Since the concept of ‘Industry 4.0′ was established in Germany in 2011, the USA, Japan and China successively implemented their own plans for industry revolution (Prause, 2015; Li, 2017; Wagner et al., 2017; Zhong et al., 2017). Industry 4.0 comprises four core elements, including Internet of Things (IoT), Internet of Services (IoS), Cyber-physical Systems (CPS), and Smart Factory (Hermann et al., 2016). The IoT is regarded as a “network of physical objects”, in which the Radio-frequency identification (RFID), Wireless sensor networks (WSN), and middleware and Cloud computing are the most essential techniques employed (Trappey et al., 2017; Ben-Daya et al., 2017). Based on the technologies of IoT and a close loop of sensors, actuators and other devices, the CPS integrates physical and cyber networks, and thus provides more intelligent, transparent and efficient actions for information exchange, both vertically inside the company and horizontally across the holistic value chain (Barreto et al., 2017; Hofmann and Rüsch, 2017; Li, 2017; Wagner et al., 2017; Zhong et al., 2017). These technologies assist companies to achieve more robust, closer and flexible linkages in manufacturing, and thus fulfill the optimisation of value chains, cost reduction and energy saving (Branke et al., 2016; Hofmann and Rüsch, 2017; Zhong et al., 2017).

In current years, the techniques of Industry 4.0 have been employed in the pharmaceutical industry (see Lee et al., 2015; Stegemann, 2016; Herwig, 2017; Yu and Kopcha, 2017), and has been strictly regulated by several stakeholders to ensure safety and to protect the wellbeing of whole society (Xie and Breen, 2012; Brown and Vondráček, 2013). Over many years, the majority of pharmaceutical industries are still under batch-based mass production processes rather than continuous production (Lee et al., 2015; Stegemann, 2016). Lack of robust on-line quality control and flexible production are the bottleneck of reliable drug supplies, and sometimes shortages occur even when encountering emergency situations (Lee et al., 2015). It is worthy to note that improving access to medicines is a core responsibility for pharmaceutical companies, given that medicines are special commodities – as access to and affordability of these commodities directly influence the lives of patients (Schneider et al., 2010; Nematollahi et al., 2017). With the exception of availability issues, when compared with the more flexible and efficient continuous production that requires lower raw material consumption, as well as decreased hazardous solvent, traditional batch productions impose more serious impacts on the ecosystem in terms of air emissions, chemical pollution, waste water and residual waste (Stegemann, 2016; Klatte et al., 2017). As “the second largest source of GHG emissions” (Bengtsson-Palme et al., 2018: pp. 138), the increasing energy price, the potential impacts on climate change, and the strict regulations have resulted in the pharmaceutical industry, focusing more on energy usage and emission reduction throughout the entire life-cycle of pharma products (Schneider et al., 2010; Low et al., 2016).

Benefiting from the Process Analytical Technology (PAT), real-time data processing, 3D printing, robots, and other techniques emerging from Industry 4.0, the key point “close-loop” and “on-line” quality monitoring of continuous process can be realised, thereby resulting in the industry reducing its carbon footprint, improving its energy efficiency, solvent utilisation, as well as mitigating other potential environmental impacts while enhancing the quality and control of the entire system (Gernaey et al., 2012; Stegemann, 2016; Aquino et al., 2018). Moreover, with the development of genomic information, along with an increasing number of old people with chronic diseases, the demand for future patient-centered medicines is increasing (Stegemann, 2016). Furthermore, the value chain creation and higher data density reducing productivity also motivate the pharma industry to manufacture more tailored and personalised pharmaceutical products, suitable for individualised drug therapy instead of the current “one-size-fits-all” approach (Gernaey et al., 2012; Branke et al., 2016; Stegemann, 2016).

Apart from pharma manufacturers, the other participants within the pharmaceutical supply chain, including distributors, healthcare providers, pharmacies, etc., should also upgrade their services and technologies to cater to the demands of the future Pharma 4.0, including technologies from smarter logistics to specifically personalised medication therapies. The relevant techniques, i.e. auto-ID tags, smart vehicles, patient-centric information exchanges, cloud computing, big data analytics, etc. thus provide a feasible solution (Campbell, 2017; Herwig, 2017; Hofmann and Rüsch, 2017; Yu and Kopcha, 2017; Zhao et al., 2017). However, extending the concept of Pharma Industry 4.0 from solely being manufacturers to the entire pharmaceutical supply chain includes several other challenges such as additional human involvement, end-to-end collaboration, sustainable issues, safety, and disastrous consequences if there are any mistakes, etc. The conventional research focus of the PSC on solely economic aspects, such as profitability, cost, lead time, etc. (see Narayana et al., 2014a), is incomplete; it is imperative to understand how to establish a smart and sustainable PSC across the holistic life-cycle of pharmaceutical products that is suitable for future pharma industry developments.

As mentioned above, the exploitation of new technologies of Industry 4.0 will facilitate sustainable value creation that will lead to more sustainable PSC designs and management, which, in turn, will assist pharma companies to obtain competitive advantages in the long run (Stock and Seliger, 2016; de Man and Strandhagen, 2017; Ansari and Kant, 2017). Therefore, this study will investigate the key challenges that inhibit the implementation of sustainable practices within the PSC, and, by merging the findings from current literature, explore how the PSC can benefit from the new technologies of Industry 4.0.

The paper is organised as follows: The review methodology and sample selection are described in Section 2. Then Section 3 outlines the major challenges within different stakeholders of PSC and implications of Industry 4.0 for them. Subsequently, Section 4 discusses the main enablers, inhibitors and research gaps in the sustainable PSC. Finally, Section 5 presents the conclusions and limitations of this literature review.