ENZYME LINKED IMMUNOSORBENT ASSAY MARKET ANALYSIS

Market Challenges And Opportunities

Restraints & Challenges:

• Product recalls being ordered by regulatory authorities

Global Enzyme Linked Immunosorbent Assay (ELISA) Market: Restraint

Product recalls being ordered by regulatory authorities is expected to hamper growth of global Enzyme Linked Immunosorbent Assay (ELISA) market over forecast period. For instance, On December 01, 2020, The U.S. Food and Drug administration (FDA) issued a notice to recall the Class 2 Device Recall ACCEL ELISA COVID19 Test, which is indicated for the detection of total antibodies to SARS-CoV-2 and manufactured by VEO Diagnostics, a manufacturer of medical diagnostic products.

Increasing product development activities for ELISA kit are expected to drive growth of the Global Enzyme Linked Immunosorbent Assay (Elisa) Market.

Increasing product development activities for ELISA kit are expected to drive growth of the global Enzyme Linked Immunosorbent Assay (ELISA) market. For instance, On May 21, 2021, The Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of Defence Research and Development Organization (DRDO), India had developed an antibody detection-based kit 'DIPCOVAN', the DIPAS-VDx COVID-19 IgG Antibody Microwell ELISA for sero-surveillance. The DIPCOVAN kit can detect both spike as well as nucleocapsid proteins of SARS-CoV-2 virus with a high sensitivity of 97% and specificity of 99%. The kit had been developed in association with Vanguard Diagnostics Pvt Ltd, a diagnostics development and manufacturing company.

Increasing inorganic activities such as collaboration among market players is expected to drive market growth over the forecast period

Market players are focused towards expansion of their product portfolio and geographic reach by adoption of inorganic strategies such as collaboration to maintain their positions in market. For instance, on June 2, 2020, Syngene International Ltd., an integrated research and development services company, had entered into collaboration with HiMedia Laboratories, a bioscience company with expertise in media manufacturing and diagnostics for over 45 years, to manufacture and distribute its ELISA kits. HiMedia would manufacture the kits at its facility in Mumbai, India and distribute it across India.

Global Enzyme Linked Immunosorbent Assay (ELISA) Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency on January 30, 2020.

The COVID-19 can affect the economy in three main ways: by directly affecting the production and demand of clinical diagnostic devices by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with regard to the transportation of clinical diagnostic devices from one place to another.

However, the COVID-19 pandemic had a positive impact on the global Enzyme Linked Immunosorbent Assay (ELISA) market, owing to increased Emergency Authorization by regulatory authorities for ELISA Kit for detection of COVID-19 infection. For instance, on January 8, 2021, The Central Drugs Standard Control Organization (CDSCO), India announced product approval for ELISA kit, which was indicated for detection of COVID-19 infection and manufactured by CPC Diagnostics Pvt. Ltd., a manufacturing company of Medical Laboratory Equipment, analyzer products.