Report Description

Forecast Period

2025-2029

Market Size (2023)

1.74 billion

CAGR (2024-2029)

5.45 %

Fastest Growing Segment

Reagent Segment

Largest Market

North India

 

Market Overview

India In Vitro Diagnostics Market has valued at USD 1.74 billion in 2023 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 5.45% through 2029. 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.

Smart devices and apps are being used to collect and analyze diagnostic data, making it easier for patients to monitor their health and share information with healthcare providers. Nanoparticles and nanomaterials are used in IVD for enhancing sensitivity and specificity, particularly in immunoassays and nucleic acid-based diagnostics. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is being adapted for diagnostic applications. CRISPR-based tests can rapidly and accurately detect genetic material from pathogens. Multiplex assays allow for the simultaneous detection of multiple analytes in a single test, increasing efficiency and reducing the volume of sample required. Automated systems for sample processing, sample handling, and data analysis have improved the reproducibility and efficiency of diagnostic testing in clinical laboratories. This factor will help in the development of the India In Vitro Diagnostics Market.

Growing Aging Population

With advancing age, individuals are at a higher risk of developing chronic diseases such as diabetes, cardiovascular diseases, cancer, and neurodegenerative disorders. Diagnostic tests are crucial for the early detection and management of these conditions, which are more common among older adults. 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. As life expectancy increases, more individuals are reaching older ages, which contributes to the growing population of older adults who require healthcare services and diagnostic testing. This factor will pace up the demand of the India In Vitro Diagnostics Market.

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.

IVD tests are required for demonstrating the safety and efficacy of new drugs, which is essential for obtaining regulatory approval and market access. IVD data is used in health economics and outcomes research to evaluate the economic and clinical impact of new drugs and therapies. Continuous disease surveillance is essential for monitoring the impact of diseases and emerging health threats. IVD tests are used in epidemiological studies. IVD tests help stratify patients into different disease subtypes or risk categories, which enables more precise and cost-effective treatment strategies. As the pharmaceutical and biotech industries expand globally, the demand for IVD products and services also increases in various regions. This factor will accelerate the demand of the India In Vitro Diagnostics Market.

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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.

Segmental Insights

Product Insights

In 2023, the India In Vitro Diagnostics Market largest share was held by Reagent segment and is predicted to continue expanding over the coming years. 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 2023, 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.

End-User Insights

In 2023, the India In Vitro Diagnostics Market largest share was held by Hospitals & Clinics segment in the forecast period and is predicted to continue expanding over the coming years.  Hospitals and clinics typically have a high volume of patients seeking healthcare services. They serve as primary points of contact for patients, making them significant consumers of diagnostic services. This high patient footfall naturally drives the demand for IVD tests. Hospitals and clinics offer comprehensive healthcare services, including diagnostic testing. Patients visit these facilities not only for diagnostics but also for treatment and management of various medical conditions. IVD tests are an integral part of the diagnostic and treatment process. Many hospitals, particularly larger ones, offer specialized care such as cardiac care, oncology, neurology, and more. Specialized healthcare often requires a wide range of diagnostic tests to diagnose and monitor patients, further boosting the demand for IVD products. Hospitals are equipped to handle emergency and critical care cases. In such situations, rapid and accurate diagnostic tests are essential for making immediate treatment decisions. IVD tests play a critical role in emergency and critical care settings. Hospitals often have in-house pathology labs for conducting a variety of tests, including blood tests, urine tests, and tissue biopsies. These labs are major consumers of IVD products. After the diagnosis, patients visit hospitals and clinics for follow-up appointments and treatment monitoring. IVD tests are routinely used to assess the progress of treatment and make necessary adjustments.

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Regional Insights

  • The North India region dominates the India In Vitro Diagnostics Market in 2023. 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. The North has several renowned medical and research institutions, which play a crucial role in driving advancements in healthcare and diagnostics. These institutions often serve as early adopters of new IVD technologies and promote their use. The North Indian states have seen substantial investments in healthcare through government initiatives. For example, the Ayushman Bharat scheme, which aims to provide health insurance to millions of families, has a significant presence in this region.

Recent Developments

  • In November 2021, Holborn Wells, a UK-based healthcare-oriented firm that recently established an In Vitro Diagnostics (IVD) business unit in India, has finalized a collaborative venture with SpeedBio to create an IVD manufacturing facility in India. SpeedBio, a prominent IVD advocate in the area, boasts a team comprised of former executives from notable diagnostics and healthcare companies like Siemens and CORE Diagnostics. The newly established manufacturing base in India, known as Holborn Wells SpeedBio, signifies a significant stride toward realizing the positive impact of molecular diagnostics in the region in the coming decade and beyond. The fusion of Holborn Wells' technical proficiency with SpeedBio India's network positions the new joint venture entity as a frontrunner in the IVD market across the region.
  • In September 2022, Holborn Wells India, an in-vitro diagnostics (IVD) manufacturing firm, has recently inaugurated a Regulatory Consulting Division specializing in Pharmaceutical & Medical Devices. This division is dedicated to aiding local startups and providing guidance to foreign companies seeking to invest in India's pharmaceutical and medical device sectors. With their comprehensive expertise in IVD manufacturing, Holborn Wells India not only helps with documentation in accordance with CDSCO guidelines but can also provide a full spectrum of services, including technical, legal, and contract manufacturing, facilitated through their network of channel partners. The primary objective is to facilitate Foreign Direct Investments, thereby contributing to the promotion of India's 'Start-up India' initiative.

Key Market Players

  • Ortho Clinical Diagnostics India Private Limited
  • Danaher (DHR) Holding India Pvt Limited
  • Roche Diagnostics India Pvt. Ltd.
  • Abbott India Limited
  • Transasia Bio-Medicals Ltd.
  • bioMérieux India Limited
  • Becton Dickinson Private Limited
  • Thermo Fisher Scientific India Pvt. Ltd.
  • Siemens Healthineers India Pvt. Ltd.
  • Sysmex India Pvt. Ltd

 

By Product

By Test Type

By Application

By End-User

By Region

  • Instrument
  • Reagent
  • Other
  • Clinical Chemistry
  • Molecular Diagnostics
  • Hematology
  • Immuno Diagnostics
  • Other
  • Infectious Disease
  • Diabetes
  • Oncology
  • Cardiology
  • Autoimmune Disease
  • Nephrology
  • Others
  • Diagnostic Laboratories
  • Hospitals & Clinics
  • Others
  • North India
  • South India
  • East India
  • West India

 

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:

  •  In Vitro Diagnostics Market, By Product:

o   Instrument

o   Reagent

o   Other

  • In Vitro Diagnostics Market, By Test Type:

o   Clinical Chemistry

o   Molecular Diagnostics

o   Hematology

o   Immuno Diagnostics

o   Other

  • In Vitro Diagnostics Market, By Usability:

o   Disposable In Vitro Diagnostics Devices

o   Reusable In Vitro Diagnostics Devices

  • In Vitro Diagnostics Market, By Application:

o   Infectious Disease

o   Diabetes

o   Oncology

o   Cardiology

o   Autoimmune Disease

o   Nephrology

o   Others

  •   In Vitro Diagnostics Market, By End-User:

o   Diagnostic Laboratories

o   Hospitals & Clinics

o   Others

  • 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, 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).

India In Vitro Diagnostics Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]               

Table of content

1.    Product Overview

1.1.  Market Definition

1.2.  Scope of the Market

1.2.1.    Markets Covered

1.2.2.    Years Considered for Study

1.2.3.    Key Market Segmentations

2.    Research Methodology

2.1.  Objective of the Study

2.2.  Baseline Methodology

2.3.  Key Industry Partners

2.4.  Major Association and Secondary Types

2.5.  Forecasting Methodology

2.6.  Data Triangulation & Validation

2.7.  Assumptions and Limitations

3.    Executive Summary

3.1.  Overview of the Market

3.2.  Overview of Key Market Segmentations

3.3.  Overview of Key Market Players

3.4.  Overview of Key Regions/Countries

3.5.  Overview of Market Drivers, Challenges, and Trends

4.    Voice of Customer

5.    India In Vitro Diagnostics Market Outlook

5.1.  Market Size & Forecast

5.1.1.    By Value

5.2.  Market Share & Forecast

5.2.1.        By Product (Instrument, Reagent, Other Products)

5.2.2.        By Test Type (Clinical Chemistry, Molecular Diagnostics, Hematology, Immuno Diagnostics, Other Types)

5.2.3.        By Usability (Disposable In Vitro Diagnostics Devices, Reusable In Vitro Diagnostics Devices)

5.2.4.        By Application (Infectious Disease, Diabetes, Oncology, Cardiology, Autoimmune Disease, Nephrology, Others)

5.2.5.        By End User (Diagnostic Laboratories, Hospitals & Clinics, Others)

5.2.6.    By Region (North India, South India, East India, West India)

5.2.7.    By Company

5.3.  Product Market Map

 

6.    North India In Vitro Diagnostics Market Outlook

6.1.  Market Size & Forecast       

6.1.1.    By Value

6.2.  Market Share & Forecast

6.2.1.    By Product

6.2.2.