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1、Q4 2011 pharmaceuticals +5.1% in local currency terms and +13.7% in US dollar terms. ? Healthcare: TWD759bn (US$24.12bn) in 2010 to TWD769bn (US$26.43bn) in 2011; +1.3% in local currency terms and +9.6% in US dollar terms. ? Medical devices: TWD46bn (US$1.47bn) in 2010 to TWD49bn (US$1.70bn) in 201
2、1; +7.0% in local currency terms and +15.7% in US dollar terms. Business Environment Rating: Taiwan experienced a 2.49% jump in its Business Environment Rating (BER) from 60.2 in Q311 to 61.7 in Q411. This increase was due to an increase in its Industry Rewards score, which rose from 53 to 57. Thoug
3、h the country has been plague by negative news due to the presence of the plasticiser DEHP in pharmaceutical products, BMI commends the governments swift actions to ensure damage was kept to a minimum, preventing the incident from reaching a similar scale to the melamine scandal that engulfed China
4、in 2008. Key Trends the Bureau of Pharmaceutical Affairs (BoPA) the former director of which has criticised the TFDA for cutting manpower, and for raising food and drug safety concerns; the National Laboratories of Foods and Drugs; and the National Bureau of Controlled Drugs, under the Cabinet-level
5、 Department of Health (DOH), which will remain in charge of drug testing and of post-good manufacturing practice (GMP) inspection. The TFDA will be assigned the development of drug production standards and regulations in line with international norms followed in other countries in the region, includ
6、ing China, Japan and South Korea. The move will enable the country to introduce its biotech sector onto the international market and enhance the marketability of Taiwanese products. The new regulator is also expected to approve pharmaceuticals and medical devices more swiftly. In 2006, the approval
7、time for new drugs in Taiwan was calculated at an average of 30.5 months. Previously, product licences were issued in the name of the Department of Health, with the Bureau of Pharmaceutical Affairs (BPA) regulating the sector. The BPA was assisted in its evaluations by a non- governmental organisati
8、on, the Center for Drug Evaluation (CDE), which is responsible for new drug application (NDA) approvals. The task had previously been partly handled by the Drug Review Board (DRB), which in 2007 became a consulting organisation. The changes had been initiated in order to reduce approval times, altho
9、ugh they were only partly successful. The recent introduction of the Health Technology Assessment (HTA) system for new drugs has negated some of the gains achieved by the CDE, given the increased research and administrative demand on drugmakers submitting files for approval. Prior to evidence evalua
10、tion, the proposed price of a new pharmaceutical is benchmarked using existing prices in 10 other markets, presumably some more developed, such as Japan, and some less so, for example the Philippines, with prices then adjusted depending on efficacy. Additionally, BMI cautions that similar bodies in
11、other countries have been accused of delaying the introduction of innovative medicines. Taiwan Pharmaceuticals and ? Taiwan has yet to implement patent linkage in its regulatory procedures for approving generic drugs. Taiwan Pharmaceuticals regulations which are expected to affect 5,000 companies. ?
12、 In July 2010, the DOH in Taiwan set an upper limit on hospital registration fees in the country, reported the Central News Agency. The upper limit for outpatient clinic registration fees has been set at TWD150 (US$4.67), while that for accident and emergency (A foreign: 9,900). As the reclassificat
13、ion template was based on the one used by the US FDA, medical devices made in the US are exempt from being required to submit quality system accreditation if the following documents are included in the submission: establishment inspection report, certification to foreign government and the ISO 13485
14、 permit. Accordingly, US products (67%) account for a disproportionate slice of the Taiwanese medical equipment sector compared to products made in the rest of the world (28%). Other barriers to entry include not insignificant import duties (5-7.5%) and the open bid hospital tender, which can be cha
15、llenging. An experienced local distributor is a must as Taiwanese customers are highly influenced by relationships with their suppliers. In recent years, China has begun viewing Taiwan as one of the more interesting export destinations for its medical devices. The countrys highly efficient reimburse
16、ment system has been cited as one of the main attractions to market penetration. Administration costs incurred by the national healthcare insurance scheme are less than 2% of total expenditure, which compares favourably to other developed states. For example, running costs for the UKs National Healt
17、h Service (NHS) are approaching 10% of overall spending. This means that more funds in Taiwan are allocated to innovative and invariably expensive products. In fact, according to director general of the Industrial Development Bureau, the medical devices industry in Taiwan has been the fastest-growin
18、g domestic biotech industry segment in the past five years. The government is actively promoting the sector, especially medical electronics, its largest component (at 60% of the total). According to ITRI data, in 2007, turnover in the Taiwan medical equipment industry totalled US$74.9bn. While prese
19、ntly only accounting for around 1% of the global market share, the industry is growing at around 16.5%, above the average global rate. Leading local companies include Taiwan Pharmaceuticals Sources: 2 National Statistics Of Taiwan, BMI. 3 BMI Calculation; 4 Central Bank of the Republic of China, BMI
20、; 5 DGBAS, BMI. Taiwan Pharmaceuticals Everlight, a bulk pharmaceutical producer; and Standard, which produces medicines, pharmaceutical raw materials, diagnostic kits and Chinese medicines. Although the Taiwanese drug market is small and heavily reliant on imported drugs, foreign drugmakers are wid
21、ely represented on the island through direct manufacturing facilities. Most major multinationals have a presence in Taiwan, including GSK, Pfizer, Merck a pharmaceutical composition for an anti-ulcer drug; the matrix controlled-release system; a pharmaceutical composition for an anti-coagulant; and
22、novel drug- delivery systems for transdermal preparations for terazosin HCl and sub-lingual preparations for neostigmine bromide. In order to actively expand business inside and outside Taiwan, Empax founded its headquarters in Nei- Hu Technology Park in Taipei April 2002, and also in Tien-He high t
23、ech Park in Guangzhou, in China, in December 2001. Empax is also accredited by several pharmaceutical manufacturers, both foreign and domestic. This, in addition to the companys focus on developing new R +7.2%), Lipitor (US$45.1mn; +2%), Viagra (US$21.6mn) and Celebrex (US$20.8mn). In 2008, Norvasc
24、posted revenue of US$133mn. Taiwan Pharmaceuticals this accounted for 25.1% of consolidated net sales in 2009, 1.4 percentage points higher than in 2008. Net sales in China reached a value of US$706mn (+28.8%) and sales in Russia reached a value of US$700mn (+59.8%). Highlighting the companys intere
25、st in emerging markets, Taiwan Pharmaceuticals BMI calculation Table: Average Annual Manufacturing Wages, 2005-2012 2005 2006 2007e 2008e 2009f 2010f 2012f Local currency 501,012 507,516 526,467 553,106 576,580 598,441 637,400 Wage growth, % y-o-y 2.8 1.3 3.7 5.0 4.2 3.7 2.5 US$ 15,570 15,535 16,199
26、 17,333 18,401 19,556 21,461 e/f = BMI estimate/forecast. Source: ILO, BMI Taiwan Pharmaceuticals or by private entities such as non-profit institutions, commercial insurances and households acting as complementary funders to the previously cited institutions or unilaterally disbursing health commod
27、ities. The revenue base of these entities varies by country and comprises multiple sources. The inclusion of this in BMI forecasts necessitates taking into account the essential Taiwan Pharmaceuticals pharmaceutical trade associations; company press releases and annual reports; subscription informat
28、ion providers; local news sources; information from market research firms that is in the public domain. ? Data that has been validated by BMIs pharmaceutical and healthcare analysts using a composite approach, which scores data sources by reliability in order to ensure accuracy and consistency of hi
29、storic data. ? Five key macroeconomic and demographic variables, which have been demonstrated, through regression analysis, to have the greatest influence on the pharmaceutical market. These have been forecast by BMIs Country Risk analysts using an in-house econometric model. ? The burden of disease
30、 in a country. This is forecast in disability-adjusted life years (DALYs) using BMIs Burden of Disease Database, which is based on the World Health Organizations burden of disease projections and incorporates World Bank and IMF data. ? Subjective input and validation by BMIs pharmaceutical and healt
31、hcare analysts to take into account key events that have affected the pharmaceutical market in the recent past or that are expected to have an impact on the countrys pharmaceutical market over the next five years. These may include policy/reimbursement decisions, new product launches or increased co
32、mpetition from generics. Taiwan Pharmaceuticals & Healthcare Report Q4 2011 Business Monitor International Ltd Page 108 Pharmaceuticals Business Environment Ratings Risk/Reward Ratings Methodology BMIs approach in assessing the risk/reward balance for Pharmaceutical & Healthcare Industry investors g
33、lobally is fourfold. First, we identify factors (in terms of current industry/country trends and forecast industry/country growth) representing opportunities to would-be investors. Second, we identify country and industry-specific traits which pose or could pose operational risks to would-be investo
34、rs. Third, we attempt, where possible, to identify objective indicators that may serve as proxies for issues/trends to avoid subjectivity. Finally, we use BMIs proprietary Country Risk Ratings (CRR), ensuring that only the aspects most relevant to the Pharmaceutical & Healthcare Industry are incorpo
35、rated. Overall, the system offers an industry-leading, comparative insight into the opportunities and risks for companies across the globe. Ratings Overview Ratings System Conceptually, the ratings system divides into two distinct areas: Rewards: Evaluation of the sectors size and growth potential i
36、n each state, as well as broader industry/state characteristics that may inhibit its development. Risks: Evaluation of industry-specific dangers and those emanating from a states political/economic profile that call into question the likelihood of anticipated returns being realised over the assessed
37、 time period. Indicators The following indicators have been used. Overall, the ratings use three subjectively measured indicators and 41 separate indicators/datasets. Taiwan Pharmaceuticals & Healthcare Report Q4 2011 Business Monitor International Ltd Page 109 Table: Pharmaceutical Business Environ
38、ment Indicators Indicator Rationale Rewards Industry Rewards Market expenditure, US$bn Denotes breadth of pharmaceutical market. Large markets score higher than smaller ones Market expenditure per capita, US$ Denotes depth of pharmaceutical market. High value markets score better than low value ones
39、 Sector value growth, % y-o-y Denotes sector dynamism. Scores based on annual average growth over five-year forecast period Country Rewards Urban-rural split Urbanisation is used as a proxy for development of medical facilities. Predominantly rural states score lower Pensionable population, % of tot
40、al Proportion of the population over 65 years of age. States with ageing populations tend to have higher per-capita expenditure Population growth, 2003-2015 Fast-growing states suggest better long-term trend growth for all industries Overall score for Country Structure is also affected by the covera
41、ge of the power transmission network across the state Risks Industry Risks Intellectual property (IP) laws Markets with fair and enforced IP regulations score higher than those with endemic counterfeiting Policy/reimbursements Markets with full and equitable access to modern medicines score higher t
42、han those with minimal state support Approvals process High scores awarded to markets with a swift appraisal system. Those that are weighted in favour of local industry or are corrupt score lower Country Risks Economic structure Rating from CRR evaluates the structural balance of the economy, noting
43、 issues such as reliance on single sectors for exports/growth, and past economic volatility Policy continuity Rating from CRR evaluates the risk of a sharp change in the broad direction of government policy Bureaucracy Rating from CRR denotes ease of conducting business in the state Legal framework
44、Rating from CRR denotes the strength of legal institutions in each state. Security of investment can be a key risk in some emerging markets Corruption Rating from CRR denotes the risk of additional illegal costs/possibility of opacity in tendering/business operations affecting companies ability to c
45、ompete Source: BMI Taiwan Pharmaceuticals & Healthcare Report Q4 2011 Business Monitor International Ltd Page 110 Weighting Given the number of indicators/datasets used, it would be inappropriate to give all sub-components equal weight. Consequently, the following weight has been adopted. Table: Wei
46、ghting Of Components Component Weighting Rewards 60% Industry Rewards 75% Country Rewards 25% Risks 40% Industry Risks 60% Country Risks 40% Source: BMI Sources Sources used include national industry associations, government ministries, global health organisations, officially released pharmaceutical company results and international and national news agencies.