Analysis of the pharmaceutical market in the USA for the implementation of new products

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Orenburg State University (Orenburg, Russia)

Analysis of the pharmaceutical market in the USA for the implementation of new products

Ogarkov A., specialist

Annotation

This article presents an analysis of the pharmaceutical market in the USA, focusing on the introduction of new products. It explores market size, trends and key drivers. Along with opportunities for innovation and growth, the issues faced by companies, such as regulatory constraints and competition, are discussed. Successful case studies are examined to highlight effective market entry strategies. Emphasis is placed on the need for companies to adeptly navigate the regulatory environment, harness innovation, and meet evolving healthcare demands.

Keywords: USA, pharmaceutical market, market analysis, innovation, regulatory challenges, healthcare trends, product introduction.

Аннотация

Анализ фармацевтического рынка США для внедрения новых продуктов

Огарков А., специалист, Оренбургский государственный университет (Оренбург, Россия)

В этой статье представлен анализ фармацевтического рынка в США с упором на внедрение новых продуктов. В ней исследуются размер рынка, тенденции и основные движущие силы. Наряду с возможностями для инноваций и роста обсуждаются проблемы, с которыми сталкиваются компании, такие как нормативные ограничения и конкуренция. Рассматриваются успешные примеры, чтобы выделить эффективные стратегии выхода на рынок. Особое внимание уделяется необходимости для компаний умело ориентироваться в нормативной среде, использовать инновации и соответствовать меняющимся требованиям здравоохранения.

Introduction

The pharmaceutical market (PhM) in the USA plays one of the important roles in global health care, driving innovation, and providing essential medications to patients across various therapeutic areas. The development of technologies and changes in consumer preferences lead to the need for a comprehensive market analysis to justify the introduction of new products. Understanding the dynamics of the PhM is essential for pharmaceutical companies, policymakers, healthcare providers, and patients alike.

This research paper aims to provide an analysis of the PhM in the USA, focusing on methodologies and research results relevant to the introduction of new products.

Data for this study was collected from various sources including government publications, healthcare databases, and corporate financial statements. For instance, the U.S. Pharmacy Market Size & Share Analysis Report by Grand View Research provided insights into the market size and growth projections.

Figure 1. Pharmaceutical Manufacturing Market in the USA, 2023 to 2032 (USD billion) [1].

Main part

The PhM in the USA exhibits a dynamic and complex landscape, characterized by various trends, drivers, and opportunities for innovation and growth. According to a forecast by Precedence Research (Ottawa, Canada), the USA pharmaceutical manufacturing market size was valued at USD 100.06 billion in 2022 and is estimated to reach around USD 323.48 billion by 2030, growing at a CAGR of 12.5% from 2023 to 2030 (figure 1).

The analysis of PhM in the USA provides information necessary to assess the potential for the introduction of new products.

Market analysis results

The PhM in the USA continues to demonstrate robust growth, fueled by various factors including population demographics, healthcare expenditure trends, and evolving consumer preferences. According to the USA Pharmacy Market Size & Share Analysis Report by Grand View Research, the retail pharmacy segment held the largest market share in 2022 [2]. The potential of the market encourages a number of service providers to strengthen their presence in the market by opening new centers and entering into partnerships. For example, in October 2021, the Walgreens Boots Alliance (WBA) announced a $5.2 billion investment in Village MD, a primary care provider. The investment will enable Village MD to open 600 new primary care practices in more than 30 USA markets by 2025, more than half of which will be located in remote settlements [3].

Key trends and drivers influencing the market include the rising prevalence of chronic diseases, such as cardiovascular diseases, diabetes, and cancer, which has fueled the demand for pharmaceutical products and treatments. The aging population and increasing life expectancy contribute to the growing need for healthcare services and medications.

The USA PhM presents promising growth prospects and opportunities for new product introduction [4]. With increasing investments in research and development, as well as regulatory initiatives to expedite drug approvals, pharmaceutical companies are poised to capitalize on emerging therapeutic areas and unmet medical needs.

innovation pharmaceutical market united states america

In the highly competitive USA PhM, companies must employ multifaceted and strategic approaches to successfully introduce and promote their products. Table 1 presents an analysis of the key strategies used by pharmaceutical companies for market entry and product promotion in the USA.

Table 1

Characteristics of strategies for introducing new products to the USA PhM.

The analysis of strategies for entering and thriving in the USA PhM underscores the necessity of a multifaceted approach for companies aiming to succeed in this arena. These strategies collectively form a roadmap for pharmaceutical companies to not only enter the USA market but also to sustain and grow their presence effectively.

Examples of successful product implementation in PhM [5]:

• Gilead Sciences' introduction of Sovaldi (Sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection is another noteworthy example of a successful product launch. Sovaldi revolutionized the treatment of HCV by offering a highly effective and well-tolerated therapy with a shorter treatment duration compared to existing regimens. Gilead Sciences employed a value-based pricing strategy for Sovaldi. Despite initial controversies surrounding the high cost of treatment, Sovaldi quickly became a market leader and generated substantial revenues for Gilead Sciences.

• Novartis' introduction of Entresto (Sacubitril/Valsartan) for the treatment of heart failure with reduced ejection fraction (HFrEF) represents a recent success story in the PhM. Novartis invested heavily in clinical trials and real-world evidence generation to demonstrate the clinical benefits of Entresto compared to standard-of- care treatments.

Challenges faced by companies in introducing new products

Pharmaceutical companies often encounter stringent regulatory requirements [6]. The process of obtaining FDA approval in the USA, for instance, is known for its rigor and complexity, requiring extensive clinical trials and comprehensive documentation to ensure drug safety and efficacy. This process can be time-consuming and costly, significantly delaying product launches. The cost of research and development in the pharmaceutical industry is exceptionally high. Developing a new drug can cost billions of dollars, considering the expenses related to clinical trials, drug formulation, and testing. A significant portion of new drugs fail to make it past the trial phase, adding to the financial risks. For example, in 2022, the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA) of the USA approved 37 new medicinal products. This was the lowest figure for the recent period. The Center approved 50 new products in 2021, 53 new products in 2020, 48 products in 2019, and 59 products in 2018 [7].

The PhM is highly competitive. New products must compete not only with existing treatments but also with emerging therapies. Gaining market access is critical challenge. This includes negotiating with healthcare providers, insurance companies, and government health programs to ensure that the new product is accessible and reimbursable.

Opportunities for innovation and growth

One of the most significant trends is the increasing shift towards personalized medicine. Advances in genomics and biotechnology are enabling more tailored treatments, especially in areas like oncology and rare diseases.

Another key trend is the integration of digital health solutions and artificial intelligence (AI) into pharmaceutical operations, from drug discovery to patient engagement strategies [8, 9]. AI and machine learning are increasingly being used to streamline drug development processes, predict drug efficacy, and personalize patient care.

The biologics market is experiencing substantial growth, driven by their effectiveness in treating complex conditions like autoimmune diseases and cancer. However, as many biologics are going off-patent, there is a rising interest in biosimilars. Biosimilars offer a cost-effective alternative to expensive biologics, and their market is expected to grow.

As these trends evolve, they are likely to create new opportunities and challenges for pharmaceutical companies, shaping the industry's direction in the years to come.

Conclusion

The analysis of the PhM in the USA underscores a dynamic and evolving landscape, marked by both challenges and opportunities. The journey towards introducing new products in this market is complex and multifaceted, requiring a deep understanding of regulatory landscapes, market dynamics, and evolving healthcare needs.

The case studies of successful product introductions in the PhM reveal the importance of strategic planning, effective marketing, and addressing unmet medical needs. Companies like Gilead Sciences and Novartis have demonstrated that innovative approaches, coupled with a deep understanding of market dynamics, can lead to successful product launches.

Список литературы

1. Pharmerging Market / Precedence Research

2. Kapczynski A. The Political Economy of Market Power in Pharmaceuticals J Health Polit Policy Law (2023) 48 (2): 215-239.

3. Fukuyama H, Matousek R., Tzeremes N.G., Estimating the degree of firms' input market power via data envelopment analysis: Evidence from the global biotechnology and pharmaceutical industry, European Journal of Operational Research, Volume 305, Issue 2, 2023, pp.946-960, ISSN0377-2217,

4. Halwani, A.A. Development of Pharmaceutical Nanomedicines: From the Bench to the Market. Pharmaceutics 2022,14,106.

5. Kumar A., Krishna S.H., Vssavi M., Venkatrayulu Ch. Pharmaceutical product life cycle management strategies in the contemporary scenario, Journal of Pharmaceutical Negative Results, pp. 512-516, Feb. 2023

6. Shakouhi, F., Tavakkoli-Moghaddam, R., Baboli, A. et al. A competitive pharmaceutical supply chain under the marketing mix strategies and product life cycle with a fuzzy stochastic demand. Ann Oper Res 324, 1369-1397 (2023).

7. Chomac-Pierzecka E. Pharmaceutical Companies in the Light of the Idea of Sustainable Development - An Analysis of Selected Aspects of Sustainable Management. Sustainability. 2023, 15(11):8889.

8. Astapenko, N., Koshekov, K., Seidakhmetov, B. Devising An Automated Method To Form The Content Of Educational Specialization Disciplines Of Maximum Utility For Implementation In The Professional Field. Eastern-European Journal of Enterprise Technologies, 2021, 4(112), pp. 64-73;

9. Artemov A. Programming languages in data engineering: overview, trends and practical application // Инновационная наука. 2023. №10-2.

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