TOP 4 CHALLENGES OF BIOLOGICS DEVELOPMENT & MANUFACTURING
Biologics development is one of the most elegant fields in the drug-making industry. It is the driving force behind pharmaceuticals for a reason. Biologics not only focuses on antibodies but also includes other complicated procedures. Now more than ever, the momentum is picking up. Biologics products are hitting the market often.
Here are a few statistics to bring you up to speed with the biologics market trends:
Eight of the ten best-selling prescription drugs in 2016 were biopharma.
TRM estimates that the global biologics market could top $479 million by 2024.
Different market studies estimate that the annual biologics growth rates will hit 10%.
Not all is glory in this vibrant industry. Shifting from science to the business frontier is proving a challenge for Biologics. Like other mainstream businesses, it has to maintain a high level of competitiveness. And this is only possible by ensuring fair pricing, delivery, and quality performance.
The big question is: can the industry tower above these challenges? Can it deal with the problems of complexity, cost, and scrutiny?
Let’s explore the critical challenges posing a threat to the realm of Biologics.
Demand Forecasting
This challenge is evident when planning biologic drug substance manufacturing. The biologics development and endorsement process are usually lengthy and complicated. Hence, running the risk of inaccurate projection demand. Underestimating demand can lead to a tainted reputation and missed market opportunities. Overestimating demand can result in increased cost-per-unit and disposal expenses. It is fair to say that, either way, the biologics company will receive a significant blow.
The complexity of Biologic Supply Chains
A few things are certain in this dynamic industry. One, brand new products will flood the market at an astonishing rate. Two, new manufacturing technologies will follow suit. These scenarios will lead to an increase in the complexity of supply chains. Some key biologics players will fail to deliver at all. Little known intermediaries will receive attention unlike before.
Today, the line between the manufacturer and the final consumer is hardly straight. It will worsen with the introduction of new players, products, and manufacturing techniques.
Increased Demand for Affordable Pricing and Improved Accessibility
In a recent issue, Forbes labeled biologics medicine as the “largest driver of drug prices.” Based on IQVIA research data, biologics account for more than 93% in the rise of net drug spending since 2014. Why is that? The answer is pretty straightforward- there is a rise in demand for new, high-quality drugs. Biologics drugs happen to fill this market gap. As many biologics continue to hit the market every day, a new challenge arises. Customers will demand affordable pricing.
Payors will find it hard to meet the high prices that biologics products demand. Only the innovative firms will try to contend with the new reality. Balancing the thin line between the demand for quality products and low budgets will be essential.
One thing will lead to another. The outcome of these pressures will pave the way for the growth of biosimilars. This trend is already taking shape. Biosimilar interferons and human-growth hormones are available. This opens access to these products to millions of patients. If this challenge proves elusive, then the field of biologics is in for a very unpleasant ride.
New Manufacturing Technology Platform for Biologics
Biologics offer unique advantages that small molecule drugs do not. For one, they are far more sophisticated to manufacture. The entire drug production process is, in fact, riskier than any other out there. Whether it is an investment or modern technology approaches, biologics commercialization is difficult. In a few years, new molecules will need even more complicated procedures. Mind you; each will need their manufacturing, supply, and quality assessment techniques.
Back to the current situation, and biologics firms are already facing a nightmare. Struggling companies use biologics expertise in the late clinical or early commercialization phases. Setting up innovative technologies required to produce quality drugs is harder than ever.
Final Thoughts
The biologics industry is experiencing a host of challenges. Many of them boil down to the highly-engineered biologics manufacturing process. Large scale manufacturing of biologic products attracts million-dollar investments. But even then, quality control and quality assurance protocols must be in place. The demand for fair pricing and accurate forecasting will increase. So, the biologic industry will have to use strategic solutions. This will go a long way in bridging the gap between price and quality.
If you’re a newbie in the world of biologics, you will need professional CMC solutions to thrive. DSI INPHARMATICS provides the technical ability, regulatory certainty, and quality expertise you need. Our services will help your company enhance product approval, development, and marketing presence. We focus on the vital CMC issues and build programs that will take your biologics company to the next level. Contact us today.