Biologics outsourcing refers to the process of contracting out biologics drug development and manufacturing activities to specialized contract service providers by biopharmaceutical companies. Biologics include vaccines, gene therapies, blood components, and recombinant therapeutics. Outsourcing biologics manufacturing enables biopharma companies to reduce fixed costs, access advanced technologies and expertise, and improve process efficiencies.
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Global Biologics Outsourcing market is estimated to be valued at US$ 19.67 Billion in 2023 and is expected to exhibit a CAGR of 12.9% during the forecast period (2023-2030).
Key Takeaways**
Key players operating in the biologics outsourcing are Boehringer Ingelheim, Lonza, Rentschler Biopharma, Innovent Biologics, and Samsung BioLogics. These players have extensive expertise in commercial manufacturing and emerging modalities like cell and gene therapies.
There is growing biosimilars and biologics due to the patent expiry of Biologics Outsourcing Market Demand blockbusters worth billions of dollars. Moreover, the rising incidence of chronic diseases is propelling the demand for biologics globally.
Technological advancements like single-use bioprocessing technologies allow for smaller batch sizes and increased flexibility. Advanced analytics solutions enable real-time process monitoring and data-driven decision making throughout development and manufacturing.
Market Trends
Outsourcing of emerging modalities like gene therapies, viral vectors, and cell therapies is a major trend driven by biopharma's need to access advanced expertise and facilities. China and India are emerging as attractive outsourcing destinations due to lower costs and rapid expansion of capabilities.
Bioprocessing is shifting from stainless steel to flexible single-use technologies to accelerate development timelines, reduce capital costs, and improve capacity utilization for outsourcing partners. Advances in continuous bioprocessing also promise to lower costs and improve efficiency of production.
Market Opportunities
The outsourcing of biologics drug product manufacturing, an area traditionally retained in-house, offers significant opportunities for contract service providers. There is also a large market potential for outsourcing early stage research and process development activities.
Emerging Asian hubs like South Korea, China, and Singapore offer lower costs and a skilled workforce. Partnerships with regional outsourcing partners can help biopharma access local markets more efficiently.
Impact of COVID-19 on Biologics Outsourcing Market Growth
The outbreak of COVID-19 pandemic has significantly impacted the biologics outsourcing market. During the initial phase of the pandemic, many biotech and pharmaceutical companies faced challenges in outsourcing activities due to lockdowns and disruptions in supply chain. This led to delays in drug development timelines. However, as the pandemic intensified the focus on developing treatments and vaccines for COVID-19, it boosted research activities in biologics. This increased the demand for CROs and CMOs assisting companies in various stages of drug development like preclinical testing, clinical research, manufacturing and regulatory work.
With rapid approvals given to COVID vaccines, focus has now shifted to ramping up their large scale production. Many vaccine developers have outsourced manufacturing activities to CMOs with requisite infrastructure and expertise. This has provided a fillip to biologics outsourcing market. However, capacity constraints faced by CMOs in meeting the unprecedented demand is one of the key challenges. Post pandemic, demand for outsourcing is expected to remain high given learnings from COVID vaccine development. Companies may prefer outsourcing non-core activities to minimize costs and focus on drug innovation. Continued investments by CROs/CMOs in expanding capabilities would be instrumental for the market’s sustained growth.
Geographical Regions with High Biologics Outsourcing Market Value
North America has been leading the global biologics outsourcing market in terms of value. This is due to presence of many large pharmaceutical companies and thriving biotech industry in the US. These players actively outsource R&D and manufacturing tasks to benefit from technical expertise available with CROs and CMOs in the region. Europe is also a major market given stringency of regulations pertaining to biological drug development. Countries like UK, Germany, and France have a significant cluster of CROs and CMOs supporting outsourcing needs of pharmaceutical companies based in EU and worldwide.
Fastest Growing Regional Market for Biologics Outsourcing
Asia Pacific region is poised to exhibit fastest growth in the biologics outsourcing market over the forecast period. This is attributed to lower costs of operations for CROs/CMOs and growing biosimilars industry in the region. Many international pharmaceutical companies have set up R&D and manufacturing facilities in Asia to reduce expenses. Further, governments of various APAC countries like China and India offer incentives to attract investments and foster pharma industry growth. In addition, rapid economic expansion, strong talent pool availability, and rising healthcare spends are propelling the regional biologics outsourcing market.
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