Thailand is the second largest healthcare market in Southeast Asia after Indonesia making up roughly about 20% of the region’s expenditure.

Thailand’s pharmaceutical market is the eight largest in the Asia Pacific region and considered as one of the largest and most developed in ASEAN.

Why choose Thailand as your generic drug market?

Thailand’s Generic market presents numerous opportunities for foreign pharmaceutical companies

Thailand is a leading Hub of Generic Drugs for its

  • Huge market size due to
    • Aging population,
    • General trend in increasing risk of illness such as High blood pressure, Diabetes, Heart disease, Strokes, Cancer and communicable disease such as HIV/AIDS, Tuberculosis, Dengue fever etc and
    • Growth of medical tourism
  • Support from Thai government such as tax holidays and reduced import duties for equipment to foreign pharmaceutical investors
  • New Regulations that no longer requires state agencies to purchase from the Government Pharmaceuticals Organization (GPO), the state-run agency for pharmaceuticals and medical equipment providing a huge opportunity for foreign pharmaceutical companies.
  • The Government of Thailand support for usage of generics medicines in government-run hospitals
  • Thailand hospitals purchase about 75% of all medicinal drugs fabricated and sold locally in Thailand usually based on Generic tenders [1][2]

Thailand Vs other ASEAN countries

  • The Thai Generic market is large and fast growing, with the government remaining the biggest client for the industry.
  • Entry into the Pharmaceutical Inspection Co-operation Scheme (PIC/S) which opens the way for Thai manufacturers of medicines and medical supplies to expand their exports to the ASEAN region
  • The Board of Investment (BOI) (through tax exemption) is making an effort to invite pharmaceutical companies to invest in Thailand.
  • Thailand highly imports pharmaceuticals and medical devices to overcome the needs for healthcare sector and Thailand imports about 90% of the ingredients used to produce the final products.  [1][2][3][4]

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Potential therapeutic area for generics in Thailand

  • Communicable diseases such as
    • Requiring Antibiotics,
    • HIV/AIDS
    • Tuberculosis
    • Other infections etc
  • The highest value medicines, such as
    • Analgesics and
    • Medicines for treating fevers
  • The potential Non-Communicable disease market which have demand for drugs include
    • Hypertension
    • Diabetes
    • Cancer
    • Kidney disease and
    • Heart disease

Pharmaceutical market size

  • According to Thai Board of Investment, the Thai Pharmaceutical Market value is 4.6 Million US$ in 2016 and expected to be doubled by 2020
  • The Domestic market has about 160 companies which import Pharmaceutical ingredients, produce and sell them as Generic to Thai consumers and Market value is estimated to be 1 Million US$
  • The export of Pharmaceutical products has grown steadily over years and most Pharmaceuticals were exported to ASEAN regions like Myanmar, Vietnam, Cambodia etc
  • Almost 90% of Pharmaceutical trade comes from Generic drugs and Generics are mainly imported from China, India, United states, Germany, France and Switzerland  [7]

Global footprints in Thailand

Prominent foreign pharmaceutical companies that operate in Thailand include GSK, Sanofi, Roche, AstraZeneca, and Novartis

Some of the Foreign pharmaceutical companies also manufacture products in Thailand .

  • PharmaCyte Biotech (Laguna Hills, CA) announced that the company would be using Austrianova’s existing live-cell encapsulation facility in Bangkok.
  • Teva Pharmaceutical (Israel) owns a Thai generics manufacturer, Silom, after acquiring Actavis in 2016.
  • Not only multinational drug firms have made investments in in-country facilities but even foreign pharmaceutical companies generally employ several large Thai contract manufacturers to either re-package their imported drugs or produce their products locally. [1][5]

Requirements & procedure to register generic drugs

  • Regulatory Body: The Drug Control Division of the TFDA (Thai Food and Drug Administration) is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand
  • Application Format: Format followed for submission & Drug registration is ACTD (ASEAN Common Technical Document)  and additional country specific requirements
  • Type of Application: Registration requirements differ for general drugs such as generics, new medicines, new generics and traditional drugs.

Type of generic drugs

  1. Generic drug
  2. New generic grug

Generic drug

The Pharmaceutical products with the same active ingredients and the same dosage forms as those of the original products, but manufactured by different manufacturers are considered as Generics

  • Registration require only dossiers on product manufacturing and quality control along with product information

Procedure

Applications are made to the FDA

  • Step 1: Companies and individuals wishing to enter a drug on the market must obtain a licence from the FDA to manufacture, sell or import drugs in Thailand.
  • Step 2: Application for an approval of drug quality control and analytical methods. (at Department of Medical Science)
  • Step 3: Then the licensed applicant must obtain FDA registration for the medicine to market and sell the drug in Thailand.
  • The applicant should submit various details about the drug production process to be used, including:
    • Manufacturing methods.
    • In-process controls.
    • Specifications of the active ingredients
    • Excipients used in the production process
    • To register new generics, the FDA requires dossiers of bioequivalence studies, in addition
    • Information about the drug storage conditions and details about the stability of the drug are also required

New generic drug

Medicines with the same active ingredients, doses and dosage forms as those of the new compounds registered after 1992 are considered as New Generics

  • Registrations require dossiers of bioequivalence studies in addition to the required dossiers for generics submission.

Procedure

  • A protocol on bioequivalence study must be submitted for an approval at the Drug Control Division.
  • Application to seek permission for import or manufacture the drug samples.
  • Performing the bioequivalence study according to the approved protocol in a specified government institute.
  • Submitting an application for registration along with the bioequivalence report and other useful documents. [2][8]

Generic & New Generic Comparison

Review fast track

Drug application for generics can be processed in either of the two track depending on the need by the patients

  • Track 1: Standard view which takes approximately 110 working days
  • Track 2: Accelerated or Priority Review (Drugs for public health problems/life threatening) which takes about 70 working days [7]

Process flow

Requirements for drug registration in Thailand

  1. Administrative Documents
  2. Drug Product
  3. Non Clinical Documents
  4. Clinical Documents [7]

Thailand current and future market

  • According to the IMF (International Monetary Fund), Thailand’s GDP based on Purchasing Power Parity (PPP) exceeded $1.1 trillion dollars in 2016, making Thailand the second largest economy in Southeast Asia after Indonesia, which has a GDP of $3 trillion.
  • Thailand imported over $2.2 billion in pharmaceuticals in 2016, a increase from $1.8 billion in just two years ago and in 2016, over 65% of Thailand’s pharmaceutical imports came from the United States, Europe, and Canada and Germany is also a largest pharmaceutical exporter to Thailand, followed by the US, France, then Switzerland.
  • The Thai pharmaceutical market was valued at over $5 billion in 2016 and current value of $7 Billion making it the second largest market in Southeast Asia and the value of Thailand’s pharmaceutical market is expected to double by 2020.
  • Revenue in the OTC Pharmaceuticals market amounts to US$ 990m in 2019. The market is expected to grow annually by 0.7% (CAGR 2019-2023) and Pharmaceutical sales per-capita are also predicted to grow from $75 in 2016 to $125 by 2024. [1][2][3][8]

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Reference

  1. https://www.pacificbridgemedical.com/publication/thailand-drug-market-update-2017/
  2. https://www.business-sweden.se/contentassets/18717dc559704fe98f03af9de7b70a60/opportunies-in-thailands-healthcare-sector.pdf
  3. https://www.business-sweden.se/contentassets/c5a46df88398454490c8e4ce4934d1da/capture-the-business-opportunities-in-thailand-2018.pdf
  4. https://www.boi.go.th/tir/issue/201507_25_7/42.htm
  5. https://pharmaphorum.com/views-and-analysis/thailand-pharmaceutical-market-update-2014/
  6. https://www.statista.com/outlook/18000000/126/otc-pharmaceuticals/thailand
  7. https://ijdra.com/index.php/journal/article/download/158/77
  8. http://www.indianembassy.in.th/pdf/Market%20Survey%20Thailand%20Pharmaceutical%20Industry%202017.pdf

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