The skin whitening industry faces challenges and opportunities in developing effective and safe products for various skin types.
Lifescience
The biosimilars industry has emerged as one of the most transformative segments within the global pharmaceutical landscape, reshaping how biologic therapies are accessed, prescribed, and priced. Biosimilars are biologic medical products that are highly similar to already approved originator biologics, known as reference products. While they are not exact replicas—owing to the complex nature of biologics derived from living cells—biosimilars must demonstrate no clinically meaningful differences in terms of safety, efficacy, and quality. The development and approval of biosimilars have introduced a new era of competition and innovation, offering more affordable therapeutic alternatives for a range of chronic and life-threatening conditions such as cancer, rheumatoid arthritis, diabetes, and autoimmune diseases. As healthcare systems across the world grapple with rising costs and increasing demand for biologic therapies, biosimilars offer a promising solution that can alleviate financial pressures while expanding patient access to advanced treatments. The foundation of the biosimilars industry is built on the patent expiration of blockbuster biologics. As the patents and exclusivity rights of several high-revenue biologics—such as Humira (adalimumab), Herceptin (trastuzumab), and Remicade (infliximab)—expire, a large market opportunity has emerged for biosimilar developers to bring cost-effective alternatives to market. This shift is being supported by the establishment of well-defined regulatory pathways by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. These regulatory frameworks ensure that biosimilars undergo rigorous comparability studies, including analytical, non-clinical, and clinical evaluations, to confirm their similarity to reference products.
According to the research report “Global Biosimilars Market Outlook, 2030” published by Bonafide Research, the global market is projected to reach market size of USD 83.40 Billion by 2030 increasing from USD 30.84 Billion in 2024, growing with 18.42% CAGR by 2025-30. As confidence in biosimilars grows among physicians, pharmacists, and patients, the market has started witnessing increased adoption and substitution, especially in developed regions like North America and Europe. The commercial potential of biosimilars is attracting strong interest from global pharmaceutical giants as well as emerging biotech companies. Strategic collaborations, joint ventures, and in-house manufacturing investments are on the rise as companies seek to optimize development timelines, improve production quality, and ensure regulatory compliance. Moreover, governments and healthcare payers are actively promoting the use of biosimilars through reimbursement incentives, pricing regulations, and awareness campaigns. As a result, biosimilars are beginning to carve out significant market share in key therapeutic areas, particularly oncology and immunology. Monoclonal antibodies and insulin biosimilars, in particular, are seeing strong growth due to their high demand and substantial cost-saving potential.
Monoclonal antibodies (mAbs) represent the largest and fastest-growing segment due to their extensive application in treating a wide array of chronic and life-threatening diseases such as cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel conditions. These biologics are among the most expensive drugs in the world, and the expiration of patents for several high-revenue mAbs—like Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab)—has opened up significant opportunities for biosimilar manufacturers to introduce affordable alternatives. Insulin biosimilars form another critical segment, especially amid the global diabetes epidemic, where the need for cost-effective insulin therapies is growing. With leading insulin products such as Lantus (insulin glargine) and Humalog (insulin lispro) losing exclusivity in various regions, biosimilars are poised to play a vital role in ensuring widespread access to essential diabetic care. Erythropoietin biosimilars, used to treat anemia caused by chronic kidney disease and cancer treatments, have gained substantial traction, particularly in cost-sensitive markets and developing countries. These products not only provide therapeutic equivalence but also help reduce the economic burden on healthcare systems struggling with large dialysis and oncology patient populations. The "Others" category, encompassing a broad mix of recombinant proteins—both glycosylated and non-glycosylated—such as filgrastim, pegfilgrastim, somatropin, and interferons, contributes meaningfully to the market as well. These biosimilars serve multiple indications across hematology, immunology, endocrinology, and infectious diseases. The diversity of this segment highlights the expanding scope of biosimilar development beyond the high-profile therapeutic classes.
The global biosimilars market, when analyzed by therapeutic application, is primarily led by oncology, followed by chronic and autoimmune disorders, blood disorders, growth hormonal deficiency, infectious diseases, and a range of other conditions. Oncology dominates this landscape due to the exceptionally high cost of biologic cancer therapies, such as monoclonal antibodies like trastuzumab, bevacizumab, and rituximab, which are widely used in the treatment of breast cancer, colorectal cancer, lymphomas, and other malignancies. As the global cancer burden continues to rise and healthcare systems seek cost-containment strategies, biosimilars offer a much-needed pathway to make life-saving cancer treatments more accessible and affordable. Chronic and autoimmune disorders form the second largest segment, encompassing conditions like rheumatoid arthritis, psoriasis, and Crohn’s disease, which require long-term biologic therapies such as adalimumab and etanercept. The availability of biosimilars for these conditions is significantly improving patient access to biologic interventions and driving market growth. Blood disorders, including anemia and neutropenia associated with chemotherapy or chronic diseases, are also seeing increased biosimilar adoption, especially with the entry of erythropoietin and filgrastim biosimilars that deliver substantial cost savings in dialysis centers and oncology clinics. Growth hormonal deficiency, though a smaller niche, benefits from biosimilars such as somatropin, offering more affordable options for pediatric and adult hormone replacement therapies. The infectious diseases segment, including interferon-based biosimilars for hepatitis and other viral infections, adds further depth to the market, though its share remains comparatively limited due to the evolving therapeutic landscape.
The global biosimilars market, when segmented by manufacturing strategy, is broadly divided into in-house production and contract research and manufacturing services (CRAMS), each playing a pivotal role in the industry’s growth and operational dynamics. In-house manufacturing remains the dominant approach among leading pharmaceutical and biotechnology companies due to the highly complex and sensitive nature of biosimilar production. Maintaining production internally allows these companies to exercise stringent control over critical parameters such as cell line development, process optimization, quality assurance, and regulatory compliance. This control is essential to ensure consistency, safety, and efficacy, which are paramount given the biologics’ complexity and the rigorous standards set by global regulatory authorities like the FDA and EMA. Furthermore, in-house manufacturing supports the protection of intellectual property, enables faster response times to regulatory requirements, and allows for better cost management over the long term, especially as biosimilar products scale up for commercial distribution. On the other hand, Contract Research and Manufacturing Services (CRAMS) have gained substantial traction as a strategic alternative, particularly among emerging biosimilar developers, smaller biotech firms, and companies seeking to optimize capital expenditure and operational flexibility. By outsourcing research, development, and manufacturing tasks to specialized third-party organizations, these companies can leverage cutting-edge technological expertise, reduce upfront investment in expensive biologics manufacturing infrastructure, and accelerate time-to-market. CRAMS providers often offer end-to-end services ranging from cell line development and process optimization to large-scale commercial manufacturing, thereby lowering entry barriers and enabling faster portfolio expansion. The growing complexity of biologics, coupled with rising global demand, has also spurred collaboration between biosimilar developers and contract manufacturers, fostering innovation and shared risk. While in-house manufacturing dominates due to its strategic advantages, the CRAMS segment is witnessing rapid growth, driven by the increasing number of new biosimilar entrants and the industry's move toward more flexible, cost-efficient production models.
According to the research report “Global Biosimilars Market Outlook, 2030” published by Bonafide Research, the global market is projected to reach market size of USD 83.40 Billion by 2030 increasing from USD 30.84 Billion in 2024, growing with 18.42% CAGR by 2025-30. As confidence in biosimilars grows among physicians, pharmacists, and patients, the market has started witnessing increased adoption and substitution, especially in developed regions like North America and Europe. The commercial potential of biosimilars is attracting strong interest from global pharmaceutical giants as well as emerging biotech companies. Strategic collaborations, joint ventures, and in-house manufacturing investments are on the rise as companies seek to optimize development timelines, improve production quality, and ensure regulatory compliance. Moreover, governments and healthcare payers are actively promoting the use of biosimilars through reimbursement incentives, pricing regulations, and awareness campaigns. As a result, biosimilars are beginning to carve out significant market share in key therapeutic areas, particularly oncology and immunology. Monoclonal antibodies and insulin biosimilars, in particular, are seeing strong growth due to their high demand and substantial cost-saving potential.
Monoclonal antibodies (mAbs) represent the largest and fastest-growing segment due to their extensive application in treating a wide array of chronic and life-threatening diseases such as cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel conditions. These biologics are among the most expensive drugs in the world, and the expiration of patents for several high-revenue mAbs—like Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab)—has opened up significant opportunities for biosimilar manufacturers to introduce affordable alternatives. Insulin biosimilars form another critical segment, especially amid the global diabetes epidemic, where the need for cost-effective insulin therapies is growing. With leading insulin products such as Lantus (insulin glargine) and Humalog (insulin lispro) losing exclusivity in various regions, biosimilars are poised to play a vital role in ensuring widespread access to essential diabetic care. Erythropoietin biosimilars, used to treat anemia caused by chronic kidney disease and cancer treatments, have gained substantial traction, particularly in cost-sensitive markets and developing countries. These products not only provide therapeutic equivalence but also help reduce the economic burden on healthcare systems struggling with large dialysis and oncology patient populations. The "Others" category, encompassing a broad mix of recombinant proteins—both glycosylated and non-glycosylated—such as filgrastim, pegfilgrastim, somatropin, and interferons, contributes meaningfully to the market as well. These biosimilars serve multiple indications across hematology, immunology, endocrinology, and infectious diseases. The diversity of this segment highlights the expanding scope of biosimilar development beyond the high-profile therapeutic classes.
The global biosimilars market, when analyzed by therapeutic application, is primarily led by oncology, followed by chronic and autoimmune disorders, blood disorders, growth hormonal deficiency, infectious diseases, and a range of other conditions. Oncology dominates this landscape due to the exceptionally high cost of biologic cancer therapies, such as monoclonal antibodies like trastuzumab, bevacizumab, and rituximab, which are widely used in the treatment of breast cancer, colorectal cancer, lymphomas, and other malignancies. As the global cancer burden continues to rise and healthcare systems seek cost-containment strategies, biosimilars offer a much-needed pathway to make life-saving cancer treatments more accessible and affordable. Chronic and autoimmune disorders form the second largest segment, encompassing conditions like rheumatoid arthritis, psoriasis, and Crohn’s disease, which require long-term biologic therapies such as adalimumab and etanercept. The availability of biosimilars for these conditions is significantly improving patient access to biologic interventions and driving market growth. Blood disorders, including anemia and neutropenia associated with chemotherapy or chronic diseases, are also seeing increased biosimilar adoption, especially with the entry of erythropoietin and filgrastim biosimilars that deliver substantial cost savings in dialysis centers and oncology clinics. Growth hormonal deficiency, though a smaller niche, benefits from biosimilars such as somatropin, offering more affordable options for pediatric and adult hormone replacement therapies. The infectious diseases segment, including interferon-based biosimilars for hepatitis and other viral infections, adds further depth to the market, though its share remains comparatively limited due to the evolving therapeutic landscape.
The global biosimilars market, when segmented by manufacturing strategy, is broadly divided into in-house production and contract research and manufacturing services (CRAMS), each playing a pivotal role in the industry’s growth and operational dynamics. In-house manufacturing remains the dominant approach among leading pharmaceutical and biotechnology companies due to the highly complex and sensitive nature of biosimilar production. Maintaining production internally allows these companies to exercise stringent control over critical parameters such as cell line development, process optimization, quality assurance, and regulatory compliance. This control is essential to ensure consistency, safety, and efficacy, which are paramount given the biologics’ complexity and the rigorous standards set by global regulatory authorities like the FDA and EMA. Furthermore, in-house manufacturing supports the protection of intellectual property, enables faster response times to regulatory requirements, and allows for better cost management over the long term, especially as biosimilar products scale up for commercial distribution. On the other hand, Contract Research and Manufacturing Services (CRAMS) have gained substantial traction as a strategic alternative, particularly among emerging biosimilar developers, smaller biotech firms, and companies seeking to optimize capital expenditure and operational flexibility. By outsourcing research, development, and manufacturing tasks to specialized third-party organizations, these companies can leverage cutting-edge technological expertise, reduce upfront investment in expensive biologics manufacturing infrastructure, and accelerate time-to-market. CRAMS providers often offer end-to-end services ranging from cell line development and process optimization to large-scale commercial manufacturing, thereby lowering entry barriers and enabling faster portfolio expansion. The growing complexity of biologics, coupled with rising global demand, has also spurred collaboration between biosimilar developers and contract manufacturers, fostering innovation and shared risk. While in-house manufacturing dominates due to its strategic advantages, the CRAMS segment is witnessing rapid growth, driven by the increasing number of new biosimilar entrants and the industry's move toward more flexible, cost-efficient production models.
Related Press Releases
Quick Contacts
Latest Press Release
We are friendly and approachable, give us a call.