Local BE Requirement in Thailand: Entry Barrier or Advantage?

Unlike many ASEAN neighbors that accept BE data from Europe or other SRA-accredited centers, Thailand requires most oral solid dose (OSD) generics to undergo bioequivalence (BE) studies conducted locally — regardless of whether they are manufactured domestically or imported.

On paper, this is not a discriminatory trade barrier: Thai companies face the same obligation. But in practice, it acts as a strategic filter. The costs, timelines, and operational hurdles naturally tilt the field toward multinationals with resources and Thai firms already embedded in the ecosystem. The result? Fewer players, slower commoditization, and longer-lasting profitability for those who invest decisively.

Local BE Requirement in Thailand: Trading Barrier or Advantage?

Why Thailand Demands Local BE

The official rationale is patient safety and public confidence. With hospital tenders dominating the system and substitution common, regulators want assurance that generics perform identically to their reference drugs under Thai conditions.

Local BE delivers that assurance via Thai ethics committees, Thai volunteer populations, and in-country analytical oversight.

But economics are just as influential:

• Supports domestic CROs and builds the Thai BE industry.

• Slows hyper-competition, reducing the flood of “copycat” generics.

• Protects rational pricing, giving first movers room before the price collapse typical of open-entry markets.

Categories Exempted & ASEAN Recognition

Certain categories may be exempt from local BE, including:

• Oncology and life-threatening disease products.

• Urgent public health drugs (Category 1).

• Products where local BE is technically impossible (e.g., highly complex modified-release).

• ASEAN-listed BE centers: Article 6 of the ASEAN BE Agreement requires member states to recognize evaluation reports from accredited ASEAN centers.

In practice, however, Thailand remains cautious. Even when EU or ASEAN BE reports are submitted, Thai government hospitals often require product specs explicitly stating “BE with Thai volunteers.”

For biowaivers, Thailand applies the Biopharmaceutics Classification System (BCS). Class I — and occasionally Class III — molecules may qualify. But regulators demand watertight excipient sameness and dissolution profiles. For BCS II/IV, NTI, HVD, or modified-release drugs, full BE is the rule.

Market Impact: Time as the Real Currency

Open-entry markets accepting foreign BE data see multiple entrants arrive simultaneously, collapsing prices almost overnight. Thailand is different:

• First generics gain a premium window to anchor hospital tenders.

• Early followers (second to fourth entrants) can still enjoy attractive returns.

• Late entrants face commodity pricing and weak margins.

In other words: BE doesn’t just cost money — it buys time. The companies that act early monetize that time; those who hesitate lose it.

How Local BE Reshapes Price Competition (MedExport Asia)

Costs and Timelines

Executives must price BE into their investment calculus. Typical costs:

• Biowaiver (BCS I/III): €20,000–€40,000

• Standard BE (single-dose, fasting): €60,000–€120,000

• Complex BE (fed/fasting, MR/NTI/HVD): €150,000–€250,000+

• Duration: 9–15 months, dependent on CRO capacity and design study.

These figures are intimidating — but they also act as a natural moat. Many competitors simply never cross it.

Thai BE can begin once the final formulation and batches are ready. Waiting for CPP issuance is not necessary. This overlap can save months and determine securing first-mover advantage in tenders.

Who Wins? Who Pays?

Local manufacturers: Better positioned with CRO familiarity and networks, but still carry the capital burden.

• SMEs from abroad: Face a strategic fork. Those who invest gain slower price erosion and margins; those who hesitate arrive to a commoditized market.

• Multinationals: They can afford it — and it keeps smaller players out.

• Distributors: Often expect co-funding of BE. The structure of these deals (milestone-based vs open-ended) determines whether foreign firms retain profitability.

Thailand is not a market for opportunistic launches. It rewards deliberate, well-structured investment cases:

• Rank molecules by value after BE costs.

• Treat biowaivers as accelerators, not anchors.

• Negotiate partner agreements with BE cost-sharing tied to outcomes.

• Move early: the first three entrants win, the rest compete for crumbs.

MedExport Asia’s Role

At MedExport Asia, we help companies validate portfolios and quantify what Thailand’s BE requirement truly means for their business case. By aligning strategy, partner expectations, and cost-sharing mechanisms upfront, we ensure that BE becomes not a burden but a lever. For the right products, the barrier is precisely what creates the reward—because every other foreign company faces it too.

Sources; TFDA, ASEAN Guideline on BE, ICH M9, WHO TRS, ClinRegs Thailand, Chulalongkorn PK Center, Mahidol IBS, Chiang Mai University BE Unit, ProductLife Group (ACTD/CTD ASEAN), Thai CRO tariff data (2023–2025).

Produced by MedExport Asia Co,.Ltd, a consortium of pharmaceutical professionals supporting market access in ASEAN.