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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.

Healthcare M&A + M&A Support

Overcoming the Impact of COVID-19 and Preparing for a New Future in Healthcare M&A

The healthcare sector is facing tumultuous times in 2020. With the widespread COVID-19 pandemic, major business operations are disrupted, hospitals are overloaded, medical professionals are overworked, and healthcare institutions’ boards attempt to maintain normalcy. Healthcare M&A is one such crucial segment of the healthcare sector that was nearly brought to a screeching halt in the second quarter of 2020.

An increasing number of cases in North American countries and some parts of Europe and APAC have worsened the state of economies and industries. Although the healthcare and pharmaceutical industries have devoted their time and effort to the COVID-19 pandemic, the world is still a long way from a vaccine or normalcy of any kind. Consequently, this poses a challenge for the aforementioned hospitals, medical professionals, and healthcare institutions’ boards.

Currently, healthcare institutions are in the midst of a crisis with no clear ending. While investor support has increased due to the increasing need for healthcare globally, social and political unrest, struggling economies, and volatility in financial markets are testing the healthcare industry. Healthcare M&A may be one of the most effective solutions to this crisis.

In this article, Infiniti’s M&A support team has detailed the impact of the COVID-19 crisis on healthcare M&A, positive factors influencing the recovery of healthcare M&A, and the importance of M&A support.

The COVID-19 crisis has severely impacted healthcare M&A. To learn the business implications of COVID-19 on healthcare M&A, speak to our industry experts.

The Impact of COVID-19 on Healthcare M&A

The COVID-19 pandemic has taken a substantial toll on developing healthcare mergers and ongoing healthcare M&A deals. Infiniti’s experts identified the following three major challenges that healthcare institutions can expect to impact the healthcare M&A process:

Healthcare M&A + M&A Support

Regulatory Delays

Nationwide lockdowns in countries, including the United States, New Zealand, and the United Kingdom, has caused a severe delay in acquiring regulatory clearance. With all operations on hold, government bodies focusing on COVID-19 related issues, and professionals being forced to work from home, all-important regulatory approval processes have been on hold. However, companies can fast track their M&A processes by ensuring other parts of the process have been completed before the situation normalizes.

Changing Valuations

The impact of COVID-19 on healthcare M&A participants in ongoing deals will potentially change both the buyer and the seller’s valuation. This may lead to the collapse of previous deals or the need for re-valuation of both parties. Revision of the purchase price and financial statements accounting for the COVID-19 impact may help fast-track this process. However, this may still impact potential or ongoing healthcare mergers due to the continuing effects of COVID-19 and an unclear deadline on the crisis.

Due Diligence and Third-Party Approval

Healthcare M&A requires rigorous due diligence from both parties involved. Due to the lockdowns, new safety and hygiene protocols, and the need for social distancing, this process has been delayed, if not stopped. Additionally, both parties may request another round of thorough due diligence in the case of ongoing mergers. Further, third party activities such as audits, on-site visits, and inspections will be delayed, slowing down the M&A process for healthcare institutions.

Understanding the challenges of healthcare M&A is the first step towards successful mergers for healthcare companies. To gain a more comprehensive understanding of the challenges and how your organization can tackle them, request more information.

The Path to Recovery

The world is working towards recovery, pharmaceutical, and healthcare sectors worldwide are attempting to develop a vaccine. Simultaneously, governments are taking initiatives and providing support to industries to reduce the COVID-19 crisis’s impact. However, this process is expected to be slow and long-drawn. Therefore, Infiniti’s experts have highlighted the following two minor factors positively impacting healthcare M&A:

  • The hospital segment, innovation-focused biotech stocks, and large pharma companies may see a surge in valuation due to the high dependence on hospitals and the ongoing work to find a vaccine. This may encourage multiple buy-outs and influence extremely attractive valuations.
  • The capital position of private equity firms is expected to provide them with the opportunity to assess and capture resilient assets shortly.

Although there are limited positive factors influencing healthcare M&A currently, increasing demand for healthcare services and relatively minimal disruptions may fuel growth in this space. However, companies must evaluate their M&A partners and enter into healthcare mergers cautiously in these challenging times.

Importance of M&A Support during the Healthcare M&A Process

The recovering healthcare M&A sector has yet to face various challenges posed by the jarring COVID-19 crisis. As companies continue, plan, or complete deals, they must evaluate all potential risks and gain a comprehensive understanding of their partners. Infiniti’s M&A support solutions enable companies to identify, assess, and prepare for all the factors that influence any healthcare M&A.

Infiniti’s M&A support also provides healthcare companies with the following:

  • Assistance with identifying ideal partnerships and potentially beneficial mergers
  • Expert insights into appropriate valuation and important decisions regarding transactions and investments
  • A comprehensive understanding of every stage and process in the healthcare M&A process
  • Data-drive insights that also account for the changing landscape and current competitive scenario of the healthcare industry

Infiniti’s M & A support experts can help companies tackle the challenges caused by the COVID-19 pandemic and identify and evaluate the risks involved in potential deals. This will enable companies to stay a step ahead of competitors, identify and assess ideal opportunities, and keep abreast of all factors influencing the healthcare M&A process.

Leveraging Infiniti’s M&A support solutions can help identify the ideal partnership, maintain business continuity through the COVID-19, and overcome the business implications of this crisis. Request a FREE proposal to learn more about the value of M&A support solutions in the recovering healthcare M&A space.

Automotive Cybersecurity Market + Market Opportunity Analysis

The Automotive Cybersecurity Market: The Development of Autonomous Cars and Other Notable Growth Drivers

As dependence on digitization increases, all industries must take an extra step to ensure the safety and security of all consumers. Similarly, connectivity within the automotive sector has progressively increased, and Bluetooth systems, among others, have taken the industry by storm. To ensure the safety and security of consumers, OEMs have started to cooperate with suppliers, and automotive cybersecurity has become a primary focus. This has propelled growth in the automotive cybersecurity market.

Personal mobility and the increasing need for communication due to hectic schedules require consumers to stay connected constantly. Consequently, establishing and maintaining the safety of this connectivity has become a focus for consumers as well. There is an increasing number of vehicles on the road, and crucial parts like steering, brakes, and engines are dependent on computer systems. This dependence on computer systems has given rise to the need for the automotive cybersecurity market.

Why is automotive cybersecurity vital? The automotive cybersecurity market works towards ensuring that computer systems within vehicles are properly protected. Without this protection, car owners, for instance, risk losing important data or, in certain cases, even control of the car to hackers. Automotive cybersecurity protects personal data, crucial systems within the vehicle, and the consumers themselves from theft or harm.

The automotive cybersecurity market has grown exponentially over recent years, and it continues to grow unencumbered. Therefore, automotive cybersecurity market players must be aware of the opportunities for growth in their market and take pre-emptive initiatives to stay ahead of their competitors. In this article, Infiniti’s market opportunity analysis experts discuss the notable growth drivers and challenges in the automotive cybersecurity market. Additionally, the experts detail how a market opportunity analysis can help companies grow.

Digitization will continue to grow as industries adapt to the post-COVID era. Request a FREE proposal to learn how automotive cybersecurity market players can capitalize on increasing connectivity and technology dependence.

Notable Growth Drivers in the Automotive Cybersecurity Market

The need for the automotive cybersecurity market is no longer a debate. However, demand alone cannot propel growth in the market. Therefore, Infiniti’s market opportunity analysis experts analyzed the automotive cybersecurity market and identified the following three notable drivers that significantly prompt growth in this market:

Development of Autonomous Vehicles

Recently, major automakers and OEMs have been investing in and developing autonomous vehicles. These vehicles are highly dependent on efficient autonomous vehicle systems and high levels of connectivity. Developers are aiming to make vehicles completely automatic and minimize human input substantially. While this is a sign of tremendous growth and technological development, without appropriate security, it can put consumers at significant risk.

This advancement in the automotive industry has led to increasing demand for the automotive cybersecurity market among OEMs and automakers. As R&D continues, the need for automotive cybersecurity systems will continue to grow. Market players must shift their focus to creating all-encompassing systems that can ensure the safety of data and consumers in autonomous vehicles.

Electronic Control Units (ECUs) and Cloud Computing

The incorporation of radios in vehicles is one of the most enjoyed additions to vehicles for many consumers with hectic schedules or professions that require long-distance travel. Over time these systems have shifted from fixed in audio systems to screens that allow consumers and mechanics to access and control in-vehicle systems. These electronic control units enable consumers and mechanics to conduct complete diagnostics on vehicles without dismantling the vehicle. However, if these systems are hacked, it could give hackers access to crucial safety features, such as airbags, and put consumers’ lives at risk.

Additionally, ECUs allow consumers to connect their phones, laptops, and various other cloud-based applications to the car. This may be used for music, infotainment, or other forms of entertainment and communication by car-owners. However, cloud computing includes access to various types of data that may be present on the consumer’s phone and other personal devices. If ECUs are not protected, hackers will have access to the vehicle and the personal data of the consumer. Therefore, automakers and OEMs need to ensure the safety of ECUs, which has led to increasing demand in the automotive cybersecurity market.

Regulatory Mandates and Standards

Governments worldwide have become aware and highly cautious of cyber threats and the theft of personal data. Identity theft, stolen access to financial information, and hacking into citizens’ communication and interaction are some of the recent cyber threats that governments are attempting to curb. The increasing number of personal vehicles on the roads and high dependence on connectivity has encouraged governments to enforce regulations regarding cybersecurity across platforms.

Similarly, the US government proposed legislation to isolate critical software systems and safeguard the entire vehicle against cyber threats. Additionally, major automakers, OEMs, and suppliers are establishing standards and promoting the use of appropriate automotive cybersecurity systems across vehicles. As the adoption of cybersecurity systems increases steadily, the automotive cybersecurity market is expected to grow.

Staying ahead of market trends and growth drivers is the first step towards leading your market. Speak to our industry experts and understand what your next step to being a leader in the automotive cybersecurity market should be.

Restraints in the Automotive Cybersecurity Market

Although the automotive cybersecurity market has been growing exponentially, there are various restraints to this trajectory of growth. The supply chain in the automotive industry is highly fragmented, which leads to a higher number of stakeholders and a combination of contributors to every unit. Additionally, OEMs do not have the technical capabilities to incorporate cybersecurity systems into the vehicles and require cybersecurity system suppliers to do the same. This often leads to a time lag in the delivery of cybersecurity updates and hampers the growth of the automotive cybersecurity market.

Why does The Automotive Cybersecurity Market Need Market Opportunity Analysis?

In a rapidly evolving market like the automotive cybersecurity market, companies need to keep abreast of market opportunities. To stay ahead of competitors, one must identify, evaluate, and strategize for market opportunities before other market players. Infiniti’s market opportunity analysis enables automotive cybersecurity market players in the following ways:

  • Companies can identify ideal M&A opportunities to scale
  • They can also understand and solve for consumers’ pain points
  • Keep abreast with competitors’ performance issues
  • Identify growth opportunities and assess the market’s readiness for their offerings

In the automotive cybersecurity market, a market opportunity analysis can also assist companies in understanding regulatory mandates, stay ahead of market dynamics, and devise appropriate strategies to cope with changing ECUs and vehicle software systems. Staying a step ahead of the market can be the biggest differentiator for companies in a fast-growing market.

Infiniti’s market opportunity analysis can help your organization set an industry standard. As competition grows, learn how our research solutions can propel you to the top by requesting more information.

Electric Vehicles Market + Market Trends Analysis

The Evolving Electric Vehicles Market: What trends and challenges do the future hold?

The automotive industry has seen a major change in recent times. As technology advances, the need for personal mobility increases, and the demand for environmentally friendly options increase, the automotive industry has shifted its focus towards better alternatives. This search for alternatives has led to increased demand for alternative fuels and electric vehicles.

The electric vehicles market has seen immense growth over the past decade. Moving from prototypes to popular luxury electric cars and electric busses, the market is on the ideal path to proliferation. There is a range of options within the electric vehicles (EVs) market, including hybrid EVs, plug-in hybrid EVs, and battery EVs. This range enables consumers to choose the best option for themselves while shifting from vehicles that use traditional petroleum fuels.

Some of the most significant contributors to the increasing demand for electric vehicles have been the need to reduce personal carbon footprints and the high prices of petroleum. As economies struggle due to various factors, and fossil fuels run short, millennial and Gen Z consumers are willing to invest more in safer, environmentally responsible alternatives.

While the COVID-19 pandemic took a huge toll on the automotive industry, experts forecast further growth for the electric vehicles market as most countries work towards recovering their economies and industries. However, as electric vehicles market players aim towards recovery, it is important to identify and understand the trends influencing demand and the market. Therefore, Infiniti’s industry experts discuss the impact of COVID-19, major trends, and challenges in the electric vehicles market in this article. Additionally, they discuss the role of market trends analysis in an evolving and easily influenced market, such as the electric vehicles market.

As the world recovers from the COVID-19 pandemic, find out how the electric vehicles market can effectively prepare for the post-COVID era by requesting a free proposal.

The Impact of COVID-19 on the Electric Vehicles Market

The automotive industry and electric vehicles market witnessed a substantial decrease in demand since the advent of the COVID-19 outbreak. The pandemic has negatively impacted the global economy and significantly damaged GDPs in many developed and developing countries. This has led to job losses, further economic disparity, and reduced income for working professionals in every stratum of the corporate hierarchy. With lower disposable income, consumers are focused on near-time expenses, and major investments such as personal automobiles have been termed an unnecessary expense.

Additionally, due to nationwide lockdowns and imposed safety measures, many manufacturers were required to pause all production for an indefinite amount of time. The economic toll and supply chain challenges posed by this sudden disruption has caused significant losses for companies. Although electric vehicles require lower consumption costs daily, the initial investment is higher than that for most traditional fuel-run vehicles. Fuel prices have seen a momentary reduction in many markets, affecting the demand for electric cars shortly. However, all industries are on the path to recovery. Electric vehicle market players must prepare for the trends and challenges that await them on the other side of the pandemic.

Major Trends in the Electric Vehicles Market

As the electric vehicles market continues to grow, various trends will impact this growth and propel or challenge it. Infiniti’s industry experts identified the following three major trends that continue to impact the electric vehicles market:

Electric Vehicles Market + Market Trends Analysis

Rising Environmental Concerns

Increasing awareness about the impact of various industries on the current environmental situation has changed consumers’ buying behaviors substantially in recent years. The automotive industry and automobiles particularly are notoriously known to produce an extremely high amount of carbon emissions. This has led to consumers being more cautious and selective about their transport and automobile investments. With a range of electric vehicles, from bicycles to large vehicles like busses, consumers are now more likely to choose EVs over vehicles that require fuel. However, this has also led to an increase in more stringent government policies and regulations. With particular stipulations for the emission levels permitted in different vehicles, electric vehicle market players must be particularly careful in their development and production processes. This requires major investment, increased scrutiny, and compliance with various regulations.

Investment and Government Support

Due to the rising concerns regarding carbon emissions and environmental safety, governments and automakers have increased investments in the electric vehicles market. Governments worldwide are taking initiatives to increase deployment of EVs on the roads. Additionally, through the shock of the COVID-19 pandemic on economies, many governments launched schemes and offers to encourage investment in automobiles. As the industry starts to recover, governments are attempting to promote EVs and reduce dependence on fossil fuels.

Consumers’ Preferences

In a challenging and competitive market like the automotive industry, understanding consumers’ preferences are crucial to success. As consumers shift their focus from fuel-dependent vehicles to EVs, the demand for variety and options is expected to rise substantially. While many automakers have started offering EVs ranging from hatchbacks to luxurious sedans, there will be a growing demand for more options as this shift takes place.

Additionally, since vehicles are widely-used for personal mobility of varying kinds – short trips to work, weekend trips, or long road-trips – consumers will demand a higher battery range. The presence of gas stations along highways and within cities enables consumers to travel long distances conveniently. This requires companies to ensure that their vehicles have lasting power and can be conveniently recharged, even on long trips. Many car rentals companies have shifted to EVs, and are often preferred by Millennial and Gen Z consumers. However, to attract a wider audience, including older consumers, or consumers with hectic schedules, the electric vehicles market will need to adapt and grow.

In a fast-paced and growing market, staying ahead of the trends is the first step to long-term success. Speak to our industry experts to learn how Infiniti’s market trends analysis can help your organization prepare for the future of the electric vehicles market.

Challenges in the Electric Vehicles Market

While the electric vehicles market is expected to witness growth in the post-COVID era, automakers must be aware of and strategize for the various challenges within the industry. Due to the low demand for EVs currently, R&D costs require automakers to attribute higher prices for EVs. While these costs will reduce as demand increases, demand for EVs will not be par with the demand for fuel-dependent vehicles shortly due to the price difference.

Additionally, the lack of available charging stations along highways or within cities can affect the demand for EVs. Electric vehicle market players must set up a higher number of charging stations for consumers with EVs. These challenges can be tackled if the market continues to grow. However, these challenges may simultaneously be a detriment to growth. Therefore, electric vehicle market players need to strategize for these challenges and help the market grow.

The Importance of Market Trends Analysis in the Electric Vehicles Market

The various trends in any industry can propel or disrupt growth in the market. In the automotive industry, various trends can have a major impact on the development, investment, and production processes for automakers. The different market trends similarly impact the electric vehicles market. Therefore, market players must identify, evaluate, and understand the various trends in the market.

Infiniti’s market trends analysis is among the best ways for automotive industry players to understand their market, prepare for the various market trends, and succeed. Here’s how Infiniti’s market trends analysis can help:

  • This analysis helps companies study the market and identify major market trends that may impact their operations soon.
  • It also enables companies to strategize for these dynamic market trends appropriately and avoid sudden shocks within their supply chain and production processes.
  • With market trends analysis, companies can forecast possible growth drivers within trends and stay a step ahead of their competitors with pre-emptive production according to consumers’ needs and market dynamics.

In the electric vehicles market, market trends analysis enable companies to understand how the varying environmental changes affect them, understand and comply with the various government regulations, and forecast consumers’ demands. This helps players stay ahead of their competitors, increase consumer satisfaction, create effective market expansion plans, and realize huge savings within their organization.

Understanding a complex market requires expertise and appropriate guidance. Request more information to learn how Infiniti’s experts can guide companies in the electric vehicles market.

Banking M&A + M&A Strategies

Is M&A the Best Way Forward in the Recovering Banking Sector? Thought Leaders Discuss

Until 2018, the impact of the financial crisis of 2007-08 was visible in the US banking sector. Banking mergers and acquisitions had become limited, and the sector struggled to grow. However, in 2018 banking M&A witnessed recovery and prepared for substantial growth over the following years. In early 2020, this growth was suddenly interrupted by the advent of the COVID-19 pandemic.

As industries across the world attempt to recover from the aftermath of the COVID-19 pandemic, experts forecast growth for the recovering banking sectors across the world as well. Banking M&A has recently become crucial due to the increasing need for investment in technology and digital capabilities, and the various regulatory changes. Prior to the pandemic, consolidation had recovered to levels that were last seen before the financial crisis.

After the initial staggering impact of the pandemic, all industries have started preparing for recovery and are attempting to adapt to the new normal of the post-COVID era. Similarly, banks are on the path to recovery, and M&A is one of the most effective and crucial ways to recover successfully. Banking M&A is a challenging process and requires appropriate planning and unparalleled M&A strategies.

In this article, Infiniti Research experts discuss the impact of the COVID-19 pandemic on banking M&A. Additionally, as banks return to banking M&A with renewed motivation, it is important to be aware of the potential challenges, and the ideal way to approach this process and the difficulties encompassed. Therefore, this article details the significant upcoming challenges and the role of appropriate M&A strategies, as highlighted and discussed by Infiniti’s M&A support experts.

Attempting to recover from the aftermath of the COVID-19 pandemic through banking M&A? To learn how Infiniti’s M&A strategies can help you assess, identify, evaluate, and choose the ideal consolidations, request a FREE proposal.

Impact of COVID-19 on Banking M&A

With the rising number of cases in the United States and declining GDPs worldwide, all industries suffered substantial losses. Similarly, banking M&A saw a rapid decline in valuations and total shareholder returns. Additionally, boards and CXOs have shifted their focus to maintaining business continuity and stabilization of current businesses.

Further, the uncertainty of capital flexibility and losses, and the duration of the economic pressure has made M&A unappealing to buyers. In the instance of major distress due to factors such as capital pressure or material risk of failure, struggling organizations may need to sell. Apart from extreme measures, however, selling is not the ideal option in a struggling economy.

However, as banking M&A increases,  several trends are expected to surface. For instance, the rising need for fintech and digital capabilities, accompanied by the potential lack of funding for new fintech firms with limited market experience, may promote consolidation between traditional financial institutions and fintech firms. Additionally, the sudden upsurge in demand for digital platforms in every industry due to the pandemic will promote the need for banks and fintech companies to consolidate.

As these and other market trends begin to influence the recovering market, banking M&A is expected to recover within 2020 marginally. However, the COVID-19 pandemic will have a lasting impact on the foreseeable future of the banking sector.

Speak to our experts to know more about the impact of COVID-19 on your industry, the ideal path to recovery, and adapting to the new normal.

What companies need to prepare for during Banking M&A

As the banking sector starts on the path to recovery, the banking M&A process is set to face various challenges and opportunities. Although there will be a steady increase, the industry is expected to take a substantial amount of time before it has made a complete recovery. After a sudden impact like that of the COVID-19 pandemic, banks and fintech firms should be prepared for various factors in banking M&A to ensure successful transactions and avoid further losses.

Banking M&A + M&A Strategies

Therefore, Infiniti’s M&A strategy experts identified the following four crucial factors for banking M&A participants to prepare for:

Staying Ahead of Regulations

Changing political, social, and economic environments have previously posed substantial challenges for the financial and banking sectors. As 2020 proceeds, the political and economic scenario of the US continues to be precarious, and that directly impacts the regulatory environment of all industries. In the case of the banking sector, particularly, potential political regime changes can easily alter the future of all industry players and M&A transactions.

When strategizing for M&A transactions, participants need to prepare for possible regulatory changes and the impact of a new political regime on the economic environment. Additionally, choosing a partner that will be beneficial and supportive through changing factors is highly crucial and contributes significantly to a successful M&A. Therefore, key players have recently shifted their focus to acquiring professional assistance in developing M&A strategies. This helps ensure effective and successful strategizing and implementation of consolidations.

Accepting the New

The need for technological and digital capabilities has increased substantially over the last decade. Industries and consumers have become increasingly dependent on technology to carry out all major commercial transactions and activities. This has created the need for traditional financial institutions to consider and execute consolidations with financial-technology (fintech) firms. With increasing M&A transactions between traditional banks and fintech firms, the banking sector is headed on a path to digitization. However, although it is widely accepted that it is time for banks to shift from their legacy systems to modern fintech is necessary for survival and proliferation, many institutions struggle to make the change.

As the term legacy suggests, these systems are highly dated and a core part of the traditional banking systems and brand identities. However, they no longer fulfill the requirements of the modern consumer. Therefore, traditional financial institutions must prepare to consolidate with their agile fintech competitors and accept the new wave of technology. Adapting is crucial to survival, and changing to modern, adaptable, and consumer-centric systems is one of the essential changes for the banking sector.

Understanding Cultural Integration

During integrating, two independent organizations, boards, and CXOs often fail to account for the impact on their employees. This has led to a high failure rate in banking M&A in the best. Therefore, as companies work towards new M&A transactions, it is crucial to account for employee sentiment towards the consolidation process and ensure clear communication with all company employees. The right M&A strategy helps banks clearly communicate with and adequately train their employees for the new changes in the organization.

It is also important to ensure that employees on both sides of the deal agree with new policies regarding compensations, benefits, and organizational culture. Ensuring appropriate cultural integration can make or break an M&A. Proper cultural integration helps increase employee satisfaction and promotes efficiency and productivity. In some cases, organizations create an integration management office, with an integration CEO that helps manage every segment of the integration process, ensuring appropriate cultural and employee integration.

A Slow Path to Recovery

Although banking M&A is expected to recover through the remainder of the year, this process will be long-drawn and limited for a certain period. Currently, the scale is critical, and many struggling financial institutions and fintech firms will require M&A transactions to survive through the pandemic.

However, the economic impact of the pandemic has sent tremors through various segments of the banking and financial services sector, leading to an increased focus on short-term business continuity and reduced attention towards major investments such as M&A transactions. Therefore, companies must prepare for a slow and steady recovery and the possibility of limited options and partnerships. The right M&A strategies can help banks and fintech firms identify and execute the ideal M&A transactions even in a slow market.

Request more information and learn how Infiniti’s M&A strategies can transform the challenging banking M&A process into an attainable target for your organization.

How the Right M&A Strategies Can Help in Banking M&A

As financial institutions enter this phase of recovery, and banking M&A makes a long-awaited return, M&A strategies can be the major difference between successful and unprosperous consolidations. Infiniti’s experts help financial institutions overcome the challenges of banking M&A while maintaining business continuity and enabling a successful merger.

Three ways in which Infiniti’s M&A support and M&A strategies can help financial institutions in these challenging times are as follows:

  1. Organizations can create systematic and programmatic approaches to the process and enable the continuous development of potential M&A candidates.
  2. Boards, investors, and CXOs are offered data-driven insights and advice through the M&A process, with unparalleled guidance and research support.
  3. Financial institutions can assess all potential opportunities, identify the ideal partnerships for their organization, and make well-informed decisions about their future.

Recovering from the COVID-19 pandemic is expected to be a long-drawn and challenging process for all industries. However, with the right assistance and guidance from Infiniti’s M&A support experts, financial institutions can develop and execute successful M&A strategies that will boost the recovery process of their organization and the financial services industry.

ATM Managed Service

Understanding Evolving Perspectives Due to COVID-19 in ATM Managed Service and Retail Banking Sectors

The global financial sector is constantly evolving its business outlook and strategies to cope with regulatory and competitive pressures, stressed interest rates, and dynamic customer expectations. The COVID-19 pandemic poses greater challenges to companies in ATM managed service and retail banking markets as they strive to manage daily operations while ensuring services are not disrupted. Amidst these changing market conditions, retail banks are encouraging customers to leverage online banking facilities or rely on ATM centers for basic transactions. As a result, ATM service providers need to upscale existing technology to prevent fraudulent practices and ensure seamless transactions to their customers.

During this time of upheaval, it is essential to have the right guidance and market information to plan your next course of action. Is your business unprepared to face the ongoing crisis? Request a FREE proposal from our industry experts to know more about our COVID-19 support solutions for business.

How the retail banking sector will be affected

Decline in Cash Flow and Credit

Government restrictions due to COVID-19 across countries have disrupted business operations in the end-user sectors. This includes industries such as retail, logistics, and manufacturing. Also, due to lockdowns and economic uncertainty, businesses have restricted spending (new investments). Also, they are not willing to avail credit from banks, which in turn is leading to a decline in cashflow in retail banks.

Increasing Focus to Reduce In-person Meeting and Physical Interactions

Banks are evolving by implementing digital technologies such as remote operations, advanced kiosks, and virtual meetings (video KYC) to replace in-person meetings and minimize physical interactions. For instance, a prominent multinational investment bank and financial service provider has mandated work from home for its employees in the UK from February 2020 due to the COVID-19 pandemic. This ensures a reduced physical interaction between both employees and customers.

ATM managed service providers need to be aware of

Introduction of Advanced ATMs

The ATM managed service providers are introducing Mobile Cash ATMs, a new contactless ATM, enabled with QR code-based operations. Mobile Cash ATMs allow customers to scan the QR code with the help of smartphones to reduce contact with ATMs. Globally around 325 companies are currently working on advanced ATMs equipped with a voice-enabled feature for entering the PIN and restricts contact with ATMs.

Struggling to stay relevant amidst the fast transformations in the banking industry? Get in touch with an industry expert to know how our market intelligence solutions can help you keep a close watch on the changing market trends and make strategic moves to adapt.

Difficulty in ATM Service Operations

The COVID-19 pandemic has affected operations across the ATM service market globally. Cash replenishment and on-site repair services is a major challenge for ATM operations and service providers. Take the example of an ATM service provider in India. It faced disruption in servicing and refilling during the lockdown. During normal circumstances, the company used to service and refill around 60,000 ATMs. But during the lockdown, it was able to serve only approximately 30,000 ATMs in two weeks’ duration.

Download Infiniti’s FREE resourceKeeping up with transformations in the ATM managed services market, for comprehensive insights.

In-Vitro Diagnostics Market + Market Research Services

What’s Next for the In-Vitro Diagnostics Market? Discussing Growth Driving Factors with Experts

The healthcare industry and in-vitro diagnostics market have grown exponentially in recent decades. Advancements in technology, changing customer expectations, and increased investment in healthcare have contributed to this growth. As the industry continues to grow, in-vitro diagnostics (IVDs) have gained substantial momentum as a modern medical diagnostic system. Currently, the in-vitro diagnostics market is expected to witness significant growth in the coming years.

Advancing diagnostic technologies, acceptance of precision medicine, and improved quality of life in developed and developing countries are some of the factors influencing and influenced by the in-vitro diagnostics market. As these factors and various other trends and challenges affect the market, key players are shifting their focus to new strategies.

With increased attention towards developing new products and strategic initiatives, such as mergers and acquisitions (M&A), key players are attempting to gain greater market share. However, the first step to achieving a greater market share is having a comprehensive understanding of the drivers influencing growth in the in-vitro diagnostics market.

Growth drivers such as increasing automation, supportive government policies, rising geriatric population, and increased demand for point-of-care testing are currently most prominent. Being aware of the driving factors in the in-vitro diagnostics market assists companies in their efforts to grow, expand, and gain a strategic advantage. In this article, Infiniti’s healthcare research experts discuss the driving factors in the in-vitro diagnostics market and highlight the need for market research services in this fast-growing and highly competitive market space.

As the in-vitro diagnostics market continues to grow, pioneering development and staying abreast with the market is key to being an industry leader. Request a free proposal to gain in-depth insights into the market, and develop optimal strategies to gain higher market share.

What are the expected driving factors in the In Vitro Diagnostics Market?

While the in-vitro diagnostics market faces challenges such as the lack of fully developed clinical laboratories, various driving factors in the market are often overlooked. Identifying, evaluating, and capitalizing on these growth drivers can be a significant differentiator for companies in the market. Additionally, awareness of growth drivers, trends, and opportunities enables companies to pioneer development and change in specific segments. Currently, biomarkers have gained value and interest in the medical industry for the screening, diagnosis, and treatment of specific diseases. As this develops with the increased availability of biomolecular tools, the market will soon see new opportunities. However, companies must stay abreast of trends and driving factors to capitalize on opportunities successfully. Therefore, Infiniti’s healthcare market research experts identified and discussed the following four noteworthy expected driving factors in the in-vitro diagnostics market:

In-Vitro Diagnostics Market + Market Research Services

Increasing Automation

Diagnostic laboratories are increasingly adopting fully automated instruments. Automation in laboratories enables increased efficiency and accuracy of diagnostic tests. Additionally, automated instruments deliver faster results, decrease hands-on time, are easily scalable and high-performance. Due to these benefits, the potential of total laboratory automation, and the reduced need for batch tests, key players are working on developing automated instruments. The increasing demand for automated medical devices, accuracy, efficient diagnostic systems, and faster results are expected to drive growth in the in-vitro diagnostics market.

Supportive Government Policies

Favorable regulations to spur the approval of medical devices by governments across the globe is contributing substantially to the growth of the in-vitro diagnostics market. Additionally, governments have undertaken various initiatives to provide information and education on IVD tools and personalized medicine for effective patient management, which is expected to further influence growth in the market. Increased government funding to support research and development in the healthcare and medical devices industry has improved awareness and boosted the market further.

Rising Geriatric Population

With improving quality of life, better diagnostic tools, improved healthcare systems, and increased awareness about health and wellness, the global geriatric population has grown substantially. Consequently, improved life expectancy has increased the prevalence of chronic and cardiovascular diseases. Additionally, the rising population has led to an increased prevalence of infectious diseases. Therefore, the demand for efficient and accurate diagnostics systems and improved healthcare systems has increased. These changes have directly influenced demand, product development, and growth in the in-vitro diagnostics market.

Increasing Demand for Point-of-Care Testing

Advanced techniques such as biochips and nano-biotechnology have facilitated easy access to point-of-care tests. Additionally, these techniques enable accurate and fast results, further fueling the demand for IVD instruments. Companies are now developing point-of-care testing for the diagnosis of infectious diseases, which will further influence the shift from traditional diagnostic tools towards IVD tools. The increased adoption of point-of-care testing is due to the ability to conduct tests and procure results in close proximity to patients. This enables faster diagnosis, and in turn, more immediate treatment. Therefore, point-of-care testing is expected to increase demand and fuel growth in the in-vitro diagnostics market.

Request more information to further understand the impact of the noteworthy driving factors in the growing in-vitro diagnostics market.

Why does the In Vitro Diagnostics Market need Market Research Services?

The in-vitro diagnostics market is developing and growing at an exponential pace. This has led to increasing competition and a constant battle of wits. Higher market share is often acquired by companies that understand their market and are prepared for all factors that influence it. Infiniti’s healthcare market research services provide companies with the ability to gain and maintain substantial market share.

Infiniti’s healthcare market research enables companies to stay abreast of influencing factors in the in-vitro diagnostics market. Additionally, it includes the following services that each serve a crucial function:

  • Market Trends Analysis: Our market trend analysis solutions enable companies to identify and understand significant current and future trends in the in-vitro diagnostics trends.
  • Product Development Research: With product development research, companies can analyze the complete product development lifecycle, gain insights on the most profitable and relevant segments, and boost value proposition.
  • M&A Support: Mergers and acquisitions (M&A) can help companies gain significant market share. With our M&A support, companies can identify potential opportunities and have our team support investors at each stage of the process.

In the growing in-vitro diagnostics market, staying updated on market trends assists companies in developing appropriate strategies to approach and capitalize on them. New product development is the optimal way to become an industry leader, an innovative and evolving community. Additionally, M&A has become a common strategy adopted by key players in the in-vitro diagnostics market. To gain exclusive insights into the why healthcare market research services are the new norm for healthcare industry players, gain limited period free access to our resource here.

To gain market share and become an industry leader, companies must efficiently approach and capitalize on ideal opportunities in this highly competitive space. Infiniti’s healthcare market research services assist and support companies by providing these specific and essential services for efficient growth.

To gain comprehensive insights into the scope and benefits of Infiniti’s market research services in the in-vitro diagnostics market, speak to our experts.

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.

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