Gene Therapy Scaling Up for Commercial Success with CDMO Collaborations
According to data published by Precedence Research, the gene therapy industry is experiencing significant growth, transitioning from small-scale, high-cost production to large-scale, cost-effective manufacturing. This shift aims to make life-changing therapies accessible to a broader population, with viral vectors playing a pivotal role in providing long-term genetic correction.
Ottawa, Feb. 11, 2026 (GLOBE NEWSWIRE) -- The gene therapy has evolved from a niche experimental concept to an evidence-based, widely accepted treatment modality. Gene therapy is becoming a mainstream medical approach; this rise in popularity is driven by a deep insight into rare genetic disorders, a high FDA approval rate for new drugs, and improved efficiency in manufacturing gene therapies. The approval of 29 gene therapies marks a pivotal era, as advanced viral vectors can now provide long-term genetic correction.
In recent years a paradigm shift has been seen in the gene therapy industry from low-volume manufacturing to large-scale, cost-effective commercial production. Initially gene therapy was focused more on rare genetic diseases, but it has transitioned to common diseases through viral vectors. As of 2025, a number of studies are in progress, indicating an expedited commercial launch of these therapies. This industry is shifting from small-scale, expensive, laboratory-style to large-scale, cost-effective, commercialized production largely by collaborating with CDMOs to make these life-changing therapies accessible to broader aspects of populations.
The sector is experiencing a bottleneck, with a supply-demand mismatch, with new therapies outstripping production capabilities.
The current analysis for 2024-2025 states that while a huge amount of funding is flowing into this sector to build capacity, these investments are not solving its core issue, which is to produce viral vectors rapidly and cost-effectively. The challenges this sector faces are lack of standardized procedure, inefficient production and high-cost inputs, quality control, and limitations in scaling. Most of the ventures are replicating the existing infrastructure rather than inventing a more efficient platform or making slow-paced organizational changes. This sector is still developing, so expertise needed for this complex living system is rare; hence, capital alone cannot solve this problem.
The industry's standard approach for the production of viral vectors used in gene therapy and vaccines
It has two main phases: upstream and downstream. The upstream bioprocessing is an initial stage that focuses on growing host cells and encouraging them to produce viruses. Once a virus is produced, it must be separated from cell debris and impurities. This is downstream bioprocessing, and the final step is the purified concentrated virus is transformed into a final stable form and filled into a vial for clinical use.
For small-scale production of viral vectors, the 2D adherent method is used, but now this sector is shifting towards 3D suspension systems for large-scale single-use bioreactors. This evolution is needed for increasing production, minimizing cost, and ensuring the final product is of superior quality and safe for the patient.
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Advancements in viral vectors are overcoming traditional limitations.
Traditional Limitation
- Lack of standardised production: The upstream production system cannot use a single solution approach; they must strategically balance flexibility, scalability, and quality based on the development phase.
- Poor Downstream Processing: The production of viral vectors is challenging, as only half of the viral vectors created in the lab make it into the final product due to the empty shell problem. There are technical hurdles in manufacturing that cause high contamination and low efficiency.
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Regulatory partnership: Currently regulations vary by region or type of sector, which forces manufacturers to interpret them by themselves; hence, there is a need for standardized universal regulation, which will give more confidence to manufacturers
Developing Prospects
- Dynamic Sourcing Strategy: Cell and gene therapy developers must strategically choose between building in-house capabilities, which will provide IP protection and better control, and outsourcing to CDMO for speed, expertise, and cost-efficiency. The aim to achieve from both options is to overcome high-risk, complex manufacturing challenges and bring advanced therapies to patients.
- Smart Capital Deployment: These gene therapies offer a cure rather than a treatment, so there is immense pressure to accelerate the production from labs to a commercial level, yet this sector is facing challenges due to technical limitations and a lack of standardized protocol.
- Refining operational processes: Streamlining the journey from research to final product while maintaining high quality can be achieved by end-to-end operation streamlining wherein all the processes are integrated. The challenge is that there is a major surge in demand for gene therapies, but production is slow, and storing them for long periods is difficult, creating a bottleneck.
- Smart Manufacturing: A major transition is seen in gene therapies as they are moving away from manual, error-prone, and slow methods to smart factors driven by data, automation, and AI. Digitalization is converting complex art into precise science; ultimately, it is making gene therapy affordable, accessible, and safe.
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Pioneering Future Innovations: The pharmaceutical industry is evolving from conventional, manual, expensive small-batch manufacturing to smart, automated, and continuous manufacturing for gene and cell therapies.
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The future of gene therapy requires prioritizing manufacturing excellence over treating it as merely operational backup. It highlights improving production, choosing the correct vector platform, and adopting digital technology to minimize cost and enhance the quality. To succeed, a developer must go beyond basic production and focus on chemistry, manufacturing, and control and must master the downstream processing. Companies should invest in smart, unique technologies by selecting appropriate, reliable, and low-cost platforms.
Companies are focusing on developing new formulations that are unique, sustainable, and innovative instead of copying established methods. Using digital tools and developing novel expandable production strategies is essential to reduce cost and enhance overall product quality. This development must be aligned with patient needs, market size, and commercial expandability. Developers are increasingly outsourcing to specialized CDMOs to avoid high capital expenses. Developers must choose between platforms like AAV, lentivirus, or adenovirus based on target diseases and scale. Standardizing CMC processes is essential to shift from laboratory-scale to commercial-scale production, ensuring consistency and regulatory approval.
The industry is transitioning towards an industrialized paradigm, making advanced, proprietary manufacturing capabilities the critical differentiator for market dominance. The focus is shifting toward targeting specific patient populations' unmet needs and market size rather than just technical feasibility, aiming for affordable, high-impact therapies. Though viral vectors are not without their challenges, rapid advancements in vector engineering are turning the tides. Viral vectors are leading the future of medicine, enabling treatments from the inside out.
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