World Thermometer Market to Grow 6.2% annually from 2014 to 2018

Global demand for thermometers is forecast to expand 6.2% p.a. between 2014 and 2018. Bangladesh, Belgium, China, Germany and the United States are considered the highest potential markets in the coming years.

According to recently published research conducted by a leading international market research company, Global Research & Data Services, the expansion of the global thermometer industry is forecast to reach 6.2% p.a. in the coming years. Between 2007 and 2013 the market increased with an average annual growth of 8.4%. Currently, liquid-filled thermometers account for 8.6% of the global demand while other thermometers have a 91.4% share of the market.   China, Germany, Sweden, the United Kingdom and the United States represent the largest thermometer markets while the strongest annual growth is forecast to occur in Bangladesh (15.1%), Belgium (13.9%), Vietnam (11.2%), the United States (10.9%) and Azerbaijan (10.6%).

Thermometer market size compared to market growth in different countries. Based on in-house analysis and an advanced model which takes into consideration the actual market size, trends, forecast market growth, and changes in the market environment, Global Research and Data Services calculates the Market Potential Rates, the predicted market potential of the country in the coming years. The larger the Market Potential Rate, the more potential the market has in the coming years; and conversely, the smaller the rate, the less potential the market is considered to have in the future.

Based on these Market Potential Rates, the top 20 highest potential thermometer markets in the coming years are: 

The information are extracted from our recently published reports, you can browse country wise reports here: World Thermometer Market MarketReports

The market information is based on new industry data reports recently published by Global Research & Data Services. The reports offer the most up-to-date market data on the actual market situation, trends, and future outlook for thermometers in the world and individually for the following countries:   Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Moldova, Mongolia, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam.

The reports include historic market data from 2007 to 2013 and forecasts until 2018 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, analysts, and other people looking for key industry data in readily accessible and clearly presented tables and graphs.

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The latest market data for this research include:

• Overall thermometer market size, 2007-2018
• Thermometer market size by product segment, 2007-2018
• Growth rates of the overall thermometer market and different product segments, 2007-2018
• Shares of different product segments of the overall thermometer market, 2007, 2013 and 2018
• Market Potential Rates of the overall thermometer market and different product segments

The product segments discussed in the reports include:

• Liquid-filled thermometers
• Other thermometers

The report s help answering the following questions:

• What is the current size of the thermometer market in the world and in different countries?
• How is the thermometer market divided into different product segments?
• How are the overall market and different product segments growing?
• How is the market predicted to develop in the future?
• What is the market potential compared to other countries?

Healthcare, Regulatory and Reimbursement Landscape - United Arab Emirates, New Report Launched

The UAE’s healthcare market has significant potential for growth, driven by an increasing burden of lifestyle-related diseases, medical tourism, straightforward regulatory guidelines and a preference for branded imported products. However, factors such as frequent price cuts by the government and usage of counterfeit drugs will restrict the growth of the pharmaceutical market.

The UAE is the second largest country in the Middle East in terms of capital invested in the pharmaceutical sector. In 2013, the UAE’s pharmaceutical market was estimated to be worth $2.4 billion, having increased from $1.3 billion in 2008 at a Compound Annual Growth Rate (CAGR) of 12.6%. The market is expected to reach $3.7 billion in 2020 at a CAGR of 5.3% (Kulkarni, 2010). Increased healthcare expenditure, the growing popularity of medical tourism and a growing elderly population are the main contributors to market growth.

Due to its growing healthcare infrastructure and lower treatment costs compared to competitors, the UAE is quickly gaining popularity as a medical tourism destination due to its low costs, English-speaking medical staff and virtually non-existent queues for treatment (Woodman, 2012). Dubai Health Authority is working to develop the medical tourism sector. It is formulating different healthcare packages according to patient requirements and the first package (wellness and preventive services package) is to be launched in October 2014 (UAEinteract, 2014f).

Branded imported drugs dominate the pharmaceutical market, with approximately 80% of the market share. Therapeutic segments such as cardiovascular diseases and cancer are expected to grow significantly in the coming years due to the growing incidence of certain lifestyle diseases. Multinational companies will continue to penetrate the market as they offer largely patented drugs, whereas a lack of R&D activities from domestic manufacturers has limited their ability to offer patented drugs.

The UAE government has been reducing the prices of drugs since 2011 to make them more affordable for people as the prices of pharmaceutical medicines were comparatively much higher than in other neighboring GCC countries. Since 2011, the Ministry of Health (MoH) has reduced the prices of medicines five times, by percentages ranging from 1% to 60% (Sophia, 2014; Zain, 2014).

The proliferation of counterfeit drugs in the UAE is very high. According to a 2010 European Commission report, 73% of the drugs seized in the European Union (EU) were routed through the UAE (Underwood, 2010). These factors hamper the pharmaceutical market in the UAE.

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In 2008, the UAE’s medical device market was valued at approximately $600.2m and $733.3m in 2013. The medical device market is estimated to reach $978.9m in 2020, at a CAGR of 4.2% from 2014, mainly due to positive demographics, increased healthcare awareness and a rise in healthcare spending. The significant demand for medical devices in the UAE is met through imports.

In an attempt to prevent age-related chronic diseases and lifestyle diseases, the government has implemented the national Weqaya program and set up various specialty healthcare facilities.

The regulatory authority provides an efficient system for approving pharmaceutical products and medical devices, positively influencing the growth of the healthcare market.

In 2008, the MoH introduced an online registration system with the aim of increasing transparency and expediting the overall process by making the filing process easier and allowing companies to determine the status of their application at any time.

To overcome the language barrier, the government allows filing in both English and Arabic.

In 2012, according to the World Intellectual Property Organization (WIPO), the UAE registered 50 patents and was second only to Saudi Arabia, which had 339 registered patents (WIPO, 2014).

In 2008, in order to strengthen clinical trial regulations the MOH issued instructions for the approval and registration of a research ethics committee to help the country to meet global clinical trial regulation standards. In the same year, the MOH established the Emirates Health Authority (EHA), which will allow the government more control over their healthcare delivery system in the northern emirates, which comprise Ajman, Umm al-Quwain and Ras al-Khaimah.

The UAE’s healthcare system is characterized by high public expenditure on the implementation of healthcare policies and growing private infrastructure to provide more sophisticated facilities.

The overall healthcare system is in a development stage, and total healthcare expenditure increased from approximately 2.7% of the Gross Domestic Product (GDP) in 2008 to an estimated 2.9% in 2013, at a CAGR of 1.6%. Healthcare services and medicines provided by public hospitals are free to citizens, while expatriates must pay for services. The number of private hospitals increased from 58 in 2008 to an estimated 67 in 2013, and the government is encouraging investment by promoting specific zones for healthcare (NBS, 2014b).

The UAE government provides easy access to healthcare facilities through primary care services. The public-sector share accounted for 61.7% of the overall healthcare expenditure in 2008 and increased to an estimated 69.3% in 2013. In 2008, OOP payment (as a percentage of total healthcare expenditure) was 28.1%, and decreased to an estimated 18.8% in 2013.

In 2012, the government started the Labor Abroad Medical Fitness Program to protect the country against communicable diseases spread by the immigrant labor force. Its main aim was to make it compulsory for individual workers to have a certificate confirming them as being free of infectious diseases. A school health program was initiated in 2012 with the aim of increasing disease awareness among children.

The wealth generated from strong economic growth, favorable government initiatives, high investment from global players and political stability will further aid development.

According to the Global Competitiveness Report 2012-2013, the UAE is the 24th largest economy in the world, compared to 27th in 2011-2012 report. In 2011, it ranked fifth worldwide in terms of basic requirements. At the same time, an almost tax-free and trade-barrier-free environment placed the UAE third in terms of cross-border trading (Schwab, 2013).

Since 1980, the government has adopted a strategy of economic diversification in order to reduce its dependence on non-renewable sources of energy for economic growth. This has led to the development of a number of new service sectors and hubs of non-oil industrial activities such as Dubai Healthcare City and Dubai Biotechnology and Research Park, among others.

The government’s free zone initiatives have encouraged foreign investors to invest strongly in the UAE, through the introduction of 100% ownership and tax-free income conditions for foreign companies.

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Dengue Vaccines - Opportunity Analysis and Forecasts to 2020, New Report Launched

After the Launch of the First Dengue Vaccine in 2015, the Market is Projected to Experience Rapid Growth Through 2020

In 2015, Publisher projects the dengue vaccine market to be valued at $69.6m across the five pharmaceutical markets covered in this report: Brazil, India, Mexico, Singapore, and Thailand. Two of the earliest adopters of dengue vaccines, Brazil and Mexico, are together expected to account for well over 95% of the 2015 market share, with sales of $44.6m (64.1% market share) and $23.6m (34.0% market share), respectively. For the purposes of this report, Publisher defines the market as the sales of dengue vaccines in the countries of interest that are likely to incorporate these vaccines into their routine immunization programs.

By 2020, Publisher expects dengue vaccine sales to grow substantially and reach a combined $398.6m in Brazil, India, Mexico, Singapore, and Thailand, at a Compound Annual Growth Rate (CAGR) of 41.8%. This rapid uptake of dengue vaccines will be driven primarily by the inclusion of live-attenuated vaccines in national immunization programs. Brazil ($97.0m; 24.4% market share) and Mexico ($216.7m; 54.4% market share) are anticipated to continue their dominance of the market, although Publisher projects India ($58.6m; 14.7% market share), Singapore ($16.1m; 4.0% market share), and Thailand ($10.0m; 2.5% market share) to still experience solid growth from 2015-2020. Sales growth, however, will likely be hindered by the arrival of less expensive, publically-supplied vaccines in Brazil and India, which are expected to rapidly garner patient share from premium-priced vaccines.

Given their superior clinical and commercial positioning, Publisher anticipates that live-attenuated dengue vaccines — led by Sanofi’s CYD-TDV and Takeda’s DENVax — will dominate the market, with 2020 sales projected to reach $166.4m (41.8% market share) and $148.5m (37.3% market share) across the five pharmaceutical markets covered in this report, respectively. Despite being second to market, Publisher expects DENVax to seize significant market share from Sanofi’s first-to-launch vaccine due to its more convenient dosing schedule and a competitive pricing strategy. Despite their overall market dominance, Publisher projects both CYD-TDV and DENVax to lose market share to the domestically-produced live-attenuated vaccine, TV-003 ($80.2m; 20.1% market share), in Brazil and India by 2020, primarily because of its lower price. Publisher expects the earlier-stage pipeline vaccines — GlaxoSmithKline’s (GSK’s) TDENV-PIV and Merck’s DEN-80E — to garner less than 1% market share by 2020.

Publisher expects the major drivers of growth in the dengue vaccine market across Brazil, India, Mexico, Singapore, and Thailand to include:

- The launch of the first live-attenuated dengue vaccines, particularly Sanofi’s CYD-TDV and Takeda’s DENVax. These vaccines will be heralded by physicians, public health officials, and policymakers as a welcome relief to the growing global healthcare burden of dengue.

- Dengue’s growing socioeconomic and public health burden will lead countries to push for widespread immunization as a preventative measure. Specifically, the past failures of vector control initiatives to curtail the spread of the Aedes aegypti mosquito have left a glaring void in the prevention and landscape, which will hasten the uptake of vaccines.

- The integration of dengue vaccines into routine childhood immunization schedules. Taking into account the existing immunization program infrastructure and disease epidemiology, Publisher’s primary research indicates that targeting the pediatric population for vaccination will likely improve coverage rates and provide a sustained revenue source for vaccine manufacturers.

Publisher anticipates the formidable barriers to growth in the dengue vaccine market across Brazil, India, Mexico, Singapore, and Thailand to include:

- Formidable logistical and financial hurdles must be overcome in order to successfully assimilate a novel vaccine into the immunization program infrastructure of developing nations. Publisher projects the growth in these markets to be slowed by these barriers relative to novel vaccine adoption in the developed markets.

- Domestically-supplied vaccines — most notably, the Butantan Institute’s TV-003 in Brazil and Panacea Biotech’s/Biological E’s TV-003 in India — will stymie market growth due to their low cost relative to vaccines produced by privately-held foreign companies.

- The failure of current disease surveillance programs and vector control programs in developing nations may slow growth in the dengue vaccines marketplace, as key opinion leaders (KOLs) view the integration of vaccines into a holistic prevention program as the most promising approach to dengue control.

From a Barren to Competitive Market: Vaccine Developers Will Need to Leverage Innovative R&D Strategies to Differentiate Themselves from Their Rivals

Over the last several years, much progress has been made towards the development of safe and effective dengue vaccines. As of May 2014, six investigational vaccines were being studied in humans, and the leader of these pipeline candidates, Sanofi Pasteur’s CYD-TDV, is currently undergoing Phase III efficacy and safety studies. The desire to bring the first dengue vaccines to market has led companies to utilize a variety of different research and development (R&D) strategies, which include diverse approaches to antigen construction, vaccine formulation, and clinical trial design. Since 2008, Big Pharma has demonstrated its desire to penetrate this untapped market, increasing its stake in the marketplace through partnerships, licensing deals, and acquisitions. However, as the dengue vaccine marketplace becomes increasingly crowded over the forecast period (2015-2020), Publisher anticipates that firms will turn to innovative R&D strategies, in particular, the exploration of alternative approaches to early-stage clinical trial design, such as the dengue human infection model (DHIM), in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over their rivals.

High Unmet Need for Safe and Efficacious Dengue Vaccines Expected to Facilitate Rapid Uptake of Pipeline Agents

Publisher classifies the overall level of unmet need in the global dengue vaccines marketplace as high. As the morbidity and mortality associated with dengue continue to climb, KOLs agree that the absence of a safe and efficacious dengue vaccine represents the greatest unmet need across the five markets covered in this report: Brazil, India, Mexico, Singapore, and Thailand. The failure of vector control to limit the spread of the virus’ mosquito vectors has further boosted the importance of vaccines as an additional disease prevention tool. Publisher expects that the high level of unmet need in the marketplace will lead to the rapid incorporation of live-attenuated dengue vaccines into routine childhood immunization programs, with Brazil, Mexico, Singapore, and Thailand quickly achieving ≥90% coverage rates within the projected target age cohort of two years by 2017. Slowed by poor disease surveillance and a weak immunization program infrastructure relative to the other four markets, Publisher projects India to more gradually incorporate novel dengue vaccines into its childhood vaccination schedule, with coverage rates only topping 60% by 2020.

Opportunities for Current and Future Players to Exploit Gaps in the Treatment Landscape Will Exist Throughout the Forecast Period and Beyond

While Publisher expects several dengue vaccines with solid clinical profiles, led by Sanofi Pasteur’s CYD-TDV and Takeda’s DENVax, to receive licensure during the forecast period, opportunities will still exist for later entrants to compete with these first-in-class products. Experts revealed to Publisher that vaccine developers should focus their efforts on evaluating more convenient vaccine dosing schedules, gaining an improved understanding of dengue immunity, identifying more robust immunological correlates of protection, exploring novel approaches to clinical trial design, and improving animal models in order to best position their respective pipeline products.

From a commercial perspective, Publisher contends that companies must prioritize engaging healthcare policymakers and other stakeholders in order to expedite the launch of new dengue vaccines. Historically, vaccine launches in the developing world have taken several years, so early planning is essential for the rapid adoption of new dengue vaccines. Dengue vaccine developers must adopt a country-specific approach to planning for vaccine adoption, as this strategy represents an attractive opportunity for positioning a vaccine for rapid adoption in multiple countries once it receives regulatory approval. KOLs also indicated that one of the most important issues that must be addressed pre-launch is vaccine pricing, a factor that will heavily influence the rate and extent of uptake in low- and middle-income nations. Developers will also need to consider that healthcare policymakers will take into account how vector control and disease surveillance spending will influence a country’s ability to afford mass dengue immunization programs.

Live-Attenuated Vaccines, Led by Sanofi’s CYD-TDV, are Expected to Dominate the Dengue Vaccine Marketplace from 2015-2020

While the dengue vaccine pipeline possesses a high level of diversity in terms of vaccine class and technological approach, Publisher expects the live-attenuated vaccines, which include Sanofi Pasteur’s CTD-TDV, Takeda’s DENVax, and the US National Institute of Health’s (NIH’s) TV-003 (licensed to the Butantan Institute in Brazil and Panacea Biotech/Biological E in India), to rule the marketplace for the duration of the forecast period. Despite lingering questions regarding their safety and ability to provide balanced short- and long-term protection against the four dengue virus (DENV) serotypes, KOLs interviewed by Publisher cited live-attenuation as the most promising technological approach to dengue vaccine R&D. While the other vaccine classes in clinical development — inactivated virus, subunit, and deoxyribonucleic acid (DNA) vaccines — may theoretically minimize the chance of viral interference and could be perceived as safer by patients, KOLs overwhelmingly viewed them as inferior to live-attenuated vaccines and cited their need for adjuvants and late arrival to the marketplace as key weaknesses. Publisher projects live-attenuated dengue vaccines to account for over $395m in sales by 2020, with a CAGR of 41.5% from 2015-2020.

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Critical Care Market to Reach $2.5 Billion in the Major Developed Markets by 2020, Reveals New Report

The critical care market in the eight major developed markets (the US, UK, France, Germany, Italy, Spain, Japan and Canada) was worth an estimated $1.8 billion in 2013 and is expected to grow to $2.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 4.7%. The majority of this revenue was due to albumin sales which amounted to $1.1 billion in 2013 and are expected to grow to $1.6 billion by 2020. In terms of markets, the US held the largest share with 41% of the total critical care market in 2013 and is projected to grow at the highest rate of any market at 7.5% during the 2013–2020 period.

Albumin was used to treat the highest share of the critical care treatment population across all eight markets with 2.2 million patients of a total of 2.4 million in 2013. Expectedly, the highest share of these patients was in the US, a total of 46% in 2013. A further 39.3% of the 2013 treatment population were located in the top five countries of Europe, followed by Japan with 9.5% and rest from Canada. The treatment population in the US is estimated to grow at a CAGR of 0.9% until 2020 with highest growth expected in the number of patients treated with Prothrombin Complex Concentrate (PCC) which is expected to grow at a CAGR of 2%. Globally, the treatment population receiving Anti-Thrombin (AT) concentrates and PCCs is expected to be larger than any other category and will grow at a CAGR of 1.5% during the 2013–2020 period.

The projected high growth rate of revenues in the US market of 7.5% is mainly due the increased uptake of factor concentrates over older alternatives (such as Fresh-Frozen Plasma (FFP)), higher price inflation and the launch of new drugs such as Kcentra (PPC, human) and Tretten (Factor XIII concentrate, recombinant) in 2013. Kcentra is the first four-factor PCC in the US and Tretten is the first recombinant factor XIII concentrate. In the top five European critical care markets there have been no recent significant product launches and none are expected during the forecast period. These markets are therefore anticipated to grow slowly during the forecast period, the UK market will grow at a CAGR of 3.0%, followed by France at 2.5%, Germany and Spain will each grow at 2.3% and Italy at 2.0%.

Increased Uptake of Four-Factor Prothombin Complex Concentrates in the US will Boost Growth

Although four-factor PCCs have been available in the European Union (EU) since 1996 , Kcentra became the first four-factor PCC to be approved in the US in 2013. Kcentra is a non-activated four-factor PCC which contains the vitamin K-dependent coagulation factors II, VII, IX, and X and antithrombotic proteins C and S. It is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g. warfarin) therapy. In the US 35–40 million prescriptions of warfarin are dispensed each year and the incidence of fatal bleeding in patients on this treatment is 1–3%. Kcentra is already available in other markets such as Europe and Australia under the brand names Beriplex and/or Confidex and was first approved in Europe in 2008. Kcentra has been awarded new technology add-on payment status by the Centers for Medicare and Medicaid Services which grants additional reimbursement for inpatient costs under Medicare. Another four-factor PCC from Octapharma is in late-stage development in the US and is expected to be launched in late 2014 which will present another four-factor PCC option for clinicians. As the US has a large patient pool and a higher cost of therapy than other markets, the launch of these new four-factor PCCs is expected to give a tremendous boost to the PCC market during the forecast period.

Recombinant Factor Concentrates to Witness Strong Uptake

The use of factor concentrates is relatively recent in the US where vitamin K, FFP or cryoprecipitate were the traditionally preferred options in most critical care settings covered in this report. For example, although off-label use of three-factor PCCs and recombinant Factor (F) VII is prevalent, vitamin K and plasma were the recommended options for vitamin K antagonist reversal in the US. With the recent approval of several new factor concentrates in the US, the critical care market landscape is expected to change drastically. For congenital factor deficiencies, availability of more concentrated forms of the required factors in factor concentrates is much more efficacious and less risky than FFP treatment as factor concentrates are subjected to a viral inactivation process. However, recent recombinant products present a much better safety profile as they are not blood- or plasma-derived products and therefore completely avoid any related risks. While factor concentrates are established treatments in the EU, recombinant products are relatively new. Atryn (AT concentrate, recombinant) and NovoThirteen (or Tretten) are two recombinant products that expected to gain a good share of their respective markets in both the US and EU. Atryn, a recombinant AT concentrate, was approved in the US in 2009 and Tretten, a recombinant FXIII concentrate, in 2013.

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Latest Guidebook for Conducting Pharma Clinical Trials in China - From Regulations to Practice (2014 Edition), New Report Launched

China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an aging population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. By 2013, total value of drugs on Chinese healthcare market has reached RMB 1114 billion. On the Chinese healthcare market, imported drugs made by overseas and multinational pharmaceutical manufacturers account for about one fourth. It is estimated that total value of drugs on Chinese healthcare market will be likely to be more than RMB 1450 billion by 2015, and will surpass Japan to become the second largest drug market following the United States.

The Chinese healthcare market will attract more and more overseas pharmaceutical manufacturers and producers to penetrate such market. Many overseas and multinational pharmaceutical manufacturers are ardently conducting clinical trials for their drugs in China to seize a larger part of such drug market. However, the Chinese approach to GCP compliance is unique, from the application and approval process, the requirements for ethics committees, sponsors and investigators to the application dossiers. To enter such a lucrative drug market, overseas and multinational pharmaceutical manufacturers and producers must have a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introdued the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep drug development lean and agile in the “post-patent-cliff” world step by step.

Target Audience:

• Overseas pharmaceutical companies wishing to enter into the Chinese drug market.
• Multinational pharmaceutical companies have penetrated into the Chinese drug market.
• Companies interested in understanding the latest Chinese laws and regulations for pharmaceutical product clinical trials.
• Senior executive officers engaging in regulatory affairs for imported drugs into Chinese lucrative drug market.
• Senior executive officers engaging in conducting clinical trials for imported drugs in China.

Report Highlights:

• An overview of the Chinese applicable laws and regulations for drug clinical trials.
• An overview of organizational structure of Chinese regulatory authorities for drug clinical trials to give the direction of gateway for clinical trials of imported drugs.
• The Chinese definitions of some basic terms used in application and approval process of drug clinical trials for drug registration, and the Chinese unique classification of drug registration, from the chemical drugs, biological products, natural medicines to traditional Chinese medicines (TCMs).
• Chinese unique every party’s responsibilities in clinical trials for imported drug registration.
• An entire process of application and approval procedures for clinical trials of imported drug registration.
• The full text in English of Drug Registration Application Form for Imported Drug.
• The practical guidance for clinical trials of imported chemical drug registration, from the general and special regulations on clinical trials for imported chemical drug registration, the requirements for data and materials of application for approval of clinical trials for imported chemical drugs to the data and materials submission of application for approval of clinical trials for imported chemical drugs to smoothly navigate complex regulatory requirements step by step.
• The practical guidance for clinical trials of imported biological product registration, also from the general and special regulations on clinical trials for imported biological product registration, the requirements for data and materials of application for approval of clinical trials for imported biological products to the data and materials submission of application for approval of clinical trials for imported biological products to smoothly navigate complex regulatory requirements step by step.
• The practical guidance for clinical trials of imported natural medicine and traditional Chinese medicine registration, again from the general and special regulations on clinical trials for imported natural medicine and traditional Chinese medicine registration, the requirements for data and materials of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to the data and materials submission of application for approval of clinical trials for imported natural medicines and traditional Chinese medicines to smoothly navigate complex regulatory requirements step by step.
• A set of full text in English of Chinese laws and regulations for pharmaceutical product clinical trials.

Spanning Over 191 pages, “Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)” report covering the Chinese Applicable Laws and Regulations for Drug Clinical Trials, An Overview of Chinese Authorities for Drug Clinical Trials, Knowledge Preparation before conducting Imported Drug Clinical Trials, General Regulations on Application and Approval for Clinical Trials of Imported Drug Registration, Every Party’s Responsibilities in Clinical Trials for Imported Drug Registration, Application and Approval Procedures for Clinical Trials of Imported Drug Registration, Application Form for Imported Drug Registration, Practical Guidance for Clinical Trials of Imported Chemical Drug Registration, Practical Guidance for Clinical Trials of Imported Biological Product Registration, Practical Guidance for Clinical Trials of Imported Natural Medicine and Traditional Chinese Medicine Registration, Appendices.

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Botulinum Neurotoxins - A comparative industry analysis of products, pipelines, technologies and stakeholders, New Report Launched

This business report from July 2014 is based on the identification, description and assessment of all relevant stakeholders in the field of botulinum neurotoxins. The report analyzes the existing product portfolios in regulated and less regulated markets, commercial information, and measures to maintain sales and market shares by upside indications and life cycle management measures. The report addresses the new wave of botulinum neurotoxin product candidates in development, such as biosimilars and biosuperior botulinum neurotoxins.

Special emphasis is put in the report on improvements by pharmaceutical technologies, such as liquid protein formulations and transdermal drug delivery technologies. The significance of recombinant DNA technology is discussed regarding botulinum neurotoxin engineering, modification and manufacturing. Chances and challenges for the stakeholders in the botulinum neurotoxin market are evaluated.

The market for botulinum neurotoxin products has significantly grown over the last years, due to new medical indications developed and due to more cosmetic procedures performed with botulinum neurotoxins in ageing societies in which physical appearance is highly valued. Although the botulinum neurotoxin market commercially is dominated by only one company, existing competitors, new players and technologies are setting the ground for biosuperiors as well as for biosimilars. As biosimilar botulinum toxins will put the price of first generation products under pressure, only innovation can justify higher prices.

Benefits from the report:

• Identify established and emerging players in the field
• Find out which enabling technologies are attractive for the next generation
• Understanding the driving forces for the future of the botulinum neurotoxin market
• Learn the key success factors in marketing new botulinum neurotoxin products
• Recognize the challenges acting on established stakeholders
• Learn which technologies and product candidates are attractive for partnering

Spanning over 169 pages,“Botulinum Neurotoxins: A comparative industry analysis of products, pipelines, technologies and stakeholders” report covering the Executive Summary, Overview, Botulinum Neurotoxin Products Available in Regulated Markets, BoNTs in Less Regulated Markets, Biosimilar Botulinum Neurotoxin, Biosuperior, Next Generation Botulinum Neurotoxins, Botulinum Neurotoxin Market Stakeholders and Enabling Technologies, Botulinum Neurotoxin Company Profiles, References, Competitor Analysis Tables. The report covered few companies are - Allergan, Alphaeon, Anterios, CROMA Pharma, Daewoong Pharmaceutical Co, Eisai, Escape Therapeutics, Galderma, Hugel, Ipsen

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Cystic Fibrosis - Opportunity Analysis and Forecasts to 2018 - Event-Driven Update, New Report Launched

This report has been updated due to Cystic Fibrosis (CF) entering an exciting phase with:

• The June 24, 2014 announcement of positive Phase III clinical trial data for Vertex’s lumacaftor in combination with Kalydeco (ivacaftor) in patients with CF who have two copies of the F508del mutation.
• The label expansion of Vertex’s Kalydeco for the treatment of CF patients with eight additional gating mutations in the CFTR gene in February 2014 in the US, and in June 2014 in the EU.
• The June 30, 2014 announcement of the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for the approval of Vertex’s Kalydeco in patients with CF ages 18 years and older who have the R117H mutation in the CFTR gene.

Rapid Growth in the CF Market

Publisher estimates the 2012 sales for CF to be approximately $1.2 billion across the six markets covered in this forecast: the US, France, Germany, Italy, Spain and the UK. By the end of the forecast period, sales will grow to approximately $5.3 billion, with a CAGR of 28.96%. The majority of sales  will come from the US, which will represent 60% of the market by 2018.

Reasons to buy

• Epidemiology, etiology, pathophysiology, symptoms and current treatment options
• Annualized market revenue, annual cost of therapies and forecasts for five years to 2018
• Strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design and implications for the CF therapeutics market
• Pipeline analysis: comprehensive data split across different phases, emerging trends and mechanisms of action under development, including inhaled antibiotics, CFTR modulators and pancreatic enzyme products
• Analysis of the current and future market competition in the US and five major EU CF therapeutics market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies. Insightful review of the key industry drivers, restraints and challenges
• Key countries covered: the US, France, Germany, Italy, Spain and the UK.

Spanning over 149 pages, “OpportunityAnalyzer: Cystic Fibrosis - Opportunity Analysis and Forecasts to 2018 - Event-Driven Update” report covering the Disease Overview, Epidemiology, Current Treatment Option, Unmet Needs Assessment and Oppportunity Analysis, R&D Strategies, Pipeline Assessment, Pipeline Valuation Analysis, Appendix.

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AndroScience's ASC-J9 to Renew Hope for More Disease-Modifying Therapies that can further Challenge the Established Acne Landscape, Reveals New Report

There is considerable excitement around the potential of AndroScience's ASC-J9 in the acne market. ASC-J9 not only represents a novel mechanism of action, but also its entry to the market will be a much-needed addition to a stagnant market. ASC-J9 functions to target the principal hormone receptor associated with acne, the androgen receptor, a cause of acne in both men and women.

In addition to use in female patients with moderate to severe acne, ASC-J9 will allow penetration into the male acne market, something not achieved with currently available hormonal treatments. Furthermore, due to its topical formulation, systemic side effects are likely to be reduced, if not  altogether ameliorated. When compared with isotretinoin, the current standard for patients with severe acne, ASC-J9 has a better safety profile and is not teratogenic, which poses a major barrier for isotretinoin. ASC-J9 is expected to become a major product for the treatment of patients with severe acne and is forecast to experience rapid uptake.

A competitive assessment of AndroScience's ASC-J9 and Photocure's Visonac is provided in the Figure below.

Key Questions Answered

• How will the US and 5EU acne markets evolve over the forecast period from 2012 to 2018 in terms of sales and patient numbers?
• How will the launch of late-stage pipeline therapies such as ASC-J9 and Visonac shape the future treatment landscape?
• How do the clinical and commercial attributes of late-stage pipeline therapies compare to one another and against existing treatment options?
• Why has there been a void of R&D interest from Big Pharma in this highly populated dermatology indication?
• What are the remaining unmet needs and opportunities for drug developers within the acne space?

Spanning over 177 pages, “OpportunityAnalyzer: Acne Vulgaris - Opportunity Analysis and Forecasts to 2018” report covering the Disease Overview, Epidemiology, Current Treatment Options, Unmet Needs Assessment and Opportunity Analysis, R&D Strategies, Pipeline Assessment, Pipeline Valuation Analysis, Appendix.

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Serbia Pharmaceuticals and Healthcare Report Q3 2014, New Report Launched

The new Serbian government is actively trying to stabilise the country's fiscal position through cutting spending, encouraging outside investment and demand pickup for Serbian exports in order to reduce its debt burden. However, pharmaceutical spending is also a target for cuts. Local drug makers are set to feel the worst of these new measures as they cannot compete on cost compared to larger players in the market. The Serbian government has amended the Medicines Act with the specific aim of considerably lowering drug prices, and therefore reducing the liabilities of the National Health Insurance Fund (RFZO). Serbia's pharmaceutical spending growth will remain depressed for the next two to three years. Overall, Serbia's pharmaceutical market's high price-sensitivity will constrain the market's short-term potential, although we are optimistic towards the market's long-term growth prospects.

Headline Expenditure Projections

• Pharmaceuticals: RSD90.46bn (USD1.05bn) in 2013 to RSD97.00bn (USD1.06bn) in 2014; +7.2% in local currency terms and +1.2% in US dollar terms.
• Healthcare: RSD389.82bn (USD4.53bn) in 2013 to RSD412.61bn (USD4.53bn) in 2014; +5.8% in local currency terms and -0.1% in US dollar terms.

Spanning over 132 pages, “Serbia Pharmaceuticals and Healthcare Report Q3 2014” report covering the Industry Forecast, Market Overview, Company Profile and Methodology.

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Diagnostic X-ray Imaging - APAC Analysis and Market Forecasts, New Report Launched

An early diagnosis of disease is the foundation for increasing survival rates. Diagnostic X-ray imaging is the most widely used technique to achieve early detection and clinical assessment of adult and pediatric patients alike, making it a cornerstone of disease control. This report provides an analysis of the diagnostic X-ray imaging market in the US, the 5EU (France, Germany, Italy, Spain, and the UK), and some of the Asia-Pacific (APAC) regions (Australia, China, India, and Japan), and identifies the unmet needs in this diagnostic X-ray systems market. This report also discusses physician attitudes towards the utilization and perception of different types of X-ray imaging techniques, and the future of diagnostic X-ray imaging in the face of rapid technological advancements and other advanced imaging modalities.

According to Publisher’s estimates, GE Healthcare, Siemens, and Philips together accounted for over 40% of the market share within the APAC diagnostic X-ray imaging market in 2012. This is mainly attributed to these companies’ geographical and product portfolio diversity. They are all a part of large conglomerates with robust financial resources to invest in inorganic growth and R&D; therefore, these players have a significant market share.

Scope

• An overview of Diagnostic X-Ray Imaging, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
• Annualized APAC Diagnostic X-Ray Imaging market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020.
• Investigation of current and future market competition for Diagnostic X-Ray Imaging.
• Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
• Competitor assessment including device approval analysis and device sales forecasts.
• Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
• Analysis of unmet needs within the market and opportunities for future players.
• Technology trends evaluation to assess strength of pipeline.
• An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
• Company profiles including business description, financial overview and SWOT analysis.
• Coverage of key market players.
• Strategic assessment of the Diagnostic X-Ray Imaging sector through market impact analysis, future market scenario and company analysis.
• Direct quotes from Key Opinion Leaders (KOL) as well as doctors.

Reasons to buy

• Understand the trends shaping and driving the APAC Diagnostic X-Ray Imaging market.
• Realize device preferences of physicians who have performed the tests already.
• Access market sizing, forecasts and quantified growth opportunities in APAC Diagnostic X-Ray Imaging market through 2018.
• Quantify candidate patient populations to better design product pricing & launch plans.
• Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
• Perform benchmarking analysis of growth opportunities against currently marketed products.
• Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
• Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
• Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
• Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
• What’s the next big thing in APAC Diagnostic X-Ray Imaging market landscape? Identify, understand and capitalize.

Spanning over 209 pages, “MediPoint: Diagnostic X-ray Imaging - APAC Analysis and Market Forecasts” report covering the Industry Overview, Unmet Needs Analysis, Market Opportunity Analysis, Market Drivers and Barriers, Competitive Assessment, Pipeline Assessment, Current and Future Players, Market Outlook, Appendix. The report covered companies are - Agfa Healthcare, Allengers Medical Systems, Canon, Carestream Health, China Resources Wandong Medical Equipment, Fujifilm Holdings, GE Healthcare, General Medical Merate, Hitachi Medical, Konica Minolta, Mindray Medical International, Neusoft Medical, Philip.

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North America Duodenoscopes Market Outlook to 2020, New Report Launched

North America Duodenoscopes Market Outlook to 2020, provides key market data on the North America Duodenoscopes market. The report provides value, in millions of US dollars, volume (in units) and average prices (in US dollars) within market segments - Flexible Video Duodenoscopes and Flexible Non-Video (Fibre) Duodenoscopes.

The report also provides company shares and distribution shares data for each of these market categories, and global corporate-level profiles of the key market participants, pipeline products, and news and deals related to the Duodenoscopes market wherever available.

The data in the report is derived from dynamic market forecast models. Publisher uses epidemiology and capital equipment-based models to estimate and forecast the market size. The objective is to provide information that represents the most up-to-date data of the industry possible.

The epidemiology-based forecasting model makes use of epidemiology data gathered from research publications and primary interviews with physicians to establish the target patient population and treatment flow patterns for individual diseases and therapies. Using prevalence and incidence data and diagnosed and treated population, the epidemiology-based forecasting model arrives at the final numbers.

Capital equipment-based forecasting models are done based on the installed base, replacements and new sales of a specific device/equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. Data for average number of units per facility is used to arrive at the installed base of the capital equipment. Sales for a particular year are arrived at by calculating the replacement units and new units (additional and first-time purchases).

Extensive interviews are conducted with key opinion leaders (KOLs), physicians and industry experts to validate the market size, company share and distribution share data and analysis.

Scope

• Market size data for Duodenoscopes market segments - Flexible Video Duodenoscopes and Flexible Non-Video (Fibre) Duodenoscopes.
• Annualized market revenues (USD million), volume (units) and average prices (in US dollars) data for each of the market segments. Data is provided from 2005 to 2013 and forecast to 2020.
• 2013 company shares and distribution shares data for Duodenoscopes market.
• Global corporate-level profiles of key companies operating within the North America Duodenoscopes market.
• Key players covered include Olympus Corporation, Hoya Corporation, Fujifilm Holdings Corporation and KARL STORZ GmbH & Co. KG.

Reasons to buy

• Develop business strategies by identifying the key market categories and segments poised for strong growth in the future.
• Develop market-entry and market expansion strategies.
• Design competition strategies by identifying who-stands-where in the market.
• Develop investment strategies by identifying the key market segments expected to register strong growth in the near future.
• What are the key distribution channels and what’s the most preferred mode of product distribution - Identify, understand and capitalize.

Spanning over 67 pages, “North America Duodenoscopes Market Outlook to 2020” report covering the Duodenoscopes Market, North America, Duodenoscopes Market, Canada, Duodenoscopes Market, Mexico, Duodenoscopes Market, United States, Overview of Key Companies in North America Duodenoscopes Market, Appendix. Ther report covered 4 companies - Olympus Corporation, PENTAX Medical Company, Fujifilm Holdings Corporation, KARL STORZ GmbH & Co. KG

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