Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond

By Sabyasachi Ghosh, Future Market Insights

The advanced therapy sector stands at a transformative juncture in 2025, with contract manufacturing outsourcing emerging as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide. The global cell and gene therapy manufacturing market is forecast to reach $32.11 billion in 2025, setting the stage for growth to $403.54 billion by 2035, representing a remarkable CAGR of 28.8%, according to market research by Future Market Insights.

Contract development and manufacturing organizations have evolved from service providers to strategic partners essential for advanced therapy commercialization. The complexity of manufacturing living medicines has driven pharmaceutical companies to increasingly rely on specialized CDMOs with expertise in regulatory compliance, process development, and scalable production.

The European Medicines Agency's adoption of new guidelines for investigational advanced therapy medicinal products, which came into effect on July 1, 2025, has further validated the critical role of CDMOs. The guideline provides comprehensive requirements for quality, non-clinical, and clinical documentation, emphasizing the need for specialized expertise that CDMOs provide. Similarly, the FDA's 2025 guidance agenda includes multiple new frameworks for cell and gene therapy products, including potency assurance and post-approval safety monitoring, reinforcing the regulatory complexity that drives outsourcing decisions.

Decentralized Manufacturing: A Paradigm Shift

One of the most significant trends in 2025 is the movement toward decentralized and point-of-care (POC) manufacturing. The Alliance for Regenerative Medicine predicts that more than five new gene therapies will gain regulatory approval by 2025-end, increasing demand for decentralized manufacturing capabilities. Strategic collaborations are emerging to enable this shift, such as the partnership between Galapagos and Blood Centers of America, which leverages 50 existing community blood centers across 43 states to create a decentralized CAR-T manufacturing network.

Recently, researchers in Mexico have successfully demonstrated the feasibility of point-of-care CAR-T cell manufacturing by implementing and validating an automated, closed-system process for producing CD19 CAR-T cells (see here, here, and here). This process yielded high-quality products that met all predefined release criteria, including standards for appearance, sterility, impurity levels, and a median cell viability of 97.7%. The research team overcame significant regulatory and logistical hurdles, such as securing the country's first-ever permit to import a vital viral vector. The study's outcomes were comparable to international reports, confirming that point-of-care manufacturing is an effective and viable option for academic centers in middle-income countries with appropriate infrastructure and training. These developments address critical challenges in the traditional centralized model, including lengthy turnaround times, complex logistics, and limited patient access.

Cell And Gene Therapy Manufacturing Evolution

The cell therapy manufacturing landscape demonstrates particularly robust growth patterns. According to our research, autologous cell therapy manufacturing leads the global cell therapy manufacturing market with an approximately 56% share, though the industry faces critical challenges in scaling from small patient populations to broader accessibility. The complexity of these therapies has made outsourcing particularly attractive, with CDMOs offering specialized capabilities that many pharmaceutical companies lack internally.

RNA Therapeutics And Oligonucleotide Manufacturing Surge

The oligonucleotide sector represents a rapidly expanding opportunity for CDMOs. The oligonucleotide API market was valued at $2.81 billion in 2024 and is set to reach $4.84 billion by 2034, growing at a CAGR of 5.60%. The antisense oligonucleotide segment holds approximately 78% of the global oligonucleotide API market, driven by precise targeting capabilities for RNA sequences implicated in disease pathways.

Manufacturing complexity in this sector drives significant outsourcing. For example, Korea's ST Pharm announced a $126 million investment to construct its second oligonucleotide manufacturing plant, with a goal to reach 14 moles per year by 2025. This expansion reflects growing demand for customized synthesis services, particularly as oligonucleotide APIs play crucial roles in advancing precision medicine.

The shift from pandemic-scale mRNA vaccine production to personalized RNA therapeutics presents unique challenges for CDMOs. Manufacturing infrastructure that was scaled up for COVID-19 vaccines must now adapt to small-batch production for personalized cancer vaccines and rare disease treatments, requiring significant operational flexibility and new process development capabilities.

Automation And Advanced Manufacturing Technologies

AI-integrated bioprocessing platforms are enabling real-time quality control, automated error detection, and predictive analytics for process optimization. Smart automation improves accuracy in processes such as cell expansion, differentiation, and cryopreservation, resulting in more consistent therapeutic products.

Advanced manufacturing technologies are reducing traditional timelines dramatically. Some CDMOs have demonstrated 24-hour CAR T cell manufacturing processes in studies and pilot implementations, compared to the traditional seven- to 14-day timeline, through the use of automated, closed, lentivirus-based methods with fewer manual touchpoints. These innovations are critical for improving patient access and reducing the cost of goods for advanced therapies.

Regulatory Harmonization And Quality Standards

The regulatory landscape in 2025 shows increasing convergence between major agencies, though significant differences remain. The EMA's new guideline on clinical-stage ATMPs, effective July 1, 2025, demonstrates substantial alignment with FDA approaches, particularly regarding CMC requirements. However, differences persist in areas such as donor eligibility determination, GMP compliance expectations, and comparability assessments.

Both the FDA and EMA are adapting frameworks to accommodate decentralized manufacturing models. The FDA's draft guidance on CAR T cell products addresses multisite manufacturing, acknowledging that while it may contribute to product variability, appropriate controls can ensure consistency across sites. This regulatory flexibility is essential for enabling the growth of point-of-care manufacturing models.

Top 10 CDMOs For Advanced Therapies By Market Share

1. Lonza: Lonza’s Cell & Gene division generated ~$760 million in 2023, about 10% of the global cell and gene therapy CDMO market. It has facilities in Houston, Portsmouth, and Geleen, plus major acquisitions with locations elsewhere.
2. Catalent: Catalent built its advanced therapy scale through Paragon (AAV) and MaSTherCell (cell therapy) acquisitions. Novo Holdings is acquiring it for $16.5 billion.
3. Thermo Fisher Scientific: Thermo Fisher expanded into the cell and gene therapy sector via Brammer Bio and Novasep, making it a leading viral vector producer. It has multiple facilities and a $90 million new site.
4. WuXi AppTec: WuXi Advanced Therapies earned ~$100 million in H1 2023 with strong double-digit growth. Its U.S. and China sites offer end-to-end cell and gene therapy services.
5. AGC Biologics: AGC manufactures several FDA-approved therapies, including Autolus’ CAR-T and Orchard’s gene therapy. It has a new Cell & Gene Technologies division.
6. Fujifilm Diosynth Biotechnologies: Fujifilm has invested heavily in cell and gene therapies, with a large Texas gene therapy campus and Atara Bio’s cell therapy site.
7. Minaris Regenerative Medicine: Minaris operates six facilities and has delivered 7,500+ GMP batches, supporting both autologous and allogeneic therapies. It manufactures two approved products and has long-term supply contracts.
8. Oxford Biomedica: Oxford Biomedica generated ~$160 million revenue in 2024, up 44% year-on-year. Focused on lentiviral and AAV vectors, it holds ~3% global share, ranking in the top 10.
9. Resilience: Resilience, launched in 2020 with $800 million, acquired multiple viral vector and cell therapy plants. Despite consolidating to four sites in 2025, it remains a top 10 CDMO by capacity.
10. Charles River Laboratories: Charles River entered cell and gene therapies via Cognate BioServices and Vigene Biosciences. Although it faces client losses in 2025, its infrastructure keeps it a notable niche player.

Future Outlook: Challenges And Opportunities

Looking ahead, the advanced therapy CDMO sector faces both significant opportunities and challenges. Its growth depends on addressing critical challenges including scalability, cost reduction, and ensuring consistent quality across decentralized manufacturing sites.

The trend toward integrated services continues to intensify, with CDMOs offering end-to-end solutions from process development through commercial. By 2025, more pharmaceutical and biotech companies are expected to outsource comprehensive services, with smaller biotech firms particularly reliant on CDMOs for formulation, clinical packaging, and technology transfer.

The contract manufacturing outsourcing trend for advanced therapies in 2025 represents a fundamental transformation in how lifesaving therapies reach patients. As CDMOs continue to invest in infrastructure, technology, and expertise, their role as enablers of the advanced therapy revolution becomes increasingly central to the future of medicine.

About The Author:

Sabyasachi Ghosh, associate vice president at Future Market Insights, holds over 15 years of experience in the healthcare, medical devices, and pharmaceutical industries. His primary expertise lies in areas such as market entry and expansion strategy, feasibility studies, competitive intelligence, and strategic transformation. Ghosh holds a degree in microbiology. The market projections presented here are based on research conducted by Future Market Insights.