“That's how they can continue to innovate and be relevant in this industry right now.”

Swathi Rangan

For Rangan, that ambiguity is part of both the appeal and the challenge. In her view, rather than navigating traditional pathways involving multiple intermediaries, DTP models attempt to streamline how therapy reaches the individual. “It's asking, ‘How can we subvert a lot of the access barriers that we currently see which cause a lot of delays and gaps?’” she explains. “Whether it's from the aspect of just general access in terms of affordability of product, but also how quickly can you get it into the hands of the patient?”

However, realising that vision is not as straightforward as one may hope. Telehealth providers, pharmacies, data platforms, patient support programmes, hubs, and logistics partners all play a role, creating what Rangan describes as “a pretty convoluted network.”

Consequently, as companies experiment with different configurations, understanding what is required for specific products to thrive in the DTP space is essential and deciding where to build internally versus partner externally is becoming a central strategic question.

“The more that a manufacturer can take control of their own data and be able to make their own decisions, be able to make changes quickly, that's how they can continue to innovate and be relevant in this industry right now,” Rangan says. The answer will increasingly define competitive differentiation; companies that rely entirely on outsourced platforms could risk ceding both data ownership and the agility to iterate.

“It’s almost a sense of losing a little bit more control, rather than empowering them to make more informed decisions.”

Swathi Rangan

“In the past, […] the perception was it was always the healthcare provider who owned that journey,” says Rangan. “Then, […] especially with specialty drugs and rare disease, […] it’s the pharmacy and the hub. Now, you are putting the onus on the patient and the manufacturer across a multitude of products.” As she describes it, “owning the journey is becoming a lot more consumer-friendly, where they interact directly with the manufacturer, or through a specified channel/platform. Patients are now potentially empowered to drive more of their healthcare decision-making.”

This shift mirrors a broader consumerisation of healthcare, where patients have begun to expect the same level of dynamic accessibility found in other industries. Direct interaction with platforms, telehealth providers, or manufacturer-led services allows individuals to take a more active role in their treatment journey. In theory, this can shorten time to therapy and improve continuity, particularly in areas where demand is high and patients are actively seeking treatment.

However, the transition is not without discomfort for manufacturers. Moving closer to the patient introduces new operational and reputational considerations, from safety reporting to compliance oversight. It also challenges long-standing industry norms around control. “When you think about the industry, especially in pharma, they’re very risk-averse […] If I put everything in the hands of the patients, what are all the potential issues that could crop up?” Rangan says. “It’s almost a sense of losing a little bit more control, rather than empowering them to make more informed decisions.”

That caution has slowed adoption, even as interest grows. According to Rangan, it was only with the momentum created by GLP-1 therapies (alongside regulatory and policy developments) that more companies began seriously exploring whether DTP could extend beyond early adopters. The result is a model that promises greater patient autonomy, but also requires manufacturers to rethink their role in supporting, monitoring, and guiding the treatment journey.

“What is the value of actually exploring DTP for your asset, and what specific unmet need or gap are you solving for?”

Swathi Rangan

A central consideration, she notes, is whether DTP meaningfully expands reach. For some therapies, particularly those with strong patient awareness or high unmet demand, the model can create new entry points to treatment. In others, where diagnosis is complex or patient identification is limited, the benefits may be less evident.

As Rangan notes, companies should first examine whether the model helps answer core commercial and patient access questions. “Are you actually getting more patients on product? How are you measuring that? How are you able to track a patient’s experience and make sure you’re intervening at the right time?” she says. These considerations ultimately shape whether DTP becomes a viable business case. “If you don’t have that, and you don’t have the buy-in for that, it becomes really challenging whether your asset is a fit for this or not.”

Equally important is defining the value of the model beyond simply following industry momentum. “There’s the aspect of going the DTP route because it’s genuinely beneficial for your patients, and then there’s the aspect […] of merely checking the box because it is a current trend,” Rangan explains. “What is the value of actually exploring DTP for your asset, and what specific unmet need or gap are you solving for?” The distinction matters commercially, as well as ethically: DTP programmes built around access gaps tend to demonstrate measurable ROI, while those built around optics often struggle to justify the infrastructure investment.

Speed to therapy is often cited as one of the clearest advantages. “Is it because we think the time to fill is too convoluted with where we sit in the access spectrum?” Rangan asks. “We think by deploying this, we can, in fact, take something that might be a 30-day fill to […] within three to eight days. Are we ensuring that patients are starting quicker?” In demand-driven categories such as obesity, migraine, and women’s health, where patients are actively seeking treatment, these improvements can be particularly compelling.

However, operational realities also shape suitability. Cold chain requirements, complex administration, and monitoring needs may introduce additional costs or infrastructure demands that limit feasibility. In these instances, DTP may still play a role, but only as part of a hybrid approach, rather than a fully integrated model.

“If you're creating and deploying this, you have to be willing to invest from a budgetary, resourcing, and organisational standpoint.”

Swathi Rangan

A key challenge, Rangan notes, lies in balancing internal ownership with external partnerships. DTP models rely on a network of providers, logistics partners, and data platforms, but coordinating those components requires a foundation of strong internal governance. “Your internal infrastructure […] gets very challenging,” Rangan explains, pointing to the need to work with external agencies while also building internal capabilities. “Being able to actually manage that and plan for that, I think, is very critical. A lot of companies tend to subvert that element when they're thinking about DTP, ‘[They’ll].. just have other external agencies do it […] It’ll be connected, we’ll get all the information’,” she explains as a common misstep some manufacturers take without providing the appropriate attention to navigating the technical complexity.

In practice, however, outsourcing alone rarely delivers the level of oversight required to make DTP a success. Internal coordination is essential, which often means building new operational structures, including teams focused specifically on platform management, compliance, and cross-functional alignment.

According to Rangan, this is not something that can be layered onto existing roles. “From an infrastructure standpoint, is your company willing to invest? You will need a separate team. You will need a separate focus. This isn't a half-time job of some individual that you can pull in,” she says. “If you're creating and deploying this, you have to be willing to invest from a budgetary, resourcing, and organisational standpoint and ensure that […] you're willing to give it the remit that it needs.”

That investment extends beyond headcount. Legal, regulatory, medical, and compliance stakeholders must be involved early to define guardrails and workflows, particularly as pharmacovigilance and patient interaction volumes increase. Internal data platforms may also need to be developed or expanded to track patient journeys, measure performance, and enable timely interventions. Without these foundations, even well-designed DTP models risk becoming fragmented or difficult to scale.

“It’s thinking about scenario planning as well and justifying the long term commercial shift in infrastructure.”

Swathi Rangan

“This is not something that you can be extremely lean with in launch,” Rangan cautions. “Because it is so new, the level of exposure that you have when you're launching is going to be higher. You are going to have more risk. Even from a legal and compliance perspective, you're open to more risk as well.”

Beyond operational considerations, the broader market environment is also evolving. Early DTP launches have already encountered payer resistance, prompting the emergence of adjacent models, such as direct-to-employer. At the same time, policy developments and pricing pressures are shaping how these approaches may develop over time. “One thing that I would caution is, what will this look like in three, four years? And how can we shift this to scale in the future versus this current market alone?” Rangan says. “It’s thinking about scenario planning as well and justifying the long term commercial shift in infrastructure.” That means stress-testing the model against potential shifts in payer policy, pricing reform, and the competitive landscape – not just optimising for the current access environment is key.

Looking ahead, the evolution of DTP is likely to extend beyond the high-demand categories that first drove adoption. While GLP-1 therapies have provided early proof of concept, interest is growing in how similar approaches could apply to specialty products, where traditional access pathways can be particularly complex. “Seeing how that will continue to evolve, […] especially as we think about specialty products, rare disease, and evolving therapeutic advances […] some of these that don’t necessarily fit the DTP model right now, but could in the future, I think will be really compelling,” Rangan says.