driving the expansion of the
immunoassay market in India.
In addition to
the increasing patient awareness and the prevalence of lifestyle diseases,
government initiatives are also contributing to the growth of the immunoassay
market. By focusing on improving healthcare infrastructure and making
sophisticated diagnostic services more accessible, the Indian government is
creating an environment that supports the adoption of immunoassay testing. This
combination of increased patient awareness, the rise in lifestyle diseases, and
government initiatives is driving the expansion of the immunoassay market in
India.
Emerging Trend
of Smartphone-Based Formats and Multiplex Bead Assays
Emerging
trends in Smartphone-Based Formats and Multiplex Bead Assays are propelling the
growth of Immunoassay in India. The integration of smartphones with immunoassay
systems offers a multitude of benefits such as portability, affordability, and
the ability to handle multiple tests simultaneously, making it a practical
choice for areas with limited resources. The use of smartphone technology is
revolutionising the field of diagnostics, by providing real-time interpretation
of test results and facilitating seamless data sharing between healthcare
professionals. Multiplex Bead Assays, on the other hand, enable the
simultaneous detection of multiple analytes in a single sample, thereby
enhancing the efficiency and accuracy of diagnostic procedures. This technique
is particularly beneficial in the detection of complex diseases, such as
autoimmune disorders and cancers, where multiple biomarkers are often involved.
The rising prevalence of such diseases in India necessitates more efficient
diagnostic tools, thereby increasing the demand for advanced immunoassay
techniques. The growth of the immunoassay market is supported by
the Indian government's initiatives to improve healthcare infrastructure and
accessibility. By embracing these innovative technologies, India is setting a
new benchmark in the field of immunoassays, paving the way for rapid, accurate,
and affordable diagnostics.
Segmental Insights
Product Insights
Based
on the product, Reagents and kits contributed to the largest market share in
the India immunoassay market for 2023. This segment is projected to maintain
its lead over the forecast period, driven by the high demand for immunoassay
reagents and kits for diagnostic purposes. With the growing prevalence of
infectious and autoimmune diseases, there is an increasing need for reliable
and efficient immunoassay solutions. The approval and launch of novel
immunoassay kits are expected to further support the growth of this segment,
providing more advanced and accurate diagnostic options.
On
the other hand, the software and services segment is anticipated to register a
steady compound annual growth rate (CAGR) over the forecast period. This can be
attributed to the increased availability and high demand for cost-effective
immunoassay services, especially in developing markets. For example, in June
2020, Sysmex Corporation began offering novel coronavirus (SARS-CoV-2) antibody
lab assay services, addressing the urgent need for reliable testing during the
pandemic. Overall, the India immunoassay market is poised for significant
growth, driven by the continuous advancements in reagents, kits, software, and
services, which are crucial in the accurate and timely diagnosis of various
diseases.
Technology Insights
Based
on technology, the Enzyme Immunoassays (EIA) technology is expected to continue
its dominance in the India immunoassay market. This is primarily attributed to
its extensive application in various areas such as clinical diagnostics, drug
monitoring, and pharmaceutical analysis. EIA stands out due to its remarkable
accuracy, affordability, and ability to deliver rapid results, making it a
preferred choice in the Indian medical landscape.
The versatility of EIA in detecting a wide range of diseases is another key
factor contributing to its dominance. From infectious diseases to chronic
diseases and even cancer, EIA has proven its effectiveness in diagnosing and
monitoring various health conditions. This comprehensive disease detection
capability further solidifies EIA as the technology of choice for healthcare
professionals in India. With its widespread adoption and numerous benefits, the
Enzyme Immunoassays technology continues to play a vital role in advancing
medical diagnostics and improving patient care in India.
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Regional Insights
The Western
region of India, encompassing the vibrant cities of Mumbai and Pune, is currently
exerting its dominance in the immunoassay market across the nation. This
remarkable feat can be attributed to the remarkable growth of the healthcare
sector in this region, which has seen a surge in advanced diagnostic
facilities, coupled with the prevalence of chronic diseases. The
region's robust ecosystem benefits from the presence of leading pharmaceutical
companies and renowned research institutes, further bolstering its market share
and solidifying its position as a key player in the field. The healthcare
sector in the Western region has witnessed significant advancements in recent
years. The availability of state-of-the-art diagnostic facilities has
contributed to accurate and timely detection of various diseases. This, in turn,
has led to improved patient outcomes and a higher demand for immunoassay
technologies. The region's proactive approach towards healthcare
has attracted leading pharmaceutical companies to establish their presence
here. Their collaborations with renowned research institutes have resulted in
groundbreaking discoveries and innovations in the field of immunoassays. This
collaborative approach has not only enhanced the region's market share but also
positioned it as a hub for cutting-edge research and development.
In addition,
the Western region's strategic geographical location and well-developed
infrastructure have played a crucial role in its dominance in the immunoassay
market. The region's easy accessibility, coupled with efficient logistics, has
facilitated the seamless distribution of immunoassay products to various parts
of the country. The Western region of India has emerged as a frontrunner in the
immunoassay market, driven by its remarkable growth in the healthcare sector,
strong ecosystem, and strategic advantages. With continuous advancements and
collaborations, the region is poised to further expand its market share and
solidify its position as a key player in the field.
Recent Developments
- In July
2023, Mylab, a biotech startup headquartered in Pune, introduced the MyBox+
device featuring proprietary Dry Luminescence Immunoassay technology. This
innovative device offers a selection of crucial tests, including Thyroid panel
(T-3, T-4, TSH), Cardiac marker (Troponin), and biomarker (CRP, D-Dimer).
- In
January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd announced
their collaboration through a Contract Development and Manufacturing
Organization (CDMO) partnership. This partnership focuses on the production of
cartridge-based CLIA system reagents for the immunology analyzers Mispa i60 and
Mispa i121. Under this agreement, the analyzers and reagents will be marketed
under Agappe’s brand, establishing Agappe as the first Indian company to offer
a complete chemiluminescence solution with locally manufactured reagents.
- In
July 2023, Roche Diagnostics India introduced the Elecsys HCV Duo, a
groundbreaking dual antigen and antibody diagnostic test. This marks the launch
of India’s first commercially available fully automated immunoassay capable of
simultaneously and independently determining the hepatitis C virus (HCV)
antigen and antibody status using a single human plasma or serum sample. The
innovative test enables the detection of HCV during the early stages of
infection, throughout chronic infection, and during recovery. The introduction
addresses the growing recognition of viral hepatitis as a significant public
health challenge in India.
- In
September 2024, diagnostic tools developed under the 'Make in India' initiative
for the early detection of critical diseases such as Alzheimer’s, cancer, and
gastrointestinal disorders were officially launched. Approved
by the Drugs Controller General of India (DCGI), these innovative in-vitro
biomarkers will be produced in Kochi, Kerala. This milestone collaboration
brings advanced Chemiluminescent Enzyme Immunoassay (CLEIA) technology to the
forefront, marking a significant advancement in India’s healthcare sector for
early disease detection.
Key Market Players
- F. Hoffmann-La Roche Ltd.
- Abbott India Ltd.
- BioMérieux India Pvt. Ltd.
- Bio-Rad laboratories India Pvt.Ltd
- Becton Dickinson Pvt.Ltd
- Thermo Fisher Scientific India Pvt. Ltd.
- Danaher India (DHR Holding India Pvt. Ltd.)
- Siemens Healthcare Private Limited
- Randox Laboratories (India) Pvt. Ltd.
- Sysmex India Pvt. Ltd.
|
By Product
|
By Technology
|
By Indication
|
By End User
|
By Region
|
- Reagents and Kits
- Analyzers/Instruments
- Software and Services
|
- Radioimmunoassay (RIA)
- Enzyme Immunoassays (EIA)
- Fluoro Immnoassay (FIA)
- Chemiluminescence Immunoassay (CLIA)
- Rapid Test
- Others
|
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Diseases
- Autoimmune Diseases
- Others
|
- Hospitals & Clinics
- Pharmaceutical & Biotechnology Companies
- Academic & Research Institutions
- Others
|
|
Report Scope:
In this report,
the India Immunoassay Market has been segmented into the following categories,
in addition to the industry trends which have also been detailed below:
- India Immunoassay Market, By Product:
o Reagents and Kits
o Analyzers/Instruments
o Software and Services
- India Immunoassay Market, By Technology:
o Radioimmunoassay (RIA)
o Enzyme Immunoassays (EIA)
o Fluoro Immnoassay (FIA)
o Chemiluminescence Immunoassay (CLIA)
o Rapid Test
o Others
- India Immunoassay Market, By Indication:
o Therapeutic Drug Monitoring
o Oncology
o Cardiology
o Endocrinology
o Infectious Diseases
o Autoimmune Diseases
o Others
- India Immunoassay Market, By End User:
o Hospitals & Clinics
o Pharmaceutical & Biotechnology Companies
o Academic & Research Institutions
o Others
- India Immunoassay Market, By Region:
o North
o South
o West
o East
Competitive
Landscape
Company
Profiles: Detailed analysis of the major companies
present in the India Immunoassay Market.
Available
Customizations:
India Immunoassay
Market report with the 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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