3.8.3 Plastic Pre-Filled Syringes: Drivers and Restraints

Transcription

1 3.8.3 Plastic Pre-Filled Syringes: Drivers and Restraints Figure 3.18 identifies the major drivers and restraints that will impact demand for plastic pre-filled syringes in the period Higher uptake for plastic pre-filled syringes will be driven by demand from biopharmaceutical companies for lower risks of drug interaction. This demand will largely come from developers of biologics and biosimilars, although small molecule drug manufacturers will also demand improved safety profiles. Development of viscous drug products will also raise demand for plastic pre-filled syringes, which have a lower risk of breakage than their glass counterparts. Increased use of autoinjectors, for viscous biologics and other drugs, will also drive growth in the plastic pre-filled syringe market. Figure 3.18 Plastic Pre-Filled Syringes Market: Drivers and Restraints, Drivers Restraints Increased development of biological therapies will result in more companies looking for more inert syringe materials Pharmaceutical companies will demand improved safety profiles for drugs Lower risk of breakage in plastic syringes than in glass syringes, resulting in improved safety and lower risk of recalls Plastic syringes are sensitive to scratches that can cause visual impairment of dosing Limited experience with plastic syringes will restrain early uptake for some pharmaceutical companies Plastic syringes are higher cost than glass syringes and there is less manufacturing capacity for these products worldwide; under-capacity may be an issue Restraints to submarket growth for plastic pre-filled syringes will include the lower cost of glass syringes, which makes them more suitable for low-cost generics, as well as improved manufacturing of glass syringes, reducing extractable and leachable profiles. Additionally, pharmaceutical companies have a lot of experience in using glass syringes for their drug products and some may be unwilling to switch to plastic syringes. Concerns with plastic syringes include the risk of scratches on the surfaces of the syringe plastic syringes are reportedly easier to scratch than glass syringes. Scratches could lead to an impaired view of drug administration. Scratched Page 73

2 $11.8bn allocated for advancing biotech innovation by the Ministry of Health. The CFDA has begun drafting guidelines for biosimilar drugs and established teams of experts to prepare for regulatory processes. The CFDA has also implemented faster regulatory review of new drugs for special approval from 29, which covers drugs that include biologicals and drugs for diseases without effective treatment Indian Pre-Filled Syringes Market Forecast The Indian submarket for pre-filled syringes and pen injectors will grow rapidly in this decade, visiongain forecasts. By 225, it will be worth $295m, up from $69m in 214 and $135m in 219 (Table 4.11 and Figure 4.13). Table 4.11 Indian Pre-Filled Syringes Market Forecast: Revenues ($m),, C, India ($m) Annual Growth Rate (%) CAGR (%, and ) CAGR (%, ) 14.1 Figure 4.13 Indian Pre-Filled Syringes Market Forecast: Revenues ($m),, Year Page 98

3 hold only a small share of the market in the US and EU. Other growth drivers in this market include a small increase in the incidence of growth hormone deficiency due to population growth, development of long-acting growth hormone therapies (LG Life Sciences/Biopartners and OPKO Health have developed or are developing such products) and product lifecycle management strategies such as new formulations. Table 5.9 Growth Hormones Market Forecast: Revenues ($m),, C, Growth Hormones ($m) 3,43 3,6 3,74 3,88 4,2 4,15 4,28 4,41 4,513 4,617 4,72 4,819 Annual Growth Rate (%) CAGR (%, and ) CAGR (%, ) 3.1 Figure 5.4 Growth Hormones Market Forecast: Revenues ($m),, , 6. 5, 5. 4, 3, 2, , 1. Year Market share for biosimilars will grow in this decade, as healthcare payers looking for low-cost therapies to cut rising healthcare costs. Expanded use of growth hormone therapies will drive demand for pen injectors to 225, visiongain predicts. However, doctors and healthcare payers will increasingly demand novel devices for growth hormone administration that reduce pain and inconvenience for patients. Non-adherence to dosing is a significant problem in the growth hormone sector, reports suggest. Companies have already launched somatropin products in Page 119

4 Table 6.13 Novo Nordisk: Norditropin Revenue ($m),, C, Norditropin ($m) 1,15 1,173 1,178 1,143 1,97 1, Annual Growth Rate (%) CAGR (%, and ) CAGR (%, ) -3.2 Source: Novo Nordisk 215; visiongain 215 Figure 6.9 Novo Nordisk: Norditropin Revenue ($m),, ,4 3. 1,2 1, Year Source: Novo Nordisk 215; visiongain Genotropin: Sales Forecast Genotropin, like Norditropin, is available in a proprietary pen injector, as well as in pre-filled disposable syringes. The Genotropin MiniQuick syringes are marketed as an ideal travel choice for growth hormone deficiency patients as they are packaged as a seven-day supply and are available in ten dosage strengths, from.2 mg to 2. mg. Genotropin syringes are also available for use with a reusable mixing device that reconstitutes Genotropin from cartridges. Pfizer has also launched a range of pen injectors for use with lyophilised Genotropin cartridges, the Genotropin Pens. These reusable pens reconstitute the drug and have an automatic digital display to aid patients in dosing. However, unlike Novo Nordisk, Pfizer has not developed a room temperature-stable formulation of Genotropin pre-filled syringes must be refrigerated for extended storage. Norditropin in the FlexPro pens can be kept at room temperature for up to three weeks. Page 151

5 Solutions revenues prior to 212, we have estimated Datwyler s pharma packaging revenue for as 6% of Sealing Solutions revenues (Table 7.22 and Figure 7.8). Sealing Solutions growth in 213 was accelerated by the acquisition of two companies, Zhongding Sealtech in China and Hankook Sealtech in South Korea, in October 212. Table 7.22 Datwyler: Pharma Packaging Revenue ($m), AGR (%), C, Datwyler: Pharma Packaging Revenue ($m) Annual Growth Rate (%) CAGR (%, ) 11.2 Source: Datwyler 215; visiongain 215. We estimate Pharma Packaging Revenues as 6% of Sealing Solutions division revenues. Figure 7.8 Datwyler: Pharma Packaging Revenue ($m),, Year Source: Datwyler 215; visiongain 215. We estimate Pharma Packaging Revenues as 6% of Sealing Solutions division revenues. Datwyler reported that demand was moderate in the first half of 214 due to supply chain optimisation leading to the company s customers reducing their inventories. In addition, FDA restrictions on manufacturing plants in India owned by Datwyler s customers also limited sales. The company has identified several strategic priorities for the division: expanding its global presence, Page 189