Blockbuster medicines are on the decline; their product pipelines diminishing and major products approaching patent cliff. In 2012, $130 billion of prescription drugs had become off patent, which left a financial vacuum for generic companies to seize the opportunity to provide affordable copies of the same drug. Subsequently, over last eight years, many other patents have expired and become generics. In 2018 alone, the patent cliff affected drugs that had combined annual sales revenue of $67 billion. AstraZeneca experienced a revenue fall of 19 per cent as well as a 50 per cent fall in earnings per share. After its patent expired, Merck’s anti-asthmatic drug – Singulair, saw a 90 per cent drop in sales and over 10 generic substitutes filled the market.

The global generic drugs market was valued at $387.9 billion in 2020 and is expected to grow at 5.7% (CAGR) over the forecast period of 2021 to 2030. However, the business of generics is influenced by factors such as regulatory challenges and role of insurance companies. Nevertheless, the projected increase in pharmaceutical sales over the next decade is set to come from generics.

Future of generics business

Around 84 per cent of the approximately 4 billion prescriptions written every year are for generic medicines. These help governments save billions every year. With numerous blockbusters off-patent now, it is a big business. 

The current generic market is saturated and hence there is a need to develop generics based on newer technology. Already there are advances made in newer areas such as super generics, repurposed generics & use of artificial intelligence and complex generics. 

By 2025, 56 per cent of new generic drugs will be small molecules. Future molecules will focus on targeted patient groups, innovative delivery systems and complex conditions. 

Technology that will inspire

1. Super generics: Super generics are small molecule drugs. They are an improved version of the original drugs which offer a therapeutic advantage over them. They show improved delivery, dosage or manufacturing process.

Super generics have a major advantage– their rejection rate by regulatory bodies is very low, owing to their prior approval in other forms. Majority of the data is already available from original submission. This space is expected to grow at 17 per cent CAGR.  

Following are a few examples of the drugs developed as super generics – 

1) Docefrez injection – marketed by Sun Pharma. Docefrez is the generic version of French company Sanofi Aventis Docetaxel drug Taxotere used to treat breast, lung and prostate cancer. US FDA granted approval for new drug application for anticancer Docefrez injection

2) Ambil and Doxisome – marketed by Taiwan Liposome. Ambil is the liposomal encapsulate formulation of Amphotericin B.  Doxisome is the liposomal formulation of Doxorubicin. Both formulations are super generics and show marked improvement in patients’ compliance by reducing side effects and providing the effective dosage.

2. Repurposed generics and use of artificial intelligence

It is an alternative means of drug development which consists of identifying new uses that are beyond the scope of original medical indication, for approved drugs or those drugs under investigation.

Repurposed generics caught pace during the COVID-19 pandemic. It was found that dexamethasone, an old steroid reduced mortality among hospitalised patients who required mechanical ventilation or supplemental oxygen for COVID-19. Hence, use of off-label dexamethasone was encouraged. 

However identifying these alternate applications is a challenge. However, this challenge can be addressed by the use of artificial intelligence. An example of this application is the discovery of Triclosan, a common ingredient found in toothpaste, could potentially treat drug-resistant malaria parasites. AI can also assist in finding suitable drug delivery systems. It is also currently being used to screen known moieties to evaluate their potential use in treatment and/or prophylaxis of coronavirus.

3. Complex generics: Complex generics are generics of products that have either a complex active ingredient, delivery mechanism or are a drug-device combination. Complex generics include cancer treatment, metered dose inhalers for asthma and other products for other challenging diseases. They offer more value than conventional generics by addressing additional unmet needs.

Their development requires more expertise, sophisticated planning and development. Hence, the main focus in the near future will be on super generics and repurposed generics.

Indian pharmaceutical formulators such as Lupin, Cipla, Cadila Healthcare, Torrent pharmaceuticals and Sun Pharmaceuticals have stepped up investments in R&D to build up their presence in the complex generics space. The companies that can adapt this more complicated development process are positioned to profit greatly in the years to come. 

To avoid pitfalls in the transition to complex generics, companies should liaise with industry partners with clinical experience and global regulatory know-how, along with site networks and quality/compliance expertise to rapidly deliver validated results. In this way they can meet the needs of regulators in shorter time lines and at lower costs, while ensuring the long term supply of the product.

Examples: 

1. Formulations – Liposomes, abuse-deterrent generics, parenteral microspheres

2. Delivery routes – topical ointments and locally-acting GI drugs

3. Drug- Device combinations – such as DPI, MDI, nasal sprays, and transdermal systems

Countries driving generic sales

Global sales of branded generics expected to progress at 8 per cent CAGR through 2029 but US and Europe are not set to drive this growth. North America will stay low on the global branded generics revenues scale. 

China, India, Asia Pacific will lead the global branded generic market. Emerging markets are not the only ones promising growth opportunities for generic makers. Japan, with its ageing population and focus on increasing generics usage has become a prime target for out-of-town generics makers.s

Regional markets are driven by large-scale pharmacy chains due to rising generic drugs adoption. Conducive regulatory environment is also a driving force in the growth of generics.

Generic therapy areas in focus

Drugs for cardiovascular diseases and diabetes – account for more than 20% of the total global sales of branded generics. They are expected to remain on top till 2029. Demand for gastrointestinal disease generic drugs is also rising. Oncology related branded generics offer lucrative growth potential. In next 10 years, anti-hypertensive generic drugs is expected dominate the market.

Oral generics comprise the largest share of about 50 per cent followed by parental, topical and others which is about 42 per cent.

Patients are living longer; hence the need for sustainable generic medicines will be ever increasing. Disease spaces related to lifestyle diseases will attract the suitable generic therapy. The areas to look for in the short term are super generics and refurbished generics as they are easy to manufacture and face less regulatory challenges and the generic industry will certainly move towards these areas. Complex generics will be slow to pick up owing to the high cost. 

Shopping photo created by freepik – www.freepik.com

By Dr R B Smarta

Managing Director – Interlink Consultancy

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