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      With the rapid emergence of groundbreaking Life Sciences innovations, the pharmaceutical and medtech landscape is transforming at an unprecedented pace.

      From advanced therapies and digital health platforms to smart devices and AI-powered diagnostics, innovation is reshaping how care is developed, delivered and scaled globally. 

      But as these therapies and technologies advance, the challenge of delivering them to patients also grows more complex. Strict regulations, high development costs and scaling challenges are slowing progress from innovation to impact. 

      At KPMG, we help biotech, pharmaceutical and medtech companies translate scientific breakthroughs into scalable, accessible solutions. From research and development (R&D) strategy and manufacturing transformation to pricing, regulatory positioning and market access, we provide the strategic insights and operational guidance to deliver advanced therapies – such as cell and gene therapies, RNA therapies or antibody-drug conjugates – to patients efficiently and at scale. 

      Our efforts also support progress across the broader field of gene therapy advancements, helping companies accelerate innovation in the growing global gene therapy market.

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      Our latest thinking

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      CAR-T and other cell and gene therapies are changing the way treatment is done. However, efficiently and equitably scaling them remains the key challenge. 

      How can manufacturing become more accessible? What role must stakeholders play together? 

      Learn how today's strategic choices will impact the future of cell therapy.

      From innovation to impact: scaling new therapeutic modalities to serve patients

      While new therapeutic modalities expand patient care possibilities, they also present significant operational challenges. These modalities require new infrastructure, technology and regulatory systems. Below, we share our insights on select emerging modalities that are shaping the future of medicine. 

      1. CAR-T therapy: personalized oncology

      Chimeric Antigen Receptor T-cell (CAR-T) therapy is a revolutionary treatment for blood cancers, including lymphoma, leukemia and multiple myeloma. As an advanced medicinal product (ATMP), CAR-T therapy delivers remarkable results in fighting cancer cells, with response rates exceeding 80%. 

      However, fewer than 20% of eligible patients in the U.S. currently receive CAR-T therapy. What barriers stand in the way? Limited infrastructure, high manufacturing costs, complex CAR-T reimbursement processes and a shortage of highly specialized treatment centers. 

      The key levers for scaling up CAR-T therapy are:

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      The USD 30k CAR-T therapy: a future within reach?

      How Life Sciences leaders can increase accessibility and drive CAR-T costs down through supply chain innovation
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      • Apheresis scale-up

        A projected 30% shortfall in collection capacity by 2030 necessitates the use of mobile apheresis units and integration with community care settings. 

      • Cold chain optimization

        More flexible and standardized cryogenic transport solutions are needed to maintain cell integrity.

      • Outpatient and hybrid care models

        For some patients, receiving CAR-T therapy outside of a hospital setting with remote monitoring can reduce costs and improve access.

      • Manufacturing transformation

        Robotic systems and modular platforms are reducing production time to fewer than 10 days from collection to infusion.

      • Proof of cost reduction

        High CAR-T therapy costs remain a major barrier to access. Cutting expenses at each step of the manufacturing process is essential to serving patients at scale.

      KPMG partners with cell and gene therapy leaders to deliver end-to-end strategies, from manufacturing processes to delivery models, regulatory readiness and pricing frameworks.

      We help our clients craft scalable, accessible business models centered on cutting-edge therapies.

      2. RNA therapeutics: infrastructure for precision therapies

      RNA-based therapies are at the core of current precision medicine trends.

      While best known for their role in the COVID-19 mRNA vaccine, RNA vaccines are now being explored against a broader spectrum of infectious diseases, including influenza and respiratory syncytial virus (RSV).

      Yet, the path to commercialize RNA therapies is fraught with complexity.  

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      RNA therapies: entering a new age

      Rapid advances shaping a lucrative investment landscape
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      The RNA therapeutics landscape faces several challenges:

      • Specialized, high-cost manufacturing

        Production depends on advanced, expensive equipment and specialized expertise that remain scarce. 

      • Limited CDMO capacity

        Most companies rely on a handful of contract development and manufacturing organizations (CDMOs), resulting in capacity constraints and competitive bottlenecks. 

      • Stringent cold chain requirements

        RNA therapies require ultra-cold storage and transportation, adding costs and logistic complexity. 
         

      • Crowded therapeutic space

        Multiple developers targeting the same conditions, such as cardiovascular disease or rare genetic disorders. This makes it harder to stand out and capture market share. 

      KPMG helps clients mitigate risk in RNA development by defining robust asset strategies, forging optimized manufacturing partnerships and creating scalable go-to-market plans.

      RNA innovation demands pioneering infrastructure – and we’re here to build it.

      3. Microbiome therapeutics: from concept to commercialization

      Following the FDA’s approval of the first live biotherapeutic product (LBP) for recurrent C. difficile infection (recurrent CDI) in 2022, interest in the human microbiome in healthcare has surged, transforming it from an R&D curiosity into a therapeutic platform that triggered a new wave of microbiome innovation across biotech.

      The gut microbiome plays a key role in digestion, immune regulation and even central nervous system function. This broad influence positions microbiome-based interventions as crucial for treating infectious diseases, addressing mental health issues and advancing personalized medicine.

      But they also present unique challenges:

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      Harnessing the power of the human microbiome

      Introduction to a nascent market
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      Manufacturing


      Unlike conventional drugs, these treatments involve live microbes. Ensuring product quality and stability on a large scale requires specialized production processes and facilities.

      Regulatory


      There is no global standard yet for microbiome drugs. Developers must adapt to the different regulatory expectations of each target market. 

       

      Intellectual property


      Since bacteria sourced from biological samples cannot be patented, some products may face intellectual property challenges.

      KPMG guides clients through commercialization strategies, regulatory pathways and market access planning, helping innovators build compliant, scalable and investor-ready business models. 

      Next generation of therapeutic platforms: investing with purpose

      Biotech innovation is no longer constrained to traditional pipelines. A new wave of therapeutic platforms is reshaping Life Sciences research and drug development:

        • Protein degradation (e.g., PROTACs)

          unlocking previously “undruggable” proteins

        • Epigenetic therapies

          precise modulation of gene expression in oncology and rare diseases

        • CRISPR-based editing

          expanding from rare disease trials to broader therapeutic applications

        • AI-powered drug discovery

          improving hit identification, trial design and biomarker analysis

        These novel therapeutic platforms signify paradigm shifts rather than incremental advances.

        Companies that invest early in emerging pharma technologies, integrated data ecosystems and AI-enhanced pipelines are poised to gain secure competitive edge throughout the entire process, from R&D to delivery. 

        Cost & access: pharma innovation with inclusion

        Advanced therapies offer enormous clinical value, but their six- and seven-figure price tags pose major access challenges.

        Pharma companies must transition to more inclusive models that reward outcomes and extend reach.  

        Leading strategies include:

        • Value-based pricing

          aligning payments with outcomes rather than volume

        • Outcome-based contracts

          payers reimburse only if therapies deliver the promised results

        • Tiered pricing strategies

          adapting to local affordability in emerging and low-income markets

        • Blended finance and partnerships

          leveraging public and philanthropic capital to improve access and scale

        KPMG helps clients design market access strategies that integrate payer expectations, regulatory trends and real-world data integration.

        These approaches make innovation sustainable and inclusive while maximizing value for patients, payers and innovators.

        Scaling innovation: four challenges pharma must overcome

        Advanced therapies require advanced systems. Even the most groundbreaking science can stall without proper clinical, regulatory and operational infrastructure. 

        Key challenges include:

        Complex trial
        design

        Personalized and rare-disease therapies require adaptive, decentralized and biomarker-driven trials. 
         

        Regulatory
        variation

        Differing global standards for gene editing, RNA and microbiome products complicate harmonization. 

        Manufacturing
        scale-up

        From autologous cell therapies to GMP production for RNA or live organisms, scaling remains difficult. 
         

        Patient identification
        Personalized medicine depends on precise targeting, supported by diagnostics, real-world data and AI models. 
         

        While these challenges are significant, they create opportunities for innovators.

        At KPMG, we help our clients de-risk their innovation pipelines, build operational resilience and unlock market access through ecosystem collaboration and digital enablement. 

        Looking ahead: innovation is a strategic imperative

        Therapeutic innovation is about more than discovering the next molecule. It’s also about establishing systems, partnerships and strategies that deliver science to patients equitably, efficiently and at scale. 

        The therapeutic modalities featured here demonstrate what’s possible (with more content coming soon) and what’s required: new care models, agile supply chains, smarter reimbursement frameworks and cross-sector collaboration.

        Our strategic consulting teams work across R&D, manufacturing, the supply chain and market access to help clients capture value at every stage of the innovation journey. This hub is your guide to the future of medicine – and how to lead it. Explore how we can support your next phase of innovation – let’s talk strategy.

        Meet our experts

        Deborah Lancaster
        Deborah Lancaster

        Partner, Life Sciences Strategy

        KPMG Switzerland

        Camal Handor
        Camal Handor

        Director, Life Sciences, Global Strategy Group

        KPMG Switzerland

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