Over the last few years, we’ve noticed a growing interest in suppositories as a dosage form. Because semi-solid dosage (SSD) forms, including suppositories, are a manufacturing specialty for us at LGM, we realize we could be biased, but as it turns out, our observations are backed by data.
According to Allied Market Research, the global pharmaceutical suppositories market is projected to reach $2.8 billion by 2032, with a CAGR of 5.7% from 2023-2032.
This growth is being fueled by rising demand for precise, localized, medication delivery that allows for targeted treatment while avoiding systemic side effects or first-pass liver effects. Suppositories meet this need, making them a valuable dosage delivery form across medical disciplines and especially for geriatrics, pediatrics, chronic conditions, and women’s health.
While the suppository market as a whole is experiencing significant growth, it’s particularly notable in the area of women’s health. This post provides an overview and analysis of this expanding market, with a special emphasis on suppository usage for women’s health. We’ll explore some of the key factors driving this growth so you can make informed business decisions about the delivery vehicle for your drug candidate. Our analysis covers the benefits of vaginal suppositories in women’s health, as well as the potential challenges and opportunities.
Context and Key Drivers of Suppository Market Growth
Pharmaceutical suppositories are semi-solid dosage (SSD) forms designed for insertion into various body cavities, primarily the rectum, vagina, or urethra. Suppositories combine active pharmaceutical ingredients (APIs) with a base material that becomes liquid at or near body temperature such that upon insertion, the suppository dissolves, releasing the medication for absorption through the mucous membranes and local tissues.
Historically, suppository treatments have carried social stigmas due to the invasive and potentially embarrassing routes of administration. Negative user perception has also been shaped by problematic formulations featuring unpleasant textures, leakage, and other issues. However, more recent advances pharmaceutical engineering and manufacturing innovations have improved the user experience of suppository products.
The COVID-19 pandemic brought with it an accelerating societal shift toward self-administered treatments. As a result of their experience during the COVID-19 pandemic, individuals want more discretion, autonomy, and options for managing sensitive chronic health issues from the comfort of home. Suppositories are an example of an optimal delivery mechanism suitable for private at-home use without involving health providers for routine care.
Improved product formulations
Pharmaceutical engineering breakthroughs in recent decades have led to dramatic improvements in the texture, permeability, absorption kinetics, user ergonomics, extended-release capabilities and overall product appeal of modern suppositories to benefit patient experience. These improved formulations have brought a renewed clinical recognition of the therapeutic benefits of suppositories which has contributed to a widening acceptance of suppositories over time by prescribers and patients alike. And as provider and consumer familiarity and comfort level grow, older stigmas fade.
Key Drivers of Growth for Suppositories in Women’s Health
Along with the societal shift toward self-administered treatments triggered by the COVID-19 pandemic, several additional converging trends are driving growth within the women’s health suppository market:
- Increase in prevalence of chronic vaginal infections and sexually transmitted diseases
- Demand for hormone replacement therapies to treat menopause symptoms
- Need for more user-friendly contraceptive options
- Continuous research enhancing drug compatibility and stability
Together, these developments are dramatically expanding the role of suppositories in managing urgent women’s health concerns, including bacterial vaginosis, vaginal atrophy, fertility regulation, HIV and other sexually transmitted infections, as well as pregnancy-related conditions.
The Suppository Advantage in Women’s Health
Suppositories present a number of inherent advantages that make them well-suited for treating sensitive health conditions often encountered by pregnant and non-pregnant women.
The benefits of vaginal suppositories include:
- Delivering localized treatments direct to site of action. Suppositories enable precise drug delivery to affected regional tissues while minimizing systemic exposure/side effects.
- Avoiding first-pass metabolism. Suppositories prevent drug degradation in stomach and liver so more active compound is bioavailable where needed locally.
- Reducing systemic side effects. Not only does this contribute to flexibility for dose adjustment, it enhances patient adherence.
- Controlling precise dosages allows for higher medication concentration and extended drug release times. Which in turn enables custom tailoring of drug release kinetics from one-time acute to long-acting chronic scenarios.
- Gaining greater user control. Suppositories can be self-administered, allowing the patient an extra layer of autonomy in self-managed care.
- Bypassing ingestion issues. Provides option when nausea, vomiting, or swallowing difficulty would impair oral medications.
- Rapid onset of therapeutic effects. Drugs administered as suppositories are absorbed into the local blood supply quicker than oral route.
The increasing recognition of the benefits of vaginal suppositories has fueled this rapid market expansion.
The Research & Development Opportunities
Innovations such as nanotechnology and biomaterials-based drug delivery are opening new frontiers in suppository formulation to help treat reproductive tract and pregnancy disorders in the face of microenvironments presented by the vaginal mucosa and placenta.
LGM has long counseled clients not to underestimate the complexities of developing and commercializing suppositories.
That’s because the complex nature of SSD products means that every step of the manufacturing process, no matter how small or seemingly insignificant can affect the end product’s characteristics. For example, preventing entrapped air during degassing ensures product stability.
The scaling process is also challenging for complex products like SSDs because large scale production equipment is different from bench equipment. Mixers with larger capacity may not be as efficient and can lead to an uneven distribution of API, which could lead to adverse effects for the end user.
A further challenge is one of technical expertise. As the market grows, the need for companies with personnel that know how to handle the specific technical challenges presented by SSDs will grow, as well.
And when it comes to SSD production, practical experience is the best teacher. Especially when reference texts are known to offer incomplete information about the technical aspects of suppository production.
A critical review of Pharmaceutical Technology, a popular industry reference book, points out the book omits critical information that must be considered when choosing and preparing bases in suppository formulations. When the omitted information could lead to costly delays in production or worse, it’s important for production personnel to have the full understanding that comes with hands-on work experience.
When faced with producing bigger batch sizes under tighter timelines within a rapidly changing regulatory environment, personnel with experience can become your manufacturing partner’s greatest asset.
The Manufacturing Opportunity
Given the rising demand, the suppository market offers a myriad of opportunities… if you have the right CDMO partner. What you’re looking for is an experienced team, a facility with state-of-the-art equipment and end-to-end capability, with the ability to move production efficiently from bench to large scale.
You’ll want to ensure that your partner has specialized expertise around formulation, technical knowledge of manufacturing processes, excellent quality control and testing procedures, and the regulatory navigational skills to help you take your drug candidate to market.
Developing a suppository project?
LGM Pharma has more than 40 years’ experience helping companies commercialize products in the suppository market. Leveraging turnkey developments through CGMP manufacturing services enables you to capture business growth without needing to invest heavily upfront in infrastructure buildout, technical training, or regulatory approvals.
We assist our client partners in getting custom-developed suppository treatments from conception through scaled commercial batches rapidly and cost-effectively at our dedicated suppository manufacturing facility in Rosenberg, TX.
Contact us to discuss your next suppository project today.