Tag: biopharma

pharmaceutical industry

Illuminating the impact of Brexit on Europe’s Pharmaceutical industry

Pharmaceutical industry products are in the list of top five products that are most imported and exported from the UK to the EU and vice versa.

Brexit can have several implications of Europe’s pharmaceutical industry. From product development to market approval to the shipping of medicines and medical devices, pharmaceutical companies can expect to be affected in a broad range of areas. Companies in the pharmaceutical industry in the UK will have to manage the impact of Brexit carefully to prevent some of the negative aspects. However, uncertainty will have adverse effects on pharmaceutical and life sciences companies in other European countries as well. Experts at Infiniti predict how Brexit will affect life science and pharmaceutical industry.

Rising demand for personalized treatments, an ageing population, and the rise of new manufacturing technologies are some of the primary growth opportunities for the UK pharmaceutical sector. Request a free proposal to know how our solutions can help you stay prepared to cope with the market trends and changes.

Relocating European Medicines Agency (EMA)

One of the key pharmaceutical industry market access challenges that Brexit brings along with it, irrespective of the path it takes is related to the future location of the European medicines agency. Since its inception in 1995, EMA had been located in London. However, the Netherlands has now won the bid to host new EMA headquarters post-Brexit. With the EMA headquarters soon moving to Amsterdam, they may implement several changes to rules for medicinal products that are developed and tested in the UK. However, the extent of Brexit-induced changes to the pharmaceutical industry has yet to be decided.

Movement of people and pharma products

Pharma products form a considerable part of goods that are exported to and from the UK. Any post-Brexit hurdles to the free movement of goods could mean trouble for those supplies, potentially leading to temporary drug shortages. This is especially true in the case of drugs such as medicinal insulin that are not manufactured in the UK nor is it easily stored, as it requires temperature-controlled conditions. In order to reduce the risk of drug shortages in the case of a no-deal Brexit, the British government has asked pharmaceutical companies to add a minimum of six weeks’ worth of additional backup supply of medicines to their usual buffer stocks by the exit date, and to ensure that contingency plans were in place for drugs with shorter shelf lives. However, it is not only the movement of medicines that’s at risk. As the possibility of stricter rules regarding the flow of people between the UK and the EU looms, companies in the pharmaceutical industry are concerned about their ability to attract talent from outside Britain in the future. It is vital that pharmaceutical companies to still be able to access the best talent from around the world.

Emerging markets represent an exceptional opportunity for the pharmaceutical sector. Get in touch with our experts for more insights on how to capture the true value of the pharmaceutical market.

Change in the UK’s contribution to drug regulation

UK plays a major role in drug regulation in the EU through the work of the Medicines and Healthcare Products Regulatory Agency (MHRA). The UK frequently serves as rapporteur/co-rapporteur in the EU’s centralized procedure and as the reference member state in the decentralized procedure. It will prove to be a challenging task to replace the MHRA’s capacity and expertise, particularly if the timetable for reform is aggressive.

 

Safe supply of blood and organs

Another pressing challenge faced by companies in the pharmaceutical industry due to Brexit is linked to ensuring blood and blood products are safe. If there is a no-deal Brexit, the EU Blood Directives will not apply to the UK and it will be considered a third country by the EU regarding sharing blood, blood components, and information. The UK Government has declared that in the event of a no-deal, the current blood safety and quality standards for blood and blood components will remain the same, and therefore adhere to EU standards, allowing them to be imported into the EU. Similarly, the UK Government has laid out its provisions for ensuring the supply, as well as the safety and quality, of organs, tissues, and cells in the event of a no-deal. The UK would no longer be part of the EU Organ and EU Tissues and Cells directives, however, relevant UK establishments, such as stem cell laboratories and fertility clinics, would be required to work to the same standards. These organizations would need to individually agree on import and export of the products with EU and EEA authorities and establishments.

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Opportunities and Challenges in the Global Biopharmaceutical Market

Biopharmaceuticals is currently at the core of the pharmaceutical sector. The opportunities in the global biopharmaceutical market are big and growing too rapidly. In fact, biopharmaceuticals generate global revenues over $150 billion, making up about 20 per cent of the total pharma market. It’s by far the fastest-growing part of the industry. Biopharma’s current annual growth rate is double that of conventional pharma, and the growth is expected to continue at that rate for the foreseeable future. However, the global pharmaceutical market is not entirely free of challenges and flaws. As biopharma companies move from the scientific frontier to the business mainstream, the companies in the global biopharmaceutical market will increasingly be forced to confront the same challenges of maintaining competitiveness by ensuring affordability, quality, and delivery performance.

Only through deep operational excellence can biopharma companies fulfill its potential to transform the health expectations of millions of people across the globe and successfully navigate both the promising and challenging elements of the sector. Request a free proposal to know how we help our clients in the biopharma sector achieve this.

Opportunities in the biopharmaceutical industry

Biopharmaceutical products are known for their efficacy and safety. Furthermore, the ability of these products to address and cure previously untreatable conditions allows companies in the global pharmaceutical market to command high prices for new and innovative drugs. Despite the high prices, the strong demand for biopharma products are driving sales and profitability in this market. According to our pharma industry analysis, investments made in the global biopharmaceutical market has yielded better returns than the pharma industry average, prompting clinical trials to become unprecedently high. The success of the clinical pipeline will lead to a higher number of new molecule launches, rising from a handful a few years. Moreover, robust, low-cost genetic profiling will improve treatment outcomes and serve to accelerate and enhance the outcomes of clinical trials, helping to reduce the cost of drug development.

Challenges in the global biopharmaceutical market

Managing demand for improved access

The downward cost pressure is expected to intensify with healthcare systems increasingly attempting to balance the rising demand with the reducing budgets. Consequently, payers may also find it challenging to justify the annual treatment costs demanded for some biopharmaceutical products. Furthermore, governments in emerging markets understand the critical role that biopharma will play in boosting healthcare outcomes, and they are demanding alternative ways to fulfill the rising demand for these products.

Many of the next major opportunities for biotech will require companies to develop new and different technologies and operating models. Get in touch with our experts to know how we can help you stay updated with latest innovations and strategies for success in the global biopharmaceutical market.

Quality compliance and regulatory scrutiny

Companies in the global biopharmaceutical market are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. In the last five years, the industry has been subject to an unprecedented number of warning letters, and scrutiny is unlikely to decrease. Furthermore, the rising relevance of global markets (beyond the United States, European Union, and Japan) is increasing the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency are keys to success for companies in the global biopharmaceutical markets.

Complexity in supply chain operations

The complexity of supply chain operations of companies in the global biopharmaceutical market are bound to increase with the rise of new processes and technologies. Moreover, the current production programs are already stretching the industry as even several top biopharmaceutical companies are failing to deliver to the market.

Know more about how Infiniti can help overcome key challenges faced by companies in the global biopharmaceutical market.

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Top Trends Shaping the Asian Biopharma Industry

Some of the earlier events in Asia, such as China’s market access blockade, Japan’s spending controls, and deceleration in Southeast Asia and India have contributed towards a flat enthusiasm for the biopharmaceutical sector in Asia. However, certain recent trends have reignited the interest in biopharma in this region, with key implications for pharma executives.

Asia is popular for its dynamic markets and its rapid growth. Although over the past year the enthusiasm in the region for biopharma has been flat, several recent biopharma trends have turned the tables. This has brought about several market changes that make it essential for companies to reassess their strategy and go-to-market model. In this blog, biopharmaceutical industry experts at Infiniti Research discuss some of the recent biopharmaceutical industry trends in Asia and share perspectives on their implications for executives in biopharmaceutical companies.

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Key biopharma trends in Asia

CDFA reforms in full stride in China

The recent China Food and Drug Administration (CFDA) reforms are more optimistic fundamentals that aim to support industry growth through innovation. Over the past few years, the CDFA has made significant strides in terms of addressing critical gaps in the system. Furthermore, there have been several reforms published on the drug-registration policy. These policies have been designed to improve the registration process and to encourage companies in the biopharmaceutical industry to bring innovation to China. This includes therapies for addressing severe and rare diseases and fast tracking approval for therapies. As a result of these new drug approvals, a record number of approvals and new product launches were seen over the last couple of years. The biopharma industry in China is accelerating against the backdrop of the new CDFA reform.

Price reforms in Japan

The Japanese ministry of health made a proposal in 2017 to overhaul the current drug pricing regulations. This reform will affect both the new drug pricing and in market pricing revisions across all drug categories including off-patent long-listed products, patented prescription drugs, and generics. This includes changes such as narrowing price maintenance premium (PMP) for patented products. The PMP will now be applicable only to selected drugs and full premium will be awarded only to a subset of companies. The scope of the premium will be limited to innovative drugs and the amount of premium will be matched to a company’s contribution to R&D.

Emerging fund pools in Southeast Asia and China

In China, there has been an upward trend in the expansion of reimbursement of innovative drugs. Furthermore, companies in the biopharma industry in China have also started to experiment with new models to improve patients’ access to medicines. China remains an important growth engine for companies. With these biopharma trends and changing outlook in China, the country remains a highly lucrative market and an important growth engine for companies in the biopharma industry.

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Digital and advanced analytics in healthcare

Although big data and other digital technologies have been constant buzzwords in the biopharma industry in Asia, now we are seeing their gradual uptake by several companies in the sector. Governments in Asian countries like China and Japan have introduced policies to promote the application of such advanced biopharma trends. Furthermore, even physicians and medical reps, especially in Japan, have already shifted away from pharmaceutical sales reps as their primary information source and use digital channel as their primary source. In China, for instance, studies show that doctors spend over two hours of their working day on an average online and have switched from computers to smartphones to support many of their professional activities. Consequently, digitalization is going to be one of the key biopharma trends that are going to revolutionize Asia.

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How to Rollout a Successful Biopharmaceutical Product Launch Plan

A product launch is no child’s play, a significant amount of planning and execution strategies are decided on before the actual product launch. A product’s performance during its launch often indicates how successful it will be during its life cycle. Take the example of the movie business; the opening weekend is the critical barometer to predict how popular the movie will turn out to be at the box office. That dynamic holds true in the biopharmaceutical industry as well. However, in the current market scenario, biopharmaceutical product launch is more challenging than ever before. Rising regulatory issues, growing stakeholder expectations, numerous market-access hurdles, and stiff competition are some of the critical hindrances coming in the way of biopharma companies. So how can players in the biopharmaceutical space overcome these hurdles and roll out a successful product launch plan?Request Free Proposal

Create a game plan

Managers need to think strategically if they aim at leading their team to victory in the case of a product launch. They must take into account market conditions, how much companies have spent to support a competing product, and the product’s positioning at a particular point in time. Considering only competitors’ past actions leaves managers unprepared to react to changes in rivals’ tactics. Instead, companies must plan for the “game” that lies ahead, predicting the successive moves that competitors might make in to tackle a new market entrant. War-gaming can prove to be a useful tool for identifying possible market disruptions, study the probability of various competitive actions, estimate their impact, and design an appropriate response.

Cross-functional market access team

Traditionally, winning in the marketplace has been achieved by having sales representatives continually communicating information about a product’s efficacy and safety directly to physicians. Today, biopharmaceutical companies need to effectively make the case for their product to a host of payers and health technology assessment (HTA) agencies, which are now operating in most markets. Though many companies have a market access team, it rarely includes individuals from different verticals across the organization. To have a constructive conversation with payers, companies must create a cross-functional market-access team comprised of individuals from various departments such as R&D, sales and marketing, and medical affairs. This team can get in touch with payers and HTA agencies and then keep them updated on the decisions made throughout the R&D process. The team should especially communicate the type of patient populations that are being targeted and the expected benefits. This will give payers and HTA agencies the opportunity to provide guidance on the kind of efficacy and safety data they would be looking for.

Innovative pricing

Price increases have been a significant driver of growth for pharmaceutical companies, accounting for 65% of the industry’s growth worldwide. Although the biopharmaceutical industry has relied heavily on price increases, it is not leveraging pricing as a tool for gaining competitive advantage. Biopharmaceutical companies should study innovative pricing strategies during product development and make pricing a core pillar of the product’s profile. Innovative pricing is often critical to gaining market access and receiving reimbursement.

Build stakeholder relationships

The ideal biopharmaceutical selling model focuses on a single channel: the physician. But this approach is no longer relevant in a world where myriad stakeholders exert significant influence over prescribing decisions. A consistent challenge is getting a comprehensive view of which stakeholders matter the most, who is connected to whom, and who influences the stakeholder network. Social-network analysis helps biopharma companies to identify which institutions or individuals – key opinion leaders, payers, HTA agencies, guideline committees, or physician and patient groups are the most influential across stakeholder groups.


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A Biopharmaceutical Company Enhances Operational Efficiency using Market Intelligence Engagement

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LONDON: Infiniti Research, a global market intelligence solutions provider, has announced the completion of their latest market intelligence engagement for a biopharmaceutical company. The biopharmaceutical companies are investing heavily in clinical development to prevent and treat the growing number of life-threatening diseases effectively. Also, the rising concern to reduce the cost of drug development is prompting biopharma companies to ensure quality, affordability, and performance in the products offered.

“Market intelligence solution helps businesses gain timely and relevant information about the company’s market to ensure accurate and confident business decision. Furthermore, businesses can ascertain the demand for products and services and understand the competitive effectiveness of the products in the market., “says an expert at Infiniti Research.

 

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The market intelligence solution offered helped the biopharmaceutical company to streamline their marketing resources based on the customer requirements. The client was also able to identify and address the potential bottlenecks in the compliance requirements and supply chain disruptions which helped them to enter potential markets in an agile and seamless manner.

Additional Benefits of The Market Intelligence Solution

  • Devise effective marketing campaigns to meet the business requirements
  • Minimize the risk of the investment decisions going wrong.
  • To know more, request a free proposal

To know more about how our market intelligence solution helped the Biopharmaceutical company

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IR23

Single-Use Technology – Taking Biopharmaceuticals to a Whole New Level

Largely used in the biopharma industry, the single use technology (SUT) has emerged as one of the foolproof methods to bring down contamination and improve the overall quality of the pharma products. Industry majors like GEHealthcare, ThermoFisher, and VWR, have already made major investments in this technology. Cleaning validation is critical in the biopharma industry, and this is what single use technology offers – right from biosynthesis to the formulation process, this technology reduces the risk of cross-contamination, is eliminating the need for cleaning validation altogether.

How single use technology will help the biopharma companies?

Regarded as one of the most important trends in the biopharma space, Single Use Technology helps in:

1.     Bringing down negative impact on the environment

When compared to the carbon footprint created by wastewater, energy, and chemicals, the plastics used in the SUT process are relatively safer. In spite of being incinerated, the carbon footprint contributed by this technology is negligible.

2.     High productivity and low cost

Being used just for a one time, the need to clean and reuse the utilities have come down. This not only saves time, but also reduces the cost of the entire operation. Also, the amount of energy consumed is brought down. When it comes to productivity, Single Use Technology helps in increasing it, as the time spent by the labor on changing the disposable systems, and sanitizing the traditional stainless steel system.

3.     Efficient manufacturing and sustainable process

Sustainability is a major goal which many biopharma companies are working to attain. And this is exactly what is attained through the single use technology process. Also, by making significant reductions in labor, not only does single use technology speed up the manufacturing process, but it also makes product changeovers easier to achieve. Not to forget, adherence to high quality and safety makes it easier for biopharma companies to manufacture products which meet the requirement of the regulatory agencies.

It is due to these advantages that industry experts regard the single use technology as a major game changer in the biopharma industry. With growth of the global market for biopharmaceuticals, the demand for SUT is also on a rise – which is good news for both the producers as well as consumers of the biopharma products.