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Case Study: ASEAN Regulatory & Market Access Strategy for Japanese Pharmaceutical Manufacturer

Updated: Mar 8

ASEAN Regulatory Market Access Singapore Malaysia Philippines Hong Kong Thailand Indonesia Taiwan Ophthalmology

Artixio, a leading consulting provider in the regulatory and commercial landscape, assisted a Japanese pharmaceutical company in expanding its footprint across ASEAN countries through Regulatory and Market Access strategy. The client, having successfully marketed its products in Japan, the USA, and Europe, sought to bolster its revenue streams by strategically venturing into the dynamic Asian markets, including Singapore, Malaysia, Philippines, Taiwan, Thailand, Indonesia, and Hong Kong.

Client Background:

  • Japanese Pharmaceutical Company: A well-established manufacturer of pharmaceuticals, biosimilars, consumer goods, and over-the-counter (OTC) products.

  • Expansion Goals: To tap into the burgeoning ASEAN markets and enhance revenue through strategic expansion.

Artixio’s Approach: Regulatory & Market Access Strategy for ASEAN Countries

Artixio, leveraging its expert regulatory and commercial teams based in the target countries, devised a two-stage strategy to guide the client toward successful market entry and sustainable growth.

Stage 1: Commercial and Compliance Roadmap

Sales Forecasting Study:

  • Artixio meticulously analyzed the market dynamics, consumer behavior, and competitive landscape in each ASEAN country.

  • By conducting a comprehensive Sales Forecasting study, Artixio provided the client with accurate projections of product demand, potential market share, and revenue generation.

This data-driven approach enabled the client to make informed decisions regarding product positioning, pricing, and distribution channels.

Country-Specific Regulatory Strategy:
  • Artixio’s regulatory experts delved into the intricacies of each country’s regulatory framework.

  • They identified the unique requirements, registration processes, and compliance norms for pharmaceutical and consumer products.

  • Based on this analysis, Artixio crafted a tailored Regulatory Strategy for the client, ensuring smooth product registration and adherence to local regulations.

  • The strategy covered aspects such as dossier preparation, submission timelines, and post-approval compliance.

Stage 2: Gap Analysis and Comprehensive Strategy

Gap Analysis of Approved Dossier:

  • Artixio meticulously reviewed the client’s existing product dossier, which had gained approval in Japan, the USA, and Europe.

  • By comparing it with the specific requirements of each ASEAN country, Artixio identified gaps and discrepancies.

  • These gaps included variations in labeling, safety data, and clinical trial documentation.

  • The gap analysis served as a foundation for the next crucial steps. Comprehensive Expansion Strategy:

  • Building upon the gap analysis, Artixio developed a holistic strategy for the client’s expansion.

  • This strategy addressed:

  • Product Adaptation: Customizing product labels, packaging, and formulations to align with local preferences and regulations.

  • Clinical Trials and Data: Ensuring compliance with country-specific clinical trial requirements.

  • Distribution Channels: Identifying optimal distribution partners and channels.

  • Pricing Strategies: Considering affordability and market dynamics.

  • Post-Market Surveillance: Establishing mechanisms for monitoring product safety and efficacy.

Results and Impact - Clearly Defined Regulatory & Market Access Roadmap:

  • Armed with Artixio’s strategic guidance, the Japanese pharmaceutical company successfully navigated the complexities of ASEAN markets.

  • The client achieved timely product registrations, streamlined compliance, and efficient market entry.

  • Revenue growth ensued as the company’s products gained traction among diverse consumer segments in the target countries.

In summary, Artixio’s expertise in regulatory affairs, commercial insights, and meticulous planning played a pivotal role in propelling the client’s expansion journey across ASEAN countries. 🌏🚀


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