The year 2020 was shaped by the COVID-19 pandemic and pharma was not only at the forefront of efforts to combat the virus, but was similarly vulnerable and impacted by the effects of lockdowns. The race for a vaccine usurped existing capacity and clinical development programs, but it catalyzed unprecedented collaboration across the industry. Restrictions on international travel exposed frailties in supply chains, lockdowns prevented access to healthcare providers and prevented patients from accessing care and trial sites. But the industry responded in kind, pivoting to digital-led communications and more sophisticated logistics and distribution while localizing supply where it could. Here, leaders from across the contract pharma industry review 2020 and discuss how the trends will likely continue influencing the space in 2021.

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Tom Hochuli
CEO
Vibalogics

The race for a COVID-19 vaccine throughout 2020 highlighted the important role of viral vectors in the virotherapy and vaccine sectors in delivering effective vaccines and pharmaceutical treatments. It also demonstrated the industry’s impressive agility and ingenuity.

As the end of this race approaches, we will see many virotherapy developers return to focus on their pre-COVID projects—particularly those in the viral vector gene therapy and oncolytic virus space. Many of these projects will benefit from lessons learned by the sector during the COVID-19 outbreak, helping to speed up their successful development.

For example, the outbreak highlighted the benefits of collaboration, such as outsourcing drug development and manufacturing to viral vector specialist CDMOs. These partners offer a number of benefits, particularly to smaller biotechs with limited funds to invest in their own capacity.

There is a very real need in the industry for additional biologics manufacturing capacity. CDMOs can provide the infrastructure to develop and manufacture new treatments, eliminating the need for customers to invest in their own costly construction and expansion projects. This saves biotechs money and significantly shortens the time-to-market for their virotherapy innovations. Moreover, CDMOs have the flexibility and agility to adapt their lines in order meet customers’ unique requirements and changing demands.

This flexibility, ready-made capacity and convenience has been vital for CDMOs in the virotherapy space during the outbreak and will continue to be important in 2021 and beyond in order to meet growing demand for viral vector treatments. We estimate virotherapy development and manufacturing capacity will need to increase by 80% over the next decade to meet demand.  

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Roger Lias
CEO
Stelis

In 2020 the Coronavirus pandemic has, unsurprisingly, proved to be the primary driver behind a number of trends across the global biologics industry. This has been very much a “double edged sword” for many companies across pharma and biopharma. 

On the positive side, demand for both high quality and high volume CGMP drug substance and drug product manufacturing services has soared, particularly for CDMOs able to support a wide range of COVID vaccine technologies and, to a lesser extent, therapeutic monoclonal antibody products.

The pandemic has, however, also had some negative knock-on effects as budgets and resources are diverted to “COVID products” at the expense of other biologics projects in development for other therapeutic areas and, it’s likely we’ll see a real impact across the board on project timelines as a result.   

In line with this, readily available capacity has become harder to come by, putting a premium on it and also triggering a wave of investment in capacity expansion to meet anticipated future demand.

Less well publicized is the stress that the pandemic is putting on the supply chain for critical manufacturing components. In particular, disposable components for single use systems are being allocated to support major COVID programs leaving unacceptably high lead times for delivery of consumables required to support other critical programs. Vendors are working hard to increase capacity, but the impact is undoubtedly starting to be recognized.

A further highly visible COVID-driven trend that will likely change the way we do business over the long term is the move towards remote working and the use of technology for communication, not only for those able to perform their duties from a remote environment, but also as it is being applied to site visits and audits—both from clients and regulatory bodies. 

Promisingly, it has been encouraging to see companies that might be seen as competitors under normal circumstances rising to the challenge and working cooperatively in support of pandemic control efforts, opening the door for better support of customer needs in future as a result of closer collaboration.

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Kay Schmidt
Senior Vice President, Technical Operations
Catalent


As we play an integral role in the global supply of life-changing medicines, when the pandemic struck in early 2020, the major priorities for Catalent were to ensure employee safety and secure supply chains. We quickly mobilized a crisis management team and instigated our business continuity plans based on initial assessments suggesting that the pandemic had the potential to disrupt supply chains. It soon became clear that the ramifications were much greater, so plans were evolved, and have continued to evolve, since.

It meant a change in working practices for the thousands we employ at over 45 global sites: about thirty percent of our associates were able to work from home, but operators, scientists, leadership and others were needed at our facilities, so we had to find ways to help them work safely. This meant changing shift patterns and working hours, and ensuring physical distancing measures, while enhanced cleaning regimes were also applied in facilities. Physical distancing is almost impossible in some labs and production areas, so additional engineering controls and personal protective equipment was deployed in conjunction with new practices. Employees have helped us monitor their health closely too. Whereas previously we could welcome visitors to observe work being undertaken, now we are using more remote viewing technology such as Google Glass, and other communications tools, to facilitate administration and observations, and the company has extended remote inspection technologies with all major global regulatory agencies as well as customers.

The efforts to find targeted vaccines and therapies against COVID-19 have driven increased demand for Catalent’s services, and especially for our tech transfer, development and scale up expertise. What quickly became apparent was the need to accelerate timelines to the point that programs that would typically have taken years can be safely be accomplished, with quality and compliance, in a matter of months. This has led to greater collaboration and innovation between partners, regulators, and throughout supply chains, to meet key milestones, and effective management, planning and communication, both internally and externally, to ensure equipment and resource allocation for multiple programs. Proactive investment was expedited where necessary to ensure future commitments could be delivered, and many critical projects were even expedited “at risk,” before contracts were formalized, with a view to saving time. Risk management techniques were heavily utilized throughout this acceleration process.

Now, Catalent is working on more than 80 COVID-19-related compounds, and the transformative acquisitions the company has made over the last several years, combined with our strategic internal growth investments throughout the organization, were well-timed to enable us to play an important role in efforts to supply treatments and the millions of vaccine doses needed.

It will be some time before many of us return to more familiar working practices, and the way we work may never be the same as before the pandemic, but the experiences we have gained in expediting projects rapidly and with increased flexibility will stand us in good stead for other industry challenges. These include the accelerated adoption of new technologies to further reduce any risk of human contamination, and the ongoing transition to more flexible resources that suit lower volumes and more rapid development and scale up, as with for orphan programs and more personalized medicines.
Emerging modalities too, including cell and gene therapies, will require that we have the capacity and infrastructure, equipment, and process know-how needed to meet the needs of multiple customers. Continuous improvement is not a new philosophy to Catalent, and we need to continue to search for and implement suitable resources and assets such as flex suites and micro environments, that have been pivotal to assisting in the COVID-19 programs.

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James Rogers
Head of Manufacturing and Supply
Sterling

Throughout 2020 the COVID-19 pandemic has caused global economic turmoil. The pharmaceutical industry in particular has had to adapt quickly to the impact on its operations and the resulting worldwide shortages of active pharmaceutical ingredients (APIs) to ensure a return to business as usual in as efficiently as possible. However, the impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.

At Sterling our flexibility, paired with our diverse supply chain, has meant we have been able to continue to deliver for our customers without disruption while safeguarding our employees’ health. Solid operational foundations, an agile team and a comprehensive business continuity plan meant we had access to alternative sources for vital raw materials when we needed them. However, for many in the supply chain there has been a much greater impact on operations, highlighting an industry-wide need for change that will protect the supply of APIs in future.

Many governments are seeking to onshore their supply chain, or at the very least bring supply closer to home or diversify supply chains to avoid over-reliance on any one market, to minimize the risk of future disruption to pharmaceutical manufacturing. India, for instance, is looking to incentivize the localization of its own API supply—companies in the country currently rely on Chinese suppliers for 70% of their ingredients.

With this in mind, it seems certain that supply chain resilience and reliability will be given the same importance as price by pharmaceutical companies when developing supply strategies in the future.

COVID-19 has also accelerated the introduction of innovative technology in the pharmaceutical industry. At Sterling, we’ve worked more flexibly to counter the impact of COVID on our operations and adapted our facilities to ensure all the appropriate precautions are in place. In addition, we have also expedited internal projects that were underway prior to the pandemic to support virtual interaction with our customers, for example our virtual facility tours.

Such advances have enabled us to build better relationships with potential customers and give them the information they need to make effective outsourcing decisions, without the need for regular on-site visits if these are not feasible. 

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Troy Player
President, Drug Product and Early Stage Development & Testing Business Unit
Cambrex


The COVID-19 pandemic brought many challenges to organizations around the world, but for pharmaceutical development companies undertaking work to supply medicines to patients who rely on them, there was a need to ensure that this continued—leading to changes in operational practices.

At Cambrex, measures were introduced to protect staff, such as wearing PPE, ensuring workplaces employed social distancing policies, and balancing remote and on-site working. For laboratory-based staff, this included bringing in shift patterns, although managers were acutely aware of that there may be consequences of breaking up established teams, and that some people could be uncomfortable working from home. As with probably every company, teleconferencing quickly became the normality at Cambrex, but even with functional improvements, it does not replace the dynamic of a team meeting. This meant managers needed to be effective in ensuring the focus on key projects, and to ensure continuity of work within laboratories and plants to ensure staff safety—both physically but also in respect of staff’s mental health.

As a wider industry, there were effects on the drug research and development pipeline, with companies having had to delay or even stop programs. This applies to the larger pharma companies, and also the smaller, virtual companies where funding may be an issue without clinical data to support next steps. Having an established and robust supply chain resilience within the company meant that Cambrex was able to ensure delivery of necessary products, while minimizing delays and the impact of the initial pandemic. This resilience is under constant review within Cambrex as a way to protect the company against global crises, whether geopolitical or in instances such as a pandemic.

To allow continuity of communications with customers when travelling and site access was limited, Cambrex accelerated the introduction of Realwear technology across its network of facilities, allowing users within Cambrex manufacturing sites to communicate with customers through a wireless headset, equipped with both a camera and microphone. Realwear is able facilitate a range of activities, from a virtual site tour, to overseeing tech transfer of a project, or the ability to observe entire processes from a remote location, with the ability to talk in real time to scientists and experts engaged on a project.

For Cambrex, the focus is always on ensuring the delivery of the highest quality products to its customers and reacting to the needs of the industry. Although the pandemic brought challenges, that focus did not falter, and the strength of the industry has given rise to a need to expand facilities. Before the pandemic brought about lockdown, an expansion project was underway at the company’s facility in Edinburgh, U.K., which provides solid form screening and crystallization process development services. This expansion has now been completed, allowing the site to work on a greater number of projects with customers, and at greater scale. In terms of manufacturing capacity, Cambrex announced in November 2020 that it had begun a $50 million expansion project at its site in Charles City, Iowa, which will see the site’s capacity increase by 30 percent.

If the pandemic has shown one thing, it is that partnerships and collaboration are vital to develop drugs and therapies rapidly and efficiently. Cambrex has, and will continue to, invest and adapt to the needs of drug innovators to ensure it can be a leading development partner, and is equipped to support the industry throughout this current time and into the future.

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Danita Broyles
Senior Market Development Manager of Verification Programs
U.S. Pharmacopeia (USP)


The COVID-19 pandemic is a disrupter unlike any the global supply chain has seen, and with disruption comes increased risk. Companies have had to streamline and simplify operations more than ever before, which can impact quality assurance. Additionally, high demand for certain ingredients and products are causing shortages, which, in turn, are leading to surges in production of those ingredients or products. While shortages are worrisome, so are surges—materials coming from new suppliers to combat shortages may lack quality. For the same reason, there is increased risk of adulteration or subpotent ingredients from these new suppliers.

Another issue permeating the conversation is how the pandemic has disrupted the Food and Drug Administration’s (FDA’s) inspection process. The FDA reported more than 18,000 inspections of domestic and foreign pharmaceutical manufacturers in 2019, the last year untouched by the pandemic, compared to nearly 6,000 inspections in 2020. The decrease in on-site inspections has the potential to increase quality risks to the global supply chain and puts increased pressure on manufacturers and suppliers to ensure the quality of their ingredients and drug products.

With the pharmaceutical industry facing so many concerns, many companies are seeking solutions to ensure that consumers can trust their products. U.S. Pharmacopeia (USP) offers a comprehensive source of quality standards for ingredients and drug products that serve as a roadmap for helping to ensure quality and prevent fraud. Additionally, USP is committed during these extraordinary times to supporting manufacturers by providing assistance to drug product manufacturers to verify ingredient quality through the USP Ingredient Verification Program.

Due to the disruptions from COVID-19, many companies have had to bring on new contract manufacturers or ingredient suppliers due to increasing demands. In 2021, as we continue to see an influx of manufacturers having to change or add more contract manufacturing organizations and ingredient suppliers to meet their supply demands, we anticipate there will be an increased focus on how to ensure they maintain quality. Bringing on a quality-driven contract manufacturer is a time-consuming and resource-consuming process, especially during COVID-19 when on-site audits are not always feasible. One way to combat this challenge is through third-party quality verification services, such as USP’s Ingredient Verification Program, which can help ensure continuous quality surveillance among ingredient suppliers.

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Sylvia Hinds
Sr. Director, Business Development
Avid Bioservices

Jason Brady
Sr. Director, Business Development
Avid Bioservices

2020 was the year during which the critical role and function of the contract pharma industry was brought to the forefront of the broader healthcare universe. Throughout the year, we saw adaptation to new technologies and implementation in diagnostic testing, monoclonal antibody manufacturing, vaccine production and distribution logistics prove crucial to fighting the COVID-19 pandemic.

Importantly, the pandemic highlighted the need for more local, US-based contract pharma services, as well as the importance of closely aligning academia, drug innovators, manufacturers and regulators to deliver new treatments to patients at “warp speed.” To date, Avid’s production schedule has not been adversely impacted by COVID and we continue to plan and execute the expansion of our CGMP manufacturing capacity to stay ahead of the growing demands of the market and our clients.

Moving forward, biologics (drug substance and drug product) production capacity and supply chain will continue to be tight as CDMOs race to produce COVID-19-related therapies. As an industry, we are seeing continued regionalization, if not localization, for the outsourcing of biologics and we don’t anticipate that to change in 2021.

New manufacturing technologies and rapid clinical development timelines will likely become the norm. We expect that the successful development of multiple COVID-19 vaccines at “warp speed” will lead therapeutic developers to shorten their time-to-market expectations for their products.

At the same time, the trend of academia, drug innovators, manufacturers and regulators collaborating efficiently to speed up the time it takes new drugs to enter the market will continue. In addition, the manner in which clinical trials are conducted will likely evolve as well, highlighted by a pronounced shift from centralized clinical sites to de-centralized locations or even site-less trials.

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Jonathan Hunt
CEO
Syngene International Ltd.


While all our lives have been impacted on a day-to-day basis by COVID-19, I think at an industry level the pandemic has brought out the very best of the biopharma industry and seen unprecedented collaboration between scientists, physicians, and policymakers worldwide. The speed at which the broader scientific community responded to the pandemic, both in terms of developing diagnostic solutions to restrict the spread of the infection and in developing vaccines, has been astounding. True collaboration, with an energy to restore the world to a better place, is a true reflection of the values the industry holds dear.

From an industry operating perspective, we witnessed innovations which are here to stay even after the pandemic is over: work from home; innovative sourcing practices; and virtual audits are all learnings that will stay with us. Another major learning is that timelines in discovery, development and manufacturing, which were long held to be sacrosanct are not written in stone after all. I suspect that we will no longer consider ten to twelve years as an acceptable timeline to bring a drug to the market.

I also think that the pandemic has highlighted the importance of contract services providers and their role in accelerating scientific innovation. While the role of CMOs in vaccine production has received most attention, CROs and CDMOs are equally appreciated. The crisis has deepened pharma and biotech companies’ relationships with their strategic CRO partners. In our business, we have seen all of this play out.

The pandemic has seen unprecedented collaboration between the scientific communities, regulators and policy makers the world over. This has made possible the discovery, development and launch of vaccines in unprecedentedly short time. I am hopeful that global acceptance of vaccines will take a material step forward and the anti-vaxxers are likely to find it much more difficult to raise non-evidence-based concerns in a world with such widespread experience of the benefits of vaccination.

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Ben Wylie
Senior Product Manager
ChargePoint Technology


It’s now been just over a year since the first reported case of COVID-19, and the world has undergone an extraordinary amount of economic turmoil in that short space of time, as nations across the globe fight the outbreak.

The pandemic has necessarily resulted in considerable growth in demand for essential and innovative pharmaceutical treatments for COVID-19 patients as well as those fighting existing illnesses. Worldwide sales of biopharmaceuticals, for instance, are now more than $300 billion, increasing at an annual rate of about 12%, and this trend is only expected to continue. On the other side of the market, small molecule drug products continue to dominate, valued at $24,976.14 million in 2019 and projected to reach $ 50,823.06 million by 2027; it is expected to grow at a CAGR of 9.5% from 2020 to 2027.

This spike in demand for drug products, however, has coincided with a drop in the supply of active pharmaceutical ingredients (APIs), caused by the closure in Q1 of a number of factories in China—one of the world’s major API suppliers—as the country attempted to tackle its own COVID-19 outbreak.

Having experienced the vulnerability of the global pharmaceutical supply chain, many governments are now pushing the industry to rethink its model to safeguard drug production. India, for instance, recently launched a production-linked incentive scheme to on-shore the production of critical drugs and APIs. The country currently relies on China for 70% of its ingredient supply and suffered particularly badly from the API squeeze.

Given this new stance from governments around the world, it is no surprise that pharmaceutical companies are having to reconsider their ingredient supply partnerships. Increasingly, they are opting for suppliers that are either in the same country or in a neighboring one in order to protect themselves from future lockdowns.4 Many are also looking to diversify their supply chain by appointing multiple suppliers located in different markets to reduce risk.

To meet this growing demand for localization, API producers are already investing in their facilities within key target markets, to expand their capacity. At the same time, though, they need to do all they can to maintain the same high levels of validated containment and sterile transfer in order to protect line operatives from highly potent materials and guarantee sterility for those treatments that need it.

This is a particular challenge in modern pharmaceutical manufacture, given the complexity of contemporary production lines. With this in mind, it is vital that API suppliers focus on investing in the best possible engineering controls for their expanded lines to optimize containment and ensure the integrity of aseptic processing. By choosing the right equipment now, they can be confident they can meet future demand for more localized API manufacture, while safeguarding employees and ensuring the highest levels of product quality.

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Jean-François Hilaire
Executive Vice President – Strategy and Global Integration
Recipharm

The COVID-19 pandemic this year placed unprecedented pressure on the pharmaceutical supply chain, exposing the vulnerability of the world’s API and intermediates supply chain. It is no surprise, then, that some governments are considering incentivizing companies to relocate their API and pharmaceutical production closer to home.

The calls for businesses to onshore their production raises some key questions for the industry as a whole. Who is willing to give up their low-cost supply? How will localization impact the cost of the finished product, and how can we ensure adequate supply in each target market?

In spite of all this, there are good reasons why it may be a good option for drug companies to relocate their supply chain and manufacturing. For instance, in Europe they can enjoy access to highly skilled scientists, considerable funding, as well as tax reductions granted by government or European research institutions. However, there would need to be favorable conditions in order for this to take place.

So, what would it take for companies to relocate? Considerable long-term spending commitments are needed to upgrade outdated facilities. This shouldn’t just come from individual businesses, but from the relevant authorities and institutions as well. Additionally, simplified regulatory and administrative requirements, reviewed tax rules and higher remuneration will also be needed to support onshoring.

As such, in September 2020, the president of the European commission, Ursula van der Leyen called for the creation of a European Biomedical Agency, similar to the US Biomedical Advanced Research and Development Authority (BARDA), which provides for American companies. The coordinated efforts of members states to negotiate jointly the procurement of COVID vaccines is also encouraging.

CDMOs have been integral in retaining pharmaceutical manufacturing and capacity in recent years. As a result, they have a key part to play in future efforts to localize pharmaceutical production.
Nevertheless, a scheme similar to BARDA could help rebalance the pharmaceutical industry’s supply chain dilemma, encouraging them to focus less on cost, and more on public health. Such support could go a long way towards revitalizing the industry. 

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Dr. Katrien Lemmens
Medical Director, Clinical Pharmacology Unit
SGS


The COVID-19 pandemic has hampered the conduct of clinical trials and continues to pose unprecedented challenges.

When the pandemic struck in March 2020, stringent governmental regulations forced many clinical facilities to reduce activities to a minimum. Regulatory agencies published guidance how to manage clinical trials, stating that priority was to be given to COVID-19 studies, slowing down and halting non-COVID-19 trials.

Phase 1 studies with healthy volunteers were particularly affected due to uncertainty on viral spread among the population and because access to the units was restricted. This was also the situation in our SGS Clinical Pharmacology Unit (CPU) in Antwerp, putting on hold start-up of any new cohorts.

To restart trial activities after the first lock-down, a risk implementation plan was put in place, based on guidelines from the Belgian government, the regulatory authorities, the hospital in which the CPU is located, and SGS global policy. Strict measures are since adopted to avoid any potential spread of the virus, to ensure safety of volunteers and staff, as well as integrity of the trial data.

Procedures have been implemented for staff and visitors, including handwashing, sanitizing hands with alcohol gel, wearing face masks and physical distancing. Staff works partially from home and monitoring visits are limited, as with an eSource system in place most data can be reviewed remotely.

To make screening visits safer, telephone interviews are conducted prior and each reception area is equipped with a device to measure temperature. Volunteers receive an Informed Consent Form document and the facility COVID-19 procedures via email, to read prior to arriving at the unit. During screening only one staff member is present in a room with a participant for assessments.

Upon every admission, SARS-CoV-2 testing is performed with an onsite PCR (BioFireFilmArray), results being available within 1 hour. Subjects receive separated appointments and follow a “one-way” route through the facility. Bed capacity is reduced by half and specific attention is paid to toilets, bathrooms and dining rooms, to ensure disinfection of furniture and to limit simultaneous occupancy.

A decision flow chart is created to handle all suspected COVID-19 cases occurring within the unit. First actions are immediate isolation and nasal swabbing for PCR testing. When the test result returns negative, the subject returns to the ward, staff can return to work or go home pending the symptoms. If positive, the subject will stay in isolation within the CPU, and a mutual decision by the Investigator and sponsor is made to evaluate the subjects’ safety and continuation in the trial. Contact tracing starts with subsequent testing if needed.

Clinical trials are essential, and continuation must be ensured. As infection rates seem to go up and down in waves, COVID-19 risk mitigation will be part of our common practice for some time. Measures may change in line with the epidemiological situation, but general approaches of social distancing and hygiene appear to stay for a long time.

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Dr. Michelle Longmire
CEO and co-founder
Medable


As an unimagined consequence of the pandemic, we are starting to see the impact that decentralization will have on trials—making them both more efficient and effective.

This past year, the decentralized model provided a vital stopgap to overcome the halt of clinical trials for thousands of shut-in patients and trial staff. What served as a band-aid in the short term quickly developed into a recognition that decentralized approaches can deliver a variety of benefits to sponsors, CROs, sites, and patients. We saw faster enrollments and greater retention for patients participating from home. We saw more and higher quality, real-world data. We saw more efficient processes and a dramatically improved patient experience. We saw the resistance to digital and mobile technologies melt away, as televisits and remote screening and enrollment made participation easier for more patients from more places.

As the life sciences industry continues to march forward with its adoption of a decentralized model, it is critical to continue evolving the technology. Companies simply will not go back to pre-pandemic ways. As the industry continues to learn and innovate, the domino effect will drive 50-70% increases in trial access and efficiency—ultimately leading to more effective therapies for more people around the world.

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Maria Fotiu
Executive Vice President of Decentralized Solutions
Syneos Health


Clinical monitors (CRAs) today continue to perform a wide range of activities while on site, with a heavy reliance on source document verification, albeit in a reduced fashion with the implementation of risk-based monitoring. With the addition of decentralized capabilities and a wide range of new data flows, less data will be found in direct source and will require enhanced ways to review. 

No longer will CRAs be performing source document verification, but rather they will be evolving to clinical data review and more complex analytics about the data they are supporting. Time on site will be managed closely with a primary focus on establishing stronger relationships with site staff, supporting the site in managing study risks, and driving quality across all activities. Finally, increased use of technology to enable both site and patient involvement in the clinical study will require CRAs to serve as a first line troubleshooter, and importantly as a therapeutic area expert in incorporating these tools in the study delivery.

Traditional CRA therapeutic expertise will be enhanced with deeper understanding of the patient population and analytical skills that include comparison of multiple data inputs and outputs that will not always originate at the site but from the patient themselves, via home health care, and from wearables. Collaborating across the site staff, DCT vendors, and clinical trial delivery partners takes on new meaning.

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John Ross
President
Mayne Pharma U.S and Metrics Contract Services 


Covid-19 and the relentless pursuit for vaccines and other therapies for the virus have rightfully been the primary focus in pharma in 2020. Behind the scenes, a vast amount of development and clinical work in small molecule oral solid doses (OSDs) has continued to progress.

These products remain the largest segment of the market both in development candidates and commercially approved drugs. Over the last five years (2015-19), between 70 and 80% of New Molecular Entities (NMEs) approved by the FDA were small molecules. In 2019, 68% of the small molecules approved were delivered through oral dosages.

In the development pipeline, oral delivery routes have remained prevalent despite the increasing popularity of injectables. Small molecules still dominate all clinical stages accounting for 60% of all products and 76% at the registration phase. 

While biopharma is gradually investing more in complex biologic molecules, the small molecule OSD development market has been and will continue to remain a priority for pharma. The inherent ease of use and patient-friendliness of OSDs, combined with stability and lower manufacturing costs means they will remain a dosing staple for years to come.

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Frédérique Bordes-Picard
Business Development Manager for Innovative Products
Lonza Capsules and Health Ingredients


Asthma and chronic obstructive pulmonary disease (COPD) are currently the world’s two leading chronic respiratory conditions. According to World Health Organization (WHO) data, estimates show that COPD will become the third leading cause of death worldwide by 2030.  In recent years the demand for respiratory treatments has grown drastically.

The drivers behind this are two-fold.

Promoting affordable and friendly DPI treatment: One of the key drivers in the development of inhalation products is keeping the treatments affordable. Among the various DPI technologies and platforms available, the complexities of reservoir based, or blister-based systems can make manufacturing more costly. On the contrary, capsule-based DPIs (cDPIs) are recognized for their simplicity, cost efficiency, patient friendliness and overall effectiveness in delivering dry, inhalable therapeutics.

Inhalation is increasingly identified as a promising new dosage route: Beyond respiratory diseases there is increasing interest in expanding cDPI application to treat neurological diseases such as Parkinson’s and Alzheimer’s through systemic delivery application routes. There is also interest in developing inhalable compounds for nasal/sinus membrane routes for conditions affecting the central nervous system (CNS).

Currently many companies are looking at reformulating existing products to be delivered through inhalation.

Selecting the right capsule for cDPI products is crucial in ensuring active stability and reproducible delivery to the lungs. Properties such as reproducibility during manufacturing to ensure low lubricant value, the ability to reduce variability in capsule weight and an overall flexible capsule design, as well as access to a team of experts with experience in working with cDPIs are key to success. As such demand for third-party providers who can provide more than just the capsules and can support customers in the development and manufacture of cDPIs is on the rise, and this is something we expect to continue over the coming years.

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Nicole Strauss
Pipeline Development and Innovation Lead
Pfizer CentreOne


A range of new treatment modalities and administration routes are being introduced to the pipeline, bringing new complexities and prompting demand for experienced collaborators.
Novel, orphan and emerging biologic development pathways are also affecting batch scale and manufacturing economies, calling for precision-processing environments, technical flexibility and operational capabilities. Partnerships allow drug developers to avoid the time and resources required to build that capability in house and leverage existing experience to bring more effective treatments to patients faster.

The pipeline’s trajectory requires clinical manufacturing infrastructure and commercial partners with the combination of development and commercial experience to do the job efficiently and effectively. Drug innovators can benefit when working with a CDMO positioned to complete scale-up and technology transfer under one roof.

Regulatory services are also in demand as a strategic value-add as many complex drug projects require in-depth understanding of global regulatory requirements. A big part of this is leveraging the technical capabilities of both existing and new-build infrastructure providing flexible capacity and scale profiles to match the molecule’s targeted therapy.

With the industry demanding more than ever before from contract partnerships, a broader offer is essential. From integrated development and commercial scale capabilities to a long-term robust supply chain, the industry depends upon CDMOs to get the job done. With project scopes widening, this means that details like data integrity, digital security and environmental and financial sustainability are emerging as top priorities.