How Emerging Biotech Startups Reshaping the Bioprocessing Future

In an interaction with Thiruamuthan, Assistant Editor of India Pharma Outlook, Ankush Kapoor, Founder & CEO of PharmNXT Biotech, discusses how India’s biotech ecosystem is redefining bioprocessing through Single-Use Technologies, Defined Tubing Routing, and digital innovation. These advancements are enhancing scalability, sustainability, and compliance while significantly reducing energy, water use, and contamination risks. Startups are increasingly adopting modular, AI-driven, and continuous systems to overcome resource constraints, advance cell and gene therapy production, and position India as a global hub for efficient, sustainable, and technologically advanced biomanufacturing.

With Indian biotech startups rapidly innovating enzyme and cell culture platforms, what strategies are redefining bioprocessing efficiency while overcoming technical and resource constraints?

India’s biotech surge is indeed being led by startups. The ecosystem has grown to roughly 9,000–10,000 biotech startups as of mid-2025. Government schemes like BIRAC and state incubators are major drivers here, as they channel new capital into enzyme, cell-culture, and related platform plays. As India’s biotech startups accelerate innovation across enzyme and cell-culture platforms, efficiency becomes all about flexibility and precision. Personally, we see single-use technologies (SUTs) and Defined Tubing Routing (DTR) as game-changers in this evolution.

Single-use systems reduce downtime, eliminate cross-contamination risks, and allow faster product changeovers, helping startups operate with agility even in resource-constrained settings. They shrink the facility footprint and lower contamination risk. It also cuts life-cycle greenhouse impact by 34 percent and cumulative energy demand by 32 percent, with major water savings during use due to the elimination of cleaning and sterilization.

Through our integration of DTR, a European-engineered tubing management platform now made in India, we’re reducing misconnections, trip hazards, and audit findings, while speeding product changeovers in high-mix facilities. This helps in not only working in resource-constrained settings but also advancing the cause of resource efficiency and sustainability.

In light of growing adoption of modular and continuous bioprocessing, which technological approaches are startups using to address scale-up and reproducibility challenges effectively?

Biotech startups in India are increasingly moving towards modular and continuous manufacturing. In BioPlan’s latest multi-year survey, facilities running elements of continuous processing rose from 24.2 percent in 2023 to 33.9 percent in 2025. The global continuous-bioprocessing market itself is pegged around USD 4–4.2 billion in 2024–2025, growing 11–15 percent CAGR through 2033.

The key to reliable scale-up is smarter process engineering. From our experience at PharmNXT, two technologies stand out for making reproducible results possible and practical for resource-conscious firms:

One is Single-Use Technologies where pre-sterilised bags, tubing and connectors remove the variables tied to cleaning and sterilization, which translates to fewer delays and more consistent outcomes. Life-cycle studies show SUTs often cut energy use and greenhouse-gas emissions by more than 30 percent each, compared to traditional stainless-steel systems. Defined Tubing Routing (DTR) is also beneficial when you’re running multiple small-batch or parallel lines, where mix-ups in tubing are a real risk. Other tools like digital sensors, modular skid design, perfusion intensification also have their place. But if you’re a startup trying to scale without bloated capex and unpredictable outcomes, SUTs + DTR are the fastest, smartest win in our view.

As regulatory scrutiny and cost pressures intensify, what measures are emerging biotech startups implementing to ensure compliance while maintaining robust, affordable processes?

One can say that, in some measure, regulatory scrutiny is heightening in the post-pandemic era. Over 256 inspections of manufacturing sites were conducted by the FDA in 2024, which is up significantly from the pandemic trough. In this exercise, only around 40 percent of Indian facilities obtained a “No Action Indicated” (NAI) status. Compared to around 74 percent NAIs for U.S. sites, one can gauge the real gaps in compliance.

We fully support this regulatory focus. Compliance is about safeguarding quality, patient safety, and credibility. In our experience, we’ve seen that Strong data integrity systems secure audit-trails, validated electronic records, and clear change-control procedures, which ensure that regulators can trace every critical decision. Quality by Design (QbD), continuous monitoring, clear documentation, and using modular units with standard operating procedures (SOPs) means fewer validation documents, shorter qualification timelines, and lower cost. Lastly, knowing the origin of materials, lot control, supplier qualification, and prompt corrective actions for deviations helps meet GMP expectations without excessive overhead.

With rising investment in cell and gene therapy platforms, how are startups tackling raw material shortages and process scalability to meet increasing demand?

India’s cell and gene therapy (CGT) space has entered a defining phase. The approval of India’s first indigenous CAR-T therapy, NexCAR19, in 2024 marked a turning point, with over 350 patients being treated across nearly 70 hospitals, at almost 90 percent lower cost than comparable global therapies. With this momentum, demand for CGT manufacturing capacity and raw materials such as viral vectors and plasmid DNA has surged worldwide, and India is no exception.

The challenge today, as we see it, is not intent but infrastructure. Startups are facing supply constraints for GMP-grade vectors, resins, and high-quality consumables. At PharmNXT Biotech, we see Single-Use Technologies and Defined Tubing Routing as practical answers to this bottleneck. Single-use systems enable flexible, contamination-free scale-out, which is critical when every batch counts. On the other hand, DTR provides engineered, labelled flow paths that cut process errors, improve reproducibility, and conserve costly materials. Together, they help startups move from pilot to commercial scale without heavy CAPEX or long downtime.

India’s next growth leap in CGT manufacturing will come from such resource-efficient technologies that turn scarcity into scalability and position the country as a serious global manufacturing hub in advanced therapies.

Also Read: Bridging Collaboration Gaps to Boost India's Pharma Discovery

As automation, digital twins, and AI-driven monitoring transform biomanufacturing, in what ways are startups enhancing process control, reducing errors, and improving reproducibility?

Automation and AI are fast emerging as the backbone of reliable manufacturing in India. Studies show that AI-enabled process models can cut batch variability by nearly 20 percent and shorten process-development timelines by about 25 percent. India’s own digital-twin market is expanding at over 40 percent CAGR, showing how quickly the sector is digitising. For startups working on enzyme and cell-culture platforms, this shift is transformative.

We’re seeing an increased usage of digital twins to virtually simulate entire production lines before scaling, spotting bottlenecks and layout inefficiencies early. AI-driven monitoring and inline sensors are allowing them to detect deviations in parameters like pH or oxygen in real time and correct them automatically, reducing human error. When combined with Single-Use Technologies (SUTs) and Defined Tubing Routing (DTR), these digital tools create a controlled, repeatable environment, eliminating variability from cleaning, setup, and routing mistakes. The outcome is faster scale-up, consistent product quality, and lower wastage, all achieved within tighter regulatory and resource constraints.

Looking forward, what innovations or strategies could enable startups to scale sustainable, green biomanufacturing while navigating environmental and resource constraints in India?

The next phase of India’s biotech growth will be defined by how sustainably we scale. Our sector is already valued at over USD 165 billion and is targeting USD 300 billion by 2030, but this ambition must align with environmental responsibility. Single-Use Technologies are already making biomanufacturing greener. Life-cycle studies show they cut energy use by about 32 percent, greenhouse emissions by 34 percent, and eliminate thousands of litres of water and harsh chemicals used in traditional cleaning and sterilisation. When combined with Defined Tubing Routing (DTR), they also minimise material waste and optimise facility layouts, reducing both environmental and operational footprints.

Looking ahead, sustainability will evolve beyond disposables. Other startups we know are beginning to explore bio-based or biodegradable single-use materials, recycling and circular-economy systems for plastic waste, and energy-efficient, solar-powered modular facilities. Intensified manufacturing with smaller bioreactors, higher cell densities, and perfusion systems can further lower energy and water use per batch. Finally, digital twins and inline sensors are reducing failed batches and resource wastage through predictive control.