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Breaking Barriers in Market Access to Ensure New Therapies Reach Patients in Need

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Pharmaceutical companies invest significant amounts of time and resources in the research and development of new drugs. Introduction of new drug entities to market requires passing through various challenges and complex dynamics, including ensuring the safety and efficacy of new drugs, adhering to regulatory compliance, discovery and development processes, conducting clinical trials, maintaining supply chain logistics, and much more.

Understanding the Complex Landscape:

Once the requisite regulatory approvals for a pharmaceutical product are secured, the pharmaceutical industry requires continuous adherence to regulatory standards and consistent monitoring post-approval. First and foremost, the potential drug needs to work for the targeted patients, it should be competitive (in terms of quality and priced competitively), and above all it should also satisfy payers and reimbursement providers.

Health economics and outcomes research (HEOR) along with market access strategies can ensure that the new therapies reach the targeted patients that are safe, efficient and cost-effective. HEOR helps in assessing commercial and real-world outcomes and provides insights to the stakeholders on the impact of the new drug. Whereas, market access strategies help in breaking the barriers between patients, payers and reimbursement process and helps in maximizing returns on investment.

It is also important to note that regulatory authorities are focused on providing safe and efficient drugs. However, payers are always more interested in the commercial aspects of new therapies. The overall success of the drugs depends on successful negotiation among manufacturers and payers and robust reimbursement process. The drug must reach the target patient population, it should fulfill the unmet needs of the patients, and it should offer value for money for the investors.

Understanding the Barriers:

The goal of the pharmaceutical companies, regulatory bodies, and other stakeholders is to develop quality drugs, price them competitively and make them accessible to target patients irrespective of demographics, geographies and social status. However, despite extensive efforts, new therapies occasionally fail to achieve the intended outcomes. Drug formulation issues, misaligned results of clinical trials, compliance issues, or poorly designed market access strategies can result in a negative impact on the patient outcomes and commercial aspect.

There are many barriers to medical market access and it is important to identify the challenges faced with each of it:

Scarcity of Funds or Resources:

This is the most common challenge encountered by the researchers. Financial obstacles in securing funds for adequate R&D or grants for clinical trials and other resource scarcity.


Inability by a large set of patients to pay out of pocket expenses due to financial constraints, cost of the drug/therapy, procedure or premiums can severely impact the commercial aspect of drug business.

Healthcare Infrastructure Barrier:

Unavailability of staff or required number of professionals for R&D or clinical trials, difficulties due to geographical location, policies or inadequate training of healthcare providers can result in efficient and effective delivery of healthcare services to individuals.

Patient-Related Barriers:

Lack of awareness, language barriers, financial constraints, mental health condition/stigma or lack of trust in healthcare providers can severely impact patient adherence.

Drug and Treatment Utilization:

These types of barriers are majorly encountered during the development or implementation of the therapy. It can be due to molecular complexity or drug formulation, drug resistance or toxicity.

Institutional Barriers:

Lack of regulatory bodies compliance including non-compliance of patient protection laws, failure in following pharmacovigilance laws can lead to delay in getting necessary approvals and hinder timely drug launch.

Role of Market Access from Early Stage to Post-Launch Stage:

In the post-COVID era, healthcare expenditure has been rising steadily while major world economies have become stagnant. This has put enormous pressure on the government to cut spendings and use strict regulations and measures on new therapy launches. R&D and sales force were the central figures of managing marketing & sales, meeting physicians and pharmacists, taking care of price and reimbursement. On the other hand, medical affairs and market access is a broader concept, it focuses on solving patient’s unmet needs, ensures regulatory compliance, manages supply chains and involves all the stakeholders (patient, payers, healthcare providers, government bodies) in decision making.

Market access experts play a critical role beyond cost management and commercialization. They contribute throughout drug discovery, development, and planning stages, applying their expertise to address unmet patient needs, such as:

  1. Providing process related guidance for a better outcome
  2. Improving patient’s quality of life?
  3. Assessing and recommending clinical trial designs

In conclusion, market access is vital to bridge the gap between medical innovations and unmet need of the patients. Although regulatory requirements, pricing strategies, and reimbursement policies present significant challenges, utilizing market access analytics, the pharmaceutical industry can dismantle these barriers. Market access ensures that novel treatments are not only developed, but also are delivered to those who can benefit from it. With strategic approaches and persistent dedication, market access ensures that every patient has access to a better quality of life.