Market Research Blog

Brexit’s uncertainties have plagued all industries alike, pharmaceuticals is no exception either. As UK heads for a possible no deal Brexit this year, Germany’s drug regulator has assured its patients that Brexit will not expose them to a loss of access to essential drugs. Ireland is drawing up a list of 24 most vulnerable medicines whose supply would be threatened if Britain exits without a deal.

The Irish drug market is heavily dependent on UK for transit of the drugs as around 60-70% of its drugs transit through or come from the UK. Prime Minister Leo Varadkar has said that he has been undertaking regular discussions with the health officials for the past 2 years to examine the possibility of any severe disruption in supply. Mr. Varadkar told the parliament that any stockpiling of the key drugs will eventually lead to a break in supply as a result they have decided against stockpiling. They are working with wholesalers and the pharmaceutical industry to ensure supply of the 24 key watch listed drugs they are most concerned about.

Germany’s BfArm Federal Institute for Drugs and Medical Devices tasked the country’s main pharmaceutical industry associations to find out the effect of a no-deal Brexit on the supply of drugs. The regulator on its official website posted its analysis that no significant shortage of medicines is expected which are thought to have critical importance. 2600+ drugs used in the country at some stage or the other are manufactured in Britain. 45 million patient packs flow out of UK while 37 million in the opposite direction, according to the figures provided by the industrial bodies.

UK’s drug industry have been given a target by the government to stockpile six weeks of additional medicines to prepare for a no-deal Brexit. The industry said that the target will be a challenge. EU’s central drug authority European Medicines Agency is extra vigilant and has set up a task force to lessen the disruption in supply of drugs over the next 2 years. EMA said that Brexit would likely effect the supply of some drugs. EMA which is currently located in London is shifting to Amsterdam post-Brexit which has prompted many drugmakers to prepare for duplicate licensing and drug testing arrangements.

UK Prime Minister Theresa May’s epic loss in passing the Brexit deal in parliament has left her scrambling for a means to get her deal approved in the coming months. While Britain lingers on deal or no-deal Brexit, European Commission has prepared to publish no-deal Brexit contingency plan. The plan includes 14 urgent and essential policies that EU member states must adopt.

Edwards Lifesciences is on the cusp of resolving the longstanding patent dispute with Marlborough, MA-based Company Boston Scientific over the Transcatheter aortic valve replacement device patents. The Irvin, CA based company has agreed pay $180 million as one-time payment to Boston Scientific.

The companies were involved in multiple patent office lawsuits and disputes in Germany, UK and the USA. Under the settlement which was announced on 15 Jan 2019, both the companies have resolved to withdraw the multiple complaints and disputes pending in various courts after Edwards Lifesciences pays the mutually agreed amount to Boston Scientific. However Boston Scientific has not revealed as to how the $180 million figure was decided.

This has cleared the path for relaunching of LOTUS aortic valve device later this year, a significant development after UK’s patent court and German Court gave mixed verdicts on the alleged infringement of Boston’s patent by Edward’s Sapien 3 device and a Delaware Courts verdict affirmed the infringement allegations.

Boston Scientific in 2017 announced the recall of the LOTUS devices due to delay in manufacturing and commercialization timeline. Reuters had forecasted the device sales in the 2017 year to reach between $100 million to $125 million in global annual sales. The LOTUS device is to be used for treating patients with aortic stenosis involves a relatively new development in treatment called transcatheter aortic valve replacement. The surgical which is minimally invasive, blood flow is regulated by replacing the damaged valve by inserting a replacement valve. The American Heart Association believes that it may lead to alleviation of some of the risk factors involved in open heart surgery for high and intermediate risk patients.

Boston Scientific has also recently announced the acquisition of Claret Medical Inc. which is a strategic acquisition considering the company’s extensive involvement in TAVR devices which are FDA- approved and able to filter of debris from the heart during medical procedures. The company is also acquiring Britain’s BTG Plc. for a $4.2 billion. The new settlement is another feather in the cap of Boston’s aggressive Intellectual property rights protection strategy. The settlement has given boost to the stock prices of the company, as Boston’s stock prices rose by over three percent to $36.48.  The TAVR device market is expected to reach $6.5 billion by the year 2022.  The company is one of the most formidable companies in the industry which in 2018 only undertook 9 new acquisitions along with couple of strategic investments worth $6 billion.

An InnovateUK initiative with cumulative funding of £700,000 is aimed at helping pharmaceuticals to manufacture particulates by the use of computer simulations. The Project is called Manufacturing of Particulate Process. The project which is led by Centre for Process Innovation is a 2 year long project which will improve the productivity of industrial processes through the use of computer modelling across the length and breadth of manufacturing processes.

The funding will be used to link the academic researchers to the industry experts so that laboratory processes could be adopted for addressing a range of industry requirements, which has for now culminated into the formation of a generic framework to be used by manufacturers for practical and industrial adoption of particle models. The initial application of the models will be used in pharmaceutical industry which in the manufacture of drugs uses cohesive powders.

The key feature of the framework includes a decision tool to be used by industrial organization based in UK for quicker access and easier adoption of particle models. The design provides engineers and product scientists a simulation based platform to better design and develop models involving particulates. And more importantly it will improve the quality of cohesive and fine powders used by pharmaceutical companies. The project will significantly enhance the productivity of the entire manufacturing process as well as aid in reducing manufacturing cost.

The MPP project manager Dr Caroline Kelly believes that the project involves world’s leading partners in several fields to deliver an innovative new process for translating particle modelling from academic research into industrial scale formulations.

EDEM, simulation based software process provider along with Process Systems Enterprise (PSE) were used by the project for developing models and were also validated using real life trials.

Head of Dept. formulated products at PSE, Dr Sean Birmingham is hopeful about CPI’s excellent demonstration on the capability of gPROMS PBM environment developed using the ADDoPT project for pharmaceutical digital design can be applied to other products industries as well which include specialty chemicals and fast moving consumer goods.

DEM and PBM which were previously constrained to only academic and research environment will find a mainstream industrial scale commercial application through the project. CPI is funded by InnovateUK which is an innovation agency which works independently of the government for supporting development of cutting edge research. CPI works in innovation in processing to aid diverse industries which include Electronics, Food, Energy and Healthcare.

Microsoft has joined hand with pharmaceutical manufacturing and distribution company Walgreens Boots Alliance for its cloud computing solutions. The pharmacy chain as part of this strategic partnership will use Microsoft’s Azure cloud computing software as the two companies start innovation in healthcare sector.

Under the deal which spans seven years, Microsoft will provide Walgreens Boots Alliance 380,000 plus employee strength Office365 software, Windows 10 and other productivity tools, Walgreen on its part will move most of its information technology and cloud infrastructure to Microsoft’s artificial intelligence and cloud computing software Azure.

 In addition to partnership in cloud computing solutions, Microsoft and Walgreens are working ways to innovate in health care delivery systems for low cost and quality health outcomes. The research and development investment will span several years by which the companies are planning to establish joint innovation centers in strategically important markets. Walgreens will start 12 digital health corners in its stores. They’re aimed at sale and merchandising of health care related select devices. Microsoft and Walgreens have resolved to focus more personalized health care related experiences from disease management to preventive self-care.

The deal is the most strategic move by Microsoft when other huge conglomerates including Amazon are pushing boundaries and have entered into healthcare and health technology space. Amazon in 2018 has pushed aggressively into the healthcare sector with filings of several healthcare related technology patents as well as partnerships with companies like Berkshire Hathaway and JP Morgan for employee health initiative.

To launch in Healthcare which a complex industry with number of players including pharmaceuticals, wholesalers, hospital, medical device maker, distributor  and retail chains, a technology company like Microsoft needs tremendous expertise in the field. A partnership with a major enterprise in the industry like Walgreens gives Microsoft the credibility to go after other players in the space. Walgreens and other retail pharmacy players are wary of Amazon after the e-commerce giant bought pharmacy chain PillPack in June 2018. Walgreens has also recently partnered with Alphabet’s Life sciences division Verily for a project to help people take their medicine.

Microsoft has been actively pursuing partnerships with major companies for providing artificial intelligence and cloud computing solutions through its Azure platform.  The recent partnerships include Kroger, the grocery store chain, Walmart and Gap, the fashion retailer. It has inked deals with MasterCard, Nielson, General Electric and Royal Dutch Shell.  Microsoft’s stocks rose to 105.01 by 2.9% and Walgreens to 71.79 by 1.6% post announcement of the deal.

Multiple factors have contributed in the increasing sleeping disorders in adults, which in turn have surged the demand for sleeping pills. A new research published by Behavioral Neuroscience in the Frontiers journal proposes a safer substitute to sleeping pills. As compared to conventional sleeping pills which strongly cause drowsiness and prevent the transmission of any signal to the brain, the proposed drug is said to have specific characteristics, wherein the one who takes them can sense threat even in the state of deep slumber. Once the threat is over, the individual can drift back to sleep.

According to CDC – Centers for Disease Control and Prevention, 1/3^rd of U.S. adults find it difficult to get sound sleep on a daily basis. Additionally, about 50 to 70 Mn individuals in U.S. suffer from either sleep deprivation or insomnia. CDC report further stated that approximately 4% of the U.S. population above 20 years pop sleeping pills and this percent intensifies with education and age. Furthermore, 1 in every 8 adults rely on sleeping pills to get adequate sleep. However, whether sleeping pills are safe for consumption is yet debatable.

Various researches have been carried out which have highlighted the adverse effects of popping a sleeping pill on a daily basis. With a continued usage of sleeping pills over a long period of time, one can easily get accustomed to these drugs and as a result, the body needs a higher dose of the drug. If the dose of the drug consumed is too high, it could cause breathing issues during sleep, which can eventually cause death. Moreover, a prolonged usage of these pills can cause drowsiness the next morning, since the chemical contents may still have their deposits in the body. Diarrhea, dizziness, and impairment on the following day are some of its additional side-effects.

The most dangerous side-effect is however, when an individual cannot sense a threat-like situation and fall a victim to it. The new drug developed by Behavioral Neuroscience possesses an intrinsic property that enables a person to wake up from his sleep and respond to the dangerous situation. Prof. Kuwaki, along with his team devised this novel solution by testing the drug on mice. He reported that the rodent woke up as soon as his brain sensed danger. Additionally, once the threat was over, the mice fell asleep. The professor and his team proposed a solution named, “Dual Orexin Receptor Antagonists (DORAs)” to enable the transmission of threat signals to the brain even during deep slumber.

A senior market analyst, at Future Market Insights discusses the changing dynamics of the surface Plasmon resonance market and how are biotechnology and pharmaceutical companies responding to the same.

Used for achieving detailed analysis of the interactions between biomolecules, surface Plasmon resonance (SPR) finds extensive applications in the fields of biotechnology and pharmaceuticals, for the production of bio-sensors, new drugs, and also for material sciences procedures testing. With the growth of healthcare infrastructure, the demand in the surface Plasmon resonance market is anticipated to witness higher rate of growth.

How will SPR procedures fare in assisting the development of innovative new drugs?

The prohibitive restrictions of time, cost, and reduced rate of success for drugs incorporating small molecules has generated a demand for faster and precise activity and characteristic measurements through the drug development life cycle.

For instance, the binding characteristics of small molecule towards a targeted protein compound with SPR allows accurate profiling of the molecules binding behavior. The process allows researchers to study the stability and speed of formation for new compounds, which can significantly affect the behavior of the medication.

Unlike other similar procedures, SPR has the added advantage of being able to provide results without any labels, that too in real time.

What are the major innovative products defining the future of SPR procedures?

A recent product by Bruker named the SierraTM SPR-32 makes use of an innovative frame-inject technology that provides new opportunities for mechanistic study on interactions of molecular interactions, with a faster rate of analysis. This is made possible through the pre-stabilization of the molecules surface through the application of a portion of molecular co-factors that comprise added buffers, prior to the injection process of the compound. This allows the kinetics of the compound to be monitored in a disassociated stage allowing major savings on time, and expenses on consumable items.

When being used in conjunction with spectrometry equipment, superlative results from high throughput screening activities can be achieved easily, making this technology a massive change for pharmaceutical development.

What is SPR’s role in disease control?

Researchers at the Monash University have developed an unique Surface Plasmon Resonance (SPR) sensor with the application of specialized antimonene materials, which can detect cancer-related bio markers such as MicroRNA-155 and Micro-RNA 21, with nearly 150,000 cases of early detection of cancer in the last year alone, through research conducted by The Australian Research Council Centre of Excellence in Future Low-Energy Electronics Technology.  The technology has increased the accuracy of 2D cancer detection by approximately 10,000 times.

Throw some light on the challenges facing the development of SPR-based point-of-care devices?

Key aspects such as the mass production of metallic nanostructures on the biomolecule substrates, lack of detection sensitivity capabilities, and prohibitive expenses for combining microfluidic chips with point of care equipment is significantly restricting the creation of such devices.

To know more? Download sample report.