Five trends shaping the autoimmune disease market

The autoimmune disease market is entering a new era

Autoimmune Diseases (AIDs ) are a large group of chronic and debilitating conditions that affect between 5-9% of the population (source), creating significant personal and public health burdens. Their incidence and prevalence are rising, and many have gender and ethnic disparities. AIDs are characterized by immune system dysfunction; while the exact causes for most diseases remain unknown, these likely develop due to an interplay of genetic, environmental and lifestyle factors.

And while the science underlying these conditions continues to evolve, so does the market landscape. Scientific breakthroughs, faster drug development, and shifting dynamics in access and innovation are converging to redefine how AIDs are diagnosed, treated, and new drugs commercialized.

What was once a slow-moving field now presents high-reward opportunities across multiple therapeutic areas, from rheumatoid arthritis to Inflammatory Bowel Disease and Multiple Sclerosis.

If you are a biopharma company, investor, or healthcare provider, understanding the forces driving this transformation is essential for shaping your strategy.

Here are five forces reshaping autoimmune therapeutics:

1. Multi-target therapies take the lead

In recent decades, autoimmune treatment evolved from broad immunosuppression to highly targeted interventions, promising greater efficacy with fewer side effects. The first wave of therapeutics revolutionized Rheumatoid Arthritis (RA) care by selectively targeting TNF-alpha, while subsequent waves of therapies targeted other pathways like IL-6 and IL-17. However, due to the complex nature of AIDs, single-target therapies may not suffice. This has led to innovation in multi-target treatments:

• Rise of bispecific antibodies (BsAbs ): The global BsAb market was estimated to be around $3B in 2021, and is projected to grow over 30% annually to $13B by 2028 (source). These next-gen therapies bind two targets simultaneously, making them ideal for multifactorial diseases like lupus or RA. Johnson & Johnson for example recently acquired the global rights to a first-in-class bispecific antibody, NM26, targeting IL-4Rα and IL-31 in atopic dermatitis (source).
• Advanced combination treatment (ACT): ACT involves combining two or more biologic agents, or a biologic and a small molecule, each with distinct mechanisms of action. In diseases such as inflammatory bowel disease (IBD), ACT can enhance efficacy and improve response rate in patients compared to monotherapy.

2. Biosimilars unlock access and new market potential for pharma companies

As patents expire on blockbuster biologics like Humira and Stelara, a new wave of opportunity is emerging. Biosimilars are entering the market with comparable efficacy at a significantly lower cost, opening the door to broader global access, especially in fast-growing regions like Asia-Pacific and Latin America. In 2014 for example, before Humira lost exclusivity in EU and US, Zydus Lifesciences launched a biosimilar in India (Exemptia), at roughly one-fifth of Humira’s price point. In Brazil and Mexico, biosimilars of infliximab are also increasing access, as the prices were reduced by 35% and 44% respectively compared to the original drug’s price. Both countries are also promoting the development of the biosimilars industry (source). Finally, biosimilars not only result in lower prices but also increased usage of drugs. In a study analyzing 14 countries where Humira biosimilars became available, the volume of treatment significantly increased, even as spending dropped, indicating that more patients were treated without added cost burden (source).

For forward-looking pharma companies, the shift to biosimilars isn’t just about defending market share, it’s about redefining it . Patent expiration is forcing big companies to backfill their innovation pipeline and invest in new drugs that could be a potential next blockbuster. Johnson & Johnson for example acquired the biotech Momenta in 2020 bringing in a novel autoimmune antibody, and more recently big pharma have become more interested in bispecific antibody programs to bolster immunology portfolios. Sanofi for example, recently acquired Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion.

Although the expiration of patents is often seen as a key risk, it also opens the door to new innovations, affordable healthcare and global expansion of life-saving drugs.

3. AI is accelerating discovery and development

Artificial intelligence is no longer a buzzword, it’s a business driver. AI tools are not only reducing the time necessary for identifying new targets, but they are also bringing efficiencies across the entire drug development life cycle:

• Target discovery and molecular design: AI algorithms are identifying novel targets, streamlining compound screening, and optimizing trial design. By analyzing immense biological datasets, they can identify new therapeutic targets and generate novel drug candidates far faster than traditional methods. Atomwise’s platform AtomNet for example incorporates deep learning for structure-based drug design, allowing the rapid, AI-powered search of its proprietary library of more than three trillion synthesizable compounds. In April 2024 they published results from a 318-target study highlighting AtomNet as a viable alternative to high-throughput screening, with the platform identifying structurally novel hits for 235 of the 318 targets evaluated in the study (source).
• Clinical development: During clinical development, AI can automate a range of different tasks including:
  • Automating aspects of trial protocol writing and design: Novartis invested in the AI firm Yseop in 2023 to automate and improve elements of clinical trial protocol writing and data structuring. By leveraging historical data from many prior studies, AI can flag likely causes of failure and allow researchers to adjust the trial design proactively.
  • Replacing the enrolment of large placebo groups by having AI-simulated control arms: In 2022, the startup Unlearn.AI, in collaboration with European pharma partners, tested AI-generated control arms in Phase 2 and 3 clinical trials. Results showed that these synthetic controls could closely mimic actual patient outcomes, which in the future could enable smaller and more efficient trials, reducing the number of volunteers needed on placebo. At the end of 2022, Unlearn.AI was qualified by the European Medicines Agency (EMA) for use as primary analysis in Phase 2 and 3 clinical trials. In early 2024, they also received positive comments from the Food and Drug Administration (FDA), stating that the FDA concurs with the EMA.
  • Improving patient recruitment: TrialGPT, a large language model, can read through medical records and clinical trial criteria to find suitable matches. In tests, TrialGPT matched patients to appropriate trials with 87% accuracy, on par with expert clinicians (80-90% accuracy), and in hospital settings it enabled screening patients 40% faster than manual methods.
• Post-market monitoring: Once therapies are on the market, AI can sift through data generated in real time and detect safety signals or efficacy trends that humans might miss. The FDA-cleared platform Biofourmis for example, analyses data from wearable sensors and has been shown to predict hospital readmissions up to a week in advance, allowing proactive treatment changes that keep patients stable at home.

It’s clear that AI is speeding up development, cutting costs and enhancing decision-making in clinical development, this can also be harnessed in the autoimmune therapy space. Biotech and big pharma who deploy AI across the lifecycle may gain a competitive edge in bringing innovative autoimmune treatments to patients faster and more efficiently.

4. Demand is rising and the window to lead is now

Macro-level forces are accelerating demand across the autoimmune landscape.

• Demographic shift: An aging global population is pushing AID incidence upward.
• Unmet need: Many immune-related conditions still lack effective treatments and there is increased awareness among the public about these conditions.
• Improved diagnostics: Advances in biomarkers and diagnostic tools are enabling earlier detection and more tailored treatment.
• Healthcare access: In many countries, healthcare systems are investing more in managing chronic diseases, including autoimmune conditions. This is particularly true in high-growth markets such as in Asia, leading to expansion of treated populations and market revenue.
• Investor confidence: Immunology drugs have high revenue and multi-indication potential, making them an attractive destination for capital. For example, many of the top revenue-generating therapeutics today are immunology drugs, such as Stelara and Skyrizi. Leading disease areas, such as rheumatoid arthritis, psoriasis, IBD, and multiple sclerosis, are seeing rapid innovation and intensifying competition. Although rheumatoid arthritis accounts for the largest revenue share in the autoimmune disease therapeutics market, the IBD segment is projected to grow the fastest.

As in any market, the AID drug market faces cost pressures and access challenges, but overall demand and outlook remains strong. AIDs are typically chronic, lifelong treatments, resulting in a stable and growing need for therapeutics. Combined with a rich pipeline and expanding global access, this translates into a healthy growth trend for the market, which companies can capitalize on throughout the next decade.

5. Nanomedicine and CAR-T: The next frontier

Although a still young and evolving field, we are already seeing several cutting-edge modalities that will advance autoimmune therapeutics to the next level:

• CAR-T cell therapy: Originally developed to treat/cure cancers, early trials with cell therapies have shown promise for AIDs like systemic lupus erythematosus (SLE), though clinical use remains years away.
• Nanomedicine: Nanotechnology is being leveraged to create therapies that reprogram the immune system instead of just suppressing it. One example is the use of nanoparticles to induce antigen-specific tolerance in autoimmune disorders. “Tolerance” nanoparticles are designed to target antigen-presenting cells in lymphoid organs and modulate them to elicit a tolerogenic (immune calming) signal.
• Nanoparticle-based delivery: These systems enhance tissue penetration and reduce off-target effects, with research showing superior precision over traditional delivery routes.

While these therapies are still mostly experimental, they offer game-changing possibilities, such as inducing true remission or cure, and thus are important components of any forward-looking strategy in the autoimmune market.

What this means for companies playing in the autoimmune market

Recent leaps in scientific advancements are leading to better and faster drug discovery. Because of their multi-indication potential, many agents are being tested in several AIDs, maximizing their value. This versatility also diversifies risk and increases potential return. Propelled by such drivers R&D pipelines are increasingly shifting towards more immunology candidates, second only to oncology in many firms. However, it’s also always important to ask yourself when the right time is to invest in new trends: If you’re developing or investing in novel delivery platforms, consider when you want to explore autoimmune applications, do you want to be an innovator, early adapter or follower?

For biopharma, investors, or healthcare providers, the autoimmune space offers:

• Strong market fundamentals with growing demand and multi-indication potential
• Global expansion potential, especially in Asia-Pacific and LatAm
• High-reward pipelines supported by scientific and technological breakthroughs

The AID market is rich with opportunity, but success requires foresight, flexibility, and a willingness to embrace change. The future belongs to those who innovate early and execute wisely.

At a-connect we support healthcare and biopharma leaders as they bring precision therapies to patients, scale innovation and market access as well as respond to emerging scientific and commercial shifts. If you have any questions or require support in this area, do get in touch with us.

About the author

Alicia is an Associate with an MSc in Applied Biosciences and Biotechnology and a BSc in Applied Medical Sciences. She supports our Life Sciences and Agri & Food clients. She is passionate about accelerating innovation in Women’s Health and thrives on applying her scientific knowledge to drive impactful solutions.

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