A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 21st Year of Publication
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Cover Story

Emerging Trends In Medical Plastics

Aayush Agarwal
General Manager, F (R&D)
Roselabs Group, India

 

The Lucrative Challenges of Pre Filled Syringe Technology

PFS is taking the parenteral drug delivery industry by storm in India.Today, 85% of healthcare professional prefer PFS over other parenteral delivery systems. It  constitutes one of the fastest growing markets in the pharmaceutical sector with estimated revenues of $2.7 bn in 2010 & predicted to reach $5.20 bn by 2021.

  • The word PFS is commonly known as Pre Filled Syringe. When we use the word PFS, it could be either Pre Fillable Syringe (an empty syringe) or it could be Pre Filled Syringe (a filled syringe). In this article PFS stands for the later meaning.

  • A PFS can be of basically two configurations namely Staked Needle (with needle assembled) and Leur-Lock (without needle). A whole set of difference come into picture right from the manufacturing process to the regulatory requirements of these two different configurations. When talking about the volumes, it ranges from 0.2 ml to 10 ml usually, however in some customized requirements the volumes are as high as 20 ml and 50 ml.

  • Today, PFS is taking the parenteral drug delivery industry by storm in India. It is not at all a new invention but has been around for a long time even during the world war II. However, its in the last couple of decades that PFS has become a preference in the injectable market credited to its numerous benefits. Thus, making it no more a desired product but now a required product in many situations.

  • It not only comes under the drug packaging sector but also is a part of the drug delivery sector since it performs a dual function of storage as well as delivery of the drug. Today, 85% of healthcare professional prefer PFS over other parenteral delivery systems.

PFS Market:

  • PFS constitutes one of the fastest growing markets in the pharmaceutical sector with estimated revenues of $2.7 bn in 2010. These are predicted to reach $3.92 bn by 2015, $4.6 bn by 2018 and $5.20 bn by 2021. Some of the key players in the global market include Becton & Dickinson (BD), SCHOTT, Abbot Laboratories, Gerresheimer and others but the key influencer would be the companies which are setting up in developing nations like India and China. Such companies include Roselabs Group of companies in India and Weigao Holding in China.

  • However, US (40% share) is the largest market and the fastest growing market for PFS followed by Japan market. This small nation shares over 10% of the world market with China (3.4%) and India (1.2%) standing at 6th and 9th position respectively. But the good news is India’s market is one of the fastest growing markets at close to 8% every year over the next 10 years.

Some of the most commonly marketed drugs in PFS:

  • Insulin preparations like Novorapid and Novomix, treatment for rheumatoid arthritis namely Enbrel and Humira, cotreatment with chemotherapy in cancer patients namely Neulasta. In India, Enoxaparin is a popular product in PFS delivery system.

  • Other diseases treatments where PFS products are seeing a tremendous growth and opportunity are Osteoporosis, Multiple sclerosis, Fertility, Anaemia, Haemophilia to name a few. While is case of therapeutic areas, Vaccines, Anti-coagulants, Antiinflammatory, Hormones and Pain relievers serve as the major areas. Specific to Biological drugs, the market is driven by Monoclonal antibodies, Insulins, Erythropoetins, Interferons, G-CSF etc.

  • In case of vaccines, Typhoid live, BCG live, yellow fever, rabies, measles, mumps and rubella are some of the market driving formulations. Various benefits associated with PFS:

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