Express Pharma

Market trends driving new advanced drug delivery devices in injectable space

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Kirat Majumdar, Business Director, BD Medical – Pharmaceutical Systems elaborates on how  companies like BD are catering to varied patients’ requirements through advanced innovation and solutions in drug delivery that are tailored to meet their specific needs

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Kirat Majumdar

The medical device sector in India, though relatively small, has witnessed an expeditious growth over the last few years. Valued at $5.5 billion, the sector has showcased an annual growth rate of 13-14 per cent over the last few years and is expected to continue with this growth in the coming decade. From patients’ perspective, the recent growth in the medical devices sector has proved significantly prudent, catering to extensive patient-centric requirements in a more effective manner.

India is placed fourth in terms of medical device market size in the APAC region, after Japan, China and South Korea, while figuring in the top 20 markets globally. This growth can be largely attributed to socio-economic factors such as increase in healthcare expenditure, insurance coverage potential, number of doctors and unserved population. Although, these factors lead to a greater demand of healthcare facilities, substantially defining the market trends for the drug delivery devices sector, they also act as barriers on many fronts for the Indian medical device manufacturers.

The extensive nature of the medical device sector, coupled with varying patient demand, has posed a challenge for domestic medical device manufacturers in making an immersion in all aspects of the sector. Currently, approximately 70 per cent medical device demand is met through imports, with only 70-80 Indian medical device companies out of 800 boasting a turnover of more than `500 million. While domestic players are conspicuous in the low-priced and high volume segments, the innovation in the sector is largely driven by MNCs, with noticeable market presence in high-end products (especially diagnostic equipment and instruments) augmenting the efforts of the domestic sector.

In a broad sense, the stunting of the domestic medical device manufacturers can be boiled down to poor regulatory systems, void of harmony with global standards and the lack of quality testing infrastructure. Furthermore, domestic manufacturing is neglected in the face of imports due to inverted duty structure. MNCs have proved substantially assistive in this regard, lending technological know-how and necessary skill to improve innovation in the domestic sector.

20170228ep18Becton Dickinson (BD), a global medical technology company, is working actively in India for the past several years to help advance its health sector by encouraging medical discovery, diagnostics and healthcare delivery. The company leads in patient safety and the technologies that enable medical research and clinical laboratories, as well as provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.

The company partners with organisations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower healthcare delivery costs, increase efficiencies, improve health care safety and expand access to health. As part of this, the company offers dedicated departments (regulatory, supply chain, quality, marketing, etc.) focussed on ensuring good products and value added services, regulatory support including online support and worldwide operations – BD Medical – Pharmaceutical Systems plant to ensure business continuity.

Although, India’s contribution to global sales is very limited, the company sees it as a market with a lot of opportunity and a market with a great potential form medical intervention, primarily due to drug delivery devices space in the country. The Indian drug delivery devices market is largely driven by increased prevalence of chronic disease, technological advancements, increase in individual therapy, increased understanding about drug metabolism among the population and requirement of controlled drug release. Despite the extensive demand, the growth of this industry is hampered by several restraints. Injuries and infections fear while usage, high cost of development, and strict regulatory framework are the core issues facing the market. Patient safety plays a pivotal role in overcoming these challenges and in turn, improving the healthcare provision.

20170228ep19BD Pharmaceutical Systems has a renowned history of drug delivery devices, dating back to 1898 and starting with the first all glass syringe developed by H Wulfing Luer. Since, the company has taken long strides in the injectable space, making its mark as one of the leading medical device companies in the world. In 1925, BD received the Luer – Lok syringe patent which provided simple and secure method for needle attachment, heightening stability in drug delivery and ensuring patient safety. The next major milestone came in 1954, with first completely disposable syringe used in large scale field test of polio vaccine by Dr Jonas Salk, defining the trend in the injectable space. In the year 1975, BD Hypak glass disposable prefillable syringe was developed.

Today, BD Pharmaceutical Systems is a market leader in high – quality, clinically proven prefillable parental drug delivery systems. With one of the most diverse portfolios in the medical device sector, BD offers a wide array of drug delivery systems and services, including glass prefilled syringes, plastic prefilled syringes safety and shielding systems and self-administration injection systems, with customisable solutions befitting patients’ requirements. These solutions are developed with a conscious focus on various governing issues like disease indications, ease of administration, convenience and affordability with respect to the market and patients profile.

In addition to developing innovative drug delivery devices, BD also collaborates with the pharma companies to help them select the right device which is optimised for the patient and integrates device design through industrialisation, thereby ensuring successful commercialisation of the drug. An integrated approach as such can enhance the efforts of different players in a demographically, economically and geographically diverse country like India and catalyse formulation of an effective way forward.

20170228ep20BD successfully partners with 27 of the 30 top pharma companies in the world. This, in turn, results in capacity building, with worldwide production capacity of 2.5 billion syringes per year. This also helps significantly in performance enhancement, as majority of high – quality drugs are injected through BD prefilled syringes. Moreover, 94 per cent of the leading global blockbuster drugs available in prefillable syringes are filled in BD Hypak Glass Prefillable Syringes.

BD’s integrated solutions ensure Safety and Performance of drug delivery systems that helps to cater to the increasing demand for combination products that require complex container systems. The company has developed a systems approach to integrating the multiple components into a unique system that meets each patient’s needs, such as, compatibility of drug with key container components, deep understanding of interactions between all components and functions, safety solutions that adapt seamlessly to existing container, healthcare worker and patient safety, rigorous compatibility testing of packaging components and seamless integration of BD components into the supply chain.

The most successful example in this regard is BD’s partnership with a biosimilar insulin drug to develop BD Vystra, a Disposable Liquid Pen (DLP), which was not only launched in the domestic market but also for other export markets.

Additionally, BD has been actively engaging/ partnering with patients in India, especially when it comes to them being a knowledge partner. BD has been carrying out one on one discussions with patients in addition to extensive strategic workshops to understand detailed patients’ perspective and therefore, cater to different patients’ needs.

The company has also been engaging with the industry stakeholders through their flagship programme – ‘Technovation’, which has been a ‘value differentiator’ from the patients’ perspective. Technovation shares global trends, new regulation and latest technologies in the field of pre-fillable syringes with the pharmaceutical companies. BD, being a pioneer in this space, has scaled up the initiative with the object of maximising participation. As part of this, BD annually contributes the latest topics of interest to be shared over the platform of Technovation.

To tackle the challenges of the diverse medical device sector in India, BD’s approach has evidently been a step in the right direction. Through understanding different patients’ perspectives, BD has been able to cater to varied patients’ requirements through advanced innovation and solutions tailored to meet their specific needs. With the help of its thoughtful initiatives and extensive engagement with stakeholders and experts from the industry, BD has mastered in understanding the medical device market dynamics in India and serving them through long-term investment in
quality innovation. Keeping in mind the diverse needs of the Indian patients, BD delves into a wide range of therapeutic classes including vaccines, anaesthesia, antibiotics, cardiovascular, diabetes, hepatitis, oncology and Parkinson’s disease from a total of 37.

This innovation is backed by consistent product quality and compliance, as all plants are certified according to international quality standards – ISO 9001 and ISO 13485 – and complimented with multiple checks; every BD Prefilled syringe batch undergoes a stringent battery of tests to ensure consistent quality across batches.

India’s healthcare needs are constantly evolving, be it technological advancements in the sphere of medical device and diagnostic equipment, or the changing disease profile stunting collective health. In this context, understanding patients’ needs take precedence, with a conscious focus on the provision of quality health care delivery to suit their specific profile. BD has been investing in improving the healthcare innovation system in the past several years, spending approximately six per cent of sales revenue in R&D. The company continues to build capacity in the overarching mechanism of social care in India by rigorously boosting medical discovery and health care delivery. BD’s efforts must be scaled in all aspects of the medical device industry to compliment the work of the domestic market, thus advancing the healthcare sector as a whole.

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