Editor’s Note

The story of botanical drugs is one of persistence — and promise. In nearly twenty years, the FDA has approved only four botanical or plant-based products, yet more than 700 INDs and pre-IND requests tell a different story: momentum is building. Advances in analytics, rising patient demand for natural therapies, and new global partnerships are creating fertile ground for innovation.

In this issue, we explore the U.S. regulatory pathway, spotlight the challenges and successes of development, and compare how regions like China, Japan, and Europe have integrated botanicals more deeply into healthcare. For sponsors and investors alike, the message is clear: botanical drugs are no longer a niche experiment — they are a strategic growth frontier in global pharma.

Why Focus on Botanicals Now?

• Market Momentum: Global market projected to grow from USD 41–42 billion to over USD 60–74 billion by 2031–33.
• Patient Demand: Consumers continue to prioritize natural, plant-based medicines, especially for chronic and complex conditions.
• Pipeline Appeal: Complexity of multi-target botanical actions aligns well with oncology, CNS, and GI therapeutic areas.
• Regulatory Evolution: FDA’s guidance and greater clarity from global regulators make botanical pathways increasingly navigable.

Global Botanical Landscape: Scale & Opportunity

Market Overview

• The global botanical drug market was valued at USD 41.43 billion in 2024, projected to grow to USD 74.27 billion by 2033, at a CAGR of 6.7.
• Another estimate places the market at USD 37.5 billion in 2024, reaching USD 58.0 billion by 2033, at a CAGR of 5.0%.

Regional Highlights

• North America: Largest share (~40%), driven by clinical innovation and regulatory clarity.
• Asia-Pacific: With CAGRs of 6.5%–7.5%, fastest growth, fueled by Traditional Chinese Medicine (TCM) and Indian Ayurveda.
• Europe: ~25–30% share, with EMA pathways for traditional and well-established use products.
• Latin America: Leveraging biodiversity for phytomedicine innovation

Botanical Drugs in the U.S.: Building Momentum

In the U.S., botanical drugs must meet the same rigorous standards of safety, efficacy, and quality as conventional drugs. Unlike dietary supplements, which can be marketed without FDA evaluation, botanical drugs intended to treat or prevent diseases require an IND application, even if marketed as supplements otherwise.

Regulatory Framework

• The FDA’s Botanical Drug Development Guidance for Industry (2016) outlines expectations for quality, manufacturing, and clinical study design.
• Physical variability in plant material and complex mixture composition pose unique challenges for ensuring consistency and quality.
• Clinical development must follow standard protocols—randomized, controlled trials are required.

Approved Botanical Drugs

Key Observations:

• FDA approvals remain rare — just 4 products in ~20 years.
• Pathways include both NDA (most common) and BLA (NexoBrid® only).
• Indications cover infectious disease, dermatology, wound care, and rare disorders, reflecting the FDA’s case-by-case acceptance of botanical evidence.
• The gap between 2012 and 2023 highlights the challenges of botanical development under U.S. regulatory standards

Sponsor Action Guide

• Engage regulators early to align quality specifications and trial strategy.
• Invest in analytics and AI, especially metabolomics, to ensure consistency across batches.
• Target niche indications where botanicals can offer advantages or faster paths to approval.
• Build strategic alliances with partners in Asia-Pacific, Europe, or Latin America for sourcing and development efficiencies.
• Monitor global harmonization, as smoother cross-border regulatory alignment may ease multi-region launches.

What’s Next: Industry Watchlist

• AI-Driven Analytics: Rapid advances in bioinformatics and predictive modeling will help deconvolve botanical mixtures and support regulatory evidence.
• Regulatory Harmonization: Efforts to streamline botanical pathways across FDA, EMA, and NMPA could reduce redundancy and speed timelines.
• Funding Surge: Venture and biotech investment in botanicals is increasing, signaling confidence and appetite for innovation.
• Future Approvals: Oncology or rare-disease focused botanicals are poised to become the next wave of FDA-approved plant-based therapies

References

1. FDA. Botanical Drug Development Guidance for Industry. U.S. Food and Drug Administration, December 2016.
2. FDA. What is a Botanical Drug? Center for Drug Evaluation and Research (CDER). FDA Website.
3. FDA. Veregen (sinecatechins) Ointment – Approval Information. Drugs@FDA Database, 2006.
4. FDA. Fulyzaq / Mytesi (crofelemer) – Approval Information. Drugs@FDA Database, 2012.
5. FDA. NexoBrid (anacaulase-bcdb) – Biologics License Application Approval. FDA Drug Approvals and Databases.
6. FDA. Drug Trials Snapshots: Filsuvez. FDA Drug Approvals and Databases, 2023.
7. Botanical Drug Association. Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective. Botanicaldrug.org.
8. PubMed / NIH. Chen, S. L. et al. Botanical Drug Development in the U.S.: Recent Progress and Future Opportunities. (Review summarizing IND statistics).
9. Straits Research. Botanical Drugs Market Size, Share & Growth Report 2024–2033.
10. Business Research Insights. Global Botanical Drug Market Report 2023–2033.
11. Verified Market Reports. Botanical & Plant-Derived Drugs Market Size and Forecast 2024–2033.
12. EMA (European Medicines Agency). Herbal Medicinal Products Committee (HMPC) Guidelines.
13. NMPA (China). Guidelines on Traditional Chinese Medicine and Botanical Drug Registration.
14. Chiesi Global Rare Diseases. Press Release: FDA Approval of Filsuvez for EB Wounds. December 2023.