05 October 2025 | Sunday | News
Takeda Pharmaceutical, one of the world’s most globalised pharma companies, has confirmed it will step away from in-house development of its cell and gene therapy (CGT) pipeline. Citing prohibitive costs, complex manufacturing needs, and unresolved safety risks, Takeda announced it will halt its internal CGT programmes and instead seek external partners to advance certain assets. The Japanese drugmaker had invested heavily in cell therapies—most notably a gamma delta T-cell platform acquired via GammaDelta Therapeutics in 2021—but will now refocus on more traditional modalities such as biologics, small molecules, and antibody-drug conjugates.
This strategic pivot represents a striking moment for the CGT sector—one that blends realism with renewed possibilities. While the promise of CGT as “one-shot cures” remains revolutionary, Takeda’s recalibration highlights the persistent gap between scientific potential and commercial sustainability. This analysis explores the broader implications of the move, from strategic and financial dynamics to regional shifts and policy considerations.
Cell and gene therapies have been celebrated as potentially curative, one-time treatments capable of transforming patient lives. Yet Takeda’s decision underscores a crucial truth: scientific brilliance does not automatically translate to commercial viability.
Manufacturing remains a formidable challenge. The processes required to produce advanced therapies—viral vector production, precise cell engineering, stringent quality control, and cold-chain logistics—are intricate and expensive. Treatments currently approved by regulators can cost anywhere from hundreds of thousands to several million dollars per patient. These costs make widespread access difficult, with only a fraction of eligible patients globally having received approved CGT treatments.
Safety concerns have also tempered early enthusiasm. Despite clinical successes in oncology and rare diseases, reports of serious immune reactions and inflammatory responses during trials serve as reminders that the field is still learning. The complexity of genetic modification, combined with variability in patient responses, adds uncertainty to an already challenging value chain.
In short, Takeda’s move recognises that the industry is entering a second phase of maturity—one focused not on proving that CGTs work, but on proving that they can be produced and delivered sustainably and safely at scale.
Takeda’s withdrawal is not a surrender; it’s a recalibration. Rather than chasing every technological frontier, the company is sharpening its focus on therapeutic areas with predictable pathways and proven scalability. By prioritising biologics, small molecules, and ADCs, Takeda aims to strike a balance between innovation and commercial dependability.
This pragmatic approach echoes similar moves across the industry. GlaxoSmithKline exited its in-house gene therapy programmes in 2018, transferring assets to Orchard Therapeutics. Vertex recently halted its AAV vector-based gene therapy work, while Pfizer scaled back after regulatory challenges. These are not failures of ambition—they are expressions of strategic realism.
For Takeda, the pivot also protects shareholder value. The company has acknowledged significant write-downs related to its CGT efforts but views this as a necessary correction. Instead of funnelling resources into long-horizon, high-risk platforms, Takeda will pursue therapies that align with its established infrastructure and global reach. It’s a signal to the market: innovation remains the goal, but disciplined innovation is the path forward.
Takeda’s decision reflects a broader shift towards distributed innovation—a partnership-driven ecosystem where large pharmaceutical companies collaborate with biotech start-ups, academia, and specialised manufacturers. The logic is clear: no single organisation possesses all the expertise, infrastructure, and capital required to master CGT development from end to end.
This emerging “partnership economy” is transforming how cutting-edge therapies are conceived and delivered. Smaller biotechs bring agility and daring science, while large pharmas offer financial stability, regulatory experience, and market access. The result is a shared-risk, shared-reward model that can accelerate development timelines and improve success rates.
Industry precedents abound. Eli Lilly’s collaboration with Sangamo Therapeutics to advance CNS gene therapies exemplifies this model. The CAR-T therapy Carvykti, co-developed by Johnson & Johnson and Legend Biotech, highlights how partnerships can turn early-stage innovation into commercial success. Meanwhile, multiple major pharma companies have jointly invested in next-generation technologies such as in vivo CAR-T and AI-driven manufacturing, spreading risk and expanding opportunity.
Takeda’s future CGT ambitions will likely unfold through such collaborations. Rather than shouldering the entire burden of development, it will participate as a strategic integrator, leveraging alliances to keep promising science alive while maintaining capital discipline.
From a financial perspective, Takeda’s recalibration sends a dual signal. To investors, it communicates prudence—an acknowledgment that the company is managing R&D risks responsibly in an era where drug development costs are escalating. This discipline may stabilise investor confidence, particularly as Takeda focuses on its late-stage pipeline projected to deliver significant revenue growth.
However, the broader CGT investment landscape could experience turbulence. The “boom-and-bust” pattern that defined early enthusiasm for cell and gene therapy appears to be entering its consolidation phase. Overstretched biotech firms, once buoyed by venture capital, now face liquidity challenges. Takeda’s exit may be viewed as an inflection point—heralding an era in which only the most resilient, technically sophisticated, or well-capitalised players will endure.
Yet opportunity persists. Takeda’s move to divest assets creates acquisition prospects for venture-backed or private equity investors seeking undervalued CGT platforms. History suggests that one company’s retreat can seed another’s success. Novartis’s acquisition of the CAR-T asset that became Kymriah remains a classic example. Investors are likely to pivot towards enabling technologies—automation platforms, AI-led manufacturing, and allogeneic cell solutions—that tackle the cost and scalability bottlenecks stifling the sector.
While some Western firms are scaling back, Asia is entering a period of acceleration in CGT development and manufacturing.
China has already emerged as a powerhouse. With substantial government backing, favourable regulation, and robust venture capital, the nation now leads in the number of active CAR-T and gene therapy clinical trials. Local champions like Legend Biotech have achieved international recognition, while domestic approvals of CAR-T products signal a maturing market. The combination of lower production costs and vast patient populations positions China as a global hub for both research and deployment.
India is also stepping into the CGT spotlight. The opening of Bharat Biotech’s integrated cell and gene therapy facility signals intent: India aims to build a cost-effective innovation and manufacturing ecosystem capable of competing globally. With strong government support, expanding biotech corridors, and cost-efficient operations, India could become a preferred destination for technology transfer and out-licensing from global companies seeking scale without prohibitive expense.
Meanwhile, Singapore and South Korea continue to advance as regional leaders in biologics and regenerative medicine. Singapore’s investment in cell therapy infrastructure and South Korea’s progressive regulatory stance are laying the groundwork for pan-Asian manufacturing and trial networks. Collectively, these developments hint at a multi-polar innovation model, where breakthroughs emerge not only from the West but from a globally distributed landscape of capable, ambitious players.
The ultimate test of any biopharma strategy lies in its impact on patients. Takeda’s recalibration, while strategically sound, prompts questions about access. If fewer large players pursue CGT development directly, how will the industry ensure continuity for patients awaiting novel therapies?
Governments and payers must now evolve policies to keep innovation accessible. The conversation is shifting from scientific feasibility to economic sustainability. Expect to see increased use of value-based pricing models, outcomes-based reimbursement, and public-private partnerships that share the financial burden of high-cost cures. The U.S. CMS pilot on gene therapy payment reform and Europe’s annuity-based approaches are early examples of this adaptive thinking.
Regulatory frameworks will also need to adapt. More flexible manufacturing oversight, allowing for post-approval process improvements, could help companies integrate automation or cost-saving innovations without full trial resets. Similarly, policies promoting early payer engagement and patient input can ensure that reimbursement and access frameworks evolve in parallel with scientific progress.
Patient advocacy groups will continue to play a critical role, pressing for expanded access programmes and transparent communication around therapy timelines. If Takeda’s move becomes the industry norm, patient trust and regulatory agility will be paramount in keeping CGT momentum alive.
While some see retrenchment, others see recalibration as creative renewal. The CGT field is entering its next evolutionary stage, and several pathways could define its future:
Platform Consolidation – Expect mergers and acquisitions as smaller CGT biotechs combine to pool resources and technology. Larger pharmas may selectively acquire enabling capabilities rather than entire pipelines.
Next-Generation Modalities – Focus is shifting toward in vivo gene editing, RNA-based delivery systems, and allogeneic “off-the-shelf” therapies—technologies that promise efficiency without sacrificing efficacy.
Digital Manufacturing – Automation, AI-driven optimisation, and digital twin modelling are poised to make CGT production faster, cheaper, and more reliable, potentially transforming cost structures across the board.
Hybrid Business Models – A new generation of “virtual biotechs” may emerge, orchestrating networks of partners for discovery, manufacturing, and commercialisation, reducing the capital intensity of traditional pharma operations.
Patient-Centred Innovation – Co-development involving payers, regulators, and patient organisations from early stages will ensure therapies are not only scientifically sound but economically and operationally viable from launch.
Takeda’s withdrawal from in-house CGT development should not be mistaken for retreat—it is a strategic reset born of realism. The company’s decision reflects a broader truth: the future of advanced therapies will depend less on solo ambition and more on collaborative orchestration.
The next decade will reward those who integrate bold science with operational discipline, financial pragmatism, and genuine collaboration. The winners will not be the ones with the largest laboratories, but those who build the most resilient networks—linking discovery, regulation, manufacturing, and policy into a coherent, sustainable system.
The CGT revolution is far from over. It is merely entering a more intelligent phase—one defined by global partnerships, smarter economics, and a renewed focus on accessibility. In this light, Takeda’s decision becomes not an endpoint, but a signal of maturity—an inflection point guiding the industry from exuberant experimentation to sustainable execution.
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