The Upswing of Sterile Injectables

Global Sterile Market

The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.

By 2026, contract manufacturing of sterile injectables will account for 25.7% of contract final dosage form (FDF) manufacturing revenues, up from 22.3% in 2014. This reflects the general trend in drug development towards injectable therapies.

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Factors of Growth

  • The Rising Prevalence of Chronic Diseases
  • Growing Biosimilars and Generic Injectables Market
  • Increased Focus on Development of Biologics/ADCs
  • Expanded Drug Delivery Technologies such as Pre-Filled Syringes , Pen Injectors, Auto-Injectors

Global Vial Market

Liquid and Lyophilized:

With many parenteral products going off-patent in the next 5-7 years, the Global parenteral liquid vials market grew at 6% to $33bn in 2015 and is expected to continue this trajectory.

Sterile liquids contribute around 53% by value and 60% by volume to the sterile injectable market. Therapeutic areas like CNS, Cardiovascular and Metabolic Disorders contribute to 60% of the sterile liquids.

Potent and Non-Potent:

The Potent Compounds market is growing at a CAGR of 5% due to selective targeting characteristics. Therapeutic areas like Oncology and Hormones contribute to 78% of the potent vials market i.e., $14.8 bn. US is a dominating market with 40% market share for potent compounds. Tremendous growth in HP-API market which is growing at 7.8% ($ 25Bn -2022 from $ 12 Bn in 2014) is a major growth driver.

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End to End Services for Sterile Injectables:

The Lexington parenteral development and manufacturing site is comprehensively integrated within the Piramal global network to streamline end-to-end pharmaceutical development, manufacturing and supply from API to final dose or ADC. Support from pre-clinical to routine commercial manufacturing, we have successfully supported over 100 liquid and lyophilized drug candidates for both large and small molecules.

Our mobile isolator technology, provides Class A environment to handle your most potent and cytotoxic products. Our scientist and process engineers have substantial experience with multiple homogenization techniques, excipient compatibility and justification, formulation development expertise for viscosity modifying agents, and surfactant selection and feasibility studies to determine critical process parameters.

Our Service Offerings:

At Piramal we have the expertise in:

  • Non-aqueous formulations ( Liquid/Lyophilized)
  • Sterile suspension, nanoparticles, liposomes
  • Lyophilized products
  • In-situ salt formations
  • Large and small molecules
  • Non-potent and Potent compounds (such as hormones, cytotoxics, steroids)

Site Capabilities:

  • Vials from 2 – 100 mL
  • Dispensing volume as low as 0.5 mL up to 50 mL
  • Two Class C Formulation Rooms, each with a Class A Laminar Flow Cabinet
  • Two isolator based automated filling lines, fill speeds up to 40 vials per minute
    • Two additional filling lines (Steriline and Bausch & Stroebel) to be operational 2Q-4Q 2017, increasing the fill speeds to 100 vials/min

Facility Expansion:

With Piramal’s ongoing commitment to sterile manufacturing, the Lexington, KY site is undergoing a phased facility expansion that includes increased capacity with the addition of isolator-based commercial-speed sterile filling lines, additional terminal sterilization capability, and expanded lyophilization capacity.

In addition to two new fully integrated isolator-based filling lines, the site expansion encompasses two 25 square-meter lyophilization chambers with automated loading and unloading. Both filling lines and lyophilization chambers are designed to support potent and non-potent products as well as aqueous and non-aqueous formulations.

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