Pharmaceutical Market Europe • July/August 2025 • 22-23

BOTANICAL DRUGS

Are botanical drugs part of the future of medicine?

Botanical drugs are stepping into the space between traditional remedies and modern pharmaceuticals

By Joel Stanley

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For generations, we believed that human intellect, with all its complexity and brilliance, held the ultimate answers to our well-being and the health of our planet. Yet, we are part of a world shaped by billions of years of co-evolution. For most of our history, medicine has emerged from this relationship. Using bark, roots, resins and flowers, we treated our bodies using the intelligence of the ecosystems we lived in.

In the last century, however, a different paradigm has taken shape. Laboratories replaced landscapes. Pills replaced plants. We embraced the controlled precision of synthetic chemistry. This shift brought tremendous progress, but also new limitations.  We gained precision, often at the expense of broader context. We learned to suppress symptoms, but not always to support systems.

Many patients with conditions that defy simple categorisation – chronic pain, anxiety, neurodevelopmental disorders – are still left without satisfactory options.

Today, something long buried is beginning to return, but this time with structure, data and scientific rigour. Botanical drugs are stepping into the space between traditional remedies and modern pharmaceuticals. These are not supplements. They are full-spectrum plant-based therapies, developed under FDA frameworks, clinically tested, and designed to meet the highest standards of consistency and efficacy.

Patients are asking for more integrative options: treatments grounded in nature but validated by science. And science, at last, is catching up to what ecosystems have long understood: therapeutic value may lie not in the solo performance of one compound, but in the orchestration of many. Imagine a single molecule as one clear, targeted piano note. In contrast, systemic healing often requires an orchestra of molecules working together. Botanical medicine does not abandon the advancements of modern pharmacology – it expands them, bridging the gap between historical and modern medicine.

Redefining what a drug can be

Botanical drugs represent a reimagining of modern medicine within the highest scientific and regulatory standards. Unlike dietary supplements, which remain largely unregulated and inconsistent, botanical drugs are held to the same standards as any pharmaceutical: clinical trials; FDA oversight and strict manufacturing protocols. Rather than relying on a single isolated molecule, they use full-spectrum extracts, preserving the natural complexity of the plant to achieve therapeutic effects.

‘Botanical medicine does not abandon the advancements of modern pharmacology – it expands them’

This complexity is not a flaw, but a feature. The entourage effect – where multiple compounds in a plant work synergistically – has been shown to enhance efficacy and reduce adverse reactions. For example, in cannabinoid therapies, terpenes and minor cannabinoids can amplify or modulate the effects of CBD and THC. In other plants, these compounds improve absorption and regulate delivery – or provide secondary benefits that isolated molecules cannot replicate. For decades, botanicals were seen as too difficult to standardise, too complex to model and too inconsistent to scale. Thanks to advancements in analytical chemistry, biomanufacturing and quality control, we now have the tools to meet nature with the precision it deserves.

Why botanical drugs are so complex

Nature does not operate in straight lines or single-variable equations. It is interdependent, adaptive and alive. Our bodies operate in the same way and are not separate from nature. It should not surprise us that plant-based therapies often meet our needs in ways that synthetic pharmaceuticals do not.

Botanical drug development is highly technical. Unlike conventional pharmaceuticals, which rely on a single active ingredient, botanical drugs must account for hundreds of compounds working together. It is not enough to demonstrate efficacy; developers must map the chemical fingerprint of the drug and ensure it can be replicated across every batch, every harvest, every bottle. This is the essence of the FDA’s Chemistry, Manufacturing and Controls (CMC) requirements, which is why so few botanical drugs have crossed the regulatory finish line.

But it is not just about what is inside the bottle. Everything that leads up to it matters – soil health, sunlight, water, climate and harvest time all shape the final product. When your raw material is a plant, the farm becomes part of your lab. Such consistency requires stewardship that is both scientific and ecological.

Restoring trust in natural therapies

Decades of unregulated supplements and exaggerated claims have clouded the reputation of plant-based therapies. The global supplement market, though vast and accessible, is rife with inconsistency. A 2019 international study found that over a quarter of tested herbal products were adulterated, with undisclosed fillers, contaminants or outright substitutions.

Amid this gap in credibility, there is a new path forward – one that is rooted in scientific rigour. Botanical drugs are distinct from supplements. They undergo the same clinical trials as any other investigational drug, are reviewed by the FDA and are manufactured under cGMP conditions. They are not folklore repackaged – they represent a new category of evidence-based medicine, drawing on nature’s intelligence, guided by science and designed to serve the patient first.

Serving the unmet need

Consider autism spectrum disorder (ASD). Today, there are only two FDA-approved treatments for ASD-related symptoms, and both are antipsychotics – medications originally designed for schizophrenia, not for the nuanced needs of neurodivergent children. Both drugs are accompanied by formidable side effects, such as sedation, weight gain and metabolic risk. For many families, the trade-off is too high.

To find solutions, families turn to the margins: cannabinoids; adaptogens and plant-based therapies not designed by pharmaceutical logic, but discovered through lived experience. Without clinical oversight or regulatory clarity, these efforts become a patchwork of trial and error. The potential is there, but the infrastructure is missing.

This is where botanical drugs can change the story. Imagine a full-spectrum hemp extract, developed specifically to address the irritability often associated with ASD. A solution tested in trials, standardised in formulation, prescribed by a physician and covered by insurance for many. Not a supplement. Not a gamble. A repeatable therapeutic outcome, built for patients who have long waited for science to catch up with the grassroots movement created by thousands of anecdotal reports.

A market positioned for growth

As public interest in natural wellness continues to surge, the pharmaceutical landscape is beginning to shift. In 2024, the global botanical drug market was valued at approximately $37.5bn, and by 2033, it is expected to grow to $58-73bn.

‘Botanical drugs are held to the same standards as any pharmaceutical – clinical trials, FDA oversight and strict manufacturing protocols’

We are welcoming in a new era where we are combining innovative regulatory pathways with state-of-the-art technologies to characterise and standardise complex botanical mixtures to pharmaceutical-grade consistency. This is happening at a time when cultural scepticism of conventional pharmaceuticals is increasing, while trust in plant-based therapies is growing. In fact, over 50% of American adults already use supplements, many of which are botanically derived. The desire is clear.

While conventional drugs serve a purpose, botanical drugs will help fill the void left by synthetics, particularly in chronic and multifactorial conditions, offering more options for physicians to effectively treat their patients. As major pharmaceutical companies begin to recognise this, we are likely to see more partnerships, acquisitions and investment in this emerging category.

The future of drug discovery

For too long, drug discovery has been driven by a reductive impulse: to isolate the ‘active’ molecule and discard the rest. This model has its place, but when it becomes the only model, it limits our access to important therapies.

Botanical drugs invite a shift in perspective. They encourage us to consider that therapeutic value might lie beyond the dominance of a single compound. They shift our focus from targeting symptoms to supporting systems, and from disrupting biological pathways to restoring balance within them.

This shift is not just scientific – it’s cultural. It invites us to revisit ethnobotanical knowledge and learn from how different civilisations have used plants for healing. We can merge ancestral intelligence with the precision tools of modern pharmacology. In doing so, we will address many unmet needs that linger in the margins, in areas where conventional drug development does not reach. I believe we do not have to choose between nature and science – instead, we should design therapies rooted in both.


Joel Stanley is Co-founder and CEO of Ajna BioSciences

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