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 increases, 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.
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.