Single-use technologies in the biopharmaceutical industry

This article is authored by Dhanendra Kumar, chairman, Competition Advisory Services LLP.

The importance of biopharmaceutical industry which was responsible for swiftly developing and producing life-saving vaccines and therapeutic solutions in response to the Covid pandemic has been recognised globally. Amidst the looming threat of another potential outbreak, it is crucial to steadfastly keep focus on the pivotal role played by the sector and keep it geared up for any such challenges. We cannot lose sight of the fact that with over 772.84 billion cases cumulatively, the Covid-19 pandemic, to date, has claimed the lives of 6.9 million people and significantly affected global trade and the livelihoods of billions.

Biopharma(Reuters Photo)

Biopharma, in its most basic sense, is a subset of the pharmaceutical industry that involves the production, manufacturing, or extraction of therapies through biological organisms. Examples of biopharmaceutical drugs include vaccines, antibody treatments, gene therapies, cell implants, modern insulin, and recombinant protein drugs. With global revenues estimated at $163 billion, biopharmaceuticals constitute approximately 20% of the pharmaceutical market. The biopharma industry stands as the fastest-growing sector within the industry, boasting an annual growth rate of over eight per cent — twice that of traditional pharmaceuticals.

Over the past two decades, India's biotechnology industry has experienced a remarkable transformation, emerging as a prominent player in the expansive landscape of global life sciences. Currently, India stands among the top 12 global destinations for biotechnology and is the third-largest hub for biotechnology in the Asia Pacific region. As of 2023, the Indian biotechnology industry has surpassed an estimated value of $92 billion, reflecting an impressive 15% growth compared to the preceding year.

A significant aspect of this trajectory is also the growth of single-use technologies (SUTs) – a shift away from the traditional utilisation of stainless steel tanks/equipment for production lines – which denotes a paradigm shift in the broader landscape of biopharmaceutical manufacturing. The contemporary landscape of single-use technologies includes an array of components, including bio-reactors, tangential-flow filtration devices, depth filters, disposable filter cartridges, media bio-containers, mixing systems, tubing assemblies, sampling systems, and various others.

These single-use elements offer multiple advantages with cost-efficiency being a particularly compelling attribute – SUTs require a lower upfront capital investment, making them an appealing choice for the biopharmaceutical industry. SUTs also offer the benefits of speed and flexibility in biopharmaceutical manufacturing. Moving ahead, ensuring the prevention of cross-contamination is a critical facet of biopharmaceutical manufacturing, driven by stringent regulatory demands. In this context, SUTs stand out. By systematically replacing components in single-use systems, the risk of contamination is significantly reduced. Further, SUTs also optimise efficiency by minimising downtime during equipment cleaning and sterilisation, encouraging a more streamlined manufacturing process that aligns seamlessly with the rapid advancements in the industry.

Over the past decade, the utilisation of single-use technologies has exhibited consistent growth. Approximately 85% of all pre-commercial biomanufacturing operations currently embrace these methodologies. The Covid-19 pandemic, which was characterised by the need to quickly roll out vaccines with greater efficacy, saw biopharmaceutical companies reaching for single-use bioprocessing technologies and equipment. The speed, adaptability and cost-effectiveness of SUTs made them especially valuable assets in addressing the pressing pharmaceutical needs dictated by the global health crisis.

In fact, according to a research report by Markets and Markets (2021), the global single-use bioprocessing market is expected to reach $20.8 billion by 2026 from $8.2 billion in 2021, at a growth rate of 20.5% during the forecast period. Contract manufacturing organisations (CMOs) were amongst the earliest adopters of SUTs and over the last decade, a growing number of Indian manufacturers have followed suit in adopting SUTs.

In India, in recent years, the government has undertaken robust measures to further the growth of the pharmaceutical sector–exemplified by a $1.3 billion fund aimed at incentivising domestic manufacturing of pharmaceutical ingredients by 2023. Moreover, the country is actively pursuing initiatives to emerge as a global leader in biopharmaceuticals by 2030, in line with the vision outlined in the National Biopharma Mission (NBM), a collaborative effort between industry and academia.

In this context, the demand for single-use technologies in India is set to grow in alignment with the nation's aspirations for self-sufficiency and its vision to become a global biomanufacturing hub. India is recognised as a high-potential country for single-use systems, supported by government backing, escalating private investments in bio-manufacturing infrastructure, and the presence of a skilled workforce. There may be some environmental concerns which could be addressed by various measures like process intensification, usage of renewable energy and reduction of plastic wastes.

The increasing utilisation of SUTs presents an opportunity for India to propel its biopharma industry to new heights. As the biopharmaceutical landscape continues to embrace the era of SUTs, it is clear that the convergence of increased efficiency, cost-effectiveness, and reduced risk of contamination not only fortifies production capabilities but also presents the industry an opportunity for delivering excellence in health care—a commitment that echoes into a future where innovation and patient well-being are in sync.

This article is authored by Dhanendra Kumar, former executive director, World Bank, for India, Sri Lanka, Bangladesh and Bhutan and first chairman, Competition Commission of India. Currently chairman, Competition Advisory Services LLP.