Leumas Mission Document
Next-Gen Factories for Pharma & Wellness
Modular Scale AI-led Autonomy Distributed Manufacturing
1
What we Believe
The Future of Pharma & Wellness Manufacturing is Modular, AI-led, and Globally Distributed
The Pharma & Wellness industry is bottlenecked by centralized, rigid and capital-intensive Factories. These ‘Monolith’ Factories lack the agility, resilience, and scalability demanded by today’s precision medicine revolution.
At Leumas, we believe the future of pharma & wellness lies in a globally distributed network of modular, software-led factories — a bold shift from today’s centralized, capital-heavy systems. Rising demand for precision medicine and global reshoring trends are fast-tracking this transformation.
Leumas is building a fleet of modular, AI-driven factories — designed from the ground up to bring AWS-style, on-demand pharma production to brands, at a fraction of the cost and with equal or better quality than traditional factories.
The industry is shifting from mass production to precision production at scale—and Leumas is building the infrastructure enabling that shift.
2
Introduction & Context
Traditional Factories are a Bottleneck
The pharmaceutical & wellness industry is at a crossroads. While medical science & consumer diagnostics have made significant strides, manufacturing processes have not kept pace to unlock full potential.
Production is still concentrated in a handful of mega-sites, often in low-cost regions — creating fragile, high-risk supply chains. In today’s VUCA world, disruptions like tariffs, sanctions, and logistics failures have gone from rare to routine. [1]
Traditional Factories are rigid and product-specific, designed for mass production of select broad spectrum products. This makes them inefficient and costly to reconfigure in response to shifting market demands, evolving formulations, and increasing product diversity [3].
Inflexible infrastructure leads to underutilized capacity, costly changeovers, and operational inefficiencies—making it difficult for brands to scale dynamically or respond to demand fluctuations in real time.
Building (comparable) traditional plants demands over $20-100M in investments and 5–7 years to become operational—creating a significant barrier to speed, scalability, and innovation[4]. These factories, once built, are fixed and inflexible, making it costly and slow to adapt to new product formulations, scale capacity, or pivot based on market demand. Early-stage innovations often struggle to find production capacity, and heavy reliance on manual operations drives up costs, risks errors, and raises contamination concerns.
“Pharma companies must rethink their supply chains, move away from overdependence on offshore mega-sites, and build greater resilience through regionalized, flexible production. Traditional operational models are no longer sufficient.”
– McKinsey & Company, "The Future of Pharma Operations"
3
Why Now?
Four powerful forces across Demand, Supply, Technology, and Regulation are converging to make Agile, AI-driven manufacturing inevitable.
Increasing Demand Variability
Growth in the Specialty Pharma segment and targeted therapies, rise in chronic diseases, geopolitical shocks, and fast-changing consumer wellness trends are driving unprecedented demand variability [5]. Outbreaks and preventive healthcare innovations further fragment markets, forcing manufacturers to pivot production in real time. Traditional factories can’t keep up — but agile, modular ones can. They pivot in real time, adapt to shifting needs, and handle growing SKU complexity with ease.
Increasing Number of Products
SKU counts in pharma and wellness are exploding — and with them, the need for flexible production. Top pharma firms now manage 2x more SKUs than in 2015, yet 40% of factory capacity sits idle due to rigid, outdated workflows.
This SKU surge is fueled by chronic diseases, targeted therapies, and personalized wellness. Today, 70% of new drug launches target niche conditions, demanding high-mix, agile manufacturing — something traditional plants simply weren’t built for.
Precision Medicine getting Unlocked
Unlocking $175B+ precision medicine market demands agility in production. While all other pieces are in place viz. diagnostics, genomics, microbiome, biomarkers etc., what is missing is an agile manufacturing solution. It also requires coupling digital technologies with physical factories to compound, produce, pack and dispatch individualized products at scale. Traditional CDMOs and pharma factories struggle with such a high product mix leading to long delays and high costs for innovators.
Leumas’ modular, cyber-physical manufacturing systems—designed for autonomous operation and built-in containment—are purpose built to unlock the next generation of targeted and precision therapies, including those involving HPAPI molecules.
By combining:
- Macro-containment technology due to continuous, closed loop manufacturing
- Reprogrammable, unmanned robotic lines for high-mix manufacturing,
- And a dramatically lower CapEx footprint,
Leumas could enable brands, CDMOs, and innovators to manufacture oncology, endocrine, and rare disease therapeutics with unmatched agility, compliance, and cost-efficiency.
Need for Supply Chain Resiliance & Diversification
Centralized factories create major supply chain risks amid trade wars, tariffs, geopolitical crises, pandemics, and conflicts.
Today, 60% of pharma companies are moving toward nearshoring and local production to reduce these risks [8]. But scaling distributed sites while ensuring quality and controlling costs is tough.
Leumas’ modular, software-driven factories solve this — enabling decentralized, cost-efficient production with consistent quality and remote supervision. [2]
Reshoring / Nearshoring Movement & Localized Production
Trade barriers, geopolitical shifts, rising freight costs, and logistics challenges are driving the move to local and nearshore manufacturing. Governments worldwide are backing this with grants and tax incentives. [9, 10]
Yet, high setup and operating costs remain a hurdle in many regions. Modular, software-led factories offer a solution — enabling low-investment, near-autonomous facilities staffed by local, upskilled workers, making onshore manufacturing both viable and scalable.
Sustainability Imperative
Governments and consumers demand eco-friendly production – pushing brands to reduce carbon footprints, waste, and excessive energy use. Traditional large-scale factories generate significant waste due to overproduction, cold-start problems, inefficient batch processing, downstream fulfillment logistics and cold chain requirements. Distributed, continuous production cuts waste by making products on-demand, using fewer resources, lowering energy use, slashing logistics and storage costs, and supporting local workforces — all while shrinking the carbon footprint. [11]
Cyber Physical Tech. unlocking (truly) Modular, Universal Factories
Advanced robotics, Industrial IoT, and cyber-physical systems are making factories modular and instantly reconfigurable. Unlike traditional plants that take months to adapt, modular systems can pivot production in hours. [12] Think of software-driven factories like cloud computing — making manufacturing as agile and flexible as deploying software.
Thanks to advances like 32-bit microprocessors powering Leumas’ factories, AI-driven autonomous manufacturing has gone from science fiction to reality in just five years.
AI Unlocking (true) Autonomy & Downstream Efficiencies
AI-layer on top of physical factories create unparalleled upstream and downstream operational efficiencies and production floor optimizations [13]. For example, Leumasware® enabled dynamic routing for continuous production runs ensures maximum production throughput and yield. Real-time quality control using edge computing reduces cost of quality and strengthens compliance —a critical advantage in an industry with high regulatory compliance demands
The shift towards precision medicine requires greater flexibility in manufacturing. Agile, modular, and digitally enabled manufacturing will be necessary to respond to increasingly dynamic demand.
— McKinsey & Company, “Biopharma Operations 2030: The Way Forward"
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A New Manufacturing Model
Our modular, software-driven factories replace outdated monoliths—empowering brands to scale effortlessly, pivot instantly to market needs, and optimize continuously with AI.
- Globally Distributed, Modular Production lines for Standardized Output
-
Production Line Erection & Changeover in
monthshours - Distributed Production Capacity with software led Cost & Quality control
- Real-Time Production Scheduling & Routing
- Continuous, In-Line Quality Control
- End-to-End Digitalized Ops from Order to Fulfilment
- Scale by adding Modules, not entire Plant
- Pivot from one Product / process to another in hours
- Marginal costs decrease as volume scales (vs. traditional linear cost models)
Modular and automated platforms are spearheading a transformative shift... enabling manufacturers to meet regulatory standards, enhance productivity, and reduce waste.
— Frost & Sullivan, “Next-Gen Pharmaceutical Manufacturing: Modular and Automated Platforms"
5
The Technology
BUILDING THE FACTORY SYSTEM OF THE FUTURE
Integrating AI-driven robotics with advanced process engineering, Leumas is building an intelligent, modular cyber-physical production platform that redefines how brands produce, scale, and innovate.
Leumas® Modular Factories for Agility, Scale & Operational Autonomy
Leumas® modular production skids enable true plug-and-produce manufacturing—delivering agility, scalability, and near-autonomous operations to pharma and wellness production.
Built from the ground up, our process modules cover everything from volumetric and gravimetric dispensing to bulk fluid flow, agglomeration, homogenization, compaction, encapsulation, fill-finish, and robotic material handling.
This modular infrastructure lets brands pivot across products, processes, and scales—in just hours, not months.
Leumasware® OS - Orchestrate entire Manufacturing Workflow
Leumasware® is the AI-driven operating system that orchestrates every aspect of manufacturing & supply chain—from order placement to final dispatch. Modules include :-
- Product Recipe & Master Formulae Management,
- Materials & Movement Management,
- Sourcing & Purchase Management,
- Production Planning Execution
- Quality Assurance and
- Compliance Documentation.
At this point in time countries are trying to be self-sufficient in Pharma and companies and countries are trying to be balanced from a tarrif perspective. We may begin to see setting up of distributed facilities in the US - "Modular sort of things". Automation and tech-led efficiencies will go a long way in running manufacturing plants. We have to chase efficiency and quality.
- Umang Vohra (CEO, Cipla) & Nilesh Gupta (MD, Lupin). Appeared Business Standard Feb 28, 2025
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Early Market Validation
Leumas is partnering with leading wellness brands to co-develop next-gen production using its Third-Generation Factory Technology. Early pilots show strong commercial impact—driving capital-efficient growth, lowering innovation costs, and boosting supply chain resilience through Dedicated, Modular factories.
✅ Brands using Leumas’ On-Demand Production scaled existing product lines by up to 50% without increasing inventory capital [15]
✅ Leaner Inventory, Lower Costs – Brands reduced warehousing & logistics costs by as much as 30%, optimizing working capital [15]
✅ Faster Inventory Turnover – On-demand manufacturing enabled quicker liquidation of stock, reducing excess inventory risks.
✅ Brands launching new products with Leumas went to market 60% faster compared to traditional CDMO timelines. [15]
✅ 75% Lower Initial Investment – Reduced formulation-to-commercialization costs, allowing rapid scale-ups without heavy initial investments [15]
✅ Dedicated innovation lab in under 12 weeks for a large brand
✅ Satellite factory for early scale pilot production of novel peptides
✅Legacy Brand launched and scaled entire D2C product line
Our Factory platform isn’t just technology—it’s a partnership model. We co-design factories that grow with our partners - Turning Agility and Advanced Manufacturing tech. into a competitive moat for them
- Nitesh Kumar (CEO Leumas)
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Call to Action & Roadmap
From Pills to Peptides: Building Next-Gen Factories that Leapfrog Pharma & Wellness
Leumas is building pharma’s most agile production infrastructure—scaling both horizontally and vertically.
Horizontally, we’re expanding our proven Gen 3 platform—originally designed for small-molecule OSDs and topicals—into high-potency and specialty products with built-in containment for safe, unmanned HPAPI manufacturing.
Vertically, we’re attempting to build a modular, robotic platform for peptide drug substance manufacturing. This compact system enables continuous SPPS, purification, and formulation—fully automated and digitally orchestrated.
Together, these dual tracks position Leumas as one of the few platforms capable of powering the entire pharma value chain—from niche drug products to precision peptide APIs—with unmatched agility, cost-efficiency, and GMP-grade automation.
Future-proofing manufacturing isn’t just about resilient supply chains, capital-efficient growth, and faster innovation—it’s about defining the future of medicine. In the short term, it will empower brands to scale smarter and move faster. In the long run, it is the only path to realizing precision medicine at scale—giving humanity its best chance at extending healthy lifespans.
- Subhajit Biswas (CTO Leumas)
References
[1] – Smith, M., & Thomas, J. (2024). Global pharmaceutical supply chains: Lessons from the COVID-19 pandemic. Journal of Pharmaceutical Policy and Practice, 17(22).
[2] – Distributed, Modular Manufacturing may become a future trend – Pharma Inc. Appeared Business Standard April 7, 2025
[3] – Scholz, S. M., & Maier, R. M. (2021). The Case for Flexibility in Pharmaceutical Manufacturing. American Pharmaceutical Review.
[4] – Buehler, K., Herzberg, E., & Hieronimus, S. (2013). Building new pharmaceutical manufacturing capacity: The need for speed and flexibility. McKinsey & Company
[5] – Pavlov, A. (2019). An analysis and mitigation of demand variability on external supply chain operations for new products. MIT Libraries.
[6] – Pharmaceutical Strategy Group (PSG). (2022). Specialty Drug Trend Report. PSG.
[7] – Deloitte. (2022). The future of pharma operations: Accelerating transformation through modular, flexible manufacturing. Deloitte Insights.
[8] – PwC. (2022). Pharma 2025: Reshoring and resilience in manufacturing. PricewaterhouseCoopers LLP.
[9] – Office of the Assistant Secretary for Preparedness and Response (ASPR). (2021). Strengthening Pharmaceutical Supply Chains Through Onshore Manufacturing Investments. U.S. HHS.
[10] – Government of India – Department of Pharmaceuticals. (2020). Production Linked Incentive (PLI) Scheme for Pharmaceuticals. Ministry of Chemicals and Fertilizers.
[11] – European Medicines Agency (EMA). (2021). Reflection Paper on the Use of Continuous Manufacturing Systems in the Manufacture of Medicinal Products. EMA/CHMP/CVMP/QWP/214958/2017
[12] – National Institute of Standards and Technology (NIST). (2020). Cyber-Physical Systems and Advanced Manufacturing in Pharma. NIST Special Publication 1900-203.
➤ Explores the application of CPS, robotics, and IoT in enabling flexible, smart pharma manufacturing.
[13] – U.S. Food and Drug Administration (FDA). (2023). Artificial Intelligence and Machine Learning in Drug Manufacturing: Discussion Paper. U.S. Department of Health and Human Services.
[14] – Deloitte. (2022). Regulatory Innovation in Pharma Manufacturing: The Rise of Precision & Agile Production. Deloitte Insights.
➤ Discusses how regulators are shaping the shift from mass production to continuous and patient-specific drug manufacturing.
[15] – Internal Brand Data
Authors
Nitesh Kumar, Co-Founder & CEO @ Leumas®
Subhajit Biswas, Co-Founder & CTO @ Leumas®
Sandeep Boora, VP Manufacturing Operations @ Leumas®
Supply Chain & Sustainability Inputs – Dr. Balchandra Patil, Professor @ Indian Institute of Science, Bangalore 🇮🇳