Nutraceutical clinical trials are steadily increasing in the Asia-Pacific region. The nutraceutical market in the Asia-Pacific is experiencing tremendous growth and is expected to expand further. The Asia-Pacific region, encompassing countries like Australia, India, Japan, and China, offers significant opportunities for the nutraceutical market due to its large population, rising disposable income, and growing focus on health and well-being. 

Between 2024 and 2029, the Asia-Pacific nutraceuticals market is projected to grow at a compound annual growth rate (CAGR) of 10.26%, rising from USD 110.5 billion in 2024 to USD 180.1 billion in 2029.

This article provides an overview of the current status of nutraceutical clinical trials in the Asia-Pacific region, along with some rationale for conducting clinical research here.

What are nutraceuticals?

• The term ‘nutraceutical’ originates from ‘nutrition’ and ‘pharmaceuticals,’ referring to compounds derived from food sources with potential physiological effects.
• They play a significant role in promoting health and safeguarding against illnesses that traditional medications typically do not address.

Clinical trials for nutraceutical products

• Research studies conduct nutraceutical clinical trials to evaluate the safety, efficacy, and potential health benefits of nutraceutical products or ingredients.
• These clinical trials aim to investigate the effects of nutraceuticals on various health outcomes, such as reducing the risk of chronic diseases, improving cognitive function, enhancing athletic performance, or supporting overall well-being.
• These studies can help sponsors get successful claims and regulatory approval by providing evidence of a nutraceutical’s efficacy.

Contribution of clinical trials in the success of nutraceuticals

The importance of clinical trials in the success of nutraceutical products can be summarized as follows:

1. Evaluation of safety: Clinical trials help to identify any potential side effects or dangers associated with its use. This is required to ensure that the product does not harm persons who use it, particularly over an extended period.
2. Claims: Scientific evidence from clinical trials about the product’s efficacy decides if a product meets its claimed health benefits. 
3. Dosage adjustment: Clinical studies assist in determining the optimal dose for nutraceutical products to achieve the desired health outcomes.
4. Eliminating the placebo effect: To determine if the effect is related to the nutraceutical and not the placebo, researchers could compare the nutraceutical and placebo.
5. Regulatory approval: A nutraceutical product cannot be promoted as a health-improving product without evidence from clinical trials.
6. Building trust: Medical professionals are more likely to recommend a nutraceutical product with strong clinical evidence, and consumers are more likely to believe in and purchase goods that have undergone extensive research.

Given the points mentioned above, let’s explore the distinction between nutraceutical and pharmaceutical clinical trials.

Differences between nutraceutical and pharmaceutical clinical trials

Nutraceutical clinical trials	Pharmaceutical clinical trials
Usually, the clinical trial requires a targeted population such as women, athletes, or the elderly.	The trial evaluates the product’s efficacy among a broader group of healthy volunteers of both sexes, varying in age.
Small sample size	Large sample size
Has higher dropout rates	Comparatively lower dropout rates
Safety reviews are usually not necessary before trial initiation.	Require an Investigational New Drug (IND) Application
Less expensive	Comparatively expensive
These trials often do not have PK or PD details available	For these trials, extensive pharmacokinetic (PK) and pharmacodynamic (PD) studies are required
Usually, these trials are designed in free-living environments (e.g., at home, on vacation)	These trials are designed in highly controlled environments (e.g., the hospital or clinic).
These trials usually have only one phase, take several weeks to months to conclude, are carried out at a single study site, and have a small chance of adverse effects.	Drug trials take several years to complete, are conducted at multiple study sites, and are expected to result in adverse events

Design strategy for nutraceutical clinical trials

In nutraceutical clinical trials, the chosen study strategy should align with the product’s final claim while also facilitating the publication of results to support marketing efforts. The objectives of the company’s product development program will influence the selection of design and the number of studies conducted.

Depending on the program’s specifics, certain clinical trial phases may not be applicable or could be merged, especially for nutraceutical product manufacturers. For example, if pre-clinical safety and toxicity research, or published human studies, provide data supporting a product’s safety, a phase I study may not be required.

The following are some approaches for effective nutraceutical trial design:

• In nutraceutical trials, it is critical to consider lifestyle variables and adhere to strict participant inclusion and exclusion criteria. This ensures that the effects of the nutraceuticals can be noticed and documented in the selected subjects.
• Double-blind studies using placebos are the gold standard for reducing bias and ensuring study integrity. When designing appropriate placebos gets difficult, open-label trials may be considered.
• Using surrogate markers can rapidly evaluate the product’s preventive potential. 
• Clinical trial data should be typical of a larger population, with a balance of homogeneity and diversity. Running trials at various places gathers diverse demographics and environmental factors, improving data consistency and reliability.

Why is the ASIA-PAC region favorable for conducting your nutraceutical trials?

The Asia-Pacific (ASIA-PAC) region is often preferred for conducting nutraceutical clinical trials for several reasons:

• Diverse Population: The region encompasses a wide range of ethnicities, lifestyles, and dietary habits, providing a diverse pool of participants for clinical studies. This diversity can enhance the generalizability of trial results.
• Regulatory Environment: Some countries within the ASIA-PAC region have established efficient regulatory pathways for nutraceutical products, facilitating the approval process for clinical trials. This can lead to faster initiation of studies and reduced regulatory burdens.
• Access to Resources: Many countries in the region have well-developed healthcare infrastructure, experienced researchers, and clinical trial facilities. This enables access to the necessary resources and expertise for conducting high-quality trials.
• Cost-effectiveness: Compared to Western countries, conducting clinical trials in the ASIA-PAC region can often be more cost-effective due to lower operational costs, including lower labor costs and infrastructure expenses. This can lead to significant cost savings for sponsoring companies.
• Market Potential: The ASIA-PAC region represents a rapidly growing market for nutraceutical products, driven by increasing health consciousness and disposable income. Conducting trials in this region allows companies to assess the efficacy and market potential of their products in a relevant consumer demographic.
• Geographical Diversity: The ASIA-PAC region offers a wide range of geographical landscapes and climates, which can be advantageous for studying the effects of nutraceuticals in different environmental conditions.

Overall, the ASIA-PAC region presents numerous advantages for conducting nutraceutical clinical trials, making it an attractive choice for companies and researchers in the field.

Nutraceutical products are classified differently across various regions. Let’s explore how we can categorize them in different areas.

Nutraceutical classification with their respective regulatory authority in ASIA-PAC

Table representing nutraceutical classification with their respective regulatory authority

Country	Classification	Regulating Body
Australia	The Australian Register of Therapeutic Goods (ARTG) lists complementary medications, such as vitamins and herbal items. Nutraceuticals with no medicinal claims are classified as foods by Food Standards Australia New Zealand (FSANZ).	Therapeutic Goods Administration (TGA)
India	Nutraceuticals are naturally occurring compounds that are extracted, isolated, and purified from food or other food sources. When consumed in measured doses, they provide a physiological benefit and aid in the maintenance of good health.	Food Safety and Standards Authority of India (FSSAI)
Singapore	In Singapore, health products, including nutraceuticals and dietary supplements, are classified according to their ingredients, intended purpose, and safety profiles. Products may be labeled as “General Sale” or “Pharmacy Only,” depending on their risk profile.	Health Sciences Authority (HSA)
South Korea	In South Korea, Health Functional Foods (HFFs) contain bioactive compounds with proven health benefits. Dietary Supplements are not subject to the same stringent scientific evaluation.	Ministry of Food and Drug Safety (MFDS)
Japan	Japan regulates nutraceuticals as “foods for specified health uses” (FOSHU)	Japanese Ministry of Health, Labour and Welfare (MHLW)

Conclusion

The APAC region is at the forefront of the intensely competitive global drug development market. Clinical trials in the region have increased dramatically in the last decade, outpacing those in the United States and Europe. Because of the aforementioned advantages of the APAC region in conducting clinical trials, sponsors can select Asia-Pacific countries for the clinical development of their nutraceuticals with a low risk of failure. Many of the world’s major CROs are establishing sites in Asia-Pacific to meet this demand.

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Have questions about conducting clinical trials for your nutraceuticals in the Asia-Pacific region?

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