I.    Introduction: Market Overview

Due to its high demand, accuracy and utility, in-vitro diagnostic solutions defined as medical devices and reagents used to examine specimens derived from the human body, such as blood, tissues, and other body fluids, to detect diseases, conditions, and infections have piqued the curiosity of the healthcare ecosystem. IVD tests can be performed in a stand-alone laboratory, hospital-based laboratory, and point-of-care (POC) centres and typically include polymerase chain reaction (PCR), microarray techniques, sequencing technology, and mass spectrometry, which are used for test sample preparation. 

The global IVD industry was valued at $67,110 million in 2019 and is projected to reach $91,092 million at a CAGR of 4.8% from 2020 to 2027, owing to a rise in incidences of chronic and infectious diseases such as cardiovascular diseases and diabetes, growth of geriatric population, and an increase in the popularity of personalized medicine approach. 

II.    Impact of COVID-19 on IVDs

The COVID-19 pandemic has changed the contours of healthcare and has particularly prompted seismic shifts within the IVD industry. As the pandemic gathered momentum, demand grew for not only faster testing but also testing in higher volumes, with molecular assays, particularly the reverse-transcription polymerase chain reaction (RT-PCR), being regarded as the “gold standard” and the optimal confirmatory test for diagnosing the prevalence, rate, and cyclicity of viral load. In Europe and the United States alone, the demand for molecular-diagnostic tests rose 20-fold between March and October 2020.

The volume of point-of-care (POC) testing has predictably risen during the pandemic due to a rise in demand for faster on-site screening wherein COVID-19 testing singularly added $9,000 million to the IVD market's value, mostly from RT-PCR testing. 

While the cases of COVID-19 continue to plateau globally, the demand of such in vitro diagnostics is likely to keep growing, making it a champion within the medical devices industry. 

III.    India’s Ascent: The Leap in IVD Industry

The medical devices market in India is growing at a staggering pace & the country is poised to become a global manufacturing hub in the medical devices space, with 100% FDI allowance under the automatic route for both brownfield and greenfield setups adding to its growth & resilience. 

The Indian in vitro diagnostics market was valued at $1240 Million in 2019, and is projected to reach $2060 Million by 2027, registering a CAGR of 7.5% from 2020 to 2027. The demand in the Indian market for IVDs is expected to grow in the long run, driven by ageing population, increasing disposable income, growing health awareness, changing attitudes towards preventive healthcare, increasing lifestyle diseases, POC diagnostics, and insurance access.

The Indian government’s recent launch of the Production Linked Incentive Scheme (PLI 2.0) aims to enhance India’s manufacturing capabilities by increasing investment and production in the IVD sector and intends to create global champions out of India who have the potential to grow and scale using cutting edge technology and thereby penetrate the global value chains. To scale the next growth trajectory within the IVD sector, the scheme is inviting applications within the following groups: 

1. Group A: Applicants having global manufacturing revenue (FY 2019-20) of pharmaceutical goods and/or in vitro diagnostic medical devices more than or equal to Rs. 5,000 crore. 
2. Group B: Applicants having global manufacturing revenue (FY 2019-20) of pharmaceutical goods and/or in vitro diagnostic medical devices between Rs. 500 (inclusive) crore and Rs. 5,000 crore. 
3. Group C: Applicants having global manufacturing revenue (FY 2019-20) of pharmaceutical goods and/or in vitro diagnostic medical devices less than Rs. 500 crore.

Furthermore, the selection of applicants for in vitro diagnostic medical devices will be governed by the following parameters:
 

Such initiatives and schemes are set to position India as a global IVD manufacturing power and silently aid the sector to take the next leap of faith. 

IV.    Quick facts about PLI 2.0

• The scheme shall be open for applications till July 31st, 2021.
• Online applications to be made online at https://pli-pharma.udyamimitra.in/ maintained by Small Industries Development Bank of India (SIDBI).
• SIDBI would notify the applicant(s) within 15 days of the application submission. Any incomplete application to be submitted within the next 15 days.
• Applications would be processed within 90 days of the deadline.