Sterile Small Molecule Fill/Finish Services by Fill/Finish Technique, Type of Packaging, Type of Dosage Form and Geography: Industry Trends and Global Forecasts, 2020-2030

Overview

Small molecule drugs account for nearly 90% of the contemporary therapeutics pipeline. In fact, in 2019, the FDA’s Center for Drug Evaluation and Research approved 48 small molecule drugs, representing 70% of the new molecular entities (NMEs) clearing regulatory review in the same year. Given that the demand for small molecule drugs is still on the rise, the importance of contract manufacturing and third party services is also increasing in the pharmaceutical industry. Sterile fill/finish is considered among the most crucial steps in the pharmaceutical production process. In fact, aseptic conditions during fill/finish operations are not only essential for ensuring end user safety, but also maintaining pharmacological efficacy and product quality. As small molecule APIs are gradually becoming more complex, the demand for appropriate aseptic fill/finish processes is growing.  

Given the high cost of specialized equipment and the affiliated expertise required for aseptic fill/finish operations, it is difficult for drug developer companies with limited finances and capacity constraints to meet clinical/commercial scale demands. This has led many of the smaller players in the industry and certain pharma giants, as well, to outsource various aspects of their production processes, including fill/finish, to contract service providers. Currently, over 130 companies are actively providing sterile fill/finish services for small molecules. In the recent past, many of the aforementioned service providers have also forged strategic alliances and/or acquired other players, in order to further enhance their respective service offerings. We believe that this trend is likely to persist in the foreseen future, as well. Overall, the contract services market for fill/finish of small molecule drugs is anticipated to witness steady growth, till 2030.

Scope of the Report

The ‘Sterile Small Molecule Fill/Finish Services Market, 2020-2030’ report features an extensive study of the current market landscape and the future potential of sterile fill/finish services for small molecule drugs. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. 

In addition to other elements, the study includes: 

• A detailed review of the overall landscape of contract fill/finish services market for small molecules, featuring a list of service providers and detailed analysis based on a number of relevant parameters, including developer information (year of establishment, company size and location of headquarters), scale of operation (preclinical, clinical and commercial), type of fill/finish technique (aseptic filling/terminal sterilization and blow-fill-seal), dosage forms handled (liquid, lyophilized, micelles/liposomes and powder), and types of primary packaging containers handled (vials/ampoules, pre-filled syringes/syringes/cartridges and bottles/others).
• A region-wise, company competitiveness analysis, highlighting prominent fill/finish service providers, based on supplier strength (considering experience of the service provider) and portfolio strength (considering the number of dosage forms handled, number of containers for which fill/finish service is being provided, number of fill/finish techniques adopted and scale of operation).  
• Elaborate profiles of key players across key geographies (North America, Europe and Asia-Pacific), which were shortlisted based on our proprietary company competitiveness analysis. Each profile provides an overview of the company, details related to their fill/finish service portfolio, financial performance (if available), and an informed future outlook. 
• A detailed analysis of the expansions undertaken (since 2016) by various service providers, based on a number of parameters, including year of expansion, type of expansion (capacity expansion, capability expansion, new facility, geographical consolidation and geographical expansion), geographical location of facility and most active players (in terms of number of instances).
• An estimate of the global, contract fill/finish capacity, by taking into consideration the capacities of various fill/finish service providers (as available on respective company websites), collected via secondary research. The study examines the distribution of number of packaging units and volume of small molecules filled, across various types of packaging (ampoules, bottles, pre-filled syringes and vials), based on the size of the company/organization (small-sized, mid-sized and large/very large)  and geography (North America, Europe and Asia Pacific).
• A case study to highlight the benefits of using robotic/automated equipment for aseptic fill/finish processes; the study provides a list of equipment manufacturers providing robots suitable for pharmaceutical operations.
• A case study to highlight the role of ready-to-use packaging containers in aseptic fill/finish operations; the study provides a list of suppliers providing the ready-to-use components.

One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for sterile small molecule service providers. Based on parameters, such as such as growth of the overall pharmaceutical market, the cost associated with fill/finish operation and outsourcing trends related to these operations, we have provided an informed estimate on the likely evolution of the market over the period 2020-2030. 

Year-wise projections of the current and future opportunity have further been segmented on the basis of:

• fill/finish technique (aseptic filling, terminal sterilization and blow-fill-seal)
• type of packaging (ampoules, bottles, pre-filled syringes and vials)
• type of dosage form (liquid, lyophilized and others) 
• key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia-Pacific (Australia, India, South Korea and rest of the Asia), Middle East and North Africa and Latin America). 

To account for the uncertainties associated with this industry and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.