Introduction
Shellac, a natural resin derived from the lac insect, has been used historically in the pharmaceutical industry as a film coating for solid oral dosage forms. However, its usage has significantly declined in recent years due to several factors. Here, we will delve into the market dynamics and financial trajectory of shellac as a pharmaceutical excipient.
Historical Use of Shellac in Pharmaceuticals
Shellac was once a popular excipient for film coating due to its excellent film-forming properties. However, its use has diminished over the years as the pharmaceutical industry has increasingly turned to synthetic resins for enteric coating[4].
Decline in Usage
The decline in shellac's use is evident from the data provided by the US Food and Drug Administration (FDA). In 1988, shellac was used in 278 New Drug Application (NDA) listings, which dropped to 219 in 1992 and further to just 73 listings in 1996. This decline is attributed to the limitations of traditional methods of film preparation using shellac, which provide good short-term results but extend the release characteristics of drugs after six months or a year[4].
Current Market Size and Forecast
The global shellac market, while not exclusively focused on pharmaceuticals, provides insight into the overall trend. As of 2023, the shellac market was valued at $156.5 million and is projected to reach $183.1 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 1.88% from 2023 to 2032[5].
Pharmaceutical Excipient Market Context
To put shellac's market dynamics into perspective, it is essential to consider the broader pharmaceutical excipient market. The global pharmaceutical excipients market was valued at $8.37 billion in 2023 and is expected to grow to $14.72 billion by 2033, with a CAGR of 5.81% from 2024 to 2033. However, shellac does not contribute significantly to this growth due to its limited use in modern pharmaceutical formulations[3].
Challenges and Limitations
Several challenges hinder the growth of shellac as a pharmaceutical excipient:
- Shortage and Cost: The shortage of shellac and the rising costs of the product are significant barriers to its use.
- Allergic Reactions: Some individuals may experience allergic reactions to shellac, further limiting its application.
- Technological Limitations: Traditional methods of film preparation using shellac are not as effective in the long term, leading to extended drug release characteristics that are undesirable[5].
Competitive Landscape
The pharmaceutical excipient market is dominated by other types of excipients, such as lactose-based excipients, which captured 41.26% of the revenue share in 2023. Major players in the pharmaceutical excipient market include Ashland Global, BASF, Evonik, and Roquette Frères, among others. These companies focus on more advanced and versatile excipients, leaving shellac with a marginal role[1][3].
Potential for Revival
Despite its current marginal status, there is a potential for shellac to make a comeback under certain conditions:
- Research and Development: Increased research and development activities could lead to new methods of using shellac that overcome its current limitations.
- Niche Applications: Shellac might find niche applications where its unique properties are beneficial, such as in specific drug delivery systems or for particular patient populations[4].
Financial Trajectory
Given the current market trends and challenges, the financial trajectory for shellac as a pharmaceutical excipient is not promising. The market size for shellac is small and growing at a slow rate compared to other excipients. Here is a summary of the financial outlook:
- Market Size: The shellac market is valued at $156.5 million in 2023 and is expected to reach $183.1 million by 2032.
- Growth Rate: The CAGR for the shellac market is 1.88% from 2023 to 2032, which is significantly lower than the growth rate of the overall pharmaceutical excipients market.
- Revenue Share: Shellac does not contribute significantly to the revenue of the pharmaceutical excipients market, which is dominated by other types of excipients[5].
Key Takeaways
- Shellac's use in pharmaceuticals has declined significantly due to technological limitations and the preference for synthetic resins.
- The global shellac market is small and growing slowly, with a projected value of $183.1 million by 2032.
- The pharmaceutical excipient market is dominated by other types of excipients, leaving shellac with a marginal role.
- There is potential for shellac to be revived through research and development, but it faces significant challenges.
FAQs
What is shellac, and how has its use in pharmaceuticals changed over time?
Shellac is a natural resin derived from the lac insect. Historically, it was used as a film coating for solid oral dosage forms, but its use has declined significantly in favor of synthetic resins due to technological limitations and extended drug release characteristics.
What are the main challenges facing the use of shellac in pharmaceuticals?
The main challenges include the shortage and rising costs of shellac, allergic reactions in some individuals, and technological limitations that lead to extended drug release characteristics.
How does the growth rate of the shellac market compare to the overall pharmaceutical excipients market?
The shellac market is growing at a CAGR of 1.88% from 2023 to 2032, which is significantly lower than the 5.81% CAGR of the overall pharmaceutical excipients market from 2024 to 2033.
Which companies dominate the pharmaceutical excipient market?
Major players in the pharmaceutical excipient market include Ashland Global, BASF, Evonik, DuPont, Roquette Frères, and others, which focus on more advanced and versatile excipients.
Is there potential for shellac to be revived in the pharmaceutical industry?
Yes, there is potential for shellac to be revived through increased research and development activities that could overcome its current limitations and find niche applications where its unique properties are beneficial.
Sources
- PharmaCompass, "Excipient Market Overview: Biologics spur growth in lipid-based agents as Asahi Kasei opens new plant," September 28, 2023.
- Servier, "Servier confirms its 2025 trajectory to achieve its 2030 ambition," February 7, 2024.
- BioSpace, "Pharmaceutical Excipients Market Size USD 14.72 Billion by 2033 and CAGR 5.81 percent," May 9, 2024.
- Outsourcing-Pharma, "Shellac: time for a comeback?" May 26, 2017.
- Zion Market Research, "Global Shellac Market Size, Share and Forecast 2032," 2023.