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Demand Planning + Vaccines Market

Tackling Supply Chain Challenges in the Vaccine Market with Data-Driven Strategies and Demand Planning Solutions

The eradication of widespread diseases has historically been achieved through the large-scale introduction of vaccinations. Over the decades, vaccines have become a necessity in most professional spaces, educational institutions, and countries. With the aim to avoid and eradicate diseases such as polio, smallpox, and malaria, the vaccine market has grown from a niche sector within the pharmaceuticals industry to an exponential and crucial market. Experts forecast further growth for the market; however, pharmaceutical companies continually struggle to maintain a streamlined, efficient, and durable supply chain.

Demand Planning

Demand planning is the first step toward maintaining a healthy supply-demand balance and the foundation for an optimized supply chain. This process helps companies forecast demand, efficiently manage inventory, improve sales and operations, and reduce costs. As the vaccine market grows and becomes increasingly challenging, avoiding supply-demand mismatch has become more complex. Therefore, in this article, Infiniti’s demand planning experts provide insight into significant challenges in the vaccine market and discuss how demand planning solutions can help companies overcome them.

The vaccine market is growing exponentially, and companies must ensure their supply chain strategies are efficient and current. Request a free proposal to learn how Infiniti’s demand planning solutions can help you prepare for industry developments and growth.

Significant Supply Chain Challenges and Demand Planning Solutions

The vaccine market has grown exponentially due to increased focus on public health, awareness about vaccines’ impact, and rising government expenditure. However, growth and expansion are often accompanied by various supply chain challenges. With demand planning solutions, pharmaceutical companies can identify, evaluate, and tackle these challenges within their supply chains and improve their overall performance. To further illustrate the impact of demand planning in the vaccine market, Infiniti’s experts discuss significant market challenges and potential solutions.

Challenge 1: Increasing Awareness Regarding Preventable Diseases

The most significant factor encouraging the adoption of vaccines is the potential of avoiding preventable diseases. Due to the commonly hectic and unhealthy lifestyle led by individuals across the globe and the deteriorating environmental condition, there has been a significant increase in various chronic diseases. Therefore, consumers are inclined to take precautionary steps to avoid any detriment to their health, including healthier habits and vaccinations.

Demand Planning

These changes have led to significant growth in the industry, and as demand increases, supply chain challenges become increasingly complex. With demand planning solutions, companies can forecast demand, analyze the growing market, and ensure no disparities between supply and demand. This, in turn, enables efficient inventory management, helps reduce holding costs or a waste of inventory, and ensure order fulfillment.

Vaccines have become a global necessity, and as they tackle preventable diseases, demand planning tackles potential supply chain complexities. Request more information to gain further insights into the vaccine market’s current challenges and demand planning solutions.

Challenge 2: The Impact of a Crisis – COVID-19

A medical crisis, a pandemic, or a sudden need for vaccines, can set market players back significantly if they are not prepared. Therefore, maintaining an agile, data-driven, and efficient demand planning strategy is imperative to growth and success. Although predicting potential crises may not be possible, proper demand planning can help avoid demand shortfalls. Currently, the COVID-19 pandemic has led to a significant focus on developing and distributing a new vaccine. This sudden development requires quick, efficient action and a comprehensive plan.

Demand Planning

Due to the COVID-19 pandemic, the pharmaceutical industry and vaccine market players search for solutions to long-lasting supply chain problems and complexities. With demand planning, companies can analyze relevant data, ensure their supply chain supports the operations required, and increase demand for the COVID-19 vaccine.

Challenge 3: Innovation and RNA Vaccines

Medical advancements have created a space for faster, inexpensive, and safer alternatives to traditional vaccines. RNA vaccines are a prime example of innovation and development in the vaccine market. The process can be standardized, and experts state that RNA vaccines can tackle allergies, cancer, and various infectious diseases. Preparing supply chains to develop and produce new products is crucial in this competitive and growing market.

Demand Planning

Demand planning solutions can help companies keep abreast of industry developments, innovations, and upcoming changes. With continuous and relevant data, market players can forecast demand, strategize for the distribution of new vaccines, and keep pace with consumers’ changing needs.

Innovation, COVID-19, and exponential growth have challenged vaccine market players. Speak with our experts to learn how our demand planning solutions can help your business overcome these market challenges.

Demand Management + Generic Drugs Manufacturer

Rising Above the Competition with Demand Management Solutions: Streamlining Supply Chains in the Generic Drugs Manufacturing Market

Generic Drugs Manufacturing Market Overview and the Need for Demand Management

The generic drug manufacturing market has witnessed immense growth in recent years due to the increasing prevalence of chronic diseases, rising population, and higher dependence on the pharmaceutical industry. However, this market’s time-sensitivity and highly competitive nature have made it increasingly challenging for industry players to grow and succeed. Significant challenges that impact generic drug manufacturers are the need for fast and efficient delivery of products, the importance of differentiating offers, and the increasingly crowded and competitive marketplace. Over recent years, industry leaders have focused on improving their supply chains and ensuring speed and quality in all their products. Demand management solutions help businesses address supply chain complexities, analyze past and present trends that affect their demand and identify the ideal management processes required to succeed in this combative market.

Growing demand for generic drugs and increasing competition have created a highly challenging marketplace. Request a free proposal to learn how our demand management solutions help generic drug manufacturers dominate their market.

Demand Management + Generic Drugs Manufacturer

Business Challenges:

The client is a generic drug manufacturer based out of the United States. Rising competition and increasing consumer demand for differentiated offerings were challenging for the client due to the lack of supply chain visibility and rising costs. Additionally, the generic drug manufacturer could not spearhead the introduction of highly demanded new off-patent drugs into the market and meet their consumers’ needs. This led to the client losing ground to competitors and an increase in customer attrition. The client also struggled to keep pace with competitive pricing and efficiently market their offerings, causing further losses. The manufacturer needed to streamline its supply chain, forecast and estimate consumer demand, and keep abreast of name-brand drugs’ patent expiration. Therefore, the generic drug manufacturer approached Infiniti Research to leverage our expertise in offering demand management solutions.

By partnering with Infiniti’s experts, the manufacturer of the generic drug also sought to:

  • Capitalize on profitable market opportunities
  • Identify suppliers for high-quality raw materials
  • Improve visibility into the supply chain
  • Understand and meet consumers’ demands

Ensuring an efficient supply chain and identifying strategic partnerships in the crowded generic drugs manufacturing space is imperative and challenging. Request more information to learn how Infiniti’s demand management solutions can help your business stay ahead of competitors.

Our Integrated Approach:

Infiniti’s demand management solution experts developed a comprehensive three-phased approach to assist the generic drug manufacturer in addressing their business challenges. The demand management engagement included the following:

  • The initial phase of the demand management engagement included creating transparency in the manufacturer’s supply chain, which required working closely with the company to identify, evaluate, and address supply chain complexities and potential obstacles.
  • The second phase involved a competitive benchmarking analysis to help the client identify strategies and approaches adopted by key competitors and industry leaders to ensure fast and high-quality new generic drugs into the market. Additionally, the client gained an understanding of their competitors’ pricing strategies.
  • For the third phase, Infiniti’s demand management experts helped the client improve communication across the supply chain and carried out strategic supply chain planning to enhance the manufacturer’s strategic relationships with consumers and suppliers.

Business Outcome of the Demand Management Solution:

By leveraging Infiniti’s demand management solution, the generic drug manufacturer successfully streamlined its supply chain by tackling complexities, mitigating potential obstacles, improving communication, and increasing visibility. The client also identified strategic supplier partnerships and successfully built a supplier base for high-quality ingredients and raw materials. Additionally, with our demand management experts’ insights, the client developed comprehensive strategies to improve their go-to-market timeframe and kept abreast of patent expirations to stay ahead of competitors. With an efficient supply chain and improved supplier partnerships, the generic drug manufacturer reduced costs and employed better pricing strategies. Furthermore, understanding their consumers’ needs and demands helped the client develop better demand management processes and increase customer retention. The demand management solution helped the generic drug manufacturer regain market share, reduce costs, and streamline their supply chain.

Waiting for the opportunity to become an industry leader? Speak with our industry experts to learn how our demand management solutions can help you create your path to the top.

Pharma Logistics + Market Research

Three Optimal Post-COVID Strategies for Pharma Logistics: Thought Leaders Identify and Discuss

The pharmaceutical industry is potentially the most challenging industry, with regard to supply chain complexities, regulations, competition, and logistics functions. Pharma logistics is an industry sector dedicated to acquiring, warehousing, and transporting pharmaceutical drugs, equipment, and devices. It is a challenging and tumultuous market, and requires a significant investment, strategizing, and data-driven decision-making.

Pharma logistics challenges include the risks of contamination, the need for temperature-controlled environments, regulatory changes, and ensuring no disruption of public health. Pharma companies have attempted to streamline their supply chain and logistics operations; however, these pharma logistics challenges continue to plague industry players.

The COVID-19 pandemic has caused various pharmaceutical industry challenges, including significant supply chain disruption, further regulation changes, added risks, and creating obstacles for important business operations, such as mergers and acquisitions. As companies attempt to overcome the various pharma logistics challenges introduced by the pandemic, it is equally crucial to establish sustainable strategies for the upcoming post-COVID era.

These strategies should aim to negate the pandemic’s impact and ensure that business continuity is secured in the case of other crises. Additionally, strategic business decisions will help pharmaceutical companies stay a step ahead of their competitors, enter the post-COVID era with robust business plans, and launch themselves into a period of growth. Therefore, in this article, Infiniti’s market research experts discuss the pharma logistics challenges caused by the COVID-19 pandemic and provide insights into our solutions and the ideal strategies for all market players.

The COVID-19 pandemic has had a jarring impact on the world and caused various pharma logistics challenges. To overcome these challenges and prepare for the post-COVID era with our market research solutions, request a free proposal.

Impact of COVID-19 on Pharma Logistics

The COVID-19 pandemic has taken a substantial toll on normalcy across industries, demographics, countries, and lives. Causing severe amounts of economic, political, and social unrest, the pandemic has inflicted further pressure on struggling pharmaceutical and healthcare industry players. The need to innovate is a constant pressure in the pharmaceutical industry, and the demand for an effective vaccine has enforced and increased this pressure substantially. Additionally, due to the impact on personal lives, employees, and professionals, most industries and companies have had to pause, stop, or restructure supply chains.

In the pharmaceutical industry, this change has included changes to the pharma logistics sector and increased the need for improved strategies and streamlined operations. Transportation has been paused in many countries, raw materials are challenging to acquire, companies have suffered losses, and these challenges have left the pharma industry at a major disadvantage.

However, as governments, researchers, and companies discover and develop the ideal vaccine to the COVID-19 virus, industry players can develop strategies to tackle pharma logistics challenges. Comprehensive and sustainable strategies can help negate the impact of the pandemic and ensure an overall improved supply chain across the industry.

Overcoming the business implications of COVID-19 can be highly challenging. Request more information and learn how your company can identify, evaluate, and address all pharma logistics challenges caused by the pandemic with our solutions.

Strategies for Pharma Logistics in the Post-COVID Era

Infiniti’s market research experts have analyzed the impact of the COVID-19 pandemic on the pharma logistics sector and studied industry players’ pain points. With their observations, they have identified three significant challenges and their ideal solutions in this article. These strategies aim to help pharmaceutical industry players tackle the major pharma logistics challenges and ensure smooth operations in the post-COVID era.

Pharma Logistics + Market Research

Strategy 1: Identify Multiple Supply Sources

Most pharmaceutical companies witnessed their operations come to a screeching halt as the pandemic impacted China and India. Being the most prominent countries sourcing crucial active pharmaceutical ingredients (APIs), the global pharmaceutical industry was set-back substantially by the sudden unavailability of imperative raw materials. Although the US and Europe manufacture APIs, China and India hold a much larger market share, and India is known to be the largest manufacturer of generic drugs.

This overdependency on one particular vendor, source, or country led to huge losses and disruptions in the pharmaceutical industry. Therefore, Infiniti’s market research experts highlight the importance of identifying and enlisting other suppliers and vendors for the sake of emergencies or general raw material procurement. With our market trackers, pharmaceutical companies can keep track of vendors, suppliers, products, and services from around the world. This allows companies to find stand-by vendors and gain comprehensive guidance from our experts regarding identifying and establishing the ideal partnerships in the pharmaceutical industry. Additionally, market trackers can help companies overcome pharma logistics challenges regarding raw material sources with constant global updates and data.

Strategy 2: Establish Crisis Management Systems

The pandemic spread fast and caused a global panic. Governments closed down their countries, companies had to stop operations, and individuals had to quarantine. The economic impact of these decisions was vast and unfettered due to the lack of pre-emptive measures. Understandably, preparing for a pandemic is neither expected nor easy to plan. However, market risk, natural disasters, and economic uncertainty are impending and potential challenges that industries and governments face.

Establishing efficient, data-driven, and comprehensive crisis management strategies can be the differentiator between industry leaders and companies experience losses. Infiniti’s risk assessment solutions help businesses identify potential risks in their markets, establish effective risk or crisis management systems, and mitigate risks substantially. With our risk assessment solutions, pharmaceutical companies can identify potential risks, reduce significant problems, and stay prepared for future pharma logistics challenges.

Strategy 3: Protect Employees and the Supply Chain

Social distancing, renewed hygiene protocols, regulations regarding personal protective equipment, and strict enforcement of these protocols have become standardized across countries. This has led to various pharma logistics challenges, including the inability to continue previous operations without risking employee safety and the possibility of contaminated drugs, devices, and equipment being transported. Additionally, pharma industry players must comply with more challenging regulations and hygiene protocols to maintain business continuity and avoid customer churn.

To ensure employee safety and minimize potential contamination through the supply chain, pharmaceutical companies can adopt industry best practices and efficiently comply with government policies. Infiniti’s industry best practices assessment enables pharmaceutical companies to benchmark and analyze best practices used by industry leaders or key competitors and utilize them to ensure employee and supply chain safety from the virus, contamination, and other challenges.

Infiniti’s market research solutions can help your business enter the post-COVID era with robust and sustainable strategies. Speak with our experts and learn how our solutions have assisted pharmaceutical industry players through the pandemic.

Drug Development Process + Product Research

Simplifying the Drug Development Process with Expert Insights and Product Research Solutions

In an industry as competitive as the pharmaceutical industry, innovation is the best strategy for success. Unfortunately, innovation in this industry is a challenging process. The drug development process is a long, taxing, and exhaustive process, regardless of the size of a company. Although the process becomes easier with more available resources, workforce, and a better understanding of the regulatory requirements, many major pharma companies may still struggle to complete the process without experts’ guidance.

The drug development process across the world is divided into various phases, starting from drug discovery to post-marketing safety surveillance. There are five phases of drug development in the United States, including discovery, research, and acquiring regulatory approval from the US Food and Drug Administration (FDA).

Many top pharmaceutical companies leverage market research services and product research solutions to ensure an effective drug development process. In this article, Infiniti’s experts discuss the five phases of the drug development process and the value of product research services during each phase.

The pharmaceutical industry is highly competitive, and companies must prepare for every aspect of competing in this market. Speak to our industry experts to learn how Infiniti’s solutions can help pharmaceutical companies stay ahead of the curve.

Five Phases of the Drug Development Process and How Infiniti’s Product Research Services Can Help

Infiniti’s experts analyzed the drug development process in the US pharmaceutical process and identified the following five phases of drug development:

Discovery and Development

The first phase of the drug development process is the discovery of a hit compound. Academic and industry scientists identify a potential target for any disease and aim to discover and develop a compound that can alter the druggable target activity. A target is considered druggable if it can be changed or treated by therapeutic agents. Various screening methods such as phenotypic screening or fragment-based screening are then used to identify a hit compound, and the effect of the said compound is analyzed. Multiple hit compounds may be used to address the same or various druggable targets for a disease. To determine the drug candidate that the scientists choose to take forward as a clinical candidate, they must ensure that it affects the selective target, generates the desired effect, and has adequate bioavailability. Additionally, it must have a toxicity profile, manufacturing suitability, and cost-effectiveness.

Product research solutions enable companies to evaluate and understand this phase of discovery and development. With advice from Infiniti’s product research experts, companies gain in-depth insights into the scalability of the clinical candidate and illustrative guidance regarding the cost-effectiveness of their drug. Additionally, with data-driven insights, scientists can identify unmet needs and target the ideal population, and companies can analyze competitors’ targets.  

Preclinical Research

The second phase of drug development involves proving the efficacy and safety of the drug candidate. In vitro and in vivo testing methods are utilized to study the candidate’s biological effects. This includes testing animal models and evaluating the impact on a species with a similar genetic makeup. To acquire approval from regulatory bodies, such as the US FDA, it is crucial to conduct this research while considering species-specific physiology and sex-specific responses in the animals. The FDA provides a specific set of regulations for the second phase of the drug development process. These regulations include basic requirements for personnel, facilities, equipment, and more. While preclinical studies are short, they must provide information regarding toxicity and dosing levels. This helps the researchers determine if the drug candidate meets preclinical requirement levels and can be tested on human subjects.

With guidance from product research experts, researchers and companies can attain crucial information regarding regulatory requirements. They can also understand the strategies, technologies, and equipment leveraged by their competitors, and always remain a step ahead. Additionally, product research solutions can enable companies to identify gaps in their offerings or operations and address them by developing data-driven strategies.

Clinical Research

Designing an effective clinical trial requires rigorous research, planning, and studying. Researchers must develop a specific protocol or plan, review preliminary information about the clinical candidate, and accordingly develop research questions and objectives. This information helps the researchers decide various important factors, such as selection criteria, number of participants, length of the study, administration and dosages, methods of collection, and data analysis. One of the crucial stages of the clinical research phase is submitting an Investigational New Drug (IND) Application. There are three kinds of IND applications, investigator, emergency use, and treatment. The FDA team has 30 days to review the IND application and respond in one of two ways, approval, or a clinical hold to delay or stop the investigation. The clinical research stage of the drug development process has between three to four phases within it, which depends on the protocol decided by the researcher. Obtaining guidance from the FDA at this stage of the process is possible, including extensive technical assistance, if a drug developer chooses to leverage the aid.

Infiniti’s product research experts can enable companies to design an effective clinical trial protocol, gain a comprehensive understanding of the FDA guidance and approval requirements. Further, researchers can analyze and evaluate the factors being taken into consideration regarding the clinical trial design with expert guidance. Additionally, the drug developers will receive recommendations and directions regarding the crucial IND application.

The drug development process is challenging and long drawn. To learn more about the process, and overcoming obstacles with product research solutions, request more information.

Drug Development Process + Product Research

FDA Drug Review

Once a researcher or company has evidence regarding the drug’s safety and efficacy, they may file a New Drug Application (NDA) to market the drug with the FDA. This application includes all the relevant data from the preclinical and clinical research phases. The application should consist of details regarding the proposed labeling, safety updates, drug abuse information, patent information, directions for use, and more. The FDA then reviews all the details of the application. In the case that the application is incomplete, they will refuse to file the NDA. If it is complete, the FDA review team can take between 6 to 10 months to review the drug and the data and decide to approve it. This process includes a thorough review of each section by the relevant team member, routine inspections of clinical study sites across the country, and the compilation of all reviews and documents into an “action package.” Often, there is a set of issues that need to be resolved before the FDA approves the drug. In certain cases, resolution may include conducting more studies, at which point the drug developers can decide if they want to complete the drug development process. In particular situations, the FDA may approach their advisory committees for independent, expert inputs and advice, including a representative to provide the patient perspective.

Infiniti’s product research solutions can enable drug developers to ensure the NDA is complete and qualifies for all the regulatory requirements. Additionally, our experts can provide researchers with crucial information regarding other patents in the market and the patent process. Product research solutions also help developers understand the patient’s perspective, ensure that their drug fulfills unmet needs, and is positively received by patients and representatives.

Approval and Post-Marketing Safety Surveillance

Once a drug has been approved, and companies begin manufacturing and marketing, the FDA continues to survey the drug in the market. This includes the announced or unannounced inspection of manufacturing facilities and regulations regarding prescription drug advertisements and promotional labeling. The post-marketing safety surveillance aims to evaluate the long-term efficacy and safety of the drug, potential problems that could arise outside of a controlled environment, and possible use for unapproved conditions. The FDA also has various programs that allow professionals, consumers, and manufacturers to report any issues associated with a drug. Additionally, the introduction of the Sentinel Initiative enables the FDA to use major existing electronic health databases to spot safety issues easily.

Product research solutions enable drug developers to stay a step ahead of the FDA regulations and ensure their drug meets all the requirements. Infiniti’s experts can also guide companies regarding the compounds, packagers, and manufacturers to ensure post-marketing safety with well-researched insights. Manufacturers can also learn about the ideal equipment and technologies for manufacturing the drug and the FDA regulatory requirements.

Final Thoughts

Infiniti’s product research solutions can enable companies to overcome the difficult drug development process’s various challenges. Our experts provide insights regarding regulatory requirements, ideal technologies, competitors’ strategies and patents, and consumers’ unmet needs. This offers companies and researchers a substantial strategic advantage, a clear plan through the five phases, and the post-marketing and manufacturing stages. With expert insights, experienced advice, and crucial data, drug developers can prepare, implement, and complete an efficient and safe drug development process.

Infiniti’s product research solutions can enable companies to overcome the drug development challenges and establish themselves as industry leaders. Request a free proposal to leverage Infiniti’s data-driven insights, expert guidance, and unparalleled strategies.

Pharmaceutical Value Chain + Market Intelligence

Restoring Normalcy in the Pharmaceutical Value Chain: The Impact of COVID-19 and the Next Step to Success

The COVID-19 pandemic has challenged industries, countries, and governments endlessly over recent months. The spread of the virus has led to a range of issues that impact the foundation and functioning of business operations, GDPs’, and supply chains. All industries are now working towards recovery, and the pharmaceutical industry is attempting to regain control and functionality across the pharmaceutical value chain.

The pharmaceutical value chain includes every component and every process from manufacturer to end-consumer. This includes, but is not limited to, manufacturing, acquiring regulatory approval, import and export, distribution, and retail. The safety regulations, nationwide lockdowns, and transportation disruptions caused by the COVID-19 pandemic are among the biggest factors impacting the pharmaceutical value chain.

Pharmaceutical companies have attempted to develop more streamlined processes and taken various initiatives prior to the COVID-19 pandemic due to the pharmaceutical value chain’s fragmented nature. However, few have succeeded, and the different strategies utilized by companies did not protect the value chain from the hard-hitting impact of the COVID-19 pandemic.

As the pharmaceutical industry focuses its effort towards recovering the pharmaceutical value chain, companies must understand the impact of the pandemic. Therefore, in this article, Infiniti’s market intelligence experts detail the effects of the COVID-19 crisis on the pharmaceutical value chain. Additionally, they discuss the best path to recovery for pharmaceutical companies and highlight the value of market intelligence solutions in this attempt to return to normalcy.

The pharmaceutical industry is on the path to recovery and companies need to strategize for the changing market dynamics and impact of the COVID-19 pandemic. Speak to our industry experts to learn how companies can develop the optimal strategies to face these challenges.

Impact of COVID-19 on the Pharmaceutical Value Chain

As is the case with most industries, there have been innumerable problems posed by the advent of the COVID-19 pandemic in the pharmaceutical value chain. However, three major segments have been severely impacted and will need the most focus and recovery strategies from pharmaceutical companies. The impact of the COVID-19 pandemic on the pharmaceutical value chain can be witnessed in the following three segments:

Pharmaceutical Value Chain + Market Intelligence

APIs and the Dependence on APAC Countries

The pharmaceutical industry’s raw material supply chain was disrupted by the high dependence of pharmaceutical companies on China and India. The two APAC countries source a majority segment of the active pharmaceutical ingredients (APIs), intermediates, and reagents required by pharma companies. Since China was the first infected country, the raw material supply chain was slightly challenged. However, the spread of the virus has impacted India severely and caused a major disruption in the pharmaceutical value chain.

While China is on the path to recovery and is attempting to return to normalcy, India has many obstacles to overcome before it can successfully overcome the impact of the COVID-19 crisis. Restoring operations and recovering from the effects of the pandemic will cost the pharmaceutical value chain a substantial amount of time and effort due to this factor.

Logistics and Distribution Challenges

Countries across the globe have announced nationwide lockdowns and severely limited domestic and international transportation. Although this step was crucial for the containment of this deadly virus, it has led to major logistical challenges across industries. The pharmaceutical value chain has been similarly impacted due to transportation and distribution limitations.

The fragmented nature of the pharmaceutical value chain is one of the reasons the transportation restrictions are impacting the industry severely. The process involves the procurement of various raw materials from different locations in the APAC, North American, and European regions. Additionally, the manufacturing, packaging, distribution, and retailing are conducted in various areas. With the continuous spread of the virus and government restrictions on population movement and transportation, pharmaceutical companies need to evaluate their distribution and logistics strategies to maintain business continuity.

Paused Clinical Trials and the Drug Development Process

A large number of clinical trials worldwide have been suspended, postponed, or halted since the advent of the COVID-19 pandemic. Stakeholders consider this the most impacted segment in the pharma industry. Due to the need for social distancing, the limitations on transport, and the requirements of new hygiene protocols, conducting clinical trials and collecting real-world evidence has been challenging for pharma companies. The halting of clinical trials translates into a delay in the development and time-to-market for various therapies and drugs.

Simultaneously, pharmaceutical companies are struggling to conduct clinical trials to develop a vaccine for the SARS-CoV-2 virus, which causes COVID-19. However, they face challenges finding ideal candidates and carrying out their clinical trials despite the various limitations. Pharma companies and governments are working towards digitalizing the clinical trial process with innovative alternatives such as telemedicine and mailing trial drugs. Efficiently digitalizing, and overcoming the various challenges caused by the COVID-19 pandemic will help companies develop a vaccine and fast-track recovery worldwide.

Understanding the impact of the COVID-19 pandemic on the pharmaceutical value chain is a crucial step for recovery in the pharmaceutical industry. Request more information to gain more in-depth insights into the challenges caused by the pandemic and the next step to recovery.

How can Market Intelligence Solutions help Pharmaceutical Companies Overcome the Impact of COVID-19?

Pharmaceutical companies need a series of solutions to assist them in their attempt to recover from the impact of the COVID-19 pandemic. The pharmaceutical value chain has been significantly disrupted through 2020, and by re-establishing normalcy soon, companies can minimize the long-term implications of the pandemic across the value chain.

Infiniti’s market intelligence solutions can provide companies with insights, guidance, and strategies to help their industry recover as quickly as possible. There are various crucial factors that pharma companies must focus on during the process of recovery, and Infiniti’s market intelligence solutions can help them adapt and recuperate as required. Our market intelligence experts can help pharma companies and the pharmaceutical value chain in the following crucial ways:

  • Companies must improve transparency on the various levels of the supply chain and identify alternative sources for the different raw materials or services that are unavailable. Infiniti’s demand planning solutions enable companies to provide visibility into their operations and supply chains required to make real-time decisions and keep stakeholders informed.
  • There is also an increasing need for companies to analyze their inventory, estimate the available inventory across the value chain, and attempt to continue production and delivery to customers. With Infiniti’s inventory management solutions, companies can try to fulfill customers’ demands despite the disruptions caused by the COVID-19 pandemic.
  • Pharmaceutical companies must also focus on understanding and strategizing for the changing demands of their consumers. With social distancing and new hygiene protocols, consumers have been less likely to renew their prescriptions. Infiniti’s demand management solutions can enable companies to predict, plan, and meet customer demands accurately.

The pharmaceutical industry can successfully recover the pharmaceutical value chain with efficient planning, management, and strategizing. Infiniti’s market intelligence solutions provide companies with the data-driven insights and expert guidance they require to efficiently overcome the impact of the COVID-19 pandemic across the value chain.

Infiniti’s market intelligence solutions can serve as the differentiator between a quick recovery and additional challenges for companies attempting to recover the pharmaceutical value chain. Request a free proposal to enter the post-COVID era as a pharmaceutical industry champion with our expert insights and guidance.

Pharmaceutical Manufacturing Companies + Market Entry

Breaking the Norm: Overcoming Barriers to Entry in the Pharmaceutical Manufacturing Industry

The pharmaceutical manufacturing industry is expected to witness substantial growth in the coming years due to various contributing factors. As lifestyles and habits change, awareness about health and wellness increase, and demand for immediate relief grows, the market is bound to continue growing. Due to advancements in the pharmaceutical and technological fields, there has been an increase in the average life expectancy globally. This directly translates to a larger population of elderly or geriatric individuals, and a continuous need for the pharmaceutical manufacturing industry.

Although awareness about health and wellness is growing, the prevalence of terminal and chronic diseases has grown substantially in recent years, and the need for pharmaceutical drug discovery and development has increased. The pharmaceutical manufacturing industry has also seen a rise in demand due to easy access in the market, with the increased availability of over-the-counter (OTC) medicines. With these market growth drivers, the industry has become a highly competitive space and is attempting to recover from the disruptions caused by the COVID-19 pandemic.

Additionally, pipeline players are now attempting to establish themselves in the recovering industry successfully. However, this industry is considered among the top 10 industries with the highest barriers to entry. Therefore, Infiniti’s market entry experts analyzed the market and identified the most significant barriers to entry in the pharmaceutical manufacturing industry.

With their in-depth analysis, the experts identified four significant barriers to entry, among many others. While identifying and understanding these barriers to entry is important, it is essentially the first step in the process of becoming an industry leader. Infiniti’s market entry analysis helps companies identify, evaluate, and efficiently maneuver the barriers to entry in the pharmaceutical manufacturing industry. In this article, Infiniti’s experts discuss the significant barriers to entry in the pharmaceutical manufacturing industry and highlight the benefits of our market entry analysis.

Entering a market as competitive as the pharmaceutical manufacturing industry is a challenging ordeal. Request a free proposal to successfully break the norm and overcome market entry barriers.

Pharmaceutical Manufacturing Market Entry Barriers

Every industry is plagued with various barriers to entry. Not only is the pharmaceutical manufacturing industry one among these industries, but it also stands among the top 10 most difficult industries to enter. Therefore, our market entry experts identified and evaluated the following four most significant barriers to entry in the pharmaceutical manufacturing industry:

Economies of Scale

The pharmaceutical manufacturing industry requires a well-established distribution network and appropriate infrastructure. This is challenging for new entries into a market and serves as a major barrier to entry. As large pharmaceutical companies dominate the industry, it is difficult for new companies to produce the same drugs at the exact costs and gain market share. Economies of scale play a role in industries such as this one, wherein producers manufacture large quantities of small products. Additionally, brand name recognition plays a crucial role in prescription drugs, particularly drugs with certain effects. Consumers will rarely if ever, choose a brand that is not widely acclaimed or trusted. Therefore, new companies struggle to establish a brand name and gain market share when competing with larger, established pharmaceutical manufacturing companies.

Regulations and Approval

The pharmaceutical manufacturing industry has highly stringent and continually increasing regulations. In the US, the Food and Drug Administration (FDA) takes an average of approximately 21 months to approve a new drug. All pharmaceutical drugs must gain all required regulatory approvals before marketing. Additionally, acquiring FDA approval has proven to be highly challenging, with an extremely low success rate. Obtaining the required approvals is long-drawn and can be extremely expensive for small or new pharmaceutical companies. More often than not, this waiting period allows well-established companies to replicate the product and file a 180-day market exclusivity patent, which in turn provides them with a temporary monopoly. Following this, establishing a monopoly for the new drug can pose a tremendous challenge for the newer company.

Investment Capital

Establishing the required infrastructure, conducting clinical trials, and acquiring all regulatory approvals is extremely expensive. As companies attempt to enter this highly competitive market, they must invest a substantial amount over multiple years. Clinical trials alone require large investments and can still not be approved by the FDA and its parallel administrations across the world. In the US, it can take between 10 to 15 years for a new drug to complete the research and development process, and still face the possibility of not being approved to prescribe for customers. These expenses can be higher depending on the purpose and components of the drug being developed. For new market entries, this translates into high levels of investment, over a prolonged period with no revenue, and the possibility of not gaining approval. Whereas, established pharmaceutical companies continue to earn revenue from previously approved drugs and have the infrastructure in place.

Intellectual Property and Patents

The legal aspect of pharmaceutical manufacturing is agreeably one of the most significant barriers to entry in this market for two reasons. Larger pharmaceutical companies have approved patents that enable them to legally stop new companies from entering the market without establishing a new drug. Additionally, acquiring a patent is a challenging process, and often, patents expire before new companies can acquire the regulatory and FDA approvals that are needed to market and distribute the drug. This enables larger companies to replicate the product and use their distribution and marketing networks to establish a monopoly with the new drug, making it more challenging for new companies to gain revenue and market share.

Request more information to gain more in-depth insights into the impact of investment, regulations, and patents on new companies in the pharmaceutical manufacturing industry.

Pharmaceutical Manufacturing Companies and Market Entry Analysis

Infiniti’s market entry analysis helps new pharmaceutical manufacturing companies identify market entry barriers. It also helps identify and capitalize on appropriate market opportunities and understand the market that they choose to expand into or enter. Infiniti’s market entry experts also help companies with the following:

  • Understanding the needs and expectations of customers, identifying and developing the ideal consumers-centric products that gain the trust of their consumer base
  • Identifying and planning for the most profitable segments of a market, and making optimum use of the company’s resources
  • Evaluating and efficiently maneuvering various barriers to entry, improving profit margins, and extending its business in new, and existing markets

In the pharmaceutical manufacturing industry, Infiniti’s market entry analysis enables companies by providing in-depth insights into the barriers to entry discussed above and other potential obstacles. It also allows them to gain market share in their category and generate substantial savings. Additionally, market entry analysis provides companies with the information they need to develop or adopt strategic initiatives to overcome common challenges, such as regulatory issues or changing market dynamics.

To learn how market entry analysis addresses regulatory and intellectual property challenges in the pharmaceutical manufacturing industry, speak to our experts.

Pharma secondary packaging market

Infiniti’s Competitive Intelligence Solution for A Prominent Company in The Pharma Secondary Packaging Market: Exploring Key Packaging Innovations And competitive landscape Insights

In pharmaceuticals, secondary packaging constitutes the packaging which does not come in direct contact with the dosage form. Pharma secondary packaging is becoming widely adopted and essential as they offer critical functionalities, such as, for physical and barrier protection, secondary containment, adherence to regulations, and consumer safety. It also creates a buffer and protects primary packages from each other during transportation.

Business challenge

A prominent pharmaceutical company headquartered in San Francisco, CA sought to explore the changing trends in the secondary pharma packaging market by focusing the research on major design/technology innovations and best practices adopted by leading players in the pharma secondary packaging market. Through the engagement, the client wanted to support their future packaging developments and track industry trends over time. By leveraging Infiniti’s competitive intelligence solution, the pharmaceutical company wanted to understand the competitor landscape in the US and European pharma secondary packaging market, new features of secondary packaging being incorporated by competitors, product portfolio descriptions, and competitor strategies to promote adherence.   

Want comprehensive insights into the market drivers, challenges, key industry players, and more in the pharma secondary packaging market? Request a complimentary proposal.

Our Approach

Experts at Infiniti Research started by delving deeply into the pharma secondary packaging market transformation over the past decade in the US and Europe. This involved a well-balanced combination of primary and secondary research. Telephonic discussions were undertaken with over 45 respondents with expertise in the development, sales, marketing, and usage of products and services related to secondary packaging market such as pharmaceutical packaging specialists, packaging engineers, and packaging development experts. The secondary research undertaken by our analysts included comprehensive research materials from company websites, industry news CPA, HCPC, CHPA, packaging digest, and public database.

Through extensive competitive intelligence study and research methodologies, experts at Infiniti Research were able to identify the top pharma secondary packaging designs that are predominantly used. This includes medication adherence packaging, extended labels, and increasing use of sustainable materials in pharma secondary packaging. Furthermore, Infiniti’s competitor landscape assessment also identified some of the key competitors in the US and Europe, their respective packaging initiatives, and critical initiative undertaken to promote adherence.

With a focus to ensure product integrity, better manufacturing efficiency, and enhancing customer satisfaction, experts at Infiniti Research have identified that companies are developing innovative technologies such as thermochromic indicators and contemporary cartons designs. Furthermore, with Infiniti’s recommendation, the client adopted robotics and process automation that significantly improves production output, lowers operating cost, and enhances worker safety.

Business Impact

By leveraging Infiniti’s competitive intelligence solution, the client was able to successfully track their key market competitors and identify some of the most innovative and viable trends in the pharma secondary packaging market. Apart from this client was also able to:

  • Increase investments on their primary and secondary packaging lines by adopting technologies which result in faster turn-around time, fewer errors, and higher adaptability to incorporate and reproduce design changes
  • Collaborate with the CPO to formulate innovative packaging designs which are senior-friendly, child- resistant, medication adherence promoting, and offers unique dispensing mechanisms
  • Expedite early market entry for biologics and personalized medicine by identifying advancements such as 3D printing in pharmaceutical packaging
  • Reduce operational cost by 30% within this first quarter by adopting RPA into packaging operations
  • Focus on packaging designs that are cost-effective and have shorter production turnaround times
  • Incorporate adherence features in the secondary packaging design to help practitioners promote the use of the drugs to the patients
  • Build an effective planning and production process to minimize packaging errors and prevent product recalls, saving the company over $1.2 million within six months

For similar engagements for your business, get in touch with an industry expert

pharma M&A

Capturing Value from Pharma M&A: Critical Considerations for Success

The pharmaceutical industry is one of the major sectors that is actively involved in huge mergers and acquisition (M&A) deals, both in terms of numbers of deals and the amount of money spent. Most companies in the sector, especially the big pharma consider pharma M&A as a major factor to bolster innovation and overall growth. A recent research by our pharma industry experts shows that revenues coming from innovations sourced outside of Big Pharma is currently stands at over 45%. Over the years, several large, game-changing deals have continuously and profoundly changed the competitive landscape of the sector, while smaller yet significant transactions remain an integral part of pharma industry operations.

Why Pharma M&A is a driver of strategic repositioning?

Pharma M&A has become a common practice for companies that have non-diverse pipelines or have top revenue drugs that are nearing patent expiration and subsequent generic erosion. According to industry experts at Infiniti Research, some of key reasons why companies favor pharma M&A include:

  • The critical size requirements across various market segments have increased exponentially over the years. At this rate, it becomes nearly impossible for a single company for companies to survive on their own. This made strategic pharma M&A a necessity for most companies
  • Large mergers in the pharma industry allow bundling of sub-critical businesses, and thereby change the culture and to build new platforms
  • Another motivation for pharma M&A is to capture annual cost synergies by scaling up

For more insights on our portfolio of services for companies in the pharma industry

Consideration for successful M&A

Achieving Successful Integration Post Pharma M&A

Approximately only 60% of pharma merger deals succeed in the long run. A successful merger is one wherein the resulting company achieves the strategic intentions driving the merger when the deal was initially formed. Mergers that fail often show traits including focusing more attention on back-office integration, cost control, and systems consolidation.

Creating business synergies

Revenue increases during pharma M&A can often more difficult to achieve and take longer than expected. During pharma mergers and acquisitions teams must develop strategies such as the degree to which the existing portfolios need to be rationalized, how teams can be used to increase efficiency, how salesforce can be consolidated to remove overlap, and how the projects of each of the brands can be enhanced.

Defining the integration strategy

The successful integration of two companies largely depends on having a consistent approach with strategic intent. Guiding principles, priorities, and governance must reflect the logic behind the merger. A reliable integration strategy must be efficient in articulating both financial and nonfinancial goals, as well as risk-mitigation strategies.

Request a free proposal for more insights on how we can support your pharma M&A efforts.

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