Small molecules remains an attractive and growing market with 52% of all molecules in clinical development comprised of small molecules (approximately 10,000 molecules). In the next five years, the clinical market for the number of small molecules is estimated to grow by 30%1.
In 2023, the outsourced small molecules market was valued at $70bn and we estimate that this market will grow at 4 to 6% per year through to 20282. Our primary focus is to support the development and manufacturing of innovative products and we expect this segment to grow at the higher end of this range.
Growth is driven by three main therapeutic areas, including Oncology, CNS and Endocrine (in particular diabetes). Thirty percent of FDA small molecules new molecular entities (NME) approvals are targeted towards oncology, a disease area estimated to sustain double-digit sales revenue growth per year through to 2028. Looking at the oncology market, small molecules make more than 60% of FDA NME approvals, of which approximately 90% are administered orally.
The required potency of products that destroy cancer cells means that they are often highly potent and need high containment manufacturing capabilities. We have a long and successful history of developing processes to manufacture highly potent active pharmaceutical ingredients (HPAPIs). In such complex containment environments, manufacturing experience and expertise is as critical as process control.
Increasingly, new therapies are on expedited timelines for approval and our quality system and regulatory experts support customer filings. This is a particularly important service for small companies who may not have in-house capabilities.
Lonza internal analysis, Citeline
Lonza internal analysis, FDA, Evaluate Pharma
We are focused on helping customers develop and manufacture innovative small molecules. Over the last 40 years, we have developed a leading reputation, supported by our commitment to science, technology and delivery.
We work in close partnership with our customers, helping them to solve patient challenges and support molecule progression through clinical stages. Our team of experts support development throughout the product lifecycle, from pre-clinical stages through to commercialization. Entry points in this lifecycle can vary from early clinical development to late-phase or commercial supply.
Our Small Molecules services can broadly be split into three categories: Drug Substance, Drug Product and Particle Engineering, which forms a bridge between Drug Substance and Drug Product.
Our Drug Substance services relate to the development and manufacturing of active pharmaceutical ingredients (APIs). Our Particle Engineering services relate to our micronization and spray dry dispersion technologies which support enhanced bioavailability. Finally, our Drug Product services support oral and inhaled formulations of APIs in tablet and capsule dosage forms.
pre-clinical and clinical small molecules1
commercial small molecules1
Including active pharmaceutical ingredients (API), highly potent API (HPAPI), dosage form and delivery systems and particle engineering.
Our current portfolio includes more than 150 commercial programs and more than 200 clinical programs. These are delivered by a global asset network capable of supplying a range of volumes to meet both clinical and commercial demand. Our ability to provide integrated supply chains for products, within or across divisions, is a compelling customer offering to simplify ways of working.
In Drug Substance, we continue to build on our existing capabilities in developing and manufacturing highly potent small molecules, especially the payload and linker manufacturing of antibody-drug conjugate (ADC) products. These represent a particularly attractive market segment within the high potent API category.
Candidates in the small molecules pipeline are increasingly complex and are often accompanied by a decrease in bioavailability due to their limited solubility. We help customers to address these challenges through a portfolio of bioavailability enhancement technologies, phase-appropriate and proprietary processing equipment and drug delivery capabilities. Our site in Bend (US) is recognized as a global leader in improving bioavailability, leveraging our scientific expertise and spray dried dispersion technology.
Our Small Molecules division supports customers throughout their journey from clinical to commercialization, across drug substance and drug product. We provide contract development and manufacturing services for customers including large pharmaceutical and small biotech companies.
The following two new offerings have progressed towards market introduction in 2023:
Poor oral absorption in drug candidates can delay critical pre-clinical and clinical studies, leading to extended timelines and costs for drug manufacturers. With low solubility molecules becoming more prevalent, we offer deep expertise in the application of PBPK modelling to help customers better understand the risks to absorption and develop better formulation strategies.
PBPK modelling simulates the dynamic physiological factors impacting oral performance. When coupled with in vitro testing and experience in addressing key formulation challenges such as bioavailability, it has proven to be effective in applications throughout the drug development cycle.
The complexity of small molecule APIs is rising and this is creating significant challenges to timely clinical readiness. We are leveraging innovative technologies including Artificial Intelligence (AI) to help our customers accelerate clinical readiness, reduce costs and improve supply chain decision making for their drug substances.
Comparison vs. Prior Year
Sales (CHF)
CORE EBITDA (CHF)
CORE EBITDA Margin
Sales growth, expressed as a percentage (%), are at constant exchange rate (CER)
Our commercial and clinical portfolio is strongly represented across the main therapeutic growth areas. In 2023, the Small Molecules division achieved more than 10% growth, with the majority driven by the manufacturing of newly introduced products. Particular milestones were reached in 2023, as multiple oncology products on which we collaborate with our customers received FDA approval.
Our global network of sites offer different services to deliver a highly connected supply matrix. This allows us to support a range of volume needs through clinical progression and niche to high volume for commercial products.
President, Small Molecules Division
In Small Molecules, we continue to adapt our capabilities and commercial offerings aligned with market needs, further augmented with additional capacity to meet sustained customer demand, particularly supporting highly potent API products. Looking ahead, we will continue to focus on the acquisition of early-phase clinical projects to help drive future growth.
We completed the expansion to our Solid Form Services (SFS) offering by expanding our facilities in Bend (US) to meet accelerated timelines for increasingly complex molecules. The enhanced facility includes remodeled and dedicated laboratory space, primarily used to support biotech and mid-size pharma companies in developing early-stage compounds.
The offering complements our API development services and first-in-human services, aimed at the rapid advancement of small molecules.
Our Small Molecules site in Tampa (US) has been upgraded to include universal powder flow testing alongside automated particle size and shape analysis capabilities. The addition of new capabilities at this site is enabling a greater understanding of the behavior of powdered drug substances, excipients and blends used in the development of new dosage forms.
Looking at the global development and manufacturing pipeline, the complexity of small molecules is increasing and this can bring longer synthetic routes to access the target molecule. Over the last decade, the number of chemical steps from raw materials to an active pharmaceutical ingredient (API) increased on average from 8 to more than 20 steps1,2. More than 50% of the approved drugs in 2022 contained at least one chiral center and the associated regulatory demands for enantiomeric purity further complexify the task of process chemists3. The key features for a successful synthetic route include safety, high overall yield, high productivity (space-time-yield), impurity purge understanding, waste reduction, freedom-to-operate and a robust supply chain for starting materials and intermediates.
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