Pushing through — looking at the challenges and opportunities in injectables market

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SHL Group looks at the important challenges and opportunities facing device manufacturers and pharma companies in the growing injectables market.

Recent years have witnessed significant global market growth for injectable drug delivery devices. This trend is expected to continue well into the future. Self-injection devices are expected to grow at a CAGR of 16.1%, continuously increasing the market share.1 What explains this growth?

  • Growing life expectancy and chronic disease prevalence mean that many treatments are moving from hospital to home.
  • Biological drugs are on the rise. They were providing 22% of big pharma sales in 2013 and are expected to account for 32% by 2023.2
  • A rise of biosimilars leads pharmaceutical companies to use delivery devices for drug life-cycle management and product differentiation.

These trends mean that drug delivery devices are becoming an integral part of the healthcare industry. Therefore, both device manufacturers and pharma companies have to stay well informed of the most important challenges and opportunities for innovation.

Higher viscosities

Since the creation of the first recombinant DNA molecule in 1973, the advances in biotechnology and genetic engineering have been driving the growth in biological drugs. Now they are used across a wide range of indications, including diabetes, autoimmune diseases and cancer.

One challenge posed by the new generations of biologics is that many of them are large molecules and have to be administered in high concentrations. The resulting formulations reach high viscosities, sometimes together with high volumes, thus creating a challenge for traditional delivery systems. Is there a way to provide these drugs for self-administration?

Considering that adherence is one of the major issues in chronic condition management, the challenge of high viscosity must be approached with patient comfort and device usability in mind. These were the main considerations during development of SHL’s Rotaject technology. Using clock spring technology for injections, this system allows for delivery of formulations with viscosities up to several hundred centipoise. At the same time, it can be encased into a two-step disposable auto injector using a 1.0 mL or larger 2.25 mL syringe.

Patient-centricity

With major pharma companies introducing chief patient officers3 and FDA considering the new ‘Office of Patient Affairs’,4 the patient is becoming not just the recipient of the innovation, but also one of the main gate-keepers. Powered by human factor engineering and usability studies, device companies consider satisfying end-user needs to be one of the most important requirements for their products.

Behind this is the simple fact that a patient will not benefit from the treatment that he can’t administer. From fear of needles to dexterity issues to the variety of feedback mechanisms — every feature of an injection device has to be thought through and based on the needs of the particular patient population.

One of the most important steps here are user studies conducted to see how a device works in the real world. The data from such studies should be collected, centralised and analysed to guide the design, revealing what real patients want from their interaction with a drug delivery device. For this reason, SHL has invested in a new design centre that will include a dedicated interview studio featuring equipment for recording and documenting patient experience and feedback.

Digital health

Digitalisation of healthcare is happening and connected solutions will continue to play an increasing role for patients, healthcare providers, payers and pharmaceutical companies. In drug delivery, connectivity is realized by enabling the drug delivery device to communicate with a mobile or the cloud. The collected data can be used by patients, carers, physicians, payers, pharma and other stakeholders. From simple reminders to in-depth understanding of the therapy, this information can help improve adherence and health outcomes, streamline communication and save costs. Importantly, it provides new and exciting insights into the current and future needs, inspiring and guiding further innovation.

Whether realized through an existing device add-on or developing a completely new connected auto injector, a smart connected product is a timely and necessary innovation. Combining internal knowledge and experience with active partnerships, SHL Group has already started a number of initiatives in the digital space to stay ahead of the curve and bring innovation to the market.

References

  1. Injectable Drug Delivery Market: By Devices, Therapeutics & Formulations 2015–2020, Research and Markets, 2015.
  2. Going Large, The Economist, 2015, http://www.economist.com/news/business/21637387-wave-new-medicines-known-biologics-will-be-good-drugmakers-may-not-be-so-good
  3. Sanofi aims for outcomes with brand-new Chief Patient Officer, March 2014, http://www.fiercepharma.com/sales-and-marketing/sanofi-aims-for-outcomes-brand-new-chief-patient-officer
  4. FDA Considers Creating New 'Office of Patient Affairs', March 2017, http://www.raps.org/Regulatory-Focus/News/2017/03/13/27103/FDA-Considers-Creating-New-Office-of-Patient-Affairs/