Biopharmaceutical Industry in Taiwan

Until now, the plans of science and technology development of the biopharmaceuticals industry as executed by the various commissions and agencies have exhibited some achievements: Building an international standard biological resources center, providing various biological resources from various sources of Taiwan information and relevant R&D technology platform, building biopharmaceutical pioneering factory, integrating domestic optoelectronics and medical technology, building the protein drug biological safety testing system and protein drug biological and chemical properties analysis technology platform. The Bureau of Industry, MOEA, is responsible for the promotion of two projects including the Vaccine Industry Root-Taking Project and Biotechnology Industry Development and Investment Cooperation Promotion Project. The Medium and Small Business division, MOEA, is responsible for the Biotechnology Industry Cluster Incubation Promotion project.

2.3Biopharmaceutical Industry

2.3.1 Biopharmaceutical Industry in Taiwan

The biotechnology industry is one of the emerging industries that have been generally known to have the potential for development and the most significant impact on the quality of human life in the future. The leaing countries of Europe and North America generally consider the emerging biotech industry to be limited to those firms engaged in genetic engineering. Asian countries generally define biotech industry

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categories more broadly. In view of the fact that the developments of pharmaceuticals and medical devices are closely linked with biotechnology, based on the current state of the industry and industry assistance considerations, apart from the emerging biotech industry, Taiwan also defines the biotech industry as including the pharmaceutical and medical devices industries(IDB, 2010).In terms of data from MOEA ,refer to Figure 2-5, except of the data of 2006, the investment in biotechnology show a gradual increase from 2000 to 2009. The reason why the investment decreased at 2006 is that the combination influences of economic depression, inflation, and the worsen situation in Iraq (IDB, 2010).

Figure 2- 5 Investment of Taiwan Biotech Industry

Taiwan’s biotechnology industry includes mainly three fields: biotechnology, pharmaceuticals and medical devices. It is worth noting that in 2009, the top 3 production value in biotechnology are respectively food biotech/ hearbal medicine

, 2009

Total

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(49.8%), in vitro diagnostics (13.6%) and pharmaceutical/biomedical (12%), refering to Figure 2-6. Today biotech it is the fastest growing sector in the drug industry with annual growth rates almost double that of the overall drug industry average(Bradfield

& El-Sayed, 2009). The growth of biopharmaceutical approvals is predicted to grow at a rate of 16% to 30%, compared with about a 4% growth of traditional small-molecule biopharmaceuticals.(Nagle, Nicita, Gerdes, & Schmeichel, 2008) Biopharmaceutical enjoy a relatively high success rate while an average of 34% of biotech products will pass clinical trails and reach the market, only 8% of pharmaceutical products do so(Bradfield & El-Sayed, 2009). Hence, in the last few years, several articles have been devoted to the study of biotechnology and pharmaceutical industry.

Pharmaceutical/bi

Figure 2- 6 Taiwan Biotechnology Production Value

Although the biotechnology and pharmaceutical industry have been objects of study for a long time, there is little research about the combination of these two industries.The conventional pharmaceutical formulations are relatively simple molecules manufactured mainly through trial and error technique for treating the symptoms of a disease or illness. It could be categorized into generic drug, new molecular entities

Source: IDB(2010)

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(NMEs) and new chemical entities (NCEs), Me too NCEs, and biological drug by the making processes (refer to Figure 2-7), and western medicines, Chinese medicines, and Active Pharmaceutical Ingredients (API) by regulations in Taiwan (refer to Figure 2-8).

Figure 2- 7 Pharmaceutical Industry Categorized by Making Process

Figure 2- 8 Pharmaceutical Industry Categorized by Regulations

However, biotechnology is fundamentally reshaping the pharmaceutical industry, that is to say, biopharmaceuticals are complex biological molecules, commonly known as proteins that usually aim at eliminating the underlying mechanisms for treating diseases(PDM, 2010). There are several definitions from different authors and departments in the Table 2-4.

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Table 2- 4 Definitions of Biopharmaceuticals

Nagle, et al.( 2008) Biopharmaceutical was defined as“any biology-based

therapeutic that structurally mimics compounds found within the body.” This includes recombinant proteins, monoclonal and polyclonal antibodies, peptides, antisense

oligonucleotides, therapeutic genes, and certain therapeutic vaccines.

BPIPO(2008) The biotech drug industry mainly specializes in the production of drugs with therapeutic or preventive properties that are made from living organisms via gene recombination. Biotech drugs are currently defined as including genetically

engineered protein drugs, genetic therapies, stem cells, blood preparations, vaccines and toxoids, and allergen preparations.

Walsh, G (2005) Biopharmaceuticals are recombinant therapeutic proteins, monoclonal antibody-based products used for in vivo medical purposes and nucleic acid-based medicinal products.

Source: Compiled by the authority.

Hence, this research defined the biopharmaceutical industry simply as the production process of pharmaceutical industry which applies biotechnology in it. Therefore, the biopharmaceutical industry in this study has the integrated characteristics of the biotechnology and pharmaceutical industry(Chu, 2008; Kesi, 2009; Shyu & Chiu, 2000):

1. Strict regulation to garentee the safty and effectiveness. Increased importance of

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regulatory issues (registrations, intellectual property, litigations).

2. The prices were set according to the demands and regulations.

3. It’s a highly professional industry.

4. Huge investments needed for R&D.

5. Highly value added.

6. Increased competitiveness,

7. It should combine with multifield industry.

8. Long innovation time.

9. Brand reliability.

10. It should provide professional service.

11. Low price sencititvity.

Taiwan has many of the attributes for a successful biopharmaceutical sector.

Importantly, it has existing expertise in advanced technologies such as electronics, which can be easily trasitioned to the life sciences. What’s more, a strong legal framework rewards innovation without prejudice. There is a highly educated workforce, particularly in IT and biology. Facilities including laboratories and manufacturing plants have been constructed to state-of-the art criteria(BMI, 2010).

However, Taiwan needs to implement a two-pronged strategy: innovative research-orientation and niche-orientation, in order to be a vital cog in global biotechnology for the coming future. Furthermore, it will look to aggressively develop products that have the most growth potential and which are extremely competitive, laying strong foundations on which future development can build on(MOEA, 2009).

In order to know the situation of biopharmaceutical research, the author had

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searched (searched in November, 2010) relevant category at the National Digital Library of Theses and Dissertations in Taiwan which is the main digital system for dissertations in Taiwan. There are 18 essays about biopharmaceutical industry after the year 2000. However, most of the issues are about investment evaluation, business strategy, and innovation policy. In this research background in Taiwan, it is worth while conduct a study about biopharmaceutical industry.