The life science industry faces rapid innovation, technological advancement, growing complexity, and uncertainty. In this evolving landscape, convergence of AI, real-world evidence (RWE), downward pressure on pricing, and focus on incorporating the patient voice will continue to shape how therapies are discovered, evaluated, and delivered to patients.
Amid these changes, accelerating time to value remains imperative, both for economic returns and patient outcomes. Each day a treatment remains in development, it costs manufacturers approximately $500,000 in lost revenues. But more importantly, it represents a lost opportunity for improved patient health outcomes.
Maximising value in a complex healthcare ecosystem
Life science companies must increase efficiency in product development and commercialisation while facing significant challenges. The traditional pathway often exceeds a decade, with commercialisation considerations frequently addressed only in later stages. This sequential approach is becoming increasingly inadequate amid mounting pressure to demonstrate value alongside efficacy, particularly in light of the pharmaceutical industry’s uncertainty and evolving drug pricing policies.
These challenges are particularly keen for first-time launchers, who, according to , now account for approximately 40% of new assets approved by the US Food and Drug Administration (FDA) but experience lower success rates than established organisations. Most importantly, these delays directly affect patients awaiting potentially life-changing treatments. In rare diseases or conditions with limited therapeutic options, commercialisation delays can significantly impact patient outcomes and quality of life. McKinsey’s analysis notes that first-time launchers are disproportionately developing breakthrough therapies for rare diseases, with cell and gene therapies comprising 22% of their portfolios compared to 12% for established pharmaceutical companies.
Integrating market access and real-world evidence earlier
One of the most effective approaches to accelerating time to value involves early integration of pricing, reimbursement, and value considerations into development planning. Organisations that postpone market access strategy until late-stage development frequently encounter unexpected hurdles that could have been addressed through thoughtful clinical trial design.
Early engagement of access teams and stakeholders enables the development of evidence generation strategies that satisfy both regulatory requirements and payer evidence standards. Clinical trials can capture endpoints meaningful to all stakeholders while early health economic modelling informs strategic decision-making. By engaging key stakeholders early, manufacturers create a more direct path to reimbursement and patient access following approval.
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By GlobalDataLeveraging real-world data and evidence to improve efficiencies
The growing utility of real-world data (RWD) and the significance of RWE present another opportunity to accelerate time to value. Strategic research partnerships between pharmaceutical companies, healthcare systems, and academic institutions can generate valuable real-world evidence to support various goals. These include clinical trial optimisation and simulation, enhanced understanding of disease progression and unmet needs, the development of value-based contracting models, post-marketing surveillance requirements, and ongoing demonstration of product value.
By partnering with organisations specifically focused on data and analytics to transform RWD into meaningful RWE, manufacturers can rapidly scale resources to meet project needs. Leveraging expertise in these collaborations can yield insights that simultaneously strengthen regulatory submissions and payer value propositions, potentially shortening time to market while enhancing market position.
The strategic application of RWD analytics at each phase of the commercialisation journey can dramatically improve efficiency and outcomes when supported by consistent partner expertise across the development continuum. A study by the Tufts Center for the Study of Drug Development found that leveraging real-world data for patient identification can reduce enrollment periods by up to 30%, directly accelerating time to market.
When designing clinical trials, RWD can inform external control arms that augment traditional randomised controlled trials, particularly valuable in rare disease settings where recruitment is challenging. Research from the Duke-Margolis Center for Health Policy demonstrates that external control arms powered by robust RWD can reduce trial costs by up to 40% while maintaining statistical validity when properly implemented.
Agile research teams with cross-functional expertise can rapidly adapt to evolving regulatory guidance, ensuring trial designs remain compliant while maximising efficiency.
Using real-world data and evidence to drive value-based healthcare models
Beyond clinical development, RWD proves invaluable for informing value propositions to payers and health technology assessment bodies. Companies that effectively integrate real-world outcomes data into health economic models can demonstrate treatment value more convincingly have the potential to reduce time to favourable reimbursement decisions and earlier access for patients.
This approach aligns perfectly with the growing emphasis on value-based healthcare models and the focus on incorporating the patient voice into decision-making. Working with research partners that provide expertise across multiple RWD sources, HEOR [Health Economics and Outcomes Research], RWE, value communications, and market access workstreams ensures coherent value narratives backed by robust evidence, further accelerating time to value.
Leveraging the support of a cross-functional partner for greater agility, flexibility, and efficiency
Organisations that leverage research partners through agile, flexible and integrated team models can effectively close experience gaps. The ability to smoothly transition between tasks and methodological experts within one unified team accelerates time to value demonstration. This approach allows pharmaceutical companies to outsource cross-functional aspects of development and commercialisation efficiently while maintaining oversight and control over processes and data.
By partnering with a single provider such as Genesis Research Group, companies gain the flexibility to scale resources based on project needs while streamlining processes for improved efficiency.
For first-time launchers facing experience gaps, these agile partners can provide expertise across multiple functional areas, helping navigate complex regulatory and market access landscapes. The result is significant cost efficiencies through optimised resource allocation, access to on-demand specialised talent, and customised solutions tailored to specific challenges along the lifecycle.
For first-time launchers facing potential experience and expertise, agile partners can provide rigorous expertise across multiple functional areas, helping to navigate complex regulatory and access landscapes.
Accelerating time to value new therapies requires reconsideration of traditional development approaches. By integrating commercialisation considerations from the earliest stages, leveraging RWD/RWE, prioritising market access strategies, and engaging flexible cross-functional partners, pharmaceutical companies can significantly reduce the time between innovation and patient impact.
This integrated approach not only reduces development costs but also increases revenue potential while getting life-changing treatments to patients faster, representing not just a competitive advantage but a strategic necessity for sustainable success through accelerating time to value for all stakeholders throughout the healthcare ecosystem.
