The estimated value of the global inhaled drug delivery devices market was US$27.10bn in 2013 and is expected to grow with a CAGR of 12.20% to reach US$48.20bn by 2018.
The respiratory sector is one of the most highly regulated, resulting in high barriers to entry. A number of key drugs are shortly coming "off patent", resulting in a number of new generic entrants and associated opportunities for Bespak to supply both metered dose inhaler (MDI) and dry powder inhaler (DPI) devices. Although sales remain relatively flat in the traditional Western economies, significant volume growth is being seen in emerging markets, with the Brazilian, Russian, Indian and Chinese (BRIC) markets becoming more important to Bespak.
The Group intends to increase its share of the respiratory market through the development of new drug delivery devices; selling into new and developing geographical markets; and offering customers finished dose formulation and manufacturing services as well as integrated drug/device development, formulation and manufacturing services. The Group intends to maintain its competitive position by continuing to leverage continuous improvement activities as products move into the mature stage of their product life cycle.
The global injectable drug delivery devices market is forecast to increase from around U$11.6bn in 2013 to around US$17.5bn in 2018. Self-injection devices are forecast to grow at the highest growth rate of 16.1% with conventional injection devices forecast to grow at 7.4% over this period. Growth is being driven by a large number of new drugs coming to the market for the first time that require delivery by injection. Whilst Bespak currently has a negligible share of this market, it is estimated that c.40% of all new drugs in development will be delivered parenterally and may, therefore, require some form of auto-injector.
Many of these new "large molecule" biologic drugs are highly viscous and require specialist devices to enable them to be effectively administered, often by patients themselves in a non-clinical environment. The continued drive to greater self-administration with the associated improvements to patient compliance, patient outcomes and healthcare economics will create significant opportunities for the Group to develop and manufacture auto-injectors to meet these needs.
In 2013, Consort Medical commercially unveiled the Syrina®, Vapoursoft® and Lila® injection technology ranges. In 2014, Consort Medical commercially unveiled Lapas®, a new range of innovative wearable bolus injection devices powered by Vapoursoft®. In FY2016, Bespak unveiled its latest addition to the Syrina® range of auto-injectors. The new Syrina® 2.25 is one of the most compact versions of auto-injector available today utilising a standard 2.25ml pre-filled syringe, and is based on Bespak's proprietary Vapoursoft® technology.
All of these technologies leverage Bespak's expertise and IP in gas propulsion and, using IP acquired through the acquisition of The Medical House, combine them into a family of innovative next-generation auto-injectors. These innovative drug delivery devices demonstrate Bespak's capabilities from device feasibility, concept and initial design through device development and also demonstrate the ability of the Innovation team to deliver product diversification opportunities in the drug delivery sector.
Consort Medical's Syrina®, Lila® and Lapas® range of auto-injectors positions the Group well to participate in this growing market. Our strategy is focused on the commercialisation of the existing pipeline in conjunction with the development of further IP and the exploitation of "innovation on demand" opportunities through the growing Innovation team in Cambridge. Consort Medical intends to continue to move up the value chain by offering assembly and drug handling and will continue to look for additional, selective acquisitions in this area.
The global nasal drug delivery market was estimated to be valued at US$8.9bn in 2013, and is forecast to reach US$15.0bn by 2018, a CAGR of 8.60% over this period. Growth is being delivered from two main areas. Firstly, a number of existing branded drugs are coming off patent leading to generic entrants, all requiring their own delivery system as the original device associated with the branded drug is normally unavailable to them. Secondly, the nasal drug delivery route is extremely effective and a number of existing and new drugs are being reformulated to enable delivery in this way, increasing demand for this type of drug delivery product. This is now a strategic market for Consort Medical and it currently has two firm development pipeline opportunities.
The Group's strategy for the nasal market is focused on the delivery of Bespak's existing development programmes plus further exploitation of the Group's growing IP portfolio via a number of "innovation on demand" opportunities. In addition, the Group intends to offer customers finished dose formulation and manufacturing services as well as an integrated drug/device development, formulation and manufacturing services.
The global ophthalmic drugs market was estimated to be valued at US$16bn in 2012 and is forecast to reach a valuation of US$21.6bn in 2018, a CAGR of 5.20% over this period. The global ophthalmic drugs market is driven by key factors such as rising prevalence of ocular disorders such as diabetic retinopathy and macular degeneration, largely driven by the rising percentage of ageing population in the world.
In FY2016, the Group was awarded a new strategic development and manufacturing agreement with retinal therapeutics company, Precision Ocular. The contract is related to novel ocular device and drug applications designed to access specific small spaces in the eye and to provide unique drug distribution to treat retinal diseases. As well as representing the Group's first combined device/ formulation contract, it also extends the Group's competencies into the ocular therapeutic area, in line with our stated strategy.
Aesica's oral delivery capabilities and drug formulation and manufacturing services are highly complementary to Bespak's business. The global oral drug delivery market was estimated to be valued at US$64.3bn in 2013 and is forecast to reach US$100.8bn in 2018, a CAGR of 9.40% over this period, reflecting an increase in demand for innovative oral drugs. The implementation of different technologies for oral drug delivery is changing the market scenario, with this area receiving high levels of attention from pharmaceutical companies due to the advantages that research can provide, such as reformulations, which can reposition drugs and delay patent expiry.
The Group's strategy is to continue to drive organic growth in oral drug formulation and manufacture by building on Aesica's foundations of new business development, key account management, project management and continuous improvement.
Although the non-tobacco nicotine delivery market is relatively new and fragmented and, therefore, difficult to analyse in terms of market size and market value, there is a consensus that it is a rapidly growing and dynamic market. The key drivers for this growth are the consumer and regulatory appetite for safer alternatives to tobacco smoking, coupled with the associated public health and healthcare economic benefits.
Consort Medical's approach to the nicotine delivery sector is to successfully industrialise and commercialise Nicovations' Voke® device, and then to increase the value add content, and exploit wider geographic opportunities as the business and market develop.
Point of Care (POC) Diagnostics
The global point of care diagnostics market is forecast to grow at a CAGR of 9.3% from 2013 to 2018, to reach an estimated value of US$27.5bn in 2018. Market growth is being driven by the combined benefits of increased patient compliance, improved patient outcomes and lower cost of provision. Pharmaceutical companies are looking to exploit POC systems as part of a companion diagnostics strategy where drugs and tests are sold as combined "test and treat" packages.
The Group's POC Diagnostics strategy is focused on the commercialisation of the Atlas Genetics device as a first stage penetration of the market. Substantial progress has been made in the last year in the POC card development, in conjunction with Bespak who separately provide development and manufacturing services to Atlas, and with the development of the card reader and assay tests. In FY2016, Atlas announced that it had received approval to CE Mark its Chlamydia trachomatis (CT) test to be launched on the Group's io® platform. By meeting the requirements of the IVD Directive (98/79/EC), the CT test is now cleared for sale within the European Union.
Following a successful outcome to this programme, Consort Medical intends to leverage the Group's development, manufacturing and regulatory know-how in order to grow its market share, possibly in conjunction with additional selective investments or acquisitions.