Biopharmaceuticals: Shaping the Future of Medicine in India and Bangladesh
Biopharmaceuticals, also known as biological medical products, represent the future of medical treatment in both Bangladesh and India. These innovative therapies are poised to become the cornerstone of the pharmaceutical industry across the region.
As a class, biological products have revolutionized treatment across numerous medical specialties, including rheumatology, oncology, cardiology, dermatology, neurology, gastroenterology, and autoimmune disorders. They offer powerful therapeutic options for conditions that previously lacked effective treatments or where conventional therapies proved insufficient.
The rise of biopharmaceuticals will drive significant transformation across laboratory technologies, operational frameworks, and marketing strategies. Medical representatives will need to evolve into knowledge-driven professionals, while their leadership teams will assume newly defined roles to guide this transition.
Over the next 15 to 20 years, current pharmaceutical business models will undergo a profound metamorphosis, shaped by the growing influence of biopharmaceuticals and biosimilars. These technologies will unlock novel approaches to treating and potentially curing a broad spectrum of diseases.
A compelling report from Fierce Biotech highlights this shift:
“The biotech industry is becoming the most active group for later-stage pipeline work. While Big Pharma sees its R&D share drop, emerging life science companies are better prepared to go it alone.”
The report also notes that 2018 was a landmark year for FDA approvals, with 59 new therapies receiving the green light. Interestingly, large pharmaceutical companies were responsible for fewer than half of these filings. Emerging biopharma firms originated 38 of the 59 approved drugs—an impressive 64%. While Big Pharma’s role in molecule origination is diminishing, they remain vital partners for biotech ventures. However, the reliance of smaller biopharma companies on Big Pharma’s expansive sales networks is steadily declining.
The Five Challenges Facing Biopharmaceuticals
1] Unique Challenges for Biopharmaceutical Scientists
The development of biologic therapies presents a distinct set of challenges for formulation scientists. Unlike small-molecule drugs, most biologics require parenteral administration, necessitating delivery via injection. This introduces a host of complexities tied to the unique physicochemical properties of biologic substances. Key considerations include the stability of the biologic in solution, as well as the feasibility of manufacturing, storage, transportation, and administration.
These challenges have catalyzed the emergence of ancillary industries—most notably, the prefilled syringe (PFS) sector. PFS are ready-to-use, disposable syringes preloaded with precise doses of medication. They offer numerous advantages: reduced dosing errors, enhanced accuracy, and most importantly, improved patient adherence. For individuals managing chronic conditions who rely on self-administration, PFS can significantly enhance treatment compliance and quality of life.
In India, however, only one company currently manufactures and fills sterile PFS. As demand for biologics continues to surge, the potential for growth in this sector is immense.
2] Biopharmaceuticals Are Inherently Sophisticated
Biopharmaceuticals represent some of the most advanced innovations in modern science. Their large, intricate molecular structures—often visualized through 3D modeling—are not only visually impressive but also functionally superior. These therapies exhibit high specificity and potency, translating into greater efficacy and fewer side effects compared to traditional small-molecule drugs.
This precision is particularly beneficial in treating complex conditions such as cancer and autoimmune diseases, where minimizing collateral damage to healthy cells is critical.
3] Biopharmaceuticals Have High Molecular Weight and Complexity
As Dr. Chad Eichman notes, “Biologics are significantly larger and more complex than their small molecule counterparts.” These macromolecules range from 3,000 to 150,000 Daltons in molecular weight. For example, insulin weighs 5,808 Da, while adalimumab weighs a staggering 144,190 Da. Their size and structural complexity make them susceptible to degradation, posing significant formulation and delivery challenges.
Unlike small molecules, biologics cannot be chemically synthesized. They are produced through recombinant DNA technology using engineered cells and are often derivatives of natural human proteins—making them ideal for targeted therapies. Rather than penetrating cell membranes indiscriminately, biopharmaceuticals bind to specific external receptors, triggering precise cellular responses while sparing healthy cells.
To address delivery challenges, scientists have embraced advanced strategies such as microsphere-based controlled-release systems, protein modification using polyethylene glycol (PEG), and genetic manipulation of therapeutic proteins.
4] Biosimilars Must Mirror Their Reference Products
Biosimilars must match their reference biologics in every critical aspect: quality, stability, specifications, efficacy, safety, pharmacokinetics, pharmacodynamics, toxicity, and immunogenicity. Achieving this level of equivalence is no small feat—especially amid a global shortage of skilled labor in biopharmaceutical manufacturing.
While automation may alleviate some workforce challenges, the need for highly trained professionals remains paramount. Manufacturing personnel must possess expertise in cell and molecular biology, bioprocess engineering, and data analytics powered by artificial intelligence. Operational proficiency in aseptic techniques, cell culture, chromatography, filtration, virus reduction, and single-use systems is also essential.
On the commercial front, sales teams must evolve into knowledge-driven professionals. With the rise of personalized medicine, a patient-centric marketing approach is becoming the new norm. This shift demands not only retraining of sales and marketing personnel but also a transformation in the mindset of trainers themselves.
Continuous learning is critical. Immersive technologies such as virtual reality (VR) and augmented reality (AR) are gaining traction as effective tools for upskilling. To build a sustainable talent pipeline, collaboration among industry, government, and academia is vital—alongside the deployment of diverse, inclusive training programs across all levels.
5] The Cost of Treatment: A Double Burden
For many in Bangladesh and India—especially those in the middle and lower-income brackets—illness brings a double burden: the suffering caused by disease and the financial strain of treatment. Biologics, despite their therapeutic promise, often remain out of reach for the majority.
As Favour Danladi Makurvet aptly observes, “Though much progress in healthcare has been made with biologics, end-user access to these innovative drugs is gradually being ignored or, at least, seldom prioritized.” She emphasizes the need to balance drug efficacy with affordability to prevent the exclusion of economically disadvantaged patients.
A study by the Boston Consulting Group revealed a stark contrast in production costs: approximately $5 per pack for small-molecule drugs versus $60 for biologics—a difference of $55. This disparity stems from the complexity of biologics manufacturing. While a drug like aspirin requires just five ingredients, producing insulin involves genetic engineering of living microorganisms. Moreover, the proprietary nature of biologics manufacturing, often not fully disclosed in patents, makes replication by competitors exceedingly difficult.
Gary Owens puts it plainly: “Some of the therapies range from $10,000 to $40,000 a year, and if patients do not have adequate coverage, they may find that access to them is limited.”
For the economically disadvantaged in countries like Bangladesh and India, this reality often forces them to rely on cheaper small-molecule drugs to merely “manage” conditions that could potentially be cured with more effective—but unaffordable—biologics. Unfortunately, these lower-cost alternatives are frequently less effective.
To address this disparity, the pharmaceutical industries in both countries must work in tandem with their respective governments to establish publicly funded healthcare systems akin to the United Kingdom’s National Health Service (NHS) or Brazil’s Sistema Único de Saúde (SUS). These models provide universal healthcare access at no cost to patients at the point of service, with funding sourced through taxation. Notably, SUS covers nearly 100% of Brazil’s 220 million citizens.
Brazil’s Constitution enshrines this commitment to public health, stating: “Health is a right of all and an obligation of the State, guaranteed by socioeconomic policies which seek to reduce the risk of disease and other grievances, and to ensure universal and equal access to actions and services for its promotion, protection, and recovery.”
Until such a system is implemented, interim solutions can be pursued. The healthcare industry could partner with financial institutions—such as SBI, HDFC, or Grameen Bank—to offer low-interest medical loans with affordable EMI repayment options. Such collaborations could bridge the affordability gap and expand access to life-saving biologic therapies for those who need them most.
Summary: Strategic Imperatives for Biopharmaceutical Advancement in Bangladesh and India
- Capitalize on emerging opportunities: Pharma leaders in Bangladesh and India should proactively develop strategies to harness both short- and long-term opportunities arising from the rapid shift toward biological medical products.
- Explore alternative delivery systems: Formulation and development (F&D) teams must prioritize research into non-parenteral delivery routes, including transdermal, oral, and pulmonary systems. Microsphere-based controlled-release technologies also warrant serious investigation.
- Modernize learning and development: Continuous Pharma Education (CPhE) should be adopted to replace outdated sales training methods. Innovative formats such as phygital platforms, video content, and podcasts can enhance engagement and knowledge retention.
- Champion equitable access: The industry, in collaboration with governments and global health organizations like WHO, should embrace an altruistic approach to ensure access to biopharmaceuticals for underserved populations. All efforts should be guided by the ultimate goal: improved patient outcomes.