Prefilled Syringes
Market, Supplier, Risk and
Competitive Intelligence

Industry Outlook & Drivers

Global Market Demand

• The global market for PFS is expected to grow by about 9–10 percent CAGR over 2018-2023, driven by the increasing preference for PFS over other parenteral containers, such as vials and ampoules, especially for high-growth segments, such as biologics.
• With a market share of about 35 percent, North America will continue to remain the largest regional market. The APAC is forecasted to be the witness the fastest demand growth with a CAGR of about 12–13 percent over the next five years, owing to the high rate of chronic diseases and high growth for vaccines and insulin

• Glass PFS hold a market share of about 88–90 percent, but many recent drug recalls triggered by glass delamination particulate formation, and glass breakage has forced the market to invest in developing alternative plastic PFS systems
• The demand for such plastic PFS is expected to grow at about 10–12 percent over the next five years, compared to about 9–9.5 percent for glass PFS

Regional Demand Overview

Global players have engaged in acquisitions and partnerships to expand their product and technology capabilities and continue  to invest into expansions in high growth markets of North America and APAC

Key Trends and Innovations

Key Trend: Integrated Needle Stick Safety Device

• Many markets in North America and Europe continue to mandate the use of safety systems that prevent needlestick injuries to ensure end-user safety. As a result, companies, like BD and Nipro, have launched many innovative safety and shielding systems to incorporate such measures into the existing line of products and the new product developed by the firms

Key Trend:COP- COC based Plastic PFS

• Issues such as delamination and flaking in glass have forced the industry to look for alternative materials in COC and COP plastics. The high chemical stability and the design flexibility of these materials have added to their favorability, in spite of excess cost that they command over glass alternatives. Recent issues with compatibility of plastic PFS with some biological drugs has increased investment towards developing more stable resins

Key Trend: Customized Drug-Device Combinations

• The advent of PFS and allied devices, such as auto-injectors, have given rise to a number of customized drug device combinations. Pharma companies continue to switch to such systems, as they ensure dosage accuracy and prevent wastage. Also, devices, like Nemera's Safelia systems, increase patient convenience by adopting minimal-invasive devices, like micro-needle injectors, spring-based auto injectors

Global Market Overview: PFS

• PFS demand is expected to grow between 9 and 10 percent in the next five years, owing to the growing rate of lifestyle disease globally and large number of biologic drugs coming in the PFS format
• PFS is the fastest growing segment within parenteral packaging, owing to the growing market for drug-device combinations, increasing need for safety, accuracy in dosage, and also to reduce wastage
• Vaccines and anti-coagulants form more that 60 percent of the PFS end-use market, and drive the demand of PFS at over 9 percent CAGR in 2018-23
• Glass is the preferred packaging format for PFS and constitutes about 88 percent of the PFS globally, but plastic PFS made from COC and COP resins have continued to increase penetration, especially in categories, such as advanced devices, and is expected to grow at about 10–12 percent CAGR over 2018-23

• Japan has been the forerunner of plastic adoption in parenteral packaging, with over 50 percent of the PFS made from plastic and growing at about 13 – 15 percent CAGR
• Currently, over 80 percent of the PFS available in the market are of ready to fill/sterile devices. The increasing adoption of PFS integrated into pen-injectors and auto-injectors is  expected to further strengthen this segment and drive the penetration

PFS: Downstream Demand

High growth in downstream products, such as biopharma (9–10 percent) and vaccines (10–11 percent), especially in emerging markets in APAC, continues to drive the demand for PFS.

Key Downstream Demand Segments

Biopharma

• The demand for bio pharma products is driven by the increasing aging  population, increasing levels of investment in healthcare and R&D
• The technological advancements in biopharmaceuticals had increased the treatment options available for various diseases, which also contributes to the demand growth

Vaccine

• Increasing demand for healthcare infrastructure and high awareness of the benefits of immunization are the major factors driving the market growth
• North America is the most developed region with the largest market share of more than 40 percent, while APAC would experience the fastest growth, due to increasing awareness and income growth

Insulin

• The global insulin market is primarily driven by the growing prevalence of diabetes and advancements in the field of insulin delivery devices and favorable medical reimbursements
• Developed regions of North America and Europe have the largest market share for insulin in 2018, with Asia experiencing strong demand growth rates

Downstream Demand Outlook

Growing geriatric population

The World Bank estimates that the population aged over 60 would double from around 11 percent to 22 percent in 2050, especially in the emerging economies of APAC.

Prevalence of chronic diseases

Increase in the prevalence of epidemic diseases, such as cancer, diabetes, hepatic failure, and chronic intestinal diseases will also play a role in ramping up the demand for parenteral packaging.

Increasing government spending

Favorable government policies, combined with the rising adoption of injection-based treatment will also continue to influence the market positively.

Regional Market Overview of PFS

In the next 3–5 years, the market for traditional disposable syringe will be gradually replaced with safety PFS with advanced retractable features, owing to stringent regulations on needle stick injury prevention in the western market.