Cutting-Edge Pharma Machinery: A New Era Begins Exploring the Technologies Redefining Pharmaceutical Manufacturing

In the previous issue of Pharma Now magazine, we highlighted the key market trends in pharmaceutical technology. This issue highlights a smaller niche within this vast field: pharma manufacturing equipment.

So, let’s begin!

The pharmaceutical industry is heavily dependent on manufacturing equipment because the type, quality, performance, efficiency, and downtime of all machines decide the overall products manufactured by a pharmaceutical company. Generally, pharmaceutical companies are always searching for ways to upgrade their existing processes and equipment to increase their overall production capacity and efficiency. However, practically, it is not always possible for companies to upgrade equipment every time a new technology or machine hits the market, primarily because of the high costs. Hence, technological developments in pharma manufacturing equipment are often limited. Regardless, experts have highlighted some key trends shaping this niche in today's fast-paced markets.

This article highlights some of the key market trends that will shape the pharmaceutical equipment segment in the near future.

Key Trends Shaping Pharmaceutical Manufacturing Equipment

Automation and digitalisation

Automation and digitisation of pharma equipment are coming into increasing focus as companies look to improve their operational efficiency, enhance quality control, decrease error rates, and improve compliance with regulatory guidelines. Here are some technologies that play key roles in the automation and digitisation of pharma equipment:

• Robotics: Robots are already being used for simple manual labour like material transfer, labelling, and packaging. However, they are also being integrated for complex processes like aseptic filling of formulation and high-throughput screening. The integration of robots aims to reduce human error and increase precision in pharmaceutical manufacturing.
• Internet of Things (IoT): IoT allows communication between pharma equipment, realizing remote monitoring and predictive maintenance. IoT-enabled machinery can also be used to identify production bottlenecks and track production metrics, which will help reduce downtime and improve savings.
• Digital twins: Digital twins are mimics of real-world objects. Digital twin models are being used to replicate physical equipment, allowing manufacturers to stimulate and optimize processes as well as troubleshoot problems before actually integrating new processes.

While these technologies offer significant advantages, the primary challenge limiting their use is cost. The high investment for these technologies originates from high initial purchase costs, personnel training costs, and facility reorganization/update requirements. Furthermore, cybersecurity concerns due to automation persist. However, the industry seems to be leaning towards automation and digitisation, and ongoing and future advancements are expected to make these technologies more accessible and safe.

Sustainable equipment

The pharmaceutical industry has a huge carbon footprint. As the consequences of this come to light, several pharmaceutical companies have vowed to decrease their emissions and develop sustainable practices. For example, Johnson & Johnson aims to source 100% of its electricity needs from renewable sources by 2025. Sanofi aims to attain carbon neutrality by 2030 and net-zero emissions by 2045.

However, to achieve these goals, companies have to integrate sustainable processes that have lower or no emissions, which depends heavily on the equipment used. There are several types of equipment under investigation:

• Energy-efficient equipment: Energy-efficient equipment such as optimized heating and cooling systems, low-energy-requiring robots, and other similar machinery are being investigated to lower the overall energy required to complete manufacturing.
• Minimal-waste equipment: Equipment that supports closed-loop systems is becoming increasingly attractive because it supports the recycling of solvents, reagents and by-products. These systems allow companies to reduce the overall wastage from the manufacturing process and simplify waste management and disposal.
• Biodegradable equipment: Single-use biodegradable technologies are being investigated to reduce the environmental impact of the pharma industry. Currently, while there is no notable equipment developed to support this goal, biodegradable materials like disposable bioreactors and packaging have been developed.

In an effort to become more sustainable, companies are also looking to integrate continuous manufacturing processes.

Continuous manufacturing

It is well-established that continuous manufacturing consumes less energy than batch manufacturing. Hence, the shift to continuous manufacturing has been one of the goals of many pharmaceutical companies. Several companies like Johnson & Johnson and Pfizer integrated continuous manufacturing into their operations years ago. However, there are still others that are looking to integrate them now or in the near future.

This shift toward continuous manufacturing depends on advanced machinery that can integrate multiple production states within a continuous flow. Consequently, new equipment with real-time monitoring, process analytics, feedback loops, and sensors needs to be developed. While some aspects of these have already been designed and integrated, there is definitely room for improvements, which we can expect in the near future.

Continuous manufacturing also demands the use of scalable systems—There’s no point in having a continuous manufacturing facility that churns out 50,000 doses a day if the monthly demand is not meeting this production capacity. Hence, modular or flexible systems that allow manufacturers to reconfigure equipment for producing different drugs are the key. This allows manufacturers to produce other drugs when the demand is met. These systems support scalability, allowing companies to manufacture as and when needed. However, it is necessary to consider regulatory requirements when integrating such systems.

Single-Use Systems

Single-use systems (SUSs) represent a transformative innovation in biopharmaceutical production, replacing traditional stainless steel systems with disposable components designed for one-time use. These systems include bags, filters, tubing, bioreactors, and connectors, which are pre-sterilized and ready for immediate deployment. By eliminating the need for cleaning and sterilization between production cycles, SUSs dramatically reduce downtime and cross-contamination risks, making them especially valuable in the production of biologics such as monoclonal antibodies and vaccines.

SUSs offer unmatched flexibility, allowing manufacturers to quickly switch between product lines, which is crucial for handling multiple products in the same facility or adapting to fluctuating market demands. The reduced reliance on water, energy, and chemicals for cleaning also contributes to significant cost savings and environmental benefits.

SUSs have various applications in biopharmaceutical manufacturing:

• Flexible manufacturing: SUSs enable manufacturers to produce multiple products in the same facility by simplifying transitions and reducing the risk of contamination.
• Clinical trials: SUSs are ideal for small-scale production runs, such as those required during clinical trials, where flexibility and speed are paramount.
• Pandemic response: During crises like the COVID-19 pandemic, SUSs allowed manufacturers to quickly ramp up vaccine production without the need for costly and time-consuming infrastructure modifications.
• Biologics production: SUSs are particularly suited for biologics, which are often produced in smaller batches and require stringent sterility.

SUSs have large scope for development, and some possible directions include:

• Increased customization: Manufacturers are developing customized SUS solutions tailored to specific production processes, enhancing efficiency and compatibility.
• Integration with automation: Automation technologies are being integrated with SUS to further streamline operations, enabling real-time monitoring and control.
• Sustainability Initiatives: Innovations in biodegradable and recyclable single-use components are being explored to address environmental concerns.

3D Printing: Customization at Its Peak

3D printing, also known as additive manufacturing, is emerging as a transformative technology in pharmaceutical production. It enables the creation of highly complex drug formulations, precise dosages, and tailored release mechanisms. This technology empowers manufacturers to design and produce drugs with an unprecedented level of personalization, which is particularly valuable in precision medicine, where therapies are customized to individual patient needs.

Unlike traditional drug manufacturing, which relies on bulk production of standardized formulations, 3D printing offers flexibility in creating small batches or even single doses with specific attributes. Using computer-aided design (CAD), pharmaceutical scientists can control the structure, layering, and composition of drugs to achieve desired release profiles, bioavailability, or combination therapies.

The FDA's approval of Spritam (levetiracetam) in 2015—the first 3D-printed drug—highlighted the potential of this technology. It paved the way for further innovation in areas such as polypills, bioprinting, and custom implants. Today, 3D printing has comprehensive scope in pharmacetucials. 

• Personalized medicine: It allows tailored doses for individual patients based on genetic, metabolic, or lifestyle factors. Customized formulations for pediatric or geriatric patients who require specific drug strengths or release profiles can be made.
• Polypills: Combination pills integrating multiple drugs for chronic conditions like diabetes, hypertension, or cardiovascular diseases can be manufactured.
• Drug development: It allows rapid prototyping of new drug formulations for preclinical and clinical testing.
• Orphan drugs: It allows cost-effective production of small batches of rare disease drugs, reducing wastage and lowering costs.
• On-demand manufacturing: It allows decentralized production for clinical trials or remote areas, ensuring timely delivery of essential medications.

Where & How?

According to a Mordor Intelligence report, the pharmaceutical equipment market size is expected to grow at a compound annual growth rate (CAGR) of 4.6% between 2024 and 2029. So far, North America has been the dominant market, and it will continue to enjoy its position as the largest market for pharmaceutical equipment. However, in this forecast period, the Asia-Pacific region is expected to be the fastest-growing market for pharmaceutical equipment. There are several forces behind these developments.

Increased investment

Pharmaceutical companies are allocating higher budgets to improve their manufacturing capacity and equipment. For example, in 2022, Fujifilm invested USD 1.6 billion to expand its cell culture manufacturing services, which will expand their sites in the US. Similarly, in November 2021, Sartorius AG, a Germany-based international pharmaceutical and laboratory equipment supplier, announced that it would be investing approximately USD 300 million to expand operations in South Korea. Reportedly, this project will include the establishment of a cell culture media production and sterile assembly line. This assembly line is expected to be operational by the end of 2024. These investments will accelerate the growth rate of the pharmaceutical equipment sector in the Asia-Pacific region.

Increased pharmaceutical demands

The overall demand for pharmaceutical products has increased in the past several decades, driven by the ageing population, chronic disease prevalence, and healthcare expansion. This increased demand necessitates that companies produce more products at a faster rate, with more efficiency, and with high efficacy. Consequently, pharma companies need to expand current operations, set up new facilities, or outsource to smaller manufacturing companies to meet demand—all of which results in higher spending on equipment and facilities.

Technological advancements

As anyone following the pharma news will know, new technologies have rapidly emerged in the pharma space in the last few years. This includes monoclonal antibodies, mRNA technology, cell therapy, gene therapy, and much more. However, the use of these advanced technologies to develop efficient therapies is currently limited by equipment and facilities. However, as the advantages of these therapies become more and more apparent, advanced equipment designed for specialised production processes will be developed.

Post-pandemic growth

Recently, the World Economic Forum and Deloitte exposed a glaring disparity in vaccine access realised during the COVID-19 pandemic: The production and distribution of vaccines is localised in specific regions. In the face of a crisis, other regions are dependent entirely on the manufacturing capacity of these regions. In addition, the supply of vaccines in non-vaccine-producing regions is also dependent on the resilience of the manufacturer’s supply chain. The COVID-19 pandemic especially highlighted the need to build resilient supply chains and flexible production chains not only in one country but in multiple regions so that vaccine supply is not halted in the face of crisis. Consequently, several countries, like South Africa and the UAE, are investing in local vaccine development and production.

These drivers will collectively ensure robust growth in the pharma equipment sector in the years to come. But how are these drivers coming into play in the real world?

How Companies Can Embrace the Future?

To remain competitive and harness the full potential of emerging trends and innovations in pharmaceutical manufacturing, companies must adopt a proactive and strategic approach. Successfully integrating advanced technologies like automation, continuous manufacturing, single-use systems, PAT, AI, and 3D printing requires not only investment but also a cultural shift toward innovation and sustainability.

Here’s a roadmap for companies to embrace these transformative changes:

1. Invest in training: Equip employees with skills to manage advanced systems such as robotics, AI, and 3D printing. Collaborate with universities and tech providers for tailored training programs.
2. Collaborate with innovators: Partner with technology providers and startups to integrate cutting-edge solutions. Build vendor ecosystems for tools like single-use systems and IoT devices.
3. Adopt agile practices: Use flexible manufacturing setups and lean methodologies to respond quickly to market changes. Employ 3D printing for rapid prototyping and small-batch production.
4. Focus on sustainability: Incorporate eco-friendly practices like energy-efficient systems, waste reduction programs, and sustainable sourcing to meet environmental goals.
5. Leverage data: Centralize data using AI and cloud-based platforms for predictive analytics and process optimization. Maintain robust records for regulatory compliance.
6. Align with regulatory standards: Engage regulators early to align technologies with compliance requirements. Update SOPs to reflect innovations and ensure traceability.

What’s Next?

The pharmaceutical machinery industry is not merely evolving—it’s undergoing a revolutionary transformation. Driven by the demand for faster drug development, higher quality standards, and stricter regulatory compliance, this shift is fueled by groundbreaking technologies. These innovations are not mere upgrades; they’re game-changers, reshaping production processes, advancing sustainability, and enabling companies to meet the challenges of modern pharmaceutical demands.

Pharma companies rely heavily on equipment to ensure they meet production and regulatory requirements. With new tech and therapies being developed every day, new equipment needs to be developed and integrated to ensure pharma companies remain efficient and compliant. Automation, digitisation, sustainability, and continuous manufacturing are the keywords in the pharma equipment sector—these are the words deciding which equipment will be used for manufacturing and which will be discarded.