How Market Access Has Changed in the Past Decade

Although considered a critical element in planning and commercial success, market access is still not well-defined. Pharmaceutical companies have to ensure that their medicines are accessible worldwide. They also have to confirm if these medicines are reimbursed and reach the patients who need them.

Market access encompasses all this. It ensures that all patients who require medicines are able to afford quick and consistent access to them.

Factors Critical to Market Access

Market access is vital throughout a drug’s life cycle. The following are factors critical to successful market access:

  • A drug’s quality and popularity, which is influenced by the severity of the disease it treats, its performance, regulatory approval, and unmet needs and health outcomes associated with it.
  • Patient population, information about which prompts pharma companies to develop and launch drugs.
  • The right price, which depends upon patients’ willingness and ability to pay.
  • Competition, which can be a barrier because consumers can choose from many medicines at affordable prices.
  • Multiple stakeholders—usually the government, insurance companies, investors, key opinion leaders (KOLs), employers or patients—who assess a drug’s value based on its cost and clinical merits.
  • Network of influential groups, such as patient advocacy groups, politicians and investors, who create awareness and alleviate obstacles.
  • Delays in regulatory approval, such as approval from the U.S. Food and Drug Administration (FDA), which will limit sales and profits.
  • Health technology assessment (HTA), which provides information about technology used in drug development or insurance coverage applicable to them.

Pharma Market Access: Past, Present and Future



The pharmaceutical industry used to rely on the ‘push’ strategy to ensure the success of their products. Drug approval was as simple as submitting data on efficiency, safety, and tolerability to the regulatory authorities. Once approved, companies marketed drugs to the targeted physicians and dispensed them via pharmacies.Market access involved only a few stakeholders—regulatory agencies, physicians, and pharmacies.

Over the years, market access has changed. Healthcare expenses, chronic illnesses, and the geriatric population increased. Authorities started scrutinizing product value and limiting new products’ pricing and reimbursement. The number of stakeholders and their involvement also increased.

In 1997, the FDA allowed consumer-directed broadcast advertisements for prescription drugs and biological products, leading to direct communication between pharma companies and patients.

In the past 10-20 years, the industry did not launch many new drugs. In 2000-2011, only four percent of novel approved products for treating neglected tropical diseases (NTDs) were developed. However, in 2018, many significant new drugs gained FDA approval.


The cost of providing healthcare is still on the rise. Drug therapy is making great advances. R&D expenditure has also risen over the last decade. There is immense pressure on governments and healthcare systems to reduce costs. As a result, market access has become increasingly important.

While many innovative drugs are available now, they do not often succeed commercially as most payers cannot afford them. This is driving payers to control new product endorsement, be involved in market access decisions, and insist on cost-effectiveness. They are using new methods to limit costs, such as evidence-based pricing, managed entry agreements, and volume limits.

Companies that understand patients and incorporate their feedback are gaining more market access. They are building direct-to-consumer marketing skills and including marketing in strategies, instead of focusing only on R&D and sales.

In the quest to improve their expertise and their market position, pharma companies also have been merging with others or acquiring them.


Market access for the life sciences industry is transforming, with political, regulatory, and economic issues influencing price sensitivity and willingness to pay. Pharmaceutical companies need to engage with the key stakeholders and adopt a cross-functional approach to keep up with potential future needs.

They should also adapt to all changes to organizational structure and business processes. Most importantly, pharma companies must adopt a mindset oriented to market access—consider market access strategy while launching products and even while developing them.

A customized strategy combined with the right people and processes can help counter all market access challenges, improving commercialization and drug accessibility for patients.

About the Author

My name is Jason and I’ve been writing for online and offline publications for the most part of my writing career. I love writing on technology and business. Anything else is fine too unless it doesn’t skip me completely. Social media is not my cup of tea, but I find online messaging services extremely handy. My pastimes include reading books and magazines, and also watching movies and sports with my favorite people.

Jason T is a freelance writer who writes about lifestyle and travel.

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