Coring and Fragmentation of a Rubber Stopper

Jul. 02, 2024

Coring and Fragmentation of a Rubber Stopper

Understanding Risks of Coring and Fragmentation of Rubber Stoppers

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When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.

Björn Henze

Manager, TCS. Commercial, EU

Sleeve Rubber Stoppers Market Size, Share & Forecast-

Sleeve Rubber Stopper Market Outlook from to

The sleeve rubber stopper market is likely to record a robust CAGR of 3.4% during the forecast period. As of , the market is valued at USD 663.8 million. It is slated to surpass USD 927.3 million by . The rapid expansion of the pharmaceutical industry, especially since the pandemic, has been one of the major drivers for this growth. In , the market was estimated to be valued at USD 637.1 million.

The industry is also experiencing sustained growth as sleeve rubber stoppers are essential components in drug packaging, particularly for vials and injectable drugs. The rising incidences of chronic diseases like obesity, hypertension, and diabetes, have also led to an increased demand for medications that require secure and reliable packaging.

Besides this, the recent pandemic has instilled a sense of health consciousness among the general populace. This factor has also driven the demand for vaccines and other injectable medications, which in turn has pushed the clamor for rubber sleeve stoppers in the medical sector.

Sleeve Rubber Stopper Industry Assessment

Attributes Key Insights Historical Size, USD 637.1 million Estimated Size, USD 663.8 million Projected Size, USD 927.3 million Value-based CAGR ( to ) 3.4%

With the increasing emphasis of industry giants on biotechnology and biologics, the sleeve rubber stopper industry is set for a plethora of opportunities in the coming future. These segments of pharmaceuticals are continuously growing, and so is their need for specialized packaging solutions that can ensure the stability and efficacy of complex biological drugs. Manufacturers in the industry must develop innovative sleeve rubber stoppers that cater specifically to the needs of biopharmaceuticals so that they can hop on the ongoing industrial trend.

The expansion of healthcare facilities in emerging economies has also had a significant impact on the industry. In countries like India, China, Thailand, Brazil, etc., where the government is actively promoting medical inclusion policies, these rubber stoppers are in great demand. The increasing demand for pharmaceuticals and related packaging solutions is expected to increase, providing a substantial growth opportunity for the sleeve rubber stopper market.

Technological advancements in the field of medicare and pharmaceuticals have also impacted the market in a positive manner. Companies in this sector are investing billions of dollars in curating advanced drug delivery technologies, such as pre-filled syringes, auto-injectors, and dual-chamber systems. These advancements require the use of highly reliable and compatible packaging components and sleeve rubber stoppers play a crucial role in these systems.

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Semi-Annual Market Update

The table beneath shows the predicted CAGR for the global sleeve rubber stopper market across multiple semi-annual periods from to . The business is foreseen to develop at a marginal rate of 3.1% in the second half (H2) of the same decade after plunging at a CAGR of 3.2% in the first half (H1) of the decade from to .

Particular Value CAGR H1 3.2% ( to ) H2 3.7% ( to ) H1 3.5% ( to ) H2 3.1% ( to )

Moving forward, from H1 to H2 , the CAGR is anticipated to fall slightly to 3.2% in the first half and stay relatively stable at 3.1% in the second half. The market value retained by 50 BPS in the first half, but remained constant at 40 BPS in the second half.

Key Industry Highlights

Pre-filled Syringes to Shape the Future of Sleeve Rubber Stopper Industry

There has been an increasing adoption of pre-filled syringes and self-administered injectable devices in the medical sector. The demand for these advanced systems is touching the skies due to their convenience, accurate dosing, and reduced risk of contamination. This, in turn, has driven the demand for precision-engineered sleeve rubber stoppers that can seamlessly integrate with these sophisticated drug delivery systems, ensuring safety and efficacy.

Sustainability Drive to Influence the Sleeve Rubber Stopper Market

There is an observed shift towards sustainable and eco-friendly packaging solutions in the medicare and pharmaceutical sector. Pharmaceutical companies are actively seeking biodegradable and non-toxic materials for their packaging needs. This has led to innovations in the production of rubber stoppers made from sustainable materials, such as natural rubber blends or recyclable synthetic polymers. Healthcare facilities are thus turning towards manufacturers that can provide these environmentally friendly options.

Competition from Alternative Packaging Solutions to Slow Down Industry Growth

Advancements in the material science and the pharmaceutical sector have led to the development of a multitude of packaging solutions in the medicare industry. Alternative packaging solutions made from plastic and glass offer similar or even superior performance characteristics. This has posed a challenge to the market share of rubber stoppers, particularly in applications where cost-effectiveness and ease of manufacturing are prioritized over specific material properties.

Ismail Sutaria

Principal Consultant

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to Sleeve Rubber Stopper Demand Outlook Compared to Demand Forecast from to

The sleeve rubber stopper market, in the last couple of decades, has seen fluctuations in its demand. The industry is reliant on the performances of the pharmaceutical and medicare industries. The sleeve rubber stopper industry experienced sustained growth before the pandemic hit the world. The emergence of biologics and biopharmaceutical industries led to increasing demand. Also, advancements in drug delivery systems further drove the need for high-quality sleeve rubber stoppers.

The pandemic brought unprecedented transformation in these industries, which in turn, significantly boosted the demand for rubber stoppers. The urgent need for COVID-19 vaccines and treatments significantly raised the prominence of vial closures, including sleeve rubber stoppers. In this period, from to , the industry reported a CAGR of 2.7%. Disruptions in supply chains and shifts in healthcare priorities temporarily affected market dynamics did affect the market in the initial phases.

During the aftereffects of the pandemic, as economies opened and healthcare facilities in emerging economies the sleeve rubber stopper market began to recover and grow. With people becoming more health conscious, the demand for advanced pharmaceuticals also increased. This helped the businesses involved in the manufacturing of sleeve rubber stoppers gain more consumers.

Market Concentration

Tier one companies like West Pharmaceutical Services, Inc., Datwyler Holding Inc., and AptarGroup, Inc. are leading the sleeve rubber stopper sector by heavily investing in research and development and technological advancements. They are also focusing on developing high-performance, safe, and reliable stoppers that meet stringent regulatory standards. These companies are also expanding their global manufacturing capacities and enhancing their supply chain resilience to ensure a steady supply of quality products amidst growing pharmaceutical demands.

VWR International, LLC, SGD Pharma, and DWK Life Sciences GmbH, some of the few examples of tier-two companies in the industry, are catering to the increasing demand by improving their production processes and incorporating sustainable practices. They are adopting advanced materials and technologies to produce rubber stoppers that are not only effective but also eco-friendly. Additionally, these companies are enhancing their product portfolios to offer a wider range of solutions tailored to the specific needs of the pharmaceutical and healthcare sectors.

Tier-three companies including Hebei First Rubber Medical Technology Co., Ltd., Jiangsu Hualan New Pharmaceutical Material Co., Ltd., and RubberMill, Inc. are focusing on cost-effective production and niche markets. They are investing in modern manufacturing facilities and quality control measures to meet international standards.

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Comparative View of Adjacent Industries

This section dives into a comparison of two packaging options within the industry: sterile rubber stoppers and rubber tapes.

Rubber Tapes Industry Assessment:

Expansion of the automotive industry across several countries, especially in the Asia Pacific region is expected to provide an impetus to growth in the market. Increasing adoption of adhesive products such as rubber tapes which are a perfect solution for sealing, insulating, and joining in different automotive parts may propel sales. Besides this, expanding trade and logistics business, increased retail purchasing, and growing demand for packaged food goods are factors influencing the market.

Attributes Description Related Market Rubber Tapes Industry CAGR ( to ) 4.5% Growth Factor Increasing sales of rubber tapes for repairing and protecting, along with rising expenditure on regular upkeeping and maintenance of machines and equipment could continue driving the market. Key Trend Leading players are increasingly shifting their production units to tropical countries for cheap sourcing of rubber and to reduce cost

Sterile Rubber Stopper Industry Assessment:

As advancements in medical technologies continue to rise, the need for reliable and aseptic packaging of pharmaceuticals and medical devices becomes paramount. Sterile rubber stopper makers are in a good spot as the demand for cleaner packaging is booming. They can benefit from the rise of pharmaceutical and biotech industries. The push for better quality and safety in delivering drugs creates opportunities for using new technologies and materials.

Attributes Description Related Market Sterile Rubber Stopper Industry CAGR ( to ) 4.3% Growth Factor The ability to forge robust seals and shield against gases, moisture, and UV rays has propelled the demand for sterile rubber stoppers Key Trend Shift toward sustainable and environmentally friendly materials in packaging

Country-wise Insights

The following segment delves into an industry analysis of the sleeve rubber stoppers market across various countries. It offers insights into market demand across key nations in several regions globally, encompassing North America, Asia Pacific, Europe, and other areas. India is projected to maintain its leading position within the Asian region, with an anticipated CAGR of 4.3% extending to .

Countries Value CAGR ( to ) Canada 2.8% The United States 2.9% Germany 2.7% India 4.9% Thailand 4% South Korea 3.7% China 4.4%

Well Established Pharmaceutical Sector to Drive Market Growth in India

The sleeve rubber stopper industry in India is slated to show a 4.9% CAGR for the forecast period of to .

In India, the growth of the sleeve rubber stopper market is expanding, primarily due to the rapid expansion of the pharmaceutical sector. The country is a major hub for generic drug production, which necessitates large quantities of reliable and high-quality packaging materials, including rubber stoppers. The government's initiatives to boost domestic manufacturing and exports have further spurred demand.

India's large population with increasing access to healthcare services means a higher consumption of medications, particularly injectables. The rise in chronic diseases and the growing emphasis on preventive care and vaccination programs also contribute significantly to the demand for sleeve rubber stoppers.

China&#;s Sleeve Rubber Stopper Industry Exhibits Decent Growth Rate

China also is a promising country in this industry. Over the next ten years, the sleeve rubber stopper industry is projected to rise at 4.4% CAGR.

China's sleeve rubber stopper market is experiencing robust growth due to its booming pharmaceutical industry, supported by strong government policies and investments in healthcare infrastructure. China has been witnessing a high demand for medical packaging solutions to support its vast production of both traditional and modern medicines. The country's aging population and increasing prevalence of chronic diseases drive the need for injectable medications, thus increasing the demand for sleeve rubber stoppers.

China's focus on becoming a leader in biotechnology and biologics production further fuels the need for high-quality rubber stoppers that ensure the stability and integrity of sensitive pharmaceutical products.

Rising Incidences of Chronic Diseases in the United States Push the Sleeve Rubber Stopper Industry

The United States is also one of the most profitable countries in the global sleeve rubber stopper industry. The country is anticipated to exhibit a CAGR of 2.9% through .

The high incidence of chronic diseases and the aging population contribute to the ongoing need for injectable medications, driving demand for sleeve rubber stoppers. The United States also remains a key market for sleeve rubber stoppers due to its advanced pharmaceutical and biotechnology sectors. The country's strong focus on innovation and development of new drug formulations, including biologics and biosimilars, requires reliable and compatible packaging solutions.

Stringent regulatory standards set by the FDA necessitate the use of high-quality, safe, and effective packaging materials. The healthcare system's emphasis on patient safety and drug efficacy ensures continued demand for precision-engineered rubber stoppers.

Category-wise Insights

The sleeve rubber stopper industry is categorized on the basis of material, end-use, product, and region. The section discusses the top two categories in this industry.

Sleeve Rubber Stopper made from Butyl Rubber are Increasingly Preferred by Industries

Based on material, the sleeve rubber stopper industry is bifurcated into natural and butyl rubber. Among these, the butyl rubber segment accounts for a majority share of 54.3% in the global marketplace.

Material Butyl Rubber Value Share () 54.3%

Sleeve rubber stoppers made from butyl rubber are increasingly preferred by industries due to their superior properties compared to natural rubber. Butyl rubber offers excellent chemical resistance, which is crucial for maintaining the integrity of pharmaceutical products. The demand for rubber stoppers made from butyl rubber is touching the skies as they provide an impermeable barrier to gases and moisture. This ensures the long-term stability of medications.

The reduced risk of allergic reactions associated with butyl rubber compared to natural latex enhances its appeal, particularly in medical applications where patient safety is paramount. Also, butyl rubber's consistent performance and reliability make it a preferred choice for industries that require high-quality packaging solutions.

Sleeve Rubber Stopper are Highly Sought After in the Healthcare Sector

Sleeve rubber stoppers are used in a wide spectrum of industries such as biotech, cosmetic, healthcare, and laboratory and research industry. The healthcare segment holds a market share of 28%, as of .

End-use Healthcare Value Share () 34.6%

Sleeve rubber stoppers are highly sought after in the healthcare sector due to their critical role in ensuring the safety and efficacy of injectable medications. These stoppers provide a secure seal that prevents contamination and maintains the sterility of drugs, which is essential for patient safety. The precision-engineered design of sleeve rubber stoppers ensures a tight fit, reducing the risk of leaks or exposure to external elements.

The demand for sleeve rubber stoppers is also touching the skies as they are integral to pre-filled syringes, vials, and other packaging solutions that facilitate easy and accurate administration of medications. Governments in several countries are investing billions of dollars to medically include their citizens. This infrastructural development has also instigated a significant demand for rubber stoppers in the global healthcare sector.

Competitive Landscape

The sleeve rubber stopper market is very competitive, with an enormous number of companies fighting for monopoly. These companies are investing in research and development to create innovative and long-lasting stoppers. These companies are also provide excellent customer service and support can significantly impact a company's reputation and customer loyalty.

Companies are also targeting mid-sized pharmaceutical firms and emerging markets where the demand for high-quality but reasonably priced packaging solutions is very prevalent.

Recent Developments

In May , DWK Life Sciences completed its acquisition of Assem-Pak | Aluseal, enhancing its range of customizable packaging solutions and strengthening its presence in the Life Science industry by integrating Assem-Pak's manufacturing expertise in rubber stoppers and aluminum seals.
In September , Stahp & Go launched an innovative silicone spill stopper designed for Stanley Cups. The three-piece set instantly made Stanley Tumblers leakproof, providing a reliable seal to prevent messy spills and drips during transport or activities.

Leading Manufacturers in the Sleeve Rubber Stopper Industry

West Pharmaceutical Services, Inc.
Datwyler Holding Inc.
AptarGroup, Inc.
VWR International, LLC
SGD Pharma
DWK Life Sciences GmbH
Hebei First Rubber Medical Technology Co., Ltd.
Jiangsu Hualan New Pharmaceutical Material Co., Ltd.
RubberMill, Inc.
Shandong Pharmaceutical Glass Co., Ltd.
Ningbo Xingya Rubber & Plastic Co., Ltd.
Sagar Rubber Pvt. Ltd.
Stelmi Italia S.p.A.
Saint-Gobain Performance Plastics
The Plasticoid Company
Adelphi Group
Bharat Rubber Works Pvt. Ltd.
JSR Life Sciences
GCL Pharma
Alfasigma S.p.A.

Key Segments of the Sleeve Rubber Stopper Industry

By Material:

The sleeve rubber stoppers market is segmented by material into natural rubber and butyl rubber.

By Product:

The product categories include solid stoppers, two-hole stoppers, three-hole stoppers, lyophilization stoppers, injection stoppers, septum stoppers, and rubber stoppers.

By End Use:

The end-use sectors encompass biotech, cosmetics, healthcare, and the laboratory and research industry.

By Region:

Key countries of North America, Latin America, Europe, East Asia, South Asia, Middle East and Africa (MEA), and Oceania have been covered in the report.