2020 04 20
New quarterly pharma market review
SoftDent is providing quarter and annual Lithuanian, Latvian, and Estonian pharma markets' secondary sales analysis based on the data collected by PharmaZOOM project.
Summarized Lithuania, Latvia and Estonia pharma market overview reports for 2020 I quarter is already generated with the forecast for 2021
If you would like to buy these pharma market review reports, please contact PharmaZOOM team.
2020 07 14
Data for the period 6-12th 2020 is uploaded to PharmaZOOM LT.
2020 06 15
Data for May 2020 is uploaded to PharmaZOOM LV.
2020 01 16
Extra data source
Information on Procurement Contract Data has been integrated into the PharmaZOOM LT system. Every month together with updated wholesalers sales it will be possible to analyze data of the concluded contracts.
2016 06 29
Additional data source
Every month together with regularly updated wholesalers sales, we will integrate VVKT sales of packages which sales we did not have before. These sales are extrapolated by territories.
Pharmaceutical Market News
2020 07 13
Pharma sales to increasingly rely on virtual platforms due to COVID-19
Virtual tools are being increasingly utilised by pharma companies to replace in-person meetings following the outbreak of the COVID-19 pandemic.
According to researchers at GlobalData, virtual platforms will experience an extra boost after already having a transformational impact on the healthcare landscape, due to the impacts of the COVID-19 coronavirus.
Dr Valentina Gburcik, Senior Director of Cardiovascular and Metabolic Diseases, Gender Health and Digital at GlobalData, commented:
“The shift from in-person to digital is seen in advertising, medical conferences and sales rep meetings with physicians. Virtual health tools are already there enabling companies to have broader engagement with patients and physicians throughout various phases of the patient journey. Sales forces from pharma companies are now using this technology even more to interact virtually with physicians – particularly during the COVID-19 outbreak.”
The COVID-19 pandemic has seen cancellations of clinical events and conferences, as well as a surge of virtual meetings while all face-to-face contacts halt, highlight the researchers.
Gburcik added: “In-person meetings have their own advantages such as people being able to express themselves by using body language and facial expressions that can better convey a message and create a deeper bond with a customer.
The lack of a physical component in human interaction may lead to a weaker influence of reps over respective physicians and therefore reduced drug sales. Nevertheless, the ever-increasing internet speed, with 5G on our doorstep and evolving video conferencing software such as WebEx, Zoom and Skype for Business, will somewhat alleviate these problems.”
However, the researchers emphasise that it remains to be seen whether the current conditions will push humanity further into virtual space with no return to the circumstances seen before the COVID-19 pandemic.
Gburcik concluded: “The pharma sales forces and physicians may get used to the new reality and thus the use of the virtual meetings and tools may get boosted far beyond the pandemic.”
2020 01 02
Key trends studied for diabetes drug development in 2020
Functional links between metabolic, cardiovascular and renal diseases, as well as a focus on digital and a personalised approach will shape diabetes drug development in 2020, says new analysis.
Valentina Gburcik, PhD, Senior Director of Cardiovascular and Metabolic Disorders and researchers from GlobalData have looked at the key trends that will shape the metabolic disorders pharmaceutical space in 2020, focusing on diabetes.
Gburcik says that the diabetes market has long been a lucrative space for drug developers. According to a GlobalData study, 165 million people were diagnosed with type 2 diabetes globally in 2018, a number that is going to increase to 212 million by 2028.
“It comes as no surprise that many major pharmaceutical companies have been investing in this area,” Gburcik said, “leading to an enormous number of marketed branded therapies, as well as a rich pipeline, which is predominantly filled with ‘me-too’ therapies entering a very saturated market.”
According to the researchers, a growing body of scientific evidence is showing interconnectedness between metabolic disorders and cardiovascular and renal diseases and an increasing number of scientists and drug developers are now focusing on understanding the functional links between these diseases to jointly address cardio-renal-metabolic risks, which should eventually lead to better and more holistic treatments.
Gburcik further continued that digital transformation in healthcare, including the use of artificial intelligence (AI) and big data, will be a game-changer to diabetes prevention and management.
“These technologies have the potential to revolutionise the treatment of diabetes by employing continuous remote monitoring of patients’ symptoms, physiological data and environmental factors through the use of wearable tech, sensors and smartphone technologies,” Gburcik said.
Patient centricity and personalised medicine are another rising theme in healthcare, Gburcik said. “Oncology is currently the most advanced field in terms of personalised molecular diagnosis and treatments tailored based on genetics. However, diabetes research is experiencing rapid progress too,” Gburcik explained.
“Although the studies so far have not shed enough light on the genetic contribution to the phenotype of heterogeneous metabolic diseases such as diabetes, big data that is currently being accumulated through the use of digital technology will soon lead to better characterisation of clusters, which may define specific subtypes of the disease, leading to more tailored treatments and better outcomes.”
2019 12 31
Packaging security trends in the pharmaceutical industry
Drug safety is a huge concern for big pharma and tampering and counterfeiting in the market is dangerous for both consumers and brands. In this article, Prakash Shetty shares the latest innovations in packaging design and highlights how tamper proofing and developments in technology can protect all concerned.
THE $20 BILLION pharmaceutical packaging industry is the frontrunner in deploying technology for advanced security through packaging. The rise of e-commerce and efficient logistics have made sophisticated drugs accessible worldwide, irrespective of their manufacturing locations. However, this presents a challenge to protect products throughout their lifecycle and against counterfeiting. Pharmaceutical packaging innovations are important not only for the effectiveness of drugs, but also to ensure authenticity, traceability, product protection and patients’ comfort.
Pharmaceutical products require responsible packaging, especially for life-saving drugs, medical devices and nutraceuticals. The possible threats to these products include misuse and counterfeiting.
The World Health Organization (WHO) reports that about 10 percent of drugs are counterfeited globally. While counterfeiting is a result of human antisocial practices, tampering can occur due to inefficient handling or storage. However, technology and digitilisation can prevent counterfeiting, as well as tampering, to a great extent.
Pharmaceutical packaging – security through technology
Technology can help identify unauthorised access by making tampering evident and also creating a barrier to it. Tamper-proofing solutions ensure product safety during storage and transit. Tamper-resistant packaging relies on two principles: the requirement for multiple layers of protection and making tampering evident in case of unauthorised access or when the package integrity is compromised. Tamper proofing is challenging, as the package requires protection from external intervention. One strategy for tamper proofing that is popular in the pharmaceutical industry involves the following five layers of protection:
Primary closure: This involves securing the lid of the container such that any adjustments made after dispatch are recognizable.
Sealing: The process of making the primary closure permanent against transit pressure
Isolating: Shrink wraps are used to safeguard the sealed container from moisture and other shipments
Identification: Unique identification numbers prevent replication. It also makes the product identifiable in the supply chain.
Secondary packaging: The outer shipping containers that are designed in accordance with the shippers’ guidelines.
Tampering can be made evident through overt security features. Overt technology involves authentication through visual inspection without any expert knowledge. Hologram, colour shift inks and tear tapes are scalable and cost-effective systems for tamper evidence. Consumers can refuse to accept the package or report it if they spot damage.
Holograms: Brands usually use hologram techniques on their logo to indicate authenticity. Wear and tear on the hologram indicates rough handling and/or inappropriate storage.
Colour shift inks: Colour shift inks may appear as two or more distinct colours when shifted to different angles and give an illusional 3D effect.
Tear tapes: These are single-use polypropylene tapes. Consumers can identify tampering if the package lacks sealing tape or the tape is broken. Tear tapes are impossible to remove without destroying, hence making unauthorised access evident.
Tamper-proofing technology combined with covert security features can help in preventing counterfeiting. Covert technology includes infrared (IR) and ultraviolet (UV) pigments, microtext and microscopic tagging, which are invisible through naked eyes. These are difficult to detect and replicate without specialist detection equipment. Security graphics and digital watermarks are the other techniques widely used in pharmaceutical packaging to confront counterfeiting.
Security graphics: Design elements like line modulation and line embossing can produce a fine line colour printing similar to currency printing. Furthermore, microtext and latent images can make replication detectable.
Digital watermarks: Digital watermarking or encoding involves invisible markings within graphics. Special software and readers are available to verify these markers.
Security through digitilisation
Digitilisation refers to the process of converting information into computer-readable format, which is easy to access irrespective of geographical location. The pharmaceutical packaging industry is deploying digital technology to combat counterfeiting and introduce efficient supply chain tracking.
By simply scanning the medicine, anti-counterfeiting apps can tell the consumer whether the drug is fake or authentic. For example, the Drugsafe app, winner of the Big Data award at the 2018 Microsoft Imagine Cup, uses optical character recognition (OCR) to check the medicine’s authenticity in accordance with the Azure Cosmos database.
Digital mass serialisation
Counterfeiting in the pharmaceutical market is dangerous for consumers and brands. While consumers may become victims of poor medicines, brands can lose their credibility. Digital packaging solutions are a saviour, especially in supply chain management. Digital mass serialisation is one of the most common and scalable techniques employed; involving generation of a sequence of pseudo code that enters the consumers’ database for verification at later stages.
Security through product design
Ensuring safety for consumers is another important aspect of pharmaceutical packaging. Sophisticated drugs need careful handling and include age restrictions. Patients can become the victim of taking expired drugs, or children might access medicines that are not meant for them. The following packaging solutions are solving these consumer-centric challenges through design:
Expiry date validation – “A picture speaks a thousand words and a QR code encodes a maximum of 4,296 alphanumeric characters.” A QR code is capable of coding the dose regimen for medicine along with its manufacturing and expiry date. Post consumption, the consumer can rescan the pack, enabling the app to update the regimen and send notifications accordingly.
Childproofing and senior-friendly packaging – Uflex introduced an innovative packaging known as Child Resistant and Senior Friendly (CRSF) foils. These are available in two variants: push-through and peel-push, based on their operating mechanism. While it requires some amount of pressure for a child to open it, the procedure is easy for a senior citizen. This prevents unintentional handling damage to conventional blister foils.
Timely drug dosage – Taking the right medicine in the right dosage is essential. Pill Pack, an Amazon company, took the initiative of coordinating with the patients’ drugs requirement and automatically shipping them refills as required.
Security in pharmaceutical packaging is essential for both consumers’ safety and maintaining a brand’s integrity. Pharma is a sophisticated sector and its investment in secure packaging is essential. With innovations, technology and consumer acceptance, the serious problems of counterfeiting and tampering can be conquered.
2019 05 31
Algae could prevent limb amputation
A new algae-based treatment could reduce the need for amputation in people with critical limb ischaemia, according to new research funded by the British Heart Foundation, published today in the journal npj Regenerative Medicine. Researchers at St Thomas' Hospital and King's College London have made small capsules from brown algae which hold macrophages, a type of white blood cell. Tests in mice have shown that these algae capsules may be able to increase blood flow in the limbs where tissue has been damaged. The researchers now hope to progress this research into human clinical trials to help the people visiting hospital with critical limb ischaemia (CLI). It is estimated that there are up to 60,000 new cases of CLI per year in the UK.
Scientists have been experimenting with cells as a treatment to grow arteries in the leg for years, however, these treatments have not been effective in humans. A big challenge is that many of the cells injected into the injured area die, move away to surrounding areas, or are detected as 'foreign' by the immune system and rejected.
In this study, surgeon Professor Bijan Modarai and his team of scientists delivered the new algae-based capsules containing macrophages to areas of injured muscle tissue in the back legs of mice. Alginate from the cell walls of brown algae, which is mainly found in cold waters in the Northern Hemisphere, was used to form the capsules. They found that these macrophages successfully remained in the injured area, new blood vessels formed, and as a result more blood reached the damaged area.
CLI is a serious condition which occurs when the arteries in the limbs become blocked as a result of a build-up of fatty deposits, reducing blood flow to the hands and feet. Smoking, diabetes, obesity and high blood pressure can all lead to CLI. If blood flow is not restored, up to 50 per cent of people with CLI will either die or need amputation within one year.
Currently, to treat CLI and restore blood flow in the limbs, the blocked section of the artery has to be either bypassed during surgery or widened using a small piece of expandable mesh called a stent. However, in up to a third of patients, these methods will eventually fail or are not possible to begin with and amputation is the only option.
Professor Bijan Modarai therefore hopes that this new way of delivering cells could be the key to creating an effective treatment for people suffering with CLI.
Professor Bijan Modarai, Professor of Vascular Surgery and BHF Senior Fellow at King's College London/St Thomas' Hospital, said:
"We hope that this new method of cell therapy will greatly reduce the need for limb amputations in those people whose CLI is untreatable, and would otherwise have no other option.
"The beauty of this new algae-based treatment is that it harnesses the potential of natural materials. Not only does this make it a very attractive solution, but we know we can use it to safely treat people with CLI."
Professor Metin Avkiran, Associate Medical Director at the British Heart Foundation which funded the research said:
"You might associate algae with your garden pond, but our researchers are proving these diverse organisms could hold the key to a new treatment for one of the leading causes of limb amputation - CLI.
"Losing a limb is an all too devastating reality for many patients with CLI. The condition is caused by blockages in arteries that supply blood to the legs and feet, and is triggered by the same process that blocks coronary arteries when someone has a heart attack.
"This research brings us a step closer to finding treatments for the thousands of people affected by this disabling condition in the UK."
2019 02 15
New pill can deliver insulin
An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 2 diabetes have to give themselves every day. About the size of a blueberry, the capsule contains a small needle made of compressed insulin, which is injected after the capsule reaches the stomach. In tests in animals, the researchers showed that they could deliver enough insulin to lower blood sugar to levels comparable to those produced by injections given through skin. They also demonstrated that the device can be adapted to deliver other protein drugs.
"We are really hopeful that this new type of capsule could someday help diabetic patients and perhaps anyone who requires therapies that can now only be given by injection or infusion," says Robert Langer, the David H. Koch Institute Professor, a member of MIT's Koch Institute for Integrative Cancer Research, and one of the senior authors of the study.
Giovanni Traverso, an assistant professor at Brigham and Women's Hospital, Harvard Medical School, and a visiting scientist in MIT's Department of Mechanical Engineering, where he is starting as a faculty member in 2019, is also a senior author of the study. The first author of the paper, which appears in the February 8 issue of Science, is MIT graduate student Alex Abramson. The research team also includes scientists from the pharmaceutical company Novo Nordisk.
Several years ago, Traverso, Langer, and their colleagues developed a pill coated with many tiny needles that could be used to inject drugs into the lining of the stomach or the small intestine. For the new capsule, the researchers changed the design to have just one needle, allowing them to avoid injecting drugs into the interior of the stomach, where they would be broken down by stomach acids before having any effect.
The tip of the needle is made of nearly 100 percent compressed, freeze-dried insulin, using the same process used to form tablets of medicine. The shaft of the needle, which does not enter the stomach wall, is made from another biodegradable material.
Within the capsule, the needle is attached to a compressed spring that is held in place by a disk made of sugar. When the capsule is swallowed, water in the stomach dissolves the sugar disk, releasing the spring and injecting the needle into the stomach wall.
The stomach wall has no pain receptors, so the researchers believe that patients would not be able to feel the injection. To ensure that the drug is injected into the stomach wall, the researchers designed their system so that no matter how the capsule lands in the stomach, it can orient itself so the needle is in contact with the lining of the stomach.
"As soon as you take it, you want the system to self-right so that you can ensure contact with the tissue," Traverso says.
The researchers drew their inspiration for the self-orientation feature from a tortoise known as the leopard tortoise. This tortoise, which is found in Africa, has a shell with a high, steep dome, allowing it to right itself if it rolls onto its back. The researchers used computer modeling to come up with a variant of this shape for their capsule, which allows it to reorient itself even in the dynamic environment of the stomach.
"What's important is that we have the needle in contact with the tissue when it is injected," Abramson says. "Also, if a person were to move around or the stomach were to growl, the device would not move from its preferred orientation."
Once the tip of the needle is injected into the stomach wall, the insulin dissolves at a rate that can be controlled by the researchers as the capsule is prepared. In this study, it took about an hour for all of the insulin to be fully released into the bloodstream.
Easier for patients
In tests in pigs, the researchers showed that they could successfully deliver up to 300 micrograms of insulin. More recently, they have been able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with type 2 diabetes would need to inject.
After the capsule releases its contents, it can pass harmlessly through the digestive system. The researchers found no adverse effects from the capsule, which is made from biodegradable polymer and stainless steel components.
The MIT team is now continuing to work with Novo Nordisk to further develop the technology and optimize the manufacturing process for the capsules. They believe this type of drug delivery could be useful for any protein drug that normally has to be injected, such as immunosuppressants used to treat rheumatoid arthritis or inflammatory bowel disease. It may also work for nucleic acids such as DNA and RNA.
"Our motivation is to make it easier for patients to take medication, particularly medications that require an injection," Traverso says. "The classic one is insulin, but there are many others."
2018 03 28
Medical expansion has improved health - with one exception
While Americans debate the rising cost of health care, a new study of 30 countries over 27 years found that medical expansion has improved overall health - with one major exception. Researchers found that increased spending on health care and increases in specialized care were both associated with longer life expectancy and less mortality in the countries studied. But pharmaceutical industry expansion was linked to negative health effects.
"This study isn't the first to suggest prescription drugs can pose a health risk. But it is the first to find that the growth of the pharmaceutical industry itself may be associated with worse rather than better health," said Hui Zheng, lead author of the study and associate professor of sociology at The Ohio State University.
"The findings were surprising to us."
Zheng conducted the research with Linda George, professor of sociology at Duke University. Their study is published in the March 2018 issue of the Journal of Health and Social Behavior.
The medical industry has undergone a massive expansion all over the Western world since the mid-20th century, Zheng said. In the United States, health care expenditures as a percentage of the gross domestic product increased from 5.1 percent in 1960 to 17.1 percent in 2014.
But it has been unclear whether this expansion has benefited overall public health.
To help answer this question, the researchers used data from 30 countries, including the United States, that are members of the Organisation for Economic Co-operation and Development. This includes most of the world's affluent democracies.
Zheng and George looked at how different types of medical expansion were related to population health between 1981 and 2007. Specifically, they linked expansion to life expectancy at birth; men's and women's life expectancy at age 65; and all-cause mortality rate.
They controlled for a variety of social, economic and demographic variables that also might account for relationships between medical expansion and health.
Medical investment, pharmaceutical expansion and medical specialization increased over time for virtually all 30 countries, although the amount of increase varied substantially, Zheng said.
The United States had the largest increase in medical investment and a steep increase in pharmaceutical expansion, but one of the flattest trajectories over the 29 years in the increase of medical specialization.
All three types of medical expansion were associated with two or more indicators of population health, results showed.
Increased medical investment and increased medical specialization were related to growth in all three life-expectancy measures and a decrease in overall mortality.
Two measures of expansion in the pharmaceutical industry - increased sales and more money spent on research and development - were linked to lower life expectancy among women aged 65 and older, and with increased mortality rates. The pharmaceutical measures were not associated with the other health outcomes studied.
The researchers ran tests to confirm that it wasn't the other way around - that lower life expectancy and increased mortality were causing an expansion of the pharmaceutical industry. But that wasn't the case.
That wasn't the only negative finding about the growing drug industry.
"We found that as the pharmaceutical industry expands, there is a decrease in the beneficial impact of medical specialization on population health," Zheng said.
This study can't say why expansion in the pharmaceutical industry is leading to negative population health effects, Zheng said.
"It could be due to toxic side effects of drugs, doctors' prescribing practices, patients' misuse of prescription drugs, reasons related to pharmaceutical industry's marketing strategies or some combination of these factors," he said.
He said they plan on studying this issue further.
2017 08 24
A startling new cost estimate for new medicines is met with skepticism
In the pharmaceuticals business there are few issues more loaded than the cost of developing a new drug. For a number of years estimates from industry groups on either side of the Atlantic have put it at $1.2 billion-1.8 billion. A new study by the Centre for the Study of Drug Development at Tufts University in Massachusetts reckons the average cost for drugs developed between 1995 and 2007 was $2.6 billion. Among those rejecting this new figure as highly misleading are Médecins Sans Frontières, a charity, and the Union for Affordable Cancer Treatment, a patients’ group.
The main point of controversy over such estimates is that they roll in the costs of those drugs that failed to win approval and, for good measure, the cost of capital required for the R&D. Tufts’s estimate includes $1.2 billion for the return on capital forgone while a drug is in development, on the assumption it would have otherwise earned a generous 10.5% a year. The remaining $1.4 billion is the average R&D cost of a random selection of drugs, multiplied by risk factors that account for the chances of failure at each stage.
Successful drugs cost far less than even the lower, $1.4 billion figure. But the road to approvals is littered with casualties such as the $800m that Pfizer blew on torcetrapib, a potential treatment for high cholesterol, before giving up in 2006. Jeff Williams, the boss of Clinipace, a contract-research organisation, has said that the small to medium-sized drugs firms his company works for manage to get their candidate drugs through development for less than $500m.
Another criticism of Tufts’s work is that it is based on secret data provided by a self-selected group of drug companies. The Tufts study group gets much of its funding from the industry; it says the group’s members are independent academics. Another criticism is that although such estimates embrace all the risks of developing drugs, they say little of the rewards.
The industry inevitably quotes such figures whenever it is suffering criticism for the high price of patented drugs. James Love, the head of Knowledge Ecology International, a group that studies and comments on issues of social justice, says drugs giants have used these big estimates of average costs to try to talk developing countries like India out of breaking the patents on specific medicines that, in practice, cost a lot less to develop.
Joseph DiMasi, director of economic analysis at the Tufts centre, says the most useful aspect of the $2.6 billion figure in his study is that it is comparable with previous figures. In 2003 his centre put the cost of drug development at $802m. This implies that in real terms costs have risen by 145%. Mr DiMasi says the increase has been caused by larger and more complex trials, a greater focus on chronic and degenerative diseases, and higher failure rates.
However, the life-saving cancer drugs that feature in many of the most emotional disputes over pricing are far from typical. Regulators often pass them after far smaller clinical trials than for other, less urgent medicines, thereby greatly reducing the most costly element of their development. Such drugs are also likely to qualify for “orphan drug” tax credits—an issue the Tufts study does not consider. It may be that the average is being inflated by other types of new drug, such as psychotropics, which may be only a bit more effective than existing ones but require big, expensive trials to gain approval.
2017 08 09
Drug costs vary by more than 600% in study of 10 high-income countries
In a study of 10 high-income countries with universal health care, costs for prescription drugs in 6 of the largest categories of primary care medicines varied by more than 600%, according to research published in CMAJ (Canadian Medical Association Journal). All countries except Canada offered universal coverage of outpatient prescription drugs.
The study looked at data on the volume and daily cost of primary care prescriptions in 10 high-income countries with universal health care: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the United Kingdom. Because of the high cost of pharmaceutical drugs and the lack of universal health care, the United States was not included.
Researchers focused on 6 categories of widely used primary care drugs usually purchased at retail pharmacies rather than hospital pharmacies. These included hypertension treatments, pain medications (nonsteroidal anti-inflammatory drugs as well as opioids), cholesterol-lowering drugs, noninsulin diabetes treatments, gastrointestinal medications and antidepressants. They measured frequency of use of the medications by average number of days of therapy purchased per capita.
Medications for treating high blood pressure accounted for the largest number of days of therapy in all countries.
In the 5 countries with universal, single-payer coverage of prescription medications, the average per-person cost was $77. Average costs were $99 in the 4 countries with universal social insurance for prescription drugs and $158 in Canada, which has a mixed system of private and public financing. Higher costs of drugs and the mix of therapies chosen accounted for most of the cost differences between countries.
"The volume of therapy purchased in Canada was about the same as that in the comparator countries; however, Canadians spent an estimated $2.3 billion more than they would have in 2015 if these primary care treatments had had the same average cost per day in Canada as in the 9 comparator countries combined," writes Dr. Steven Morgan, School of Population and Public Health, University of British Columbia, with coauthors.
"Average expenditures are lower among single-payer financing systems, which appear to promote lower prices and selection of lower-cost treatment options within therapeutic categories," the study authors conclude.
In a related commentary, Dr. Joel Lexchin, York University, Toronto, Ontario, writes "Canada is not doing well when it comes to ensuring that its population has access to prescription medications; we can and must get to a better place."
He says that we need universal pharmacare to reduce drug prices so that Canadians are not deterred from taking their medications.
2017 06 26
Pharmaceutical Industry Overview: Top Regions for Drug Companies
The world’s pharmaceutical industry is dominated by the American and European markets. According to Forbes top companies of 2017, the 10 biggest drug companies are all located in these two regions.
Although other regions like China and India have seen growth in recent years when it comes to the life science markets due to potent capital opportunities and an expanding demand for products and devices, the US and Europe remain on the top of the line for pharmaceutical consumption and development.
Top pharmaceutical regions: United States
The US dominates the pharmaceutical market, both in consumption and development. In 2016 medicine spending in the US reached was projected to reach $450 billion total.
In 2016 through the Center for Drug Evaluation and Research (CDER) the US Food and Drug Administration approved a total of 22 new drugs into the market. Among them included treatments for certain types of ovarian cancer, Duchenne muscular dystrophy, all six major hepatitis C virus.
The US is the world’s leader in research and development. In 2013, the industry sponsored over 6,000 clinical trials in the US, involving 1.1 million volunteer participants in this endeavor.
According to PhRMA’s 2016 Profile, the American pharmaceutical sector spends 18.3 percent of sales on research and development (R&D)—the highest ratio across the manufacturing industry. PhRMA members spent an estimated US$58.8 billion on R&D last year.
A strong intellectual property system, which rewards innovation and improvement of current treatments ensures a supportive pharmaceutical market for public companies, according to a report from the International Trade Administration.
“The United States attracts the majority of global venture capital investments in start-up biopharmaceutical enterprises,” the report stated.
US biopharmaceutical companies directly provide jobs to more than 810,000 Americans and indirectly support the jobs of 3.5 million Americans. Overall, the economic output of this work was valued at approximately US$1.2 trillion in 2014, making it one of the most important sectors of the American economy.
Top pharmaceutical regions: Europe
The rest of the top 10 pharmaceutical companies on Forbes for the top pharmaceutical regions include enterprises from Switzerland, France, and the UK, including some names like Novartis (NYSE:NVS) and Sanofi (NYSE:SNY).
Production of pharmaceutical products reached €225,000 million in 2015 according to the European Federation of Pharmaceutical Industries and Association. This, in turn, boosted the continent to account for 23 percent of the total pharmaceutical sales in the world–just behind the US which represents 58 percent of sales of new medicines launched during 2010 and 2015.
2016 11 15
How Will Personalized Medicine Shift From Great Concept To Reality?
In a recent Oxford Economics study, “Healthcare Gets Personal,” 120 healthcare professionals were asked to respond to questions regarding their organizations’ use of personalized medicine. Of those surveyed, over two-thirds reported improved patient outcomes from personalized-medicine initiatives and three-quarters of respondents expect to see value on their organizations in the next two years.
Technology is the Driving Force
By leveraging high speed in memory analytics technology, healthcare organizations can now comprehend astronomical amounts of data.
And by tapping into all this data, like patient EMR information, healthcare professionals can categorize patients into micro-buckets based on ethnic, environmental, lifestyle, and DNA similarities. From there, they can make educated predictions on how different patients will react to different treatments.
With faster access to more effective treatments, physicians have time to serve more patients without sacrificing quality of care.
Changes in Organizational Structures and Regulations
In addition to the right technology, personalized medicine will only thrive under a transformed economic framework, updated regulatory structures, and by remedying issues like privacy concerns.
Of the organizations surveyed, 64% say that they’ve already changed their privacy policies to reflect the increasingly personal nature of healthcare research and treatment. In addition, 60% noted that they’ve already increased patient data security.
However, in order for personalized medicine to truly work, patients must be willing to share their medical data. As the Oxford Economics study states, “The huge amounts of data required to make personalized medicine a reality are more than any single institution can generate.”
Dr. Eduardo M. Sotomayor, MD, Director of the George Washington University Cancer Center in Washington, DC said it best, “We need to share data; otherwise we are going to take decades to conquer cancer. I strongly believe that you need to share Big Data in order to make significant advances in the biology and the treatment of cancer patients.”
The more information we can extract information from EMRs, clinical trials, and medical research with analytical software, the better we can target treatments to offer the best results for patients.
2016 06 07
Getting personal – the changing role of 3D printing in pharma
We have read about 3D printed pharmaceuticals but the technology has an increasing role to play in personalised medicine. Professor Ricky Wildman, University of Nottingham explains.
Additive Manufacturing, also known as 3D printing, is a disruptive technology, that can potentially revolutionise the way we manufacture goods. It has become widely recognised due the expiration of a number of key patents that has allowed small manufacturers to explore the technology for home use. This use most often focuses on the creative and democratic aspects of 3D printing. However, it has the most utility when being used for the fabrication of objects that require complexity, multiple and graded materials or lend themselves to a distributed manufacturing model. Most importantly, the near zero marginal cost of changing a design, means that the technology is particularly suitable for personalisation. These latter advantages also apply strongly to biomedical and pharmaceutical applications. For both the need to personalise is becoming a driving force – biomedical devices are often required to have a personalised fit to be effective and the pharmaceutical world is moving beyond single blockbuster drugs and towards treatments that match the growing recognition that is the genotype that provides the key to treatment.
However, the manufacturing model developed to service large numbers of single dosage drugs – tabletting, is not best placed to offer personalisation. One possible route to achieving this ‘bespoke’ manufacturing is 3D printing. This is not without precedent – Aprecia has just received FDA approval for a 3D printed tablet. 3D printing of tablets is not without challenges – it requires an intimate understanding of process and design, exquisite control over material process and production and in line characterisation for quality assurance. However, 3D printing offers significant benefits to companies and patients alike. We are looking at the production of personalised tablets, within which have been embodied one or more drugs with release rates that are tuned to the need of the patient and that can be placed near to point of care (in the local pharmacy for example). In the future these can be combined with sensors and diagnostics that provide clinical carers with real time information on the treatment.
To achieve this requires a multidisciplinary effort. At Nottingham, our team includes chemists and chemical engineers, pharmacists and physicists all working together, with support from the UK funding agency EPSRC and key movers in the industry such as GSK and Astra-Zeneca, to solve key challenges to realise mini desktop factories that can bring personalised treatments to the patient. 3D printed polypills and controlled release tablets are already available in the lab and have shown to be effective – in the future, new materials, new formulations and new processes offer the prospect of a new way of delivering drugs that will be more tailored, more precise and most importantly, more effective than the tablet 1.0!
2016 05 17
France gets G7 to discuss global regulation of medicine prices
France will press its G7 partners this month to launch an "irreversible" process to control the prices of new medicines, part of a global drive to make life-saving drugs more affordable, three sources told Reuters.
President Francois Hollande said in March he would push for the international regulation of drugs prices when he meets other G7 leaders in Ise-Shima, Japan on May 26-27.
The sources said the issue was now on the summit agenda and health ministers will continue work on it in Kobe in September when other parties, such as the pharmaceutical companies themselves, could potentially be involved.
"We need to initiate this process with firmness, and the president wants it to be irreversible," said a source close to Hollande.
The rising cost of ground-breaking medicines has been criticised around the world, with campaigners in developing countries demanding reform of the patent system to make vital treatments more affordable.
G7 nations are home to most of the leading drug makers and while governments are keen to tackle rising health costs they may be reluctant to pitch themselves against their own pharmaceutical industries.
Any regulation would have to balance the need to keep costs down with the need for pharmaceutical companies like U.S group Pfizer, France's Sanofi or Britain's GlaxoSmithKline to retain financial incentives for innovation.
G7 delegations have begun initial talks on the issue but no one expects a breakthrough in the near future, one of the sources said.
A United Nations panel is discussing ways to improve access to medicines and presidential candidate Hillary Clinton has promised to rein in prices in the United States.
In the latest move by the pharmaceuticals industry to address criticism on prices, GlaxoSmithKline said in March it would adopt a graduated approach to patenting its medicines depending on the wealth of different countries. (Additionnal reporting by Ben Hirschler; Editing by Richard Lough and Robin Pomeroy)
2016 05 10
Pharma heart failure market to rise by £5.8bn
The heart failure market is set to rise by £5.8bn ($8.6bn) within the next century, according to GlobalData
Research and consulting firm, GlobalData, said that the heart failure market is set to rise from around £2.18bn ($3.2bn) in 2015 to £8bn ($11.8bn) by 2025, representing a compound annual growth rate of 13.7%.
The company’s latest report states that the key drivers of this substantial growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be the launch of Novartis’ first-in-class drug, Entresto, and several acute heart failure add-on therapies, as well as an increase in the global prevalence of chronic heart failure.
Elizabeth Hamson, GlobalData’s analyst covering cardiovascular and metabolic disorders, explains: “Novartis’ Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNi), which was launched in the US in 2015 and the five European countries in 2016, and is set for release in Japan by 2020.
“Entresto has struggled to penetrate the chronic heart failure market, achieving dismal sales in the US since its launch in July 2015.
“GlobalData has identified high pricing and the general reluctance of cardiologists and physicians to adopt new therapies as the main barriers to the uptake of this drug.
“Despite this, it is expected that Entresto will begin to dominate the global heart failure space, particularly after its label expansion to heart failure with preserved ejection fraction, which is expected to occur in 2020, making it the strongest driver of market growth.”
Despite these significant advances for chronic heart failure, particularly with reduced ejection fraction, there have been no advances in the treatment of acute heart failure for the past two decades. However, two drugs currently undergoing Phase III evaluation for the treatment of acute heart failure have the potential to shape how this condition is treated, according to GlobalData.
Hamson continues: “Cardiorentis’ ularitide and Novartis’ serelaxin represent novel and exciting treatment options for acute heart failure.
“Both are recombinant forms of human proteins that are intended to be used on top of the current standard-of-care for acute heart failure, intravenous administered loop diuretics.
“While the heart failure market will be invigorated by exciting new therapies over the forecast period, there will remain a major unmet need in the lack of a therapy which can reverse disease progression, rather than merely slowing it down.
“In this way, GlobalData believes that the scope for the development of even better and more exciting heart failure drugs is still very broad.”
2015 08 14
Sales of vitamin D supplements in Lithuania - a biannual overview
Vitamin D represents a group of substances responsible for a healthy absorption of calcium, iron, phosphate and zinc. Therefore, vitamin D is essential in order to maintain a healthy body and mind.
As generally known, the main source of vitamin D is a direct exposure to sunlight. However, dietary options for vitamin D are scarce, thus with colder weather people tend to turn to their pharmacists for an alternative. Such behaviour is well documented by the quarterly unit sales data that is available in the PharmaZOOM databases.
Even though people are still willing to purchase vitamin D supplements during the summer months, the sales tend to soar during the rest of the seasons.
Moreover, our data indicates of an overall increase in the demand for the vitamin D supplements across two year time span.
2015 08 12
Are we seeing a new dawn of innovation in pharma?
Innovation has always been the blood pumping through the body of the pharmaceutical industry, but in recent years the supply seemed to be getting poorer. Yet now a slew of breakthroughs in treatment for diseases like Hepatitis C, Ebola, malaria and even Alzheimer's, the memory-destroying condition on which much time and effort has been spent to little avail so far, has prompted hope of an era of new ideas and treatments in the industry.
There is a new sense of optimism among investors and analysts. HSBC analysts recently produced a punchy, bullish note on the European pharma sector, which argued that "the sector's re-rating is set to continue", "companies are largely through the patent cliff period", and slapped Buy ratings on Novartis, Sanofi, Bayer and GSK.
Rather than internal advances, many of the most exciting new treatments at big pharma companies are as a result of buying in scientific breakthroughs made elsewhere rather than concentrating on in-house research and development – and this is set to continue. Global healthcare M&A volume stands at is at a year-to-date record high of $422.8 billion this year, after a torrent of deals motivated by both record cash piles and tax benefits, as well as innovation. The latest bid to rock the sector is Shire's $30 billion attempt to gain control of Baxalta, the rare diseases company spun out of Baxter in June.
"There's a huge flow of M&A that's driving the sector," Jo Pisani, UK pharma and life sciences consulting leader at PricewaterhouseCoopers, told CNBC.
"Many deals have been around strategic areas that people don't understand at the time – AstraZeneca and MedImmune, which got AZ into immuno-oncology, for example."
The increasing number of harder-to-copy complex biologics will also aid the firms which have the existing economic capacity to research and manufacture these drugs.
"Those companies that prefer their own discovery have done less well with it than those who have forged strong external networks," according to Mike Rea, chief executive of IDEA Pharma.
Ultimately, the Pfizers of this world may need to be more worried about competition from Apple and Google than from their peers in the pharma industry, according to Pisani. As these companies move into the healthcare space via smartwatches and healthcare applications, they are likely to offer more diagnoses and even prescriptions. Uber, the cab company, has also recently started taking doctors to house calls via the Pager app, which is mostly concentrated in New York at the moment.
2015 05 08
Antidepressants Aren't Taken By The Depressed
Depression’s increase has been persisting for years, and it’s going on decades. While the increase in antidepressant use has followed a predictably similar path, not all cases can be explained by the parallel rise in disease. Many people, in fact, take antidepressants regardless of a diagnosis.
A new study published in The Journal of Clinical Psychiatry reports some 69 percent of people taking selective serotonin reuptake inhibitors (SSRIs), the primary type of antidepressants, have never suffered from major depressive disorder (MDD). Perhaps worse, 38 percent have never in their lifetime met the criteria for MDD, obsessive compulsive disorder, panic disorder, social phobia, or generalized anxiety disorder, yet still take the pills that accompany them.
In a society that is increasingly self-medicating itself, capsules, tablets, and pills are turning from last resorts to easily obtained quick fixes. Any medications that are taken without the oversight of a physician, especially drugs with abuse potential, are very concerning for the development of dependence. Solving this problem of antidepressant overuse may be partly systemic as well as personal.
2015 03 17
New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025
AKI is a worldwide problem, killing affected patients who have no means to reach appropriate therapy in developing countries, and who could be saved with as little as $150.
The AKI “Global Snapshot” is the first in a series of landmark projects to be launched by ISN under the 0by25 Initiative. The far-reaching, cross-sectional, global cohort study was designed to better understand the growing burden of AKI and how it is identified, managed and treated in different settings worldwide.
The study was carried out from September to December 2014 with over 320 participating centers in 72 countries globally. Data was provided for over 4000 pediatric and adult patients, with significant new information coming from Africa, Asia, and Latin America.
“This is the first time that ISN has carried out a web-based, prospective data collection exercise, simultaneously, in hundreds of centers around the world,” remarks ISN President, Dr. Giuseppe Remuzzi. “The Global Snapshot has helped us address the information gap on AKI and moves us a step closer to our goal of zero preventable deaths. We are excited to share these findings with our international colleagues and the wider global health community.”
According to the study, nearly 2/3 of the AKI cases were reported to be community-acquired, rather than developing in the hospital setting. This is a significant new finding, which points to an opportunity and need for early recognition and detection in these out-of-hospital settings.
The most common causes of AKI reported across all countries were: hypotension (low-blood pressure) and shock, infections, dehydration, cardiac events and nephrotoxic drugs. It was also reported that over 2/3 of the AKI cases had one or more of the recognized risk factors for AKI, e.g. diabetes, heart disease and anemia, and patients with these risk factors experienced a higher mortality and lower rate of recovery of kidney function.
“This study provides us with clear evidence of the need to identify and target high risk groups to improve the prevention and early detection of AKI,” comments Dr. Ravindra Mehta, 0by25 Project Leader and Global Snapshot Coordinator. “This essential new information can now be used to design targeted education and training to enable the rapid recognition of AKI based on these key indicators.”
2015 01 20
Two volunteers with potential exposure to Ebola transported to UK for precautionary monitoring
Public Health England (PHE) can confirm that, as a highly precautionary measure, a volunteer who had potential contact with the Ebola virus while working in Sierra Leone, has been transported to the UK today (Friday) for assessment and monitoring. A second volunteer, who had potential contact in a separate incident, is also being transferred to the UK today.
The individuals have not been diagnosed with Ebola, do not currently have any symptoms, and their risk of developing the infection remains low. On arrival in the UK, the arrangements are for these individuals to be initially assessed in hospital and subsequently monitored for any symptoms for the remainder of their 21 day incubation periods, in line with standard procedures for returning workers.
2014 12 16
The Cancer Drugs Fund has been the subject of much debate in recent weeks following the decision by NHS England to limit the number of drugs which can be financed.
Labour that 40,000 cancer patients each year stand to benefit from radiotherapy which they don't currently receive.
But Labour 's plan raises the question of how rising demand can be met if the Fund is expanded to include treatments as well as drugs. Mr Burnham's extra £50m a year might be accounted for quickly and still leave oncologists and their patients feeling short-changed.
The funding for these cancer measures has come under scrutiny.
Labour wants to use a rebate from the pharmaceutical industry after a deal with the companies to cap the NHS medicines budget. But the Conservatives say the money has already been committed to the NHS. In other words, if Labour wants to re-direct it to the newly relaunched Cancer Drugs Fund, something else will have to be cut.
So what's the Conservative plan for the next parliament?
The Fund is of course David Cameron's baby, his personal initiative after taking office in 2010.
Government sources make it clear that Mr Cameron is committed to continuing the Fund from 2016 if he is still Prime Minister after the election. Technically, though, it is not yet a Conservative manifesto pledge.
All this begs a question - what do the pharmaceutical industry think? Some drug companies don't like the Cancer Drugs Fund. They believe the watchdog National Institute for Health and Care Excellence (NICE) should authorise a wider range of new drugs to bring availability of cancer drugs on the NHS into line with many other countries. Other pharma players are happy to do business with the CDF, aware that the prices they can charge are not controlled (though that will change when the restrictions take effect next year).
Another complication has just emerged.
I understand that the Association of the British Pharmaceutical Industry, the trade body for drug companies, is not happy that politicians pledge money from the rebate deal to specific schemes. They say the arrangement was for the money to be ploughed back into general front line NHS services. Their unhappiness is both towards Labour for earmarking cash for their Cancer Drugs Fund plan and the Government for increasing the CDF from £200 million to £280 million. Watch this space.
The Cancer Drugs Fund has been the subject of much debate in recent weeks following the decision by NHS England to limit the number of drugs which can be financed.
Demand grew as more drugs became available and the £200m of original annual funding was under severe strain. That has been increased to £280m but with a cap on the number of drugs which can be made available.
It has not been clear before now what might happen to the Fund, which is run for patients in England, after the 2015/16 financial year, the last in which firm financing has been committed.
Labour has now come out with a pledge, if elected in May next year, to continue the work of the Cancer Drugs Fund (CDF) but to rebrand it and include treatment such as advanced radiotherapy as well as drugs.
The annual budget, under Labour's plan, would be increased from £280m to £330m.
Labour's Andy Burnham argues that it is perverse for the CDF to pay for expensive drugs which are not available on the NHS but not treatments.
2014 10 09
European doctors want more drug info
New research shows that 72% of EU doctors surveyed believe new drugs and treatments will significantly improve the outlook for their patients in the next three years, according to findings by M3 Europe. The research by the global provider of technology services in healthcare also found that the majority of European doctors also want to keep up-to-date with developments on new drugs. Also the research took in account new market trends:
· Doctors’ digital behaviour
· Their optimism for the future, set against their caution over funding
· Their attitude to pharma and what influences their treatment of patients
· How all this will affect the future of healthcare and pharma’s place in it.
M3 – the global provider of technology services in healthcare – is teaming up to run a free webinar and research about EU doctors and new trends in Pharma market.
2014 10 08
Germany top for dealing with mental illness, UK second
Of 30 European countries, Germany, closely followed by the UK, is most able to respond to the needs of people who suffer from mental illness.
That is the view of The Economist Intelligence Unit’s Mental Health Integration Index, a study looking at how the European Union plus Switzerland and Norway integrate those with mental illnesses into their communities. The research, commissioned by Janssen, looked at five key areas - medical provision, human rights, stigma, the ability to live a fulfilling family life and employment.
Germany comes top, the report says, because of its strong healthcare system and generous social welfare programme which have helped better integration into society. The UK’s second place is largely down to “a long-term, progressive commitment at a policy level to mental health care and enhancing the position of people with mental health problems in society”.
Aviva Freudmann, the EIU’s research director EMEA, stated that mental illness “is among Europe’s most difficult, complex and yet least-addressed issues” and 38% of Europeans suffer from such a condition at some point in any given year. She added that the countries with the best results tend to be in the north and west of Europe, whereas the weakest are largely in the south-east, “which can be attributed to low levels of investment and state treatment for those with mental illness. However those countries that have ranked highly are still far from perfect”.