FAQ: Pharmaceutical Outsourcing Trends and Innovations

What should pharma industry professionals know about outsourcing?

Pharma teams should recognize that outsourcing can deliver cost efficiencies, scalability, and specialized expertise, but it also brings risks—including regulatory compliance gaps, data-security issues, and unforeseen expenses. Success requires careful planning, rigorous vendor evaluation, well-structured contracts, clear communication, continuous oversight, and full alignment of the partner with the company’s quality system (1-5).

What is the outlook for pharmaceutical outsourcing?

Contract service providers are currently challenged to step up their game to stay competitive in an increasingly complex bio/pharma market. As molecular complexity increases, there is a growing need for preclinical testing expertise.

How are relationships between sponsors and outsourcing partners evolving?

Outsourcing partners are increasingly providing end-to-end service. Customizable relationships are enhancing speed to market. Sponsor companies and CDMOs (Contract Development and Manufacturing Organizations) are starting to view each other not merely as transactional relationships, but as true partners sharing the common goal of getting drugs to patients faster.

What is the role of a CDMO in the supply chain?

The role of the CDMO is evolving, as discussed at CPHI Americas 2025. Key focus areas include the CDMO’s role in API quality and the importance of building trusted CDMO relationships.

What recent collaborations or partnerships have been announced?

• A worldwide, exclusive license was granted for the development and commercialization of enzyme replacement therapies using proprietary platform technology as part of a Chiesi–Aliada partnership focused on BBB-crossing tech for lysosomal storage disorders.

• An alliance for radiopharmaceuticals was created by Medicines Discovery Catapult and Crown Bioscience, collaborating on an integrated translational biology platform. This effort also included collaboration on the development of radiopharmaceuticals.

• MilliporeSigma and Simtra launched a five-year agreement for drug substance and drug manufacturing services, designed to offer a turnkey service to companies seeking faster time to market.

• ten23 health joined Gerresheimer, SCHOTT, and Stevanato Group in the “Alliance for RTU” (Ready-to-Use), formed in response to increasing demand for aseptic filling technologies and processes.

• AstraZeneca partnered with CSPC Pharmaceuticals on AI-enabled research to identify pre-clinical candidates for high-priority targets, including a small molecule oral therapy for immunological diseases.

What recent investments and expansions have outsourcing providers undertaken?

Several companies have announced major expansions or acquisitions in their manufacturing and services:

• Bora Pharmaceuticals is expanding its Midwest manufacturing site in Maple Grove, Minnesota, focusing on manufacturing and packaging capabilities, following its 2024 acquisition of Upsher-Smith Laboratories. Bora also made announcements at CPHI Frankfurt.

• Piramal Pharma held a groundbreaking at their $80 million Kentucky facility, part of a $90 million investment plan.

• SK pharmteco is strengthening the domestic API supply chain with a new peptide facility.

• Aenova added a cold chain warehouse to its Latina, Italy site, expanding supply chain solutions for biologics and temperature-sensitive pharmaceuticals.

• ESTEVE CDMO acquired Regis Technologies, which expands the CDMO’s small-molecule API development and manufacturing services in the US.

• Nelson Labs expanded its laboratory capacity and services at its German facility in Wiesbaden to respond to growing demand for packaging and microbiological testing.

• Sanner is expanding its CDMO offerings and showcasing packaging innovations.

How are tariffs and trade policy impacting the bio/pharmaceutical outsourcing industry?

Industry survey results indicate that the bio/pharma sector faces tariff-driven rising costs and supply strain. Firms are aiming to boost compliance and diversification while seeking stable trade and R&D support.

References

1. NSF. The Five-Step Guide to Effective Pharma Manufacturing Outsourcing. Accessed Nov 25, 2025.
2. GForce Life Sciences. 5 Big Challenges of Outsourcing in Pharma (And How to Avoid Them). Accessed Nov 25, 2025.
3. Qualistery. Building Strong Partnerships: Effective Outsourcing in the Pharmaceutical Sector. Accessed Nov 25, 2025.
4. G.C. Chemie Pharmie Ltd. Why Outsource Manufacturing? Top 5 Advantages for Pharma & Supplements. Accessed Nov 25, 2025.
5. Manufacturing Chemist. Outsourcing in Pharma: A Comprehensive Guide to strategic Advantages and Considerations. Accessed Nov 25, 2025.