The pipeline for specialty and advanced therapies continues to expand. Gene therapies, targeted oncology treatment, and high-cost biologics are expected to significantly affect pharmacy benefits over the next decade. Employer-sponsored health plans should start preparing now for how they are going to handle these costs.
The specialty market was $92.5 billion in 2023 and could reach $965.5 billion by 2030.
A Growing Specialty Pipeline
The specialty drug landscape is more robust than it was even five years ago, driven by several trends:
- Biosimilar growth — Use of biosimilars, particularly in oncology and immunology, increased in 2025. Eased approval pathways and incentives for rare disease products are accelerating biosimilar development. As of June 3, 2026, there have been 86 biosimilar approvals in the U.S.
- Oncology expansion — Over 1,300 cancer medicines are currently in development. In 2025, the FDA approved 46 new drugs, of which 16 were for cancer. Earlier this year, an experimental drug for pancreatic cancer was found to double survival rates in advanced cases. Pancreatic cancer is one of the most difficult cancers to treat and has one of the lowest cancer survival rates. And in early May 2026, Veppanu™ was approved to treat ESR1m, ER+/HER2- advanced breast cancer. It was the first time that the FDA approved a PROteolysis TArgeting Chimera (PROTAC), which is a system to destroy proteins.
- Immunology momentum — Drugs in rheumatology, gastroenterology, and dermatology continue to generate significant interest.
- Cell and gene therapy — Twenty-five cell and gene therapies are now approved in the U.S., with over 400 more in development. The cell and gene market was valued at $12.2 billion in 2025 and is projected to reach $143.55 billion by 2034.
Biologics now make up about 55% of the drug pipeline, and oncology spending is expected to grow 75% over the next five years.
Financial Implications for Employer-Sponsored Plans
As specialty therapies expand from rare diseases into more common conditions, employers face growing exposure to catastrophic claims. According to a recent NFP report, 75% of employers said pharmacy costs felt “unsustainable” in 2025. This is up from 67% in 2024.
Plan sponsors have many considerations, including:
- Inclusion of biosimilars, which offer cost savings. On average,biosimilars cost 50% less than the reference product at the time of the biosimilar launch.Adoption of biosimilars continues to grow.
- Cell and gene therapies can cost millions per patient and require proactive policy design.
- Outcome-based contracting with manufacturers can shift financial risk and improve accountability.
- Biomarker testing allows for earlier diagnosis, which could lead to better patient outcomes and lower long-term costs.
- Clinical vetting is essential. The specialty pipeline is too full to make coverage decisions without detailed analysis.
Plans need creative, innovative partnerships to navigate coverage for high-cost therapies while balancing formulary access with fiduciary responsibility.
The Importance of Forecasting and Modeling
Forecasting and modeling are critical tools that can help employers as they grapple with rising costs. Effective modeling helps employers:
- Assess their population’s risk profile.
- Anticipate how many members may need emerging therapies in the coming years.
- Make proactive coverage and contracting decisions.
Predictive analytics and AI are increasingly useful when it comes to forecasting and modeling. AI can process large datasets, while underwriters and clinicians can refine model assumptions over time. That can produce more accurate results.
Looking Ahead
The next decade will bring transformation in the world of specialty drugs. Conditions once considered untreatable will have treatments. And diseases that once required lifelong management may have one-time cures.
Preparing for this future means more than reacting to new therapies as they come on the market. Employers that invest now in pipeline visibility, risk modeling, and proactive policy development will be in a better position to deliver benefits and to manage costs.
Gateway Health Partners works with plan sponsors to turn specialty complexity into proactive strategy. Reach out to learn how we can help you prepare for what’s ahead. Contact us at [email protected]
