In this insightful interview with BioPharmaAPAC, Marc Yates, Senior Director at Research Partnership, shares his extensive experience and unique insights into the evolving healthcare landscapes of Latin America and Asia-Pacific regions. With over three decades in market research, specializing in healthcare since 1996, Yates provides a critical analysis of the strategic shifts necessary to meet the demands of aging populations and the rise of high-cost innovative treatments. From discussing the impact of digital health technologies to the importance of preventative healthcare models, Yates elaborates on how these regions can navigate their challenges and opportunities to align more closely with global healthcare standards. Join us as we delve into a conversation that bridges the gap between emerging markets and developed healthcare systems, shedding light on the critical role of strategic collaborations and regulatory enhancements needed to propel the APAC region to the forefront of global healthcare innovation.

With your extensive experience in navigating the complexities of healthcare systems in Emerging Markets, particularly in LATAM and APAC, how do you compare the challenges faced in these regions with those in more developed markets?

Healthcare policymakers in regions as diverse as Brazil, China, Canada, and Germany all confront a fundamental challenge: balancing the nation’s budget with the healthcare needs of an aging population in an era of high-cost innovative drugs.

A strategic approach involves transforming the healthcare model from a treatment-based to a preventative one. This shift presents a significant challenge in China and Brazil, where unlike in more mature markets, there is extreme overutilization of top-tier hospitals, accompanied by a limited primary care or community clinic sector that could provide preventative or early disease treatment roles.

In China, for decades, there has been significant overutilization of top-tier hospitals, known as Tier 3 hospitals. A unique aspect of the Chinese healthcare system is the ability of patients to self-present without a referral. This leads to scenarios where patients with minor ailments seek treatment at the nation’s leading Tier 3 hospitals, resulting in long patient waiting times and a substantial drain on healthcare budgets.

Patients in China generally have low levels of trust in smaller, lower-tier hospitals, which are often perceived as overcharging for unnecessary treatments and consultations to support hospital revenue. Conversely, Tier 3 hospitals attract patients with the prospect of access to leading physicians and are facilitated by significant improvements in the country's transport infrastructure.

Despite the government’s efforts to develop a nationwide primary healthcare system since the Five-Year Plan in 2012, patient reluctance persists, primarily due to ongoing concerns about quality.

In Brazil, the situation is somewhat similar, with the healthcare model also being heavily dependent on hospitals. Brazil faces a significant shortage of primary care physicians, nurses, and clinics, particularly in rural areas. There is an established primary care sector within the Universal System (SUS), but inefficiencies in referrals often lead patients to take their own initiatives, navigating a fragmented public/private system to seek care directly from leading specialist hospitals.

Both countries exemplify a healthcare model that is overly centered on hospitals, with insufficient emphasis on primary and preventative care.

Considering the demographic shift towards an aging population in APAC, how should pharmaceutical companies adjust their strategies to address the increasing demand for medical treatments and chronic disease management?

Emerging markets are experiencing a faster aging of populations compared to developed regions. With rising life expectancy and declining birth rates, these regions see a dramatic demographic shift. This trend translates to a projected annual growth of 2.7% in the over-65 population over the next 30 years, more than double the rate in developed nations. Consequently, this growing elderly population will drive a surge in demand for healthcare services.

To be future-focused, pharmaceutical companies should prioritize understanding which diseases will see increased prevalence among the elderly in the coming decades. Geriatric Major Depressive Disorder (MDD), for example, has seen a significant rise in prevalence from 3% in India during the 1990s to 34% today. Factors such as increased life expectancy and the stress of urban living contribute to this trend.

Market access strategies also need to be amended to address these unmet healthcare needs and the growing budget impact of this demographic shift. In China, for instance, inclusion in the National Reimbursement Drug List (NRDL) requires real-world evidence of drug efficacy and safety for the elderly. Tailoring medications to fit the needs of this population, such as through convenient dosing, is also critical.

Furthermore, the elderly generation is becoming increasingly digitally connected. For example, China boasts 122 million internet users over 60 years old. Considering how digitally engaged emerging market elderly populations are—often encouraged by younger family members—it is crucial for pharmaceutical companies to consider how digital health patient support services can better support desired healthcare outcomes.

In light of APAC's adoption of new technologies like digital health and personalized medicine, what do you believe are the most significant impacts of these innovations on the pharmaceutical industry, especially in emerging markets?

Emerging markets have led the way in integrating digital health solutions for patients, driven by specific healthcare challenges such as a limited number of healthcare providers, patient affordability issues, and favorable technological market conditions.

These regions typically have fewer doctors per capita compared to developed countries—for instance, India has only 0.7 doctors per 1,000 people versus 3 per 1,000 in the UK. This scarcity is often more acute in urban areas. Moreover, in most emerging markets, the direct cost of healthcare to patients or their families can deter or delay seeking professional help. This has created a demand for more convenient and cost-effective consultations, which digital solutions can provide.

Furthermore, the environment in emerging markets is particularly conducive to digital health innovations. For example, in India, where 88% of households have smartphones—often their only way to access the internet—there is a notable openness among patients to digital health services, a contrast to more mature markets. Additionally, payers in these markets are more willing to reimburse digital health services compared to their counterparts in Europe and North America.

This situation offers a unique opportunity for the pharmaceutical industry. Emerging markets can often provide a blueprint for effective digital solutions that could be adapted for use in more developed markets. Notable examples include digital adherence support services and telemedicine. For instance, the SIMPill system, initiated in South Africa, helps ensure medication adherence by alerting caregivers and family when a patient has not taken their medication. Similarly, in India, Apollo Hospital’s integrated mobile health service has been pioneering telemedicine for over two decades, offering insights that could benefit systems even in developed countries like the UK.

Emerging markets, therefore, are not just adapting to technological advancements but are setting the stage for future global healthcare practices.

How critical are collaborations and partnerships between biopharma startups, research institutions, and healthcare providers in driving innovation and drug development in the APAC region?

Collaborations between the pharmaceutical industry, academia, and healthcare providers have long been foundational in advancing drug development and innovation across the APAC region. Noteworthy examples include the Shanghai Institute for Biological Sciences (SIBS) and its various industry collaborations, partnerships between the National University of Singapore (NUS) and industry leaders, and Australia’s Cooperative Research Centres (CRCs), which facilitate collaborations across sectors.

These partnerships are crucial as they bring together diverse expertise to tackle complex health challenges. Academic institutions primarily lead in discovering new scientific insights, while the industry applies these discoveries to develop practical and marketable medical solutions.

Challenges in these collaborations often include aligning goals, navigating intellectual property rights, and managing data privacy concerns. Effective strategies to address these challenges include establishing clear communication channels, setting mutual goals at the outset, and agreeing on data handling protocols.

A standout example is the Digital Health Cooperative Research Centre (DHCRC) in Australia. Funded through the Commonwealth Department of Industry, Science and Resources’ Cooperative Research Centres Program, the DHCRC fosters innovation by utilizing data and digital technologies to improve health outcomes. It brings together over 60 participant organizations from universities, healthcare, and technology sectors, demonstrating the power of collaborative efforts. 

Annette Schmeide, CEO of the DHCRC, emphasizes the transformative potential of such collaborations: “Digital Health CRC is a key enabler of digital healthcare innovation; empowering the next generation of health professionals and implementing digital health projects that improve health outcomes for all Australians.”

In summary, strategic partnerships are pivotal in shaping the future of healthcare in the APAC region. By fostering innovation, enhancing patient care, and streamlining operations, these collaborations are integral to addressing global health challenges and advancing the medical field.

With various APAC countries enacting beneficial policies and regulatory frameworks to expedite drug development, what are the key regulatory challenges that still need to be addressed to improve healthcare access and pharmaceutical innovation?

The ASEAN Pharmaceutical Regulatory Framework (APRF) exemplifies regional efforts to accelerate drug development and improve access, particularly for conditions with significant unmet needs. This framework aims to provide an integrated approach by closing gaps in quality, safety, and efficacy of pharmaceuticals, aligning with international standards, eliminating country-specific requirements, and promoting reliance and mutual recognition agreements.

Despite these advancements, several key regulatory challenges remain. Intellectual property (IP) concerns are prominent as collaborations often involve sharing knowledge, data, and technologies. This can lead to hesitance in open sharing and result in slowdowns, particularly in regions where IP protections are not as robust as in Singapore and Japan. Other APAC markets are still working to catch up in this area.

Another challenge is the misalignment of regulatory pathways. Expedited drug approval policies vary significantly across APAC countries, indicating a pressing need for a standardized framework that can streamline the process and promote consistency throughout the region.

Alignment with global standards is yet another hurdle. Not all APAC countries are members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which currently includes only China, Japan, Singapore, South Korea, and Taiwan. Full alignment with these global standards is crucial as it prevents unnecessary duplication of clinical trials and enhances cross-border collaborations, facilitating a more unified approach to pharmaceutical innovation.

Addressing these challenges is essential for APAC to further enhance its regulatory environment, supporting faster and more equitable access to innovative healthcare solutions.

As Singapore emerges as a leading innovation hub in healthcare, how can other APAC countries leverage this model to foster their own biopharmaceutical advancements and become part of the global healthcare innovation ecosystem?

Singapore has established a robust foundation for healthcare innovation, characterized by strong intellectual property protection and alignment with global standards through its membership in the International Council for Harmonisation (ICH). These elements encourage international collaboration and set a high standard for regulatory practices.

Additionally, Singapore's digital health infrastructure has proven to be a catalyst for innovation. On a broader scale, the Singapore government has implemented policies that foster innovation and collaboration across various sectors, including pharmaceuticals. These policies include streamlined regulations, tax incentives, and substantial support for research and development. Simultaneously, a business-friendly environment has been cultivated, attracting private investment and venture capital crucial for innovation.

A prime example of Singapore's dedication to supporting biopharmaceutical advancements is the Pharma Innovation Programme Singapore (PIPS). This industry-led platform synergizes public sector research capabilities with the domain expertise of the pharmaceutical industry. By leveraging novel manufacturing technologies and data analytics, PIPS enhances productivity and operational efficiency within Singapore’s pharmaceutical sector. Notable pharmaceutical leaders such as GSK, Sanofi, and Takeda have engaged with the research community in Singapore to bolster biologics manufacturing capabilities.

Singapore’s approach creates a fertile environment for collaboration from which many countries could benefit. Other APAC nations looking to replicate Singapore’s success might focus on adopting similar strategic policies, tailored to their unique regulatory, economic, and cultural contexts. This adaptation could facilitate their integration into the global healthcare innovation ecosystem, leveraging their own strengths and regional characteristics.