Biopharma licensing is becoming more operational. Buyers and partners still begin with the quality of the science, but they also need evidence that an asset can be transferred, scaled and supplied without weakening its commercial potential. For outsourced assets, the right contract development and manufacturing organisation (CDMO) can strengthen confidence in technical, regulatory and financial viability, linking CMC readiness directly to asset value.
This is increasingly important as pharmaceutical companies look outside their own laboratories for pipeline growth, and chemistry, manufacturing, and controls (CMC) should be regarded as an integral part of the asset strategy.
How licensing supports biopharma growth
In an out-licensing agreement, an innovator grants defined rights to another company, often in exchange for an upfront payment, development and commercial milestones and royalties. The structure can give a smaller developer access to capital, regulatory expertise, manufacturing capacity or commercial reach while sharing the cost and risk of advancing the asset.
In-licensing reverses the perspective; a company acquires rights to an external asset and assumes responsibility for some or all of its continued development and commercialisation. This can strengthen a pipeline faster than relying solely on internal discovery, although the licensee also inherits technical, regulatory, and market risks.
The agreement is only one point in a longer process, as asset valuation and partner identification are followed by data-room preparation, due diligence, negotiation and final contracts. The relationship then continues through development, regulatory submissions, manufacturing and launch. Decisions made before signing can therefore shape cost, timing and supply resilience years later.
Asia-Pacific has become central to this model, particularly as China develops into a major source of innovative assets. GlobalData’s 2026 conference analysis found that agreements in which US biopharma companies in-licensed an innovative drug from China reached almost 50% in 2025. The trend continued into 2026 at the JP Morgan Healthcare Conference, with AbbVie announcing a licensing agreement worth $5.6bn for RemeGen’s Phase II bispecific antibody RC148, while Novartis signed a collaboration worth more than $1.6bn with SciNeuro Pharmaceuticals for Alzheimer’s disease candidates.
The attraction also extends beyond lower development costs. GlobalData’s analysis points to faster clinical trials, stronger research capabilities and a deeper pipeline of differentiated therapies. In 2025, out-licensing activity included GSK’s $12.5bn agreement with Jiangsu Hengrui.
These cross-border deals also make CMC due diligence more important. A potential licensee must establish whether the clinical product can be reproduced at the required scale, whether data can support filings in target markets and whether manufacturing knowledge can be transferred across companies, facilities and regions. A CDMO that knows the asset can help prospective partners test those assumptions against the underlying process, capacity and regulatory evidence.
The importance of CMC due diligence and CDMOs
Financial models commonly consider revenue forecasts, development expenditure, patent life, competitive positioning and the probability of regulatory and commercial success. Weak manufacturing assumptions can affect every one of these inputs. Conversely, evidence on process robustness, cost of goods, capacity, technology transfer and regulatory readiness can strengthen confidence in the assumptions underpinning valuation.
CMC due diligence examines whether the process is understood and scalable, whether analytical methods are suitable, whether stability data supports the proposed shelf life and whether drug-substance and drug-product specifications are justified. It should also investigate impurities, degradation products, quality systems, batch history and previous regulatory interactions. These questions can reveal liabilities that are not apparent in clinical data. More importantly, that evidence is a strategic input into the asset’s technical, regulatory, and financial viability, not just a way to identify manufacturing risk.
An immature process may require additional development before pivotal trials, and incomplete stability work can restrict supply planning. Additionally, weak analytical methods can make it difficult to demonstrate comparability after a manufacturing change, and an unrealistic cost-of-goods assumption can weaken the commercial case for an otherwise promising therapy.
A recent Thermo Fisher Scientific webinar explored this in detail, recommending an audit-ready CMC package with traceable, consistent data; evidence of process robustness; early scale-up planning; and a clear narrative explaining what is known, what remains uncertain, and how gaps will be closed. That approach can help a prospective partner distinguish manageable development work from risks that could delay a programme or require a valuation adjustment. It can also strengthen confidence in scalability, cost and capacity assumptions, technology-transfer readiness and the path to commercialisation.
Anil Kane, global head of technical and scientific affairs, Pharma Services at Thermo Fisher Scientific, described CMC due diligence as a direct part of asset valuation: “The CMC package and due diligence act as a strategic gate to evaluate a variety of factors and the value of the asset.”
A CDMO with experience across development, technology transfer, regulatory filing and commercial supply can add value across the transaction. Before a deal, it can help build a licensing-ready CMC package, identify gaps and strengthen process and scale-up readiness; during diligence, it can support technical assessments, audits, gap analysis, manufacturing feasibility, cost and capacity assumptions and regulatory considerations; after signing, it can turn findings into remediation, technology transfer, scale-up, regulatory support and commercial supply.
In the webinar, Thermo Fisher Scientific gives examples of supported drug-product development, technology transfer, clinical manufacturing and scale-up for an Asian biotech’s low-dose oncology tablet. The CDMO was later audited, and its work underwent gap analysis during diligence by several prospective partners. According to the webinar, a global biopharma company ultimately acquired the asset in a deal worth more than $1bn, showing how CMC execution can drive transaction confidence and asset value.
Strategies for maximising deal success
Licensing teams can improve their position by strengthening CMC readiness before formal due diligence begins, rather than treating it only as a risk exercise. This starts with an audit-ready CMC package that brings together process knowledge, analytical methods, specifications, stability data, and batch history in a consistent, traceable form.
The package should distinguish between resolved issues and remaining development work. It should also explain how critical quality attributes are controlled, what evidence supports process robustness and how the asset could be transferred to a new facility or manufacturing partner. Presenting these points early helps potential licensees assess the scale of the remaining work without assuming that every gap represents a fundamental weakness.
Teams also need to account for equipment differences, material sourcing, comparability requirements, available capacity and the time required to complete technical work. Responsibilities should be assigned before negotiations progress, including which activities must be completed before signing and which can continue under the new partnership.
An experienced CDMO can strengthen this preparation by testing assumptions around cost, timelines, process performance and supply. This independent challenge can expose weaknesses before they become negotiating issues and provide both parties with a more credible basis for valuation and risk allocation. After signing, the same partner can help turn diligence findings into remediation, technology transfer and scale-up, connecting assessment with execution.
Kane summarises the preparation required: “Build a licensing-ready data package, including well-organised, audit-ready documentation.” He also urged companies to prioritise transparency, so development, manufacturing and analytical information is traceable, accessible and presented consistently.
Clinical performance will remain the principal driver of an asset’s prospects. However, a well-supported route from development to commercial supply can reduce uncertainty, improve confidence in execution and make it easier for both sides to reach terms that reflect the asset’s true potential.CMC readiness and CDMO expertise can thus enhance asset value and mitigate risk.
