In response to the implementation of the US Biosecure Act, life sciences companies and Contract Development and Manufacturing Organizations (CDMOs) based in India are gearing up for the anticipated requirements from Western pharmaceutical firms. This preparation aims to enhance their capabilities in both the manufacturing and Quality Assurance/Quality Control (QA/QC) testing of intricate molecules. Mr. T Anil Kumar, President of Waters India, shared these insights in an email to Nandita Vijayasimha. Highlights:
Waters, a global frontrunner in analytical instrumentation and software, has led the way in innovations in chromatography, mass spectrometry, and thermal analysis, servicing numerous sectors, including the life, materials, food, and environmental sciences, for over sixty years.
Perspectives on Laboratory Instruments for Lifesciences in India and Globally
Waters focuses on markets for LC-MS (Liquid Chromatography–Mass Spectrometry) and laser light scattering instruments, software, and consumables. Currently, India represents Waters’ fastest-growing market globally, not limited to the pharmaceutical sector. There is evident industrial growth in chemical analysis, the food and environmental sectors, and TA Instruments, part of Waters, continues to be a global leader in manufacturing top-tier systems for thermal analysis, rheology, microcalorimetry, and mechanical analysis.
In India, the industrial segment of Waters constitutes about a third of its pharmaceutical division. For Waters, sales of QA/QC instruments, software, and chemistries related to small molecule generics dominate the Indian market, with large molecule biologics and biosimilars being the next expansion frontiers.
Anticipated Market Trends
The Indian pharmaceutical industry, encompassing large and small molecules, is expected to drive growth in life science tools in India due to sustained global demand for generics. The commitment by Indian companies to provide affordable and quality-assured pharmaceuticals and their robust R&D focus on complex formulations and biologics are perceived as catalysts for ongoing growth in Indian pharma exports.
The revenue potential from the initial wave of biosimilars, including insulin, has broadened industry aspirations for investment in novel, complex biological solutions.
With the advent of the U.S. Biosecure Act, biologics innovators and CDMOs in India are strategizing to meet prospective demands from Western pharmaceutical manufacturers, necessitating an enhancement in their manufacturing and QA/QC testing capacities for advanced molecules.
India’s pharmaceutical sector ranks third worldwide in production volume and 14th in value. By 2022-23, domestic and export figures for pharmaceuticals stood at approximately US$ 50 billion, forecasting to climb to around $200 billion by 2030.
The domestic growth trajectory, experiencing a CAGR of over 11% since 2003, has been driven by evolving clinical requirements, expanded coverage, enhanced spending power, and increased healthcare investments.
The prevalence of non-communicable diseases, which accounts for 56% of fatalities in India, will foster demand for chronic treatments, currently bolstered by the surge in cardiac and anti-diabetic medications.
India is also the leading global provider of vaccines, catering to over 150 nations, with the market value at US$ 1.75 billion and export figures at US$ 950 million in 2022.
Indian pharma exports mainly consist of drug formulations and biologics, accounting for 73% of exports in 2023, equaling US$18.4 billion, alongside bulk drugs and vaccines as main areas of emphasis.
Strategically adopting sustainability mandates can secure operations’ longevity while propelling growth via specialized innovations like green chemistry solutions and sustainably built lab instruments, such as those with ACT Labels from My Green Lab. These industry sub-segment initiatives can not only spur growth but also transform the industry focus from profitability-driven to value-driven.
Challenges in the Sector
Training remains a critical facet of the industry. Suppliers must consistently enhance their knowledge and skillsets, simultaneously empowering users with best practices for optimal equipment and software usage.
A significant need exists to upscale QA/QC measures for biologics and biosimilars. The life science tools industry must strategically partner with biopharma pioneers, biosimilar manufacturers, and CDMOs to devise and implement cost-effective, quality-assured methodologies.
Instrument modernization poses a substantial challenge. As advancements occur, replacing outdated instruments is necessary to deliver better results and enhanced throughput. Though prolonging the lifespan of instruments in labs saves costs, it ultimately impacts lab efficiency and efficacy.
Role of Technology in Sector Growth
The COVID-19 pandemic underscored the power of technology in problem-solving. Numerous chromatographic and biological techniques have rapidly adapted for viral vector measurements. Increased opportunity and funding have significantly driven the development of enhanced analytical platforms, particularly for R&D in routine evaluation such as mass spectrometry.
The biopharmaceutical sector has developed several emerging treatments, including mRNA vaccines and cell and gene therapies. Advanced methods strengthen analytical processes, allowing for accelerated development and comprehensive product testing, using sophisticated high-throughput equipment and methodologies.
Purpose-built technologies, such as Waters’ Alliance iS Bio & BioAccord, are seeing increased adoption. Ensuring the testing of complex biosimilars requires deeper QA/QC analysis, with new technology combinations, including SEC and MALS, facilitating this requirement.
Per- and polyfluoroalkyl substances (PFAS) have emerged as contaminants of significant concern due to their environmental persistence and potential adverse health effects. Recent research has highlighted high PFAS levels in the water sources in Chennai. Waters’ innovative technologies, like the TQ Absolute, provide cutting-edge sensitivity and ppt detection thresholds for contaminants and non-organic pollutants like PFAS.
Such technological advancements are contributing to the development of new therapies and ensuring the safety of food and water supplies.