The life sciences landscape is evolving rapidly.
In the next few years, immunology, cell therapy and biosimilars are among the most dynamic sub-sectors shaping the industry.
Across global markets, regulatory shifts, technology adoption, and competitive pressures are redefining what success looks like for both innovative and value-driven therapies.
For research labs, biotech innovators and biopharma partners, understanding these trends is essential. This article explores what to expect, why it matters and how robust reagent design and validation such as deNOVO’s can support long-term success?
Immunology: A Growing Market
The immunology therapeutic landscape remains substantial and is projected for robust expansion.
According to market forecasts, the global immunology market, valued around USD 108.49 billion in 2025, is expected to reach over USD 246 billion by 2032, with a CAGR of ~12.4% during this period.
This growth is being driven by:
1. Expanding indications for monoclonal antibody therapies
2. Rising prevalence of autoimmune and inflammatory diseases
3. Continued innovation in targeted immunomodulators
However, the growth profile is also becoming more nuanced. Some analysts note that immunology’s 5-year growth outlook may now trend slightly below broader pharma growth as blockbuster patent cliffs and biosimilar competition reshape dynamics.
Regardless, immunology remains central to biotech investment and therapeutic pipelines, especially where precision immune modulation and data-backed validation intersect.
Cell Therapy: Pushing Boundaries
CAR-T, CAR-NK, and other engineered cell products are transforming how we approach some of the most difficult diseases, including cancers that were once considered incurable.
Emerging platforms like CAR-NK cells show promise due to potential advantages such as reduced toxicity and the feasibility of allogeneic “off-the-shelf” applications. As of 2025, more than 120 clinical trials are exploring CAR-NK therapies across hematologic and solid tumors, highlighting a rapidly expanding clinical pipeline.
These next-gen cell therapies are also supported by advances in AI, computational design, and predictive modeling—reducing development risk and improving target prioritization.
For biotech companies and research organizations, this means:
- More partnerships between discovery teams and production specialists
- Greater emphasis on manufacturing consistency and reproducibility
- Early, robust assay design to translate cell biology into usable products
Biosimilars: Cost-Effective Access
The global biosimilars market is one of the fastest-growing biopharma segments. Estimates show the market could grow from approximately USD 42.5 billion in 2025 to over USD 136.4 billion by 2032, with a compound annual growth rate (CAGR) of ~18.1%.
Several factors drive this growth:
A. Patent expiries of major biologics
B. Increased focus on cost containment in healthcare systems
C. Regulatory pathways becoming more streamlined for biosimilar approvals
D. Patient demand for affordable alternatives to high-cost biologics
In specific therapeutic areas such as oncology and immunology, biosimilars are expected to play an even larger role, enabling broader access while still delivering high-quality outcomes.
The trend is clear: biosimilars are no longer a niche offering. They are a core strategy for health systems and innovators seeking sustainable models for therapeutic access.
Note to Biotech Innovators
As these three sub-sectors advance, several themes emerge:
1. Integration of data and validation
Data quality and reproducibility determine success, especially where regulatory expectations are high. Assays and reagents need to be validated in context, not just in isolation.
2. Cross-disciplinary collaboration
The future is inherently interdisciplinary. Immunology insights inform cell therapy designs. Biosimilar comparability studies push assay rigour. Teams must work more closely across functions.
3. Early emphasis on scalability
From proof-of-concept to commercial readiness, processes must be built with scalability in mind. This includes early reagent design, manufacturing foresight, and continuous quality control.
How do we supports the Next Era?
At deNOVO Biolabs, we focus on the foundations that support these emerging trends:
Application-driven reagent design that mirrors real assay contexts
High-quality antibody and antigen development that reduces uncertainty
Performance validation in real conditions, minimizing risk downstream
Scalability and reproducibility built into reagent workflows
In rapidly evolving spaces like immunology, cell therapy and biosimilars, solid technical foundations make the difference between insight and ambiguity.
Conclusion
Over the next five years, immunology, cell therapy and biosimilars will continue reshaping healthcare at both the clinical and operational levels. Understanding the markets, technological drivers, and the underlying tools that make science reliable will be foundational for success.
As these sectors mature, partnerships and products that emphasize robust validation, scalable design, and real-world performance will lead the way.
If you are shaping research or development strategies in immunology, cell therapy, or biosimilar pipelines, a short technical conversation early in your process can reveal opportunities to reduce risk and accelerate progress.
Reach out to explore how application-ready reagents and validation frameworks can support your goals in 2026 and beyond.