US Precision Medicine Market_ Market Assessment and Regulatory Landscape Study for a Biospecimen Exporter
Pharmaceutical Manufacturing Market Outlook
Although the global pharmaceutical manufacturing market has been experiencing positive growth over these years, the industry is not completely free of challenges. Pharmaceutical manufacturing companies are facing challenges in meeting global quality standards, managing supply chain operations, and adhering to new healthcare reforms. To succeed in the long-run, pharmaceutical manufacturing companies are in the need to reduce costs, increase agility, and improve speed to market. Besides, increasing visibility into the supply chain is becoming imperative for companies in the pharmaceutical manufacturing market to address supply chain challenges and meet the demands of a rapidly evolving marketplace.
At Infiniti Research, we understand that pharmaceutical supply chain management is an arduous task and requires a complete analysis of pharmaceutical supply chain challenges and solutions. Our inventory management solution can help you to achieve these strategic objectives. RFP here.
The client is a pharmaceutical manufacturing company based out of Italy. The client’s lack of adequate visibility into the supply chain made it difficult for them to track-and-trace goods. This increased the likelihood of drug shortages for the client. Also, profit margins were under pressure as costs crept up throughout the supply chain network. Besides, the client’s lack of access to timely and accurate data from supply chain parties made it difficult for them to synchronize supply and demand.
In addition, as major drugs were heat sensitive and susceptible to contamination, maintaining a desired low-temperature range was becoming a major concern for the client. Owing to such challenges, the client’s valuable customers denied renewing contract with them. The pharmaceutical manufacturing firm, therefore, wanted to adopt solutions to tackle supply chain challenges and meet the demands of rising population. By partnering with Infiniti Research, the pharmaceutical manufacturing market client also wanted to enhance supply chain management while ensuring safer products for patients.
Our market intelligence experts can help you identify inventory challenges and take the right course of action to mitigate them. Contact us here.
Our Integrated Approach
To tackle the above-mentioned challenges, the experts at Infiniti Research recommended inventory management solution to the pharmaceutical manufacturing market client. The engagement involved designing, planning, and monitoring supply chain activities of the pharmaceutical manufacturing market client. Also, the inventory management solution involved designing strategic supply chain, forecasting drug demand based on historical data, and planning outsourcing and distribution for the client.
Also, by leveraging demand management study, the experts helped the client to align inventory levels with peaks and dips in demand. Besides, by conducting supply and demand analysis, the experts helped the client to balance supply and demand in a manner that achieves the financial and service objectives of the enterprise.
By leveraging our inventory management solution, the client was able to manage supply chain activities in the most efficient way. As recommended by the experts at Infiniti Research, the client invested into SCM software and increased visibility into the supply chain. This also enabled the client to synchronize supply and demand and reduce the likelihood of drug shortages. Besides, by increasing visibility into the supply chain, the client was able to improve communication, collaboration, and coordination with vendors, transportation, and shipping companies.
The experts also recommended the pharmaceutical manufacturing market client to leverage cold chain shipping to transport drugs that are heat sensitive and susceptible to contamination. Besides, by having real-time data on the availability of raw materials and manufacturing delays, the company was able to implement backup plans, such as sourcing materials from a backup supplier to prevent further delays. With more accurate demand predictions, the client was also able to reduce the overhead costs by optimizing warehouse layout, adopting the right automation tools to improve productivity, and implementing a better inventory management system.
Within one year, the pharmaceutical manufacturing market client reduced overhead costs by 32% using inventory management solution and achieved huge savings in profit margins.
By leveraging our expertise in offering supply planning, product planning, demand planning, sales and operations planning, and supply management, we can help you efficiently synchronize supply and demand. Request more info for detailed insights into our services.
The rising concerns over preventable medical errors is one of the primary reasons for pharmacy automation to gain momentum in the healthcare sector. Providers are opting for pharmacy automation solutions in an attempt to facilitate better medication distribution and reduce to medical errors. thereby assuring greater patient safety. These systems are also known to help curb pharmacy costs, which help mitigate the increasing drug prices and reduced reimbursement. Furthermore, the increase in budgets of healthcare providers over the last few years have fueled the adoption of pharmacy automation systems in healthcare facilities. Infiniti’s healthcare industry experts are of the opinion that the trend for increased automation budget is expected to continue through the next five years. In this article, we walk you through some of the key benefits of pharmacy automation solutions.
In the US alone, hospitals and pharmacies lose billions of dollars annually due to expired or unused drugs or medications. Furthermore, keeping tabs on the inventory in hand can often prove to be a tedious and time consuming task when done manually. Pharmacy automation can help overcome such challenges by keeping track of medicines that are unused or nearing expiry date. Pharmacy automation also provides the opportunity for staff, for whom non-clinical work gets tedious and provides less satisfaction, to cater to more key tasks in patient care. Also, pharmacy automation solutions are designed to provide real-time visibility into inventory, helping providers understand accurate inventory levels and medication purchases can be optimized for actual need. It also facilitates identifying medication that are unused and these can be immediately transferred to higher-use locations to prevent wastage.
Greater patient safety
Patient safety is paramount for any healthcare provider. Studies show that robot accuracy in medication handling is greater when compared to human accuracy. This is helpful especially in a pediatric setting where any small amount of variation in medication becomes unacceptable and require precisely calibrated dosage. Reducing the number of human touchpoints by leveraging pharmacy automation systems can help healthcare providers mitigate dosage errors and achieve complete inventory control, thereby ensuring complete patient safety.
Enhanced process efficiency
In pharmacy automation, automated prescription dispensing systems select and package medications and dispenses pills individually. In most cases, the medication is barcoded to ensure that the prescription and patients are mapped accurately. Robotic dispensers can also be handy in incorporating systems that drive workflow and expediate processes to enhance efficiencies, resulting in reduced costs in one comprehensive pharmacy solution.
The growing rate of the aging population with significant unmet needs is creating a high demand for pharma manufacturing companies. However, pharma manufacturing companies are also facing headwinds from unattractive pricing and volume expansion across all regions, growing size and bargaining power of payers, the emerging biological patent cliff, and the growing competitive pressure. Amidst these challenges pharmaceutical manufacturers are seeking to reduce operational costs and streamline cycle time within R&D. Below, our pharma industry experts have listed out some key strategies that pharma manufacturing companies can use to gain efficiency and enhance their R&D process.
Outsourcing at least a small part of research and development processes to emerging markets and low-cost centers can help pharma manufacturers to considerably reduce their overall costs. Companies in the pharma sector can take inspiration from other significant industries to relocate certain operations to areas where labor costs are cheaper. However, some pharma manufacturing companies are often skeptical about outsourcing R&D as it carries a heavy risk. This is one of the prime reasons why experts suggest shifting only non-core activities to low-cost centers.
Business process management
Companies in pharma manufacturing can gain increased efficiency by relying on business process management. Redundancies in processes can be reduced through automation and optimization. This can also help pharma manufacturers reduce their time to market and enable regulatory compliance with R&D phase of a new drug such as simplifying clinical trial processes, minimizing errors, and creating a collaborative research environment.
Eliminate ‘non-value adding’ activities
This is also often termed as lean process improvement. This method has proven effective for increasing efficiency and reducing operating costs for companies across various industries. Lean techniques can help pharma manufacturing companies to improve workplace efficiency within laboratories, while the focus on eliminating unnecessary steps can help speed up certain processes to reduce cycle time.
This is not a strictly process improvement technique, but an external strategic alliance can help pharmaceuticals manufacturing companies to streamline and improve operations that one company operating in isolation may not succeed in doing.
Every business endures pressure in terms of strict delivery schedules and meeting production efficiency. But when it comes to pharmaceuticals and healthcare product manufacturers, these deadlines become a matter of life and death, due to which ensuring product quality and timely deliveries are paramount for companies operating in this sector. This necessitates them to incorporate a changeover from existing pharma logistics strategies and traditional supply chain practices to new and innovative techniques to improve efficiency. Furthermore, in order to be adequately equipped to distribute pharmaceutical and healthcare products across Canada, pharma companies must be fully aware of the pharma logistics pain-points that the market has to offer.
Cold chains used for pharma logistics in Canada need to be highly robust due to the region’s vast territories. The region’s immense landscape provides challenging driving conditions including long distances, mountain winter conditions in the west, and unexpected weather scenarios that can result in roadblocks to effective delivery such as bridges ruined by rain, roads blocked by ice, and many other hazards. All of these factors have the potential to not only add to major transit delays but can also result in significant costs. Moreover, it can also prove to be difficult for pharma logistics providers to reach places up in the north due to limited infrastructure. In such territories, it may not be possible to place the pharmaceutical products on a direct flight to the required location, so the medicine may need to travel via truck for two days to complete the journey safely.
Extreme weather conditions
Temperatures can sometimes soar to extremes in Canada and this can sometimes compromise the quality of pharma products during transit. The pharma logistics facilities used must be able to protect the products from overheating in the hot climates or from freezing in the cold climates. This places a heavy burden on validating quality systems within the chain. The unpredictability of the weather conditions in Canada, in terms of their severity and duration, makes it extremely challenging for pharma logistics providers to preserve and ensure the quality and timely delivery of products.
Partnerships and collaborations
The pharmaceutical industry in Canada is rapidly moving towards an externalized R&D set up through partnerships and collaborations. A similar trend has been noted in the pharma logistics segment with several manufacturers outsourcing supply chain processes in an effort to benefit from the expertise of pharma logistics providers. However, this comes with challenges of its own. By delegating responsibilities externally, pharma manufacturers risk losing the end-to-end control that they once had on all their operations. Therefore, a stringent and robust quality agreement must be formed between all parties to protect the integrity of the product. Particularly well-defined standard operating procedures must be established regarding how the product and the raw materials will be treated. Cold chain partnerships with pharma logistics companies are largely a matter of trust. Once the cargo is handed to a forwarder or carrier, shippers must rely on their partners to safely steward their temperature-sensitive products through the cold chain. The success of these partnerships relies on effective communication. The best way to ensure effective monitoring of shipments is a truly collaborative approach, whereby all stakeholders charged with moving temperature-sensitive cargo work together to develop and implement the required programs.
The recent spate of selling pharmaceuticals from Canada into the US is only the tip of the iceberg. Canadian pharmaceutical companies were buying drugs at a lower price negotiated by the Canadian government and selling them across the border into the US where pricing is higher. This also occurs between borders in Europe between large wholesalers, as well as through black market transactions in developing countries. The danger here is that pharmaceutical companies lose the ability to know where these drugs are coming from. This can be largely avoided by the use of RFID technology.
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.
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.
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.
Internet of things (IoT) has the power to revolutionize pharmaceutical manufacturing in everything ranging from drug discovery to remote patient access and monitoring. Top pharma companies around the globe are increasingly adopting IoT technologies in their manufacturing plants in an effort to achieve optimization and improve process efficiency. Earlier, different data formats for different processes in a pharmaceutical manufacturing plant made data access and interpretation a significant challenge for effective communication. IoT technologies enable standardization within a pharmaceutical manufacturing plant by effectively connecting network, equipment, and systems across the plant. Furthermore, Pharma companies can also use IoT technologies to gain access to real-time data and visibility of operations through the entire manufacturing process. Here’s a detailed look on how IoT will transform pharmaceutical manufacturing.
IoT in Pharmaceutical Manufacturing
Industrial mechanics and maintenance
Although the use of industrial monitoring devices are already widespread in the pharmaceutical industry, real-time status information is yet to be widely available. Using pharma IoT monitoring sensors companies can instantaneously feed all relevant facility data into a single dashboard, alerting a supervisor in case of any abnormal conditions or urgent maintenance requirements. IoT in pharmaceutical manufacturing will also enable handling critical conditions remotely.
Managing pharma supply chain
Once the drugs leave the manufacturing plant, they travel through different modes of transport and may be subject to varying temperatures and weather conditions. Although in most cases care is undertaken to maintain the packages within the prescribed temperatures, chances of variations during transit cannot be completely ruled out. IoT can be helpful in such situations to provide real-time data to manufacturers every step of the way with improved supply chain visibility. The temperature changes or any damage to the products will be immediately notified to the manufacturers and determine whether the drugs are fit to sell or not.
Controlling drug manufacturing environment
In pharmaceutical manufacturing, sub-optimal environmental conditions can often prove to be fatal. However, this obstacle can be easily handled with the help of IoT. Pharma IoT establishes transparency in drug production and storage environment by allowing multiple sensors to monitor environmental indicators such as temperature, humidity, radiation, and light in real-time.