Introduction
The cell and gene therapy (CGT) landscape is evolving at remarkable speed, driven by major technological advancements, growing regulatory confidence, and rising global demand. More than 2,200 therapies are currently in development, and over 60 gene therapies are projected to gain approval by 2030. As programs mature from early discovery to late-stage clinical and commercial phases, the industry is being reshaped by new manufacturing approaches, next-generation technologies, the push for scalable and standardised processes, and shifting collaboration models.
Against this backdrop, the DACH region - Germany, Austria, and Switzerland - continues to strengthen its position as a global innovation hub for CGT and advanced biologics. With world-class scientific institutions, robust manufacturing infrastructures, and strong industrial leaders, the region is uniquely equipped to drive the next wave of therapeutic breakthroughs. As the field moves from scientific promise to commercial reality, the DACH ecosystem is placing increasing emphasis on scalable manufacturing, regulatory clarity, and a diversified therapeutic pipeline.
This e-book explores the key trends shaping the DACH CGT and biologics landscape for 2025–2026, offering insights for developers, manufacturers, regulators, investors, and healthcare leaders.
- Technological breakthroughs accelerating development
- Rising regulatory acceptance
- Expansion of the global pipeline (2,200+ therapies)
- Increased investment and commercialisation momentum
- Growing demand for curative and personalised therapies
2.1 Consolidation and Market Correction
- M&A activity and strategic realignment
- Funding pressures and portfolio prioritisation
2.1 Diversification and Differentiation
- Expansion beyond oncology (autoimmune, neuro, metabolic)
- Rise of next-generation modalities (allogeneic, in vivo editing, non-viral delivery)
- New commercial and access models
3.1 Automation Driving Industrialisation
- Shift to closed, automated systems
- Workflow standardisation for scalability
- Modular micro-factories for decentralised manufacturing
3.2 Digital Tools & AI Reducing Production Bottlenecks
- Real-time monitoring and digital twins
- AI-driven process optimisation
- Integrated data systems & electronic batch records
- AI-enhanced vector design and cell engineering
1. Key Drivers of Growth in the Global CGT Market
The global CGT market is entering a period of unprecedented expansion, powered by a combination of scientific progress, regulatory momentum, and surging therapeutic development. With more than 2,200 therapies currently in development worldwide and over 60 gene therapies projected to gain approval by 2030, the field is transitioning from experimental innovation to large-scale clinical and commercial reality. Several major forces are fueling this growth:
1.1 Technological Breakthroughs Accelerating Development
Innovations in gene editing, vector engineering, and cell processing are dramatically shortening development timelines. Key contributors include:
- Advancements in CRISPR, base editing, and prime editing, enabling safer and more precise modifications.
- Next-generation viral and non-viral delivery technologies, improving transduction efficiency and tissue targeting.
- Automated, closed-system processing platforms, lowering contamination risk and increasing batch consistency.
These advancements reduce production failures, increase reproducibility, and make complex therapies more commercially viable.
1.2 Growing Regulatory Acceptance and Optimised Pathways
Regulatory agencies in the US, EU, and Asia are increasingly aligned on the need to accelerate CGT access. This has resulted in:
- Faster approval pathways, such as RMAT (US), PRIME (EU), and Sakigake (Japan).
- More flexible clinical trial designs, particularly for rare diseases.
- Growing real-world evidence frameworks, enabling adaptive approvals.
This supportive regulatory environment reduces barriers to market entry and encourages investment in more complex modalities.
1.3 Expansion of the Global Clinical Pipeline
The CGT pipeline has more than doubled in the last five years, driven by:
- An influx of early-stage biotech start-ups
- Growing academic–industry partnerships
- Increased funding for translational research
- Broader therapeutic ambition beyond oncology
As larger patient populations come into focus - autoimmune, neurological, metabolic - the commercial potential increases significantly.
1.4 Increased Investment and Commercialisation Momentum
Despite recent market corrections, long-term investor confidence remains strong. Growth drivers include:
- Record levels of private and public financing for CGT innovators
- Large pharma and CDMOs expanding capacity through acquisitions and greenfield builds
- New partnership models, such as risk-sharing, co-development, and modular manufacturing alliances
These factors are solidifying the commercial ecosystem needed to bring CGT products to market at scale.
1.5 Rising Demand for Curative and Personalised Therapies
Patients, clinicians, and payers are increasingly motivated by therapies that offer:
- One-time, durable treatment potential
- Disease-modifying or curative outcomes
- Personalised solutions for previously untreatable conditions
As awareness and confidence grow, demand for CGTs - especially for chronic and high-burden diseases - is accelerating globally.
2. Major Trends Defining the Current Competitive Environment
The CGT landscape is undergoing a significant competitive reset as the sector transitions from early scientific exploration to operational and commercial maturity. Companies are reevaluating their strategies, reallocating capital, and pivoting toward differentiated, scalable solutions. Two dominant themes - Consolidation and Market Correction and Diversification and Differentiation - are shaping the global and DACH markets alike.
2.1 Consolidation and Market Correction
The past few years have seen a recalibration of the CGT ecosystem. While scientific momentum remains strong, economic pressures and the need for sustainable business models have triggered a wave of structural change.
M&A Activity and Strategic Realignment
Large pharma companies and mature biotechs are increasingly acquiring or partnering with CGT innovators to access proprietary platforms, manufacturing expertise, or pipeline diversification. Key drivers include:
- The need to secure advanced manufacturing assets
- Acquisitions of specialised vector producers and CDMOs
- Strategic prioritisation of technologies with commercial viability
This consolidation is streamlining the competitive landscape while accelerating technology transfer and scalability.
Funding Pressures and Portfolio Prioritisation
Market correction has led investors to focus on programs with strong clinical validation and clear commercial pathways. As a result:
- Companies are reducing or restructuring early-stage pipelines
- Non-core programs are being paused, out-licensed, or divested
- Capital is shifting toward platforms with demonstrated manufacturability and cost-efficiency
This refocusing is increasing discipline across the industry and elevating the most promising therapeutic and technological approaches.
2.2 Diversification and Differentiation
While oncology continues to dominate the CGT landscape, developers are expanding target indications and investing in new modalities to strengthen competitive positioning.
Expansion Beyond Oncology
DACH-region researchers and global developers are pursuing CGT applications in broader disease categories, including:
- Autoimmune diseases such as lupus, Type 1 diabetes, and multiple sclerosis
- Neurological disorders like Parkinson’s, Alzheimer’s, and ALS
- Cardiovascular and metabolic diseases, leveraging in vivo gene editing and regenerative approaches
This diversification is driven by improved delivery vectors, durable expression technologies, and robust preclinical data.
Rise of Next-Generation Modalities
Emerging modalities are offering new paths to differentiation:
- Allogeneic (off-the-shelf) therapies enabling scalability and reduced cost per dose
- In vivo gene editing for direct tissue-targeted correction
- Non-viral delivery platforms, including lipid nanoparticles and polymer-based carriers
These next-generation technologies offer safer, more flexible, and potentially repeatable dosing options.
New Commercial and Access Models
As high-cost therapies enter the market, companies are deploying novel access strategies:
- Outcomes-based reimbursement
- Annuity-style payment models
- Risk-sharing agreements between payers and developers
These models aim to balance innovation with healthcare system sustainability.
3. Technologies Streamlining and Decentralising CGT Production
Technological innovation is rapidly reshaping how CGT therapies are manufactured, moving the industry from bespoke, artisanal processes to industrialised, scalable systems. Two areas - automation and digital integration- are delivering the most impactful change.
2.1 Consolidation and Market Correction
The past few years have seen a recalibration of the CGT ecosystem. While scientific momentum remains strong, economic pressures and the need for sustainable business models have triggered a wave of structural change.
Shift to Closed, Automated Systems
The adoption of fully enclosed systems reduces contamination risk, labor dependency, and environmental variability. These systems:
- Support 24/7 operation
- Improve batch-to-batch consistency
- Facilitate regulatory compliance through controlled processing environments
Workflow Standardisation for Scalability
Standardised workflows are essential to achieve reproducibility across multiple sites. Benefits include:
- Simplified tech transfer
- Predictable performance metrics
- Faster scale-up for commercial supply
Modular Micro‑Factories for Decentralised Manufacturing
Next-generation "factory‑in‑a‑box" systems are gaining traction, allowing:
- Localised manufacturing near treatment centers
- Reduced logistics complexity for autologous therapies
- Rapid deployment of GMP capabilities in new regions
These approaches support personalised therapies while still enabling global reach.
3.2 Digital Tools & AI Reducing Production Bottlenecks
Digital transformation allows manufacturers to operate with greater precision, visibility, and predictive capability.
Real-Time Monitoring and Digital Twins
Digital twins replicate manufacturing processes in virtual environments, enabling:
- Simulation of process changes
- Early identification of performance deviations
- Improved process control and optimisation
AI‑Driven Process Optimisation
Machine learning algorithms are being applied to:
- Enhance vector yields
- Predict batch success
- Optimise cell expansion conditions
This dramatically reduces trial‑and‑error experimentation.
Integrated Data Systems & Electronic Batch Records
Integrated digital ecosystems streamline CGT production by:
- Creating end‑to‑end data traceability
- Reducing manual documentation errors
- Enabling regulatory‑ready audit trails
AI‑Enhanced Vector Design and Cell Engineering
AI is accelerating the design of vectors, gene constructs, and engineered cells by:
- Identifying optimal promoter and capsid configurations
- Reducing off-target editing risks
- Increasing therapeutic potency and durability
4. The Road Ahead
The Cell and Gene Therapy (CGT) landscape in the DACH region is entering a decisive phase - one where scientific breakthroughs must be matched by manufacturing maturity, regulatory predictability, and economic viability. Over the next two years, progress will depend on how effectively the ecosystem aligns around four imperatives:
Industrialising Advanced Therapies While Reducing Cost of Goods
To bridge the gap between early clinical success and sustainable commercial launch, the industry must continue transitioning toward automated, standardised, and digitally enabled production lines. Key priorities include:
- Reducing per-patient manufacturing costs through closed systems and robotics
- Adopting platform processes for viral vectors, genome editing, and cell expansion
- Deploying scalable in vivo delivery technologies
- Building modular and decentralised facilities that bring manufacturing closer to the point of care
These steps will determine whether CGT can move from niche, high-cost treatments to broadly accessible medicines.
Expanding the Therapeutic Impact Beyond Oncology
As pipelines diversify into autoimmune, neurological, and metabolic diseases, the DACH region must prepare for larger patient populations and higher production throughput. Success will rely on:
- Robust allogeneic platforms capable of supporting mass treatment
- Safe, efficient in vivo gene delivery enabling repeat dosing
- Precision editing technologies with superior safety margins
- Early integration of manufacturing strategy into pipeline design
This shift marks the transition of CGT from last-resort interventions to mainstream therapeutic options.
Strengthening Regulatory Navigation and Reimbursement Foundations
Even the most scientifically compelling therapies will struggle without clear, predictable pathways to approval and payment. The road ahead requires:
- Earlier engagement with EMA and national HTA bodies
- Region-wide harmonisation of quality expectations for ATMPs
- Evidence frameworks that capture long-term value in chronic and widespread diseases
- New payment models such as milestone-based reimbursement, outcomes-based pricing, and annuity schemes
The challenge is not only to prove safety and efficacy - but to prove value.
Building a Connected Ecosystem That Supports Innovation at Scale
The next phase of CGT growth will be enabled by deeper collaboration across industry, academia, regulators, and healthcare providers. Key enablers include:
- Shared manufacturing and testing infrastructure
- Workforce upskilling in automation, digital operations, and advanced analytics
- Data integration across clinical, manufacturing, and post-market systems
- Strategic partnerships to address vector supply, cold chain, and global logistics
A more interconnected ecosystem will strengthen the DACH region’s position as a global CGT powerhouse.
As Cell and Gene Therapy and advanced biologics continue to redefine the boundaries of modern medicine, the DACH region stands at a pivotal moment - one defined not only by scientific excellence but by the ability to translate innovation into scalable, accessible, and economically sustainable therapies. The coming years will determine which organisations can successfully bridge the gap between discovery and commercialisation, navigate regulatory complexity, build resilient supply chains, and leverage automation and digital intelligence to their fullest potential.
The trends highlighted in this e-book - industrialised manufacturing, pipeline diversification, next-generation gene editing, allogeneic platforms, and AI-enabled production - signal a clear shift toward a more mature, competitive, and globally influential CGT ecosystem. With the right strategic investments, collaborative frameworks, and regulatory alignment, the DACH region is poised to shape the next decade of therapeutic breakthroughs and define global standards in quality, scalability, and patient access.
The opportunities ahead are immense. The decisions made today - by developers, manufacturers, policymakers, investors, and healthcare leaders - will set up the trajectory for tomorrow's therapies. By embracing innovation, fostering ecosystem-wide partnerships, and putting long-term patient impact at the center, the DACH region can lead the world in bringing life-changing treatments to those who need them most.
The future of Cell and Gene Therapy is unfolding now - this is the moment to build it
