India Serological Testing Market Size, Share & COVID-19 Impact Analysis, By Product (Instruments, and Reagents & Consumables), By Technology (ELISA, NAT, CLIA/CMIA, and Others), By Application (Hepatitis C, Hepatitis B, HIV, Malaria, Syphilis, Blood Group Typing (BGT), and Others), By End User (Blood Banks, Hospitals & Clinics, and Others), and Regional Forecast, 2021-2030

India serological testing market size was USD 191.4 million in 2020. The market is projected to grow from USD 212.1 million in 2021 to USD 813.6 million in 2030 at a CAGR of 16.1 % in the 2021-2030 period. The global impact of COVID-19 has been unprecedented and staggering, with serological testing witnessing a negative demand shock across India amid the pandemic. Based on our analysis, the Indian market witnessed a strong decline of -15.2% in 2020. The sudden rise in CAGR is attributable to this market’s growth and demand returning to pre-pandemic levels once the pandemic is over.

Technologically advanced medical devices such as serological test equipment is used for the detection of antibodies in blood that occur after an immune response and thus are used to diagnose different disease conditions. This diagnostic procedure provides highly efficient real time results. Furthermore, these tests are also used in blood banks for the detection of infections like HIV, HCV, HBV, syphilis and malaria in blood or blood products. The serological tests are also used for blood group typing before any blood transfusion process. The rising prevalence of infectious diseases in India also drives the increasing adoption of the tests in India.

Due to the prevalence of the aforementioned infectious diseases, major market players like Abbott, Ortho-Clinical Diagnostics and Tulip Diagnostics (P) Ltd and Grifols are continuously focusing on R&D initiatives and strategic collaborations to introduce new products in the India market in order to cater to different requirements. For instance, in March 2021, the Post-Graduate Department of Transfusion Medicine at the Institute of Medical Sciences and SUM hospital introduced ID-NAT Blood Screening System by Hemogenomics. IMS and SUM hospital were some of the first medical institutes in Odisha to procure the system. This development was undertaken to ensure the safest way to transfuse blood.

Therefore, it can be witnessed that the above-mentioned factors like increasing prevalence of infectious diseases, growing awareness among the population and new technologically advanced product launches will lead to strong growth prospects in the forecast period.

COVID-19 IMPACT 

Lack of Availability of Raw Materials during the Pandemic to Decline Market Growth

The COVID-19 pandemic has negatively affected the India serological testing market. The lockdown and the stringent guidelines imposed during the initial days of the pandemic of the COVID-19 outbreak posed extreme challenges towards the diagnostic sector of the health care industry. The healthcare organizations struggled due to the uncertainties regarding manpower. Furthermore, the supply chain disruptions, lack of availability, and the high price of raw materials affected the overall market. The timely availability of lab reagents was also one of the biggest concerns. Several lab reagents and kits belonged from international markets, and therefore, due to supply chain disruptions, there was a constraint in logistics, thus negatively affecting the India serological testing market growth.

It has been reported that the blood banks in India also witnessed a negative impact in terms of blood donations during the pandemic. Although the spread of the SARS-CoV-2 virus has not been detected through blood transfusion, anxiety and fear have led to a significant decrease in the number of blood donations. Furthermore, despite taking preventive measures during blood donation campaigns, there was a negative impact on blood donations, affecting the blood supply and the blood transfusion process. Due to the lack of blood bag units' availability, comparatively fewer serological tests were performed, thus reducing the requirement for the kits and reagents and negatively impacting the market. Also, cancellations and postponement of surgical procedures lead to a decline in pre-operative serology testing. The serological screening tests for infectious diseases like HIV, HCV, and HBV has also declined due to the ongoing pandemic. For instance, according to an article published by Times of India in August 2021, Rajasthan has reported a decline in their number of HIV testing. The test rate fell by 16.1% for the year 2021 compared to 2020. The report stated that authorities conducted around 30.7 lakh (3.07 million) tests for 2019-2020, but it reduced to 25.8 lakh (2.58 million) in 2020-2021. Deferral in healthcare services during the pandemic may have led to delay in diagnosis and treatment, leaving people unaware of their disease status.

Similarly, according to an article published in NCBI in September 2021, it was estimated that a year of delay in the treatment of HCV in India would result in more than 72,000 deaths in the region. The decline in the treatment during the strict lockdown and diversions of the hospital facilities and services towards COVID is due to the lack of screening and diagnosis such as serological type of testing. The pandemic created a dual impact on the market. On one hand, it helped raise awareness among people regarding the importance of serological testing, but on the other hand, patients avoided mandatory screening tests due to the fear of the SARS-CoV-2 virus.

LATEST TRENDS

Emergence of Domestic Companies for Serological Testing in India to Determine Growth Trajectory

A significant trend observed in the market is the emergence of new domestic companies engaged in developing serological tests in India. For instance, in December 2021, Lupin announced the launch of their diagnostic division, Lupin Diagnostics. The company’s newly formed testing division’s product portfolio also includes serological tests. This strategic decision by the company was taken to provide India with integrated healthcare. The company also announced the establishment of a 45,000.0 sq. ft. National Reference Laboratory in Navi Mumbai. The facility would have all the major diagnostic services, including serology testing for their customers.

The growing prevalence of infectious diseases and the rising cases of covid-19 in the region opened various opportunities for major companies to launch various types of serological tests. This factor also catered to the increasing needs of the population of India. The plethora of opportunities available for the organizations will thus boost the growth in the forecast period.  As more companies become engaged in the development of serological testing in India, more product launches are expected to screen infectious diseases, which is expected to significantly contribute to the surge of the market in the forecast period.

DRIVING FACTORS

Robust Demand for Blood Donations in India to Drive Market Growth

One of the most critical drivers that are positively impacting the growth of the market in India is the robust demand for blood donations in the region. For instance, according to an article by India Today, in November 2019, India had the world’s largest shortage of blood. All the states in the country are facing a shortfall of an estimated 41 million units. The report also states that the demand has surpassed the supply by over 400.0%.

The current clinical demand for blood in this country entirely depends upon the healthcare system and the strong population of India. However, due to the underdeveloped nature of the Indian health infrastructure, a substantial proportion of the Indian populace suffers from a scarcity of blood during an emergency or elective procedures. However, over the past few years, there has been a unanimous increase in awareness regarding the greater need for increased blood donations. Thus, this growing demand for safe blood donations in India would help increase the demand for serological tests in the country.  Furthermore, it was reported that the already existing scarcity was exacerbated by the ongoing SARS-CoV-2 pandemic and the vaccination drives. The blood banks in India experienced problems regarding the number of donors due to the vaccination. However, the government has started new initiatives to overcome blood shortage. For instance, according to an article published in The Hindu in June 2020, the Health Department of Maharashtra had started using a feature on Facebook, which would help them overcome the shortage of blood supply during the pandemic. This strategy was implemented by the State Blood Transfusion Council (SBTC). Such initiative would help stock the declining blood bag units, thus increasing the demand for serological testing. Furthermore, the continuation of such initiatives in the long term would enable the market growth

Blood donation campaigns organized by various organizations like banks or academic institutes in collaboration with the Indian Red Cross Society also help in contributing positively towards the demand for blood units. Such strong trends are expected to lead to a strong surge in market growth during the forecast period.

Increased Awareness about Infectious Diseases to Boost Demand for Serological Testing

The growing awareness of infectious diseases in India is one of the most important reasons for the region's rising adoption for serological tests. With the increase in awareness amongst the Indian population, key players in the market, have introduced different products in the country. The region is steadily working towards reducing the prevalence of infectious diseases like hepatitis C and HIV. Therefore, the demand for these tests is also increasing significantly. For instance, according to an article in November 2015, the Prime Minister of India and 17 other Asia Pacific leaders, endorsed a plan to eliminate malaria from the region by 2030. Furthermore, it was noted that India pledged to achieve the goal by 2027, 3 years before that of the global target.

The central and state governments focus on partnering with several NGOs and major organizations to tackle these problems. For example, in January 2019, Abbott announced a partnership with the government of the eastern Indian state of Odisha and Malaria No More. According to the partnership, the organization would provide technology, expertise, and funding to advance efforts to end malaria in the state. The SARS-CoV-2 virus also boosted the demand for serological tests in the country, thus increasing the major companies' efforts to launch new antibody testing kits in the market to tackle the pandemic. Some of the recent landmark approvals in the serological testing market in India include: in July 2020, Thermo Fisher Scientific Inc. announced the launch of its MAS Omni Infectious Disease quality control set in India. It can be used for monitoring serological assay for HIV 1&2, Hepatitis B& C virus, Syphilis and HTLV I/II. Such launches are expected to lead to an increased demand for a wide range of serological testing products in India. Furthermore, such growth trends ve led to the greater presence and engagement of many companies. Such positive developments are anticipated to lead to robust growth for the market in the region in the forecast period.

RESTRAINING FACTORS

Usage of Outdated Technologies for Serology Testing to Impede Market Growth

Despite the growing requirement of serology testing in India, one of the strong hindrances towards market growth is outdated technology. In India, a large part of the blood banks are under the public health sector, and a significant proportion of the population depends on these public blood banks. However, despite increasing concerns regarding the infected blood bags available in the blood banks, the government facilities cannot adopt advanced serological tests as they cost a bit higher compared to the other tests. These blood banks still use third-generation ELISA for the screening test and the fourth-generation ELISA is proven more effective.

For instance, according to an article in the Times of India in June 2019, despite the increased availability of technology, an overwhelming proportion of the blood units are not safe. It is reported that still a sizeable percentage of the population gets infected during the blood transfusion process. According to data posted in the article, out of every 65,000 units of blood, an estimated 100 units are infected. Furthermore, according to the Global Journal of Transfusion Medicine, the public sector in India is lagging in terms of the adoption of new technologies compared to the private sector. This factor can be attributed to the lack of infrastructure and limited funding from government organizations. Advanced tests such as nucleic acid testing (NAT) are still not mentioned in India’s Drugs and Cosmetics Act. This lack of initiative by the government to adopt advanced technology due to high costs and low infrastructure strongly hinders the market growth.

SEGMENTATION

By Product Analysis

Strong Demand for Reagents & Consumables to Boost Segment’s Dominance

Based on product, the Indian market can be segmented into instruments and reagents & consumables.

The reagents & consumables segment held a dominant market share in 2020 and is expected to grow at a significant CAGR. The cost-effectiveness of these products and the comparatively easy-to-use features associated with them drives their growth. Furthermore, the growing adoption of reagents and consumables like ELISA kits amongst the blood banks and healthcare institutions is anticipated to launch new products. This factor is one of the major factors contributing positively towards the market's growth. For instance, in July 2021, PathSodh Healthcare, a startup that was incubated by the Society of Innovation and Development (SID) and Indian Institute of Science (IISc), received approval for the manufacturing and sale of their semi-quantitative electrochemical ELISA test used for the identification of COVID-19 IgG and IgM antibodies. The test kit was validated by the Translational Health Science and Technology Institute (THSTI), Faridabad, under the Indian Council of Medical Research (ICMR) guidelines.  

The instruments segment is expected to witness a lower market share and grow at a comparatively lower CAGR.  The growth can be attributed to major players' launch of new instruments in the region. For instance, in June 2020, Abbott announced that they began supplying their laboratory-based serology blood test in India. Abbott’s SARS-CoV-2 IgG test can be used for large-scale antibody testing in line with ICMR’s recommendation for the use of IgG CLIA (Chemiluminescence immunoassay) tests. The test can be run on two of Abbott’s instruments: ALINITY immunoassay systems and ARCHITECT immunoassay systems.

By Technology Analysis

Greater Adoption of ELISA Technology in India to Boost Segment’s Dominance

Based on application, the Indian market can be segmented into ELISA, NAT, CLIA/CMIA and others. The Enzyme-Linked Immunosorbent Assay (ELISA) segment held a dominant market share in 2020 and is expected to grow at a significant CAGR. The dominance of this segment is due to the nationwide adoption of ELISA technology for various serological testing procedures. The enzyme linked immunosorbent assay kits are often preferred due to the high sensitivity and specificity of these tests. The cost-effectiveness and the quick analysis obtained through this technology also play a crucial role in segment’s growth. Due to the increased demand for ELISA test kits amongst healthcare professionals, major companies are also focusing on launching new ELISA products, thus, promoting market growth.

The CLIA/CMIA segment accounts for the second-largest segment in India. The growth in the segment is due to the technology, which is reported to be more reliable and precise. They have improved specificity and a greater positive predictive value. Therefore, these factors contribute positively to the growing adoption, and these factors will eventually enable the segment to increase its market share in the forecast period. The nucleic acid testing (NAT) segment, a molecular diagnostic test, accounted for the lowest market share in 2020. The growing adoption of NAT testing in blood banks and healthcare institutions in India promotes the segment’s growth until 2030.

By Application Analysis

Robust Testing Volume of HIV to Drive Segment’s Dominance in 2021-2030

Based on application, the Indian market can be segmented into HIV, hepatitis C, hepatitis B, malaria, syphilis, blood group typing (BGT), and others. The HIV segment held a dominant market share in 2020 and is expected to grow at a significant CAGR. The dominance of this segment is due to the strong prevalence of HIV in the region.  Growing initiatives of government and non-government organizations to reduce the disease burden by introducing new products are a few of the major factors for the growth of the segment till 2030. In July 2019, F. Hoffmann-La Roche Ltd announced that their Global Access Program is being expanded beyond HIV to Hepatitis B & C and Mycobacterium Tuberculosis (MTB) in lower and middle-income countries where the disease burden is high. The program's expansion would lead to improved access to cost-effective resources for the people in need.

The others segment accounts for the second-largest segment in the India region. The segment's growth is attributed to the onset of the SARS-CoV-2 virus. Major companies launched serology test kits and assays for diagnostic and screening purpose, which eventually led to market growth in 2020. The hepatitis B segment is the third-largest segment, followed by the hepatitis C segment. The growth of the segments can be attributed to the launch of various government programs for the prevention and control of hepatitis in India. For instance, in July 2018, the Government of India announced the launch of the National Viral Hepatitis Control Program (NVHCP) on World Hepatitis Day. The program provides an integrated approach towards the prevention and control of hepatitis by providing free screening, diagnosis and treatment to the patients. The blood group typing (BGT) segment is expected to grow at a steady CAGR. Malaria and syphilis segments are expected to grow at a limited CAGR in the forecast period.

By End User Analysis

Increasing Number of Blood Screening Tests Influence the Dominance of Blood Banks in 2021-2030

On the basis of the end-user segment, the market is segmented into blood banks, hospitals & clinics, and others. The blood banks segment is expected to account for the highest share of the Indian market in the forecast period. The fundamental reason for the growth of this segment is the necessary number of tests performed before blood or blood products transfusion. The growing adoption of serological tests for blood group typing and the mandatory screening tests for HIV, HCV, HBV, syphilis and malaria are the key factors contributing to the segment's growth.

Hospitals & clinics are the second largest segment with a considerable CAGR owing to the growing number of blood transfusion processes during any medical procedures. The growing prevalence of medical conditions like thalassemia, leukemia, and kidney disorders lead to an increasing number of blood transfusion processes and pre-operative testing in hospitals and clinics, which eventually contributes to the segment's growth. For instance, according to an article published by the American Society of Nephrology in October 2020, the number of people going through chronic dialysis in India in 2018 was about 175,000, marking the prevalence to 129 per million population. The others segment comprises institutions such as diagnostic laboratories. This segment has the lowest share compared to the other two segments and is expected to grow at a lesser CAGR in the future.

KEY INDUSTRY PLAYERS

Strong Portfolio of Serology Tests by Abbott, Tulip Diagnostics, and Ortho Clinical Diagnostics to Lead to Peak Market Position

In the competitive landscape, the Indian market is characterized by the presence of key companies such as Abbott, Tulip Diagnostics and Ortho Clinical Diagnostics. Tulip Diagnostics accounts for the highest share of the India market in 2020 with the company’s strong presence in the ELISA segment and strong production capacities. Furthermore, after being acquired by PerkinElmer, the company marked a strong foothold in India. Abbott is the second company to dominate the market due to a strong CLIA/CMIA devices portfolio. In May 2020, Abbott announced that their new antibody testing blood test would be running on Abbott’s ARCHITECT i1000SR and i2000SR laboratory instruments and would be expanding it to their Alinity i system.

Ortho-Clinical Diagnostics has a wide range of product portfolios for serology testing. The approvals received by the company from the regulatory bodies in India to introduce new products in the market also lead to the organization’s increasing market share. Other established companies like Thermo Fisher Scientific, Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd and Grifols, S.A. have a vast product portfolio of serological tests through strategic collaborations and participating in various exhibitions the organizations. For instance, Grifols S.p.A formed a partnership with Hemogenomics, an organization that focuses on bringing advanced health screening solutions to India. As per the partnership, Hemogenomics is the authorized dealer for Grifols Compact Nucleic Acid Testing System, the Procleix Panther System.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Basel, Switzerland)


• Abbott (Abbott Park, U.S.)


• Thermo Fisher Scientific, Inc. (Waltham, U.S.)


• Beckman Coulter, Inc. (Danaher) (Brea, U.S.)


• Tulip Diagnostics (P) Ltd (PerkinElmer Inc.) (Bambolim, India)


• Eurofins Scientific (Luxembourg, Luxembourg)


• DiaSorin S.p.A (Saluggia, Italy)


• Grifols, S.A. (Barcelona, Spain)


• Siemens Healthineers AG (Munich, Germany)


• Mylab Discovery Solutions Pvt. Ltd. (Lonavla, India)


• Ortho-Clinical Diagnostics (Raritan, U.S.)

KEY INDUSTRY DEVELOPMENTS:

• November 2021 – Siemens Healthineers AG and Hemogenomics funded a clinical trial for a comparative evaluation of the ADVIA Centaur XP chemiluminescence system for the screening process of HIV, HCV, Syphilis in blood donors from India.


• April 2019 – Mylab Discovery Solutions launched NATSpert, an Individual Donor Nucleic Acid test (ID-NAT) to screen HIV, HBV and HCV in donated blood.

REPORT COVERAGE

The market report provides a detailed analysis of the market and focuses on key aspects such as India serological testing market statistics, regulatory status, new product launches, key industry developments, overview: standards for blood banks in India, insights on prospects of hub & spoke model in blood banking in India, the role of informatics & automation in blood banking, statistics related to blood component separation, pricing analysis, porter’s 5 forces, competition analysis: ELISA, CLIA/CMIA & NAT, number of blood banks in India, by zone, blood donation volume in India, by zone, primary, secondary & tertiary serological testing in India. Others aspects considered include technological advancements in the serological testing market and the impact of the COVID-19 pandemic on the market. Besides this, the report offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the global market over recent years.

Report Scope & Segmentation