制药业的困境：破解中低收入国家的药品可及性密码

Pharma’s dilemma: Cracking the codeof access in low- and middle-income How to crack the code of access Pharma’s dilemma: Cracking the code of access With approximately 6.82 billion people living in emerging and developing markets acrossAsia, Africa and Latin America, low- and middle-income countries (LMICs) present acompelling opportunity for pharmaceutical manufacturers. Yet the potential is paired For pharma companies seeking to expand their reach, navigating access in these countriesis no longer just about market entry but about addressing systemic barriers like pricingconstraints, infrastructure limitations, regulatory complexities and fragmented healthcaresystems. The question isn’t just how to reach these markets—it’s how to tailor solutions The stakes are high. Prioritizing the right regions, engaging with local stakeholders andbuilding sustainable models that can adapt to both economic and political shifts allrequire a deep understanding of the landscape and a flexible, nuanced approach. How can The answer lies in rethinking access strategy—starting with the basics of LMICs: A strategic imperative for pharma The global healthcare landscape is transforming. Pharmaceutical manufacturers,traditionally reliant on U.S. and European markets, face challenges due to cost control, LMICs are home to approximately 84% of the world’s population. They have been growingthree times faster than developed economies since 2005. As economic metrics in LMICshave improved, their healthcare focus is shifting from infectious diseases to chronic non-communicable diseases, creating new opportunities for pharmaceutical companies. These Yet the complexity of LMIC markets requires a tailored approach. Product suitability playsa key role, with oral therapies presenting the most viable opportunities due to easier treatments, such as CAR-T therapies, face hurdles in many LMICs due to affordabilitychallenges, limited healthcare infrastructure and logistical constraints like cold-chainrequirements. Still, the landscape is not uniform—countries like Brazil, with more advancedpayer systems and regulatory frameworks, can support complex therapies, whereas Beyond business considerations, expanding into LMICs aligns closely with the environmental,social and governance (ESG) objectives of pharmaceutical manufacturers. By improving In this evolving global healthcare landscape, LMICs offer pharmaceutical companies anopportunity not just to expand their presence, but to redefine their role as enablers ofequitable healthcare. With the right strategies, companies can navigate the complexities of Roadblocks to enter LMICs Despite the improving macroeconomic indicators, manufacturers must navigate several •Lack of healthcare infrastructure:One of the biggest challenges in LMICs is the lackof healthcare infrastructure. A 2018 report by the Lancet Global Health Commissionfound that 2.9 million lives are lost in LMICs due to lack of access to care, and another 5.7million people die due to the inadequate quality of healthcare. Additionally, the World •Lack of government funding and high out-of-pocket spend:The lack of healthcareaccess in LMICs is exacerbated by insufficient government focus. Political and economicinstabilities contribute to this issue, but for noncommunicable diseases, the lack of Even when governments fund public healthcare, this funding is often targeted at thoseliving below the poverty line or it is only partially funded with an annual cap. Privatehealth insurers offer coverage in some markets, but this coverage is mostly accessible tohigh-income earners or through select employers offering this benefit. Consequently, the •Burdensome regulatory process:The regulatory environment in LMICs variesconsiderably across countries. Usually, the timing from regulatory filing to approval can beanywhere between two to four years, with most markets favoring drugs that are alreadyon the WHO (World Health Organization) Model List of Essential Medicines. For other •Lack of long-term organizational commitment:To successfully enter emerging marketsrequires a commitment from senior leadership with a dedicated team to plan and executemarket entry. Currently, many LMIC initiatives are a patchwork of C-suite-led ESG initiatives Strategic considerations for LMIC market entry To successfully enter LMICs, manufacturers need to develop a long-term, sustainablestrategy that is built around these four steps outlined in Figure 1. When to consider an LMIC strategy? The timing of entry into LMICs varies widely based on the manufacturer’s portfolio. Formanufacturers with a large vaccine or anti-infectious-disease portfolio, entering LMICsalmost simultaneously with the advanced countries is an approach they typically choose. The decision is nuanced when the portfolio is geared toward noncommunicable diseases.In such cases, manufacturers have been more cautious, often delaying entry until theproducts are close to losing exclusivity in h