Forecast Period | 2026-2030 |
Market Size (2024) | USD 1.74 billion |
Market Size (2030) | USD 2.37 Billion |
CAGR (2025-2030) | 5.45% |
Fastest Growing Segment | Reagent |
Largest Market | North India |
Market Overview
India In Vitro Diagnostics Market has valued at USD 1.74 billion in 2024 and is expected to reach USD 2.37 Billion by 2030, with a CAGR of 5.45% during the forecast period. In Vitro Diagnostics
(IVD) refers to a category of medical tests and diagnostic procedures that are
performed on samples of blood, tissues, urine, or other bodily fluids obtained
from a patient's body. These tests are conducted outside the patient's body,
typically in a laboratory setting, and they are used to diagnose, monitor, and
manage various medical conditions. The term in vitro is Latin for in glass,
indicating that these tests are conducted in a controlled environment, such as
test tubes or lab equipment, rather than inside a living organism. IVD
tests are widely used to identify the presence of specific diseases,
infections, or medical conditions. For example, blood tests can detect markers
associated with diabetes, while molecular tests can identify the genetic
material of pathogens like viruses or bacteria. Patients with chronic diseases
or those undergoing treatment often require regular monitoring of their health.
IVD tests provide essential data to healthcare providers to assess the progress
of a disease or the effectiveness of treatment.
India's aging population is increasing, leading to
a higher demand for diagnostic tests. Elderly individuals often require more
extensive healthcare monitoring and diagnostic services. Advances in IVD
technology, including the integration of artificial intelligence (AI) and the
development of point-of-care (POC) devices, have expanded the capabilities and
applications of diagnostic tests. The growth of the pharmaceutical and
biotechnology sectors in India relies heavily on diagnostic services for
research, development, and quality control, leading to a substantial demand for
IVD products. The emergence of precision medicine and personalized
healthcare has created a need for specific diagnostic tests tailored to
individual genetic and clinical profiles. Government programs and
initiatives, such as the National Health Mission and Ayushman Bharat, have
improved healthcare access and affordability, thereby boosting the demand for
diagnostic services.
Key Market Drivers
Technological Advancements
This technology involves the
analysis of genetic material, such as DNA and RNA, to diagnose diseases.
Polymerase Chain Reaction (PCR) and nucleic acid sequencing techniques have
revolutionized the detection of infectious diseases, genetic disorders, and cancer.
Next-Generation Sequencing (NGS) enables the sequencing of entire genomes and
has applications in cancer genomics, personalized medicine, and identifying
genetic mutations. It provides valuable insights for disease diagnosis and
treatment. Point-of-Care (POC) Testing devices and tests are designed for use
at or near the patient's location, providing rapid results. These tests are
used in emergency rooms, clinics, and remote healthcare settings. They include
devices like glucometers and lateral flow assays (e.g., pregnancy tests).
Microfluidics and lab-on-a-chip platforms miniaturize and automate laboratory
functions, allowing for quick and efficient sample processing. These
technologies are used in compact, portable diagnostic devices. Enzyme-Linked Immunosorbent
Assay (ELISA) and chemiluminescence assays are key technologies for detecting
antibodies or antigens related to infectious diseases and autoimmune disorders.
Immunoassays are becoming increasingly sensitive and specific.
Biosensors incorporate
biological components, like antibodies, enzymes, or DNA, to detect specific
molecules. They are used in continuous monitoring devices for glucose, lactate,
and other analytes. Digital pathology systems digitize traditional glass slides,
making it easier to store, share, and analyze tissue samples. Artificial
intelligence (AI) is used to aid pathologists in diagnosis and decision-making.
AI and machine learning algorithms are being used to analyze large datasets of
diagnostic information. These technologies improve the accuracy and speed of
diagnosis and can identify patterns that may be missed by human analysts. These
technologies enable remote consultation and monitoring of patients. Remote
monitoring devices can relay data to healthcare providers for analysis,
including vital signs and diagnostic results. Liquid biopsies involve analyzing
blood or other bodily fluids for biomarkers related to cancer, allowing for
early cancer detection and monitoring of treatment response.
These technological advancements are supported by the Indian government's initiatives to boost the medical devices sector. The National Medical Devices Policy, 2023, aims to position India as a global leader in manufacturing and innovation of medical devices, including IVDs, by achieving a 10-12% share in the expanding global market over the next 25 years.
Growing Aging Population
India's rapidly aging population is a significant driver of the in vitro diagnostics (IVD) market. As of 2021, approximately 6.8% of India's population was aged 65 and above, totaling around 93 million individuals. This demographic shift is accompanied by an increased prevalence of chronic diseases such as diabetes, cardiovascular conditions, cancer, and neurodegenerative disorders, all of which necessitate regular monitoring and early detection through diagnostic tests.
Older adults often require more frequent health monitoring due to the increased likelihood of multiple health issues. Diagnostic tests, including routine blood tests, imaging, and cancer screenings, are essential for early disease detection and management. As individuals age, healthcare providers recommend various screenings and preventive measures, such as mammograms, colonoscopies, bone density scans, and prostate-specific antigen (PSA) tests. These screenings rely on IVD to detect diseases at an early and treatable stage.
Older adults frequently take multiple medications to manage chronic conditions. Diagnostic tests are essential for monitoring medication effectiveness, dosage adjustments, and identifying potential drug interactions. Geriatric care often involves a comprehensive assessment of an individual's health status. IVD tests help in evaluating organ function, nutritional status, and cognitive function, among other health parameters. Early diagnosis and intervention are critical for improving the quality of life and increasing the survival rates of older adults.
IVD tests are a cornerstone of early disease detection. Older adults are more vulnerable to infectious diseases, as demonstrated during the COVID-19 pandemic. IVD tests, including PCR tests and serological assays, have been crucial for diagnosing and managing such outbreaks. Advances in healthcare have led to a growing emphasis on personalized medicine. IVD tests can provide information about an individual's genetic and molecular profile, which can guide tailored treatment plans.
For older adults who may have limited mobility, remote monitoring through IVD devices can facilitate healthcare providers' access to health data, enabling timely intervention when necessary. Older adults are increasingly proactive in managing their health. They may request diagnostic tests to monitor specific health parameters or to gain a better understanding of their health status. Health insurance coverage for diagnostic tests can make it more financially feasible for older adults to seek routine health monitoring.
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Key Market Challenges
Price Sensitivity
Many people in India have limited financial
resources and may find the cost of diagnostic tests and healthcare services to
be a significant burden. Price sensitivity is particularly pronounced among the
lower-income segments of the population. India's healthcare system relies
heavily on out-of-pocket payments, where individuals pay for their healthcare
expenses directly. This can make individuals more price-conscious and hesitant
to seek diagnostic tests, especially for non-emergency conditions. The IVD market
in India is highly competitive, with numerous domestic and international
players. Competition can lead to price wars and the need for companies to offer
cost-effective solutions to gain market share. While health insurance is
becoming more common in India, there are still gaps in coverage, and not all
diagnostic tests may be reimbursed. This can make individuals more
cost-sensitive when choosing which tests to undergo. Patients may weigh the
perceived value of a diagnostic test against its cost. If the perceived
benefits of a test do not align with its price, individuals may choose to forgo
certain tests. India's population is characterized by significant economic
disparities. Price sensitivity can vary widely between urban and rural areas
and among different income groups. Patients may seek low-cost alternatives,
such as generic medications or less expensive tests, rather than more advanced
and costly diagnostic options.
Quality Control and Standardization
India's IVD market is characterized by a diverse
and evolving regulatory landscape. There are various regulatory authorities,
including the Central Drugs Standard Control Organization (CDSCO) and
state-level regulators. This fragmentation can lead to inconsistencies in
regulatory enforcement and product quality standards. The quality of diagnostic
tests and devices can vary widely among manufacturers and suppliers.
Inconsistent quality can impact the accuracy and reliability of test results,
leading to misdiagnosis or delayed treatment. The presence of counterfeit and
substandard diagnostic products in the market poses a significant challenge.
These products may not meet quality and safety standards, potentially putting
patients’ health at risk. There is often a lack of standardized protocols and
guidelines for diagnostic testing in India. This can lead to variations in
testing procedures, making it difficult to compare results across different
laboratories and healthcare facilities. The proficiency and training of
laboratory personnel and technicians can vary. Proper training and adherence to
standardized procedures are essential for quality control in diagnostic
testing. In some regions, there may be infrastructure challenges, including
unreliable power supply and inadequate facilities, which can affect the
performance of diagnostic equipment and the consistency of test results.
Accreditation of laboratories and diagnostic facilities is limited in India,
making it challenging to assess and ensure the quality of testing services.
Key Market Trends
Rise in Home Testing
Home testing provides a convenient option for
individuals who prefer to monitor their health without visiting a healthcare
facility. It eliminates the need for travel and long waiting times at clinics
or laboratories. Some medical conditions or diagnostic tests may be of a
sensitive nature. Home testing offers a more private and discreet way to
perform these tests without having to share personal health information with
others. Home testing makes diagnostic services more accessible to people living
in remote or underserved areas. It can bridge the gap in healthcare access,
especially in rural regions. With increasing health awareness, people are
proactively seeking ways to monitor their health. Home testing empowers
individuals to engage in preventive healthcare by monitoring their key health
parameters regularly. Patients with chronic conditions such as diabetes often
require frequent monitoring of specific biomarkers. Home testing devices make
it easier for individuals to manage their conditions and adjust their treatment
plans accordingly. The growth of telemedicine and remote healthcare
consultations during the COVID-19 pandemic has increased the demand for home
testing. Healthcare providers can guide patients in conducting tests and
interpreting results during virtual visits. Advancements in point-of-care
diagnostic devices have made it easier for individuals to perform tests at
home. These devices provide quick and reliable results for various health
parameters.
Rising Pharmaceutical and Biotech Industry
The pharmaceutical and biotech industries heavily
rely on IVD in their R&D activities. Diagnostic tests are essential for the
discovery and development of new drugs, as they help identify potential
therapeutic targets, assess drug efficacy, and determine patient eligibility
for clinical trials. IVD tests are crucial for patient screening, selection,
and monitoring in clinical trials. These tests ensure that participants meet
specific criteria, evaluate the effectiveness of investigational drugs, and
assess safety and tolerability. Companion diagnostics are IVD tests designed to
identify patients who are likely to benefit from specific therapies. They play
a crucial role in precision medicine, helping pharmaceutical companies tailor
treatments to individual patient profiles. Pharmaceutical and biotech companies
rely on IVD for quality control and assurance during the production of
biologics, pharmaceuticals, and medical devices. This ensures product safety
and consistency. IVD tests help identify biomarkers associated with diseases,
which can be used to develop targeted therapies and monitor disease
progression. Biomarkers are instrumental in the development of personalized
medicine.
IVD tests are used to determine how an individual's
genetic makeup affects their response to specific drugs. This information is
valuable for drug selection and dosing, reducing adverse effects and improving
treatment outcomes. IVD tests are used to monitor drug levels and therapeutic
drug effects in patients receiving medications, ensuring optimal dosing, and
minimizing side effects. Monitoring the prevalence of infectious diseases is
essential for the pharmaceutical industry. IVD tests are used to track disease
outbreaks, assess treatment effectiveness, and design vaccines. Point-of-care
IVD devices are used in pharmaceutical and biotech research settings for quick,
on-site testing of samples, which can expedite decision-making and research
progress. Emerging trends in drug development, such as immunotherapy and gene
therapy, rely on IVD tests to assess patient suitability, monitor response, and
manage potential side effects.
Segmental Insights
Product Insights
Based on Product, Reagent segment is anticipated to demonstrate the fastest growth in the India In Vitro Diagnostics Market through 2030. Reagents are essential
components in a wide range of diagnostic tests, from basic blood tests to
complex molecular diagnostics. As the demand for diagnostic testing continues
to grow in India, the need for reagents to conduct these tests also increases. Reagents
are used in various diagnostic disciplines, including clinical chemistry,
hematology, immunology, microbiology, and molecular diagnostics. This diversity
of applications ensures a broad customer base, contributing to the significant
market share of the reagent segment. Many routine diagnostic tests, such as
blood glucose, cholesterol, and liver function tests, require reagents. These
tests are conducted frequently in healthcare settings, driving consistent
demand for reagents. Reagents play a crucial role in the monitoring and
management of chronic diseases like diabetes and cardiovascular conditions.
With the increasing prevalence of such diseases in India, there is a steady
requirement for reagents used in disease monitoring. Reagents are fundamental
in diagnosing and monitoring infectious diseases, including viral and bacterial
infections. The need for infectious disease testing, especially in the context
of public health and the ongoing COVID-19 pandemic, contributes to the high
demand for reagents.
Application Insights
In 2024, the India In Vitro Diagnostics Market
largest share was held by Diabetes segment and is predicted to continue
expanding over the coming years. India has one of the
highest rates of diabetes in the world. The country is experiencing an epidemic
of both type 2 diabetes and, to a lesser extent, type 1 diabetes. This high
prevalence of diabetes naturally drives the demand for diagnostic tests to identify
and monitor the condition. The incidence of diabetes in India continues to rise
due to factors such as sedentary lifestyles, poor dietary habits, and genetic
predisposition. As more people are diagnosed with diabetes, the demand for
diabetes-related diagnostic tests increases. Diabetes is a chronic condition
that requires regular monitoring of blood glucose levels to manage the disease
effectively. IVD tests, such as blood glucose monitors and HbA1c tests, are
essential for assessing and controlling diabetes. Early detection of diabetes
and prediabetic conditions is critical for preventing the progression of the
disease and its complications. Routine screening and diagnostic tests play a
crucial role in identifying individuals at risk. Growing awareness about
diabetes and its associated health risks has led to more individuals seeking
diagnostic testing to assess their diabetes status. Healthcare campaigns and
education programs have contributed to this increased awareness.
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Regional Insights
The North India region dominates the India In Vitro Diagnostics Market
in 2024. North India is home to some of the most densely populated states in
the country, including Uttar Pradesh, Bihar, and Haryana. The high population
density translates to a larger pool of potential patients and consumers for IVD
products and services. The North Indian states, particularly the National
Capital Region (NCR), have relatively better healthcare infrastructure compared
to some other regions. This includes a higher concentration of hospitals,
clinics, and diagnostic laboratories that use IVD products. North India, with
its major cities like Delhi, Gurugram, and Noida, is a hub of economic
activity. This leads to greater healthcare expenditure, including diagnostics,
among the urban and semi-urban population.
Recent Developments
- In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd. announced the establishment of a Contract Development and Manufacturing Organization (CDMO) partnership for the production of cartridge-based CLIA system reagents. This collaboration will support the immunology analyzers Mispa i60 and Mispa i121. Notably, the analyzers and reagents will be marketed under the Agappe brand, positioning Agappe as the first Indian company to offer a complete Chemiluminescence Solution with locally manufactured reagents.
- In October 2023, the Central Drugs Standard Control Organization (CDSCO) granted approval for NexCAR19, India’s first CAR-T cell therapy for cancer patients. This "humanized" CAR-T therapy features a more human-like antibody, designed to minimize immune rejection and reduce the risk of severe side effects.
- In January 2023, a coagulation laboratory began operations at King George’s Medical University (KGMU) in the city. The new facility is designed to provide accurate test results for patients with hemophilia or platelet disorders.
Key Market Players
- Abbott
India Limited
- Danaher
(DHR) Holding India Pvt Limited
- Roche
Diagnostics India Pvt. Ltd.
- bioMérieux
India Private Limited
- Transasia
Bio-Medicals Ltd.
- bioMérieux
India Limited
- Becton
Dickinson Private Limited
- Thermo
Fisher Scientific India Pvt. Ltd.
- Siemens
Healthcare Private Limited
- Sysmex
India Pvt. Ltd
|
By Product
|
By Test Type
|
By Usability
|
By Application
|
By End User
|
By Region
|
|
|
- Clinical
Chemistry
- Molecular
Diagnostics
- Hematology
- Immuno
Diagnostics
- Other
|
- Disposable
In Vitro Diagnostics Devices
- Reusable
In Vitro Diagnostics Devices
|
- Infectious
Disease
- Diabetes
- Oncology
- Cardiology
- Autoimmune
Disease
- Nephrology
- Others
|
- Diagnostic
Laboratories
- Hospitals
& Clinics
- Others
|
- North
America
- Europe
- Asia
Pacific
- South
America
- Middle
East & Africa
|
Report
Scope:
In this report, the India In Vitro Diagnostics
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- India In Vitro Diagnostics Market, By
Product:
o Instrument
o Reagent
o Other
- India In Vitro Diagnostics Market, By Test
Type:
o Clinical Chemistry
o Molecular Diagnostics
o Hematology
o Immuno Diagnostics
o Other
- India In Vitro Diagnostics Market, By
Usability:
o Disposable In Vitro Diagnostics
Devices
o Reusable In Vitro Diagnostics
Devices
- India In Vitro Diagnostics Market, By
Application:
o Infectious Disease
o Diabetes
o Oncology
o Cardiology
o Autoimmune Disease
o Nephrology
o Others
- India In Vitro Diagnostics Market,
By End-User:
o Diagnostic Laboratories
o Hospitals & Clinics
o Others
- India In Vitro Diagnostics Market, By region:
o North India
o South India
o East India
o West India
Competitive Landscape
Company Profiles: Detailed
analysis of the major companies presents in the India In Vitro Diagnostics
Market.
Available Customizations:
India In Vitro Diagnostics 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).
India In Vitro Diagnostics
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