Fastest Growing Pharmaceutical Classes Today and Beyond

Top 10 Pharmaceutical Segments

With the increasing prevalence of different health conditions requiring expensive lifelong treatment, the global sales of therapeutics have been expected to skyrocket in the coming years. In the year 2015, pharmaceutical spending in the United States has reached 1 112.2 USD per capita. This covers expenditures on both prescription medicines as well as self-medication or over-the-counter products.

According to a report published by IMS Institute for Healthcare Informatics, therapeutic classes with the highest level of spending account for 42%  of the total pharmaceutical spending. These include treatment for chronic conditions such as cancer, diabetes, and asthma/COPD. Moreover, among these top classes, seven of which are specialty medicines known to have novel mechanisms and improved efficacy that represent the latest innovation in global medicine. Furthermore, global brand spending is also predicted to increase from $596B in 2011 to $615-645B in 2016. On the other hand, global generic spending is expected to increase from $242B to $400-430B by 2016.

The figure below conveys the top 10 therapy areas that account for a huge percentage of the total global pharmaceutical spending.

top-10-therapeutic-classes-with-highest-spending

  1. Oncologics ($83 – 88 B)

In 2014, Rituxan developed by the pharmaceutical company, Roche, was ranked as the top-selling cancer drug that generated total sales of $7546M. By the year 2020, Roche will concede long-running possession of the biggest selling oncology brand. It was predicted that Celgene’s Revlimid will take the top spot with $10110M in total sales.

  1. Antidiabetics ($48 – 53 B)

Based on the 2015 revenue, Lantus and Januvia are some of the top selling anti–diabetic drugs of all time. Though a decline of 10.8% in sales compared to its 2014 revenue, Lantus is still the world’s best-selling insulin brand. It actually generated $6.98B total sales and accounts for 17.2% of Sanofi-Aventis Group’s aggregate net sales in 2015. On the other hand, Merck Sharp & Dohme’s Januvia was the major candidate in the company’s diabetic portfolio that accounted for 64.3% of the company’s revenue from diabetes drugs in 2015.

  1. Asthma/COPD ($44 – 48 B)

Among all respiratory products sold in the United States, GlaxoSmithKline’s Advair Diskus ranked first in the year 2015. Advair Diskus generated a total revenue of $4835M. This was followed by Boehringer Ingelheim’s Spiriva Handihaler which yielded a profit of $3404M.

  1. Autoimmune ($33 – 36 B)

According to American Autoimmune Related Diseases Association (AARDA), autoimmune diseases affect almost 50 million Americans. Thus, global sales of autoimmune disease treatment are expected to rise in the coming years. In fact, in a market study titled “Global Autoimmune Drugs Market 2016-2020”, it was discussed that the market will grow at a compound annual growth rate of 5.57%.

  1. Lipid Regulators ($31 – 34 B)

AstraZeneca’s Crestor was among the top-selling branded drugs in the year 2015. Its total sales reached $6,090,223,570 which ranked 5th among the top 100 brands. Crestor was also considered as the most prescribed branded drug in the United States, which accounted for approximately 21 million prescriptions.

  1. Angiotensin II ($22 – 25 B)

According to the World Health Organization, elevated blood pressure is estimated to cause 7.5 million deaths, about 12.8% of the total of all deaths. This accounts for 57 million disability-adjusted life years (DALYS) or 3.7% of total DALYS. Hence, interventions to manage such condition have been widely available in order to minimize the risk of developing serious health complications such as coronary heart disease.

  1. HIV Antivirals ($22 – 25 B)

HIV remains one of the major challenges in public health, particularly in low- and middle-income countries. Advancement in technology has led to the development of therapeutic drugs to improve the quality and prolong the lives of HIV patients. In fact, out of 36.7 million HIV patients, 46% of them have access to antiretroviral therapy (ART).

  1. Antipsychotics ($22 – 25 B)

In a report published by the National Alliance on Mental Illness (NAMI), approximately 1 in 25 adults in the U.S. experiences a serious mental illness in a given year that substantially interferes with or limits one or more major life activities. However, not all patients have access to proper and adequate treatment, which may eventually lead to the development of chronic medical conditions. Aside from this, another problem that may arise as a consequence of this issue is its negative impact on the economy. In fact, serious mental illness costs America $193.2 billion in lost earnings per year.

  1. Vaccines ($19 -22 B)

Through the goal of providing health for all, immunization programs conducted in different parts of the world have boosted the sales of vaccines. Considering the estimated profit in the year 2015 and the projected revenue in the year 2022, Pfizer and Daewoong’s Prevnar 13 bagged the top spot. This was followed by Merck & Co.’s Gardasil, Sanofi’s Fluxone / Vaxigrip and Pentacel, and lastly, GlaxoSmithKline’s Pediarix.

  1. Immunostimulants ($16 – 18 B)

Immunostimulants are divided into two categories: specific and nonspecific. Specific immunostimulants stimulate an immune response to specific antigenic types, while nonspecific immunostimulants do not have antigenic specificity and are widely used in chronic infections, immunodeficiency, autoimmunity and neoplastic diseases. One of the most commonly prescribed immunostimulants is Provenge, a registered trademark of Dendreon Corporation.

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World’s Top 15 Biotech Companies 2016

Top 15 biotech companies 2016 - Igeahub.com - Luca Dezzani

Top 15 biotech companies 2016 - Igeahub.com - Luca Dezzani

The global biotechnology market was estimated to be USD 330.3 billion in 2015. The market is growing and the top-15 biotechnology players account for a market share of ~33% in 2015. These organizations are primarily located in U.S. and Europe. A comparative analysis of the top 15 biotechnology players was devised to develop a ranking for these organizations. The model incorporated eight criteria including revenue, revenue growth, operating expense ratio, income per share, R&D by sales ratio, income per employee, market cap and asset turnover ratio. Statistical scoring was conducted based on these criteria to arrive at the final score based on which ranks were developed.

Analysis of top-15 biotechnology companies:

tableSources: SEC filings, annual reports, Genetic Engineering & Biotechnology News and Forbes Media.

  1. Gilead Sciences Inc. (U.S.)

Gilead is the top-ranked company in this list. The organization had highest revenues of USD 32,639 million in 2015. Income per share and income per employee is one of the highest for the company. Gilead also tops the market cap list in 2015. The operating expense ratio of the company is one of the lowest in 2015. The company manufactures research-based biopharmaceuticals with focus on human immunodeficiency virus (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, oncology and inflammation, and serious cardiovascular and respiratory conditions.

  1. Celgene Corp. (U.S.)

Celgene ranks second in the list owing to its large revenue and high market cap. Another significant reason is the allocation of the high R&D budget in 2015. The company is engaged in the discovery, development and commercialization of therapies and treatment of cancer and inflammatory diseases through gene and protein regulation.

  1. Biogen Inc. (U.S.)

Biogen is the one of the largest company in terms of revenue and income per share in 2015. The company had asset turnover ratio of 55.20% in 2015. Biogen develops, markets and manufactures therapies for neurological, autoimmune and hematologic disorders.

  1. Amgen Inc. (U.S.)

Amgen accounts for the second-largest revenue share of USD 21,662 million in 2015. The company’s income per share value was USD 9.15 in 2015. Amgen had one of the highest asset per share value in 2015. The primarily focus of the company is human therapeutics based on cellular and molecular biology.

  1. Regeneron Pharmaceuticals, Inc. (U.S.)

The revenue growth from 2014 to 2015 was 45.5% for Regeneron in 2015. The company also had one of the highest asset turnovers in 2015. The company is active in biopharmaceutical products marketing for eye diseases, colorectal cancer and a rare inflammatory conditions.

  1. Shire, Plc (U.S.)

Shire had revenue of USD 6,416.70 million in 2015. The company had one of the lowest revenue growth of 6.5% from 2014 to 2015. The operating expense ratio was among the highest for the company calculated at 77.8%. The company focuses on therapies for rare diseases.

  1. CSL Ltd. (Australia)

Australia-based company, CSL Ltd. accounts for one of the lowest operating expenses ratio at 27.98%. The asset turnover ratio of the company is the highest in 2015 and stands at 81.72%. The company develops, manufactures and markets vaccines, in vitro diagnostic products and plasma protein biotherapies.

  1. Novozyme (Denmark)

Novozyme is a Denmark based company and accounted for 95.1% of research and development to sales ratio in 2015. The company had one of the lowest income per employee in 2015. The company develops and produces industrial enzymes, microorganisms, and biopharmaceutical ingredients.

  1. Vertex Pharmaceuticals Inc. (U.S.)

Vertex’s revenue for 2015 was one of the lowest but the company tops the list in revenue growth from 2014 to 2015 at 77.86%. The company had highest operating expense ratio at 145% resulting in low revenues. Furthermore, the company accounted for the highest R&D expenditure to sales ratio in 2015, measured at 96%. Vertex develops clinical development programs focused on cystic fibrosis, and has more than dozen ongoing research programs aimed life-threatening diseases.

  1. Alexion Pharmaceuticals Inc. (U.S.)

The revenue for Alexion was USD 2,604.05 million in 2015. The company has lowest asset turnover ratio and one of the lowest income per share in 2015. The company had developed therapies for treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome and aims to develop enzyme replacement therapies for rare disorders.

  1. Illumina, Inc. (U.S.)

Illumina’s revenues in 2015 were valued at USD 2,219.76 million. The company had one of the lowest expense ratio amongst others in 2015. Illumina develops, manufactures and markets systems for the analysis of genetic variation and function. It also provides sequencing and array-based solutions for genetic analysis, genotyping and whole-genome sequencing services.

  1. Grifols International, S.A. (Spain)

The revenue for the Spanish company was USD 4,167.88 million in 2015. Grifols had the lowest operating expense ratio in 2015, calculated at 24.6%. The company ranks 12th in the list owing to lowest R&D by sales ratio and income per employee in 2015. The company produces a variety of plasma derivatives.

  1. United Therapeutics Corp. (U.S.)

United Therapeutics revenue was USD 1,465.76 million in 2015. The company had the lowest market cap in 2015. The company tops the list in income per employee category valued at USD 9.16 million. The company in engaged in development and commercialization of cardiovascular and infectious diseases and cancer treatment products.

  1. BioMarin Pharmaceutical Inc. (U.S.)

BioMarine accounts for the lowest revenues and income (loss) per share value at USD 889.90 million and USD -1.07 in 2015. The company has one of the highest operating expense and lowest asset turnover ratios on 2015. BioMarine commercializes and produce therapies for mucopolysaccharidosis type I (MPS I) and phenylketonuria.

  1. Agilent Technologies (U.S.)

Agilent Technologies ranks lowest in the list owing to decline in revenue growth rate from 2014 to 2015. The company also had one of the lowest research and development budgets in 2015. Agilent is active in life sciences and diagnostics research in the field of cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, and autism amongst others.

The World’s Most Reputable Pharmaceutical Companies 2016

World's 12 Most Reputable Pharmaceutical - Igeahub.com - Luca Dezzani

Customers’ satisfaction is immensely important for the pharmaceutical companies. When these companies focus on innovation and act responsibly, they gain the required trust from the customers all over the world. Based on how good people feel about big pharma, a ranking has been published by the Reputation Institute (RI). Based on the ranking, we have chosen the following top 10 pharmaceutical companies:

World's 12 Most Reputable Pharmaceutical - Igeahub.com - Luca Dezzani

  1. Bayer

Bayer is a German pharmaceutical and life science company which is headquartered in the city of Leverkusen. The company was founded in 1873. The pharmaceutical division of the company focuses on prescription drugs for women’s healthcare and cardiology. It also concentrates on specialty therapeutics in the areas of hematology, oncology, and ophthalmology. Its annual revenue in 2015 was $52 billion.

  1. Abbott Laboratories

Abbott Laboratories is a global healthcare company headquartered in Illinois, United States. In 2015, its annual revenue was $20.4 billion. The company is trying to help people lead healthier lives by creating breakthrough products in branded generic pharmaceuticals, diagnostics, nutrition, and medical devices. More than 74,000 people work in this company, and it is operating in over 150 countries.

  1. Novo Nordisk

Novo Nordisk is a prominent healthcare company which is headquartered in Denmark. The company has been focusing on diabetes care for the last 90 years. The company is also trying to help people defeat different other serious diseases like haemophilia, obesity, and growth disorders. The company has branches in 75 countries, with 42,600 employees. Its annual revenue was $16.05 billion in 2015.

  1. Roche

Roche was founded in 1896 in Basel, Switzerland. Since then, the company has been actively trying to improve the lives of millions of people globally through innovative medicines and diagnostic tests. It was a pioneer company to deliver personalized healthcare to patients. It is also the global leader in cancer treatment. Around 90,000 people work in this company, which operates in more than 100 countries. In 2015, its annual revenue was $50 billion.

  1. Merck

Merck is one of the largest pharmaceutical companies in the world with a 125-year history. It is currently operating in more than 140 countries, with its headquarter in New Jersey, United States. In 2015, its annual revenue was $39.5 billion. The company is now focusing on diabetes, oncology, vaccines, and animal health.

  1. Sanofi

Sanofi is a global life sciences company with more than 110,000 employees. The company is trying to make a difference in patient’s daily life by transforming scientific innovation into healthcare solutions. The focus areas of the company include oncology, multiple sclerosis, diabetes, cardiovascular diseases, and human vaccines. The company has presence in more than 100 countries. Its annual revenue in 2015 was $40.5 billion.

  1. Allergan

Allergan is a global leader in Growth Pharma which is headquartered in Dublin, Ireland. The company is committed to developing products in the area of gastroenterology, women’s health, urology, central nervous system, medical aesthetics, eye care, and dermatology. The company has commercial operations in 100 countries, and 16,000 people work for this company. Its annual revenue was $18.8 billion in 2015.

  1. AstraZeneca

AstraZeneca is a global biopharmaceutical company headquartered in London, United Kingdom. The innovative medicines of the company are used by millions of patients around the world. Focus areas of the company include cardiovascular and metabolic disease, oncology, respiratory, inflammation and autoimmunity, and neuroscience. Its annual revenue was $24.71 in 2015.

  1. Eli Lilly and Company

Eli Lilly is a renowned pharmaceutical company that has been working with success for the last 140 years. It is headquartered in Indiana, America. Its business areas include oncology, bio-medicines, diabetes, and animal health. Approximately 42,000 people work for this company around the world. Its net income in 2015 was $24 billion.

  1. AbbVie

AbbVie is a global pharmaceutical company based in Illinois, United States. The company develops new drugs in several therapeutic areas, including immunology, liver disease, kidney disease, oncology, neuroscience, and women’s health. With more than 28,000 employees, the company is currently operating over 170 countries. Its annual revenue in 2015 was $22.8 billion.

11. GlaxoSmithCline

GlaxoSmithCline is a British pharmaceutical company with a mission to help people feel better and live longer. The company manufactures innovative medicines, consumer healthcare products, and vaccines. The total turnover of the company in the pharmaceuticals sector was $14.2 billion in 2015. With more than 38,000 employees, the company is currently operating in 52 countries. The focus areas of the company includes oncology, HIV infections, respiratory diseases, and immune-inflammation.

12. Novartis

Novartis is a Switzerland-based global healthcare company. The company mainly focuses on innovative patented medicines, generics and eye care devices. In particular, the company is committed to fulfill the medical needs of people with cancer and related diseases. In 2015, the company achieved the net sales of $49.4 billion. Approximately 118,000 people work for Novartis, and the products of the company are available in over 180 countries.

 

 

Top 10 Pharma Blogs 2016

Top 10 Pharma Blog 2016 - Igeahub.com - Luca Dezzani

Top 10 Pharma Blog 2016 - Igeahub.com - Luca Dezzani

Pharmaceutical industry is renowned for innovation. New drugs are continuously being discovered and marketed around the world. Furthermore, new mergers and acquisitions are happening in the pharmaceutical industry on a regular basis, and new studies are being conducted quite regularly by the pharma companies. Hence, if you want to keep yourself updated with the latest developments in this industry, then you need to follow the top pharma blogs which are informative and helpful. This article will shed some lights on the top 10 pharmaceutical blogs that are must read for every person who is interested in the pharma industry, particularly for every pharma professional. These blogs attract a lot of online traffic per month.

  1. Pharmalot

As one of the most popular pharma blogs, it emphasizes on the drug manufacturers and the new drugs that are continuously coming into the markets. In addition, this blog also covers the new regulations in this industry and also the factors related to the pricing of pharma goods. Ed Silverman, a renowned journalist who is reporting on pharma issues for more than two decades, is the editor of this blog. Ed previously worked in Wall Street Journal.

  1. In the Pipeline

In addition to focusing on the pharma industry in general, this blog primarily focuses on the discovery of new drugs. Well-known chemistry blogger and medicinal chemist Derek Lewe maintains this blog, who possesses rich experience in medicinal chemistry.

  1. Pharma Strategy Blog

This blog is created and maintained by Sally Church, Ph.D., who is an English biochemist with special interests on oncology, immunology, and hematology. This great pharma blog provides readers with insider knowledge about this industry.

  1. Pharma Marketing Blog

The editor and publisher of this blog is John Mack, who is an accomplished blogger and marketing pundit. He is also known to everyone as the ‘pharmaguy’, who started this blog in 2005. He has 26.6K followers in the Twitter. This blog focuses on the important marketing issues of the pharma industry, and has been highly appreciated by MedAdNews, Wall Street Journal, and different other reputable publications.

  1. Pharmagossip

As its name suggests, this blog deals with the gossips of all sorts regarding the pharmaceutical industry. These include which drugs are not being marketed properly, or opinions of experts on the issues related to this industry. Its popularity in Twitter is huge, with 17.7K followers.

  1. In Vivo

If you want the latest information on sales and marketing strategies, business development, policies, and research taking place in biopharmaceutical industry, then you will surely love this blog. This informative blog will keep you informed about what is happening in this industry.

  1. Drug Channels

The Drug Channels blog has been helping its readers have ideas about the drug distribution system and pharmaceutical economics since 2006. This blog covers the dynamic healthcare system by delivering timely analysis and widely regarded opinions, and also helps readers think critically about other viewpoints. This highly admired blog is created by Dr. Adam J. Fein, a renowned expert in pharmaceutical economics and drug delivery system.

  1. Drug Discovery Opinion

In 2008, this informative blog related to the pharmaceutical industry was created. It covers different methodological issues that have considerable implications in the discovery of new drugs, their efficacy, and also their marketing potentials.

  1. PharmExec

This blog is a helpful resource for those who are interested in the technological platforms and promotional techniques related to the pharma industry. It also helps the marketers stay up to date about the new happenings in this industry.

  1. FiercePharma

It covers issues like FDA decisions, big pharma, patents, generic drugs, pharmaceutical marketing, etc.

by Igeahub.com

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References

Biosimilar Products and Its Commercial Potential

Biosimilars - Igeahub.com - Luca Dezzani

The increasing demand for medicines and other biologic products paved the way to the development of methods that can speed up its production in order to meet the needs of its consumers. One of which is the utilization of biosimilar product, which is defined by the U.S. Food and Drug Administration (FDA) as ‘a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product’.

The emergence of biosimilars is known to be in accordance with the Patient Protection and Affordable Care Act (Affordable Care Act) signed by US President Barack Obama on March 23, 2010. This law was promulgated in order to establish an expedited licensure pathway for biological products that exhibited no significant difference, in terms of safety and efficacy, with an existing FDA-licensed biological product (U.S. Food and Drug Administration, 2016).

Pharmaceutical companies venturing on the production of biosimilars have envisioned market opportunities and have found some interesting advantages of this undertaking. By the year 2020, biologics with estimated sales of $100 billion will lose its patent protection. Since the development of an original biological product entails a complex process and expensive costs, several companies tend to produce biosimilars, instead. Biosimilars are thought to have greater chances of making it to the market, therefore less risky than branded biologics. Aside from this, investment in biologics is much higher compared to that of biosimilars with relatively lower probability of success. In fact, as of December 2012, it was estimated that the average cost of research and development (R&D) of new drugs may reach $1.9 billion with only 1/10 probability of commercial success after approximately 13.5 years of R&D (Blackstone & Joseph, 2013).

The following will give us an overview of some of the biosimilars which have been available in the market, according to FDA’s Center for Drug Evaluation and Research (U.S. FDA Center for Drug Evaluation and Research , 2016).

biosimilars Continue reading “Biosimilar Products and Its Commercial Potential”

Top 5 Causes of Drug Price Hike

Drug Price - Igea - Luca Dezzani

Over the years, the consistently rising medical expenditures has been affecting all the stakeholders of the current healthcare landscape around the globe. In fact, according to PricewaterhouseCoopers, the projected  growth rate of medical costs for the year 2017 will remain at 6.5%. Though the rate is the same as this year, it still outpaces the general economic inflation.

One of the top drivers of the skyrocketing health care costs is drug price hike. Given the fact that pharmaceutical companies play the major role in drug pricing, they have to consider all aspects to justify the value of their products. Through this,  they will be able to maintain profitability while ensuring the welfare of a larger patient population. The following will give us an overview of the most common factors that can significantly affect the price of drugs currently available in the market.

drug-price-hike

  1. Narrow competition in the marketplace

Due to a threat to profitability, particularly in the year 2009, many pharmaceutical companies ventured to merger and acquisitions while others decided to leave the industry. Hence, a decrease in the number of competitors gives large manufacturers a strong market power that is further influenced by the Food and Drug Administration’s (FDA’s) slow approval of new entrants into the pharmaceutical industry. This market structure leads to higher prices of drugs and other medical products.

  1. Research and development of new drugs

From idea to market, research and development (R&D) of new drugs entail complex processes. The whole course of R&D is not only long and tedious, but also enormously expensive. Most clinical research and trials involve recruitment of several patients and establishing multiple sites from different parts of the world. Thus, requiring huge budget.  Therefore, once it becomes approved, drug companies raise the price of their products to compensate for the high R&D costs and to sustain its supply in the market.

  1. Aging drugs and niche therapies

Due to very low profitability, some drugs that were approved years ago were dropped by manufacturers in exchange of newly discovered drugs with higher demand. Hence, shortages occur when some firms stop the production. Thus, leading to higher product price.

  1. Raw materials shortage

Raw materials shortage is one of the leading causes of drug shortage. In the marketplace, there may be several drug manufacturers, but few suppliers of raw materials. Multiple companies may import from other countries. However, the international supply chain may not always be reliable as it may face problems related to political issues, trade disputes, unfavorable climate conditions and contamination during transport.

  1. Drug shortage

Aside from raw materials shortage, multiple events may contribute to drug shortage. One of these is unanticipated demand, which occurs when the demand for a specific drug goes beyond the clinical demand predicted by pharmaceutical companies. This usually happens when a new indication of drug was discovered or in case of rapid progression of diseases. However, due to the strict rules governing the development and production of drugs, manufacturers cannot hasten the process to quickly top up the supply of their products in the market. Furthermore, another factor that may lead to drug shortage is manufacturing difficulties. From time to time, pharmaceutical companies may encounter problems related to the process of drug production such as outdated equipment, changes in the drug’s formulation, limited production capacity and quality control issues.

Top 10 Issues in Global Health Pharmaceutical Delivery Supply Chain

From a ‘one-size-fits-all’ approach in disease management, sophistication of hi-tech era paved the way for the development of individualized treatment options, which can cater  to the distinct needs of each patient in order to achieve optimal health outcomes. However, this advancement in the field of pharmacy and biotechnology also entails several challenges in the global health pharmaceutical delivery (GHPD) supply chain, particularly in meeting the demands for new and personalized therapeutics. The following will give us an overview of the top challenges facing GHPD supply chain, according to the study conducted by Privett and Gonsalvez in the year 2014.

ghpd-supply-chain-issues

  1. Lack of Coordination

Coordination is one of the essential factors to achieve a unified and systematic GHPD. Despite several initiatives to achieve such goal, the industry still faces this challenge due to some reasons such as pluralism of global health institutions and the informal alliances on which power in global health rests, as reported by Sridhar and Batiniji in their study titled “Misfinancing Global Health: A Case for Transparency in Disbursements and Decision Making” published in the 2008 issue of Lancet.

  1. Inventory Management

Inventory management in GHPD supply chain involves complex processes which include quantification and replenishment decisions. However, lack of accurate information lead to uncertainty that may bring a negative impact  to inventory management.

  1. Demand Information

Procurement and management decisions significantly rely on demand information that is often lacking, absent or aggregated. Several regions still use paper-based system in recording consumption and demand information. Oftentimes, such essential information is not shared with the higher levels of the supply chain. Hence, only individual health facilities are aware of the actual demands leading to large inaccuracies and poor decision making.

  1. Human Resource Dependency

The lack of qualified individuals to fill the logistics-related positions is being recognized as a threat in GHPD supply chain as it results to heavy workload and ineffective role performance. Aside from this, it also leaves key responsibilities unattended, such as making supply chain calculations and decisions. On the contrary, along with the utilization of accessible and user-friendly IT systems, pressure on HR capacity can be alleviated by hiring individuals with less expertise and training who can work with a dynamic team of responsible and trained people equipped with enough knowledge and skills

  1. Order Management

Decisions related to order management are actually based on demand information or data about the availability of products in the different levels of the supply chain. This means that lack of accurate information would make order management to solely rely on assumptions and experience. As a result, orders may arrive incomplete, inaccurate or delayed, which can negatively affect inventory management and product availability.

  1. Shortage Avoidance

Shortage avoidance may seem to play a vital role in ensuring adequate supply to meet the demands of the consumers, particularly in emergency situations such as in the case of outbreaks and epidemics. However, shortage avoidance may also bring a negative impact to the GHPD supply chain as it entails frequent ordering, frequent replenishment, large buffer stocks, and emergency ordering. The process of procurement cycles can oftentimes result to inefficient planning and inventory. Moreover, some warehouses may not have the capacity to accommodate large inventories, thereby increasing the cost and risk for product expiration. In addition, emergency ordering related to shortage avoidance comes with a greater shipping cost to expedite delivery and interrupts with the flow of other orders placed in the system.

  1. Expiration

Product wastage related to expiration has been one of the major problems in the GHPD supply chain. Such dilemma arises from failure to comply with the First-Expire-First-Out (FEFO) policy and shipment delays related to poor management that can compromise the shelf life of the ordered products.

  1. Warehouse Management

Unfortunately, not all warehouses possess adequate facilities to support large inventories. Some third party logistics may have poor organization and may not have the designated area for different functions such as receiving, shipping and storage for both damaged and expired products. In the long run, such unfavorable conditions may eventually lead to discrepancies in logistics and inaccuracies in inventory management.

  1. Temperature Control

Drug potency is highly affected by environmental conditions, particularly temperature. Hence, failure to provide the right temperature during storage and shipment of pharmaceutical products may lead to a major product wastage. Warehouses may have refrigerated containers or storage rooms. However, monitoring of temperature level may not be ensured making cold chain difficult to maintain. This challenge drives GHPD innovation, leading to the development of cutting-edge technology, such as Vaccine Vial Monitors (VVMs) and FreezeWatchTM tags.

  1. Shipment Visibility

After the manufacturer sends out the product for delivery, it becomes difficult to track its status in each level of the supply chain. Aside from this, the exact date when the products will arrive becomes unknown to both the manufacturer and the recipient.

Top 10 Orphan Drugs and Their Economic Power

Orphan Drugs - Igea - Luca Dezzani

Rare diseases are known to bring significant impact on the quality of life of thousands to millions of people across the globe. Rare diseases are also referred to as orphan diseases because pharmaceutical companies refuse to adopt them to develop treatments. In fact, according to the National Center for Advancing Translational Sciences, there are approximately 7,000 rare diseases affecting around 25 to 30 million Americans. Unfortunately, there is still a long way to go to find solutions to end the suffering because treatment exists for only 200 to 300 orphan diseases and little is known about the cause of most rare diseases.

Yet, pharmaceutical companies oftentimes look at large disease populations as the main focus of their investment and show little interest in developing orphan drugs due to a number of reasons. One of these is that rare diseases only affect a small population, which equates to very low profitability. Furthermore, recruitment of patients for research and development (R&D) is also another challenge because it is difficult to locate patients and may eventually incur additional R&D costs. Fortunately, the industry has shifted its perception. In fact, some pharmaceutical companies are willing to take the risk of developing orphan drugs, which they now consider as potential money makers that can bring big revenue and a promising return on investment.

 Aside from this, to address the unmet treatment needs of various rare diseases, laws such as the Orphan Drugs Act of 1983 in the United States that gives financial incentives, were promulgated in order to encourage companies to venture on developing orphan drugs. Moreover, according to Thomson Reuters, other benefits given to drug companies for the R&D of orphan drugs are tax credits, favorable reimbursement, R&D grants, fewer hurdles to approval, waived FDA fees, longer exclusivity, shorter development timelines, lower marketing costs, greater regulatory success, faster uptake and premium pricing.

Though orphan drugs cater to a small patient pool, the high price of the drugs offsets the aforementioned challenge. In fact, in the year 2010, Soliris, which is known to treat paroxysmal nocturnal hemoglobinuria (PNH) that affects 1 out of 500,000, was actually considered as the industry’s most expensive drug amounting to $409,000 per year of treatment, which generated a total of $541 million revenue for Alexion Pharmaceuticals. In addition, in the year 2014, the top selling orphan drug in the USA in the year 2014 was Rituxan by Roche, a chronic lymphocytic leukemia drug, which yielded to $ 3.646 billion in total sales.

Development of orphan drugs can be one of the biggest breakthroughs in the pharmaceutical industry. It is projected that by the year 2018, the market will reach $127 billion or approximately 16% of the total prescription sales. Aside from the profitability associated with the commercialization of orphan drugs, patients with rare diseases will be given greater chances of surviving and hope as they face the battle against their illness.  The figure below will give us an overview of the top 20 orphan drugs that will have the projected highest revenue in 2018.

Orphan Drugs Infographics

 

 

Approaches to Conquer Global CRA Shortage

CRA Shortage - Igea - Luca Dezzani

In the 2013 CNNMoney survey, Clinical Research Associate (CRA) was rated as one of the top 10 best jobs in America in terms of compensation, job growth, personal satisfaction, benefit to society, flexibility and stress level. However, despite all these, the industry is still facing the dilemma of CRA shortage due to lack of the minimum two-year experience. In fact, in a study conducted in the year 2015, it was found out that there are at least 10,000 open CRA positions in the US. As a result, the pharmaceutical industry can possibly experience cost increase and prolonged drug development timeline, which may eventually lead to a loss of investor confidence and potential revenue. One key to address this concern is the willingness of the industry to embrace change. This may begin by examining their current protocol in hiring CRAs and identifying the barriers that hinder new talents from filling the position.

According to  an article published in the Journal of Clinical Research Best Practices in April 2016, Quintiles, a major provider of biopharmaceutical development and commercial outsourcing services, some of the effective ways to attract a new talent pool is by offering a competitive salary, outlining a distinct career pathway within the organization and utilizing information technology in simplifying procedures to promote better work-life balance.

Aside from this, as suggested by a top-tier Clinical Research Organization (CRO), inVentiv Health, another approach that can possibly help the industry conquer CRA shortage is through talent management which entails investing in a global talent pool, thereby, equipping CRAs with enough knowledge and skills that will enable them to perform their duties and responsibilities independently. The following will give us an overview of the program that will help achieve growth and sharpen the talent of new CRAs.

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  1. In-depth screening of candidates. Educational background and clinical experience may be considered as top priorities in selecting the right candidates. However, managers should look beyond all these and must consider motivation and passion. Mere intellectual capability is not sufficient for this noble calling. Future CRAs should also be prepared to devote their time and effort in finding solutions that will help improve the patients’ quality of life.
  1. Engaging potential applicants in intensive training and simulation exercises. Through this phase of recruitment, applicants will be given background information about the fundamentals of clinical research, pharmaceutical industry, standard operating procedures and guidelines governing their chosen field. On the other hand, after providing them with theoretical background, simulation exercises will be introduced, which will let new recruits utilize the knowledge they obtained in a safe environment before they practice in the actual field.
  1. Providing CRAs with apprenticeship or on-the-job training. Allowing recruits to work alongside with experienced CRAs will give them the opportunity to learn, enhance their skills and demonstrate competence while they are still under close supervision. Through this phase, they will be given resources and support from their supervisor, trainers and class peers who are organized into a buddy system.
  1. Giving CRAs the recognition they deserve. Aside from competitive compensation, CRAs are more likely to stay in their chosen field if employers will give full trust in their leadership and support whenever they need it. Furthermore, providing them with the opportunity for both personal and professional development will encourage them to consider their job as both devotion and passion rather than, merely, a way to earn a living.

Boosting Immunization Coverage to Achieve Health for All

Immunization is known to be one of the most important factors that can significantly impact the overall health status of a particular country. However, due to the current healthcare landscape and certain unfounded dilemma that can possibly affect the health care system, several countries are still facing the challenge of achieving an improved vaccination rate, most especially among children. As a result, many of its residents are still at high risk of acquiring diseases that can be prevented by immunization.

A report  published by the World Health Organization (WHO) last July 15, 2016 can give us an overview of the current immunization status of all regions, including the African, American, Eastern Mediterranean, European, Southeast Asian and Western Pacific regions.

Vaccination Infographics

  1. Eastern Mediterranean Region – 64.9 %

The Eastern Mediterranean region (EMR) has the lowest overall vaccination rate around the globe with 0% coverage for YFV. However, among all its member states, Sudan is the only country in EMR that belongs to the yellow fever zone wherein epidemics are reported in the years 1940, 1959, 2003, 2005, 2012 and 2013. Unfortunately, there is no known cure for YFV. Thus, preventive vaccination and routine child immunization  are currently being reinforced by the region for both its residents and travelers.

  1. African Region – 65.4 %

Using the data published by WHO, the overall vaccination coverage in the African region is considered to be relatively low compared to the other regions across the globe. In fact, among all the vaccines, MCV 2 has the lowest coverage, which equates to only 18% of the target population. Aside from this, three of its member states, Equatorial Guinea, Central African Republic (CAR) and Kenya, ranked lowest in WHO’s global statistics for vaccination coverage by antigen.

Equatorial Guinea is considered as one of the most deprived  countries in terms of health resources. In fact, it has the lowest DTP 1, DTP 3, HepB3, HiB3 and Pol3 Vaccination rate, as reported by WHO. Other than inadequate resources and facilities, training programs for health workers and ineffective information dissemination are also some of the relevant issues that must be promptly addressed.

On the other hand, through WHO’s Health Resources Availability Mapping System (HeRAMS), several aspects of the CAR’s health system were adequately assessed. These include the country’s health facilities as well as availability of health workers. Such assessment gave a full picture of the current health care situation in CAR. In 2013, CAR was categorized as Grade 3, which is equivalent to humanitarian emergency, alongside with South Sudan, Iraq and Syrian Arab Republic. Moreover, the conflict encountered by CAR in March 2014 hindered immunization and other health programs geared towards preventing diseases, increased prevalence of malnutrition and destroyed hospitals and other health facilities. Until now, the country is still facing serious health problems such as malaria, respiratory infections, watery diarrhea and physical trauma.

Furthermore, the National IHR focal point in Kenya notified WHO about two cases of yellow fever that were reported last March 16 – 18, 2016. Both patients were Kenyan nationals who travelled to Luanda, Angola for work. None of them were vaccinated against yellow fever  prior to their departure to Angola. Despite this situation, WHO reported that the risk of transmission is minimal since the density of Aedes aegypti in Nairobi is very low and none of the two cases arrived in viraemic state. Hence, WHO advised to reinforce immunization of travelers going to potentially endemic areas.

  1. Southeast Asian Region – 68.4%

Covering nearly one-fourth of the global population, the Southeast Asian region has been focusing on the improvement of maternal and child health. In May 19, 2016, the whole region was able achieve maternal and neonatal tetanus elimination (MNTE), thereby, reducing the cases to less than one per 1000 live births. According to WHO Southeast-Asia regional director, Dr Poonam Khetrapal Singh, “Persistent efforts and innovative approaches to enhance tetanus vaccination coverage of pregnant women and children, increase skilled birth attendance and promote clean cord practices made MNTE a reality.”

  1. Western Pacific Region – 70.8%

Viral hepatitis is considered a public health threat and its elimination has been envisioned by WHO by the year 2030. As one of the steps to help achieve this goal, the Western Pacific Region has been reinforcing hepatitis B vaccination, which averted 7 million deaths that could have affected children born between 1990 and 2014. Aside from this, with the theme ‘Vaccination is everyone’s job, protect your community. Immunize all throughout life’, the celebration of immunization week last April 18 – May 1, 2016  was able to empower its citizens to protect their communities through vaccination.

  1. European Region – 79.3%

Through the European Vaccine Action Plan 2015–2020 (EVAP) implemented since September 18, 2014, the whole region was able to achieve high vaccination rates to achieve its goals such as maintaining a polio-free status, eliminating measles and rubella, controlling hepatitis B infection, making evidence-based decisions related to the introduction of new vaccines and supporting national immunization programs to reach a greater population.

However, it may be contradicting that Sweden, one of its member states, has the lowest BCG vaccination rate compared to all countries across the globe, with only 24% coverage of its target population. In 1975, Sweden switched to selective BCG vaccination from routine vaccination of newborn infants due to the relatively low incidence of tuberculosis in the country. Aside from immunization, Sweden also focused on intensified active case finding identify the source of infection and eliminate it to prevent transmission of the disease to the vulnerable population.

  1. American Region – 80.9%

In order to achieve and a sustainable and equitable reduction in morbidity and mortality related to diseases preventable by vaccines, the Comprehensive Family Immunization continuously coordinates and establishes partnerships with both public and private sectors and  the international community. In this regard, despite having the lowest vaccination rates for Rota1 and Rotac, Bahamas has been exerting its greatest effort in preventing spread of preventable diseases through immunization. In fact, measles and diphtheria vaccination in the Bahamas have significantly lowered the incidence of infection and death rate among children. However, prevalence of HIV infection is still high, causing 500 deaths in the year 2013. Aside from this, the country also draws its attention in providing immunization to its adult residents in order to prevent diseases such as hepatitis B, yellow fever, diphtheria/ tetanus (DT), and influenza, as well measles, mumps, and rubella.