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Decision Framework for Localization of Pharmaceutical Manufacture with Applications to Malaysia and Indonesia

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MIT Global Scale Network

MIT SCALE RESEARCH REPORT

The MIT Global Supply Chain and Logistics Excellence (SCALE) Network is an international alliance of

leading-edge research and education centers, dedicated to the development and dissemination of global

innovation in supply chain and logistics.

The Global SCALE Network allows faculty, researchers, students, and affiliated companies from all six centers around the world to pool their expertise and collaborate on projects that will create supply chain and logistics innovations with global applications.

This reprint is intended to communicate research results of innovative supply chain research completed by faculty, researchers, and students of the Global SCALE Network, thereby contributing to the greater public knowledge about supply chains.

For more information, contact MIT Global SCALE Network Postal Address:

Massachusetts Institute of Technology 77

Massachusetts Avenue, Cambridge, MA 02139 (USA) Location:

Building E40, Room 267 1 Amherst St. Access: Telephone: +1 617-253-5320 Fax: +1 617-253-4560 Email: scale@mit.edu Website: scale.mit.edu

Research Report: MISI-2016-2

Decision Framework for Localization of Pharmaceutical Manufacture with Applications to Malaysia and Indonesia

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MIT Global Scale Network

For full thesis version please contact:

Professor Shardul Phadnis

Director of Research

MISI

No. 2A, Persiaran Tebar Layar, Seksyen

U8, Bukit Jelutong, Shah Alam,

40150 Selangor, Malaysia.

Phone: +6 03 7841 4845

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By: Mahesh B. Yedluri and Veronica Thesis Advisor: Dr. Sang Jo Kim

Summary: A pharmaceutical company, Global Pharma (fictitious name), has strong presence in the western markets of Europe and the US, where the major manufacturing base is also located. With the shift in growth from these developed markets to the emerging markets of Asia, Latin America, Eastern Europe and Middle East Africa, there is a resulting increase in transportation of goods and hence cost and carbon footprint. At the same time, the company has opportunities to reduce these costs because localizing manufacturing in emerging markets offers will reduce the transportation costs and the carbon footprint. However, it requires significant investment and long-term planning for a pharmaceutical company to determine the viability to localize its manufacture in emerging markets. Localization is establishing one or more of a company’s functions in a country. These functions include and not limited to, manufacturing, research and development, warehousing, and procurement. In this study, we develop a framework to assist a pharmaceutical company in the localization decision-making. In the framework, a comprehensive list of key external factors are obtained and analyzed for their impact on localization in a particular market. Those factors are also grouped into

pertinent categories that are arranged into logical levels according to their importance and the degree of the company’s control over them. We apply the framework for the localization decisions in Malaysia and Indonesia and the application of this framework infers that the atmosphere in the two countries is positive for localization.

Mahesh B. Yedluri holds a Bachelor of Technology degree in Civil

Engineering from Acharya Nagarjuna University in India and a Master of Science in Civil Engineering from California State University, Sacramento. Prior to the MSCM Program, he worked as a civil engineering consultant in the United States.

Veronica holds Bachelor of Economics in Air Transportation Management

from Trisakti Institute of Transportation Management. Prior to the MSCM Program, she worked at DHL Global Forwarding.

Decision Framework for Localization of Pharmaceutical Manufacture

with Applications to Malaysia and Indonesia

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Introduction

The company, Global Pharma (fictitious name), is a global pharmaceutical products manufacturer with strong emphasis in commercial pharmaceutical products. The company has a strong presence in North America, Europe, and Japan and is establishing a strong presence in the emerging markets. Global Pharma performs extensive research to develop innovative pharmaceuticals to treat ailments for which there are few

affordable treatment options. The company is also committed to provide access to affordable healthcare to the broader population. The purpose of this thesis is to develop a framework that will assist Global Pharma in localization decisions.

Localization is a process in which a

company sets up one or more of its

functions in a country. These functions can

be manufacturing, research and

development, services, purchasing, etc. Driving Factors for Localization The factors that are driving a company to localize are presented below.

Research Questions and Scope

This thesis aims to answer the following research questions:

(1) What are the key external factors that influence the localization decisions?

(2) What is the framework that will assist Global Pharma in the localization decision-making? After a framework that assists in

localization decisions is developed, it will be applied to Malaysia and Indonesia. Literature Review

Several external factors are identified and they are arranged into following

categories: Push Factors •  Increased transporation to ship finished products to emerging markets •  Increased transportation to procure raw materials from emerging markets •  Increased carbon footprint Pull Factors •  Growth in the emerging markets •  Affordable labor force •  Improving infrastructure •  Availability of skilled workforce •  Lower raw material costs KEY DEVELOPMENTS:

1. Emerging markets provide

opportunities for a pharmaceutical company to provide greater access to medicines for broader

population.

2. A list of key external factors that influence localization decisions. 3. A qualitative analysis of factors

determining their impact. 4. Categorization of factors into

pertinent groups.

5. A framework that will use a hierarchal or level approach that will assist in localization decisions. 6. An application of framework to

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Examples of key factors under each category are presented in the table below.

Category Factors Government

Policy Tendering, Tax Incentives, Business Approval Process Regulatory

Affairs Patent Protection, Quality Assurance and Quality Control Requirements, Regulatory Requirements Technology and Trade Policy Production Technology, Tracking Technology, Trade Policy

Demographics Gross Domestic Product, Population Density, Peoples beliefs in Foreign vs. Local Competitors Existing Competitors,

Competitors’ Market Share, Competitors’ Growth Foreign

Direct Investment

History of Foreign Direct Investment (FDI),

atmosphere for FDI. Longevity and

Growth Market Stability, Market Conditions, Market Trends Supply Chain Infrastructure, Reliable

Supplier Network, Customer Expectations Contributions of this thesis:

(1) A comprehensive list of key factors that influence the localization decisions for the pharmaceutical companies in emerging markets. (2) Categorization of factors and

prioritizing categories. (3) Identifying the impact of the

factors as positive, negative or unknown using literature. (4) A decision framework that uses

categories and impact to support localization decisions.

Research Method

Applications of Framework to Malaysia and Indonesia

The following table presents the

applications of framework to Malaysia and Indonesia.

A positive impact is assigned when more than 55 percent of the factors have positive impact. An unknown impact is assigned when at least than 25 percent of the factors have an unknown impact and at least 45 percent of the factors have positive impact or at least 35 percent of the factors have unknown impact and only 35 percent of factors have a negative impact. A negative impact is assigned if at least 45 percent of the factors have a negative impact.

Category Malaysia Indonesia Level 1 Government Policy P: 87% (of factors have positive impact) P: 67% Regulatory Affairs U: 33% U: 25% Technology U: 83% U: 83% Localization Decision Framework Government Policy Regulatory Affairs Technology and Trade Demographics Competitors Foreign Direct Investment Longevity and Growth Supply Chain • Mainly through Literature Review Collect Data

• Into eight pertinent categories Categorize Factors • Positive, Negative, or Unknown impact Analyze Factors

• Using three levels based on importance of categories Develop

Framework

• To Malaysia and Indonesia Apply

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and Trade Level 2 Demographics U: 33% U: 40% Competitors P: 57% P: 57% Level 3 FDI P: 100% U: 50% Longevity and Growth P: 100% P: 75% Supply Chain P: 80% P: 60% Notes: P – Positive, N – Negative, U - Unknown

A category is given a “P” when majority of the factors under that category has a positive impact. A category is given an “N” when majority of the factors under that category has a negative impact. A category is given “U” when majority of the factors, about 55 percent of the factors, are neither positive nor negative. In such cases, the factors with unknown impact will determine the overall impact of that category. Therefore, such categories were given an unknown impact.

Based on the analysis of the categories under Levels 1, 2 and 3 as well as the factors under each category, it can be inferred that Malaysia and Indonesia have a positive atmosphere for localization and it is recommended to localize in Malaysia and Indonesia provided that the internal factors in the company are also supportive. However, significant percentages of

factors under Level 1, 2, and 3 have unknown impact on localization, and thus, it is important for Global Pharma to further explore the impact of unknown factors. Conclusions

The decision framework application to Malaysia and Indonesia using external factors indicate that both countries have positive atmosphere to localize. As next steps, Global Pharma should perform the following:

(1) Identify the factors with unknown impact.

(2) Determine the impact of such factors either through market research or through surveys.

(3) Update the impact based on the results from above steps. (4) Determine if the changes will

impact the overall recommendation.

The limitations of this thesis are: (1) Only external factors are

considered.

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