Global regulatory outsourcing market to hit $15Bn by 2033: Market.us
NEW YORK, UNITED STATES — The regulatory affairs outsourcing market is projected to surge from $6.8 billion in 2023 to $15 billion by 2033, fueled by an 8.2% compound annual growth rate (CAGR), according to Market.us.
Pharmaceutical and biotech firms are increasingly relying on specialized partners to navigate complex global compliance requirements, thereby accelerating approvals while reducing costs.
Surging demand driven by regulatory complexity
An example of the Clinical Trials Regulation in the European Union requires real-time tracking and transparency of data, while emerging markets such as Asia-Pacific and Latin America propose their own local regulations.
Tighter digital requirements are becoming a trend among health authorities, including the Food and Drug Administration (FDA) and European Medicines Agency (EMA), with the requirement of the electronic Common Technical Document (eCTD) format, so smaller innovators benefit in particular when using the validated platforms and AI tools of outsourcing companies.
The transformation will enable companies to prioritize research and development (R&D), while a third party will handle the constantly changing paperwork.
Oncology and pharma lead outsourcing adoption
In 2023, the regulatory outsourcing market was dominated overwhelmingly by oncology applications, as the increasing volume of high-technology approaches to treatment drove them to capture 41.5% of the revenue.
Sponsors often hire consultants to write protocols and coordinate worldwide submissions, as these diseases often require adaptive trial designs and an expedited approval pathway. Meanwhile, pharmaceutical companies have already spent 46.3% on outsourcing, which is explained by the necessity of handling post-marketing surveillance, label updates, and multi-country filings.
With the augmented burden of biosimilars and cell treatment, the pharmaceutical industry alone accounted for 42.3% of outsourcing income. Third parties assist the companies in the task of working around pharmacovigilance regulations and real-world evidence (RWE) expectations, which have become prerequisites in expanding the labels.
Since regulators are giving importance to RWE, data analytics outsourcing providers are finding it challenging to be dispensed with in the compilation of patient records and claims data into evidence that is ready to be submitted.
Asia-Pacific and digital tools fuel market growth
In 2023, Asia-Pacific was leading with a market share of 40.1% of the regulatory outsourcing market due to the surging regulatory and research and development (R&D) harmonization processes.
The investments, such as those in GenScript that received a $224 million investment in its ProBio unit, represent a keen interest in the region in expanding biologic production.
In the meantime, North America is likely to emerge as the most rapidly growing region, with 33 FDA-approved biosimilar drugs by 2022 and an increased need for specialized regulatory services in five years.
Digital transformation is transforming the sector, enabling the use of AI for document preparation and even automatic eCTD submissions. Companies that implement these tools shorten the submission process from weeks to hours, giving them an advantage over those competitors who do not implement the same.
Outsourcers are also growing post-approval services and dealing with the long-term compliance of mature products, leaving clients to become more innovative but also guaranteeing uninterrupted market access.
